e10vk
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-K
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
April 27, 2007
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or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the transition period
from to
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Commission file
number: 0-19806
Cyberonics, Inc.
(Exact name of registrant as
specified in its charter)
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Delaware
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76-0236465
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(State or other jurisdiction
of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Cyberonics
Building
100 Cyberonics Blvd.
Houston, Texas
77058-2072
(Address
of principal executive offices)
(Zip Code)
Registrants telephone number, including area code:
(281) 228-7200
Securities registered pursuant to Section 12(b) of the
Act:
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Title of Each Class of Stock
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Name of Each Exchange on Which Registered
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Common Stock
$0.01 par value per share
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The NASDAQ Stock Market LLC
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Securities registered pursuant to Section 12(g) of the
Act:
None
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes o No þ
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K
is not contained herein, and will not be contained, to the best
of registrants knowledge, in definitive proxy or
information statements incorporated by reference in
Part III of this
Form 10-K
or any amendment to this
Form 10-K. þ
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of accelerated filer and large
accelerated filer in
Rule 12b-2
of the Exchange Act. (Check one):
Large accelerated
filer o Accelerated
filer þ Non-accelerated
filer o
Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2
of the Exchange
Act). Yes o No þ
The aggregate market value of the voting and non-voting common
equity held by non-affiliates of the registrant as of
October 27, 2006, the last business day of the
registrants most recently completed second fiscal quarter,
was based upon the last sales price reported for such date on
the NASDAQ Global Market, approximately $225 million. For
purposes of this disclosure, shares of common stock held by
persons who hold more than 5% of the outstanding shares of
common stock and shares held by officers and directors of the
registrant have been excluded in that such persons may be deemed
to be affiliates.
At June 22, 2007, 26,579,760 shares of common stock
were outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions of the definitive proxy statement of Cyberonics, Inc.
for the 2007 Annual Meeting of Stockholders, which will be filed
within 120 days of April 27, 2007, are incorporated by
reference into Part III of this Annual Report on
Form 10-K.
TABLE OF
CONTENTS
In this Annual Report on
Form 10-K,
Cyberonics, we, us and
our refer to Cyberonics, Inc. and
its consolidated subsidiary (Cyberonics Europe NV).
1
CAUTIONARY
STATEMENT ABOUT FORWARD-LOOKING STATEMENTS
This Annual Report on
Form 10-K
(this
Form 10-K)
contains forward-looking statements. These statements relate to
future events or our future financial performance. We have
attempted to identify forward-looking statements by terminology
such as expect, may, will,
intend, anticipate, believe,
estimate, could, possible,
plan, project, forecast and
similar expressions. Our forward-looking statements generally
relate to our growth strategies, financial results,
reimbursement programs, product acceptance programs, product
development programs, clinical and new indication development
programs, regulatory approval programs, manufacturing processes
and sales and marketing programs. Forward-looking statements
should be carefully considered as involving a variety of risks
and uncertainties, which include, but are not limited to:
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continued market acceptance of our VNS Therapy
Systemtm
(VNS Therapy System) and sales of our product;
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refusal by third-party payers to cover or adequately reimburse
vagus nerve stimulation (VNS) therapy (VNS
Therapy) for treatment-resistant depression
(TRD) or refractory epilepsy;
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intellectual property protection and potential infringement
claims;
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maintaining compliance with government regulations;
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obtaining necessary government approvals for new applications
and retaining governmental approvals for existing applications;
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product liability claims and potential litigation;
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reliance upon single suppliers and manufacturers for certain
components;
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the development, satisfactory completion and results of clinical
trials
and/or
market tests of the VNS Therapy System for the treatment of
epilepsy, TRD or other disorders;
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the accuracy of managements estimates of future sales,
expenses and capital requirements;
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changes in financial estimates and recommendations by securities
analysts;
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changes in market valuations of medical device companies in
general;
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additions or departures of key management personnel;
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possible acceleration of our convertible note debt;
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maintaining adequate insurance at economical rates;
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our ability to retire or refinance our debt at or before its
maturity, which could be affected by conditions in financial
markets or our financial position, and our ability to obtain any
replacement long-term financing on terms as favorable to us, if
at all;
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risks and costs associated with the previously disclosed
inquiries by the Securities and Exchange Commission
(SEC) staff and the United States (U.S.)
Attorney and with any litigation relating thereto or to our
stock option grants, procedures and practices;
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the impact of the restatement of our financial statements and
any other actions that might be taken or required as a result of
such inquiries, including a default under our credit facility or
debt instruments;
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the potential identification of new material weaknesses in our
internal controls over financial reporting; and
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uncertainties associated with stockholder derivative litigation.
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No forward-looking statements can be guaranteed to be accurate
and actual outcomes may vary materially. Although we believe
that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance or achievements. We will not
update any of the forward-looking statements after the date of
this
Form 10-K
to conform these statements to actual results, unless required
by law.
2
PART I
General
Cyberonics, Inc. is a neuromodulation company founded to design,
develop and bring to market medical devices that provide a
unique therapy, VNS Therapy, for the treatment of epilepsy, TRD
and other debilitating neurological or psychiatric diseases and
other disorders. VNS Therapy consists of the electrical
stimulation of the vagus nerve with an implantable device.
Our mission is to improve the lives of people touched by
epilepsy, depression and other chronic disorders that may prove
to be treatable with our VNS Therapy System. To achieve this
mission, our plan is to become the market leader in
neuromodulation by:
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repositioning VNS Therapy in a unique, defensible market
position in epilepsy by rejuvenating growth and accelerating
penetration of the epilepsy market;
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developing broad third-party reimbursement in TRD and
positioning VNS Therapy to satisfy the unmet medical need in
TRD; and
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focusing our financial resources to develop and expand future
revenue growth.
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The U.S. Food and Drug Administration (FDA)
approved the VNS Therapy System in July 1997 for use as an
adjunctive therapy in patients over 12 years of age in
reducing the frequency of partial onset seizures that are
refractory or resistant to antiepileptic drugs. Regulatory
bodies in Canada, Europe, South America, Africa, India,
Australia and certain countries in Eastern Asia have approved
VNS Therapy for the treatment of epilepsy without age
restrictions or seizure-type limitations. In July 2005, FDA also
approved the VNS Therapy System for the adjunctive long-term
treatment of chronic or recurrent depression for patients
18 years of age or older who are experiencing a major
depressive episode and have not had an adequate response to four
or more adequate anti-depressant treatments. Regulatory bodies
in the European Union countries and Canada approved the VNS
Therapy System for the treatment of chronic or recurrent
depression in patients who are in a treatment-resistant or in a
treatment-intolerant depressive episode without age restrictions.
Our ability to expand successfully the commercialization of the
VNS Therapy System depends on obtaining and maintaining
favorable coverage, coding and reimbursement for the implant
procedure and
follow-up
care. Currently, we have broad coverage, coding and
reimbursement for VNS Therapy for the treatment of epilepsy, but
not for TRD. In May 2007, the Centers for Medicare &
Medicaid Services (formerly the Healthcare Financing
Administration) (CMS) issued a national non-coverage
determination for TRD. CMSs national non-coverage
determination means that Medicare coverage is not available for
VNS Therapy to treat TRD. Prior to the non-coverage
determination, some patients were able to obtain coverage on a
case-by-case
basis through their local Medicare contractor or Fiscal
Intermediary. Since the national non-coverage determination is
binding on all local Medicare contractors, patients will no
longer be able to obtain Medicare coverage on a
case-by-case
basis. As a consequence, CMSs non-coverage determination
will result in fewer sales of the VNS Therapy System for TRD.
The determination may also have an adverse impact on coverage
decisions by other payers. We will continue to pursue favorable
coverage decisions to expand reimbursement to include VNS
Therapy for TRD. We will also continue to assist some patients
seeking TRD coverage on a
case-by-case
basis; however, our long-term growth in TRD is dependent on our
progress in obtaining favorable regional and national coverage
policies from third-party payers in the use of VNS Therapy to
treat TRD.
Our clinical development program has included pilot and pivotal
studies using VNS Therapy (1) as an adjunctive therapy for
reducing the frequency of seizures in patients over
12 years of age with partial onset seizures that are
refractory to antiepileptic drugs and (2) as an adjunctive
treatment of patients 18 years of age and older with
chronic or recurrent TRD in a major depressive episode. We have
also conducted or provided support for small pilot studies for
the treatment of Alzheimers Disease, anxiety disorders,
chronic headache, bulimia and other disorders. These studies
have been conducted to determine the safety and effectiveness of
VNS Therapy and to determine new indications that might be
considered for pivotal studies.
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Since inception, we have incurred substantial expenses,
primarily for research and development activities that include
product and process development and clinical trials and related
regulatory activities, sales and marketing activities,
manufacturing
start-up
costs and systems infrastructure. We made significant
investments in connection with sales and marketing activities in
the U.S. in fiscal 2006 and clinical research costs in
fiscal 2006 and 2007 associated most notably with depression;
however, we began scaling back our TRD sales and marketing
spending in fiscal year 2007 after it became apparent that
difficulties in obtaining reimbursement coverage for TRD are
limiting TRD sales. Since our inception through April 27,
2007, we incurred an accumulated net deficit of approximately
$259 million. For more information, see Item 7.
Managements Discussion and Analysis of Financial Condition
and Results of Operations in this
Form 10-K.
VNS
Therapy Epilepsy Indication Overview
Epilepsy is a disorder of the brain characterized by recurrent
seizures that are categorized as either partial or generalized
at onset. Patients who continue to have unsatisfactory seizure
control or intolerable side effects after treatment with
appropriate antiepileptic therapies for a reasonable period of
time are said to suffer from refractory epilepsy. For reasons
that are not clear, partial onset seizures are generally more
refractory to existing therapies than generalized seizures.
Epilepsy is the second most prevalent neurological disorder. It
is estimated that approximately 2.8 million individuals in
the U.S. have epilepsy, with approximately 150,000 new
cases diagnosed each year, and that there are in excess of
3.3 million individuals with epilepsy in Western Europe
with over 210,000 new cases diagnosed each year. In addition, it
is estimated that approximately 50% of patients with epilepsy
suffer from partial onset seizures and that over 30% of these
patients continue to suffer from seizures in spite of treatment
with antiepileptic drugs. The medical, psychological,
sociological and financial implications of refractory epilepsy
can be profound for individuals and their families. Medical
consequences may include brain damage from recurrent seizures,
injuries and accidents associated with the loss or impairment of
consciousness and death. Personal implications of epilepsy may
include suffering the side effects of antiepileptic drugs,
strained personal and family relations, and the inability to
obtain and hold meaningful employment or a drivers
license. There are two standard types of treatment available to
persons with epilepsy: drug therapy and surgery. Antiepileptic
drugs serve as a first-line treatment and are prescribed for
virtually all individuals being treated for epilepsy. When drug
therapy is not effective, surgical resection may be an option
for some patients. There are a number of other treatments under
development for the treatment of epilepsy, including direct deep
brain stimulation (DBS) and the Responsive
Neurostimulator System
(RNStm),
but these treatments are not currently approved for commercial
distribution.
VNS
Therapy for Epilepsy
The VNS Therapy System is indicated as an adjunctive treatment
for patients who are refractory to antiepileptic drugs. In the
two randomized, parallel, double-blind, active-controlled
studies that led to FDA approval of the epilepsy indication, the
patients who received adjunctive VNS Therapy had a mean seizure
reduction of approximately 24% and 28% during the three-month
acute phase of the studies. Additionally, many patients,
including some who reported no change or an increase in seizure
frequency, also reported a reduction in seizure severity.
Long-term
follow-up
data, derived from an uncontrolled protocol, on the
440 patients in five studies showed that efficacy was
maintained and, for many patients, improved over time during
treatment with the VNS Therapy System. Analysis of the pooled
data showed that the median percent seizure reduction was 44%
after 24 months of treatment and was sustained at that
level at 36 months. In the treatment of refractory
epilepsy, the side effects associated with the VNS Therapy
System are generally mild, localized and related to the period
of time in which stimulation is activated. The side effects
include voice alteration, neck discomfort, increased cough,
shortness of breath and difficulty swallowing. The VNS Therapy
System has not typically been associated with the debilitating
central nervous system side effects that frequently accompany
antiepileptic drugs. Additionally, side effects typically
decrease over time. To date, over 42,000 patients have
accumulated in excess of 175,000 patient years of treatment
experience with the VNS Therapy System.
VNS
Therapy Depression Indication Overview
Major depressive disorder is one of the most prevalent and
serious illnesses in the U.S. It affects nearly
19 million Americans 18 years of age or older every
year. Recently published data indicate that approximately one-
4
third of patients with major depressive disorder will not
achieve a remission of their depressive symptoms after four
acute treatment steps using standard therapies. Depression is
the second leading cause of disability for the general
population and is the leading cause of disability for American
women. Depression interferes with a persons ability to
function, feel pleasure or maintain interest in everyday living.
It is associated with increased mortality due to suicide and
co-morbid general medical conditions. Total annual costs for
depression in the U.S. are estimated to exceed
$80 billion, including $30 billion in annual direct
treatment costs. Standard treatment modalities for depression
include antidepressant drugs, psychotherapy and
electroconvulsive therapy (ECT). First-line therapy
often consists of an antidepressant drug. For patients who do
not respond adequately to initial antidepressant treatment,
physicians will often switch to a different drug or use two
drugs in combination. Physicians usually reserve ECT for
patients who have not had an adequate response to multiple
trials of antidepressant drugs or when they determine a rapid
response to treatment is desirable. There are a number of other
treatments under development for the treatment of TRD, including
repetitive transcranial magnetic stimulation (rTMS)
and DBS, but these treatments are not currently approved for
commercial distribution.
VNS
Therapy for Depression
The VNS Therapy System is indicated as an adjunctive treatment
for patients who have chronic or recurrent treatment-resistant
depression. In Canada and the European Union, the indication for
use also encompasses patients who do not tolerate standard
treatment. FDA approved the TRD indication for the VNS Therapy
System based on a long-term uncontrolled trial (the
pivotal trial) of adjunctive VNS Therapy that showed
significant, sustained improvement of depressive symptoms over
one and two years, and based on a comparison of the
12-month
outcomes in the pivotal trial with the
12-month
outcomes among a non-randomized, but well-matched, group of
patients who received only standard treatments for their TRD.
After one year of adjunctive VNS Therapy in the pivotal trial,
response to treatment ranged from 22% to 37% (depending on the
outcome measure). Moreover, 60% of the patients who responded
after three months of adjunctive VNS Therapy were still
responders at one year and 70% of the three-month responders
were responders at the two-year evaluation. For those patients
who were responders at the one-year evaluation, 69% were still
responders at the two-year evaluation. VNS Therapy was generally
well tolerated in the depression clinical studies. The most
commonly reported adverse events were similar to those observed
in patients being treated with VNS Therapy for epilepsy and
included voice alteration, neck discomfort, increased cough,
shortness of breath and difficulty swallowing. These side
effects tended to occur during stimulation, tended to be
reported as mild or moderate and tended to be reported less
frequently over time.
FDA
Post-Approval Study Commitments and Other Clinical Research
Studies
As a condition of approval for the VNS Therapy System TRD
indication, the FDA is requiring us to conduct two post-approval
studies. One is a 460-patient randomized, controlled study that
compares outcomes for different levels of vagus nerve
stimulation. The other is a patient registry that will include
1,000 patients treated with adjunctive VNS Therapy. Both
studies are actively enrolling patients. To maintain timely
progress in the 460-patient dosing study, we announced a program
in early 2007 whereby we are donating the VNS Therapy Systems
and paying for the surgical implantation of the devices (at a
negotiated rate) for patients being enrolled in the study. We
are also sponsoring post-marketing studies in refractory
epilepsy, and we are supporting a variety of
mechanism-of-actions studies to improve the fundamental
understanding of how VNS Therapy works. We expect to continue to
invest in similar research activities as appropriate.
VNS
Therapy System
VNS Therapy is the first treatment approved by FDA for both
medically refractory epilepsy and TRD. The safety profiles for
VNS Therapy and the VNS Therapy System, including the implant
procedure, are well established in clinical studies of
refractory epilepsy and TRD and in commercial use in over
45,000 patients with over 180,000 total patient years of
experience.
The VNS Therapy System is a proprietary, integrated system
consisting of an implantable generator that delivers an
electrical signal to an implantable lead attached to the left
vagus nerve. The vagus nerve is the longest of the cranial
nerves, extending from the brain stem through the neck to organs
in the chest and abdomen. The left vagus nerve has been shown to
have influence over numerous areas of the brain. Preclinical
studies and mechanism-
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of-action research suggest that intermittent stimulation of the
left vagus nerve in the neck modulates a number of structures
and alters blood flow bilaterally in several areas of the brain.
These studies have also shown that stimulation of the left
cervical vagus nerve is effective in blocking seizures and
results in persistent or carryover antiepileptic effects, which
increase with chronic intermittent stimulation. The
mechanism-of-action research associated with our TRD studies has
shown stimulation of the left vagus nerve results in modulation
of areas of the brain thought to be important in the regulation
of mood.
The VNS Therapy System consists of a pulse generator, a bipolar
lead, a programming wand and software and a tunneling tool. The
pulse generator and bipolar lead are surgically implanted in a
procedure that takes from 30 to 90 minutes, during
which time the patient is under general, regional or local
anesthesia. The pulse generator is surgically implanted in a
subcutaneous pocket in the upper left chest. The bipolar lead is
connected to the pulse generator and attached to the vagus nerve
in the lower left side of the patients neck. The patient
is generally admitted to the hospital on the day of surgery and
discharged the same or following day.
The VNS Therapy System delivers VNS on a chronic, intermittent
basis. The initial standard stimulation parameters that we
typically recommend are a 30-second period of stimulation, which
we refer to as ON time, followed by a five-minute period without
stimulation, which we refer to as OFF time. To optimize patient
treatment, the current pulse width, amplitude and frequency and
stimulation ON and OFF intervals of the pulse generator can be
programmed non-invasively and adjusted by the treating physician
with a personal or handheld computer using our programming wand
and software. In addition, the patient can use a small, handheld
magnet provided with the pulse generator to manually activate or
deactivate stimulation. On-demand therapy can be useful for
those epilepsy patients who sense an oncoming seizure and has
been reported by a number of patients to abort or reduce the
severity or duration of seizures. The magnet can also be used to
provide patient control of stimulation side effects by allowing
the patient to deactivate stimulation temporarily.
Pulse Generator. The pulse generator is an
implantable, programmable signal generator designed to be
coupled with the bipolar lead to deliver electrical signals to
the vagus nerve. The pulse generator is a battery powered
device. Upon depletion of the battery, the pulse generator is
removed and a new generator is implanted in a short, outpatient
procedure using local anesthesia.
Bipolar Lead. The bipolar lead conveys the
electrical signal from the pulse generator to the vagus nerve.
The lead incorporates electrodes, which are self-sizing and
flexible, minimizing mechanical trauma to the nerve and allowing
body fluid interchange within the nerve structure. The
leads two electrodes and anchor tether wrap around the
vagus nerve and the connector end is tunneled subcutaneously to
the chest where it attaches to the pulse generator. The leads
are available in two sizes of inner spiral diameter to ensure
optimal electrode placement on different size nerves.
Programming Wand and Software. Our programming
wand and proprietary software are used to interrogate the device
and to transmit programming information from a personal or
handheld computer to the pulse generator via electromagnetic
signals. Programming capabilities include modification of the
pulse generators programmable parameters (pulse width,
amplitude, frequency and ON and OFF intervals) and storage and
retrieval of telemetry data.
Tunneling Tool. The tunneling tool is a single
use, sterile, disposable surgical tool designed to be used
during surgical placement of the bipolar lead. The tool is used
for subcutaneous tunneling of the lead assembly between the
nerve site in the neck and the pulse generator site in the chest.
Accessory Pack. The Accessory Pack includes
two resistor assemblies used to test the function of the device
prior to implantation, the bipolar lead tie-downs and one hex
screwdriver.
The implant procedure, including the cost of the device
(approximately $17,000 for a Model 102 VNS Therapy System),
hospital charges and physician fees, generally costs between
$23,000 and $38,000.
Manufacturing
and Sources of Supply
Our manufacturing operations are required to comply with
FDAs Quality System Regulation (QSR), which
incorporates the agencys former Good Manufacturing
Practices regulations. The QSR is promulgated under
6
section 520 of the Food, Drug and Cosmetic Act. It requires
that manufacturers have a quality system for the design and
production of medical devices. The regulation also requires that:
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various specifications and controls be established for devices;
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devices be designed under a quality system to meet these
specifications;
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devices be manufactured under a quality system;
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finished devices meet these specifications;
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devices be correctly installed, checked and serviced;
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quality data be analyzed to identify and correct quality
problems; and
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complaints be processed.
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Thus, the QSR helps assure that medical devices are safe and
effective for their intended use. In addition, certain
international markets have regulatory, quality assurance and
manufacturing requirements that may be more or less rigorous
than those in the U.S. Specifically, we have authorized
KEMA Registered Quality, Inc. (KEMA) to ensure that
we are in compliance with the requirements of International
Standards Organization 13485:2003, Medical
devices Quality management systems
Requirements for regulatory purposes and the European
Council Directive 90/385/CEE relating to Active Implantable
Medical Devices (AIMD). KEMA is a Notified Body
within the scope and framework of the European Council Directive
90/385/CEE relating to AIMD. We are audited by KEMA on an annual
basis for such compliance.
The Model 102 and 102R VNS Therapy Pulse Generators, the only
pulse generators we currently offer in the U.S., are similar in
design and manufacture to a cardiac pacemaker. The Model 102 and
102R generators are comprised of one printed circuit board and a
battery hermetically sealed in a titanium case. Standard
components are assembled on printed circuit boards using
surface-mount technology. The assembled circuit boards are then
tested and mounted with the battery in the titanium case, which
is laser welded. A header to which the bipolar lead connects is
added and each unit is subject to final release testing prior to
being sterilized.
Marketing
and Sales
United
States
We market and sell our products for refractory epilepsy and
treatment-resistant depression through a direct sales force in
the U.S. Our sales and marketing plan focuses on creating
awareness and demand for the VNS Therapy System among
epileptologists and neurologists who treat refractory epilepsy,
psychiatrists who treat TRD, implanting surgeons, nurses,
third-party payers, hospitals, patients and their families.
To reach each of these groups, we are using a specialized sales
force consisting of:
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sales personnel with medical device, pharmaceutical, or nursing
experience;
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reimbursement specialists experienced in obtaining third-party
coverage and payments for new medical technologies;
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account executives and field clinical engineers experienced in
obtaining, training and maintaining adequate surgical capacity
for implanting the VNS Therapy System;
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marketing teams experienced in educational and promotional
marketing programs; and
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case managers experienced in patient education, insurance
verification and authorization issues.
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In addition to our direct selling activities, we facilitate and
support peer-to-peer interactions such as symposia, conference
presentations, journal articles and patient support groups to
provide experienced clinicians and patients the opportunity to
share their perspectives on the VNS Therapy System with others.
In July 2005, FDA approved VNS Therapy as a long-term adjunctive
treatment for patients 18 years of age or older with
chronic or recurrent treatment-resistant depression in a major
depressive episode and who have not
7
responded to at least four adequate antidepressant treatments.
Throughout fiscal 2006, we focused the efforts of our
organization on the U.S. launch in TRD, and we structured
our sales and case management organization to support
anticipated sales demand in both the epilepsy and depression
markets. Although patient and physician demand was strong, our
actual sales did not increase to the extent anticipated due to a
particularly challenging reimbursement environment. In fiscal
2007, we did not experience and do not anticipate any meaningful
sales growth in TRD until such time as we obtain favorable
coverage policies for VNS Therapy in TRD.
International
We market and sell our products in 71 countries through a
combination of a direct sales force in certain European
countries and distributors elsewhere. The VNS Therapy System is
currently sold by a direct sales force in Austria, Belgium,
Denmark, France, Germany, Italy, Luxemburg, The Netherlands,
Norway, Spain, Sweden, Switzerland and the United Kingdom. We
have distribution agreements with independent distributors
covering a number of other countries, principally in Europe,
Asia, South Africa, Australia, Mexico, South America and Canada.
The distribution agreements generally grant the distributor
exclusive rights for the particular territory for a period of
three years. The distributor generally assumes responsibility
for obtaining regulatory and reimbursement approvals for such
territory and agrees to certain minimum marketing and sales
expenditures and purchase commitments. Under the terms of the
distributor agreements, no product return rights are granted to
the distributor and no additional product performance issues
exist for us after shipment to the distributor. Pricing is
generally fixed under the terms of the distribution agreements,
but may change at our election, with as little as 30 days
prior notice under most agreements. Sales incentives, if
provided, are recorded as a reduction of net sales in the same
period revenue is recognized.
Third-Party
Reimbursement
Our ability to expand successfully the commercialization of the
VNS Therapy System depends on obtaining and maintaining
favorable coding, reimbursement and coverage for the implant
procedure and
follow-up
care. In fiscal 2007, the coding that describes VNS related
procedures was unchanged and continues to adequately and
appropriately describe services of providers. Reimbursement or
payment rates were largely unchanged over the past year, with a
slight decline in the Medicare allowable amount. In epilepsy,
the coverage environment was largely unchanged. In TRD, coverage
for VNS Therapy was difficult to obtain throughout the year.
In deciding to cover a new therapy, payers base their initial
coverage decisions on several factors including, but not limited
to:
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the status of FDAs review of the product;
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CMSs national coverage determinations, as well as local
coverage determinations by Medicare contractors;
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BlueCross BlueShield Technology Evaluation Center
recommendations;
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the products safety and efficacy;
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the number of studies performed and peer-reviewed articles
published with respect to the product; and
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how the product and therapy compare to alternative therapies.
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Our Reimbursement Department is available to assist hospitals
and physicians with reimbursement questions. Regional
Reimbursement Managers and Case Managers are available through
our Reimbursement Hotline, to help with coverage, coding and
reimbursement issues on a
case-by-case
basis and/or
policy level. In epilepsy, virtually all technology assessments
are favorable and most payers have coverage policies. In TRD,
all the technology assessments are negative, and there are few
plans with favorable coverage policies.
Medicare
Effective July 1, 1999, CMS issued National Coverage Policy
Transmittal 114 (CIM
Section 60-22).
Under the policy, VNS Therapy is covered for patients with
medically refractory partial onset seizures for whom surgery is
not recommended or for whom surgery has failed. In May 2007, CMS
issued its Coverage Decision Memorandum for
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Vagus Nerve Stimulation for Treatment-Resistant Depression,
concluding that Medicare coverage is not available for VNS
Therapy as a treatment for TRD. For additional information, see
General above.
Medicaid
Medicaid programs generally cover hospital inpatient and
outpatient services that are medically necessary and
appropriate. In epilepsy, most state Medicaid agencies have
developed their own coverage policy for VNS Therapy or have
adopted the National CMS coverage policy. In TRD, a small number
of Medicaid programs provide coverage for VNS Therapy on a
case-by-case
basis, but most are still evaluating a coverage policy or have
issued a non-coverage policy. CMSs non-coverage
determination on Medicare coverage for the treatment of TRD will
make gaining coverage with Medicaid programs more difficult.
Medicaid reimbursement mechanisms vary state by state. Medicaid
policy and payment methodologies change on a regular basis, so
vigilant and ongoing work is necessary to ensure continued
access and acceptable reimbursement for patients covered by
Medicaid programs. Reimbursement codes are already in place to
pay for the cost of the device implantation and the surgeon
implant fees, both of which are identical in the treatment of
refractory epilepsy and TRD. Existing prescriber codes for
device interrogation and dosage adjustment currently cover
medical professionals in the epilepsy medical community.
Private
Payers
Private payers generally cover hospital inpatient and outpatient
services that are considered to be medically necessary.
Currently, private payers (commercial, managed care and other
third-party payers) account for 50% to 60% of patients implanted
with the VNS Therapy System. As with other payers, many private
payers have developed clinical guidelines for coverage or
adopted the national CMS coverage policy for use of VNS Therapy
in epilepsy. As of the end of fiscal year 2007, coverage for VNS
Therapy for TRD is very limited. Only a few plans have issued
favorable coverage policies for VNS Therapy in TRD, and less
than 100 are providing coverage on a
case-by-case
basis. Most plans have either no policy or a non-coverage
policy. Following the May 2007 CMS national non-coverage
determination for TRD, we may have difficulty expanding or even
maintaining coverage among private payers.
While we believe the clinical evidence supporting VNS Therapy
for TRD should be adequate to convince private payers to provide
coverage over the long term, coverage approval is subject to
each payers assessment program. We are actively working
with private payers to gain approval of coverage for VNS Therapy
in TRD, but we cannot give any assurances that private payers
will expand or maintain coverage for VNS Therapy in TRD.
Payment rates vary among third-party plans based on contracts
and payment methods of specific providers. Audits of providers
have revealed that the average reimbursement rates for VNS
Therapy-related procedures are generally acceptable to the
providers.
Although the VNS Therapy System has been approved for commercial
distribution in European Union countries and Canada for the
treatment of chronic or recurrent depression, we do not
anticipate significant sales volumes until reimbursement
approvals are achieved in these countries. We are continuing to
pursue appropriate reimbursement approvals in these countries.
Product
Development
Our product development efforts are directed toward improving
the VNS Therapy System and developing new products that provide
additional features and functionality while improving cost
effectiveness.
In May 2005, we received approval from KEMA Medical, our
European Regulatory Notified body, to market our
DEMIPULSEtm
and DEMIPULSE
DUOtm
VNS Therapy System generators in the member countries of the
European Union for the approved epilepsy and depression
indications for use. The
DEMIPULSEtm
generator is the next generation single-connector VNS Therapy
System generator for use in new patients, and the DEMIPULSE
DUOtm
generator is the next generation dual-connector VNS Therapy
System generator for use in patients who have elected
replacement of their previous dual-connector generator at the
end of its battery life. Both the
DEMIPULSEtm
and DEMIPULSE
DUOtm
generators are capable of delivering greater functionality and
are smaller and
9
lighter than the previous models. We submitted the Premarket
Approval Application Supplement (PMA-S) for both the
DEMIPULSEtm
and the DEMIPULSE
DUOtm
generators to FDA in January 2007 and initiated limited release
in Europe in May 2007. We anticipate FDA approval during the
latter half of 2007 and commercial release prior to the end of
2007.
The VNS Therapy
PERENNIAtm
Lead was approved by FDA in May 2006 and by KEMA Medical in
August 2006. The lead is currently in a limited commercial
release. Functionally, the new lead is the same as its reliable
predecessor, the Model 302 Lead, but it incorporates a new
design and is constructed from more durable components.
Mechanical tests conducted in a laboratory setting have shown
the
PERENNIAtm
Lead to be more robust than its predecessor.
We received approval for Model 250, Version 7.1 software from
KEMA in May 2006 and from FDA in June 2006.
We are conducting ongoing product development programs to
enhance the VNS Therapy System pulse generator, the bipolar lead
and programming software. We will be required to file for the
appropriate U.S. and international regulatory approvals,
and some projects may require clinical trials, in connection
with the introduction of new and improved products.
Competition
We believe that in the fields of refractory epilepsy and TRD,
existing and future drug therapies are and will continue to be
the primary competition for the VNS Therapy System. We may also
face competition from other medical device companies for the
treatment of partial seizures and TRD. Medtronic, Inc., for
example, continues to conduct clinical studies involving an
implantable signal generator used with an invasive deep brain
probe for the treatment of neurological disorders including
depression, and has received FDA approval for the device for the
treatment of essential tremor and Parkinsons Disease. We
could also face competition from other large medical device and
pharmaceutical companies that have the technology, experience
and capital resources to develop alternative devices for the
treatment of epilepsy. Many of our competitors have
substantially greater financial, manufacturing, marketing and
technical resources than we have. In addition, the healthcare
industry is characterized by extensive research efforts and
rapid technological progress. Our competitors may develop
technologies and obtain regulatory approval for products that
are more effective in treating epilepsy or TRD than our current
or future products. In addition, advancements in surgical
techniques could make surgery a more attractive therapy for
epilepsy. The development by others of new treatment methods
with novel antiepileptic and depression drugs, medical devices
or surgical techniques for epilepsy could render the VNS Therapy
System noncompetitive or obsolete.
We believe that the primary competitive factors within the
epilepsy and TRD treatment markets are the efficacy and safety
of the treatment relative to alternative therapies, physician
and patient acceptance of the product and procedure,
availability of third-party reimbursement for the treatment of
epilepsy, quality of life improvements and product reliability.
We also believe that the VNS Therapy System compares favorably
with competitive products as to these factors.
While no other therapies have been specifically approved for
TRD, a well-established array of antidepressant drugs, typically
combined with other antidepressants of complementary action or
with atypical antipsychotic drugs
and/or mood
stabilizers, are frequently used for refractory patients. For
severe patients or those at acute risk for suicide, ECT is often
used. These treatment modalities may pose a competitive threat
in the near term, to the extent that they may delay a decision
to offer VNS Therapy to TRD patients. As other forms of
neurostimulation are investigated and developed for TRD, these
may emerge as competition for VNS patient candidates. Less
invasive procedures like rTMS and MST (magnetic seizure therapy)
may compete for a similar place in the TRD treatment algorithm.
More invasive technology like DBS is also being investigated for
TRD. Finally, ECT is undergoing refinements in technique to
increase specificity and reduce the cognitive deficit side
effects; if successful, the tolerability and patient acceptance
of ECT could improve in the future. These neurostimulation
techniques could prove to be more effective, more predictable,
or have a more rapid onset of antidepressant activity than
VNS Therapy.
10
We face similar competition with respect to the development and
sale of VNS Therapy as a treatment for the other disorders we
are evaluating, including, but not limited to Alzheimers
Disease, anxiety disorders and bulimia.
Patents,
Licenses and Proprietary Rights
Proprietary protection for our products is important to our
business. We maintain a policy of seeking method and device
patents on our inventions, acquiring licenses under selected
patents of third parties, and entering into invention and
confidentiality agreements with our employees and consultants
with respect to technology that we consider important to our
business. We also rely on trade secrets, unpatented know-how and
continuing technological innovation to develop and maintain our
competitive position.
We have an exclusive license agreement with Jacob
Zabara, Ph.D., a co-founder and consultant to us, pursuant
to which we currently maintain exclusive licenses on five
U.S. method patents (and such international counterparts as
have been or may be issued) covering the VNS Therapy System for
vagus nerve and other cranial nerve stimulation for the control
of movement disorders (including epilepsy), neuropsychiatric
disorders (including depression) and other disorders. We believe
that these patents give us an advantage by limiting competition
in vagus nerve stimulation to treat refractory epilepsy and TRD.
The license agreement will give us coverage until expiration of
the licensed patents in July 2011 for movement disorders and May
2011 for neuropsychiatric disorders. Pursuant to the license
agreement, we are obligated to pay Dr. Zabara a royalty
equal to 3.0% of net sales through July 2011, after which
royalties will be reduced to 1.0% for the duration of any
remaining patents covering licensed products.
We have an agreement with Mitchell S. Roslin, M.D. on two
U.S. patents that we co-own with Dr. Roslin for
bilateral VNS for the treatment of obesity. Pursuant to the
agreement, we are obligated to pay Dr. Roslin a royalty
rate of 1.0% of the first $10 million of net obesity sales
covered by one of the patents and 0.5% of net obesity sales
thereafter. Pursuant to the agreement, we paid Dr. Roslin
advances on royalties in the amount of $25,000 per year for five
years beginning January 1, 2000, and we will be obligated
to pay, upon the completion of certain milestones, up to
$325,000 in additional advances on royalties.
Including the patents referred to in the agreements described
above, as of April 27, 2007, we owned or licensed 34
U.S. patents and 75 pending U.S. patent applications,
covering various aspects of the VNS Therapy System, potential
improvements to the VNS Therapy System and methods of treatment
for a variety of disorders through electrical stimulation of the
vagus nerve or other cranial nerves. In addition to movement
disorders, other method patents cover the fields of eating
disorders (including obesity and bulimia), endocrine disorders,
migraine headaches, dementia, neuropsychiatric disorders
(including depression and anxiety disorders), motility
disorders, sleep disorders, coma, chronic pain, cardiac
disorders and hypertension. We have filed counterparts of
certain of our key U.S. patent applications in certain key
international jurisdictions and currently own or license 31
patents issued by the European Patent Office or other
international authorities and 48 patent applications pending in
the European Patent Office or before other international
authorities.
We cannot assure you that patents will issue from any of the
pending applications or if patents issue, that they will be of
sufficient scope or strength to provide meaningful protection
for our technology. Notwithstanding the scope of the patent
protection available to us, a competitor could develop treatment
methods or devices that are not covered by our patents.
We believe that the patents we own and license provide us with
protection in the U.S. in the field of cranial nerve
stimulation, including VNS for the control of epilepsy and other
movement disorders, (including Parkinsons Disease and
essential tremor), neuropsychiatric disorders (including
clinical depression), eating disorders, anxiety disorders,
obesity, dementia (including Alzheimers Disease) and
additional indications for which method patents have been
issued. The protection provided by our international patents is
not as strong as that provided by our U.S. patents due to
differences in patent laws. In particular, European and other
countries prohibit patents covering methods for treatment of the
human body by surgery or therapy.
There has been substantial litigation regarding patent and other
intellectual property rights in the medical device industry. In
the future, we may need to engage in litigation to enforce
patents issued or licensed to us, to protect our trade secrets
or know-how or to defend us against claims of infringement of
the rights of others and to determine the scope and validity of
the proprietary rights of others. Litigation could be costly and
could divert our
11
attention from other functions and responsibilities. Adverse
determinations in litigation could subject us to significant
liabilities to third parties, could require us to seek licenses
from third parties and could prevent us from manufacturing,
selling or using the VNS Therapy System, any of which could
severely harm our business. We are not currently a party to any
patent litigation or other litigation regarding proprietary
rights and are not aware of any challenge to our patents or
proprietary rights.
Product
Liability and Insurance
The manufacture and sale of our products subjects us to the risk
of product liability claims. We are currently named as a
defendant in two product liability lawsuits alleging negligence,
strict liability and breach of warranty. We likely will be named
in the future as a defendant in product liability lawsuits
alleging claims of negligence, strict liability, breach of
warranty, negligent misrepresentation, failure to warn, wrongful
death and other claims. We do not believe that the VNS Therapy
System is defective or otherwise has caused or will cause injury
to patients who are or may be involved in these lawsuits;
however, the outcome of litigation is inherently unpredictable
and could result in an adverse judgment and an award of
substantial and material damages against us. We establish a
liability reserve on our balance sheet in an amount less than
our self-insured retention for all matters that we believe is
probable of payment as a result of a judgment or settlement.
Although we maintain product liability insurance in amounts that
we believe to be reasonable, coverage limits may prove not to be
adequate in some circumstances. Product liability insurance is
expensive and in the future may be available only at
significantly higher premiums or not be available on acceptable
terms, if at all. A successful claim brought against us in
excess of our insurance coverage could severely harm our
business and consolidated results of operations and financial
position.
We endeavor to maintain executive and organization liability
insurance in a form and with aggregate coverage limits that we
believe are adequate for our business purposes. On May 31,
2007, we renewed our executive and organization liability
policies through May 31, 2008.
Employees
As of June 1, 2007, we had approximately 547 full-time
employees. We believe that the success of our business depends,
in part, on our ability to attract and retain qualified
personnel. We believe our relationship with our employees is
good. However, we cannot assure you that we will be successful
in hiring or retaining qualified personnel. The loss of key
personnel, or the inability to hire or retain qualified
personnel, could significantly harm our business.
Financial
Information About Segment and Geographical Areas
Our financial information, including our revenues and long-lived
assets by geographical area, is included in the Consolidated
Financial Statements and the related Notes beginning on
page F-1.
Internet
Website and Availability of Public Filings with the
SEC
Our internet address is www.cyberonics.com. We make
available free of charge on or through our website our annual
reports on
Form 10-K,
quarterly reports on
Form 10-Q,
current reports on
Form 8-K,
and amendments to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended (Exchange Act), as soon as
reasonably practicable after electronically filing such material
with, or furnishing it to the SEC. Also available on our website
are our corporate governance guidelines, corporate code of
business conduct and ethics, financial code of ethics and
charters for each standing committee of our Board of Directors.
Materials we file with the SEC may be read and copied at the
SECs Public Reference Room at 100 F Street, NE,
Washington, D.C. 20549. Information on the operation of the
Public Reference Room may be obtained by calling the SEC at
1-800-SEC-0330.
The SEC also maintains an internet website at www.sec.gov
that contains reports, proxy and information statements, and
other information regarding our company that we file
electronically with the SEC.
We may from time to time provide important disclosures to
investors by posting them in the investor relations section of
our website, as allowed by SEC rules. Information on our website
is not incorporated into this
Form 10-K.
12
Our
common stock price constantly changes.
Our common stock is traded on the NASDAQ Global Market under the
ticker symbol CYBX. The price of stock on that
trading market fluctuates, and we expect that the market price
of our common stock will continue to fluctuate. For example,
during the fiscal year ended April 27, 2007, our stock
traded from a high of $27.55 to a low of $14.70 per share. Our
stock price may be affected by a number of factors, some of
which are beyond our control, including, without limitation:
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changes in the general conditions of the economy;
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regulatory activities and announcements;
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federal and state enforcement initiatives related to medical
device companies;
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changes in market valuations of medical device companies in
general;
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national and regional coverage determinations by third-party
payers, including private insurance companies, Medicare, state
Medicaid programs and others;
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results of studies regarding the safety and efficacy of drugs or
devices that are potential competitors to our VNS Therapy System;
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results of studies regarding the safety and efficacy of our VNS
Therapy treatment for various indications including epilepsy,
depression, Alzheimers Disease, anxiety and other
disorders;
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quarterly variations in our sales and operating results;
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announcements of significant contracts, acquisitions or capital
commitments;
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changes in financial estimates by securities analysts;
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additions or departures of key management personnel;
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risks and costs associated with the previously disclosed
inquiries by the SEC staff and the U.S. Attorney and with
any litigation relating thereto or to our stock option grants,
procedures and practices;
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the impact of the restatement of our financial statements and
any other actions that might be taken or required as a result of
such inquiries, including a default under our credit facility or
debt instruments;
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the potential identification of material weaknesses in our
internal controls over financial reporting; and
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uncertainties associated with stockholder derivative litigation.
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In addition, the stock market in recent years has experienced
broad price and volume fluctuations that have often been
unrelated to the operating performance of companies. These broad
market fluctuations have also adversely affected, and may
continue to adversely affect, the market price of our common
stock.
We are
not profitable now, and we have been profitable for only seven
fiscal quarters since our inception.
Through April 27, 2007, we incurred an accumulated net
deficit of approximately $259 million. We continue to incur
substantial expenses, including:
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sales and marketing expenses related to our U.S. launch of
VNS Therapy in TRD and to our re-launch of VNS Therapy in
epilepsy;
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clinical expenses related to our commitment for post-market
studies in the TRD indication;
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regulatory expenses related to our post-market surveillance and
other regulatory obligations and manufacturing expenses; and
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general administrative expenses, including substantial expenses
related to internal and governmental investigations of our stock
option granting practices and procedures.
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We can provide no assurance that our revenues will grow or that
our expenses will decline sufficiently to enable us to become
profitable in the future. The report of our auditors with
respect to their audit of our Consolidated Financial Statements
for the fiscal year ended April 27, 2007 contains an
explanatory paragraph relating to the preparation of our
financial statements as a going concern. While our
management expects to resolve the conditions referenced in
Note 2. Going Concern in the Notes to the
Consolidated Financial Statements, we can offer no assurance
that we will be able to resolve these conditions and continue as
a going concern.
In the
future, we could have a material weakness in our internal
control over financial reporting.
We reported in our Annual Report on
Form 10-K
for the fiscal year ended April 28, 2006 (2006
Form 10-K)
that management identified a material weakness in our internal
control over financial reporting. Our management concluded that,
as a result of this material weakness, our internal control over
financial reporting was not effective as of April 28, 2006
based upon the criteria issued by the Committee of Sponsoring
Organizations of the Treadway Commission. This material weakness
resulted in the material misstatement of stock-based
compensation expense in our consolidated financial statements
for the 2004 and 2005 fiscal years and each of the quarters of
fiscal 2005 and 2006 and we restated previously issued financial
statements for the 2004 and 2005 fiscal years and each of the
quarters of fiscal years 2005 and 2006. We have successfully
remediated this material weakness. However, if management
determines or our independent registered public accountants
conclude that we have a material weakness in the future, it
could adversely affect our credit rating, lead to short-term
price volatility, trigger an investigation by a regulatory
authority or result in additional stockholder litigation, any of
which could severely harm our business, our consolidated
financial position and results of operations.
Our
quarterly operating results may fluctuate in the future, which
may cause our stock price to decline.
Our quarterly revenues, expenses and operating results may vary
significantly from quarter to quarter for several reasons,
including, without limitation:
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the extent to which the VNS Therapy System gains market
acceptance;
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the timing of obtaining marketing approvals for the VNS Therapy
System for other indications, if any;
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the existence and timing of any approvals or non-coverage
determinations for reimbursement by third-party payers;
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the rate and size of expenditures incurred as we expand our
clinical, manufacturing, sales, marketing and product
development efforts;
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our ability to retain qualified sales personnel;
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the availability of key components, materials and contract
services, which depends on our ability to forecast sales among
other things;
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investigations of our business and business-related activities
by regulatory or other governmental authorities;
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product recalls or safety alerts; and
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litigation, including product liability, securities class
action, stockholder derivative, general commercial and other
lawsuits.
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As a result of any of these factors, our consolidated results of
operations may fluctuate significantly and may be below security
analyst expectations, which may in turn cause our stock price to
decline.
We may
fail to comply with one or more of the many regulations that
govern our business activities.
We are subject to extensive and rigorous ongoing regulation of
the research, development, testing, manufacture, labeling,
promotion, advertising, distribution and marketing of our
product. Our failure to comply with regulations or to identify
and resolve manufacturing or safety problems prior to commercial
marketing could lead to the need for product marketing
restrictions, product withdrawal or recall or other voluntary or
regulatory action, any
14
of which could delay further marketing until our product is
brought into compliance. Our failure to comply with these
requirements could have a significant negative impact on our
future operating results and may also subject us to stringent
penalties and lawsuits.
Our
indebtedness and debt service obligations may adversely affect
our cash flow, cash position and stock price.
As of April 27, 2007, we had approximately
$125.0 million in convertible debt with aggregate annual
debt service obligations, excluding full repayment of principal,
of approximately $3.8 million and $7.5 million in
outstanding borrowings against our revolving credit facility. If
we issue other securities in the future, our debt service
obligations and interest expense will increase further. We
intend to fulfill our debt service obligations from earnings and
our existing cash and investments. In the future, if we are
unable to generate cash or raise additional cash through
financing sufficient to meet these obligations, we may have to
delay or curtail our research, development and commercialization
programs. Our indebtedness could have significant additional
negative consequences, including, without limitation:
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requiring the dedication of a portion of our cash to service our
indebtedness and to pay off the principal at maturity, thereby
reducing the amount of our expected cash available for other
purposes, including funding our research, development and
commercialization efforts and planned capital expenditures;
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increasing our vulnerability to general adverse economic
conditions;
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limiting our ability to obtain additional financing; and
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placing us at a possible competitive disadvantage to less
leveraged competitors and competitors with better access to
capital resources.
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Upon
the occurrence of a fundamental change, holders of our senior
subordinated Convertible Notes may force us to purchase their
Convertible Notes at the full amount owed, including accrued but
unpaid interest.
If we undergo a fundamental change, including, but not limited
to, the acquisition by any person of the beneficial ownership of
50% of our common stock, our consolidation or merger with or
into any other person, our liquidation, or our common stock
being removed from listing on The NASDAQ Global Market, holders
of our $125.0 million of 3% Senior Subordinated
Convertible Notes due in 2012 (Convertible Notes)
may, at their option, require us to purchase their Convertible
Notes for the full amount owed including accrued but unpaid
interest. This amount may be greater than the value of the
Convertible Notes at the time of repurchase. As a result, the
possibility of a repurchase requirement may inhibit the
consummation of certain transactions such as mergers that may be
beneficial to our stockholders.
Upon
the occurrence of certain events, the initial conversion rate of
our Convertible Notes will be adjusted, which could result in an
increased number of shares being issued upon
conversion.
The initial conversion rate of our Convertible Notes will be
adjusted upon the occurrence of certain events, including, among
others, the issuance to our stockholders of certain rights to
purchase our common stock at less than the current market price
of our common stock or the issuance of cash dividends to
substantially all of our stockholders. If the conversion rate is
adjusted, holders of our Convertible Notes will receive a
greater number of shares of our common stock per Convertible
Note, resulting in increased percentage ownership of our common
stock by the noteholders.
We may
be forced to repay the full amount of our outstanding
$125.0 million convertible note indebtedness and senior
credit indebtedness on an accelerated basis.
In July 2006, we received a notice of default and demand letter
(Notice of Default) from Wells Fargo Bank, National
Association (the Trustee), pursuant to which the
Trustee asserted that we were in default of our obligations
under the Indenture dated September 27, 2005
(Indenture), between us, as issuer, and the Trustee
with respect to our Convertible Notes, as a result of our
failure (1) to file with the SEC our 2006
Form 10-K
by July 12, 2006 and (2) to deliver a copy of the 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received a notice of
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acceleration and demand letter (Notice of
Acceleration) from the Trustee informing us that, pursuant
to the Indenture, the Trustee has declared the Convertible Notes
due and payable at their principal amount together with accrued
and unpaid interest, and fees and expenses and demanding that
all such principal, interest, fees and expenses under the
Convertible Notes be paid to the Trustee immediately. As a
result, although the Convertible Notes mature in 2012, we have
included them as a current liability on our Consolidated Balance
Sheet as of April 27, 2007. We deny that a default occurred
under the Indenture, and on June 13, 2007, a federal
district court granted summary judgment to Cyberonics and
declared that no default occurred under the Indenture. In its
court filings, the Trustee stated that it was seeking
approximately $20.0 million in damages plus interest and
attorney fees, but it reserved the right to seek immediate
payment of full value of the Convertible Notes. The Trustee has
not appealed the district courts decision; however, if the
Trustee appeals the decision of the district court, and if the
court of appeals reverses the district courts decision and
determines that a default occurred, then all unpaid principal
and accrued interest on the outstanding Convertible Notes could
be due and payable immediately unless we negotiate an amendment
to the terms of the Indenture. In addition, a default under the
Indenture constitutes a default under our Credit Agreement dated
January 13, 2006 (Credit Agreement) with
Merrill Lynch Capital, a division of Merrill Lynch Business
Financial Services Inc. (Administrative Agent) and
the lenders who are party thereto (Lenders). If the
principal and accrued interest on the outstanding Convertible
Notes and our outstanding indebtedness under the credit
agreement must be repaid immediately, we may not have or be able
to obtain access to the funds needed to repay the indebtedness,
and we may be forced to seek protection under the
U.S. Bankruptcy Code.
We may
not be able to access sufficient additional capital sources or
to access capital on terms which are acceptable to
us.
Our capital requirements are substantial and depend on many
factors, including market acceptance of our product and clinical
and strategic development opportunities. A large portion of our
expenses is currently fixed, including expenses related to our
facilities, equipment and personnel, and we may need to spend
significant amounts to conduct our post-marketing clinical
studies or for product improvement and development. We will need
to generate significant additional revenues to achieve
profitability in the future. Even if we do achieve
profitability, we may not be able to increase profitability on a
quarterly or annual basis. Furthermore, if additional capital is
required, we may not be able to access sufficient sources or to
access capital on terms which are acceptable to us.
We may
not be successful in our efforts to develop VNS Therapy for the
treatment of other indications and, as such, we may not
experience revenue growth from these other
indications.
We have conducted or supported animal studies or small human
pilot studies for the treatment of a number of therapeutic
indications beyond refractory epilepsy and TRD. Regulatory
approval for any likely new indications would require us to
conduct one or more larger scale pivotal trials. We have not
conducted such pivotal trials for any indication beyond
refractory epilepsy and TRD, nor do we have any immediate plans
to do so. In the event that we do invest in future studies for
new indications, we cannot assure you that our study results
will be positive. If we elect not to conduct research with
regard to new indications, our study results are not positive,
we do not receive additional regulatory approvals, or
alternative indications do not prove to be commercially viable,
our revenue growth, if any, would be limited to revenue from our
existing approved indications in refractory epilepsy and TRD.
We may
not be able to expand or maintain market acceptance of the use
of the VNS Therapy System to treat epilepsy or depression, which
could cause our sales to be lower than
expectations.
Our product portfolio is limited to VNS Therapy Systems for two
indications, refractory epilepsy and TRD. Market acceptance of
the VNS Therapy System for these indications depends on our
ability to convince the medical community and third-party payers
of the clinical efficacy and safety of vagus nerve stimulation
and the VNS Therapy System. On May 4, 2007, CMS issued a
national non-coverage determination with respect to VNS Therapy
for TRD. Prior to the non-coverage determination, some patients
were able to obtain coverage on a
case-by-case
basis through their local Medicare contractor or Fiscal
Intermediary. Since the national non-coverage determination is
binding on all local Medicare contractors, patients will no
longer be able to obtain Medicare coverage on a
case-by-case
basis. In addition, CMSs non-coverage determination may
have a detrimental effect on coverage decisions by other payers,
including Medicaid. While the VNS Therapy System has been
implanted in more than
16
45,000 patients, many physicians are still unfamiliar with
this form of therapy. We believe that existing pharmacological
therapies, surgery (for refractory epilepsy) and ECT (for TRD)
are the only other approved and currently available therapies
competitive with the VNS Therapy System. These therapies may be
more attractive to patients or their physicians than the VNS
Therapy System in terms of efficacy, cost or reimbursement
availability. Furthermore, we have not funded significant
post-market clinical research that could change physicians
opinions or use of our product for refractory epilepsy. We
cannot assure you that we will receive broad reimbursement
coverage for TRD or that our sales will increase for epilepsy or
TRD. Additionally, we cannot assure you that the VNS Therapy
System will achieve expanded market acceptance for the treatment
of epilepsy, depression or for any other indication. Failure of
the VNS Therapy System to gain additional market acceptance
would severely harm our business, our consolidated financial
position and results of operations.
We may
not be successful in our marketing and sales efforts, which
could severely harm our business.
We launched VNS Therapy for TRD in August 2005 following
expansion of our sales and case management organization to
support anticipated sales demand in both epilepsy and TRD
markets. Although patient demand has been strong, our sales have
not increased to the extent we anticipated in August 2005. At
the present time, we do not expect sales of the VNS Therapy
System for TRD to result in any consistent revenue growth until
the product receives broader regional or national coverage by
insurers and other payers. In addition, the absence of broad
regional or national insurance coverage may have a negative
effect on psychiatrists prescribing habits, resulting in
decreasing sales of VNS Therapy Systems for TRD. Our inability
to achieve annual or quarterly revenue growth could
substantially harm our consolidated results of operations and
financial position.
Patient
confidentiality and federal and state privacy and security laws
and regulations may adversely impact our selling
model.
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) establishes federal rules protecting the
privacy and security of personal health information. The privacy
and security rules address the use and disclosure of individual
health care information and the rights of patients to understand
and control how such information is used and disclosed. HIPAA
provides both criminal and civil fines and penalties for covered
entities that fail to comply with HIPAA. We intend to comply
with applicable privacy and security standards. However, if we
fail to comply with the applicable regulations, we could suffer
civil penalties up to $25,000 per calendar year for each
violation and criminal penalties with fines up to $250,000 and
potential imprisonment. In addition to HIPAA, virtually every
state has enacted one or more laws to safeguard privacy, and
these laws vary significantly from state to state and change
frequently. Even if our business model is compliant with the
HIPAA Privacy and Security Rule and the Texas privacy laws, it
may not be compliant with the privacy laws of all states.
Because the operation of our business involves the collection
and use of substantial amounts of protected health
information, we endeavor to conduct our business as a
covered entity under the HIPAA Privacy and Security
Rule and consistent with the Texas privacy laws, obtaining
HIPAA-compliant patient authorizations where required to support
the collection and use of patient information. We also sometimes
act as a business associate for a covered entity.
Despite extensive efforts to conduct our business as a covered
entity under the HIPAA Privacy and Security Rules, the Office
for Civil Rights of the Department of Health and Human Services
or another government enforcement agency may determine that our
business model or operations are not in compliance with the
HIPAA Privacy and Security Rules, which could subject us to
penalties, could severely limit our ability to market and sell
VNS Therapy under our existing business model and could harm our
business growth and consolidated financial position.
We may
be unable to obtain and maintain adequate third-party
reimbursement on our product, which could have a significant
negative impact on our future operating results.
Our ability to commercialize the VNS Therapy System successfully
depends, in part, on whether third-party payers, including
private healthcare insurers, managed care plans, Medicare and
Medicaid programs and others, agree to cover the VNS Therapy
System and associated procedures and services and to reimburse
at adequate levels for the costs of the VNS Therapy System and
the related services in the U.S. or internationally. While
we currently have reimbursement approval for epilepsy, we have
not yet received substantial reimbursement coverage approval for
the treatment of depression. In May 2007, CMS issued a national
non-coverage determination with respect to VNS Therapy for TRD.
17
This non-coverage determination means that Medicare will not
cover VNS Therapy for TRD. Prior to the non-coverage
determination, some patients were able to obtain coverage on a
case-by-case
basis through their local Medicare contractor or Fiscal
Intermediary. Since the national non-coverage determination is
binding on all local Medicare contractors, patients will no
longer be able to obtain Medicare coverage on a
case-by-case
basis. In addition, the CMS non-coverage determination also may
have a detrimental effect on potential and existing coverage by
Medicaid and private payers. In addition, periodic changes to
reimbursement methodology for medical devices under the Medicare
and Medicaid programs occur and may reduce the rate of increase
in federal expenditures for health care costs. Such changes, as
well as any future regulatory changes and the failure of the VNS
Therapy System to continue to qualify for reimbursement under
these programs, may have an adverse impact on our business.
Healthcare, as one of the largest industries in the U.S.,
continues to attract substantial legislative interest and public
attention. Congress and state legislatures are constantly
reassessing the propriety of coverage for various health
services and the payment level for such services. Certain reform
proposals and other policy shifts, if enacted, could limit
coverage for VNS Therapy or the reimbursement available for VNS
Therapy from governmental agencies or third-party payers.
Changes in Medicare, Medicaid and other programs,
cost-containment initiatives by public and private payers, a
failure to obtain substantial regional and national coverage
policies for VNS Therapy in TRD, and proposals to limit payments
and health care spending could have a significant negative
impact on our future operating results.
Our
current and future expense estimates are based, in large part,
on estimates of our future sales, which are difficult to
predict.
We may be unable to, or may elect not to, adjust spending
quickly enough to offset any unexpected sales shortfall. If
increased expenses are not accompanied by increased sales, our
consolidated results of operations and financial position for
any particular quarter could be harmed.
If our
suppliers and manufacturers are unable to meet our demand for
materials, components and contract services, we may be forced to
qualify new vendors or change our product design, which would
impair our ability to deliver products to our customers on a
timely basis.
We rely upon sole source suppliers for certain of the key
components, materials and contract services used in
manufacturing the VNS Therapy System. We periodically experience
discontinuation or unavailability of components, materials and
contract services, which may require us to qualify alternative
sources or, if no such alternative sources are identified,
change our product design. We believe that pursuing and
qualifying alternative sources
and/or
redesigning specific components of the VNS Therapy System, if or
when necessary, could consume significant resources. In
addition, such changes generally require regulatory submissions
and approvals. Any extended delays in or an inability to secure
alternative sources for these or other components, materials and
contract services could result in product supply and
manufacturing interruptions, which could significantly harm our
business.
Our
products may have defects that result in product recalls, which
may result in substantial costs and reduced sales.
The VNS Therapy System includes an electronic pulse generator
and lead designed to be implanted in the human body and a
programming wand connected to a handheld computer for
programming the pulse generator. Component failures,
manufacturing or shipping problems or hardware or software
design defects could result in the product not delivering the
therapy for which it is indicated or the product delivering a
therapy that is not intended. The occurrence of such problems or
other adverse clinical reactions could result in a recall of our
products, possibly requiring explantation and potential
reimplantation of the VNS Therapy System, which may increase
risk to the patient. Any product recall could result in a
substantial loss of physician and patient confidence in our
products, with a consequential substantial decrease in sales,
and could result in substantial product liability litigation,
with liabilities well in excess of our product liability
insurance coverage limits, any or all of which could severely
harm our business and our consolidated financial position and
results of operations.
In November 2006, we sent physicians a safety alert letter
warning of a rare software anomaly that can cause the VNS
Therapy System pulse generator to deliver an output current of
eight milliamps during an interrupted programming session. This
amount of output current is within the range of currents
originally approved by the FDA
18
as safe and effective, but it is higher than is recommended for
use. We are aware of eight occurrences of this anomaly, among
more than 45,000 VNS Therapy Systems implanted. Although none of
the occurrences was associated with permanent injury to a
patient, most resulted in at least temporary discomfort. FDA has
classified this anomaly as a Class II recall, which we have
addressed by means of the safety alert letter. If we fail to
follow up appropriately regarding distribution of the safety
alert letter, we could be subject to regulatory sanctions.
We may
not be able to protect our technology from unauthorized use,
which could diminish the value of our products and impair our
ability to compete.
Our success depends upon our ability to obtain and maintain
patent and other intellectual property protection for the VNS
Therapy System and its improvements. To that end, we have
acquired licenses under certain patents and have patented and
intend to continue to seek patents on our own inventions used in
our products and treatment methods. The process of seeking
patent protection can be expensive and time consuming, and we
cannot assure you that patents will be issued from our currently
pending or future applications or that, if patents are issued,
they will be of sufficient scope or strength to provide
meaningful protection of our technology or any commercial
advantage to us. Further, the protection offered by the licensed
international patents is not as strong as that offered by the
licensed U.S. patents due to differences in patent laws. In
particular, the European Patent Convention prohibits patents
covering methods for treatment of the human body by surgery or
therapy. Without effective patent protection, whether in the
U.S. or abroad, we may be subject to competition that
negatively affects our business and our consolidated financial
position and results of operations.
We may
engage in litigation to protect our proprietary rights, or
defend against infringement claims by third parties, causing us
to suffer significant liabilities or expenses or preventing us
from selling our products.
There has been substantial litigation regarding patent and other
intellectual property rights in the medical device industry.
Litigation, which could result in substantial cost to and
diversion of effort by us, may be necessary to enforce patents
issued or licensed to us, to protect trade secrets or know-how
owned by us or to defend ourselves against claimed infringement
of the rights of others and to determine the scope and validity
of the proprietary rights of others. Adverse determinations in
litigation could subject us to significant liabilities to third
parties, could require us to seek licenses from third parties
and could prevent us from manufacturing, selling or using the
VNS Therapy System, any of which could severely harm our
business.
Intense
competition and rapid technological changes could reduce our
ability to market our products and achieve sales.
We believe that existing and future pharmaceutical therapies
will continue to be the primary competition for the VNS Therapy
System. We may also face competition from other medical device
companies that have the technology, experience and capital
resources to develop alternative devices for the treatment of
epilepsy and depression. Medtronic, Inc., for example, continues
to conduct clinical studies involving an implantable signal
generator used with an invasive deep brain probe, or thalamic
stimulator, for the treatment of neurological disorders,
including depression, and has received FDA approval for the
device for the treatment of essential tremor, including that
associated with Parkinsons Disease. Many of our
competitors have substantially greater financial, manufacturing,
marketing and technical resources than we do and have obtained
third-party reimbursement approvals for their therapies. We may
not have invested in the past, or be investing in the future,
sufficient resources in engineering research and development to
prepare the VNS Therapy System for competition in the future
with other neurostimulation technologies. In addition, the
healthcare industry is characterized by extensive research
efforts and rapid technological progress. Our competitors may
develop technologies and obtain regulatory approval for products
that are more effective in treating epilepsy and depression than
our current or future products. In addition, advancements in
surgical techniques may make surgery a more attractive therapy
for epilepsy and depression. The development by others of new
treatment methods with novel drugs, medical devices or surgical
techniques for epilepsy and depression could render the VNS
Therapy System non-competitive or obsolete. We may not be able
to compete successfully against current and future competitors,
including new products and technology, which could severely harm
our business and our consolidated financial position and results
of operations.
19
We are
subject to claims of product liability and we may not have the
resources or insurance to cover the cost for losses under these
claims.
The manufacture and sale of the VNS Therapy System, an
implantable medical device, entails the risk of product
liability claims, which we have received from time to time in
the ordinary course of business. We may be responsible for large
self-insured retentions for each claim, and our product
liability coverage limit may not be adequate to pay defense
costs and judgments that may result from these claims. Product
liability insurance is expensive and in the future may only be
available at significantly higher premiums or may not be
available on acceptable terms, if at all. A successful claim
brought against us in excess of our insurance coverage could
significantly harm our business and consolidated financial
position.
If we
do not continue to comply with changing government laws and
regulations, we could lose our ability to market and sell our
product or be subject to substantial fines or other
penalties.
The preclinical and clinical design, testing, manufacturing,
labeling, sale, distribution, servicing and promotion of the VNS
Therapy System are subject to extensive and rigorous federal and
state laws and regulations, including regulations from the
Department of Health and Human Services (related to Medicare,
Medicaid, HIPAA and FDA) and from comparable state agencies. In
the future, it will be necessary for us to obtain additional
government approvals for other indications of the VNS Therapy
System, if we choose to develop new indications, and for
modified or future-generation products. It is also necessary for
us to ensure that our marketing and sales practices comply with
all laws and regulations. Commercial distribution in certain
foreign countries is also subject to regulatory approvals from
the appropriate authorities in such countries. The process of
obtaining FDA and other required regulatory approvals is
lengthy, expensive and uncertain. Moreover, regulatory approvals
may include regulatory restrictions on the indicated uses for
which a product may be marketed. Failure to comply with
applicable regulatory requirements can result in, among other
things, fines, suspension or withdrawal of approvals,
confiscations or recalls of products, operating restrictions and
criminal prosecution. Adverse results in post-approval studies
may result in limitations on or withdrawal of previously granted
approvals. Furthermore, changes in existing regulations or
adoption of new regulations could prevent us from obtaining, or
affect the timing of, future regulatory approvals. We may not be
able to obtain additional future regulatory approvals on a
timely basis or at all. Delays in receipt of or failure to
receive such future approvals, suspension or withdrawal of
previously received approvals or recalls of the VNS Therapy
System could severely harm our ability to market and sell our
current and future products and improvements. As a condition of
approval for the TRD indication, the FDA has required us to
conduct a post-approval 460-patient dosing study and a
2,000-patient registry of which 1,000 will be treated with VNS
Therapy. The results of these studies may be included in product
labeling. If we fail to complete these studies in a timely
manner, we may be subject to regulatory action, including
withdrawal of our TRD indication approval.
We are
subject to federal and state laws governing our sales and
marketing practices, and failure to adhere to these laws could
result in substantial fines and other penalties.
We are subject to certain laws and regulations, including the
federal Anti-Kickback Statute, the federal False Claims Act and
the HIPAA Privacy Rule, that govern the sales and marketing
practices of healthcare companies. The Anti-Kickback Statute
contains both civil and criminal sanctions, which are enforced
by the Office of the Inspector General of Health and Human
Services Department (OIG) and the
U.S. Department of Justice (DOJ). Over the past
several years, the U.S. government has accused an
increasing number of pharmaceutical and medical device
manufacturers of violating the Anti-Kickback Statute based on
certain marketing and sales practices and compensation
arrangements with referral sources. Pharmaceutical and medical
device manufacturers also have been accused of alleged
violations of the federal False Claims Act, which imposes civil
liability (including substantial monetary penalties and damages)
on any person or corporation that (1) knowingly presents a
false or fraudulent claim for payment to the
U.S. government, (2) knowingly uses a false record or
statement to obtain payment or (3) engages in a conspiracy
to defraud the federal government to obtain allowance for a
false claim. Under the qui tam, or whistleblower,
provisions of the False Claims Act, private parties may bring
actions on behalf of the U.S. government. These private
parties are entitled to share in any amounts recovered by the
government through trial or settlement. Both direct enforcement
activity by the government and whistleblower lawsuits have
increased significantly in recent years and have increased the
risk that we may be forced to defend a prosecution under the
Anti-Kickback Statute, a
20
false claims action, be liable for monetary fines or be excluded
from the Medicare and Medicaid programs as a result of an
investigation resulting from an enforcement action or a
whistleblower case.
In 2004, we adopted a healthcare law compliance program,
including our Business Practice Standards, which is a set of
policies that embody the AdvaMed Code of Ethics for Interactions
with Health Care Professionals. In January 2006, we adopted
significant revisions to our Business Practice Standards that we
believe more thoroughly address our compliance risks. We
endeavor to conduct our business in compliance with our Business
Practice Standards and to ensure continued compliance through
regular education of our employees, audits of employee
activities, and appropriate responses to violations of the
Business Practice Standards. Although we believe that these
efforts have been successful and that we are in substantial
compliance with our policies and the healthcare laws, given the
complexity of our business model, including extensive
interactions with patients and healthcare professionals, and the
large number of field personnel employed by us, violations of
our policy and the law could occur. We could be subject to
investigation by the OIG or the DOJ or a comparable state
agency. If investigated, we could be forced to incur substantial
expense responding to the investigation and defending our
actions. If unsuccessful in our defense, we could be found to be
in violation of the healthcare laws and be subject to
substantial fines and penalties, including exclusion of our
products from Medicare and Medicaid reimbursement.
Our
international operations are subject to risks not generally
associated with commercialization efforts in the
U.S.
We may not be successful in increasing our international sales
or in obtaining reimbursement or any regulatory approvals
required in foreign countries. The anticipated international
nature of our business is also expected to subject us and our
representatives, agents and distributors to laws and regulations
of the foreign jurisdictions in which we operate or where the
VNS Therapy System is sold. The regulation of medical devices in
a number of such jurisdictions, particularly in the European
Union, continues to develop and new laws or regulations may
impair our ability to market and sell our products in those
jurisdictions.
Our
failure to attract and retain qualified personnel, including key
officers, could adversely affect our operations.
In connection with the commercialization of the VNS Therapy
System in the U.S. for TRD, we made significant changes to
our organization, including an initial scale up in personnel
from February 2005 through July 2005 of approximately 50% and
subsequent reductions in personnel of 11% in fiscal 2006 and 15%
in fiscal 2007. Such activities have placed, and may continue to
place a significant strain on our resources and operations. Our
ability to grow in the future will depend upon our ability to
attract, hire and retain highly qualified employees and
management personnel. We compete for such personnel with other
companies, academic institutions, government entities and other
organizations and we may not be successful in hiring or
retaining qualified personnel. In November 2006, the Chief
Executive Officer and Chief Financial Officer resigned, and in
May 2007 we hired a new Chief Executive Officer and our Interim
Chief Financial Officer resigned. These changes in key
management positions strain our existing resources, creating a
risk of loss of other key employees. As a result, our business
could be affected detrimentally.
We
have in the past and are again now involved in an investigation
conducted by the Staff of the Senate Finance Committee resulting
in adverse publicity, expenditure of substantial resources and
diversion of management attention, all with an adverse effect on
our business.
We received a letter in November 2006 and a second letter in
March 2007 from Senator Charles Grassley on behalf of the United
States Senate Committee on Finance (SFC) requesting
our cooperation in providing certain documents and information
relating to (1) our employees, agents and consultants
regarding their meetings and communications with the CMS
regarding coverage of the VNS Therapy System for TRD and
(2) our agents and consultants participation in
presentations, preparation of publications and advice to
government agencies on VNS Therapy for TRD. A discussion of the
SFC investigation is contained in Note 15.
Litigation Senate Finance Committee
Investigation. We are unable to provide assurance at this
time as to any further action that may be taken by the SFC or
its staff in regard to this matter. Any further action taken by
the SFC or its staff could have a material adverse effect on our
business, including but not limited to increased expense to
comply with requests and diversion of management attention from
the conduct of our business.
21
We
have been named in a putative securities class action
lawsuit.
We and certain of our officers have been named as defendants in
a putative class action lawsuit. A discussion of this lawsuit is
contained in Note 15. Litigation
Securities Class Action Lawsuit. Although it is not
possible at this early stage to predict the likely outcome of
this lawsuit, an adverse result could have a material adverse
effect on us, our consolidated financial position, results of
operations and cash flows. Even if the result of such litigation
is not adverse, the cost of defending against such litigation
has been and will continue to be expensive and could have a
material adverse effect on our consolidated financial position.
We are
the subject of governmental investigations related to our stock
option granting practices and procedures and other matters, the
outcome of which could adversely affect our
business.
In June 2006, the SEC staff advised us that it had commenced an
informal inquiry of our stock option grants and related
practices, procedures and accounting. In June 2006, we also
received a subpoena from the U.S. Attorney requesting
documents related to the same matters. In October 2006, the SEC
staff made an additional request for certain documents and
information related to our revised guidance on February 8,
2006 and our financial results announced on May 1, 2006,
our sales for the quarter ended April 28, 2006, coverage or
potential coverage of our VNS Therapy System by Alabama
BlueCross BlueShield and Aetna and the aging of our accounts
receivable since January 1, 2003. We are cooperating with
these governmental investigations. A more detailed discussion of
these matters is contained in Note 15.
Litigation Governmental Investigations of Options
Granting Practices. Although it is not possible at this
early stage to predict the likely outcome of these inquiries, an
adverse result could have a material adverse effect on us, our
consolidated financial position, results of operations and cash
flows. Even if the result of such inquiries is not adverse, the
cost of defending against such inquiries has been and will
continue to be expensive and could have a material adverse
effect on our consolidated financial position.
We are
named as a nominal defendant in six stockholder derivative
lawsuits which, as a result of our indemnity obligations to the
current and former officers and directors named as defendants,
could be costly to us.
A discussion of the pending stockholder derivative claims is
contained in Note 15. Litigation
Stockholder Derivative Litigation. Our bylaws require us
to advance fees and expenses to officers and directors in
certain situations. The advancement of fees and expenses to
officers and directors, both current and former, to defend the
stockholder derivative claims could be costly and could have a
material adverse effect on our consolidated financial position.
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Item 1B.
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Unresolved
Staff Comments
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We have previously disclosed that we are subject to an inquiry
by the SEC relating to our accounting for stock option grants.
To date, we have not received written comments by the SEC
regarding any of our periodic or current reports filed under the
Exchange Act, as amended, not less than 180 days before the
fiscal year ended April 27, 2007 that remain unresolved.
We have agreed to lease approximately 143,000 square feet
of office and manufacturing space in Houston, Texas through
December 2009. We have also agreed to lease approximately
17,000 square feet in sales offices in Europe through April
2010. All leased properties have been expanded to accommodate
expected growth in our domestic and international businesses.
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Item 3.
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Legal
Proceedings
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For a description of our material pending legal and regulatory
proceedings and settlements, see Note 15.
Litigation.
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Item 4.
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Submission
of Matters to a Vote of Security Holders
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Two matters were submitted to a vote at our annual meeting of
stockholders held on February 1, 2007: (1) the
election of directors to the Cyberonics Board of Directors
and (2) the ratification of the selection of KPMG LLP as
Cyberonics independent registered public accounting firm
for the fiscal year ending April 27, 2007.
22
In the election of directors, Guy C. Jackson received 21,211,392
votes for election and 90,799 votes were withheld from voting
for Mr. Jackson; Hugh M. Morrison received 21,215,224 votes
for election and 86,967 votes were withheld from voting for
Mr. Morrison; Alfred J. Novak received 14,924,461 votes for
election and 1,370,777 votes were withheld from voting for
Mr. Novak; Alan Olsen received 21,236,043 votes for
election and 66,148 votes were withheld from voting for
Mr. Olsen; Arthur L. Rosenthal received 16,072,226 votes
for election and 223,012 votes were withheld from voting for
Mr. Rosenthal; Jeffrey E. Schwartz received 16,228,014
votes for election and 67,224 votes were withheld from voting
for Mr. Schwartz; Michael J. Strauss, M.D., M.P.H.
received 21,235,263 votes for election and 66,928 votes were
withheld from voting for Dr. Strauss; and Reese S.
Terry, Jr. received 21,235,799 votes for election and
66,392 votes were withheld from voting for Mr. Terry. There
were no broker non-votes for the election of directors.
On the proposal to ratify the selection of KPMG LLP as our
independent registered public accounting firm for the fiscal
year ending April 27, 2007, 19,178,345 votes were received
for approval of the proposal, 850,175 votes were received
against approval of the proposal and holders of
1,273,671 shares abstained from voting on this proposal.
There were no broker non-votes on this proposal.
On April 24, 2007, our Board appointed Daniel J. Moore as
President, Chief Executive Officer and member of the Board
effective on May 1, 2007, subject to his execution of an
employment agreement prior to May 5, 2007. We executed an
employment agreement with Mr. Moore on April 26, 2007
and he joined our Board on May 1, 2007.
PART II
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Item 5.
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Market
for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
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Our common stock is quoted on The NASDAQ Global Market under the
symbol CYBX. The high and low sale prices for our
common stock during fiscal years 2006 and 2007 are set forth
below. Price data reflect actual transactions, but do not
reflect
mark-ups,
mark-downs or commissions.
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High
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Low
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Fiscal Year Ended
April 28, 2006
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First Quarter
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$
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47.77
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|
|
$
|
32.70
|
|
Second Quarter
|
|
|
40.69
|
|
|
|
26.63
|
|
Third Quarter
|
|
|
35.30
|
|
|
|
26.88
|
|
Fourth Quarter
|
|
|
30.96
|
|
|
|
22.61
|
|
Fiscal Year Ended
April 27, 2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
|
27.16
|
|
|
|
19.74
|
|
Second Quarter
|
|
|
21.64
|
|
|
|
14.70
|
|
Third Quarter
|
|
|
27.55
|
|
|
|
17.30
|
|
Fourth Quarter
|
|
|
23.02
|
|
|
|
17.62
|
|
As of June 22, 2007, according to data provided by our
transfer agent, there were 387 stockholders of record.
During fiscal 2006 and 2007, we did not pay any cash dividends
to our stockholders. We currently intend to retain future
earnings to fund the development and growth of our business and,
therefore, do not anticipate paying cash dividends within the
foreseeable future. Any future payment of dividends will be
determined by our Board of Directors and will depend on our
consolidated financial position and results of operations and
other factors deemed relevant by our Board of Directors. In
addition, the credit agreement restricts us from issuing
dividends if we are in default of any term of the agreement or
if after paying the dividend, we should not be in compliance
with the financial covenants of the agreement.
For a discussion of the securities authorized under our equity
compensation plans, see Item 12. Security Ownership
of Certain Beneficial Owners and Management and Related
Stockholder Matters.
23
Item 6. Selected
Financial Data
The following table summarizes certain selected financial data
and is qualified by reference to, and should be read in
conjunction with the Consolidated Financial Statements and
related Notes and with Item 7. Managements
Discussion and Analysis of Financial Condition and Results of
Operations included in this
Form 10-K.
The selected financial data and the related Notes for the
52 weeks ended April 27, 2007, April 28, 2006 and
April 29, 2005 is derived from consolidated financial
statements that are included in this
Form 10-K.
The selected financial data for the 53 weeks ended
April 30, 2004 and 52 weeks ended April 25, 2003
is derived from unaudited financial statements that are not
included in this
Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
53 Weeks Ended
|
|
|
52 Weeks Ended
|
|
|
|
April 27,
|
|
|
April 28,
|
|
|
April 29,
|
|
|
April 30,
|
|
|
April 25,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Consolidated Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
$
|
130,968,437
|
|
|
$
|
123,441,575
|
|
|
$
|
103,442,570
|
|
|
$
|
110,721,499
|
|
|
$
|
104,466,998
|
|
Cost of sales
|
|
|
18,258,374
|
|
|
|
15,822,045
|
|
|
|
15,674,040
|
|
|
|
16,386,487
|
|
|
|
16,202,831
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
112,710,063
|
|
|
|
107,619,530
|
|
|
|
87,768,530
|
|
|
|
94,335,012
|
|
|
|
88,264,167
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
134,144,315
|
|
|
|
137,310,196
|
|
|
|
86,972,068
|
|
|
|
72,198,977
|
|
|
|
70,480,847
|
|
Research and development
|
|
|
28,092,243
|
|
|
|
29,541,707
|
|
|
|
20,092,810
|
|
|
|
17,582,527
|
|
|
|
18,376,484
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
162,236,558
|
|
|
|
166,851,903
|
|
|
|
107,064,878
|
|
|
|
89,781,504
|
|
|
|
88,857,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from operations
|
|
|
(49,526,495
|
)
|
|
|
(59,232,373
|
)
|
|
|
(19,296,348
|
)
|
|
|
4,553,508
|
|
|
|
(593,164
|
)
|
Interest income
|
|
|
4,649,394
|
|
|
|
3,211,956
|
|
|
|
1,072,488
|
|
|
|
469,924
|
|
|
|
471,213
|
|
Interest expense
|
|
|
(5,913,119
|
)
|
|
|
(3,018,969
|
)
|
|
|
(444,270
|
)
|
|
|
(565,702
|
)
|
|
|
(413,192
|
)
|
Other income (expense), net
|
|
|
(311,112
|
)
|
|
|
69,460
|
|
|
|
84,736
|
|
|
|
390,997
|
|
|
|
572,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) before income taxes
|
|
|
(51,101,332
|
)
|
|
|
(58,969,926
|
)
|
|
|
(18,583,394
|
)
|
|
|
4,848,727
|
|
|
|
37,708
|
|
Income tax expense
|
|
|
78,775
|
|
|
|
99,266
|
|
|
|
26,113
|
|
|
|
230,789
|
|
|
|
129,563
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss)
|
|
$
|
(51,180,107
|
)
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
|
$
|
4,617,938
|
|
|
$
|
(91,855
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
0.20
|
|
|
$
|
(0.00
|
)
|
Diluted earnings (loss) per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
0.18
|
|
|
$
|
(0.00
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
earnings (loss) per share
|
|
|
25,514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
|
|
22,921,031
|
|
|
|
22,034,651
|
|
Shares used in computing diluted
earnings (loss) per share
|
|
|
25.514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
|
|
25,954,640
|
|
|
|
22,034,651
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet
Data
(as of Year End):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities
|
|
$
|
84,804,876
|
|
|
$
|
92,355,071
|
|
|
$
|
61,475,892
|
|
|
$
|
58,363,731
|
|
|
$
|
43,576,305
|
|
Total assets
|
|
|
137,644,883
|
|
|
|
152,300,284
|
|
|
|
98,855,397
|
|
|
|
94,296,524
|
|
|
|
75,115,312
|
|
Convertible Notes
|
|
|
125,000,000
|
|
|
|
125,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of credit
|
|
|
7,500,000
|
|
|
|
2,500,000
|
|
|
|
3,000,000
|
|
|
|
10,031,000
|
|
|
|
8,370,000
|
|
Long-term obligations
|
|
|
295,184
|
|
|
|
1,148,457
|
|
|
|
209,928
|
|
|
|
|
|
|
|
141,066
|
|
Accumulated deficit
|
|
|
(258,646,256
|
)
|
|
|
(207,466,149
|
)
|
|
|
(148,396,957
|
)
|
|
|
(129,787,450
|
)
|
|
|
(134,405,388
|
)
|
Common stockholders equity
(deficit)
|
|
|
(16,062,229
|
)
|
|
|
4,629,866
|
|
|
|
75,595,841
|
|
|
|
68,980,479
|
|
|
|
48,512,003
|
|
As discussed in Note 10. Stock Incentive and Purchase
Plans in the Notes to the Financial Statements, we adopted
SFAS 123 (revised 2004) Share-Based
Payment (SFAS 123(R)) effective
April 29, 2006. As a result, we recognized non-cash
compensation expenses during fiscal 2007 in the amount of
$19.4 million. See Note 10. Stock Incentive and
Purchase Plans in the notes to the Financial Statements
for additional information.
24
|
|
Item 7.
|
Managements
Discussion and Analysis of Financial Condition and Results of
Operations
|
You should read the following discussion and analysis together
with Item 6. Selected Financial Data and our
Consolidated Financial Statements and the related Notes.
This discussion contains forward-looking statements based on our
current expectations, assumptions, estimates and projections
about our industry and us. For a discussion of the risks and
uncertainties affecting these statements, see Cautionary
Statement about Forward-Looking Statements as well as
Item 1. Business and Item 1A. Risk
Factors in this
Form 10-K.
We undertake no obligation to update publicly any
forward-looking statements, even if new information becomes
available or other events occur in the future.
This item provides material historical and prospective
disclosures enabling investors and other users to assess our
consolidated financial position and results of operations. The
Consolidated Financial Statements, excluding the related Notes,
include the consolidated statements of operations, consolidated
balance sheets, consolidated statements of stockholders
equity (deficit) and comprehensive loss and consolidated
statements of cash flows. The Notes are an integral part of the
Consolidated Financial Statements and provide additional
information required to fully understand the nature of amounts
included in the Consolidated Financial Statements.
Going
Concern
The accompanying Consolidated Financial Statements have been
prepared assuming that we will continue as a going concern.
Since inception, we have incurred an accumulated deficit of
approximately $259 million. We have incurred substantial
expenses, primarily for research and development activities that
include product and process development, clinical trials and
related regulatory activities, sales and marketing activities,
manufacturing
start-up
costs and systems infrastructure. For the fiscal years ended
April 27, 2007 and April 28, 2006 we had a net loss of
$51 million and $59 million, respectively. To fund our
operations, in fiscal 2006, we incurred additional indebtedness
through the issuance of $125 million of Convertible Notes
and the establishment of a $40 million line of credit.
In July 2006, we received the Notice of Default from the
Trustee, pursuant to which the Trustee asserted that we were in
default of our obligations under the Indenture with respect to
our Convertible Notes as a result of our failure (1) to
file with the SEC our 2006
Form 10-K
by July 12, 2006 and (2) to deliver a copy of the 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received the Notice of Acceleration from the Trustee informing
us that, pursuant to the Indenture, the Trustee declared the
Convertible Notes due and payable at their principal amount
together with accrued and unpaid interest, and fees and expenses
and demanding that all such principal, interest, fees and
expenses under the Convertible Notes be paid to the Trustee
immediately. We believe that no default occurred under the
Indenture, and on June 13, 2007, a federal district court
granted summary judgment to Cyberonics and declared that no
default occurred under the Indenture. In its court filings, the
Trustee stated that it was seeking approximately
$20.0 million in damages plus interest and attorney fees,
but it reserved the right to seek immediate payment of full
value of the Convertible Notes. The Trustee has not appealed the
district courts decision; however, if the Trustee appeals
the decision of the district court and if the court of appeals
reverses the district courts decision, then all unpaid
principal and accrued interest on the outstanding Convertible
Notes could be due and payable immediately. Accordingly, until
this matter is resolved, we have included them as a current
liability on our Consolidated Balance Sheets as of
April 27, 2007 and April 28, 2006. In addition, if a
default occurred under the Indenture, we would also be in
default of the $40.0 million Line of Credit. If principal
and interest on our indebtedness must be repaid immediately, we
do not have the cash resources available to repay the debt. If
we were not able to renegotiate the terms of the Indenture, or
to secure additional financing, this could raise substantial
doubt regarding our ability to continue as a going concern. The
accompanying consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
Business
Overview
We are a neuromodulation company founded to design, develop and
bring to market medical devices that provide a unique therapy,
VNS Therapy, for the treatment of epilepsy, TRD and other
debilitating neurological, psychiatric diseases and other
disorders. The FDA approved the VNS Therapy System in July 1997
for use as an adjunctive therapy in patients over 12 years
of age in reducing the frequency of partial onset seizures that
are
25
refractory or resistant to antiepileptic drugs. Regulatory
bodies in Canada, Europe, South America, Africa, India,
Australia and certain countries in Eastern Asia have approved
VNS Therapy for the treatment of epilepsy without age
restrictions or seizure-type limitations. FDA also approved the
VNS Therapy System for the adjunctive long-term treatment of
chronic or recurrent depression for patients 18 years of
age or older who are experiencing a major depressive episode and
have not had an adequate response to four or more adequate
anti-depressant treatments. Regulatory bodies in the European
Union countries and Canada approved the VNS Therapy System for
the treatment of chronic or recurrent depression in patients who
are in a treatment-resistant or in a treatment-intolerant
depressive episode without age restrictions.
Our ability to expand successfully the commercialization of the
VNS Therapy System depends on obtaining and maintaining
favorable coverage, coding and reimbursement for the implant
procedure and
follow-up
care. Currently, we have broad coverage, coding and
reimbursement for VNS Therapy for the treatment of epilepsy. We
are actively pursuing favorable coverage decisions to expand
reimbursement to include VNS Therapy for TRD. Absent favorable
national and regional coverage policies, we have been obtaining
certain TRD
case-by-case
approvals since FDA approval in July 2005. Our long-term growth
in TRD is dependent on our progress in obtaining favorable
national and regional coverage policies in TRD.
Our clinical development program has included pilot and pivotal
studies in using VNS Therapy (1) as an adjunctive therapy
for reducing the frequency of seizures in patients over
12 years of age with partial onset seizures that are
refractory to antiepileptic drugs and (2) as an adjunctive
treatment of patients 18 years of age and older with
chronic or recurrent TRD in a major depressive episode. We have
also conducted or provided support for small pilot studies for
the treatment of Alzheimers Disease, anxiety, chronic
migraine headache, bulimia and other indications. These studies
have been conducted to determine the safety and effectiveness of
VNS Therapy and to determine which new indications might be
considered for pivotal studies and, therefore, are an important
component of our clinical research activities.
Since inception, we have incurred substantial expenses,
primarily for research and development activities that include
product and process development and clinical trials and related
regulatory activities, sales and marketing activities,
manufacturing
start-up
costs and systems infrastructure. We have also made significant
investments in recent periods in connection with sales and
marketing activities in the U.S. and clinical research costs
associated with new indications development, most notably
depression. For the period from inception through April 27,
2007, we incurred an accumulated net deficit of approximately
$259 million. We anticipate increasing investments in
post-approval clinical studies in epilepsy and depression.
The primary exchange rate movements that impact our consolidated
net sales growth include the U.S. dollar as compared to the
Euro. The weakening of the U.S. dollar in fiscal 2006
generally has a favorable impact on our sales for the year. The
impact of foreign currency fluctuations on net sales is not
indicative of the impact on our operations due to the offsetting
foreign currency impact on operating costs and expenses.
Related
Proceedings
Regulatory Proceedings. In June 2006, the SEC
staff advised us that it had commenced an informal inquiry of
our stock option grants and related practices, procedures and
accounting. In addition, we received a subpoena from the
U.S. Attorney requesting documents related to the same
matters. For additional information, see Note 15.
Litigation in the Notes to the Consolidated Financial
Statements.
Legal Proceedings. We are named as a nominal
defendant in stockholder derivative lawsuits pending in Texas
state and federal courts wherein a stockholder purports to
pursue claims on our behalf against several of our current and
former officers and members of our Board of Directors. For
additional information, see Note 15. Litigation
in the Notes to the Consolidated Financial Statements. In June
2005, a putative class action lawsuit was filed against us and
certain of our current and former officers in the United States
District Court for the Southern District of Texas. For
additional information, see Note 15. Litigation
in the Notes to the Consolidated Financial Statements.
26
Significant
Accounting Policies and Critical Accounting Estimates
We have adopted various accounting policies to prepare the
Consolidated Financial Statements in accordance with accounting
principles generally accepted in the
U.S. (GAAP). Our most significant accounting
policies are disclosed in Note 1. Summary of
Significant Accounting Policies and Related Data in the
Notes to the Consolidated Financial Statements.
The preparation of the Consolidated Financial Statements, in
conformity with GAAP, requires us to make estimates and
assumptions that affect the amounts reported in the Consolidated
Financial Statements and the related Notes. The accompanying
Consolidated Financial Statements have been prepared on a going
concern basis. Our estimates and assumptions are updated as
appropriate, which in most cases is at least quarterly. We base
our estimates on historical experience or various assumptions
that are believed to be reasonable under the circumstances, and
the results form the basis for making judgments about the
reported values of assets, liabilities, revenues and expenses.
Actual results may materially differ from these estimates.
We consider the following accounting policies as the most
significant because, in managements view, they are most
important to the portrayal of our consolidated financial
position and results of operations and most demanding in terms
of requiring estimates and other exercises of judgment.
Accounts Receivable. We provide an allowance
for doubtful accounts based upon specific customer risks and a
general provision based upon historical trends. An increase in
losses beyond that expected by management or what we have
historically experienced would reduce earnings when they become
known.
Inventories. We state our inventories at the
lower of cost,
first-in,
first-out (FIFO) method, or market. Cost includes
the acquisition cost of raw materials and components, direct
labor and overhead. Management considers potential obsolescence
at each balance sheet date. An acceleration of obsolescence
could occur if consumer demand differs from expectations.
Property and Equipment. Property and equipment
are carried at cost, less accumulated depreciation. Maintenance,
repairs and minor replacements are charged to expense as
incurred; significant renewals, improvements and expansions are
capitalized. For financial reporting purposes, we compute
depreciation using the straight-line method over useful lives
ranging from two to nine years. An unanticipated change in the
utilization or expected useful life of property and equipment
could result in acceleration in the timing of the expenses.
Revenue Recognition. We sell our products
through a combination of a direct sales force in the U.S. and
certain European countries and through distributors elsewhere.
We recognize revenue when title to the goods and risk of loss
transfer to customers, providing there are no remaining
performance obligations required of us or any matters requiring
customer acceptance. We record estimated sales returns and
discounts as a reduction of net sales in the same period revenue
is recognized. Our revenues are dependent upon sales to new and
existing customers pursuant to our current policies. Changes in
these policies or sales terms could impact the amount and timing
of revenue recognized.
Research and Development. All research and
development costs are expensed as incurred. We have entered into
contractual obligations for the conduct of clinical studies.
Costs are incurred primarily at the time of enrollment and paid
under the terms of the contracts. Research and development
expenses could vary significantly with changes in the timing of
clinical activity.
Stock Options. Prior to April 29, 2006,
we adopted the disclosure-only provisions of Statement of
Financial Accounting Standards Board (SFAS)
No. 123, Accounting for Stock-Based
Compensation and SFAS No. 148,
Accounting for Stock-Based Compensation
Transition and Disclosure, which disclosures are
presented in Note 1. Summary of Significant
Accounting Policies and Related Data in the Notes to the
Consolidated Financial Statements. Because of this election, we
accounted for our employee stock-based compensation plans under
Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to
Employees and the related interpretations.
We adopted SFAS 123(R) on April 29, 2006 using The
Black-Scholes option pricing model and The Modified Prospective
Method, which requires the compensation cost to be recognized
under SFAS 123(R) for grants issued after the adoption date
and the unvested portion of grants issued prior to the adoption
date. As a result of the adoption of
27
SFAS 123(R), we recognized non-cash share-based
compensation expense of approximately $19.4 million during
fiscal 2007 including the impact associated with the resignation
of certain former officers and employees and we anticipate
recognizing approximately $11.4 million in non-cash
compensation expense during fiscal 2008. This estimate is
affected by assumptions regarding a number of complex and
subjective variables.
Income Taxes. We account for income taxes
under the asset and liability method. Under this method,
deferred income taxes reflect the impact of temporary
differences between financial accounting and tax bases of assets
and liabilities. Such differences relate primarily to the
deductibility of certain accruals and reserves and the effect of
tax loss and tax credit carryforwards not yet utilized. Deferred
tax assets are evaluated for realization based on a
more-likely-than-not criterion in determining if a valuation
allowance should be provided.
Results
of Operations
Net
Sales
U.S. net sales increased by $3.2 million, or 2.9%, in
fiscal year 2007 compared to fiscal year 2006 primarily due to
higher average selling prices. International net sales increased
by $4.3 million, or 28%, in fiscal year 2007 compared to
fiscal year 2006, due to a 22% increase in new patient sales and
a 9% higher average selling price.
U.S. net sales increased by $17.6 million, or 20%, in
fiscal year 2006 compared to fiscal year 2005, primarily due to
an 18% increase in new patient sales, partially offset by a
decrease in replacement sales. International net sales increased
by $2.4 million, or 18%, in fiscal year 2006 compared to
fiscal 2005 due to increases in new patient sales.
Gross
Profit
Gross profit increased by $5.1 million, or 5% in fiscal
year 2007, compared to fiscal year 2006 primarily due to higher
average selling prices and increased sales volumes. Gross profit
margin decreased by 112 basis points to 86.1% compared to
fiscal 2006 due to lower production volumes affecting
operational efficiencies, which had an adverse impact of
233 basis points, non-cash stock based
compensation expense of $0.8 million with an impact of
60 basis points offset by higher average selling prices
with a favorable impact of 181 basis points.
Gross profit increased by $19.9 million, or 23%, in fiscal
year 2006 compared to fiscal year 2005, primarily due to higher
sales volumes. Gross profit margin increased by 235 basis
points to 87.2% due to increased production volumes resulting in
improved operational efficiencies impacting gross profit margin
by approximately 125 basis points and improvement in
average selling prices due to mix which had a favorable impact
of 110 basis points.
Cost of sales consists primarily of direct labor, allocated
manufacturing overhead, third-party contractor costs, royalties
and the acquisition cost of raw materials and components. Gross
margins can be expected to fluctuate in future periods based
upon the mix between U.S. and international sales, direct and
distributor sales, the VNS Therapy System selling price,
applicable royalty rates and the levels of production volume.
Operating
Expenses
Selling, General and Administrative (SG&A)
Expenses. SG&A expenses are comprised of
sales, marketing, development, general and administrative
activities. SG&A expenses for the fiscal year 2007
decreased by $3.2 million, or 2.3%, as compared to fiscal
year 2006. The decrease is primarily due to a decrease of
$37.9 million in sales, marketing and related expenses
associated with the TRD launch during fiscal year 2006, which
was partially offset by higher Finance and Administration
expenses of $5.4 million primarily associated with the
resignations of our Chief Executive Officer (CEO)
and our Chief Financial Officer (CFO), proxy cost of
approximately $1.6 million associated with a director
election contest, an increase of $10.9 million in legal and
other expenses primarily due to costs associated with the
investigation into our stock options granting and accounting
practices, and an increase in non-cash charges of
$17.7 million applicable to our adoption of
SFAS 123(R). SG&A expenses increased by
$50.3 million, or 58%, in fiscal year 2006 as compared to
fiscal year 2005. SG&A expenses include pre-tax non-cash
stock-based compensation expense of $15.4 million,
($2.3) million and $6.1 million for fiscal years ended
April 27, 2007, April 28, 2006 and April 29,
2005, respectively. In fiscal 2006, SG&A expense included a
credit of $2.3 million for pre-tax non-
28
cash stock-based compensation expense due to variable accounting
treatment for certain grants and a drop in our common stock
price relative to the price at the end of fiscal 2005.
Research and Development (R&D)
Expenses. R&D expenses are comprised of
expenses related to our product and process development, product
design efforts, clinical trials programs and regulatory
activities. R&D expenses decreased by $1.4 million, or
4.9%, as compared to fiscal year 2006 and increased by
$9.4 million, or 47%, in fiscal year 2006 as compared to
fiscal year 2005. The decrease in fiscal year 2007 is primarily
due to a reduction in engineering and regulatory expenses of
$4.9 million, partially offset by an increase of
$2.4 million in international clinical expenses and
$2.5 million in higher non-cash charges. The increases
during fiscal year 2006 as compared to fiscal year 2005 were
primarily due to additional product development programs and
expanded regulatory activities primarily related to the
depression approval and launch. R&D expenses include
pre-tax non-cash stock-based compensation expense of
$3.3 million, $1.7 million and $0.9 million for
fiscal years ended April 27, 2007, April 28, 2006 and
April 29, 2005, respectively.
Interest
Income
Interest income of $4.6 million during fiscal year 2007
increased by 45% as compared to interest income of
$3.2 million for fiscal year 2006, due to increased
interest rates. Interest income for fiscal year 2006 increased
by 199% as compared to fiscal year 2005 due to higher average
investment balances attributable to the net proceeds of
$98.3 million received from the Convertible Notes and
higher interest rates.
Interest
Expense
Interest expense of $5.9 million for fiscal year 2007
increased 96% from $3.0 million in fiscal 2006 primarily
due to higher loan balances and interest and fees applicable to
the Convertible Notes, including $0.4 million of penalty
interest. The average interest rate for fiscal 2007 was 7.06% as
compared to 6.17% in fiscal 2006.
Other
Income (Expense), Net
Other expense, net of $0.3 million for the 52 weeks
ended April 27, 2007, represented a decrease of
$0.4 million, or 548% as compared to other income of
$0.1 million for the same period during the previous fiscal
year. It primarily includes income related to the transaction
gains and losses associated with the impact of changes in
foreign currency exchange rates offset by derivative expense
associated with the extension of certain stock option grants to
former employees whose grants would have expired unexercised due
to our inability to issue stock under our stock option plans as
a consequence of our delinquent SEC reports. Other income, net
was $0.1 million for the 52 weeks ended April 28,
2006 and April 29, 2005. It primarily includes income
related to the transaction gains and losses associated with the
impact of changes in foreign currency exchange rates.
Income
Taxes
At April 27, 2007, we had net operating loss carryforwards
for federal income tax purposes of approximately
$253.4 million. The following is a reconciliation of
statutory federal income tax rates to our effective income tax
rate expressed as a percentage of loss before income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Income Tax Expense
|
|
$
|
78,775
|
|
|
$
|
99,266
|
|
|
$
|
26,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. statutory rate
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
Change in deferred tax valuation
allowance
|
|
|
30.2
|
|
|
|
31.6
|
|
|
|
32.1
|
|
Foreign taxes
|
|
|
0.1
|
|
|
|
0.1
|
|
|
|
0.1
|
|
State and local tax provision
|
|
|
0.1
|
|
|
|
0.1
|
|
|
|
0.0
|
|
Other, net
|
|
|
3.8
|
|
|
|
2.4
|
|
|
|
1.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.2
|
%
|
|
|
0.2
|
%
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29
Liquidity
and Capital Resources
Overview
We generated a net loss of $51.2 million for the year ended
April 27, 2007, as compared to a net loss of
$59.1 million for the year ended April 28, 2006 and
net loss of $18.6 million for the year ended April 29,
2005. The decrease in net loss during fiscal year 2007 as
compared to the loss during fiscal 2006 is primarily due to
decreases in SG&A expenses in the amount of
$37.9 million as a result of lower sales, marketing and
related expenses associated with the TRD launch, and
$5.6 million reduction in clinical, engineering and
regulatory expenses, partially offset by $18.7 million in
higher non-cash charges, $4.3 million associated with the
resignation of the CEO and CFO, $1.6 million contested
proxy cost and $12.0 million in legal and other expenses
related to the SEC investigation. As a result, cash used in
operations was $20.7 million for the year ended
April 27, 2007, as compared to $70.9 million used in
operations for the year ended April 28, 2006 and
$4.0 million used in operations for the year ended
April 29, 2005. To fund operations, we incurred
$5.0 million in additional indebtedness in fiscal 2007
through additional borrowings against our line of credit
facility.
We believe our current financial and capital resources will be
adequate to fund anticipated business activities through fiscal
2008, although there can be no assurance of this as this
estimate is based upon a number of assumptions, which may not
hold true. Our current assumptions include, consistent with the
federal district courts June 2007 decision, the assumption
that no default has occurred under the Indenture for our
Convertible Notes, which include principal maturity of greater
than 24 months. The Trustee has not appealed the district
courts decision; however, if the Trustee appeals the
district courts decision, and if the court of appeals
reverses the district courts decision, then all unpaid
principal and accrued interest on the outstanding Convertible
Notes will be due and payable immediately, and we may not be
able to maintain our operations as a going concern. Our
projections of the future TRD markets for VNS Therapy will be
significantly impacted by the timing and outcome of pending
reimbursement decisions for depression by major payers.
Furthermore, our liquidity could be adversely affected by the
factors affecting future operating results that are discussed in
Item 1A. Risk Factors.
Cash
Flows
Net cash provided by (used in) operating, investing and
financing activities were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Operating activities
|
|
$
|
(20,688,856
|
)
|
|
$
|
(70,876,209
|
)
|
|
$
|
(3,969,672
|
)
|
Investing activities
|
|
|
(1,425,349
|
)
|
|
|
17,501,141
|
|
|
|
(11,613,173
|
)
|
Financing activities
|
|
|
14,434,408
|
|
|
|
106,994,787
|
|
|
|
10,851,738
|
|
Operating
Activities
Net cash used in operating activities during fiscal year 2007
was approximately $20.7 million as compared to net cash
used in operating activities of approximately$70.9 million
in fiscal 2006 and approximately $4.0 million in fiscal
2005. Operational cash flow increased by approximately
$50.2 million during fiscal year 2007 primarily due to a
decrease of approximately $7.9 million in net loss, and
favorable changes in non-cash expenses of approximately
$19.9 million and in operating assets and liabilities of
approximately $22.4 million. Operational cash flow
decreased by approximately $66.9 million in fiscal year
2006 as compared to fiscal year 2005 due to a net loss in fiscal
2006 of approximately $59.1 million and an increase of
approximately $15.9 million in working capital to support
the U.S. TRD launch in fiscal 2006.
Investing
Activities
Net cash used by investing activities during fiscal year 2007
was approximately $1.4 million compared to cash provided by
investing activities in fiscal 2006 of approximately
$17.5 million and cash used during fiscal year 2005 of
approximately $11.6 million. Cash used during fiscal year
2007 was invested in the purchase of property and equipment. Net
proceeds during fiscal year 2006 of approximately
$22.8 million from the sale of short-term marketable
securities were offset by purchases of property and equipment of
approximately $4.3 million and
30
approximately $1.0 million in restricted cash. Net cash
used in investing activities in fiscal 2005 was approximately
$11.6 million and included net purchases of short-term
marketable securities of approximately $7.9 million and
purchases of property and equipment of approximately
$3.7 million.
Financing
Activities
Net cash provided by financing activities during fiscal year
2007 was approximately $14.4 million compared to net
proceeds of approximately $107.0 million in fiscal 2006 and
approximately $10.9 million in fiscal year 2005. The net
proceeds during fiscal year 2007 include approximately
$5.0 million in borrowings against our line of credit
facility and approximately $9.7 million in proceeds from
issuance of common stock, partially offset by approximately
$0.3 million in payments on financing obligations. On
January 13, 2006, we established a $40.0 million
revolving line of credit that replaced the $20.0 million
revolving line of credit that expired in September 2005.
Borrowings against the line of credit were reduced by
approximately $0.5 million to $2.5 million in fiscal
2006. On September 27, 2005, we issued Convertible Notes in
the amount of $125.0 million. Interest on the Convertible
Notes at the rate of 3% per year on the principal amount is
payable semi-annually in arrears in cash on March 27 and
September 27 of each year, beginning March 27, 2006.
Holders may convert their Convertible Notes, which were issued
in the form of $1,000 bonds, into 24.0964 shares of our
common stock per bond, which equal to a conversion price of
approximately $41.50 per share, subject to adjustments, at
any time prior to maturity. This offering provided net proceeds
of approximately $121 million. We used the proceeds for
(1) a simultaneous share buyback of 301,000 shares at
$33.20 for a total of $10.0 million and (2) the net
cost of $13.0 million of separate convertible bond hedge
and common stock warrant transactions, which transactions were
designed to limit our exposure to potential dilution from
conversion of the Convertible Notes. These transactions resulted
in net cash proceeds of $98.3 million. We received
approximately $10.5 million in connection with the issuance
of shares pursuant to our stock option and employee stock
purchase plans in fiscal year 2006.
Net cash provided by financing activities in fiscal 2005 was
approximately $10.9 million. We received approximately
$18.0 million in connection with the issuance of shares
pursuant to our stock option and employee stock purchase plans
in fiscal year 2005. Borrowings against the line of credit were
reduced by approximately $7.0 million to $3.0 million.
Debt
Instruments and Related Covenants
Line
of Credit
On January 13, 2006, we established a $40.0 million
revolving line of credit (Credit Agreement) with
Merrill Lynch Capital, a division of Merrill Lynch Business
Financial Services Inc. (Administrative Agent) and
the lenders who are party thereto (Lenders). The
credit facility has a three-year term ending January 13,
2009 and is collateralized by accounts receivable, inventory,
subsidiary stock, general intangibles, equipment and other
collateral. The collateral does not include our intellectual
property and provides the lender only limited rights and
remedies with respect to the funds raised in our Convertible
Notes offering. Pursuant to the terms of the Credit Agreement,
we agreed to maintain a minimum liquidity, which is defined as
the sum of the revolving loan limit minus the revolving loan
outstanding plus the unrestricted cash and cash equivalent
balances of $25.0 million, and to provide periodic
certifications of compliance in connection with the facility.
The amount available under the facility is limited to 85% of the
eligible accounts receivable and a portion of eligible
inventory. As of April 27, 2007 our available borrowing
capacity was approximately $19.8 million with a loan
balance of $7.5 million.
On December 29, 2006, we entered into a Consent and
Amendment Agreement with the Administrative Agent and Lenders
which provided that our receipt of the Notice of Default from
the Trustee in connection with the Indenture as a result of our
failure to file and deliver our 2006
Form 10-K
as purportedly required by the Indenture will not constitute a
default under the Credit Agreement so long as there is no
determination by a court and we have not otherwise acknowledged
that a default has occurred under the Indenture. The Consent and
Amendment Agreement with the Administrative Agent and Lenders
further provided that for the term of the Consent and Amendment
Agreement our borrowing under the Line of Credit is limited to
$7.5 million. On February 1, 2007 the terms of the
Credit Agreement required that we begin paying interest on the
minimum loan balance of $10.0 million.
31
If an event of default has occurred under the Indenture as
discussed below, we would also be in default of the
$40.0 million line of credit.
Convertible
Notes
In September 2005, we issued the Convertible Notes. Interest on
the Convertible Notes at the rate of 3% per year on the
principal amount is payable semi-annually in arrears in cash on
March 27 and September 27 of each year, beginning March 27,
2006. The Convertible Notes are unsecured and subordinated to
all of our existing and future senior debt and equal in right of
payment with our existing and future senior subordinated debt.
Holders may convert their Convertible Notes, which were issued
in the form of $1,000 bonds, into 24.0964 shares of our
common stock per bond, which equal to a conversion price of
approximately $41.50 per share, subject to adjustments, at
any time prior to maturity.
In July 2006, we received the Notice of Default from the
Trustee, pursuant to which the Trustee asserted that we were in
default of our obligations under the Indenture as a result of
our failure (1) to file with the SEC our 2006
Form 10-K
by July 12, 2006 and (2) to deliver a copy of our 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received the Notice of Acceleration from the Trustee informing
us that, pursuant to the Indenture, the Trustee declared the
Convertible Notes due and payable at their principal amount,
together with accrued and unpaid interest, and fees and
expenses, and demanding that all such principal, interest, fees
and expenses under the Convertible Notes be paid to the Trustee
immediately. As such, although the Convertible Notes mature in
2012, we have included them as a current liability on our
Consolidated Balance Sheets as of April 27, 2007 and
April 28, 2006. On June 13, 2007, a federal district
court granted summary judgment to Cyberonics and declared that
no default occurred under the Indenture. In its court filings,
the Trustee stated that it was seeking approximately
$20.0 million in damages plus interest and attorney fees,
but it reserved the right to seek immediate payment of full
value of the Convertible Notes. See Note 15.
Litigation Indenture Default Litigation.
The Trustee has not appealed the district courts decision.
If the Trustee appeals the decision of the district court, and
if the court of appeals reverses the decision of the district
court and determines that a default occurred under the
Indenture, then all unpaid principal and accrued interest on the
outstanding Convertible Notes could be due and payable
immediately unless we negotiate an amendment to the terms of the
Indenture. If the principal and accrued interest on the
outstanding Convertible Notes must be repaid immediately, we may
not have or be able to obtain access to the funds needed to
repay the indebtedness, and we may be forced to seek protection
under the Bankruptcy Code.
If principal and interest on our indebtedness must be repaid
immediately, we do not have the cash resources available to
repay the debt. If we were not able to secure additional
financing, our ability to continue as a going concern would be
uncertain.
Contractual
Obligations
We are party to a number of contracts pursuant to which we are
paying for clinical studies for current operating obligations
payable totaling $2.7 million as of April 27, 2007.
Although we have no firm commitments, we expect to make capital
expenditures of approximately $2.8 million during fiscal
year 2008, primarily to expand organizational capacity and to
enhance business infrastructure and facilities.
The chart below reflects our obligations under our material
contractual obligations as of April 27, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
Convertible Notes
|
|
|
Operating
|
|
|
|
|
|
Contractual
|
|
|
|
Line of Credit(1)
|
|
|
Issuance(2)
|
|
|
Leases(3)
|
|
|
Other(4)
|
|
|
Obligations
|
|
|
Contractual
Obligations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than One Year
|
|
$
|
10,829,222
|
|
|
$
|
129,375,000
|
|
|
$
|
3,275,102
|
|
|
$
|
177,475
|
|
|
$
|
143,656,799
|
|
1-3 Years
|
|
|
621,917
|
|
|
|
|
|
|
|
5,302,343
|
|
|
|
|
|
|
|
5,924,260
|
|
3-5 Years
|
|
|
|
|
|
|
|
|
|
|
23,309
|
|
|
|
|
|
|
|
23,309
|
|
Over 5 Years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contractual Obligations
|
|
$
|
11,451,139
|
|
|
$
|
129,375,000
|
|
|
$
|
8,600,754
|
|
|
$
|
177,475
|
|
|
$
|
149,604,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32
|
|
|
(1) |
|
Consists of $10.0 million minimum loan balance requirement
and related interest. See Note 5. Line of
Credit of the Notes to the Consolidated Financial
Statements for additional information. |
|
(2) |
|
Consists of principal and interest obligations related to the
Convertible Notes issuance presented as if the Convertible Notes
were to become due and payable within twelve months from the
issuance of this annual report. Although the Convertible Notes
mature in 2012, we have classified them as current due to our
receipt of the Notice of Default from the Trustee. |
|
(3) |
|
Consists of operating lease obligations related to facilities
and office equipment. |
|
(4) |
|
Reflects amounts we expect to expend in connection with sales,
marketing and training events and debt payments applicable to
acquisition of computer hardware and software. |
Factors
Affecting Future Operating Results and Common Stock
Price
The factors affecting our future operating results and common
stock prices are disclosed in Item 1A. Risk
Factors.
|
|
Item 7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
We are exposed to limited market risk on interest rates and
foreign currency exchange rates.
Our exposure to market risk for changes in interest rates
relates primarily to our short-term investments in commercial
paper, auction rate securities and our line of credit. We do not
hedge interest rate exposure or invest in derivative securities.
Based upon the average outstanding balances in cash, cash
equivalents and our line of credit, a 100-basis point change in
interest rates would not have a material impact on our
consolidated financial results.
Due to the global reach of our business, we are also exposed to
market risk from changes in foreign currency exchange rates,
particularly with the U.S. dollar over the Euro. Our wholly
owned foreign subsidiary is consolidated into our financial
results and is subject to risks typical of an international
business including, but not limited to, differing economic
conditions, changes in political climate, differing tax
structures, other regulations and restrictions and foreign
exchange rate volatility. Accordingly, our future results could
be materially impacted by changes in these or other factors. At
this time, we have not deemed it to be cost effective to engage
in a program of hedging the effect of foreign currency
fluctuations on our operating results using derivative financial
instruments. A sensitivity analysis indicates that, if the
U.S. dollar uniformly weakened 10% against the Euro, the
effect upon the net loss recorded during fiscal year 2007 would
be favorable by approximately $0.7 million, or 1.3%.
Conversely, if the U.S. dollar uniformly strengthened 10%
against the Euro, the impact on our operations would be
unfavorable by approximately $0.4 million, or 0.8%.
Our Convertible Notes are sensitive to fluctuations in the price
of our common stock into which the debt is convertible. Changes
in equity prices may result in changes in the fair value of the
convertible subordinated debt due to the difference between the
current market price of the debt and the market price at the
date of issuance of the debt. At April 27, 2007, a 10%
decrease in the price of our common stock could have resulted in
a decrease of approximately $4.0 million on the net fair
value of our Convertible Notes, while a 10% increase in the
price of our common stock could have resulted in an increase of
approximately $5.0 million on the fair value of our
Convertible Notes.
|
|
Item 8.
|
Financial
Statements and Supplementary Data
|
The information required by this Item is incorporated by
reference to the Consolidated Financial Statements beginning on
page F-1.
|
|
Item 9.
|
Changes
in and Disagreements With Accountants on Accounting and
Financial Disclosure
|
None.
33
|
|
Item 9A.
|
Controls
and Procedures
|
Disclosure
Controls and Procedures
|
|
(a)
|
Evaluation
of Disclosure Controls and Procedures
|
We maintain a system of disclosure controls and procedures that
are designed to ensure that information required to be disclosed
in our reports filed under the Exchange Act is recorded,
processed, summarized and reported within the time periods
specified in the SECs rules and forms. Such information is
also accumulated and communicated to management, including our
CEO and Principal Financial and Accounting Officer
(CAO), as appropriate, to allow timely decisions
regarding required disclosure. Our management, under the
supervision and with the participation of our CEO and CAO,
evaluated the effectiveness of the design and operation of our
disclosure controls and procedures (as defined in
Rules 13a-15(e)
and
15d-15(e)
under the Exchange Act) as of the end of the most recent fiscal
quarter reported on herein. Based on that evaluation, our CEO
and CAO concluded that our disclosure controls and procedures
were effective as of April 27, 2007.
|
|
(b)
|
Managements
Report on Internal Control Over Financial
Reporting
|
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting as defined in
Rules 13a-15(f)
and
15d-15(f)
under the Exchange Act. Internal control over financial
reporting is a process designed by, or under the supervision of,
the companys board of directors, management and other
personnel, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles and includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In connection with the preparation of our annual consolidated
financial statements, our management, under the supervision and
with the participation of our CEO and CAO, assessed the
effectiveness of our internal control over financial reporting
based on criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Our
management has concluded that our internal control over
financial reporting was effective as of April 27, 2007.
KPMG LLP, our independent registered public accounting firm, has
issued an audit report on managements assessment of
internal control over financial reporting as of April 27,
2007.
|
|
(c)
|
Changes
in Internal Control Over Financial Reporting
|
The following were changes in our internal control over
financial reporting that occurred during our most recent fiscal
quarter that have materially affected, or are reasonably likely
to materially affect, our internal control over financial
reporting.
|
|
|
|
|
We conducted training sessions for the Compensation Committee
and other individuals involved in or responsible for the
granting and recording of equity incentive awards;
|
|
|
|
Management implemented a control which involved a review of
measurement dates, fair value assumptions, and calculations for
all grants issued in fiscal year 2007.
|
34
In addition, the Board of Directors approved and implemented a
new equity incentive policy effective November 18, 2006,
which limited the issuance of grants to certain pre-defined
dates and required that all grants be approved by the
Compensation Committee or the Board;
Based on the changes in internal control, a material weakness
did not exist as of April 27, 2007.
Other
Changes in Internal Control Over Financial
Reporting
There have been no other changes in our internal control over
financial reporting during the quarter ended in April 27,
2007 in connection with the aforementioned evaluation that have
materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Audit
Committee Oversight
The adequacy of our internal control over financial reporting,
the accounting principles employed in our financial reporting
and the scope of independent audits are reviewed by the Audit
Committee, consisting solely of outside directors. The
independent auditors meet with, and have confidential access to,
the Audit Committee to discuss the results of their audit work.
35
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Cyberonics, Inc.:
We have audited managements assessment, included in the
accompanying Managements Report on Internal Control
Over Financial Reporting (Item 9A(b)) that Cyberonics,
Inc. maintained effective internal control over financial
reporting as of April 27, 2007, based on criteria
established in Internal Control Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Cyberonics,
Inc.s management is responsible for maintaining effective
internal control over financial reporting and for its assessment
of the effectiveness of internal control over financial
reporting. Our responsibility is to express an opinion on
managements assessment and an opinion on the effectiveness
of the Companys internal control over financial reporting
based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
managements assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Cyberonics,
Inc. maintained effective internal control over financial
reporting as of April 27, 2007, is fairly stated, in all
material respects, based on criteria established in Internal
Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
(COSO). Also, in our opinion, Cyberonics, Inc., maintained, in
all material respects, effective internal control over financial
reporting as of April 27, 2007, based on criteria
established in Internal Control Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO).
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Cyberonics, Inc. and subsidiary
as of April 27, 2007 and April 28, 2006, and the
related consolidated statements of operations,
stockholders equity (deficit) and comprehensive loss, and
cash flows for the 52 weeks ended April 27, 2007,
April 28, 2006, and April 29, 2005, and our report
dated July 6, 2007 expressed an unqualified opinion on
those consolidated financial statements.
Houston, Texas
July 6, 2007
36
|
|
Item 9B.
|
Other
Information
|
None.
PART III
|
|
Item 10.
|
Directors,
Executive Officers and Corporate Governance
|
Pursuant to general instruction G to
Form 10-K,
we incorporate by reference into this item the information to be
disclosed in our definitive proxy statement for our 2007 Annual
Meeting of Stockholders.
|
|
Item 11.
|
Executive
Compensation
|
Pursuant to general instruction G to
Form 10-K,
we incorporate by reference into this item the information to be
disclosed in our definitive proxy statement for our 2007 Annual
Meeting of Stockholders.
|
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
|
Pursuant to general instruction G to
Form 10-K,
we incorporate by reference into this item the information to be
disclosed in our definitive proxy statement for our 2007 Annual
Meeting of Stockholders.
|
|
Item 13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
Pursuant to general instruction G to
Form 10-K,
we incorporate by reference into this item the information to be
disclosed in our definitive proxy statement for our 2007 Annual
Meeting of Stockholders.
|
|
Item 14.
|
Principal
Accountant Fees and Services
|
Pursuant to general instruction G to
Form 10-K,
we incorporate by reference into this item the information to be
disclosed in our definitive proxy statement for our 2007 Annual
Meeting of Stockholders.
37
PART IV
|
|
Item 15.
|
Exhibits,
Financial Statement Schedules
|
(1) Financial Statements.
The Consolidated Financial Statements of Cyberonics, Inc. and
its subsidiary, and the Report of Independent Registered Public
Accounting Firm are included in this
Form 10-K
beginning on
page F-1:
|
|
|
|
|
Description
|
|
Page No.
|
|
Report of Independent Registered
Public Accounting Firm
|
|
|
F-2
|
|
Consolidated Balance Sheets
|
|
|
F-3
|
|
Consolidated Statements of
Operations
|
|
|
F-4
|
|
Consolidated Statements of
Stockholders Equity (Deficit) and Comprehensive Loss
|
|
|
F-5
|
|
Consolidated Statements of Cash
Flows
|
|
|
F-6
|
|
Notes to Consolidated Financial
Statements
|
|
|
F-7
|
|
(2) Financial Statement Schedules
All schedules required by
Regulation S-X
have been omitted as not applicable or not required, or the
information required has been included in the Notes to the
financial statements.
(3) Index to Exhibits
The exhibits marked with the asterisk symbol (*) are filed with
this
Form 10-K.
The exhibits marked with the cross symbol () are
management contracts or compensatory plans or arrangements filed
pursuant to Item 601(b)(10)(iii) of
Regulation S-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
3
|
.1
|
|
Amended and Restated Certificate of
Incorporation of Cyberonics, Inc.
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-3
filed on February 21, 2001
|
|
333-56022
|
|
3.1
|
|
3
|
.2
|
|
Bylaws of Cyberonics, Inc.
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 12, 2000
|
|
000-19806
|
|
3.1
|
|
3
|
.3
|
|
Amendment No. 1 to the Bylaws
of Cyberonics, Inc.
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on March 30, 2001
|
|
000-19806
|
|
3.1
|
|
4
|
.1
|
|
Second Amended and Restated
Preferred Shares Rights Agreement dated August 21, 2000
between Cyberonics, Inc. and BankBoston, N.A. (formerly known as
The First National Bank of Boston), including the Form of First
Amended Certificate of Designation of Rights, Preferences and
Privileges of Series A Participating Preferred Stock of
Cyberonics, Inc., Form of Rights Certificate and Stockholder
Rights Plan attached thereto as Exhibits A, B and C,
respectively
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 12, 2000
|
|
000-19806
|
|
4.1
|
|
4
|
.2
|
|
Amendment No. 1 to Second
Amended and Restated Preferred Share Rights Agreement dated
April 26, 2001
|
|
Cyberonics, Inc.s Annual
Report and Transition Report on
Form 10-K
for the fiscal period ended April 27, 2001 and the
transition period from July 1, 2000 to April 27, 2001
|
|
000-19806
|
|
4.2
|
|
4
|
.3
|
|
Amendment No. 2 to Second
Amended and Restated Preferred Share Rights Agreement dated
October 31, 2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
4.3
|
|
4
|
.4
|
|
Amendment No. 3 to Second
Amended and Restated Preferred Share Rights Agreement dated
December 9, 2003
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on December 12, 2003
|
|
000-19806
|
|
99.2
|
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
4
|
.5
|
|
Amendment No. 4 to Second
Amended and Restated Preferred Share Rights Agreement dated
January 9, 2004
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 13, 2004
|
|
000-19806
|
|
99.2
|
|
4
|
.6
|
|
Indenture dated September 27,
2005 between Cyberonics, Inc. and Wells Fargo Bank, National
Association, as Trustee
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.1
|
|
4
|
.7
|
|
Registration Rights Agreement dated
September 27, 2005 between Cyberonics, Inc. and Merrill
Lynch, Pierce, Fenner & Smith Incorporated, as the
Initial Purchaser
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.2
|
|
4
|
.8
|
|
Form of Confirmation of OTC
Convertible Note Hedge executed September 21, 2005 to
be effective September 27, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.3
|
|
4
|
.9
|
|
Form of Confirmation of OTC Warrant
Transaction executed September 21, 2005 to be effective
September 27, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.4
|
|
4
|
.10
|
|
Amendment No. 5 to Second
Amended and Restated Preferred Share Rights Agreement
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on February 1, 2007
|
|
000-19806
|
|
4.1
|
|
10
|
.1
|
|
License Agreement dated
March 15, 1988 between Cyberonics, Inc. and Dr. Jacob
Zabara
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.2
|
|
License Agreement dated
August 22, 2000 between Cyberonics, Inc. and
Dr. Mitchell S. Roslin
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.2
|
|
10
|
.3
|
|
Lease Agreement dated
December 5, 2002 between Cyberonics, Inc., as Lessee, and
Space Center Operating Associates, LP, as Lessor, commencing on
December 8, 2002 for Space A and
January 1, 2004 for Space B, as amended
March 3, 2003 (First Amendment), October 2, 2003
(Second Amendment), March 11, 2004 (Third Amendment),
March 17, 2004 (Subordination, Non-Disturbance and
Attornment), March 19, 2004 (Transfer of Ownership to
Triple Net Properties, LLC), March 23, 2005 (Fourth
Amendment), May 5, 2005 (Fifth Amendment) and July 13,
2005 (Sixth Amendment)
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.3
|
|
10
|
.4
|
|
Letter Agreement dated
March 28, 1997 between The Clark Estates, Inc. and
Cyberonics, Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended June 30, 1997
|
|
000-19806
|
|
10.11
|
|
10
|
.5
|
|
Purchase Agreement dated
September 21, 2005 between Cyberonics, Inc. and Merrill
Lynch, Pierce, Fenner & Smith Incorporated, as the
Initial Purchaser
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 27, 2005
|
|
000-19806
|
|
10.1
|
|
10
|
.6
|
|
Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., as
Administrative Agent and as Lender and as Sole Bookrunner and
Sole Lead Arranger, and the additional Lenders thereto dated
January 13, 2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 19, 2006
|
|
000-19806
|
|
10.1
|
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.7
|
|
Consent and Amendment Agreement
effective October 31, 2006 to the Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., individually as
Lender, Administrative Agent, Sole Bookrunner and Sole Lead
Arranger, and the additional Lenders thereto
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 6, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.8
|
|
Consent and Amendment Agreement
effective July 27, 2006 to the Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., individually as
Lender, Administrative Agent, Sole Bookrunner and Sole Lead
Arranger, and the additional Lenders thereto
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on July 27, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.9
|
|
Consulting Agreement between
Cyberonics, Inc. and BK Consulting, an assumed name used by
Reese S. Terry, Jr., a founder and member of the Board of
Directors of Cyberonics, Inc., dated August 25, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 30, 2005
|
|
000-19806
|
|
99.1
|
|
10
|
.10
|
|
Amendment to Consulting Agreement
between Cyberonics, Inc. and BK Consulting dated August 23,
2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 25, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.11
|
|
Termination of Consulting Agreement
between Cyberonics, Inc. and BK Consulting effective
November 19, 2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on December 13, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.12
|
|
Consulting Agreement dated
November 19, 2006 between Cyberonics, Inc. and Pamela B.
Westbrook
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.3
|
|
10
|
.13
|
|
Cyberonics, Inc. Amended and
Restated 1996 Stock Option Plan
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on April 29, 1999
|
|
333-77361
|
|
4.1
|
|
10
|
.14
|
|
First Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated
October 2, 2000
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended September 30, 2000
|
|
000-19806
|
|
10.2
|
|
10
|
.15
|
|
Second Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated
March 21, 2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.12
|
|
10
|
.16
|
|
Third Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated
July 27, 2001
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on January 22, 2002
|
|
333-81158
|
|
4.4
|
|
10
|
.17
|
|
Fourth Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated January
2002
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on January 22, 2002
|
|
333-81158
|
|
4.5
|
|
10
|
.18
|
|
Fifth Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated
July 19, 2002
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on July 25, 2002
|
|
333-97095
|
|
4.1
|
|
10
|
.19
|
|
Cyberonics, Inc. Amended and
Restated 1997 Stock Plan
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on March 8, 2001
|
|
333-56694
|
|
4.5
|
|
10
|
.20
|
|
First Amendment to the Cyberonics,
Inc. Amended and Restated 1997 Stock Plan dated March 21,
2001
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended July 26, 2002
|
|
000-19806
|
|
10.1
|
|
10
|
.21
|
|
Second Amendment to the Cyberonics,
Inc. Amended and Restated 1997 Stock Plan dated
November 21, 2002
|
|
Cyberonics, Inc.s Proxy
Statement for the Annual Meeting of Stockholders filed on
October 15, 2002
|
|
000-19806
|
|
Annex B
|
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.22
|
|
Cyberonics, Inc. 1998 Stock Option
Plan
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on November 3, 1998
|
|
333-66691
|
|
4.1
|
|
10
|
.23
|
|
First Amendment to the Cyberonics,
Inc. 1998 Stock Option Plan dated March 21, 2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.23
|
|
10
|
.24
|
|
Cyberonics, Inc. New Employee
Equity Inducement Plan
|
|
Cyberonics, Inc.s
Registration Statement on
Form S-8
filed on August 27, 2003
|
|
333-108281
|
|
4.3
|
|
10
|
.25
|
|
Cyberonics, Inc. 2005 Stock Plan
|
|
Cyberonics, Inc.s Proxy
Statement for the Special Meeting of Stockholders filed on
April 14, 2005
|
|
000-19806
|
|
Annex A
|
|
10
|
.26
|
|
Indemnification Agreement effective
August 1, 2003 between Cyberonics, Inc. and Robert P.
Cummins
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.32
|
|
10
|
.27
|
|
Employment Agreement effective
August 5, 2005 between Cyberonics, Inc. and Robert P.
Cummins
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 9, 2005
|
|
000-19806
|
|
99.1
|
|
10
|
.28
|
|
Letter Agreement Regarding
Advancement of Attorneys Fees effective September 28,
2006 between Cyberonics, Inc. and Robert P. Cummins
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.34
|
|
10
|
.29
|
|
Resignation Agreement effective
November 17, 2006 between Cyberonics, Inc. and Robert P.
Cummins
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.30
|
|
Severance Agreement effective
June 1, 2003 between Cyberonics, Inc. and William Steven
Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 25, 2003
|
|
000-19806
|
|
10.21
|
|
10
|
.31
|
|
Officer Stock Option Plan Agreement
dated June 2, 2003 between Cyberonics, Inc. and William
Steven Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.37
|
|
10
|
.32
|
|
Employment Agreement effective
June 15, 2006 between Cyberonics, Inc. and William Steven
Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.38
|
|
10
|
.33
|
|
Indemnification Agreement effective
June 28, 1999 between Cyberonics, Inc. and Alan J. Olsen
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.44
|
|
10
|
.34
|
|
Severance Agreement effective
July 14, 2003 between Cyberonics, Inc. and George E. Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.40
|
|
10
|
.35
|
|
Officer Stock Option Plan Agreement
dated July 14, 2003 between Cyberonics, Inc. and George E.
Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.46
|
|
10
|
.36
|
|
Employment Agreement effective
July 14, 2003 between Cyberonics, Inc. and
George E. Parker
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended October 24, 2003
|
|
000-19806
|
|
10.1
|
|
10
|
.37
|
|
First Amendment to Employment
Agreement effective June 15, 2006 between Cyberonics, Inc.
and George E. Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.48
|
|
10
|
.38
|
|
Stand Alone Stock Option Agreement
dated August 23, 2001 between Cyberonics, Inc. and Richard
L. Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.49
|
|
10
|
.39
|
|
Severance Agreement effective
January 1, 2002 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended January 25, 2002
|
|
000-19806
|
|
10.3
|
41
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.40
|
|
Employee Restricted Stock Agreement
dated July 22, 2005 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.51
|
|
10
|
.41
|
|
Employment Agreement effective
June 15, 2006 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.52
|
|
10
|
.42
|
|
Stock Option Agreement Amendment
and Bonus Agreement dated December 28, 2006 between
Cyberonics, Inc. and Richard L. Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.53
|
|
10
|
.43
|
|
Employment Agreement effective
June 15, 2006 between Cyberonics, Inc. and Pamela B.
Westbrook
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.58
|
|
10
|
.44
|
|
Letter Agreement Regarding
Advancement of Attorneys Fees effective October 12,
2006 between Cyberonics, Inc. and Pamela B. Westbrook
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.59
|
|
10
|
.45
|
|
Resignation Agreement effective
November 19, 2006 between Cyberonics, Inc. and Pamela B.
Westbrook
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.45
|
|
10
|
.46
|
|
Indemnification Agreement effective
August 1, 2003 between Cyberonics, Inc. and
David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.61
|
|
10
|
.47
|
|
Severance Agreement effective
September 17, 2003 between Cyberonics, Inc. and
David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.42
|
|
10
|
.48
|
|
Employment Agreement effective
September 17, 2003 between Cyberonics, Inc. and David S.
Wise
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended October 24, 2003
|
|
000-19806
|
|
10.2
|
|
10
|
.49
|
|
First Amendment to Employment
Agreement effective June 15, 2006 between Cyberonics, Inc.
and David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.64
|
|
10
|
.50
|
|
New Employee Equity Inducement Plan
Agreement dated September 17, 2003 between Cyberonics, Inc.
and David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.65
|
|
10
|
.51
|
|
Form of Indemnification Agreement
for directors of Cyberonics, Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.66
|
|
10
|
.52
|
|
Form of Director Restricted Stock
Agreement effective June 1, 2005
|
|
Cyberonics, Inc.s Quarterly
Form 10-Q
for the quarter ended July 29, 2005
|
|
000-19806
|
|
10.52
|
|
10
|
.53
|
|
Form of Amendment to Director Stock
Option Agreement dated December 2006 between Cyberonics, Inc.
and the directors listed on the schedule attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.68
|
|
10
|
.54
|
|
Form of Stock Option Agreement
under the Cyberonics, Inc. Amended and Restated 1996 Stock
Option Plan between Cyberonics, Inc. and the executive officers
listed on the schedule attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.69
|
|
10
|
.55
|
|
Form of Stock Option Agreement
under the Cyberonics, Inc. 2005 Stock Plan between Cyberonics,
Inc. and the executive officers listed on the schedule attached
thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.70
|
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.56
|
|
Form of Employee Restricted Stock
Agreement under the Cyberonics, Inc. 2005 Stock Plan (one-year
vesting)
|
|
Cyberonics, Inc.s Quarterly
Form 10-Q
for the quarter ended July 29, 2005
|
|
000-19806
|
|
10.2
|
|
10
|
.57
|
|
Form of Employee Restricted Stock
Agreement under the Cyberonics, Inc. 2005 Stock Plan (five-year
vesting) and the executive officers listed on the schedule
attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.72
|
|
10
|
.58
|
|
Consent and Amendment Agreement,
dated December 29, 2006, by and among Cyberonics, Inc.,
Merrill Lynch Capital, and the Lenders party to the Credit
Agreement (as defined therein)
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 5, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.59
|
|
Separation Agreement between Steve
Jennings and Cyberonics, Inc., dated January 31, 2007
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on February 6, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.60
|
|
Amended and Restated Cyberonics,
Inc. New Employee Inducement Plan
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on April 30, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.61
|
|
Employment Agreement by and between
Cyberonics, Inc. and Daniel Jeffrey Moore
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on May 1, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.62
|
|
Release Agreement by and between
Cyberonics, Inc. and John Riccardi
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on May 10, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.63*
|
|
Retention Agreement by and between
Cyberonics, Inc. and John Riccardi dated November 14, 2005
|
|
|
|
|
|
|
|
10
|
.64*
|
|
Description Of Non-Equity Incentive
Compensation Plans
|
|
|
|
|
|
|
|
10
|
.65*
|
|
Consulting Agreement between
Cyberonics, Inc. and BK Consulting, an assumed name used by
Reese S. Terry, Jr., a founder and member of the Board of
Directors of Cyberonics, Inc., dated May 16, 2007
|
|
|
|
|
|
|
|
10
|
.66*
|
|
Executive Restricted Stock
Agreement between Cyberonics, Inc. and Daniel J. Moore dated
June 18, 2007
|
|
|
|
|
|
|
|
10
|
.67*
|
|
Description of Non-Equity Incentive
Compensation under the Employment Agreement of Robert P. Cummins
|
|
|
|
|
|
|
|
21
|
.1
|
|
List of Subsidiaries of Cyberonics,
Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
21.1
|
|
23
|
.1*
|
|
Consent of Independent Registered
Public Accounting Firm, KPMG LLP
|
|
|
|
|
|
|
|
24
|
.1*
|
|
Powers of Attorney (included on the
Signature Page to this Annual Report on
Form 10-K)
|
|
|
|
|
|
|
|
31
|
.1*
|
|
Certification of the Chief
Executive Officer of Cyberonics, Inc. pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
31
|
.2*
|
|
Certification of the Chief
Financial Officer of Cyberonics, Inc. pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
32
|
.1*
|
|
Certification of the Chief
Executive Officer and Chief Financial Officer of Cyberonics,
Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
|
|
|
|
43
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Cyberonics, Inc.
|
|
|
|
By:
|
/s/ George
E. Parker III
|
Interim Principal Accounting Officer
(Principal Financial Officer and
Principal Accounting Officer)
Date: July 6, 2007
POWER OF
ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints Daniel J. Moore
and George E. Parker III, jointly and severally, his
attorneys-in-fact,
each with the power of substitution, for him in any and all
capacities, to sign any amendments to this Annual Report on
Form 10-K,
and to file the same, with exhibits thereto and other documents
in connection therewith, with the Securities and Exchange
Commission, hereby ratifying and conforming all that each of
said
attorneys-in-fact,
or his substitute or substitutes, any do or cause to be done by
virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the
dates indicated:
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
/s/ HUGH
M. MORRISON
Hugh
M. Morrison
|
|
Chairman of the Board of Directors
|
|
July 6, 2007
|
|
|
|
|
|
/s/ DANIEL
J. MOORE
Daniel
J. Moore
|
|
Director, President and
Chief Executive Officer
(Principal Executive Officer)
|
|
July 6, 2007
|
|
|
|
|
|
/s/ GEORGE
E.
PARKER III
George
E. Parker III
|
|
Interim Principal Accounting
Officer
(Principal Financial Officer and Principal Accounting Officer)
|
|
July 6, 2007
|
|
|
|
|
|
/s/ GUY
C. JACKSON
Guy
C. Jackson
|
|
Director
|
|
July 6, 2007
|
|
|
|
|
|
/s/ ALFRED
J. NOVAK
Alfred
J. Novak
|
|
Director
|
|
July 6, 2007
|
|
|
|
|
|
/s/ ALAN
J. OLSEN
Alan
J. Olsen
|
|
Director
|
|
July 6, 2007
|
|
|
|
|
|
/s/ ARTHUR
L. ROSENTHAL PH
D.
Arthur
L. Rosenthal, Ph D.
|
|
Director
|
|
July 6, 2007
|
44
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
/s/ JEFFREY
E. SCHWARZ
Jeffrey
E. Schwarz
|
|
Director
|
|
July 6, 2007
|
|
|
|
|
|
/s/ MICHAEL
J. STRAUSS, M.D.,
M.P.H.
Michael
J. Strauss, M.D., M.P.H.
|
|
Director
|
|
July 6, 2007
|
|
|
|
|
|
/s/ REESE
S.
TERRY, JR.
Reese
S. Terry, Jr.
|
|
Director
|
|
July 6, 2007
|
45
CONSOLIDATED
FINANCIAL STATEMENTS
April 27, 2007, April 28, 2006 and April 29,
2005
TOGETHER WITH INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRMS REPORT
F-1
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Cyberonics, Inc.:
We have audited the accompanying consolidated balance sheets of
Cyberonics, Inc. and subsidiary as of April 27, 2007 and
April 28, 2006, and the related consolidated statements of
operations, stockholders equity (deficit) and
comprehensive loss, and cash flows for the 52 weeks ended
April 27, 2007, April 28, 2006, and April 29,
2005. These consolidated financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of Cyberonics, Inc. and subsidiary as of April 27,
2007 and April 28, 2006, and the results of their
operations and their cash flows for the 52 weeks ended
April 27, 2007, April 28, 2006, and April 29,
2005, in conformity with U.S. generally accepted accounting
principles.
As discussed in Note 1 to the consolidated financial
statements, effective April 29, 2006, the Company changed
its method of accounting for share-based payments.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of Cyberonics, Inc.s internal control over
financial reporting as of April 27, 2007, based on criteria
established in Internal Control Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), and our report
dated July 6, 2007 expressed an unqualified opinion on
managements assessment of, and the effective operation of,
internal control over financial reporting.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. As discussed in Note 2 to the consolidated
financial statements, the Company has suffered recurring losses
from operations, received a Notice of Default and demand letter
and Notice of Acceleration for the $125 million senior
subordinated convertible notes and incurred a potential default
of the $40 million Line of Credit. These matters raise
substantial doubt about its ability to continue as a going
concern. Managements plans in regard to these matters are
also described in Note 2. The consolidated financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
Houston, Texas
July 6, 2007
F-2
CYBERONICS,
INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
ASSETS
|
Current Assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
84,804,876
|
|
|
$
|
92,355,071
|
|
Restricted cash
|
|
|
1,000,000
|
|
|
|
1,000,000
|
|
Accounts receivable, net
|
|
|
18,914,206
|
|
|
|
21,341,942
|
|
Inventories
|
|
|
17,580,830
|
|
|
|
17,304,794
|
|
Other current assets
|
|
|
3,127,345
|
|
|
|
5,274,133
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
125,427,257
|
|
|
|
137,275,940
|
|
Property and equipment, net
|
|
|
8,028,037
|
|
|
|
10,322,289
|
|
Other assets
|
|
|
4,189,589
|
|
|
|
4,702,055
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
137,644,883
|
|
|
$
|
152,300,284
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY (DEFICIT)
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
Line of credit
|
|
$
|
7,500,000
|
|
|
$
|
2,500,000
|
|
Accounts payable
|
|
|
5,951,931
|
|
|
|
5,190,385
|
|
Accrued liabilities
|
|
|
14,844,266
|
|
|
|
12,655,970
|
|
Convertible Notes
|
|
|
125,000,000
|
|
|
|
125,000,000
|
|
Other
|
|
|
115,731
|
|
|
|
1,175,606
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
153,411,928
|
|
|
|
146,521,961
|
|
Long Term Liabilities:
|
|
|
|
|
|
|
|
|
Other
|
|
|
295,184
|
|
|
|
1,148,457
|
|
|
|
|
|
|
|
|
|
|
Total Long Term Liabilities
|
|
|
295,184
|
|
|
|
1,148,457
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities
|
|
|
153,707,112
|
|
|
|
147,670,418
|
|
Stockholders Equity
(Deficit):
|
|
|
|
|
|
|
|
|
Preferred Stock, $.01 par
value per share; 2,500,000 shares authorized; no shares
issued and outstanding
|
|
|
|
|
|
|
|
|
Common Stock, $.01 par value
per share; 50,000,000 shares authorized; 26,701,054 issued
and 26,400,054 outstanding at April 27, 2007; and
25,781,349 shares issued and 25,480,349 shares
outstanding at April 28, 2006
|
|
|
267,011
|
|
|
|
257,813
|
|
Additional paid-in capital
|
|
|
265,608,804
|
|
|
|
244,648,193
|
|
Common stock warrants
|
|
|
25,200,000
|
|
|
|
25,200,000
|
|
Hedges on Convertible Notes
|
|
|
(38,200,000
|
)
|
|
|
(38,200,000
|
)
|
Deferred compensation
|
|
|
|
|
|
|
(9,167,093
|
)
|
Treasury stock, 301,000 common
shares, at cost
|
|
|
(9,993,200
|
)
|
|
|
(9,993,200
|
)
|
Accumulated other comprehensive
loss
|
|
|
(298,588
|
)
|
|
|
(649,698
|
)
|
Accumulated deficit
|
|
|
(258,646,256
|
)
|
|
|
(207,466,149
|
)
|
|
|
|
|
|
|
|
|
|
Total Stockholders Equity
(Deficit)
|
|
|
(16,062,229
|
)
|
|
|
4,629,866
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and
Stockholders Equity (Deficit)
|
|
$
|
137,644,883
|
|
|
$
|
152,300,284
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
F-3
CYBERONICS,
INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Net sales
|
|
$
|
130,968,437
|
|
|
$
|
123,441,575
|
|
|
$
|
103,442,570
|
|
Cost of sales
|
|
|
18,258,374
|
|
|
|
15,822,045
|
|
|
|
15,674,040
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
112,710,063
|
|
|
|
107,619,530
|
|
|
|
87,768,530
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
134,144,315
|
|
|
|
137,310,196
|
|
|
|
86,972,068
|
|
Research and development
|
|
|
28,092,243
|
|
|
|
29,541,707
|
|
|
|
20,092,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses
|
|
|
162,236,558
|
|
|
|
166,851,903
|
|
|
|
107,064,878
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From Operations
|
|
|
(49,526,495
|
)
|
|
|
(59,232,373
|
)
|
|
|
(19,296,348
|
)
|
Interest income
|
|
|
4,649,394
|
|
|
|
3,211,956
|
|
|
|
1,072,488
|
|
Interest expense
|
|
|
(5,913,119
|
)
|
|
|
(3,018,969
|
)
|
|
|
(444,270
|
)
|
Other income (expense), net
|
|
|
(311,112
|
)
|
|
|
69,460
|
|
|
|
84,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(51,101,332
|
)
|
|
|
(58,969,926
|
)
|
|
|
(18,583,394
|
)
|
Income tax expense
|
|
|
78,775
|
|
|
|
99,266
|
|
|
|
26,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(51,180,107
|
)
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Diluted loss per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
loss per share
|
|
|
25,514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
Shares used in computing diluted
loss per share
|
|
|
25,514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
F-4
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) AND
COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
|
|
|
Hedges on
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Stock
|
|
|
Convertible
|
|
|
Deferred
|
|
|
Treasury
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid-In Capital
|
|
|
Warrants
|
|
|
Notes
|
|
|
Compensation
|
|
|
Stock
|
|
|
Loss
|
|
|
Deficit
|
|
|
Equity
|
|
|
Balance at April 30, 2004
|
|
|
23,457,397
|
|
|
$
|
234,574
|
|
|
$
|
202,769,369
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(3,589,265
|
)
|
|
$
|
|
|
|
$
|
(646,748
|
)
|
|
$
|
(129,787,450
|
)
|
|
$
|
68,980,480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options exercised
|
|
|
1,241,889
|
|
|
|
12,419
|
|
|
|
16,674,877
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,687,296
|
|
Issuance of common stock under
Employee Stock Purchase Plan
|
|
|
82,420
|
|
|
|
824
|
|
|
|
1,335,684
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,336,508
|
|
Cancellation of restricted stock
|
|
|
(250
|
)
|
|
|
(2
|
)
|
|
|
(6,620
|
)
|
|
|
|
|
|
|
|
|
|
|
6,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation relating to
stock options
|
|
|
|
|
|
|
|
|
|
|
6,417,160
|
|
|
|
|
|
|
|
|
|
|
|
(6,417,160
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation and expense of certain stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,103,005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,103,005
|
|
Net Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,609,507
|
)
|
|
|
(18,609,507
|
)
|
Translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98,059
|
|
|
|
|
|
|
|
98,059
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,511,448
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at April 29, 2005
|
|
|
24,781,456
|
|
|
|
247,815
|
|
|
|
227,190,470
|
|
|
|
|
|
|
|
|
|
|
|
(2,896,798
|
)
|
|
|
|
|
|
|
(548,689
|
)
|
|
|
(148,396,957
|
)
|
|
|
75,595,841
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options exercised
|
|
|
637,191
|
|
|
|
6,371
|
|
|
|
8,694,565
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,700,936
|
|
Issuance of common stock under
Employee Stock Purchase Plan
|
|
|
88,970
|
|
|
|
890
|
|
|
|
1,777,939
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,778,829
|
|
Issuance of restricted stock
|
|
|
278,732
|
|
|
|
2,787
|
|
|
|
9,651,358
|
|
|
|
|
|
|
|
|
|
|
|
(9,654,145
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of restricted stock
|
|
|
(5,000
|
)
|
|
|
(50
|
)
|
|
|
(174,662
|
)
|
|
|
|
|
|
|
|
|
|
|
174,712
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation relating to
stock options
|
|
|
|
|
|
|
|
|
|
|
(2,491,477
|
)
|
|
|
|
|
|
|
|
|
|
|
2,491,477
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation and expense of certain stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
717,661
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
717,661
|
|
Purchase of Treasury stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,993,200
|
)
|
|
|
|
|
|
|
|
|
|
|
(9,993,200
|
)
|
Sale of common stock warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,200,000
|
|
Purchase of convertible note hedge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,200,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,200,000
|
)
|
Net Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,069,192
|
)
|
|
|
(59,069,192
|
)
|
Translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(101,009
|
)
|
|
|
|
|
|
|
(101,009
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,170,201
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at April 28, 2006,
|
|
|
25,781,349
|
|
|
|
257,813
|
|
|
|
244,648,193
|
|
|
|
25,200,000
|
|
|
|
(38,200,000
|
)
|
|
|
(9,167,093
|
)
|
|
|
(9,993,200
|
)
|
|
|
(649,698
|
)
|
|
|
(207,466,149
|
)
|
|
|
4,629,866
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options exercised
|
|
|
798,074
|
|
|
|
7,981
|
|
|
|
9,924,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,932,371
|
|
Unregistered shares issued
|
|
|
75,000
|
|
|
|
750
|
|
|
|
1,940,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,941,000
|
|
Issuance of common stock under
Employee Stock Purchase Plan
|
|
|
6,283
|
|
|
|
63
|
|
|
|
148,030
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
148,093
|
|
Issuance of Restricted Stock
|
|
|
52,500
|
|
|
|
525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
525
|
|
Cancellation of Restricted Stock
|
|
|
(12,152
|
)
|
|
|
(121
|
)
|
|
|
121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfer of Deferred Compensation
Balance (123R adoption)
|
|
|
|
|
|
|
|
|
|
|
(9,167,093
|
)
|
|
|
|
|
|
|
|
|
|
|
9,167,093
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash compensation expense
|
|
|
|
|
|
|
|
|
|
|
18,594,246
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,594,246
|
|
Modification of Non-employee Stock
Options
|
|
|
|
|
|
|
|
|
|
|
(258,262
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(258,262
|
)
|
Excise Tax Remediation
|
|
|
|
|
|
|
|
|
|
|
(221,071
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(221,071
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(51,180,107
|
)
|
|
|
(51,180,107
|
)
|
Translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
351,110
|
|
|
|
|
|
|
|
351,110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,828,997
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at April 27, 2007
|
|
|
26,701,054
|
|
|
$
|
267,011
|
|
|
$
|
265,608,804
|
|
|
$
|
25,200,000
|
|
|
$
|
(38,200,000
|
)
|
|
$
|
|
|
|
$
|
(9,993,200
|
)
|
|
$
|
(298,588
|
)
|
|
$
|
(258,646,256
|
)
|
|
$
|
(16,062,229
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
F-5
CYBERONICS,
INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Cash Flows From Operating
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(51,180,107
|
)
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
Non-cash items included in net
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
3,708,710
|
|
|
|
3,350,988
|
|
|
|
3,274,843
|
|
Gain on disposal of assets
|
|
|
(8,189
|
)
|
|
|
(81,433
|
)
|
|
|
(50,066
|
)
|
Unrealized (gain) loss in foreign
currency transactions
|
|
|
10,968
|
|
|
|
(104,542
|
)
|
|
|
15,758
|
|
Stock-Based Compensation
|
|
|
19,421,391
|
|
|
|
717,661
|
|
|
|
7,103,005
|
|
Amortization of financing costs
|
|
|
781,638
|
|
|
|
419,497
|
|
|
|
|
|
Other non-cash items
|
|
|
36,432
|
|
|
|
(232,752
|
)
|
|
|
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
2,809,389
|
|
|
|
(4,995,947
|
)
|
|
|
747,906
|
|
Inventories
|
|
|
90,620
|
|
|
|
(8,767,305
|
)
|
|
|
(758,512
|
)
|
Other current assets
|
|
|
2,051,878
|
|
|
|
(1,488,869
|
)
|
|
|
(668,745
|
)
|
Other assets, net
|
|
|
55,641
|
|
|
|
(84,653
|
)
|
|
|
33,435
|
|
Accounts payable and accrued
liabilities
|
|
|
1,703,008
|
|
|
|
(250,778
|
)
|
|
|
4,678,684
|
|
Other
|
|
|
(170,235
|
)
|
|
|
(288,884
|
)
|
|
|
263,527
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used In Operating
Activities
|
|
|
(20,688,856
|
)
|
|
|
(70,876,209
|
)
|
|
|
(3,969,672
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Investing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of short-term marketable
securities
|
|
|
|
|
|
|
|
|
|
|
(10,400,229
|
)
|
Proceeds from sale of short-term
marketable securities
|
|
|
|
|
|
|
22,800,000
|
|
|
|
2,500,693
|
|
Restricted cash
|
|
|
|
|
|
|
(1,000,000
|
)
|
|
|
|
|
Purchases of property and equipment
|
|
|
(1,425,349
|
)
|
|
|
(4,298,859
|
)
|
|
|
(3,713,637
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided By (Used In)
Investing Activities
|
|
|
(1,425,349
|
)
|
|
|
17,501,141
|
|
|
|
(11,613,173
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in borrowing
against line of credit
|
|
|
5,000,000
|
|
|
|
(500,000
|
)
|
|
|
(7,031,000
|
)
|
Payment related to line of credit
origination costs
|
|
|
|
|
|
|
(499,814
|
)
|
|
|
|
|
Payments on financing obligations
|
|
|
(246,701
|
)
|
|
|
(192,378
|
)
|
|
|
(141,066
|
)
|
Proceeds from issuance of
Convertible Notes, net of issuance costs
|
|
|
|
|
|
|
120,700,414
|
|
|
|
|
|
Additional costs related to
Convertible Notes
|
|
|
(3,557
|
)
|
|
|
|
|
|
|
|
|
Sale of Common Stock Warrants
|
|
|
|
|
|
|
25,200,000
|
|
|
|
|
|
Purchase of Convertible Note Hedge
|
|
|
|
|
|
|
(38,200,000
|
)
|
|
|
|
|
Proceeds from issuance of Common
Stock
|
|
|
9,684,666
|
|
|
|
10,479,765
|
|
|
|
18,023,804
|
|
Purchase of treasury stock
|
|
|
|
|
|
|
(9,993,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided By Financing
Activities
|
|
|
14,434,408
|
|
|
|
106,994,787
|
|
|
|
10,851,738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on
cash and cash equivalents
|
|
|
129,602
|
|
|
|
59,460
|
|
|
|
(56,268
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase (Decrease) in Cash
and Cash Equivalents
|
|
|
(7,550,195
|
)
|
|
|
53,679,179
|
|
|
|
(4,787,375
|
)
|
Cash and cash equivalents at
beginning of year
|
|
|
92,355,071
|
|
|
|
38,675,892
|
|
|
|
43,463,267
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end
of year
|
|
$
|
84,804,876
|
|
|
$
|
92,355,071
|
|
|
$
|
38,675,892
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplementary Disclosures of Cash
Flow Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
4,979,462
|
|
|
$
|
2,213,594
|
|
|
$
|
416,986
|
|
Cash paid for income taxes
|
|
$
|
65,609
|
|
|
$
|
98,414
|
|
|
$
|
53,312
|
|
Supplemental Disclosure of
Non-cash Activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of capital assets with
notes payable
|
|
$
|
|
|
|
$
|
497,698
|
|
|
$
|
|
|
See accompanying Notes to Consolidated Financial Statements
F-6
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Note 1.
|
Summary
of Significant Accounting Policies and Related Data
|
Nature of Operations. We are headquartered in
Houston, Texas and design, develop, manufacture and market the
Cyberonics VNS Therapy
Systemtm
(VNS Therapy System), an implantable medical device
which delivers a unique therapy, Vagus Nerve Stimulation, for
the treatment of refractory epilepsy, treatment-resistant
depression and other debilitating neurological disorders. We
have regulatory approval to market and sell the VNS Therapy
System for refractory epilepsy in the United States, Canada,
Europe, Australia and other markets. In 2001, we obtained
regulatory approval for commercial distribution of the VNS
Therapy System for the treatment of depression in the European
market and in Canada. In July 2005, the Food and Drug
Administration (FDA) approved the VNS Therapy System
as an adjunctive long-term treatment of chronic or recurrent
depression for patients 18 years of age or older who are
experiencing a major depressive episode and have not had an
adequate response to four or more adequate antidepressant
treatments.
We operate our business as a single segment with similar
economic characteristics, technology, manufacturing processes,
customers, distribution and marketing strategies, regulatory
environments and shared infrastructures. We are a
neurostimulation business focused on creating new markets,
developing other indications for VNS Therapy covered by our
method patents and expanding our business into other
neuromodulation opportunities.
Consolidation. The accompanying consolidated
financial statements include Cyberonics, Inc. and our
wholly-owned subsidiary, Cyberonics Europe, NV, and have been
prepared on a going concern basis. All significant intercompany
accounts and transactions have been eliminated.
Use of Estimates. The preparation of
consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires
management to make estimates and assumptions that affect the
amounts reported in the consolidated financial statements and
accompanying Notes. Actual results could differ from those
estimates. Critical estimates that require managements
judgment relate to the allowance for doubtful accounts,
estimates of any obsolete inventory, useful lives for property
and equipment, impairment of any long-lived assets, sales
returns and allowances, product warranties, stock option
expenses and income tax valuation allowances.
Foreign Currency Translation. The assets and
liabilities of Cyberonics Europe, NV are generally translated
into U.S. dollars at exchange rates in effect on reporting
dates, while capital accounts and certain obligations of a
long-term nature payable to the parent company are translated at
historical rates. Statement of Operations items are translated
at average exchange rates in effect during the financial
statement period. The gains and losses that result from this
process are shown in the accumulated other comprehensive loss
section of stockholders equity (deficit) and comprehensive
loss, and are not included in the determination of the results
of operations. Gains and losses resulting from foreign currency
transactions denominated in currency other than the functional
currency are included in other income and expense.
Cash and Cash Equivalents. We consider all
highly liquid investments with a maturity of three months or
less at the time of purchase to be cash equivalents.
Restricted Cash. We classify as restricted
cash highly liquid investments that otherwise would qualify as
cash equivalents, but that have been set aside as collateral and
that are unavailable for immediate withdrawal, until certain
conditions are met.
Fair Value of Financial Instruments. The
carrying amounts reported in the Consolidated Balance Sheets for
cash and cash equivalents, accounts receivable, accounts
payable, accrued liabilities and line of credit approximate
their fair values due to the short-term maturity of these
financial instruments. The fair value of our Convertible Notes
is discussed in Note 7. Convertible Notes.
F-7
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Accounts Receivable. Activity in our allowance
for doubtful accounts consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Balance at beginning of year
|
|
$
|
234,478
|
|
|
$
|
275,457
|
|
|
$
|
279,699
|
|
Increase in allowance
|
|
|
161,652
|
|
|
|
51,245
|
|
|
|
75,374
|
|
Reductions for write-offs
|
|
|
(88,047
|
)
|
|
|
(92,224
|
)
|
|
|
(79,616
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year
|
|
$
|
308,083
|
|
|
$
|
234,478
|
|
|
$
|
275,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories. We state our inventories at the
lower of cost,
first-in
first-out (FIFO) method or market. Cost includes the
acquisition cost of raw materials and components, direct labor
and overhead net of obsolescence provisions.
Property and Equipment. Property and equipment
are carried at cost, less accumulated depreciation. Maintenance,
repairs and minor replacements are charged to expense as
incurred; significant renewals and betterments are capitalized.
We compute depreciation using the straight-line method over
useful lives ranging from two to nine years. Property and
equipment under capital leases are stated at the lower of the
present value of minimum lease payments at the beginning of the
lease term or fair value at the inception of the lease. Property
and equipment under capital leases are depreciated using the
straight-line method over the shorter of the lease term or the
estimated useful life of the property.
Leases. Statement of Financial Accounting
Standards Board (SFAS) No. 13
Accounting for Leases establishes standards
of financial accounting and reporting for leases by lessees and
lessors. We are a party to the contract of leased facilities and
other lease obligations recorded in compliance with
SFAS No. 13. The lease terms provide for tenant
improvement allowances that are recorded as deferred rent and
amortized, straight line, as reduction to rent expense over the
term of the lease. At April 27, 2007 and April 28,
2006, we had approximately $152,000 and $209,000 of deferred
rent, respectively. Scheduled rent increases and paid holidays
are recognized on a straight-line basis over the term of the
lease.
Long-Lived Assets. SFAS No. 144,
Accounting for the Impairment or Disposals of
Long-Lived Assets provides a single accounting model
for long-lived assets to be disposed of. SFAS No. 144
also establishes the criteria for classifying an asset as held
for sale and sets the scope of business to be disposed of that
qualifies for reporting as discontinued operations as well as
changes the timing of recognizing losses on such operations.
Other Current Assets and Other Assets. Other
current assets and other assets include prepaid expenses and
Convertible Notes origination costs, which are expensed in the
normal course of business over the periods these expenses
benefit.
Stock Options. Prior to April 29, 2006,
we adopted the disclosure-only provisions of
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123) and
SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure
(SFAS No. 148). Because of this
election, we accounted for our employee stock-based compensation
plans under Accounting Principles Board (APB)
Opinion No. 25, Accounting for Stock Issued to
Employees (APB No. 25) and the
related interpretations.
We adopted SFAS No. 123 (revised
2004) Share-Based Payment
(SFAS 123(R)) on April 29, 2006 using
The Black-Scholes option pricing model and The Modified
Prospective Method which requires the compensation cost to be
recognized under SFAS 123(R) for grants issued after the
adoption date and the unvested portion of grants issued prior to
the adoption date. As a result of the adoption of
SFAS 123(R), we recognized non-cash share-based
compensation expense of approximately $19.4 million during
fiscal year 2007 including the impact associated with the
resignations of certain former officers and employees. The
deferred compensation expense is recorded over the vesting
period of each unit of stock-based compensation.
F-8
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table illustrates the effect on net loss and loss
per share if we had applied the fair value recognition
provisions of SFAS No. 123 and SFAS No. 148
to stock-based employee compensation.
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Net loss as reported
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
(1)Add: Stock-based employee
compensation expense included in reported net loss, net of
related tax effects
|
|
|
717,661
|
|
|
|
7,103,005
|
|
(1)Deduct: Total stock-based
employee compensation expense determined under the fair value
method for all awards, net of related tax effects
|
|
|
(26,384,997
|
)
|
|
|
(21,924,138
|
)
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$
|
(84,736,528
|
)
|
|
$
|
(33,430,640
|
)
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
Basic as reported
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Basic pro forma
|
|
$
|
(3.40
|
)
|
|
$
|
(1.39
|
)
|
Diluted as reported
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Diluted pro forma
|
|
$
|
(3.40
|
)
|
|
$
|
(1.39
|
)
|
|
|
|
(1) |
|
There was no tax effect included in these amounts due to the
valuation allowance. |
Revenue Recognition. We sell our products
through a combination of a direct sales force in the United
States and certain European countries and through distributors
elsewhere. We recognize revenue when title to the goods and risk
of loss transfer to customers, providing there are no remaining
performance obligations required of us or any matters requiring
customer acceptance. We record estimated sales returns and
discounts as a reduction of net sales in the same period revenue
is recognized. Our revenues are dependent upon sales to new and
existing customers pursuant to our current policies. Changes in
these policies or sales terms could impact the amount and timing
of revenue recognized.
Research and Development. All research and
development costs are expensed as incurred.
Product Warranty. We offer warranties on our
leads and generators for one to two years from the date of
implant, depending on the product in question. We provide at the
time of shipment for costs estimated to be incurred under our
product warranties. Provisions for warranty expenses are made
based upon projected product warranty claims.
Changes in our liability for product warranties during the
52 weeks ended April 27, 2007, April 28, 2006 and
April 29, 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
Balance at
|
|
|
Warranty
|
|
|
|
|
|
the End
|
|
|
|
the Beginning
|
|
|
Expense
|
|
|
Warranties
|
|
|
of the
|
|
Year
|
|
of the Year
|
|
|
Recognized
|
|
|
Settled
|
|
|
Year
|
|
|
2007
|
|
$
|
46,991
|
|
|
$
|
27,037
|
|
|
$
|
(5,206
|
)
|
|
$
|
68,822
|
|
2006
|
|
|
46,991
|
|
|
|
10,312
|
|
|
|
(10,312
|
)
|
|
|
46,991
|
|
2005
|
|
|
50,935
|
|
|
|
29,077
|
|
|
|
(33,021
|
)
|
|
|
46,991
|
|
License Agreements. We have executed licensing
agreements under which we have secured the rights provided under
certain patents. Royalties payable under the terms of these
agreements are expensed as incurred.
Income Taxes. We account for income taxes
under the asset and liability method. Under this method,
deferred income taxes reflect the impact of temporary
differences between financial accounting and tax basis of assets
and liabilities. Such differences relate primarily to the
deductibility of certain accruals and reserves and the
F-9
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
effect of tax loss and tax credit carryforwards not yet
utilized. Deferred tax assets are evaluated for realization
based on a more-likely-than-not criterion in determining if a
valuation allowance should be provided.
Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered
or settled. The effect on deferred tax assets and liabilities of
a change of tax rates is recognized in operations in the period
that includes the enactment date.
Net Earnings (Loss) Per
Share. SFAS No. 128, Earnings
Per Share requires dual presentation of earnings per
share (EPS): basic EPS and diluted EPS. Basic EPS is
computed by dividing net earnings or loss applicable to common
stockholders by the weighted average number of common shares
outstanding for the period. Diluted EPS includes dilutive stock
options and unvested restricted stock that are considered common
stock equivalents using the treasury stock method.
The following table sets forth the computation of basic and
diluted net loss per share of common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(51,180,107
|
)
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average shares
outstanding
|
|
|
25,514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average shares
outstanding
|
|
|
25,514,232
|
|
|
|
24,916,938
|
|
|
|
24,036,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Diluted loss per share
|
|
$
|
(2.01
|
)
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Excluded from the computation of diluted EPS for the
52 weeks ended April 27, 2007, April 28, 2006 and
April 29, 2005 were outstanding options and unvested
restricted stock to purchase approximately 5.6 million,
7.3 million and 6.9 million common shares,
respectively, because to include them would have been
anti-dilutive due to the net loss.
We issued $125.0 million of Senior Subordinated Convertible
Notes due in 2012 (Convertible Notes) during fiscal
2006 and, in conjunction with the Convertible Notes, purchased
Call Options (the Note Hedge) and sold common stock
warrants (Warrants). The Convertible Notes are
convertible into approximately 3,000,000 shares of our
common stock. Dilution is measured in accordance with the
if converted method of SFAS No. 128,
Earnings Per Share, which assumes conversion
of the Convertible Notes and adjusts net earnings (loss) for
interest expense net of tax; however, due to net losses, the
Convertible Notes are anti-dilutive and are not included in the
computation of diluted EPS. We purchased the Note Hedge to buy
approximately 3,000,000 shares of our common stock at an
exercise price of $41.50 per share. Purchased call options are
anti-dilutive and are not included in the computation of diluted
EPS. We issued Warrants to sell approximately
3,000,000 shares of our common stock at an exercise price
of $50.00 per share. In accordance with the treasury stock
method of SFAS No. 128, Earnings Per
Share, the Warrants are not included in the
computation of diluted EPS because the Warrants exercise
price was greater than the average market price of the common
stock.
Comprehensive Loss. Comprehensive loss is the
total of net loss and all other non-owner changes in equity.
F-10
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The accompanying consolidated financial statements have been
prepared assuming that we will continue as a going concern.
Since inception, we have incurred an accumulated deficit of
approximately $258.6 million. We have incurred substantial
expenses, primarily for research and development activities that
include product and process development, clinical trials and
related regulatory activities, sales and marketing activities,
manufacturing
start-up
costs and systems infrastructure. For the fiscal years ended
April 27, 2007, April 28, 2006 and April 29,
2005, we had a net loss of $51.2 million and
$59.1 million and $18.6 million, respectively. To fund
our operations in fiscal 2006, we incurred additional
indebtedness through the issuance of $125.0 million of
Convertible Notes and the establishment of a $40.0 million
line of credit (Credit Agreement). In July 2006, we
received a notice of default and demand letter (Notice of
Default) from Wells Fargo Bank, National Association (the
Trustee), pursuant to which the Trustee asserted
that we were in default of our obligations under the Indenture
dated September 27, 2005 (Indenture), between
us, as issuer, and the Trustee, as trustee, with respect to our
Convertible Notes, as a result of our failure (1) to file
with the SEC our Annual Report on
Form 10-K
for the fiscal year ended April 28, 2006 (2006
Form 10-K)
by July 12, 2006 and (2) to deliver a copy of the 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received a notice of acceleration and demand letter
(Notice of Acceleration) from the Trustee informing
us that, pursuant to the Indenture, the Trustee declared the
Convertible Notes due and payable at their principal amount,
together with accrued and unpaid interest, and fees and
expenses, and demanding that all such principal, interest, fees
and expenses under the Convertible Notes be paid to the Trustee
immediately. We believe that no default occurred under the
Indenture and, on June 13, 2007, a federal district court
granted summary judgment to Cyberonics and declared that no
default occurred under the Indenture. In its court filings, the
Trustee stated that it was seeking approximately
$20.0 million in damages plus interest and attorney fees,
but it reserved the right to seek immediate payment of full
value of the Convertible Notes. The Trustee has not appealed the
district courts decision; however, if the Trustee appeals
the district courts decision, and if the court of appeals
reverses the district courts decision and determines that
a default occurred under the Indenture, then all unpaid
principal and accrued interest on the outstanding Convertible
Notes could be due and payable. Accordingly, until this matter
is resolved, we have included them as a current liability on our
Consolidated Balance Sheets as of April 27, 2007 and
April 28, 2006. In addition, if an event of default has
occurred under the Indenture, we would also be in default of the
$40.0 million Line of Credit. If principal and interest on
our indebtedness must be repaid immediately, we do not have the
cash resources available to repay the debt. If we were not able
to renegotiate the terms of the indenture or to secure
additional financing, this could raise substantial doubt
regarding our ability to continue as a going concern. The
accompanying consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
Raw materials
|
|
$
|
9,205,449
|
|
|
$
|
10,709,541
|
|
Finished goods
|
|
|
6,702,196
|
|
|
|
4,960,028
|
|
Work-in-process
|
|
|
1,673,185
|
|
|
|
1,635,225
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
17,580,830
|
|
|
$
|
17,304,794
|
|
|
|
|
|
|
|
|
|
|
F-11
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
Note 4.
|
Property
and Equipment
|
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
Computer equipment
|
|
$
|
9,164,999
|
|
|
$
|
9,158,340
|
|
Manufacturing equipment
|
|
|
8,788,850
|
|
|
|
8,057,989
|
|
Leasehold improvements
|
|
|
4,218,858
|
|
|
|
4,040,486
|
|
Furniture and fixtures
|
|
|
3,518,179
|
|
|
|
3,735,069
|
|
Office equipment
|
|
|
1,415,515
|
|
|
|
1,417,397
|
|
Construction in progress
|
|
|
528,149
|
|
|
|
1,145,828
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,634,550
|
|
|
|
27,555,109
|
|
Accumulated depreciation
|
|
|
(19,606,513
|
)
|
|
|
(17,232,820
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
8,028,037
|
|
|
$
|
10,322,289
|
|
|
|
|
|
|
|
|
|
|
On January 13, 2006, we established a $40.0 million
Credit Agreement. The Credit Agreement has a three-year term
ending January 13, 2009 and is collateralized by accounts
receivable, inventory, subsidiary stock, general intangibles,
equipment and other collateral. The collateral does not include
our intellectual property and provides the lender only limited
rights and remedies with respect to the funds raised in our
September 2005 offering of Convertible Notes. We agreed to
maintain a minimum liquidity of $25.0 million, which is
defined as the sum of the revolving loan limit minus the
revolving loan outstanding plus the unrestricted cash and cash
equivalent balances and provide periodic certifications of
compliance in connection with the Credit Agreement. The amount
available under the Credit Agreement is limited to 85% of the
eligible accounts receivable and a portion of eligible
inventory. As of April 27, 2007, our available borrowing
capacity was approximately $19.8 million with a loan
balance of $7.5 million.
Interest is payable at a base rate offered for loans in United
States dollars for the period of one month under the British
Bankers Association LIBOR rates, plus a base margin rate of
1.75% on the greater of the outstanding loan balance or the
minimum
agreed-upon
loan balance. The rates effective as of April 27, 2007 and
April 28, 2006 were a LIBOR rate of 5.32% and a base rate
margin of 1.75% for a combined rate of 7.07% and a LIBOR rate of
4.97% and a base rate margin of 1.75% for a combined rate of
6.72%, respectively. The minimum loan balance is
$2.5 million through May 31, 2006; $5.0 million
through September 30, 2006; $7.5 million through
January 31, 2007 and $10.0 million through
January 13, 2009. The fees associated with the credit
facility include a one-time commitment fee of $400,000, a
collateral fee ranging from 0.25% 1.0% of the
outstanding loan balance and other usual and customary fees
associated with this type of facility.
On April 29, 2005, we had a revolving credit facility of
$20.0 million with a one-year term that ended in September
2005. The credit facility was collateralized by accounts
receivable, inventory, equipment, documents of title, general
intangibles, subsidiary stock and other collateral. The amount
available to borrow under the facility was limited to 80% of
eligible accounts receivable and a portion of eligible
inventory. As of April 29, 2005, the eligible balance of
our accounts receivable was approximately $13.5 million. We
had borrowings of $3.0 million outstanding under the credit
facility and an available borrowing capacity of approximately
$7.8 million. Interest was payable in the amount of the
Chase Bank rate of 5.75% on the greater of $3.0 million or
the average of the net balance owed by us at the close of each
day during the period. Under the terms of the revolving credit
facility, we agreed to maintain liquidity (being the aggregate
of availability under the credit facility and our cash on hand)
equal to or greater than $10.0 million. An unused line of
credit fee was payable at the rate of 0.5%.
F-12
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As disclosed by us in a Notification of Late Filing on
Form 12b-25
filed on September 1, 2006, we were not able to file our
First Quarter
Form 10-Q
pending completion of the Audit Committees review of
previous option grants and resolution of any disclosure and
accounting issues arising from the results of the review. On
October 31, 2006, we entered into a Consent and Amendment
Agreement with the Administrative Agent and Lenders providing
that certain events will not constitute a default under the
Credit Agreement prior to December 31, 2006. Such events
included, among other events, (1) our failure to file
timely with the SEC our 2006
Form 10-K
and our quarterly reports on
Form 10-Q,
including the First Quarter
Form 10-Q;
(2) our failure to maintain compliance with the NASDAQ
listing standards because of our failure to file such SEC
reports and (3) our receipt of a Notice of Default from the
Trustee in connection with the Indenture as a result of our
failure to timely file and deliver our 2006
Form 10-K
as purportedly required by the Indenture, so long as there is no
determination by a court and we have not otherwise acknowledged
that a default has occurred under the Indenture.
On December 29, 2006, we entered into a Consent and
Amendment Agreement with the Administrative Agent and Lenders
which provided that the failure to file timely with the SEC our
2006
Form 10-K
will not constitute a default under the Credit Agreement prior
to January 8, 2007. The Consent and Amendment Agreement
with the Administrative Agent and Lenders further provided that
certain events will not constitute a default under the Credit
Agreement prior to February 28, 2007. Such events include,
among other events, (1) failure to file timely with the SEC
our 2006 quarterly reports on
Form 10-Q,
including our Quarterly Report on
Form 10-Q
for the period ended July 28, 2006 (First Quarter
Form 10-Q)
and our Quarterly Report on
Form 10-Q
for the period ended October 27, 2006 (Second Quarter
Form 10-Q);
(2) our failure to maintain compliance with the NASDAQ
listing standards because of our failure to file such SEC
reports; and (3) our receipt of the Notice of Default from
the Trustee in connection with the Indenture as a result of our
failure to file and deliver our 2006
Form 10-K
as purportedly required by the Indenture, so long as there is no
determination by a court, and we have not otherwise
acknowledged, that a default has occurred under the Indenture.
The Consent and Amendment Agreement further provided that, for
the term of the Consent and Amendment Agreement, our borrowing
under the line of credit is limited to $7.5 million. As of
April 27, 2007, loans aggregating $7.5 million in
principal amount were outstanding under the Credit Agreement.
Effective February 1, 2007, we are required to pay interest
based on the minimum
agreed-upon
loan balance of $10.0 million, but we cannot borrow more
than $7.5 million in principal amount until the Trustee
withdraws the Notice of Default or a court determines that a
default in connection with the Indenture has not occurred.
|
|
Note 6.
|
Accrued
Liabilities
|
Accrued liabilities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
Payroll and other compensation
|
|
$
|
7,279,726
|
|
|
$
|
6,839,060
|
|
Clinical costs
|
|
|
2,746,677
|
|
|
|
529,582
|
|
Professional services
|
|
|
1,214,821
|
|
|
|
680,683
|
|
Royalties
|
|
|
922,221
|
|
|
|
1,061,893
|
|
Tax accruals
|
|
|
807,909
|
|
|
|
963,426
|
|
Other
|
|
|
1,872,912
|
|
|
|
2,581,326
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
14,844,266
|
|
|
$
|
12,655,970
|
|
|
|
|
|
|
|
|
|
|
In April 2007, the Board of Directors approved a reduction in
force with an approximate accrued cost of $1.5 million. As
of April 27, 2007, $0.7 million remained unpaid and
accrued.
F-13
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
Note 7.
|
Convertible
Notes
|
On September 27, 2005, we issued $125 million of
Convertible Notes. Interest on the Convertible Notes at the rate
of 3% per year on the principal amount is payable semi-annually
in arrears in cash on March 27 and September 27 of each year
beginning March 27, 2006. The Convertible Notes are
unsecured and subordinated to all of our existing and future
senior debt and equal in right of payment with our existing and
future senior subordinated debt. Holders may convert their
Convertible Notes, which were issued in the form of $1,000
bonds, into 24.0964 shares of our common stock per bond,
which equal to a conversion price of approximately $41.50 per
share, subject to adjustments, at any time prior to maturity.
Holders who convert their Convertible Notes in connection with
certain fundamental changes may be entitled to a make-whole
premium in the form of an increase in the conversion rate. A
fundamental change will be deemed to have occurred upon a change
of control, liquidation or a termination of trading. The
make-whole premium, depending on the price of the stock and the
date of the fundamental change, may range from 6.0241 to
0.1881 shares per bond, when the stock price ranges from
$33.20 to $150.00, respectively. If a fundamental change of our
company occurs, the holder may require us to purchase all or a
part of their Convertible Notes at a price equal to 100% of the
principal amount of the Convertible Notes to be purchased plus
accrued and unpaid interest, if any. We may, at our option,
instead of paying the fundamental change purchase price in cash,
pay it in our common stock valued at a 5% discount from the
market price of our common stock for the 20 trading days
immediately preceding and including the third day prior to the
date we are required to purchase the Convertible Notes, or in
any combination of cash and shares of our common stock. This
offering provided net proceeds of approximately
$121 million. We used the proceeds for (1) a
simultaneous share buyback of 301,000 shares at $33.20 for
a total of $10.0 million and (2) the net cost of
$13.0 million related to the Note Hedge and Warrants, which
transactions were designed to limit our exposure to potential
dilution from conversion of the Convertible Notes. These
transactions resulted in net cash proceeds of approximately
$98.3 million. The estimated fair value of the Convertible
Notes as of April 27, 2007 and April 28, 2006 was
$115.0 million and $107.0 million, respectively.
Market quotes obtained from brokers were used to estimate the
fair value of this debt.
On September 27, 2005, we entered into a registration
rights agreement (the Registration Rights Agreement)
in connection with our issuance of the Convertible Notes. Under
the Registration Rights Agreement, we were required to file a
registration statement for the Convertible Notes and the shares
into which the Convertible Notes are convertible on or before
July 14, 2006 and to use reasonable best efforts to cause
the registration statement to become effective on or before
October 12, 2006. Due to delays in completing our
consolidated financial statements for the fiscal year ended
April 28, 2006, we did not file the required registration
statement. As a result of failing to file the registration
statement on a timely basis, we are obligated by the terms of
the Registration Rights Agreement to pay specified liquidated
damages to the holders of the Convertible Notes for the period
during which the failure continues. Such liquidated damages per
year equal 0.25% of the principal amount of the outstanding
Convertible Notes during the first
90-day
period (a total of $78,125 for the first 90 days) and 0.50%
of the principal amount of the outstanding Convertible Notes for
the period commencing 91 days following the failure to file
the registration statement (an additional $156,250 for each
90-day
period during which the failure to obtain the effectiveness of
the registration statement continues). The liquidated damages
are payable in arrears on each date on which interest payments
are payable. As of April 27, 2007, approximately $56,000
has been accrued in accrued liabilities and is recorded in the
Consolidated Balance Sheets. Liquidated damages were not
applicable in fiscal 2006.
Convertible
Notes Indenture Default Notice
Pursuant to the Indenture, we are required to deliver to the
Trustee within 15 days after we file them with
the SEC copies of all Annual Reports on
Form 10-K
and other information, documents and other reports that we are
required to file with the SEC pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934, as amended
(Exchange Act). In July 2006, we received the Notice
of Default from the Trustee, pursuant to which the Trustee
asserted that we are in default under the Indenture as a result
of our failure (1) to file with the SEC our 2006
Form 10-K
by July 12, 2006 and (2) to deliver a copy of the 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received the Notice of Acceleration from the Trustee informing
us that, pursuant to the Indenture,
F-14
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the Trustee has declared the Convertible Notes due and payable
at their principal amount, together with accrued and unpaid
interest, and fees and expenses, and demanding that all such
principal, interest, fees and expenses under the Convertible
Notes be paid to the Trustee immediately.
We believe that no default occurred under the Indenture. In June
2007, a federal district court declared that no default occurred
under the Indenture. For a detailed description of the lawsuit,
refer to Note 15. Litigation
Indenture Default Litigation. The Trustee has not appealed
the district courts decision. If the Trustee appeals the
district courts decision and if the court of appeals
reverses the district courts decision, then a default will
have occurred under the Indenture. If a default occurred under
the Indenture, then all unpaid principal and accrued interest on
the outstanding Convertible Notes will be due and payable
immediately unless we negotiate an amendment to the terms of the
Indenture. Until this matter is finally resolved, we have
included these Convertible Notes as a current liability on our
consolidated balance sheets as of April 27, 2007 and
April 28, 2006.
|
|
Note 8.
|
Convertible
Note Hedge and Warrants
|
On September 27, 2005, we issued $125 million of
Convertible Notes, purchased the Note Hedge and sold Warrants.
The Convertible Notes are convertible into approximately
3,000,000 shares of our common stock. We purchased the Note
Hedge to enable the purchase of approximately
3,000,000 shares of our common stock at an exercise price
of $41.50 per share. We issued the Warrants to sell
approximately 3,000,000 shares of our common stock at an
exercise price of $50.00 per share. The purpose of the purchase
of the Note Hedge and the sale of the Warrants was to limit our
exposure to potential dilution from conversion of the
Convertible Notes subject to the Note offering. The Note Hedge
and the Warrants are recorded in stockholders equity on
the consolidated balance sheet.
|
|
Note 9.
|
Stockholders
Equity (Deficit)
|
Preferred Stock. We have 2,500,000 shares
of undesignated Preferred Stock authorized and available for
future issuance, of which none have been issued through
April 27, 2007. With respect to the shares authorized, our
Board of Directors, at its sole discretion, may determine, fix
and alter dividend rights, dividend rates, conversion rights,
voting rights, terms of redemption, redemption prices,
liquidation preferences and the number of shares constituting
any such series and may determine the designation, terms and
conditions of the issuance of any such shares.
Preferred Share Purchase Rights. In January
1997, our Board of Directors declared a dividend of one
Preferred Share Purchase Right (Right) on each
outstanding share of our common stock to stockholders of record
on March 10, 1997. We amended and restated the Preferred
Share Rights (Plan) on August 21, 2000. The
Rights will become exercisable following the tenth day after a
person or group of affiliated persons (an Acquiring
Person), acquires beneficial ownership of 15% or more of
our common stock or announces commencement of a tender offer,
the consummation of which would result in such person or group
of persons becoming an Acquiring Person (a Triggering
Event). Each Right entitles the holder thereof to buy
1/1000
of a share of our Series A Participating Preferred Stock at
an exercise price of $150 (the Exercise Price). We
will be entitled to redeem the Rights at $.01 per Right at any
time prior to a Triggering Event. If, prior to redemption of the
Rights, a person becomes an Acquiring Person, each Right (except
for Rights owned by the Acquiring Person, which will thereafter
be void) will entitle the holder thereof to purchase, at the
Rights then current exchange price, that number of shares
of our common stock, or, in certain circumstances as determined
by our Board, cash, other property or other securities having a
market value at that time of twice the Rights exercise
price. In the event a person becomes an Acquiring Person and we
sell more than 50% of our assets or earning power or we are
acquired in a merger or other business combination, proper
provision must be made so that a holder of a Right which has not
theretofore been exercised (except for Rights owned by the
Acquiring Person, which will thereafter be void), will
thereafter have the right to receive, upon exercise of a Right,
shares of common stock of the acquiring company having a value
equal to two times the then current Exercise Price. At any time
after a Triggering Event and prior to acquisition by such
Acquiring Person of 50% or more of the outstanding common stock,
our Board of Directors may exchange the Rights (other than
Rights owned by the Acquiring Person or its affiliates) for our
common stock at an exchange ratio of one share of common stock
per Right.
F-15
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In April 2001, we amended the Plan to designate the State of
Wisconsin Investment Board (SWIB) as an Exempt
Person under the terms of the Plan as long as SWIB is the
Beneficial Owner of less than 20%. In December 2003, we amended
the Plan to designate Boston Scientific Corporation
(BSX) as an Exempt Person under the terms of the
Plan as long as BSX is the Beneficial Owner of less than 20% of
our common stock, or such percentage that is less than 20% as
shall be held by BSX as of the close of business on
January 15, 2004. In January 2007, we amended the Plan to
extend the final expiration date of the Plan to January 29,
2010.
|
|
Note 10.
|
Stock
Incentive and Purchase Plans
|
Stock Options. We adopted SFAS 123(R)
effective April 29, 2006 using The Black-Scholes option
pricing model and The Modified Prospective Method which requires
the compensation cost to be recognized under SFAS 123(R)
for grants issued after the adoption date and the unvested
portion of grants issued prior to the adoption date. Prior to
April 29, 2006, we adopted the disclosure-only provisions
of SFAS No. 123 and SFAS No. 148. Because of
this election, we accounted for our employee stock-based
compensation plans under APB 25 and the related interpretations.
The calculation of grant date fair market value requires
judgment, as several of the factors used must be estimated,
including stock price volatility and employee stock option
exercise behavior.
As of April 27, 2007, we have reserved an aggregate of
15,250,000 shares of common stock for issuance pursuant to
our 1988 Stock Option Plan, 1996 Stock Option Plan, 1997 Stock
Option Plan, 1998 Stock Option Plan, Amended and Restated New
Employee Equity Inducement Plan and the 2005 Stock Option Plan
(collectively, the Stock Option Plans). Options
granted under the Stock Option Plans generally vest monthly over
four or five years following their date of grant. The vesting of
certain options occurs up to eight years from the grant date.
Options granted under the Stock Option Plans have maximum terms
of 10 years. The 1997 Stock Option Plan, the Amended and
Restated New Equity Inducement Plan and the 2005 Stock Option
Plan allow issuance of either nonstatutory or incentive stock
options and restricted stock, while the 1996 and the 1998 Stock
Option Plans provide for issuance of nonstatutory stock options
exclusively. For the 52 weeks ended April 27, 2007, we
granted 156,250 options at a weighted average exercise price of
approximately $22.78 per share. In compliance with the
provisions of our stock option plans, stock option grant prices
are equal to the closing price of our common stock on the last
trading day prior to the grant date. Stock option fair values
are calculated using the closing stock price on the day of
grant. Stock options to purchase approximately 5.5 million
shares at a weighted average exercise price of $20.62 per share
were outstanding as of April 27, 2007.
Amounts recognized in the consolidated financial statements for
share-based compensation are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Total cost of share-based payment
plans during the year
|
|
$
|
19,796,954
|
|
|
$
|
717,661
|
|
|
$
|
7,103,005
|
|
Amounts capitalized in inventory
and fixed assets during the year
|
|
|
(915,111
|
)
|
|
|
|
|
|
|
|
|
Amounts recognized in operations
for amounts previously capitalized in inventory and fixed assets
|
|
|
539,548
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts charged against
operations, before income tax benefit
|
|
$
|
19,421,391
|
|
|
$
|
717,661
|
|
|
$
|
7,103,005
|
|
Amount of related income tax
benefit recognized in operations
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no income tax benefit recognized due to the deferred
tax valuation allowance. The non-cash charges applicable to
share-based compensation increased cost of goods sold by
$0.7 million, sales, general and administrative expenses by
$15.4 million, which includes $3.7 million applicable
to the resignations of the Chief Executive Officer
(CEO) and Chief Financial Officer (CFO)
in the third quarter of fiscal 2007, and research and
development by $3.3 million during the 52 weeks ended
April 27, 2007.
F-16
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes information regarding total stock
option activity for the 52 weeks ended April 27, 2007
and April 28, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
|
|
|
|
|
|
|
Wtd. Avg.
|
|
|
Wtd. Avg.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd. Avg.
|
|
|
|
|
|
|
|
|
|
Wtd. Avg.
|
|
|
Fair
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
|
Wtd. Avg.
|
|
|
Wtd. Avg.
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
Number
|
|
|
Exercise
|
|
|
Market
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
Number of
|
|
|
Exercise
|
|
|
Fair Market
|
|
|
Contractual
|
|
|
Intrinsic
|
|
Options
|
|
of Shares
|
|
|
Price
|
|
|
Value
|
|
|
Term
|
|
|
Value
|
|
|
Shares
|
|
|
Price
|
|
|
Value
|
|
|
Term
|
|
|
Value
|
|
|
Outstanding beginning
of year
|
|
|
6,839,578
|
|
|
$
|
20.18
|
|
|
$
|
15.54
|
|
|
|
|
|
|
$
|
32,873,282
|
|
|
|
6,923,046
|
|
|
$
|
17.93
|
|
|
$
|
13.98
|
|
|
|
|
|
|
$
|
42,485,418
|
|
Granted
|
|
|
156,250
|
|
|
|
22.78
|
|
|
|
11.36
|
|
|
|
|
|
|
|
173,443
|
|
|
|
1,120,513
|
|
|
|
35.65
|
|
|
|
26.48
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
798,074
|
|
|
|
11.95
|
|
|
|
9.53
|
|
|
|
|
|
|
|
7,221,524
|
|
|
|
637,090
|
|
|
|
13.66
|
|
|
|
11.02
|
|
|
|
|
|
|
|
12,360,044
|
|
Forfeited
|
|
|
497,481
|
|
|
|
25.72
|
|
|
|
19.34
|
|
|
|
|
|
|
|
1,033,370
|
|
|
|
557,208
|
|
|
|
30.49
|
|
|
|
22.99
|
|
|
|
|
|
|
|
1,232,491
|
|
Expired
|
|
|
230,910
|
|
|
|
27.91
|
|
|
|
21.20
|
|
|
|
|
|
|
|
373,183
|
|
|
|
9,683
|
|
|
|
39.01
|
|
|
|
29.11
|
|
|
|
|
|
|
|
5,154
|
|
Outstanding end of year
|
|
|
5,469,363
|
|
|
|
20.62
|
|
|
|
15.72
|
|
|
|
4.47
|
|
|
|
23,467,483
|
|
|
|
6,839,578
|
|
|
|
20.18
|
|
|
|
15.54
|
|
|
|
4.39
|
|
|
|
35,351,864
|
|
Fully Vested and
Exercisable end of year
|
|
|
4,329,499
|
|
|
|
18.72
|
|
|
|
14.45
|
|
|
|
3.61
|
|
|
|
21,610,813
|
|
|
|
4,302,595
|
|
|
|
17.18
|
|
|
|
13.35
|
|
|
|
3.57
|
|
|
|
28,344,613
|
|
Expected to vest end of
year
|
|
|
979,820
|
|
|
|
28.25
|
|
|
|
20.74
|
|
|
|
7.81
|
|
|
|
1,480,270
|
|
|
|
2,174,605
|
|
|
|
25.95
|
|
|
|
19.72
|
|
|
|
8.24
|
|
|
|
5,856,553
|
|
For the 52 weeks ended April 29, 2005, we granted
approximately 1.5 million share options at a weighted
average fair market value of $22.75 with an aggregate intrinsic
value of $22.9 million as of April 29, 2005.
Approximately 1.2 million share options at an aggregate
intrinsic value of approximately $30.5 million were
exercised and shares with a fair value of $17.6 million
vested during the 52 weeks ended April 29, 2005.
We use the Black-Scholes option pricing methodology to calculate
the grant date fair market value of stock option grants and
nonvested share grants. There are no post-vesting restrictions
on the shares issued. This methodology takes into account
variables such as implied volatility, dividend yield rate,
expected option term and risk-free interest rate. The expected
term is based upon observation of actual time elapsed between
the date of grant and the exercise of options per group of
employees.
The following table lists the assumptions used to estimate the
grant date fair market value of our stock option grants for the
52 weeks ended April 27, 2007, April 28, 2006 and
April 29, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
Per APB 25 and Pro Forma Disclosure
|
Per FAS 123(R)
|
|
Requirements of SFAS 123 and SFAS 148
|
For the 52 Weeks Ended
|
|
For the 52 Weeks Ended
|
|
|
April 27, 2007
|
|
|
|
April 28, 2006
|
|
April 29, 2005
|
|
Dividend Yield
|
|
|
|
Dividend Yield
|
|
|
|
|
Risk-free interest rate
per grant date
|
|
4.51% - 5.23%
|
|
Risk-free interest rate
rolling 12 months
|
|
3.85%
|
|
3.59%
|
Expected option term in
years per group of employees
|
|
4.98 - 6.96
|
|
Expected option term in
years for the company as a whole
|
|
6.24
|
|
5.74
|
Implied volatility at grant date
|
|
32.10% - 54.47%
|
|
Historic Volatility at the end of
each reporting period
|
|
84.58%
|
|
88.08%
|
Discount for post-vesting
restrictions
|
|
None
|
|
Discount for post-vesting
restrictions
|
|
None
|
|
None
|
Option price
|
|
Closing price on last trading day
prior to date of grant
|
|
Option price
|
|
Closing price on last trading day
prior to date of grant
|
|
Closing price on last trading day
prior to date of grant
|
Grant price
|
|
Closing price on date of grant
|
|
Grant Price
|
|
Closing price on last trading day
prior to date of grant
|
|
Closing price on last trading day
prior to date of grant
|
F-17
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Total compensation cost for the 52 weeks ended
April 27, 2007 for the stock options was approximately
$15.6 million. As of April 27, 2007, there was
approximately $20.3 million of unrecognized compensation
cost related to unvested stock options which is expected to vest
over a weighted-average period of 2.81 years.
During the 52 weeks ended April 27, 2007,
April 28, 2006 and April 29, 2005, stock options with
a fair market value of $19.7 million, $20.7 million
and $17.6 million vested, respectively.
Cash received from option exercises under all share-based
payment arrangements for the 52 weeks ended April 27,
2007, April 28, 2006 and April 29, 2005 was
approximately $9.5 million, $8.7 million and
$16.7 million, respectively. Cash received from
Employees Stock Purchase Plan for the 52 weeks ended
April 27, 2007, April 28, 2006 and April 29, 2005
was approximately $0.2 million, $1.8 million and
$1.3 million, respectively. We have realized no tax benefit
for the tax deductions from option exercise of share-based
payment arrangements. We did not settle any equity instruments
granted under share-based payment arrangements for cash for any
of the periods presented herein.
We have not repurchased common shares for the purpose of
satisfying share-based compensation obligations. We issued new
shares upon exercise of stock option grants.
Restricted Stock, Restricted Stock Units and Other
Share-Based Awards. We may grant restricted
stock, restricted stock units or stock awards to certain
employees and directors. The shares typically vest over a period
of one to five years from the date of issue. In August 2005, we
executed an employment agreement with Robert P. Cummins, our
former CEO, President and Chairman of the Board. This employment
agreement provided that we would use our best efforts to issue
an additional 75,000 shares of restricted stock on the
first and second anniversaries of its execution. This was a
liability classified award due to the provisions of his
employment agreement. Mr. Cummins employment
agreement terminated with his resignation on November 17,
2006, resulting in the reversal of a $1.0 million liability
that had been previously recognized for the above restricted
stock.
Nonvested restricted stock is issued to grantees on the date of
the grant, entitling them to dividends, if any, and voting
rights for their respective shares. Sale or transfer of the
shares is restricted until they are vested. The fair market
value of the restricted shares at grant date is amortized
ratably over the requisite service period which is one to five
years. As of April 27, 2007, our unamortized compensation
expense for these grants totaled $3.0 million which is
expected to be amortized over a weighted average period of
4.04 years. We recognized $3.0 million of compensation
expense related to these grants during the 52 weeks ended
April 27, 2007. We recognized $2.3 million and
$0.7 million of compensation expense related to these
grants during the 52 weeks ended April 28, 2006 and
April 29, 2005, respectively.
The following table details the activity in the nonvested
restricted stock awards for the 52 weeks ended
April 27, 2007 and April 28, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
|
|
|
|
Wtd. Avg.
|
|
|
Aggregate
|
|
|
|
|
|
Wtd. Avg.
|
|
|
Aggregate
|
|
|
|
Number of
|
|
|
Grant Date
|
|
|
Intrinsic
|
|
|
Number of
|
|
|
Grant Date
|
|
|
Intrinsic
|
|
|
|
Shares
|
|
|
Fair Value
|
|
|
Value
|
|
|
Shares
|
|
|
Fair Value
|
|
|
Value
|
|
|
Outstanding beginning
of period
|
|
|
270,889
|
|
|
$
|
36.10
|
|
|
$
|
6,011,027
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
Granted
|
|
|
52,500
|
|
|
|
20.89
|
|
|
|
1,164,975
|
|
|
|
278,732
|
|
|
|
36.16
|
|
|
|
6,327,216
|
|
Vested
|
|
|
150,220
|
|
|
|
37.75
|
|
|
|
3,333,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
28,309
|
|
|
|
35.29
|
|
|
|
628,177
|
|
|
|
7,843
|
|
|
|
38.30
|
|
|
|
178,036
|
|
Outstanding end of
period
|
|
|
144,860
|
|
|
|
29.03
|
|
|
|
3,214,443
|
|
|
|
270,889
|
|
|
|
36.10
|
|
|
|
6,149,180
|
|
Employee Stock Purchase Plan. Under our 1991
Employee Stock Purchase Plan of Cyberonics, Inc. (Stock
Purchase Plan), 950,000 shares of our common stock
have been reserved for issuance. Subject to certain limits, the
F-18
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Stock Purchase Plan allows eligible employees to purchase shares
of our common stock through payroll deductions of up to 15% of
their respective current compensation at a price equaling 95% of
the fair market value of our common stock on the last business
day of the purchase period. Purchase periods, under provisions
of the Stock Purchase Plan, are six months in length and begin
on the first business days of June and December. At
April 27, 2007, 413,874 shares remain available for
future issuances under the Stock Purchase Plan. No compensation
expense is recorded for the employee stock purchase plan.
Modifications. After we failed to file our
2006
Form 10-K
by July 27, 2006, our registration statements on
Form S-8
for the Stock Purchase Plan and our Stock Option Plans became
ineffective, and between July 27, 2006 and February 9,
2007, we were unable to issue stock under either plan. As a
result of our inability to issue stock under the Stock Option
Plans, we amended the stock option agreements for certain grants
that would otherwise have expired to extend the exercise or
expiration period during the 39 weeks ended
January 26, 2007. This modification impacted approximately
142,000 options that were issued to 18 ex-employees and
approximately 45,000 options issued to five active employees and
resulted in compensation expense of approximately $120,000 for
the 52 weeks ended April 27, 2007 and derivative
expense of approximately $147,000. With the filing of our
Form 10-Q
for the period ended October 27, 2006 on February 9,
2007, we became current in our filings and were again able to
issue stock under the plans. No further amendments were required.
Section 409A of the Internal Revenue Code (IRC)
imposes an excise tax on a grantees gain from the exercise
of a stock option granted with an exercise price less than the
fair market value of the common stock on the date of the grant.
The excise tax applies only to that portion of a grant that
vests after December 31, 2004, and any grants that vest
after December 31, 2004 and are exercised on or before
December 31, 2005 are exempt from the excise tax. The
proposed regulations under Section 409A permit a grantee to
avoid the excise tax by adjusting the exercise price for an
affected grant up to the fair market value on the date of the
grant. As to Section 16 officers, the adjustment was
required to be implemented by December 31, 2006. As to
non-Section 16 officers, the adjustment must be implemented
by December 31, 2007.
As discussed in Note 15. Litigation
Governmental Investigations of Options Granting Practices,
the Audit Committee concluded that incorrect measurement dates
were used for certain of our stock option grants. Unless the
exercise price for certain of these grants is adjusted to the
fair market value on the date of the grant, the grantees will be
subject to an excise tax under Section 409A. In December
2006, we entered into agreements with four current and former
Section 16 officers, not including members of our Board,
Robert P. Cummins, former CEO, President and Chairman of the
Board or Pamela B. Westbrook, former CFO, agreeing to make
payments commencing in January 2008 in consideration of the
officers agreement to amend their affected stock option
agreements to adjust the exercise price to the fair market value
on the date of the grant. At the same time, we also entered into
agreements with Ms. Westbrook and five current and former
members of our Board amending their affected stock option
agreements, without any payment from us, to adjust the exercise
price to the fair market value on the date of the grant.
During December 2006, we entered into agreements with ten
Section 16 officers including members of our Board and
Ms. Westbrook to correct the exercise price on options
representing approximately 182,000 shares impacted by
Section 409A of the IRC. The cost associated with the
remediation applicable to the grants impacted by
Section 409A will be approximately $0.4 million, of
which we recognized the vested portion that represents
approximately $0.3 million during the 52 weeks ended
April 27, 2007.
On November 17, 2006, Mr. Robert Cummins resigned his
position as Chairman of the Board, President and CEO. His
resignation agreement provided for the acceleration of all
outstanding nonvested restricted stock and stock options. Due to
these provisions, we accelerated the vesting of 80,000 nonvested
shares and approximately 172,000 stock options and recognized
additional expenses in the amount of approximately
$2.7 million during the 52 weeks ended April 27,
2007. In addition, we recognized expenses in the amount of
$1.9 million applicable to the issuance of 75,000
unregistered shares that vested immediately.
F-19
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
On November 19, 2006, Ms. Pamela Westbrook resigned
her position as CFO. Her resignation agreement provided for the
acceleration of stock options and nonvested shares that would
have vested within the 12 months following her date of
resignation. Due to these provisions, we accelerated the vesting
of 1,000 nonvested shares and approximately 11,000 stock options
and recognized additional expenses in the amount of
approximately $0.1 million for the 52 weeks ended
April 27, 2007.
The adoption of SFAS 123(R) on April 29, 2006 had the
following effects on our operations and cash flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended April 27, 2007
|
|
|
|
Without
|
|
|
Effect of
|
|
|
|
|
|
|
SFAS 123(R)
|
|
|
SFAS 123(R)
|
|
|
As reported
|
|
|
Loss from continuing operations
|
|
$
|
(35,154,136
|
)
|
|
$
|
(14,372,359
|
)
|
|
$
|
(49,526,495
|
)
|
Loss before income taxes
|
|
|
(36,728,973
|
)
|
|
|
(14,372,359
|
)
|
|
|
(51,101,332
|
)
|
Net loss
|
|
|
(36,807,748
|
)
|
|
|
(14,372,359
|
)
|
|
|
(51,180,107
|
)
|
Cash flow used in operations
|
|
|
(20,688,856
|
)
|
|
|
|
|
|
|
(20,688,856
|
)
|
Cash flow provided by financing
activities
|
|
|
14,434,408
|
|
|
|
|
|
|
|
14,434,408
|
|
Basic loss per share
|
|
|
(1.45
|
)
|
|
|
(0.56
|
)
|
|
|
(2.01
|
)
|
Diluted loss per share
|
|
|
(1.45
|
)
|
|
|
(0.56
|
)
|
|
|
(2.01
|
)
|
The $14.4 million effect of the adoption of
SFAS 123(R) is net of $0.7 million, that would have
been recorded under the intrinsic value method had we continued
to apply APB No. 25 for stock-based compensation expenses,
$4.2 million for restricted stock and $0.1 million for
stock option grants modifications.
The following table illustrates the effect on net loss and loss
per share if we had applied the fair market value recognition
provisions of SFAS 123(R) for the 52 weeks ended
April 28, 2006 and April 29, 2005.
|
|
|
|
|
|
|
|
|
|
|
For the 52 Weeks Ended
|
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Net loss as reported
|
|
$
|
(59,069,192
|
)
|
|
$
|
(18,609,507
|
)
|
(1)Add: Stock-based employee
compensation expense included in net loss, net of tax effects
|
|
|
717,661
|
|
|
|
7,103,005
|
|
(1)Deduct: Total stock-based
employee compensation expenses determined under the fair value
method for all awards, net of related tax effects
|
|
|
(26,384,997
|
)
|
|
|
(21,924,138
|
)
|
|
|
|
|
|
|
|
|
|
Pro-forma net loss
|
|
$
|
(84,736,528
|
)
|
|
$
|
(33,430,640
|
)
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
Basic as reported
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Basic pro-forma
|
|
$
|
(3.40
|
)
|
|
$
|
(1.39
|
)
|
Diluted as reported
|
|
$
|
(2.37
|
)
|
|
$
|
(0.77
|
)
|
Diluted pro-forma
|
|
$
|
(3.40
|
)
|
|
$
|
(1.39
|
)
|
|
|
|
(1) |
|
There was no tax effect included in these amounts due to the
valuation allowance. |
Stock Recognition Program. In May 1992, our
Board of Directors established the Cyberonics Employee Stock
Recognition Program. Since its inception, a total of
8,200 shares of our common stock have been reserved for
issuance as special recognition grants. The shares are granted
to employees for special performances
and/or
contributions at the discretion of our President, based on
nominations made by fellow employees. At April 27, 2007,
2,230 shares remain available for future issuances under
the program.
F-20
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
Note 11.
|
New
Accounting Pronouncements
|
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs an Amendment to ARB
No. 43, Chapter 4. This statement amends the
guidance in Accounting Research Bulletin (ARB)
No. 43, Chapter 4, Inventory Pricing,
to clarify the accounting for abnormal amounts of idle
facility expense, freight, handling costs, and wasted material
(spoilage). Paragraph 5 of ARB 43, Chapter 4,
previously stated that ...under some circumstances,
items such as idle facility expense, excessive spoilage, double
freight, and rehandling costs may be so abnormal as to require
treatment as current period charges... This statement
requires that those items be recognized as current-period
charges regardless of whether they meet the criterion of
so abnormal. In addition, this statement
requires that allocation of fixed production overheads to the
costs of conversion be based on the normal capacity of the
production facilities. The provisions of this statement are
effective for inventory costs incurred during fiscal years
beginning after June 15, 2005. The adoption of
SFAS No. 151 as of April 29, 2006 did not have a
material impact on our consolidated operating results or
financial position.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets
(SFAS 153), an amendment to APB Opinion
No. 29. The guidance in APB Opinion No. 29,
Accounting for Nonmonetary Transactions, is
based on the principle that exchanges of nonmonetary assets
should be measured based on the fair value of the assets
exchanged. The guidance in that opinion, however, included
certain exceptions to that principle. This statement amends APB
No. 29 to eliminate the exception for nonmonetary exchanges
of similar productive assets and replaces it with a general
exception for exchanges of nonmonetary assets that do not have
commercial substance. A nonmonetary exchange has commercial
substance if the future cash flows of the entity are expected to
change significantly as a result of the exchange. The provisions
of this statement are effective for nonmonetary asset exchanges
occurring in fiscal periods beginning after June 15, 2005.
The adoption of SFAS No. 153 as of April 29, 2006
did not have a material impact on our consolidated operating
results or financial position.
In December 2004, the FASB issued SFAS No. 123(R).
This statement supersedes APB Opinion No. 25 and its
related implementation guidance. This statement establishes
standards for the accounting for transactions in which an entity
exchanges its equity instruments for goods or services. It also
addresses transactions in which an entity incurs liabilities in
exchange for goods or services that are based on the fair value
of the entitys equity instruments or that may be settled
by the issuance of those equity instruments. This statement
focuses primarily on accounting for transactions in which an
entity obtains employee services in share-based payment
transactions. This statement does not change the accounting
guidance for share-based payment transactions with parties other
than employees provided in Statement No. 123 as originally
issued and Emerging Issues Task Force (EITF) Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to
Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. This statement does not
address the accounting for employee share ownership plans, which
are subject to American Institute of Certified Public
Accountants (AICPA) Statement of Position
93-6,
Employers Accounting for Employee Stock Ownership
Plans. We have adopted SFAS 123(R) starting on
April 29, 2006 using The Black-Scholes Option Pricing Model
and The Modified Prospective Method which requires the
compensation cost to be recognized under SFAS 123(R) for
grants issued after the adoption date and the unvested portion
of grants issued prior to the adoption date. As a result of the
adoption of SFAS 123(R), we recognized non-cash share-based
compensation expense of approximately $19.4 million during
fiscal year 2007 including the impact associated with the
resignation of certain former officers and employees.
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections a
replacement of Accounting Principles Board (APB) Opinion
No. 20 and FASB Statement No. 3. This
statement replaces APB Opinion No. 20, Accounting
Changes, and FASB Statement No. 3,
Reporting Accounting Changes in Interim Financial
Statements, and changes the requirements for the
accounting for and reporting of a change in accounting
principle. This statement applies to all voluntary changes in
accounting principle. It also applies to changes required by an
accounting pronouncement in the unusual instance that the
pronouncement does not include specific transition provisions.
When a pronouncement includes specific transition provisions,
those provisions should be followed. This statement requires
that retrospective application of a change in accounting
principle be limited to the
F-21
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
direct effects of the change. Indirect effects of a change in
accounting principle, such as a change in nondiscretionary
profit-sharing payments resulting from an accounting change,
should be recognized in the period of the accounting change.
This statement is effective for accounting changes and
corrections of errors made in fiscal years beginning
December 15, 2005. The adoption of FAS 154 as of
April 29, 2006 had no impact on our consolidated operating
results or financial position.
In September 2006, the FASB issued FAS No. 157,
Fair Value Measurements
(FAS 157). This statement defines fair value,
establishes a framework for measuring fair value in GAAP and
expands disclosures about fair value measurements. This
statement applies under other accounting pronouncements that
require or permit fair value measurements, the FASB having
previously concluded in those accounting pronouncements that
fair value is the relevant measurement attribute. Accordingly,
this statement does not require any new fair value measurements.
However, for some entities, the application of this statement
will change current practice. FAS 157 is effective with
fiscal years beginning after November 15, 2007. We are
currently evaluating the impact that the implementation of
FAS 157 may have on our consolidated results of operations
and financial position.
In December 2006, FASB issued a FASB Staff Position
(FSP)
EITF 00-19-2
Accounting for Registration Payment Arrangements
(FSP 00-19-2).
This FSP addresses an issuers accounting for registration
payment arrangements. This FSP specifies that the contingent
obligation to make future payments or otherwise transfer
consideration under a registration payment arrangement, whether
issued as a separate agreement or included as a provision of a
financial instrument or other agreement, should be separately
recognized and measured in accordance with FASB Statement
No. 5 Accounting for Contingencies.
The guidance in this FSP amends FASB Statements
No. 133, Accounting for Derivative Instruments and
Hedging Activities, and No. 150,
Accounting for Certain Financial Instruments with
Characteristics of both Liabilities and Equity, as
well as FASB Interpretation No. 45,
Guarantors Accounting and Disclosure Requirements
for Guarantees, Including Indirect Guarantees of Indebtedness of
Others to include scope exceptions for registration
payment arrangements. This FSP is effective immediately for
registration payment arrangements and the financial instruments
subject to those arrangements that are entered into or modified
subsequent to the date of issuance of this FSP. For registration
payment arrangements and financial instruments subject to those
arrangements that were entered into prior to the issuance of
this FSP, this is effective for financial statements issued for
fiscal years beginning after December 15, 2006, and interim
periods within those fiscal years. We are currently evaluating
the impact that the implementation of FSP
EITF 00-19-2
may have on our consolidated results of operations and financial
position.
In February 2007, the FASB issued FAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities Including an amendment of FASB
Statement No. 115 (FAS 159).
This Statement permits entities to choose to measure many
financial instruments and certain other items at fair value. The
objective is to improve financial reporting by providing
entities with the opportunity to mitigate volatility in reported
earnings caused by measuring related assets and liabilities
differently without having to apply complex hedge accounting
provisions. This Statement is expected to expand the use of fair
value measurement, which is consistent with the Boards
long-term measurement objectives for accounting for financial
instruments. This Statement is effective as of the beginning of
an entitys first fiscal year that begins after
November 15, 2007. Early adoption is permitted as of the
beginning of a fiscal year that begins on or before
November 15, 2007, provided the entity also elects to apply
the provisions of FASB Statement No. 157, Fair
Value Measurements. We are currently evaluating the
impact that the implementation of FAS 159 may have on our
consolidated operating results of operations and financial
position.
In June 2006, FASB issued FAS Interpretation No. 48
Accounting for Uncertainty in Income Taxes
an interpretation of FASB Statement No. 109
(FIN 48). This Interpretation clarifies the
accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with FASB
Statement No. 109, Accounting for Income
Taxes. This Interpretation prescribes a recognition
threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected
to be taken in a tax return. This Interpretation also provides
guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and
transition. The adoption of this Interpretation is required for
fiscal years
F-22
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
beginning after December 15, 2006. We are still evaluating
the potential impact that the adoption of FIN 48 as of
April 28, 2007 will have on our consolidated operating
results or financial position.
In September 2006, the SEC issued SAB No. 108,
Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial
Statements (SAB 108). SAB 108
provides guidance on the consideration of the effects of prior
year misstatements in quantifying current year misstatements for
the purpose of a materiality assessment. SAB 108
establishes an approach that requires quantification of
financial statement errors based on the effects of each of the
companys balance sheet and statement of operations and the
related financial statement disclosures. We are required to
adopt SAB 108 in our annual consolidated financial
statements covering the fiscal years ending after
November 15, 2006. The adoption of SAB 108 did not
have an impact on our consolidated operating results or
financial position for the fiscal year ended April 27, 2007.
The U.S. and foreign components of loss before income taxes
and the provision for income taxes are presented in this table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
Loss before income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
(48,172,762
|
)
|
|
$
|
(57,271,372
|
)
|
|
$
|
(17,917,356
|
)
|
Foreign
|
|
|
(2,928,570
|
)
|
|
|
(1,698,554
|
)
|
|
|
(666,038
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(51,101,332
|
)
|
|
$
|
(58,969,926
|
)
|
|
$
|
(18,583,394
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for current income tax
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
State and local
|
|
|
27,790
|
|
|
|
39,730
|
|
|
|
|
|
Foreign
|
|
|
50,985
|
|
|
|
59,536
|
|
|
|
26,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
78,775
|
|
|
$
|
99,266
|
|
|
$
|
26,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following is a reconciliation of the statutory federal
income tax rate to our effective income tax rate expressed as a
percentage of loss before income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
U.S. statutory rate
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
Change in deferred tax valuation
allowance
|
|
|
30.2
|
|
|
|
31.6
|
|
|
|
32.1
|
|
Foreign taxes
|
|
|
0.1
|
|
|
|
0.1
|
|
|
|
0.1
|
|
State and local tax provision
|
|
|
0.1
|
|
|
|
0.1
|
|
|
|
0.0
|
|
Other, net
|
|
|
3.8
|
|
|
|
2.4
|
|
|
|
1.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.2
|
%
|
|
|
0.2
|
%
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-23
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Significant components of our deferred tax assets are as follows:
|
|
|
|
|
|
|
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Federal net operating loss
carryforwards
|
|
$
|
82,344,559
|
|
|
$
|
74,861,125
|
|
State net operating loss
carryforwards and other
|
|
|
9,337,842
|
|
|
|
6,543,275
|
|
Deferred compensation expense
|
|
|
8,238,132
|
|
|
|
3,710,945
|
|
Foreign net operating loss
carryforwards
|
|
|
7,305,790
|
|
|
|
6,380,628
|
|
Federal tax credit carryforwards
|
|
|
4,207,517
|
|
|
|
4,309,541
|
|
Charitable contribution
carryforwards
|
|
|
877,286
|
|
|
|
507,781
|
|
Accrued expenses
|
|
|
710,119
|
|
|
|
609,128
|
|
Property and equipment
|
|
|
467,325
|
|
|
|
312,930
|
|
Inventory costs capitalized
|
|
|
400,011
|
|
|
|
310,055
|
|
Reserves
|
|
|
258,237
|
|
|
|
283,444
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
114,146,818
|
|
|
|
97,828,852
|
|
Deferred tax liabilities, net
|
|
|
|
|
|
|
|
|
Deferred tax valuation allowance
|
|
|
(114,146,818
|
)
|
|
|
(97,828,852
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets and
liabilities
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
At April 27, 2007, we have net operating loss carryforwards
of approximately $253.4 million for federal income tax
purposes, which expire during the years 2007 through 2026, and
tax credit carryforwards of approximately $4.2 million for
federal income tax purposes which expire during the years 2007
through 2021. At April 27, 2007, we had net operating loss
carryforwards of approximately $112.0 million for state and
local income tax purposes, which expire at various dates
beginning in 2007. In 2004 and 2006, we experienced an ownership
change as defined in Section 382 of the IRC. Our ability to
utilize credit carryforwards to offset future tax liabilities
and utilize certain net operating losses to offset future
taxable income may be limited pursuant to IRC Section 382.
We purchased the Note Hedge to buy approximately three million
shares of our common stock at an exercise price of $41.50 per
share in connection with the issuance of our Convertible Notes
during the quarter ended October 28, 2005. The Convertible
Notes and the Note Hedge are considered a synthetic debt
instrument under the rules of Treasury
Regulation 1.1275-6.
Tax benefits derived from Note Hedge amortization will be
recorded in equity.
A valuation allowance is established if it is
more-likely-than-not that all or a portion of the deferred tax
assets will not be realized. We have historically experienced
significant operating losses and operate in an industry subject
to rapid technological changes. We believe there is sufficient
uncertainty regarding future taxable income and realizability of
deferred tax assets such that a valuation allowance is required
to fully offset deferred tax assets for the 52 weeks ended
April 27, 2007. We continually review the adequacy and
necessity of the valuation allowance in accordance with the
provision of SFAS No. 109 Accounting for
Income Taxes. Of the total valuation allowance at
April 27, 2007, approximately $20.8 million relates to
stock option compensation deductions and $2.4 million
relates to amortization of the Note Hedge. The tax benefit
associated with stock option compensation deductions and
amortization of the Note Hedge will be credited to equity when
realized. The valuation allowance increased approximately
$16.3 million and $25.0 million for the 52 weeks
ended April 27, 2007 and April 28, 2006, respectively,
due primarily to an increase in the federal net operating loss
carryforwards for tax years 2006 and 2005.
F-24
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
Note 13.
|
Employee
Retirement Savings Plan
|
We sponsor an employee retirement savings plan (the
Savings Plan) which qualifies under
Section 401(k) of the IRC. The Savings Plan is designed to
provide eligible employees with an opportunity to make regular
contributions into a long-term investment and savings program.
Substantially all U.S. employees are eligible to
participate in the Savings Plan beginning with the first
quarterly open enrollment date following start of employment. In
July 2004, we started matching 50% of employees
contributions up to 6% of eligible earnings. We incurred
expenses applicable to the contributions to this plan in the
amounts of approximately $1.2 million, $1.5 million
and $0.8 million for the fiscal years 2007, 2006 and 2005,
respectively.
|
|
Note 14.
|
Commitments
and Contingencies
|
Post-market Clinical Surveillance. Pursuant to
the post-market surveillance conditions specified as part of our
FDA marketing approval, we are required to conduct two clinical
studies on treatment-resistant depression patients. One study of
460 patients, D-21, is a randomized controlled study
assessing three different stimulation paradigms. The other
study, the TRD Registry, is a longitudinal registry that will
follow 1,000 VNS patients and 1,000 non-VNS patients for up to
five years. Enrollment in both studies has commenced and is
ongoing. We expense the costs related to these long-term
follow-up
activities as they are incurred and establish accruals for such
costs incurred but not paid as of the respective balance sheet
dates.
License Agreements. We have executed a license
agreement which provides us with worldwide exclusive rights
under five U.S. patents (and their international
counterparts) covering the method and devices of the VNS Therapy
System for vagus nerve and other cranial nerve stimulation for
the control of epilepsy and other movement disorders, as well as
a number of other conditions and disorders. The license
agreement provides that we will pay a royalty equal to the
greater of $36,000 per year or at the rate of 3% of net sales of
licensed products during fiscal years 2004 through 2011, after
which the royalty rate will decline to one percent for the
remaining term of the licensed patents. These patents expire
between 2011 and 2022. The license agreement runs for successive
three-year terms, renewable at our election. The license
agreement, and its periods of extension, may not be terminated
by the licensor without cause. Our royalty payments pursuant to
this agreement are expensed as incurred.
We have an agreement with an inventor on two patents co-owned by
us pursuant to which we are obligated to pay 1.0% of the first
$10 million of net obesity sales covered by one of the
patents and 0.5% of net obesity sales thereafter. The agreement
also obligates us to pay minimum royalties of $25,000 per year
for five years commencing January 1, 2000 and up to
$325,000 in additional advanced royalties based on achievement
of certain milestones.
Royalty expenses for the 52 weeks ended April 27,
2007, April 28, 2006 and April 29, 2005 were
$3.8 million, $3.6 million and $3.1 million,
respectively.
Lease Agreements. We lease facilities in
Houston, Texas and several sales offices in Europe under
noncancelable operating leases, as well as transportation and
office equipment under noncancelable operating leases. The lease
terms provide for tenant improvement allowances that are
recorded as deferred rent and amortized, straight-line, as
reductions to rent expense over the term of the lease. At
April 27, 2007 and April 28, 2006, we had
approximately $152,000 and $209,000 of deferred rent,
respectively. Scheduled rent increases and rent holidays are
recognized on a straight-line basis over the term of the lease.
F-25
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Future minimum payments relating to these agreements at
April 27, 2007 are as follows:
|
|
|
|
|
52/53 Weeks Ending on the last
Friday of April:
|
|
|
|
|
2008
|
|
$
|
3,275,102
|
|
2009
|
|
|
3,144,808
|
|
2010
|
|
|
2,157,535
|
|
2011
|
|
|
23,309
|
|
2012 and thereafter
|
|
|
|
|
Our rental expense for the 52 weeks ended April 27,
2007, April 28, 2006 and April 29, 2005 amounted to
approximately $3.2 million, $3.0 million and
$2.9 million, respectively.
We have agreements whereby we indemnify our officers and
directors for certain events or occurrences while the officer or
director is, or was, serving at our request in such a capacity.
The term of the indemnification period is for the officers
or directors lifetime. The maximum potential amount of
future payments we could be required to make under these
indemnification agreements is unlimited, however, we believe the
fair value of these indemnification agreements is minimal.
Other Commitments. At April 27, 2007, we
had approximately $177,000 in noncancelable commitments related
to domestic marketing programs planned for our VNS Therapy
System during fiscal year 2008.
We are named as a defendant in lawsuits or the subject of
governmental inquires from time to time arising in the ordinary
course of business. The outcome of such lawsuits or other
proceedings cannot be predicted with certainty and may have a
material adverse effect on our consolidated financial position
or results of operations.
Indenture
Default Litigation
In July 2006, we received the Notice of Default from the
Trustee, pursuant to which the Trustee asserted that we were in
default of our obligations under the Indenture with respect to
our Convertible Notes, as a result of our failure (1) to
file with the SEC our 2006
Form 10-K
by July 12, 2006 and (2) to deliver a copy of the 2006
Form 10-K
to the Trustee by July 27, 2006. In October 2006, we
received the Notice of Acceleration from the Trustee informing
us that, pursuant to the Indenture, the Trustee declared the
Convertible Notes due and payable at their principal amount,
together with accrued and unpaid interest, fees and expenses,
and demanding that all such principal, interest, fees and
expenses under the Convertible Notes be paid to the Trustee
immediately. To clarify our rights and responsibilities under
the Indenture, we filed a declaratory judgment action on
October 3, 2006 in Texas state court seeking a declaration
that no event of default has occurred under the Indenture and
requesting attorney fees under the Declaratory Judgment Act. In
January 2007, the Trustee removed the lawsuit to the
U.S. District Court for the Southern District of Texas,
Cyberonics, Inc. v. Wells Fargo Bank, N.A. as the
Trustee under Indenture, Civil Action
No. A:07-CV-121,
and filed an answer and counterclaim seeking damages for the
alleged default. In March 2007, the Trustee filed a motion for
partial summary judgment seeking a determination that an event
of default has occurred under the Indenture. In April 2007, we
responded to the Trustees motion and filed a cross-motion
for summary judgment seeking a declaration that no event of
default has occurred. On June 13, 2007, the district court
granted our motion for summary judgment and denied the
Trustees motion, declaring that Cyberonics satisfied
its contractual obligations and has not breached the
Agreement. In its filings, the Trustee stated that it was
seeking approximately $20.0 million in damages plus
interest and attorney fees, but it reserved the right to seek
immediate payment of full value of the Convertible Notes.
The Trustee has not filed an appeal. If the Trustee appeals the
district courts decision, and if the court of appeals
reverses the district courts decision, then a default will
have occurred under the Indenture, and all unpaid principal and
accrued interest on the outstanding Convertible Notes could be
due and payable immediately unless
F-26
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
we negotiate an amendment to the terms of the Indenture. If the
principal and accrued interest on the outstanding Convertible
Notes must be repaid immediately, we may not have or be able to
obtain access to the funds needed to repay the indebtedness, and
we may be forced to seek protection under the Bankruptcy Code.
If principal and interest on our indebtedness must be repaid
immediately, we do not have the cash resources available to
repay the debt. If we were not able to secure additional
financing, our ability to continue as a going concern would be
uncertain.
Securities
Class Action Lawsuit
On June 17, 2005, a putative class action lawsuit was filed
against us and certain of our officers and
Robert P. Cummins, then Chairman and Chief Executive
Officer, in the United States District Court for the Southern
District of Texas. The lawsuit is styled Richard
Darquea v. Cyberonics Inc., et al., Civil Action
No. H:05-cv-02121.
A second lawsuit with similar allegations, styled Stanley
Sved v. Cyberonics, Inc., et al., Civil Action
No. H:05-cv-2414
was filed on July 12, 2005. On July 28, 2005, the
court consolidated the two cases under Civil Action
No. H-05-2121,
styled In re Cyberonics, Inc. Securities Litigation, and
entered a scheduling order. On September 28, 2005, the
court appointed EFCAT, Inc., John E. and Cecelia Catogas, Blanca
Rodriguez, and Mohamed Bakry as lead plaintiffs and also
appointed lead plaintiffs counsel.
The lead plaintiffs filed a consolidated amended complaint on
November 30, 2005. The complaint generally alleged, among
other things, that the defendants violated Sections 10(b)
and 20(a) of the Exchange Act by making false and misleading
statements regarding our Vagus Nerve Stimulation Therapy System
device (the VNS Device) as a therapy for TRD. On
January 30, 2006, the defendants filed a motion to dismiss
the consolidated complaint on the basis that the complaint fails
to allege facts that state any claim for securities fraud. On
July 20, 2006, the District Court granted our motion to
dismiss the consolidated complaint, allowing the plaintiffs
30 days to file an amended complaint. The court found that
the plaintiffs failed to meet their burden to plead a securities
fraud claim with particularity, including failures to allege
with particularity a material misstatement or omission, to
allege facts sufficient to raise a strong inference of intent or
severe recklessness, and to allege sufficiently the causal
connection between the plaintiffs loss and the
defendants actions. The court noted that the
deficiencies in Plaintiffs complaint might well extend
beyond the point of cure, but nonetheless granted
plaintiffs the right to amend their complaint in light of the
strong presumption of law favoring a right to amend.
On August 18, 2006, the lead plaintiffs filed a First
Amended Complaint for Violation of the Securities Laws. The
complaint generally alleges, among other things, that the
defendants violated Sections 10(b) and 20(a) of the
Exchange Act by making false and misleading statements regarding
the VNS Device as a therapy for treatment-resistant depression
(TRD). Lead plaintiffs allege that the defendants
failed to disclose that certain individuals associated with the
U.S. Food and Drug Administration (FDA) had
safety and efficacy concerns about the use of the VNS Device for
the treatment of depression and questioned the adequacy of
evidence of safety and effectiveness we presented to the FDA,
that the defendants misrepresented the prospect for payer
reimbursement for the VNS Device, that the defendants concealed
executive compensation and governance issues, and that the
defendants falsely stated that an analysts statements
about options granted in June 2004 were inaccurate and without
merit. Lead plaintiffs seek to represent a class of all persons
and entities, except those named as defendants, who purchased or
otherwise acquired our securities during the period
February 5, 2004 through August 1, 2006. The amended
complaint seeks unspecified monetary damages and equitable or
injunctive relief, if available.
On October 2, 2006, the defendants filed a motion to
dismiss the amended complaint on the basis that the complaint
fails to allege facts that state any claim for securities fraud.
The lead plaintiffs filed an opposition to the motion to dismiss
on October 23, 2006, and the defendants filed a reply to
the opposition on November 6, 2006. On October 31,
2006, a week before the defendants filed their reply in
connection with the motion to dismiss the amended complaint, the
Los Angeles County Employees Retirement Association filed a
motion seeking to intervene and asking the court to require the
lead plaintiffs to republish notice of the amended class action
claims. On November 28, 2006, the court issued an order
compelling republication of notice and staying the proceeding
F-27
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
pending determination of the lead plaintiff pursuant to the
Private Securities Litigation Reform Act. On December 18,
2006, the lead plaintiffs published notice of the filing of the
first amended complaint, stating that investors who purchased
our securities during the expanded class period
(February 5, 2004 through August 1, 2006, inclusive)
may move the court for consideration to be appointed as lead
plaintiff within 60 days. In February 2007, the court
lifted the stay, and in March 2007, the lead plaintiffs filed a
motion seeking leave to file an amended complaint. In April
2007, the court denied the plaintiffs motion to amend
without prejudice and stayed the litigation in light of issues
raised in a case that is currently submitted to the
U.S. Supreme Court. In June 2007, the court lifted the stay
and granted plaintiffs leave to supplement not
amend their first amended complaint and granted us leave
to supplement not amend our motion to
dismiss the first amended complaint. We intend to vigorously
defend this lawsuit; however, an adverse result in this lawsuit
could have a material adverse effect on us, our consolidated
financial position, results of operations and cash flows.
Stockholder
Derivative Litigation
We are named as a nominal defendant in a stockholder derivative
lawsuit brought on behalf of the company styled
Rudolph v. Cummins, et al pending in the United
States District Court for the Southern District of Texas,
Houston Division, naming several of our current and former
officers and members of our Board as defendants, alleging
purported improprieties in our issuance of stock options and the
accounting related to such issuances. The operative Amended
Complaint also purports to state a putative class action claim
against the individual defendants for violation of
Section 14(a) of the Exchange Act, as well as claims
against the individual defendants for breach of fiduciary duty,
gross mismanagement and corporate waste, against the officer
defendants for unjust enrichment, and against certain individual
defendants for insider trading.
We are also named as nominal defendant in five stockholder
derivative lawsuits brought on behalf of the company in the
District Court of Harris County, Texas, including
Smith v. Cummins, pending in the 189th District
Court, Adel v. Cummins, pending in the
234th District Court, McKeehan v. Cummins,
pending in the 11th District Court, Nussbaum v.
Cummins, pending in the 215th District Court and
Wunschel v. Cummins, pending in the
165th District Court. They allege purported improprieties
in our issuance of stock options and the accounting related to
such issuances. These cases were consolidated into a single
case, In re Cyberonics, Inc., in January 2007.
On November 18, 2006, our Board formed a Special Litigation
Committee (SLC) to investigate, analyze and evaluate
the derivative claims raised in these lawsuits and to determine
the actions, if any, we should take with respect to the
derivative claims, including whether to pursue, to seek to
dismiss or to attempt to resolve the derivative claims in the
best interests of us and our stockholders. Our Board appointed
as Chairman of the SLC, Hugh M. Morrison, an independent Board
member who was appointed to our Board on November 9, 2006.
On December 18, 2006, we moved to stay all proceedings in
the federal and state derivative lawsuits pending the completion
of the SLC process. In April 2007, the federal district court
entered an order staying the Rudolph case for
90 days to permit the SLC to complete its investigation.
Governmental
Investigation of Options Granting Practices
On June 9, 2006, the staff of the SEC advised us that it
had commenced an informal inquiry of some of our stock option
grants. On June 26, 2006, we received a subpoena from the
Office of the United States Attorney for the Southern District
of New York requesting documents related to our stock option
grants practices and procedures. On October 23, 2006,
the SEC staff made an additional request for certain documents
and information related to our revised guidance on
February 8, 2006 and our financial results announced on
May 1, 2006, our sales for the quarter ended April 28,
2006, coverage or potential coverage of our VNS Therapy System
by Blue Cross and Blue Shield of Alabama and Aetna and aging of
our accounts receivable since January 1, 2003. We are
cooperating with the SEC staff and the U.S. Attorneys
Office. Our Board directed the Audit Committee to conduct an
independent investigation of our stock option grants, practices
and procedures, including compliance with Generally Accepted
F-28
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Accounting Principles and all applicable statutes, rules and
regulations, and the Audit Committee retained independent
counsel to assist it in completing that review.
The Audit Committee, with the assistance of its independent
counsel and their forensic accountants, has completed its review
of our stock option grants, practices and procedures. The Audit
Committee concluded that incorrect measurement dates were used
for certain stock option grants made principally during the
period from 1998 through 2003. Based on the Audit
Committees investigation, subsequent internal analysis and
discussions with our independent registered public accountants,
our Board concluded on November 18, 2006, that we needed to
restate certain of our historical consolidated financial
statements to record non-cash charges for compensation expense
relating to past stock option grants. The effects of these
restatements are reflected in the consolidated financial
statements, including unaudited quarterly data. None of the
restatements have any impact on net cash provided by (used in)
operating activities.
NASDAQ
Delisting Notice
On July 13, 2006, we filed a Notification of Late Filing on
Form 12b-25
with the SEC disclosing our inability to file timely our 2006
Form 10-K
without unreasonable effort or expense. Pursuant to that filing,
the deadline for us to file our 2006
Form 10-K
was extended to July 27, 2006. On July 27, 2006, we
filed a Current Report on
Form 8-K
indicating that we were unable to file our 2006
Form 10-K
with the SEC by July 27, 2006 because we required
additional time to complete our previously announced review
being conducted by the Audit Committee of our Board of Directors
regarding option grants and to resolve any disclosure and
accounting issues that may arise from the results of the review.
On July 31, 2006, we received a Staff Determination Letter
from NASDAQ indicating that we failed to comply with the filing
requirement for continued listing set forth in Marketplace
Rule 4310(c)(14) as a result of the delay in filing our
2006
Form 10-K,
and that our securities were, therefore, subject to delisting
from The NASDAQ Global Market. On August 3, 2006, we
requested a hearing before a NASDAQ Listing Qualifications Panel
(NASDAQ Panel) to review the NASDAQ Staffs
Determination Letter. On August 4, 2006, we received formal
notice from NASDAQ that the delisting action has been stayed
pending a written decision from the NASDAQ Panel.
On September 8, 2006, we received a second Staff
Determination Letter indicating that we also failed to comply
with the filing requirement for continued listing set forth in
Marketplace Rule 4310(c)(14) as a result of the delay in
filing our First Quarter
Form 10-Q
and that our securities were, therefore, subject to delisting
from The NASDAQ Global Market.
On September 14, 2006, the NASDAQ Panel conducted a hearing
to review the NASDAQ Staffs Determination Letter.
On November 6, 2006, we received a letter from the NASDAQ
Panel informing us that the NASDAQ Panel has determined to grant
our request for continued listing on The NASDAQ Stock Market
subject to two conditions: (1) on or before
November 17, 2006, we must submit additional information to
NASDAQ; and (2) on or before December 31, 2006, we
must file with the SEC our 2006
Form 10-K
and our First Quarter
Form 10-Q
and any required restatements of our prior financial statements.
On November 17, 2006, we submitted the requested additional
information to NASDAQ. On December 13, 2006, we received a
third Staff Determination Letter from NASDAQ. This third Staff
Determination Letter indicated that we also failed to comply
with the filing requirement for continued listing set forth in
Marketplace Rule 4310(c)(14) as a result of the delay in
filing our Second Quarter
Form 10-Q
and that our securities are, therefore, subject to delisting
from The NASDAQ Global Market. This third letter advises us to
present our views with respect to this additional deficiency to
the NASDAQ Panel in writing no later than December 20, 2006.
On December 19, 2006, we sent a letter to the NASDAQ Panel
describing the current status of our efforts to regain
compliance with the NASDAQ filing requirements and requesting an
extension until January 27, 2007 to file our 2006
Form 10-K,
First Quarter
Form 10-Q
and Second Quarter
Form 10-Q.
On December 28, 2006, we received
F-29
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
a letter from the NASDAQ Panel extending through
January 29, 2007 our deadline for filing our delinquent SEC
reports.
We filed our 2006
Form 10-K
on January 5, 2007. On January 16, 2007, we sent a
letter to the NASDAQ Panel describing the current status of our
efforts to regain compliance with the NASDAQ filing requirements
and requesting an extension until February 4, 2007 to file
our First Quarter
Form 10-Q
and until March 1, 2007 to file our Second Quarter
Form 10-Q.
We filed our First Quarter
Form 10-Q
on January 26, 2007. On January 29, 2007, we received
a letter from the NASDAQ Panel extending until March 1,
2007 our deadline for filing our Second Quarter
Form 10-Q.
We filed our Second Quarter
Form 10-Q
on February 9, 2007. On February 12, 2007, we received
a letter from the NASDAQ Panel confirming that we are in
compliance with all listing requirements and that our stock will
continue to be listed.
Senate
Finance Committee Investigation
In May 2005, we received a letter from the Senate Finance
Committee (SFC) advising us that it is examining
FDAs handling of our PMA-Supplement for the use of VNS
Therapy to address TRD. Following our responses to the May
letter, we received a second letter from the SFC in July 2005,
to which we responded by providing the requested documents and
information. In February 2006, the SFC published a Committee
Staff Report entitled, Review of FDAs Approval
Process for the Vagus Nerve Stimulation System for
Treatment-Resistant Depression. The report states that a
senior FDA official approved our VNS Therapy System for TRD
despite the conclusion of more than 20 FDA scientists, medical
officers and management staff who reviewed our application and
that the application did not demonstrate reasonable assurance of
safety and effectiveness sufficient for approval in TRD. The
report concludes that the FDA did not disclose to the public the
scientific dissent within the FDA regarding the effectiveness of
the VNS Therapy System for TRD and that the FDA has not ensured
that the public has all of the accurate, science-based
information regarding the VNS Therapy System for TRD it needs.
The report does not accuse us of any misconduct and does not
conclude that FDA violated any law, regulation or procedure by
approving VNS Therapy for TRD; however, the report states that
the SFC staff received a range of allegations regarding FDA and
Cyberonics and that allegations other than those addressed in
the report may be addressed at a later date. The report follows
a year-long investigation conducted by the staff of the SFC,
including letters we received in May 2005 and July 2005
requesting documents and information. We cooperated with the SFC
staff and provided the requested documents and information.
We received a letter in November 2006 and a second letter in
March 2007 from Senator Charles Grassley on behalf of the SFC
requesting our cooperation in providing certain documents and
information relating to (1) our employees, agents, and
consultants regarding their meetings and communications with the
Centers for Medicare and Medicaid Services (CMS)
regarding coverage of the VNS Therapy System for TRD and
(2) our agents and consultants participation in
presentations, preparation of publications, and advice to
government agencies on VNS Therapy for TRD. We are endeavoring
to cooperate with Senator Grassley by providing documents and
information in response to his requests.
Our cash equivalents and trade accounts receivable represent
potential concentrations of credit risk.
We minimize potential concentrations of credit risk in cash
equivalents by placing investments in high quality financial
instruments and, as required by our corporate investment policy,
limiting the amount of investment in any one issuing party. At
April 27, 2007, management believes that we have no
significant concentrations of credit risk related to these
assets and have incurred no material impairments in the carrying
values of our cash equivalents.
Concentrations of credit risk with respect to trade accounts
receivable are limited due to the large number of customers and
their dispersion across a number of geographic areas. However,
essentially all trade receivables are concentrated in the
hospital and healthcare sectors in the U.S. and several
other countries and, accordingly, are
F-30
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
exposed to their respective business, economic and
country-specific variables. Although we do not currently foresee
a concentrated credit risk associated with these receivables,
repayment is dependent upon the financial stability of these
industry sectors and the respective countries national
economies and healthcare systems.
We rely upon sole source suppliers for certain of the key
components, materials and contract services used in
manufacturing the VNS Therapy System. We periodically experience
discontinuation or unavailability of components, materials and
contract services which may require us to qualify alternative
sources or, if no such alternative sources are identified,
change our product design. We believe that pursuing and
qualifying alternative sources
and/or
redesigning specific components of the VNS Therapy System, if or
when necessary, could consume significant resources. In
addition, such changes generally require regulatory submissions
and approvals. Any extended delays in or an inability to secure
alternative sources for these or other components, materials and
contract services could result in product supply and
manufacturing interruptions, which could significantly harm our
business.
We rely upon favorable reimbursement, coverage and coding for
VNS Therapy. Essentially all patients implanted with VNS Therapy
for the treatment of epilepsy are covered by private payers,
Medicare or Medicaid. VNS Therapy for epilepsy has specifically
approved codes for physicians, surgeons and hospitals. We are
actively pursuing favorable coverage decisions to expand
reimbursement to include VNS Therapy for TRD. Our long-term
growth may be dependent upon progress in obtaining favorable
national and regional coverage policies in TRD and maintaining
adequate coverage policies in epilepsy.
|
|
Note 17.
|
Geographic
Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
|
|
52 Weeks Ended
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
April 29, 2005
|
|
|
United States
|
|
$
|
111,077,666
|
|
|
$
|
107,906,412
|
|
|
$
|
90,281,978
|
|
International
|
|
|
19,890,771
|
|
|
|
15,535,163
|
|
|
|
13,160,592
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
130,968,437
|
|
|
$
|
123,441,575
|
|
|
$
|
103,442,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Lived Assets
|
|
|
|
April 27, 2007
|
|
|
April 28, 2006
|
|
|
United States
|
|
$
|
11,475,519
|
|
|
$
|
14,502,293
|
|
International
|
|
|
742,107
|
|
|
|
522,051
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
12,217,626
|
|
|
$
|
15,024,344
|
|
|
|
|
|
|
|
|
|
|
Sales are classified according to the country of destination,
regardless of the shipping point.
All assets located outside of the U.S. are classified as
International.
F-31
CYBERONICS,
INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
Note 18.
|
Quarterly
Financial Information Unaudited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
|
|
|
Second
|
|
|
Third
|
|
|
Fourth
|
|
|
|
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Totals(1)
|
|
|
52 weeks ended April 27,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
$
|
33,731,520
|
|
|
$
|
34,140,796
|
|
|
$
|
31,664,282
|
|
|
$
|
31,431,839
|
|
|
$
|
130,968,437
|
|
Gross profit
|
|
|
29,930,192
|
|
|
|
30,336,850
|
|
|
|
26,736,914
|
|
|
|
25,706,107
|
|
|
|
112,710,063
|
|
Net loss
|
|
|
(8,533,387
|
)
|
|
|
(12,493,703
|
)
|
|
|
(19,385,300
|
)
|
|
|
(10,767,717
|
)
|
|
|
(51,180,107
|
)
|
Diluted loss per share
|
|
|
(0.34
|
)
|
|
|
(0.49
|
)
|
|
|
(0.76
|
)
|
|
|
(0.42
|
)
|
|
|
(2.01
|
)
|
52 weeks ended April 28,
2006 Net sales
|
|
$
|
27,019,459
|
|
|
$
|
29,070,298
|
|
|
$
|
31,304,205
|
|
|
$
|
36,047,613
|
|
|
$
|
123,441,575
|
|
Gross profit
|
|
|
23,238,237
|
|
|
|
25,263,770
|
|
|
|
27,421,427
|
|
|
|
31,696,096
|
|
|
|
107,619,530
|
|
Net loss
|
|
|
(19,413,960
|
)
|
|
|
(20,551,212
|
)
|
|
|
(14,831,742
|
)
|
|
|
(4,272,278
|
)
|
|
|
(59,069,192
|
)
|
Diluted loss per share
|
|
|
(0.78
|
)
|
|
|
(0.82
|
)
|
|
|
(0.60
|
)
|
|
|
(0.17
|
)
|
|
|
(2.37
|
)
|
|
|
|
(1) |
|
EPS in each quarter is computed using the weighted-average
number of shares outstanding during that quarter while EPS for
the full year is computed using the weighted-average number of
shares outstanding during the year. Thus, the sum for the four
quarters EPS does not necessarily equal the full year EPS. |
|
|
Note 19.
|
Subsequent
Events
|
Excise
Tax Remediation Under Internal Revenue Code
Section 409A
Section 409A of the IRC imposes an excise tax on a
grantees gain from the exercise of a stock option granted
with an exercise price less than the fair market value of the
stock on the date of the grant. The excise tax applies only to
that portion of a grant that vests after December 31, 2004,
and any grants that vest after December 31, 2004 and are
exercised on or before December 31, 2005 are exempt from
the excise tax. The regulations under Section 409A permit
us to avoid the excise tax by adjusting the exercise price for
an affected grant up to the fair market value on the date of the
grant. As to non-Section 16 officers, the adjustment must
be implemented by December 31, 2007.
As discussed in Note 15. Litigation
Governmental Investigations of Options Granting Practices,
the Audit Committee concluded that incorrect measurement dates
were used for certain of our stock option grants. Unless the
exercise price for certain of these grants is adjusted to the
fair market value on the date of the grant, the grantees will be
subject to the Section 409A excise tax.
In June 2007, we launched a tender offer to our employees
offering a payment in January 2008 in exchange for their
agreement to amend their stock option agreements to adjust the
exercise price of their incorrectly priced option grants to the
lower of the fair market value on the revised measurement date
of the grant or the closing selling price per share of our
common stock on the date on which the eligible options are
amended. We estimate that the cost of this tender offer will be
approximately $0.6 million. The actual cost will depend on
the closing price of our stock on the date the tender offer is
closed and the actual number of shares tendered and will be
recorded during the first quarter of fiscal 2008.
F-32
INDEX TO
EXHIBITS
The exhibits marked with the asterisk symbol (*) are filed with
this
Form 10-K.
The exhibits marked with the cross symbol () are
management contracts or compensatory plans or arrangements filed
pursuant to Item 601(b)(10)(iii) of
Regulation S-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
3
|
.1
|
|
Amended and Restated Certificate of
Incorporation of Cyberonics, Inc.
|
|
Cyberonics, Inc.s
Registration Statement on Form S-3 filed on February 21, 2001
|
|
333-56022
|
|
3.1
|
|
3
|
.2
|
|
Bylaws of Cyberonics, Inc.
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 12, 2000
|
|
000-19806
|
|
3.1
|
|
3
|
.3
|
|
Amendment No. 1 to the Bylaws of
Cyberonics, Inc.
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on March 30, 2001
|
|
000-19806
|
|
3.1
|
|
4
|
.1
|
|
Second Amended and Restated
Preferred Shares Rights Agreement dated August 21, 2000 between
Cyberonics, Inc. and BankBoston, N.A. (formerly known as The
First National Bank of Boston), including the Form of First
Amended Certificate of Designation of Rights, Preferences and
Privileges of Series A Participating Preferred Stock of
Cyberonics, Inc., Form of Rights Certificate and Stockholder
Rights Plan attached thereto as Exhibits A, B and C, respectively
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 12, 2000
|
|
000-19806
|
|
4.1
|
|
4
|
.2
|
|
Amendment No. 1 to Second Amended
and Restated Preferred Share Rights Agreement dated April 26,
2001
|
|
Cyberonics, Inc.s Annual
Report and Transition Report on
Form 10-K
for the fiscal period ended April 27, 2001 and the transition
period from July 1, 2000 to April 27, 2001
|
|
000-19806
|
|
4.2
|
|
4
|
.3
|
|
Amendment No. 2 to Second Amended
and Restated Preferred Share Rights Agreement dated October 31,
2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
4.3
|
|
4
|
.4
|
|
Amendment No. 3 to Second Amended
and Restated Preferred Share Rights Agreement dated December 9,
2003
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on December 12, 2003
|
|
000-19806
|
|
99.2
|
|
4
|
.5
|
|
Amendment No. 4 to Second Amended
and Restated Preferred Share Rights Agreement dated January 9,
2004
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 13, 2004
|
|
000-19806
|
|
99.2
|
|
4
|
.6
|
|
Indenture dated September 27, 2005
between Cyberonics, Inc. and Wells Fargo Bank, National
Association, as Trustee
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.1
|
|
4
|
.7
|
|
Registration Rights Agreement dated
September 27, 2005 between Cyberonics, Inc. and Merrill Lynch,
Pierce, Fenner & Smith Incorporated, as the Initial
Purchaser
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.2
|
|
4
|
.8
|
|
Form of Confirmation of OTC
Convertible Note Hedge executed September 21, 2005 to be
effective September 27, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.3
|
|
4
|
.9
|
|
Form of Confirmation of OTC Warrant
Transaction executed September 21, 2005 to be effective
September 27, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on October 3, 2005
|
|
000-19806
|
|
10.4
|
|
4
|
.10
|
|
Amendment No. 5 to Second Amended
and Restated Preferred Share Rights Agreement
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on February 1, 2007
|
|
000-19806
|
|
4.1
|
|
10
|
.1
|
|
License Agreement dated March 15,
1988 between Cyberonics, Inc. and Dr. Jacob Zabara
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.2
|
|
License Agreement dated August 22,
2000 between Cyberonics, Inc. and Dr. Mitchell S. Roslin
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.3
|
|
Lease Agreement dated December 5,
2002 between Cyberonics, Inc., as Lessee, and Space Center
Operating Associates, LP, as Lessor, commencing on December 8,
2002 for Space A and January 1, 2004 for Space
B, as amended March 3, 2003 (First Amendment),
October 2, 2003 (Second Amendment), March 11, 2004 (Third
Amendment), March 17, 2004 (Subordination, Non-Disturbance and
Attornment), March 19, 2004 (Transfer of Ownership to Triple Net
Properties, LLC), March 23, 2005 (Fourth Amendment), May 5, 2005
(Fifth Amendment) and July 13, 2005 (Sixth Amendment)
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.3
|
|
10
|
.4
|
|
Letter Agreement dated March 28,
1997 between The Clark Estates, Inc. and Cyberonics, Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended June 30, 1997
|
|
000-19806
|
|
10.11
|
|
10
|
.5
|
|
Purchase Agreement dated September
21, 2005 between Cyberonics, Inc. and Merrill Lynch, Pierce,
Fenner & Smith Incorporated, as the Initial Purchaser
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on September 27, 2005
|
|
000-19806
|
|
10.1
|
|
10
|
.6
|
|
Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., as
Administrative Agent and as Lender and as Sole Bookrunner and
Sole Lead Arranger, and the additional Lenders thereto dated
January 13, 2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 19, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.7
|
|
Consent and Amendment Agreement
effective October 31, 2006 to the Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., individually as
Lender, Administrative Agent, Sole Bookrunner and Sole Lead
Arranger, and the additional Lenders thereto
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 6, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.8
|
|
Consent and Amendment Agreement
effective July 27, 2006 to the Credit Agreement between
Cyberonics, Inc. and Merrill Lynch Capital, a division of
Merrill Lynch Business Financial Services Inc., individually as
Lender, Administrative Agent, Sole Bookrunner and Sole Lead
Arranger, and the additional Lenders thereto
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on July 27, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.9
|
|
Consulting Agreement between
Cyberonics, Inc. and BK Consulting, an assumed name used by
Reese S. Terry, Jr., a founder and member of the Board of
Directors of Cyberonics, Inc., dated August 25, 2005
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 30, 2005
|
|
000-19806
|
|
99.1
|
|
10
|
.10
|
|
Amendment to Consulting Agreement
between Cyberonics, Inc. and BK Consulting dated August 23, 2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 25, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.11
|
|
Termination of Consulting Agreement
between Cyberonics, Inc. and BK Consulting effective November
19, 2006
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on December 13, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.12
|
|
Consulting Agreement dated November
19, 2006 between Cyberonics, Inc. and Pamela B. Westbrook
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.13
|
|
Cyberonics, Inc. Amended and
Restated 1996 Stock Option Plan
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on April 29, 1999
|
|
333-77361
|
|
4.1
|
|
10
|
.14
|
|
First Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated October
2, 2000
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended September 30, 2000
|
|
000-19806
|
|
10.2
|
|
10
|
.15
|
|
Second Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated March 21,
2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.12
|
|
10
|
.16
|
|
Third Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated July 27,
2001
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on January 22, 2002
|
|
333-81158
|
|
4.4
|
|
10
|
.17
|
|
Fourth Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated January
2002
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on January 22, 2002
|
|
333-81158
|
|
4.5
|
|
10
|
.18
|
|
Fifth Amendment to the Cyberonics,
Inc. Amended and Restated 1996 Stock Option Plan dated July 19,
2002
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on July 25, 2002
|
|
333-97095
|
|
4.1
|
|
10
|
.19
|
|
Cyberonics, Inc. Amended and
Restated 1997 Stock Plan
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on March 8, 2001
|
|
333-56694
|
|
4.5
|
|
10
|
.20
|
|
First Amendment to the Cyberonics,
Inc. Amended and Restated 1997 Stock Plan dated March 21, 2001
|
|
Cyberonics, Inc.s Quarterly
Report on
Form 10-Q
for the quarter ended July 26, 2002
|
|
000-19806
|
|
10.1
|
|
10
|
.21
|
|
Second Amendment to the Cyberonics,
Inc. Amended and Restated 1997 Stock Plan dated November 21, 2002
|
|
Cyberonics, Inc.s Proxy
Statement for the Annual Meeting of Stockholders filed on
October 15, 2002
|
|
000-19806
|
|
Annex B
|
|
10
|
.22
|
|
Cyberonics, Inc. 1998 Stock Option
Plan
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on November 3, 1998
|
|
333-66691
|
|
4.1
|
|
10
|
.23
|
|
First Amendment to the Cyberonics,
Inc. 1998 Stock Option Plan dated March 21, 2001
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.23
|
|
10
|
.24
|
|
Cyberonics, Inc. New Employee
Equity Inducement Plan
|
|
Cyberonics, Inc.s
Registration Statement on Form S-8 filed on August 27, 2003
|
|
333-108281
|
|
4.3
|
|
10
|
.25
|
|
Cyberonics, Inc. 2005 Stock Plan
|
|
Cyberonics, Inc.s Proxy
Statement for the Special Meeting of Stockholders filed on April
14, 2005
|
|
000-19806
|
|
Annex A
|
|
10
|
.26
|
|
Indemnification Agreement effective
August 1, 2003 between Cyberonics, Inc. and Robert P.
Cummins
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.32
|
|
10
|
.27
|
|
Employment Agreement effective
August 5, 2005 between Cyberonics, Inc. and Robert P. Cummins
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on August 9, 2005
|
|
000-19806
|
|
99.1
|
|
10
|
.28
|
|
Letter Agreement Regarding
Advancement of Attorneys Fees effective September 28, 2006
between Cyberonics, Inc. and Robert P. Cummins
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.34
|
|
10
|
.29
|
|
Resignation Agreement effective
November 17, 2006 between Cyberonics, Inc. and Robert P.
Cummins
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.1
|
|
10
|
.30
|
|
Severance Agreement effective June
1, 2003 between Cyberonics, Inc. and William Steven Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 25, 2003
|
|
000-19806
|
|
10.21
|
|
10
|
.31
|
|
Officer Stock Option Plan Agreement
dated June 2, 2003 between Cyberonics, Inc. and William Steven
Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.37
|
|
10
|
.32
|
|
Employment Agreement effective June
15, 2006 between Cyberonics, Inc. and William Steven Jennings
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.33
|
|
Indemnification Agreement effective
June 28, 1999 between Cyberonics, Inc. and Alan J. Olsen
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.44
|
|
10
|
.34
|
|
Severance Agreement effective July
14, 2003 between Cyberonics, Inc. and George E. Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.40
|
|
10
|
.35
|
|
Officer Stock Option Plan Agreement
dated July 14, 2003 between Cyberonics, Inc. and George E. Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.46
|
|
10
|
.36
|
|
Employment Agreement effective July
14, 2003 between Cyberonics, Inc. and George E. Parker
|
|
Cyberonics, Inc.s Quarterly
Report on Form 10-Q for the quarter ended October 24, 2003
|
|
000-19806
|
|
10.1
|
|
10
|
.37
|
|
First Amendment to Employment
Agreement effective June 15, 2006 between Cyberonics, Inc. and
George E. Parker
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.48
|
|
10
|
.38
|
|
Stand Alone Stock Option Agreement
dated August 23, 2001 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.49
|
|
10
|
.39
|
|
Severance Agreement effective
January 1, 2002 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Quarterly
Report on Form 10-Q for the quarter ended January 25, 2002
|
|
000-19806
|
|
10.3
|
|
10
|
.40
|
|
Employee Restricted Stock Agreement
dated July 22, 2005 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.51
|
|
10
|
.41
|
|
Employment Agreement effective June
15, 2006 between Cyberonics, Inc. and Richard L.
Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.52
|
|
10
|
.42
|
|
Stock Option Agreement Amendment
and Bonus Agreement dated December 28, 2006 between Cyberonics,
Inc. and Richard L. Rudolph, M.D.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.53
|
|
10
|
.43
|
|
Employment Agreement effective June
15, 2006 between Cyberonics, Inc. and Pamela B. Westbrook
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.58
|
|
10
|
.44
|
|
Letter Agreement Regarding
Advancement of Attorneys Fees effective October 12, 2006
between Cyberonics, Inc. and Pamela B. Westbrook
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.59
|
|
10
|
.45
|
|
Resignation Agreement effective
November 19, 2006 between Cyberonics, Inc. and Pamela B.
Westbrook
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on November 20, 2006
|
|
000-19806
|
|
10.45
|
|
10
|
.46
|
|
Indemnification Agreement effective
August 1, 2003 between Cyberonics, Inc. and David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.61
|
|
10
|
.47
|
|
Severance Agreement effective
September 17, 2003 between Cyberonics, Inc. and David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 30, 2004
|
|
000-19806
|
|
10.42
|
|
10
|
.48
|
|
Employment Agreement effective
September 17, 2003 between Cyberonics, Inc. and David S.
Wise
|
|
Cyberonics, Inc.s Quarterly
Report on Form 10-Q for the quarter ended October 24, 2003
|
|
000-19806
|
|
10.2
|
|
10
|
.49
|
|
First Amendment to Employment
Agreement effective June 15, 2006 between Cyberonics, Inc. and
David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.64
|
|
10
|
.50
|
|
New Employee Equity Inducement Plan
Agreement dated September 17, 2003 between Cyberonics, Inc. and
David S. Wise
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
10
|
.51
|
|
Form of Indemnification Agreement
for directors of Cyberonics, Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.66
|
|
10
|
.52
|
|
Form of Director Restricted Stock
Agreement effective June 1, 2005
|
|
Cyberonics, Inc.s Quarterly
Form 10-Q for the quarter ended July 29, 2005
|
|
000-19806
|
|
10.52
|
|
10
|
.53
|
|
Form of Amendment to Director Stock
Option Agreement dated December 2006 between Cyberonics, Inc.
and the directors listed on the schedule attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.68
|
|
10
|
.54
|
|
Form of Stock Option Agreement
under the Cyberonics, Inc. Amended and Restated 1996 Stock
Option Plan between Cyberonics, Inc. and the executive officers
listed on the schedule attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.69
|
|
10
|
.55
|
|
Form of Stock Option Agreement
under the Cyberonics, Inc. 2005 Stock Plan between Cyberonics,
Inc. and the executive officers listed on the schedule attached
thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.70
|
|
10
|
.56
|
|
Form of Employee Restricted Stock
Agreement under the Cyberonics, Inc. 2005 Stock Plan (one-year
vesting)
|
|
Cyberonics, Inc.s Quarterly
Form 10-Q for the quarter ended July 29, 2005
|
|
000-19806
|
|
10.2
|
|
10
|
.57
|
|
Form of Employee Restricted Stock
Agreement under the Cyberonics, Inc. 2005 Stock Plan (five-year
vesting) and the executive officers listed on the schedule
attached thereto
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
10.72
|
|
10
|
.58
|
|
Consent and Amendment Agreement,
dated December 29, 2006, by and among Cyberonics, Inc., Merrill
Lynch Capital, and the Lenders party to the Credit Agreement (as
defined therein)
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on January 5, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.59
|
|
Separation Agreement between Steve
Jennings and Cyberonics, Inc., dated January 31, 2007
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on February 6, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.60
|
|
Amended and Restated Cyberonics,
Inc. New Employee Inducement Plan
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on April 30, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.61
|
|
Employment Agreement by and between
Cyberonics, Inc. and Daniel Jeffrey Moore
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on May 1, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.62
|
|
Release Agreement by and between
Cyberonics, Inc. and John Riccardi
|
|
Cyberonics, Inc.s Current
Report on
Form 8-K
filed on May 10, 2007
|
|
000-19806
|
|
10.1
|
|
10
|
.63*
|
|
Retention Agreement by and between
Cyberonics, Inc. and John Riccardi dated November 14, 2005
|
|
|
|
|
|
|
|
10
|
.64*
|
|
Description Of Non-Equity Incentive
Compensation Plans
|
|
|
|
|
|
|
|
10
|
.65*
|
|
Consulting Agreement between
Cyberonics, Inc. and BK Consulting, an assumed name used by
Reese S. Terry, Jr., a founder and member of the Board of
Directors of Cyberonics, Inc., dated May 16, 2007
|
|
|
|
|
|
|
|
10
|
.66*
|
|
Executive Restricted Stock
Agreement between Cyberonics, Inc. and Daniel J. Moore dated
June 18, 2007
|
|
|
|
|
|
|
|
10
|
.67*
|
|
Description of Non-Equity Incentive
Compensation under the Employment Agreement of Robert P. Cummins
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEC File or
|
|
|
Exhibit
|
|
|
|
|
|
Registration
|
|
Exhibit
|
Number
|
|
Document Description
|
|
Report or Registration Statement
|
|
Number
|
|
Reference
|
|
|
21
|
.1
|
|
List of Subsidiaries of Cyberonics,
Inc.
|
|
Cyberonics, Inc.s Annual
Report on
Form 10-K
for the fiscal period ended April 28, 2006
|
|
000-19806
|
|
21.1
|
|
23
|
.1*
|
|
Consent of Independent Registered
Public Accounting Firm, KPMG LLP
|
|
|
|
|
|
|
|
24
|
.1*
|
|
Powers of Attorney (included on the
Signature Page to this Annual Report on Form 10-K)
|
|
|
|
|
|
|
|
31
|
.1*
|
|
Certification of the Chief
Executive Officer of Cyberonics, Inc. pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
31
|
.2*
|
|
Certification of the Chief
Financial Officer of Cyberonics, Inc. pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
32
|
.1*
|
|
Certification of the Chief
Executive Officer and Chief Financial Officer of Cyberonics,
Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|