form10k.htm
U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-K
x ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For the
fiscal year ended December 31, 2007
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the
transition period from _________ to _____________
Commission
file number: 0-21214
ORTHOLOGIC
CORP.
(Exact
name of registrant as specified in its charter)
Delaware
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86-0585310
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification No.)
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1275 West
Washington Street, Tempe, Arizona 85281
(Address
of principal executive offices)
Registrant’s
telephone number: (602) 286-5520
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Name
of each exchange on which registered
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Common
Stock, par value $.0005 per share
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NASDAQ
Global Market
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|
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Rights
to purchase 1/100 of a share of Series A Preferred Stock
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NASDAQ
Global Market
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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 ¨ No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act. Yes ¨ No
x
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 report(s)), and (2) has been subject to such filing requirements
for the past 90 days. Yes x No ¨
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 Registrant’s 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. ¨
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.
Large
accelerated filer ¨
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Accelerated
filer x
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Non-accelerated
filer ¨
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No
x
The
aggregate market value of the voting and non-voting common equity held by
non-affiliates of the registrant, based upon the closing sale price of the
registrant’s common stock as reported on the NASDAQ Global Market on June 30,
2007 was approximately $59,000,000. Shares of common stock held
by each officer and director and by each person who owns 10% or more of the
outstanding common stock have been excluded in that such persons may be deemed
to be affiliates. This determination of affiliate status is not
necessarily conclusive.
Documents incorporated by
reference: Portions of the registrant’s proxy statement
related to its 2007 annual meeting of stockholders to be held on May 9, 2008 are
incorporated by reference into Part III of this Form 10-K.
The
number of outstanding shares of the registrant’s common stock on February 29,
2008 was 41,758,065.
FORM 10-K
ANNUAL REPORT
YEAR
ENDED DECEMBER 31, 2007
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E-1
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F-1
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Overview
of the Business
Prior to
November 26, 2003, we developed, manufactured and marketed proprietary,
technologically advanced orthopedic products designed to promote the healing of
musculoskeletal bone and tissue, with particular emphasis on fracture healing
and spine repair. Our product lines included bone growth stimulation
and fracture fixation devices including the OL1000 product line, SpinaLogic® and
OrthoFrame/Mayo, which we sometimes refer to as our “Bone Device
Business.”
On
November 26, 2003, we sold our Bone Device Business. Our principal
business remains focused on tissue repair, although through biopharmaceutical
approaches rather than through the use of medical devices.
On August
5, 2004, we purchased substantially all of the assets and intellectual property
of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide
license for Chrysalin for all medical indications. We became a development stage
entity commensurate with the acquisition. Subsequently, all of our
collective efforts were focused on research and development of our Chrysalin
Product Platform, with the goal of commercializing our products. We currently
own exclusive worldwide rights to Chrysalin.
On
February 27, 2006, we purchased certain assets and assumed certain liabilities
of AzERx, Inc. Under the terms of the transaction, we acquired an
exclusive license for the core intellectual property relating to AZX100, a
24-amino acid synthetic peptide. We have an exclusive worldwide
license to AZX100.
Chrysalin
and OrthoLogic are registered United States domestic trademarks of OrthoLogic
Corp.
Description
of the Business
OrthoLogic
is currently a development stage biotechnology company focused on the
development and commercialization of the novel synthetic peptides Chrysalin®
(TP508) and AZX100. However, we continue to evaluate other
biopharmaceutical compounds that can complement our research activity internally
and broaden our potential pipeline for successful products.
Chrysalin
Product Platform
Chrysalin
(TP508), a novel synthetic 23-amino acid peptide, is believed to produce
angiogenic and other tissue repair effects by activating or upregulating nitric
oxide synthase (NOS) and the production of nitric oxide in endothelial cells,
and if so, it may have potential therapeutic value in tissues and diseases
exhibiting endothelial dysfunction. The Chrysalin molecule serves as
the basis for a group of potential therapeutic products we refer to collectively
as the “Chrysalin Product Platform.” We have conducted clinical trials for two
potential Chrysalin products, acceleration of fracture repair, and diabetic foot
ulcer. We previously conducted a pilot study for spine fusion. We
have conducted pre-clinical testing for cartilage defect repair, cardiovascular
repair, dental bone repair, and tendon repair. We are initiating studies of
other potential vascular indications.
The
development of each of our potential product candidates in the Chrysalin Product
Platform is based on our collective knowledge and understanding of how Chrysalin
contributes to the repair of tissue. While there are important
differences in each of the product candidates in terms of purpose (fracture
repair, diabetic foot ulcer healing, etc.) each product candidate is focused on
accelerating and enhancing tissue repair.
We are
focusing our efforts on vascular product candidates and are not currently
planning additional pre-clinical or clinical studies in fracture repair, wound
healing, spine fusion, cartilage defect repair, dental bone repair or tendon
repair.
Acceleration
of Fracture Repair
Every
broken bone is called a fracture and approximately 30 million fractures are
treated every year throughout the developed world, as reported by medical
reimbursement records in countries with national healthcare
systems. The treatment of a fracture depends on the severity of the
break. Simple fractures often heal themselves, with more complex
closed fractures potentially amenable to treatment by manipulation (also called
“reduction”) without requiring surgery. Fractures that break the skin
(or “open fractures”) or where the fragments cannot be lined up correctly
usually require surgery. Sometimes plates, screws or pins are used
for mechanical stabilization, occasionally with the use of bone grafts, all of
which are invasive, expensive and time consuming procedures.
In
pre-clinical animal studies, a single injection of Chrysalin into the fracture
gap accelerated fracture healing by up to 50% as measured by mechanical
testing. In late 1999, we initiated a combined Phase 1/2 human
clinical trial to evaluate the safety of Chrysalin and its effect on the rate of
healing in adult subjects with unstable distal radius fractures (fractures
around and in the wrist joint). We presented the results of this
Phase 1/2 human clinical trial for fracture repair at the 57th Annual Meeting of
the American Society for Surgery of the Hand in October 2002. The
data from x-ray evaluations revealed that a single injection of Chrysalin into
the fracture gap resulted in a trend toward accelerated fracture healing
compared with the saline placebo control. There were no reportable
adverse events attributable to Chrysalin in the study. A summary of these
results was published November 2006 in The Journal of Bone and Joint
Surgery.
We
completed subject enrollment in our pivotal Phase 3 human clinical trial
evaluating the efficacy of Chrysalin in subjects with unstable and/or displaced
distal radius (wrist) fractures in May 2005. We enrolled a total of
503 study subjects in 27 health centers throughout the United
States. The primary efficacy endpoint in the trial was to measure how
quickly wrist fractures in subjects injected with Chrysalin heal, as measured by
the removal of immobilization. Accelerated removal of immobilization
allows patients to initiate hand therapy and regain full function of their
wrists and hands sooner. The clinical trial’s secondary efficacy
endpoints include radiographic analysis of healing, as well as clinical,
functional, and subject outcome parameters. On March 15, 2006, we
reported results of an analysis of data from its Phase 3 clinical trial of the
novel synthetic peptide Chrysalin® (TP508)
in unstable,
displaced distal radius (wrist) fractures. Treatment with 10μg
Chrysalin did not demonstrate a statistically significant benefit compared to
placebo in the primary efficacy endpoint of time to removal of
immobilization in the overall evaluable subject
population. Within the secondary endpoints, radiographic evidence of
time to radial cortical bridging, showed a statistically significant benefit for
Chrysalin–treated subjects. This benefit mirrored findings from the
Phase 1/2 clinical trial that provided part of the foundation for the Phase 3
study. A statistically significant difference between Chrysalin
treatment and placebo in the functional secondary endpoints was not observed.
From a safety perspective, there were no adverse events related to Chrysalin
reported in this Phase 3 trial, nor were there any differences in adverse event
rates observed between the Chrysalin and placebo treated subjects.
On
February 16, 2007, we announced findings of a post hoc subgroup analysis of
data from the Phase 3 clinical trial showing that within the subset of 157 female
osteopenic subjects, treatment with 10 μg Chrysalin demonstrated a statistically
significant benefit compared to placebo in the primary efficacy endpoint of time
to removal of immobilization. Secondary endpoints including clinical
assessment of fracture healing (pain or motion at the fracture site),
time to radial cortical bridging and time to overall radiographic healing also
showed a significant effect of Chrysalin treatment. These data are
part of a post hoc
subgroup analysis, and therefore provide only supporting - rather than pivotal -
evidence of safety and efficacy.
The
Company was assessing Chrysalin in a Phase 2b human clinical trial in distal
radius fractures, which was a double-blind, randomized placebo controlled trial
that explored a wider dose range of Chrysalin, including 1µg, 3 µg, 10 µg, or 30
µg doses. Our enrollment goal was 500 evaluable subjects in
approximately 60 sites. On March 15, 2006, we temporarily interrupted
enrollment in its Phase 2b fracture repair dosing human clinical trial to
perform an interim analysis of the subjects enrolled up to that
date.
On August
29, 2006, the Company reported the results of interim analysis of data from our
Phase 2b dose ranging clinical trial of the novel synthetic peptide Chrysalin
(TP508) in unstable, displaced distal radius (wrist) fractures and termination
of the Phase 2b study. In the dataset of 240 subjects as a group that
were evaluable in the Phase 2b interim analysis, treatment with Chrysalin did
not demonstrate benefit compared to placebo in the primary efficacy endpoint of
time to removal of immobilization. Individual findings of efficacy in
secondary endpoints, including radiographic healing, were not seen in this
interim analysis and no dose response relationship was observed. The Company
stated at the time that the trial was not powered at the interim analysis stage
to detect statistically significant differences among dose cohorts regarding the
efficacy of Chrysalin. The trial met the pre-specified safety endpoint by
demonstrating no significant difference in the incidence of adverse events
between the Chrysalin and placebo groups.
Throughout
our acceleration of fracture repair efforts, Chrysalin has demonstrated an
excellent safety profile and evidence of biological
activity. However, interactions with FDA personnel have led us to
conclude that the development path (dose ranging and efficacy clinical trials to
reach an NDA filing in acceleration of fracture repair) no longer matches our
resources or strategic timetable. Accordingly, in 2008, we intend to
explore partnering opportunities for orthopedic indications.
Dermal
Wound Healing
Our
dermal wound healing studies are focused on healing diabetic foot ulcers, a
common problem for diabetic patients. The World Health Organization (WHO)
estimates that at least 171 million people worldwide have diabetes and that
number is expected to double by 2030. Diabetic patients suffer from
open wound foot ulcers because diabetes related nerve damage causes the patient
to lose sensation. Patients thus may not notice an injury to the foot
and neglect the injury. This fact and the diminished blood flow to
extremities caused by diabetes cause a diabetic patient’s wounds to heal more
slowly or not at all.
Standard
therapy for diabetic foot ulcer wounds includes sharp debridement, infection
control, moisture/exudate management and non-use of the foot (off loading) to
allow for the body’s natural healing processes to occur. These
treatments require high patient compliance and effectively heal only
approximately 33% of these ulcers. Wounds that do not respond to
treatment can sometimes result in amputation of the affected limb.
We
believe topical treatment of the wound with Chrysalin will promote new tissue
growth necessary for healing of a diabetic foot ulcer. CBI conducted
a multicenter Phase 1/2 double blind human trial with 60 subjects, the results
of which were presented at the Wound Healing Society in May 2002. We found no
drug related adverse events due to Chrysalin in this trial and complete wound
closure occurred in 70% of Chrysalin-treated ulcers versus 33% in placebo
controls, a statistically significant difference. Results of this
trial were published January 2007 in Wound Repair and
Regeneration.
In 2008,
we intend to continue to explore partnering opportunities for dermal wound
healing, and to evaluate additional pre-clinical studies or formulations of
Chrysalin to strengthen and support our partnering efforts.
Spine
Fusion
Spine
fusion surgery is most commonly performed to treat degenerative disk disease,
spinal instability and other disorders of the spine that are believed to be the
cause of back and neck pain. The surgery involves the fusing of one
or more vertebrae of the spine by placement of bone graft material around the
targeted area of the spine during surgery. The body then heals the
grafts over several months, which fuses the vertebrae together with newly formed
bone so there is no longer movement between the vertebrae.
The bone
used for the graft in this procedure is taken from another bone in the patient,
usually from the iliac crest (hip bone) and is called “autograft bone.” In some
procedures the patients and physicians elect to use “allograft” bone which is
bone processed from cadavers. Autograft bone is currently the primary type of
bone graft used in spinal fusion surgery and is considered the “gold
standard.” Allograft bone is often used but has not been an effective
stand-alone substitute for autograft bone because it has no bioactive component
to stimulate bone growth. The benefit of using allograft bone is it
does not require a separate surgical procedure from the same patient to harvest
the bone for the graft.
Our
potential solution to this problem is to combine Chrysalin with commercially
available allograft bone for use in spinal fusion surgery as an alternative to
autograft. A completed pre-clinical study, which was presented at the
North American Spine Society meeting in October 2004 in Chicago, showed that
Chrysalin, in several different formulations combined with allograft bone,
caused varying degrees of bone formation in spinal fusion models.
In
addition, we completed enrollment in a small pilot Phase 1/2 human clinical
trial evaluating Chrysalin for spine fusion in the spring of 2004. This pilot
study included approximately 50 patients and no adverse events related to
Chrysalin have been reported in this study.
Cartilage
Defect Repair
Cartilage
tissue is the smooth, slippery cushion that exists where two bones meet to make
a joint. Because damaged cartilage generally does not heal but slowly
breaks down over time, the result can lead to a complete wearing away of the
cartilage, leading to osteoarthritis.
The
primary purpose of exploring Chrysalin’s potential role in cartilage defect
repair is to develop a technique to restore, rather than entirely replace, the
original cartilage damaged due to acute traumatic events. These
techniques, if successful, may also provide a novel approach for partial
resurfacing of damaged joint (or “articular”) cartilage due to
osteoarthritis.
We have
completed several pre-clinical studies evaluating Chrysalin in sustained release
formulations for cartilage defect repair. The results to date have
been presented at two major international conferences on cartilage
repair.
Dental
Bone Repair
We’ve
focused on the use of Chrysalin in two dental bone repair
situations: dental implants and maxillo-facial
reconstruction. For some patients who need dental implants to replace
missing teeth, the patient’s bones in the jaw are not strong enough to hold the
implanted teeth or supporting structure. The standard treatment in
these cases is to insert bone graft material into or above the jaw bones and
wait for the body to naturally grow bone around the graft
material. This process can take a year or longer, during which a
patient must use a temporary external plate with the temporary
teeth. In a 2004 pre-clinical study done by CBI in conjunction with
Louisiana State University, the incorporation of Chrysalin together with a
commercially available bone graft material into the space above the rabbit jaw
bones resulted in a significant increase in new bone formation. This
could translate in a shorter wait for patients to complete their dental implant
surgery.
Tendon
Repair
Tendons
are the soft tissue that connects muscles to bone. Tendons are
crucial to the biomechanical functions of the body. Injuries to
tendons are very common, and typically these injuries are treated either
conservatively with rehabilitation techniques or with surgical
techniques. These injuries are often slow to heal or do not heal
completely. We have conducted preliminary research focused on whether
Chrysalin accelerates tendon tissue repair which may result in better
restoration of function.
Vascular
Endothelial Dysfunction (VED)
Impaired
nitric oxide (NO) production reduces the responsiveness of endothelial cells to
angiogenic factors and causes loss of endothelial function in ischemic and
inflamed blood vessels contributing to a number of chronic
diseases. We hypothesize that TP508 may produce angiogenic and other
tissue repair effects by activating or upregulating nitric oxide synthetase
(NOS) in endothelial cells, and if so, that it may have potential therapeutic
value in tissues and diseases exhibiting endothelial dysfunction.
Clinical
indications associated with VED include the broad areas of coronary artery
disease (CAD) and peripheral artery disease (PAD). Insufficient blood
supply to the myocardium can result in myocardial ischemia, injury or
infarction, or all three. Atherosclerosis of the larger coronary
arteries is the most common anatomic condition that causes diminished coronary
blood flow. PAD is frequently a marker of systemic atherosclerosis,
identifying a group of patients at high risk for cardiovascular morbidity and
mortality.
In
pre-clinical animal studies conducted, Chrysalin injections into the damaged
heart appear to trigger a complex sequence of events that culminates in the
body’s growth of new blood vessels, enhancing blood delivery to the heart
muscle.
In
December 2006 we announced during an American Society for Cell Biology
presentation, results of an experiment demonstrating that TP508 increases the
ability of endothelial cells to produce nitric oxide and that TP508 prevents
negative effects caused by oxygen deprivation, a condition found in myocardial
ischemia and chronic wounds.
These
discoveries raise the possibility that TP508 could be useful in treating a
number of vascular diseases and additional pre-clinical studies are planned in
2008. OrthoLogic is in the preliminary stages of examining these
disease states and the suitability of TP508 as a therapeutic agent to treat
vascular disorders.
Scientific
Advisory Board
On August
2, 2007, we announced the formation of a Scientific Advisory Board (SAB) with
the appointments of Michael E. Mendelsohn, MD, Tufts-New England Medical Center
and Charles A. Dinarello, MD, University of Colorado School of
Medicine. The SAB will provide independent scientific advice and
counsel to OrthoLogic management and Board of Directors regarding key
development decisions for the Company’s novel synthetic peptides Chrysalin®
(TP508) and AZX100. Dr. Mendelsohn will serve as Chairman of the
SAB.
Chrysalin
Product Platform Status
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We
believe that the results of our efforts to date support that Chrysalin may
have potential therapeutic value in tissues and diseases exhibiting
endothelial dysfunction.
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We
health of endothelial tissue in blood vessels and other
mechanism-of-action studies.
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We
are focusing our efforts on vascular product candidates and are not
currently planning additional pre-clinical or clinical studies in fracture
repair, wound healing, spine fusion, cartilage defect repair, dental bone
repair or tendon repair.
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Although
we do not currently plan to re-enter clinical trials with Chrysalin,
evaluations are ongoing as to the appropriate pre-clinical and clinical
studies which would serve to strengthen our portfolio and partnering
possibilities.
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·
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In
2008, we will continue to explore the science behind and potential of
Chrysalin.are continuing pre-clinical experiments tying Chrysalin to
potential modulation of the
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AZX100
On
February 27, 2006, we purchased certain assets and assumed certain liabilities
of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive
license for the core intellectual property relating to AZX100, a 24-amino acid
synthetic peptide.
AZX100
relaxes smooth muscle, which modulates blood pressure and the function of blood
vessels, airways, sphincters, the gastrointestinal tract and the genitourinary
tract. Sustained abnormal contraction of any of these muscles is
called spasm. Any disorders known to be associated with excessive
constriction or inadequate dilation of smooth muscle represent potential
applications for AZX100.
AZX100
may also inhibit the fibrotic phenotype of fibroblasts and smooth muscle cells
in a mechanism similar to that which causes vasorelaxation. Through
phenotypic modulation of fibroblasts and smooth muscle cells, AZX100 may inhibit
the scarring that results from wound healing and disease states in the dermis,
blood vessels, lungs, liver and other organs.
AZX100 is
currently being evaluated for medically and commercially significant
applications, such as prevention of dermal scarring, pulmonary fibrosis, the
treatment of asthma, and vascular intimal hyperplasia. We are
executing a development plan for this peptide which included the filing of an
IND for a dermal indication in 2007 and includes the intention to commence a
Phase 1 safety study in dermal scarring in the first quarter of
2008. The first safety study will include approximately 30 healthy
subjects and is expected to be completed in mid 2008. Pending
favorable results, we will initiate further safety and dose-ranging studies for
dermal scarring. In 2008, we also intend to perform further
pre-clinical studies supporting multiple indications for AZX100. We
currently plan to explore partnering opportunities for non-dermal
indications.
Our
development activities for the Chrysalin Product Platform and AZX100 represent a
single operating segment as they share the same product development path and
utilize the same Company resources. As a result, we have determined
that it is appropriate to reflect our operations as one reportable
segment. Through December 31, 2007, we have incurred $101 million in
net losses as a development stage company.
Competition
The
biopharmaceutical industry is characterized by intense competition and
confidentiality. We may not be aware of the other biotechnology,
pharmaceutical companies or public institutions that are developing
pharmaceuticals that compete with our potential products. We also may
not be aware of all the other competing products our known competitors are
pursuing. In addition, these biotechnology companies and public
institutions compete with us in recruiting for research personnel and subjects,
which may affect our ability to complete our research studies.
Chrysalin
Product Platform
We
believe that current competing technologies in tissue regeneration have focused
on three primary areas:
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Single
recombinant growth factor proteins. These proteins are
naturally produced by the body to repair and regenerate injured or damaged
tissue. The proteins are grown in laboratories and then
extracted from host cells and processed for distribution to the
patient. Examples of these include platelet derived growth
factor and bone morphogenetic growth factor proteins. Bone
morphogenetic proteins induce bone
formation.
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Osteoconductive
matrices. Osteoconductive matrices are a variety of substances
that function as a replacement for the damaged tissue, serving as a
scaffold that allows the cells to fill the gaps in the damaged
tissue. Because these matrices do not stimulate growth of new
tissue, they rely on the body’s natural healing process to graft the
matrices to the damaged tissue
area.
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Cell-based
therapeutics. Cell-based therapeutics involves the extraction
of cells from a patient, growing the cells in a lab and then reintroducing
the resultant cells back into the patient. Research in this
area is particularly intensive in the search for universal donor
materials, which would eliminate the need to customize the therapy to each
patient. Scientists have been exploring stem cells as possible
sources of universal donor sources.
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We
believe that Chrysalin may have a competitive advantage over these therapies in
safety and cost. Chrysalin’s mode of operation resembles that of
growth factors. Instead of impacting a single cell pathway, Chrysalin
stimulates a cascade of growth factors to be released by the body in the proper
combination, amounts and timing.
Fracture
Repair
As the
concept of treatment of fracture repair through biotechnology and
biopharmaceuticals gains momentum, we anticipate seeing more companies develop
new potentially competitive products in all of these areas. For example, Pfizer
received IND authorization to begin a Phase 1/2 human clinical trial for a
potential product to accelerate fracture healing in 2004. While this potential
product is being evaluated in a different fracture site than the distal radius
fracture, it has been targeted to try to achieve a similar
outcome. However, we are not aware of any other competitor that has a
drug candidate and has received authorization in the United States to begin a
human clinical trial for this indication.
Dermal
Wound Healing
Standard
therapy for diabetic foot ulcers includes sharp debridement, infection control,
moisture / exudate management, and non-use of the foot. There is only
one drug product on the market today for the healing of diabetic ulcers and we
believe it is currently a secondary treatment choice. Regranex,
marketed by Johnson & Johnson, is a gel containing platelet derived growth
factor. CBI’s proof of concept Phase 1/2 clinical trial showed
equivalent or better wound healing rates than Regranex. Currently,
several other companies are conducting human clinical trials for this
indication.
Vascular
Endothelial Dysfunction (VED)
Impaired
nitric oxide (NO) production reduces the responsiveness of endothelial cells to
angiogenic factors and causes loss of endothelial function in ischemic and
inflamed blood vessels contributing to a number of chronic
diseases. We hypothesize that TP508 may produce angiogenic and other
tissue repair effects by activating or upregulating nitric oxide synthetase
(NOS) in endothelial cells, and if so, that it may have potential therapeutic
value in tissues and diseases exhibiting endothelial
dysfunction. Currently, we have not identified specific VED
indications to pursue. While the potential product markets are
significant in size, the markets are characterized by intense competition by
both large and small companies with a variety of competing
technologies.
Clinical
indications associated with VED include the broad areas of coronary artery
disease (CAD) and peripheral artery disease (PAD). Insufficient blood
supply to the myocardium can result in myocardial ischemia, injury or
infarction, or all three. Atherosclerosis of the larger coronary
arteries is the most common anatomic condition that causes diminished coronary
blood flow. PAD is frequently a marker of systemic atherosclerosis,
identifying a group of patients at high risk for cardiovascular morbidity and
mortality.
Pharmacologic
therapies commonly used in treating myocardial ischemia include 1) aspirin and
anticoagulants; 2) ß blockers; 3) nitrates; and 4) calcium channel
blockers. Also, the use of angiotensin-converting enzyme (ACE)
inhibitors recently has been shown to be beneficial in the treatment of
myocardial ischemia. Invasive treatments such as percutaneous
transluminal coronary angioplasty (PTCA) and coronary artery bypass surgery
(CABG) may be indicated as well.
Treatment
of PAD may include pharmacologic agents such as HMG-CoA reductase inhibitors
(statins), glucose control and aggressive management of hypertension,
antiplatelet therapy (aspirin or clopidogrel) or phosphodiesterase
inhibitors. Other interventions include prostaglandins, growth
factors and revascularization therapy,
OrthoLogic
is in the preliminary stages of examining these disease states and the
suitability of TP508 as a therapeutic agent to treat vascular
disorders.
AZX100
Dermal
Scarring
Approved
There is
no approved pharmacologic treatment for scarless healing. In the
setting of keloid or hypertrophic scarring the scars are often excised and
treated with steroids with variable results.
In
Development
Among
potential competing products are recombinant transforming growth factor beta 3
(TGF ß3) and antiTGFß1 antibodies. Renovo is conducting Phase 3
clinical trials in Europe and the U.S. with recombinant TGFß3 (Juvista) for
various scar prevention indications, including a recently approved IND for
keloid revisions. While preliminary efficacy has been shown in healing in
healthy individuals, like other therapeutics, TGFß3 addresses upstream signaling
and only one fibrotic pathway and may have limited effectiveness in scar
inhibition. AZX100 inhibits fibrotic responses induced by multiple
mediators, suggesting it may be more effective than TGFß3 at scarless
healing. Renovo has also begun clinical trials using a TGFß1
antibody, which like TGFß3, blocks part of the signaling cascade resulting in
scar formation. AZX100 may be more effective than TGFß1 antibodies
through more comprehensive inhibition of multiple scarring
cascades.
While
many other companies are investigating therapeutics for wound healing, we
believe that these therapeutics may be synergistic and not competitive with
AZX100 as they are targeting more rapid healing and not scar
inhibition.
Asthma
Asthma
ranks as the third highest reason for preventable hospitalizations in the U.S.
with 470,000 hospitalizations and more than 5,000 deaths each year (American
Academy of Allergy Asthma and Immunology Report). Acute asthma
accounts for an estimated two-million emergency department visits
annually. There are many competitors with asthma products approved or
in development. AZX100 has been shown to relax ex vivo airway smooth muscle
and may be developed for the treatment of asthmatic attacks. Specific
markets include severe acute asthma and asthma that is refractory to current
therapies. Severe asthma has been defined as asthma that is
refractory to current therapeutic approaches in clinical use (anti-inflammatory
agents and bronchodilators). The current approach is to use
adrenergic agonists, which activate the cAMP/PKA pathway. AZX100 is a
mimetic of the molecule downstream of this pathway and hence may be more
sensitive and specific for the treatment of severe asthma. In
addition, patients with severe asthma usually are treated in an emergency room;
hence efficacy can be closely monitored and outcomes will be apparent in a short
time frame after treatment. Recent data has demonstrated that one out
of every six asthmatics has a mutation in the adrenergic
receptor. These patients do not respond to adrenergic agonists and in
fact do worse when treated with adrenergic agonists. This patient
population would be potentially effectively treated with the AZX100 compound in
that it acts downstream of the receptors.
Intimal
Hyperplasia
Intimal
hyperplasia is the universal response of a vessel to injury. It is
characterized by the thickening of the Tunica intima of a blood vessel as a
complication of a reconstruction procedure or endarterectomy, the surgical
removal of plaque from an artery that has become narrowed or
blocked. Scar tissue forms at the point where a blood vessel is
manipulated; as it slowly builds up, significant restenosis may
develop. Intimal hyperplasia is an important reason for late bypass
graft failure, particularly in vein and synthetic vascular
grafts. Patients with end-stage renal disease (approximately 300,000
in the U.S. alone) suffer from intimal hyperplasia due to multiple vein
insertions. We are not aware of any existing therapy that effectively
modulates this healing response.
Marketing
and Sales
Neither
Chrysalin nor AZX100 are currently available for sale and we do not expect them
to be available for sale for some time into the future. Thus, we
currently have no marketing or sales staff. External consultants and
members of our staff provide some technical marketing support relating to the
development of, and market need for, new potential products and additional
therapeutic applications of products already under research.
Research
and Development
Our
Pre-clinical, Clinical, Chemical, Materials and Controls, Regulatory and Quality
Assurance departments (research and development) consist of approximately 17
employees who are assisted by consultants from the academic and medical
practitioner fields. Our employees have extensive experience in the
areas of biomaterials, animal modeling, cellular and molecular biology, clinical
trial design and data management. Our Clinical department designs,
initiates, monitors and manages our clinical trials. Our staff has been focused
on pre-clinical studies to advance AZX100 to IND status in a dermal indication,
pre-clinical studies investigating AZX100’s potential for the treatment of
asthma and intimal hyperplasia and exploring the science behind and potential of
Chrysalin. In 2008, we intend to perform pre-clinical work on
Chrysalin in vascular indications and we intend to commence a Phase 1 safety
study in a AZX100 dermal scarring indication. Pending favorable Phase
1 results, we will initiate further safety and dose ranging studies for dermal
scarring. We incurred $9.6 million and $19.7 million, in 2007 and
2006, respectively, on research efforts on Chrysalin and
AZX100. Given the overlapping nature of our research efforts it is
not possible to clearly separate research expenditures between Chrysalin and
AZX100; however, the substantial majority of expenditures were Chrysalin-related
in 2006, and AZX100 related in 2007. We incurred $25.4 million on
Chrysalin research efforts during 2005.
Manufacturing
Currently,
third parties certified under Good Manufacturing Practices manufacture Chrysalin
and AZX100 for us in limited amounts for our clinical and pre-clinical
studies. We use a primary manufacturer for the peptides used in our
human clinical trials, but secondary manufacturers are available as
needed. Our current Chrysalin and AZX100 formulation and
manufacturing work is focused on an injectable formulation.
Patents,
Licenses and Proprietary Rights
As part
of our purchase of CBI on August 5, 2004, the license agreements between CBI and
OrthoLogic for the development, use, and marketing of the therapeutic products
within the Chrysalin Product Platform were replaced by a direct license
agreement between OrthoLogic and the University of Texas. Under this direct
license, we expanded our current license for Chrysalin from a license for only
orthopedic indications to a license for any and all
indications. Subsequently, we entered into an agreement whereby the
University of Texas assigned to us certain patents previously exclusively
licensed to us. We must pay the University of Texas continuing
royalties, sublicense fees and various other fees in connection with filing and
maintaining Chrysalin-related patents. This obligation will expire upon the
expiration of the subject patents. Chrysalin has been patented in the United
States and in some other countries for a number of methods of use, including
cardiovascular, chronic wounds, and orthopedic indications. The
patents for hard and soft tissue repair expire between 2007 and
2026.
As part
of the February 27, 2006 AzERx transaction, we acquired a license from AzTE, an
affiliate of Arizona State University, for worldwide rights to AZX100 for all
indications. Under the license agreement with AzTE, we are required
to pay patent filing, maintenance and other related patent fees as well as
royalties on future sales of products that contain AZX100. These
obligations will end on the expiration of the last patent. The license is
supported by patents that expire from 2021 to 2024.
As part
of the February 27, 2006 AzERx transaction we also acquired a non-exclusive
license from Washington University for a transduction domain carrier patent
which forms part of AZX100. Under the license, we are required to pay
license maintenance payments and royalties on future sales of products that
contain the licensed technology. These obligations will end on the
expiration of the last patent.
Chrysalin
and OrthoLogic are registered United States domestic trademarks of OrthoLogic
Corp.
Insurance
Our
business entails the risk of product liability claims. We maintain a
product liability and general liability insurance policy and an umbrella excess
liability policy. There can be no assurance that liability claims
will not exceed the coverage limit of such policies or that such insurance will
continue to be available on commercially reasonable terms or at
all. Consequently, product liability claims or claims arising from
our clinical trials could have a material adverse effect on our business,
financial condition and results of operations. We have not
experienced any material liability claims to date resulting from our clinical
trials.
Employees
As of
December 31, 2007, we had thirty employees in our operations, including
seventeen employees
in research and development, nine in administration and four in facilities and
maintenance for our building. As a pure research and development
business, we believe that the success of our business will depend, in part, on
our ability to identify, attract and retain qualified research personnel, both
as employees and as consultants. We face competition from private
companies and public institutions for qualified research
personnel. None of our employees are represented by a union and we
consider our relationship with our employees to be good.
Additional
Information about OrthoLogic
OrthoLogic
Corp. was incorporated as a Delaware corporation in July 1987 as IatroMed,
Inc. We changed our name to OrthoLogic Corp. in July
1991. Our executive offices are located at 1275 West Washington
Street, Tempe, Arizona 85281, and our telephone number is (602)
286-5520.
Our
website address is www.orthologic.com. Our annual reports on Form
10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, as well as
any amendments to those reports, are available free of charge through our
website as soon as reasonably practical after we file or furnish them to the
U.S. Securities and Exchange Commission. Once at our website, go to
the “Investors” section to locate these filings.
In March
2004, we adopted a code of conduct that applies to all of our employees and has
particular sections that apply only to our principal executive officer and
senior financial officers. We posted the text of our code of conduct
on our website in the “Investors” section of our website under “Code of
Conduct.” In addition, we will promptly disclose on our website (1)
the nature of any amendment to our code of conduct that applies to our principal
executive officer and senior financial officers, and (2) the nature of any
waiver, including an implicit waiver, from a provision of our code of ethics
that is granted to one of these specified officers, the name of such officer who
is granted the waiver and the date of the waiver.
In this document references to “we”,
“our” and the “Company” refer to OrthoLogic Corp. References to our “Bone Device
Business” refer to our former business line of bone growth stimulation and
fracture fixation devices, including the OL1000 product line, SpinaLogic®,
OrthoFrame® and OrthoFrame/Mayo.
Risks
OrthoLogic
may from time to time make written or oral forward-looking statements, including
statements contained in our filings with the Securities and Exchange Commission
and our reports to stockholders. The safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform Act of 1995
protects companies from liability for their forward looking statements if they
comply with the requirements of that Act. This Annual Report on Form
10-K contains forward-looking statements made pursuant to that safe harbor.
These forward-looking statements relate to future events or to our future
financial performance, and involve known and unknown risks, uncertainties and
other factors that may cause our actual results, levels of activity,
performance, or achievements to be materially different from any future results,
levels of activity, performance or achievements expressed or implied by these
forward-looking statements. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,” “intend,”
“plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,”
“continue,” or the negative of these terms or other comparable terminology. You
should not place undue reliance on forward-looking statements since they involve
known and unknown risks, uncertainties and other factors which are, in some
cases, beyond our control and which could materially affect actual results,
levels of activity, performance or achievements. Factors that may cause actual
results to differ materially from current expectations, which we describe in
more detail in this section titled “Risks,” include, but are not limited
to:
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unfavorable
results of our product candidate development
efforts;
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unfavorable
results of our pre-clinical or clinical
testing;
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delays
in obtaining, or failure to obtain FDA
approvals;
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increased
regulation by the FDA and other
agencies;
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the
introduction of competitive
products;
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impairment
of license, patent or other proprietary
rights;
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failure
to achieve market acceptance of our
products;
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the
impact of present and future collaborative or partnering agreements or the
lack thereof; and
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failure
to successfully implement our drug development
strategy.
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If one or
more of these or other risks or uncertainties materialize, or if our underlying
assumptions prove to be incorrect, actual results may vary significantly from
what we projected. Any forward-looking statement you read in this Annual Report
on Form 10-K reflects our current views with respect to future events and is
subject to these and other risks, uncertainties and assumptions relating to our
operations, results of operations, business strategy and liquidity. We assume no
obligation to publicly update or revise these forward-looking statements for any
reason, or to update the reasons actual results could differ materially from
those anticipated in these forward-looking statements, even if new information
becomes available in the future.
Risks
Related to Our Business
We
are a biopharmaceutical company with no revenue generating operations and high
investment costs.
We expect
to incur losses for a number of years as we expand our research and development
projects. There is no assurance that our current level of funds will be
sufficient to support all research expenses to achieve commercialization of any
of our product candidates. On November 26, 2003, we sold all of our
revenue generating operations. We are now focused on developing and
testing the product candidates in AZX100 and our Chrysalin Product Platform and
have allocated most of our resources to bringing these product candidates to the
market, either through clinical trials or partnering efforts. We may
invest in other peptide or small molecule-based therapeutics in the future, but
there can be no assurance that opportunities of this nature will occur at
acceptable terms, conditions or timing. We currently have no
pharmaceutical products being sold or ready for sale and do not expect to be
able to introduce any pharmaceutical products for at least several
years. As a result of our significant research and development,
clinical development, regulatory compliance and general and administrative
expenses and the lack of any products to generate revenue, we expect to incur
losses for at least the next several years and expect that our losses will
increase if we expand our research and development activities and incur
significant expenses for clinical trials. Our cash reserves are the
primary source of our working capital. There can be no assurance that
our cash resources will be sufficient to cover our future operating
requirements, or should there be a need, other sources of cash will be
available, or if available, at acceptable terms.
We may
not receive any revenue from our product candidates until we receive regulatory
approval and begin commercialization of our product candidates. We
cannot predict when that will occur or if it will occur.
We
caution that our future cash expenditure levels are difficult to forecast
because the forecast is based on assumptions about the number of research
projects we pursue, the pace at which we pursue them, the quality of the data
collected and the requests of the FDA to expand, narrow or conduct additional
clinical trials and analyze data. Changes in any of these assumptions can change
significantly our estimated cash expenditure levels.
Our
product candidates have reached various stages of development but may not be
successfully developed or commercialized.
If we
fail to commercialize our product candidates, we will not be able to generate
revenue. We currently do not sell any products. Our product
candidates have reached the following stages of development:
Chrysalin:
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Acceleration
of Fracture Repair
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Phase
3 / Phase 2b human clinical trials
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Diabetic
Foot Ulcer Healing
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Phase
1/2 human clinical trials
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Spine
Fusion
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Phase
1/2 human clinical trials
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Cartilage
Defect Repair
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Late
stage pre-clinical trials
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Tendon
Repair
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Early
stage pre-clinical trials
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Cardiovascular
Repair
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Pre-clinical
trials
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Dental
Bone Repair
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Pre-clinical
trials
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Vascular
Endothelial Dysfunction
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Early
stage pre-clinical testing
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AZX100:
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Scarring
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IND
filed in 2007
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We are subject to the risk that:
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the
FDA finds some or all of our product candidates ineffective or
unsafe;
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we
do not receive necessary regulatory
approvals;
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we
are unable to get some or all of our product candidates to market in a
timely manner;
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we
are not able to produce our product candidates in commercial quantities at
reasonable costs;
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our
products undergo post-market evaluations resulting in marketing
restrictions or withdrawal
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the
patients, insurance and/or physician community does not accept our
products.
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In
addition, our product development programs may be curtailed, redirected or
eliminated at any time for many reasons,
including:
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adverse
or ambiguous results;
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undesirable
side effects which delay or extend the
trials;
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inability
to locate, recruit, qualify and retain a sufficient number of patients for
our trials;
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regulatory
delays or other regulatory actions;
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difficulties
in obtaining sufficient quantities of the particular product candidate or
any other
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components
needed for our pre-clinical testing or clinical
trials;
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change
in the focus of our development efforts;
and
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re-evaluation
of our clinical development
strategy.
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We cannot
predict whether we will successfully develop and commercialize any of our
product candidates. If we fail to do so, we will not be able to
generate revenue.
Certain
results from our Phase 3 and Phase 2b clinical trials showed that the
differences in the primary endpoint analyses between our lead compound,
Chrysalin, and the placebo were not statistically significant, which will make
it more difficult to obtain FDA approval and result in a substantial delay in
our ability to generate revenue.
On March
15, 2006, we reported results of our Phase 3 fracture repair human clinical
trial. For the primary endpoint, time to removal of immobilization,
no statistically significant difference was observed between placebo and a
single injection of Chrysalin. Consistent with the Phase 1/2 human
clinical trial results, a statistically significant difference for a secondary
endpoint, radiographic evidence of radial cortical bridging, was
achieved. However, no statistically significant difference was noted
in the study’s other secondary endpoints. On March 15, 2006, we
temporarily halted our Phase 2b fracture repair dosing clinical trial to perform
an interim analysis of the data of the subjects enrolled to that
date.
We
announced on February 16, 2007 findings of a post-hoc subgroup analysis of
data from the Phase 3 clinical trial, which were presented at the American
Academy of Orthopedic Surgeons Annual Meeting. This subgroup analysis
was based on bone mineral density, a pre-specified
stratification. Within the subset of female osteopenic subjects,
treatment with 10 µg Chrysalin demonstrated a statistically significant benefit
compared to placebo in the primary efficacy endpoint of time to removal of
immobilization. Secondary endpoints including time to clinical
evaluation of healing, time to radial cortical bridging and time to overall
radiographic healing also showed a significant effect of Chrysalin
treatment.
On August
29, 2006, we reported the results of interim analysis of data from our Phase 2b
dose-ranging clinical trial of the novel synthetic peptide Chrysalin® (TP508)
in unstable, displaced distal radius (wrist) fractures and termination of the
Phase 2b study. In the dataset of 240 subjects as a group that were evaluable in
the Phase 2b interim analysis, treatment with Chrysalin did not demonstrate
benefit compared to placebo in the primary efficacy endpoint of time to removal
of immobilization. Individual findings of efficacy in secondary
endpoints, including radiographic healing, were not seen in this interim
analysis and no dose response relationship was observed. The trial met the
pre-specified safety endpoint by demonstrating no significant difference in the
incidence of adverse events between the Chrysalin and placebo
groups.
We have
implemented a strategic shift in our development approach to our Chrysalin
Product Platform. We currently intend to pursue development
partnering or licensing opportunities for our Chrysalin-based product
candidates, a change from our previous development history of independently
conducting human clinical trials necessary to advance our Chrysalin-based
product candidates to market.
The
results of our Phase 3 and 2b clinical trials increases the risk that we will
not be successful and there will be a substantial delay in obtaining FDA
approval; may lead to the termination of development efforts for the Chrysalin
fracture repair or other Chrysalin-based product candidates; will result in a
delay in our ability to generate revenue; will change the amount of revenue we
may generate; and could have a material adverse effect on our business going
forward.
Our product
candidates are all based on the same two chemical peptides, Chrysalin and
AZX100. If one of our Chrysalin or AZX100 product candidates reveals
safety or fundamental efficacy issues in clinical trials, it could impact the
development path for our other current product candidates for that
peptide.
Since we
are developing the product candidates in the Chrysalin Product Platform in
parallel, we expect to learn from the results of each trial and apply some of
our findings to the development of the other product candidates in the
platform. The fact that the results from the Phase 3 and Phase 2b
fracture repair human clinical trials showed no statistical significance between
Chrysalin and the placebo for the primary endpoint in the study will likely
impact the development path or future development of the other product
candidates in the platform. In addition, if we find that one of our
Chrysalin product candidates is unsafe in the future, it could impact the
development of our other product candidates in clinical trials.
AZX100 is
currently in pre-clinical testing and the first human clinical trial for dermal
scarring is planned to start in the first quarter of 2008. Should the
results of ongoing pre-clinical studies or human clinical trials show negative
safety or efficacy data, it may impact the development of our AZX100 product
candidates.
If
we cannot protect the Chrysalin patents, the AZX100 patents, or our intellectual
property generally, our ability to develop and commercialize our products will
be severely limited.
Our
success will depend in part on our ability to maintain and
enforce patent protection for Chrysalin and AZX100 and each product resulting
from Chrysalin or AZX100. Without patent protection, other companies
could offer substantially identical products for sale without incurring the
sizable discovery, development and licensing costs that we have
incurred. Our ability to recover these expenditures and realize
profits upon the sale of products would then be diminished.
Certain
key Chrysalin methods of use patents have expired and other patents will expire
during the development period of our Chrysalin Product Platform. We
believe our current patents covering formulations and specific indications are
adequate to protect the value of the Chrysalin Product
Platform. However, if our current patents are not adequate, the value
of the Chrysalin Product Platform may be materially adversely
impacted.
Chrysalin
and AZX100 are patented and there have been no successful challenges to the
patents. However, if there were to be a challenge to these patents or
any of the patents for product candidates, a court may determine that the
patents are invalid or unenforceable. Even if the validity or
enforceability of a patent is upheld by a court, a court may not prevent alleged
infringement on the grounds that such activity is not covered by the patent
claims. Any litigation, whether to enforce our rights to use our or
our licensors’ patents or to defend against allegations that we infringe third
party rights, will be costly, time consuming, and may distract management from
other important tasks.
As is
commonplace in the biotechnology and pharmaceutical industry, we employ
individuals who were previously employed at other biotechnology or
pharmaceutical companies, including our competitors or potential
competitors. To the extent our employees are involved in research
areas which are similar to those areas in which they were involved at their
former employers, we may be subject to claims that such employees and/or we have
inadvertently or otherwise used or disclosed the alleged trade secrets or other
proprietary information of the former employers. Litigation may be
necessary to defend against such claims, which could result in substantial costs
and be a distraction to management and which may have a material adverse effect
on us, even if we are successful in defending such claims.
We also
rely in our business on trade secrets, know-how and other proprietary
information. We seek to protect this information, in part, through
the use of confidentiality agreements with employees, consultants, advisors and
others. Nonetheless, we cannot assure that those agreements will
provide adequate protection for our trade secrets, know-how or other proprietary
information and prevent their unauthorized use or disclosure. The
risk that other parties may breach confidentiality agreements or that our trade
secrets become known or independently discovered by competitors, could adversely
affect us by enabling our competitors, who may have greater experience and
financial resources, to copy or use our trade secrets and other proprietary
information in the advancement of their products, methods or
technologies.
Our
success also depends on our ability to operate and commercialize products
without infringing on the patents or proprietary rights of others.
Third
parties may claim that we or our licensors or suppliers are infringing their
patents or are misappropriating their proprietary information. In the
event of a successful claim against us or our licensors or suppliers for
infringement of the patents or proprietary rights of others, we may be required
to, among other things:
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pay
substantial damages;
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stop
using our technologies;
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stop
certain research and development
efforts;
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develop
non-infringing products or methods;
and
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obtain
one or more licenses from third
parties.
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A license
required under any such patents or proprietary rights may not be available to
us, or may not be available on acceptable terms. If we or our
licensors or suppliers are sued for infringement, we could encounter substantial
delays in, or be prohibited from, developing, manufacturing and commercializing
our product candidates.
If we do not
successfully develop AZX100 we may not recover the value of our
investment.
On
February 27, 2006, we purchased certain assets and assumed certain liabilities
of AzERx, Inc. for $390,000 in cash and the issuance of 1,355,000 shares of our
common stock, with a market value of $7.7 million determined by the closing
share price on the date the agreement was entered into. The transaction was
completed (closed) on February 27, 2006. Under the terms of the
transaction, we acquired an exclusive license for the core intellectual property
relating to AZX100, a 24-amino acid synthetic peptide. The acquisition provides
us with a new technology platform that diversifies the portfolio, and may
provide more than one potential product. AZX100 is currently being
investigated for medically important and commercially significant applications
such as prevention of dermal scarring, pulmonary fibrosis, the treatment of
asthma and vascular intimal hyperplasia. While we performed a
reasonable level of due diligence on AZX100 and the rights acquired, and in our
pre-clinical testing AZX100 has demonstrated a satisfactory safety profile,
there can be no assurances that we will recover the costs of our investment from
the future development of AZX100 or that commercially significant applications
will be developed.
The
loss of our key management and scientific personnel may hinder our ability to
execute our business plan.
As a
small company our success depends on the continuing contributions of our
management team and scientific personnel, and maintaining relationships with the
network of medical and academic centers in the United States that conduct our
clinical trials. The resignation or retirement of members of senior
management or scientific personnel could materially adversely affect our
business prospects.
Reliance
on Outside Suppliers and Consultants
We rely
on outside suppliers and consultants for the manufacture of Chrysalin and AZX100
and technical assistance in our research and development efforts. The
inability of our suppliers to meet our production quality requirements in a
timely manner, or the lack of availability of experienced consultants to assist
in our research and development efforts, could have a material effect on our
ability to perform research or clinical trials.
We
face an inherent risk of liability in the event that the use or misuse of our
products results in personal injury or death.
The use
of our product candidates in clinical trials may expose us to product
liability claims, which could result in financial losses. Our
clinical liability insurance coverage may not be sufficient to
cover claims that may be made against us. In addition, we may not be
able to maintain insurance coverage at a reasonable cost or in sufficient
amounts or scope to protect us against losses. Any claims against us,
regardless of their merit, could severely harm our financial condition, strain
our management and other resources and adversely impact or eliminate the
prospects for commercialization of the product which is the subject of any such
claim.
Risks
of our Industry
We
are in a highly regulated field with high investment costs and high
risks.
Chrysalin
has been in the human testing phase for three potential products and earlier
pre-clinical testing phases for five other potential products. AZX100 is
currently in pre-clinical testing with a Phase 1 dermal scarring study planned
for early 2008. The FDA and comparable agencies in many foreign countries impose
substantial limitations on the introduction of new pharmaceuticals through
costly and time-consuming laboratory and clinical testing and other
procedures. The process of obtaining FDA and other required
regulatory approvals is lengthy, expensive and uncertain. Chrysalin
and AZX100 are new drugs and are subject to the most stringent level of FDA
review.
Even
after we have invested substantial funds in the development of our Chrysalin and
AZX100 products and even if the results of our future clinical trials are
favorable, there can be no guarantee that the FDA will grant approval of
Chrysalin and/or AZX100 for the indicated uses or that it will do so in a timely
manner.
If we
successfully bring one or more products to market, there is no assurance that we
will be able to successfully manufacture or market the products or that
potential customers will buy them if, for example, a competitive product has
greater efficacy or is deemed more cost effective. In addition, the
market in which we will sell any such products is dominated by a number of large
corporations that have vastly greater resources than we have, which may impact
our ability to successfully market our products or maintain any technological
advantage we might develop. We also would be subject to changes in
regulations governing the manufacture and marketing of our products, which could
increase our costs, reduce any competitive advantage we may have and/or
adversely affect our marketing effectiveness.
The
pharmaceutical industry is subject to stringent regulation, and failure to
obtain regulatory approval will prevent commercialization of our
products.
Our
research, development, pre-clinical and clinical trial activities and the
manufacture and marketing of any products that we may successfully develop are
subject to an extensive regulatory approval process by the FDA and other
regulatory agencies in the United States and abroad. The process of
obtaining required regulatory approvals for drugs is lengthy, expensive and
uncertain, and any such regulatory approvals may entail limitations on the
indicated usage of a drug, which may reduce the drug’s market
potential.
In order
to obtain FDA approval to commercialize any product candidate, an NDA must be
submitted to the FDA demonstrating, among other things, that the product
candidate is safe and effective for use in humans for each target indication.
Our regulatory submissions may be delayed, or we may cancel plans to make
submissions for product candidates for a number of reasons,
including:
|
·
|
negative
or ambiguous pre-clinical or clinical trial
results;
|
|
·
|
changes
in regulations or the adoption of new
regulations;
|
|
·
|
unexpected
technological developments; and
|
|
·
|
developments
by our competitors that are more effective than our product
candidates.
|
Consequently,
we cannot assure that we will make our submissions to the FDA in the timeframe
that we have planned, or at all, or that our submissions will be approved by the
FDA. Even if regulatory clearance is obtained, post-market evaluation
of our products, if required, could result in restrictions on a product’s
marketing or withdrawal of a product from the market as well as possible civil
and criminal sanctions.
Clinical
trials are subject to oversight by institutional review boards and the FDA to
ensure compliance with the FDA’s good clinical practice regulations, as well as
other requirements for good clinical practices. We depend, in part,
on third-party laboratories and medical institutions to conduct pre-clinical
studies and clinical trials for our products and other third-party organizations
to perform data collection and analysis, all of which must maintain both good
laboratory and good clinical practices. If any such standards are not
complied with in our clinical trials, the FDA may suspend or terminate such
trial, which would severely delay our development and possibly end the
development of a product candidate.
We also
currently and in the future will depend upon third party manufacturers of our
products, which are and will be required to comply with the applicable FDA Good
Manufacturing Practice regulations. We cannot be certain that our
present or future manufacturers and suppliers will comply with these
regulations. The failure to comply with these regulations may result
in restrictions in the sale of, or withdrawal of the products from the
market. Compliance by third parties with these standards and
practices are outside of our direct control.
In
addition, we are subject to regulation under state and federal laws, including
requirements regarding occupational safety, laboratory practices, environmental
protection and hazardous substance control, and may be subject to other local,
state, federal and foreign regulation. We cannot predict the impact
of such regulations on us, although they could impose significant restrictions
on our business and require us to incur additional expenses to
comply.
If
our competitors develop and market products that are more effective than ours,
or obtain marketing approval before we do, our commercial opportunities will be
reduced or eliminated.
Competition
in the pharmaceutical and biotechnology industries is intense and is expected to
increase. Several biotechnology and pharmaceutical companies, as well
as academic laboratories, universities and other research institutions, are
involved in research and/or product development for indications targeted for use
by either Chrysalin or AZX100. Many of our competitors have significantly
greater research and development capabilities, experience in obtaining
regulatory approvals and manufacturing, marketing, financial and managerial
resources than we have.
Our
competitors may succeed in developing products that are more effective than the
ones we have under development or that render our proposed products or
technologies noncompetitive or obsolete. In addition, certain of such
competitors may achieve product commercialization before we do. If
any of our competitors develops a product that is more effective than one we are
developing or plan to develop, or is able to obtain FDA approval for
commercialization before we do, we may not be able to achieve significant market
acceptance for certain products of ours, which would have a material adverse
effect on our business.
For a
summary of the competitive conditions relating to indications which we are
currently considering for Chrysalin and AZX100, see Part I, Item 1 in this
Report titled “Competition”.
Our
product candidates may not gain market acceptance among physicians, patients and
the medical community, including insurance companies and other third party
payors. If our product candidates fail to achieve market acceptance,
our ability to generate revenue will be limited.
Even if
we obtain regulatory approval for our products, market acceptance will depend on
our ability to demonstrate to physicians and patients the benefits of our
products in terms of safety, efficacy, and convenience, ease of administration
and cost effectiveness. In addition, we believe market acceptance
depends on the effectiveness of our marketing strategy, the pricing of our
products and the reimbursement policies of government and third-party
payors. Physicians may not prescribe our products, and patients may
determine, for any reason, that our product is not useful to
them. Insurance companies and other third party payors may determine
not to reimburse for the cost of the therapy. If any of our product
candidates fails to achieve market acceptance, our ability to generate revenue
will be limited.
Healthcare
reform and restrictions on reimbursements may limit our financial
returns.
Our
ability to successfully commercialize our products may depend in part on the
extent to which government health administration authorities, private health
insurers and other third party payors will reimburse consumers for the cost of
these products. Third party payors are increasingly challenging both
the need for, and the price of, novel therapeutic drugs and uncertainty exists
as to the reimbursement status of newly approved
therapeutics. Adequate third party reimbursement may not be available
for our drug products to enable us to maintain price levels sufficient to
realize an appropriate return on our investments in research and product
development, which could restrict our ability to commercialize a particular drug
candidate.
Risks
Related to Our Common Stock and Warrants
Our
stock price is volatile and fluctuates due to a variety of factors.
Our stock
price has varied significantly in the past (from a high of $9.32 to a low of
$1.25 during the period of January 1, 2004 through December 31, 2007) and
may vary in the future due to a number of factors, including:
|
·
|
announcement
of the results of, or delays in, preclinical and clinical
studies;
|
|
·
|
fluctuations
in our operating results;
|
|
·
|
developments
in litigation to which we or a competitor is
subject;
|
|
·
|
announcements
and timing of potential acquisitions, divestitures, capital raising
activities or issuance of preferred
stock;
|
|
·
|
announcements
of technological innovations or new products by us or our
competitors;
|
|
·
|
FDA
and other regulatory actions;
|
|
·
|
developments
with respect to our or our competitors’ patents or proprietary
rights;
|
|
·
|
public
concern as to the safety of products developed by us or others;
and
|
|
·
|
changes
in stock market analyst recommendations regarding us, other drug
development companies or the pharmaceutical industry
generally.
|
In
addition, the stock market has from time to time experienced significant price
and volume fluctuations that are unrelated to the operating performance of
particular companies. These broad market fluctuations may adversely
affect the market price of our stock.
Additional
authorized shares of our common stock available for issuance may have dilutive
and other material effects on our stockholders.
We are
authorized to issue 100,000,000 shares of common stock. As of
December 31, 2007, there were 41,758,065 shares of common stock issued and
outstanding. However, the total number of shares of our common stock issued and
outstanding does not include shares reserved in anticipation of the exercise of
options, warrants or additional investment rights. As of December 31,
2007 we had stock options outstanding to purchase approximately 3,200,125 shares
of our common stock, the exercise price of which range between $1.42 per share
to $7.83 per share, warrants outstanding to purchase 46,706 shares of our common
stock with an exercise price of $6.39, warrants outstanding to purchase 357,423
shares of our common stock with an exercise price of $1.91, and we have reserved
shares of our common stock for issuance in connection with the potential
exercise thereof. Additionally, at our Annual Stockholder Meeting on May
12, 2006, our stockholders approved the OrthoLogic 2005 Equity Incentive Plan,
which provides an additional 2,000,000 shares of our common stock for incentive
awards. To the extent additional options are granted and
exercised or additional stock is issued, the holders of our common stock will
experience further dilution. At December 31, 2007, 436,026 shares
remain available to grant under the 2005 Equity Incentive Plan. In addition, in
the event that any future financing or consideration for a future acquisition
should be in the form of, be convertible into or exchangeable for, equity
securities, investors will experience additional dilution.
Certain
provisions of our amended and restated certificate of incorporation and bylaws
will make it difficult for stockholders to change the composition of our board
of directors and may discourage takeover attempts that some of our stockholders
may consider beneficial.
Certain
provisions of our amended and restated certificate of incorporation and bylaws
may have the effect of delaying or preventing changes in control if our board of
directors determines that such changes in control are not in the best interests
of OrthoLogic Corp. and our stockholders. These provisions include,
among other things, the following:
|
·
|
a
classified board of directors with three-year staggered
terms;
|
|
·
|
advance
notice procedures for stockholder proposals to be considered at
stockholders’ meetings;
|
|
·
|
the
ability of our board of directors to fill vacancies on the
board;
|
|
·
|
a
prohibition against stockholders taking action by written consent;
and
|
|
·
|
super
majority voting requirements for the stockholders to modify or amend our
bylaws and specified provisions of our amended and restated certificate of
incorporation.
|
These
provisions are not intended to prevent a takeover, but are intended to protect
and maximize the value of our stockholders’ interests. While these
provisions have the effect of encouraging persons seeking to acquire control of
our company to negotiate with our board of directors, they could enable our
board of directors to prevent a transaction that some, or a majority, of our
stockholders might believe to be in their best interests and, in that case, may
prevent or discourage attempts to remove and replace incumbent
directors. In addition, we are subject to the provisions of Section
203 of the Delaware General Corporation Law, which prohibits business
combinations with interested stockholders. Interested stockholders do
not include stockholders whose acquisition of our securities is pre-approved by
our board of directors under Section 203.
We
may issue additional shares of preferred stock that have greater rights than our
common stock and also have dilutive and anti-takeover effects.
We are
permitted by our amended and restated certificate of incorporation to issue up
to 2,000,000 shares of preferred stock. We can issue shares of our
preferred stock in one or more series and can set the terms of the preferred
stock without seeking any further approval from our common stockholders or other
security holders. Any preferred stock that we issue may rank ahead of
our common stock in terms of dividend priority or liquidation rights and may
have greater voting rights than our common stock.
In
connection with a Rights Agreement dated as of June 19, 2007 between us and the
Bank of New York, (the “Rights Agreement”), our board approved the
designation of 1,000,000 shares of Series A Preferred Stock. The Rights
Agreement and the exercise of rights to purchase Series A Preferred Stock
pursuant to the terms thereof may delay, defer or prevent a change in control
because the terms of any issued Series A Preferred Stock would potentially
prohibit our consummation of certain extraordinary corporate transactions
without the approval of the Board. In addition to the anti-takeover
effects of the rights granted under the Rights Agreement, the issuance of
preferred stock, generally, could have a dilutive effect on our
stockholders.
We
have not previously paid dividends on our common stock and we do not anticipate
doing so in the foreseeable future.
We have
not in the past paid any dividends on our common stock and do not anticipate
that we will pay any dividends on our common stock in the foreseeable
future. Any future decision to pay a dividend on our common stock and
the amount of any dividend paid, if permitted, will be made at the discretion of
our board of directors.
Developments
in any of these areas, which are more fully described elsewhere in “Item 1 -
Business,” and “Item 7 - Management’s Discussion and Analysis of Financial
Condition and Results of Operations” could cause our results to differ
materially from results that have been or may be projected by us.
|
Unresolved
Staff Comments
|
None.
During
the years 1998 – 2007, we leased a facility in Tempe, Arizona, which is an
approximately 100,000 square foot facility designed and constructed for
industrial purposes and is located in an industrial district. It is
the same facility we leased prior to our November 2003 divestiture of our bone
growth stimulation device business. Following the divestiture, we
occupied approximately 20% of the building capacity and subleased some portions
of the building to other companies. This lease expired December 31,
2007. In July 2007, we entered into a new five-year lease for
17,000 square feet of space in the same Tempe facility, which became effective
at the end of our current lease. We believe the facility is
well-maintained and adequate for use through the end of our lease
term.
None.
|
Submission
of Matters to a Vote of Security
Holders
|
None.
|
Market
for the Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
Market
Information
Our common stock commenced trading on
NASDAQ on January 28, 1993 and is currently trading on the NASDAQ Global Market
under the symbol “OLGC.” The following table sets forth,
for the fiscal periods indicated, the range of high and low sales prices of our
common stock.
|
|
2007
|
|
|
2006
|
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
First
Quarter
|
|
$ |
1.80 |
|
|
$ |
1.35 |
|
|
$ |
6.20 |
|
|
$ |
2.08 |
|
Second
Quarter
|
|
$ |
1.64 |
|
|
$ |
1.40 |
|
|
$ |
2.18 |
|
|
$ |
1.54 |
|
Third
Quarter
|
|
$ |
1.60 |
|
|
$ |
1.35 |
|
|
$ |
1.80 |
|
|
$ |
1.25 |
|
Fourth
Quarter
|
|
$ |
1.59 |
|
|
$ |
1.28 |
|
|
$ |
1.46 |
|
|
$ |
1.26 |
|
As of
February 29, 2008, 41,758,065 shares of our common stock were outstanding and
held by approximately 1,000 stockholders of record.
Performance
Graph
STOCK
PERFORMANCE GRAPH
This
performance graph shall not be deemed to be “soliciting material” or to be
“filed” with the SEC, or subject to Regulation 14A or 14C, other than as
provided in Item 201 of Regulation S-K, or subject to the liability of Section
18 of the Exchange Act, nor shall it be deemed incorporated by reference in any
of our filings under the Securities Act or Exchange Act, except to the extent
that we specifically request incorporation by reference thereof.
Set forth
below is a graph comparing the cumulative total shareholder return on our Common
Stock to the cumulative total return of (i) the NASDAQ Biotechnology Index, and
(ii) the Russell 2000 Index. We believe that the NASDAQ Biotechnology
Index, which is composed of companies that are classified as either
biotechnology or pharmaceutical, is an appropriate index for
comparison. While many of the companies listed on that index may be
larger in size based on market capitalization, the type of research and
development work is comparable to our activities. The graph is
generated by assuming that $100 was invested on the last trading day in the
fiscal year ended December 31, 2002 in each of our Common Stock, the NASDAQ
Biotechnology Index, and the Russell 2000 Index (all assume no
dividends).
Dividends.
We have
never paid a cash dividend on our common stock. Our Board of
Directors currently does not intend to pay any cash dividends on our common
stock in the foreseeable future.
Recent
Sales of Unregistered Securities.
None.
Issuer
Purchases of Equity Securities.
None.
SELECTED
FINANCIAL DATA
The
selected financial data for each of the five years in the period ended December
31, 2007, is derived from our audited financial statements. The
selected financial data should be read in conjunction with the financial
statements, related notes to the financial statements and other financial
information appearing elsewhere in this annual report on Form 10-K and
particularly the discussion in “Management’s Discussion and Analysis of
Financial Condition and Results of Operations.” We sold our bone
growth stimulation device business (“Bone Device Business”) on November 26,
2003. On August 5, 2004, we purchased substantially all the assets
and the intellectual property of CBI. We became a development stage
company commensurate with the CBI acquisition. On February 27, 2006, we
purchased certain assets and assumed certain liabilities of
AzERx. The financial data as presented below reflects the gain on the
sale of the bone growth stimulation device business and its results of
operations prior to the sale as discontinued operations and reflects the
purchased net assets of CBI and AzERx from the dates of those respective
acquisitions.
STATEMENTS
OF OPERATIONS DATA
(A
Development Stage Company)
(in
thousands, except per share amounts)
|
|
Years
Ended December 31,
|
|
|
|
2007
|
|
|
2006(1)
|
|
|
2005(2)
|
|
|
2004(3)
|
|
|
2003(4)
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$ |
(3,738 |
) |
|
$ |
(6,558 |
) |
|
$ |
(4,910 |
) |
|
$ |
(3,306 |
) |
|
$ |
(4,331 |
) |
Research
and development
|
|
|
(9,641 |
) |
|
|
(19,661 |
) |
|
|
(25,444 |
) |
|
|
(17,116 |
) |
|
|
(9,008 |
) |
Purchased
in-process research and development
|
|
|
- |
|
|
|
(8,471 |
) |
|
|
- |
|
|
|
(25,840 |
) |
|
|
- |
|
Other
gains
|
|
|
- |
|
|
|
- |
|
|
|
250 |
|
|
|
347 |
|
|
|
743 |
|
Total
operating expenses
|
|
|
(13,379 |
) |
|
|
(34,690 |
) |
|
|
(30,104 |
) |
|
|
(45,915 |
) |
|
|
(12,596 |
) |
Interest
and other income, net
|
|
|
3,278 |
|
|
|
3,883 |
|
|
|
2,640 |
|
|
|
1,464 |
|
|
|
568 |
|
Loss
from continuing operations before taxes
|
|
|
(10,101 |
) |
|
|
(30,807 |
) |
|
|
(27,464 |
) |
|
|
(44,451 |
) |
|
|
(12,028 |
) |
Income
taxes (expense) benefit
|
|
|
- |
|
|
|
(1,106 |
) |
|
|
108 |
|
|
|
642 |
|
|
|
4,414 |
|
Loss
from continuing operations
|
|
|
(10,101 |
) |
|
|
(31,913 |
) |
|
|
(27,356 |
) |
|
|
(43,809 |
) |
|
|
(7,614 |
) |
Discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
gain on the sale of the bone device business net of taxes $0, $0, $96,
($363), $5,205 respectively
|
|
|
- |
|
|
|
- |
|
|
|
154 |
|
|
|
2,048 |
|
|
|
72,692 |
|
Income
from the operations of the bone device business net of taxes ($4,414 in
2003)
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
7,358 |
|
Net
income from discontinued operations
|
|
|
- |
|
|
|
- |
|
|
|
154 |
|
|
|
2,048 |
|
|
|
80,050 |
|
NET
INCOME (LOSS)
|
|
$ |
(10,101 |
) |
|
$ |
(31,913 |
) |
|
$ |
(27,202 |
) |
|
$ |
(41,761 |
) |
|
$ |
72,436 |
|
Per
Share Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss from continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.24 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.22 |
) |
|
$ |
(0.23 |
) |
Diluted
|
|
$ |
(0.24 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.22 |
) |
|
$ |
(0.23 |
) |
Net
income (loss) from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
0.06 |
|
|
$ |
2.43 |
|
Diluted
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
0.06 |
|
|
$ |
2.38 |
|
Net
income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.24 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.16 |
) |
|
$ |
2.20 |
|
Diluted
|
|
$ |
(0.24 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.16 |
) |
|
$ |
2.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
shares outstanding
|
|
|
41,644 |
|
|
|
40,764 |
|
|
|
38,032 |
|
|
|
35,899 |
|
|
|
32,970 |
|
Equivalent
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
613 |
|
Diluted
shares outstanding
|
|
|
41,644 |
|
|
|
40,764 |
|
|
|
38,032 |
|
|
|
35,899 |
|
|
|
33,583 |
|
1.
|
Research
and development expenses in 2006 include recognition of a $2,100,000
patent cost impairment loss. Operating expenses in 2006
included $8,471,000 of purchased in-process research and development costs
associated with the AzERx acquisition in February 2006. Income
tax expenses in 2006 included the recording of a $1,106,000 valuation
allowance for a deferred tax asset related to a Alternative Minimum Tax
credit carryover.
|
2.
|
Total
operating expenses in 2005 were reduced by $250,000 as a result of a final
settlement payment received from the buyer of the CPM
business. A net gain of $154,000 was recognized on the sale of
the Bone Device Business (defined below) due to receipt of the entire
escrow deposit outstanding.
|
3.
|
On
August 5, 2004, we completed the acquisition of CBI. OrthoLogic
expensed in-process research and development and acquisition costs of
$25.8 million.
|
A net
gain of $2,048,000 was recognized on the sale of the Bone Device Business
primarily due to a decrease in the risk related to the potential exposure of the
representations and warranties provided in the governing asset purchase
agreement.
4.
|
On
November 26, 2003, we completed the sale of all the assets and related
liabilities of our Bone Device Business. The Bone Device
Business comprised all our revenue generating operations. Our
financial statements for the year ended December 31, 2003 include the
results of operations prior to the divestiture and the related gain on the
sale as discontinued operations.
|
Total
operating expenses in 2003 were reduced by $743,000 as a result of settlement
payments received against the contingent payment due from the buyer of the CPM
business and additional collections of the accounts receivable balances which
were fully reserved.
BALANCE SHEET
DATA
(in
thousands)
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
Working
capital
|
|
$ |
37,684 |
|
|
$ |
52,533 |
|
|
$ |
78,423 |
|
|
$ |
88,955 |
|
|
$ |
112,775 |
|
Total
assets
|
|
$ |
61,862 |
|
|
$ |
72,589 |
|
|
$ |
88,343 |
|
|
$ |
115,184 |
|
|
$ |
130,106 |
|
Long
term liabilities, less current maturities
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
183 |
|
|
$ |
137 |
|
|
$ |
280 |
|
Stockholders’
equity
|
|
$ |
59,461 |
|
|
$ |
69,148 |
|
|
$ |
84,178 |
|
|
$ |
110,930 |
|
|
$ |
123,975 |
|
|
Management’s
Discussion and Analysis of Financial Conditions and Results of
Operations
|
Company
History
Prior to
November 26, 2003, we developed, manufactured and marketed proprietary,
technologically advanced orthopedic products designed to promote the healing of
musculoskeletal bone and tissue, with particular emphasis on fracture healing
and spine repair. Our product lines included bone growth stimulation
and fracture fixation devices including the OL1000 product line, SpinaLogic® and
OrthoFrame/Mayo, which we sometimes refer to as our “Bone Device
Business.”
On
November 26, 2003, we sold our Bone Device Business. Our principal
business remains focused on tissue repair, although through biopharmaceutical
approaches rather than through the use of medical devices.
On August
5, 2004, we purchased substantially all of the assets and intellectual property
of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide
license for Chrysalin for all medical indications. We became a development stage
entity commensurate with the acquisition. Subsequently, all of our
collective efforts were focused on research and development of our Chrysalin
Product Platform, with the goal of commercializing our products. We currently
own exclusive worldwide rights to Chrysalin.
On
February 27, 2006 we purchased certain assets and assumed certain liabilities of
AzERx, Inc. Under the terms of the transaction, we acquired an
exclusive license for the core intellectual property relating to AZX100, a
24-amino acid synthetic peptide. We have an exclusive worldwide
license to AZX100.
Chrysalin
and OrthoLogic are registered United States domestic trademarks of OrthoLogic
Corp.
Our
development activities for the Chrysalin Product Platform and AZX100 represent a
single operating segment as they share the same product development path and
utilize the same Company resources. As a result, we have determined
that it is appropriate to reflect our operations as one reportable segment.
Through December 31, 2007, we have incurred $101 million in net losses as a
development stage company.
Description
of the business
OrthoLogic
is a biotechnology company committed to developing a pipeline of novel peptides
and other molecules aimed at helping patients with under-served
conditions. We are focused on the development and commercialization
of two product platforms: Chrysalin® (TP508) and AZX100.
Chrysalin
Product Platform
Chrysalin
(TP508), a novel synthetic 23-amino acid peptide, is believed to produce
angiogenic and other tissue repair effects by activating or upregulating nitric
oxide synthase (NOS) and the production of nitric oxide in endothelial cells,
and if so, it may have potential therapeutic value in tissues and diseases
exhibiting endothelial dysfunction. The Chrysalin molecule serves as
the basis for a group of potential therapeutic products we refer to collectively
as the “Chrysalin Product Platform.” We have conducted clinical trials for two
potential Chrysalin products, acceleration of fracture repair, and diabetic foot
ulcer. We previously conducted a pilot study for spine fusion. We
have conducted pre-clinical testing for cartilage defect repair, cardiovascular
repair, dental bone repair, and tendon repair. We are initiating study of other
potential vascular indications.
The
development of each of our potential product candidates in the Chrysalin Product
Platform is based on our collective knowledge and understanding of how Chrysalin
contributes to the repair of tissue. While there are important
differences in each of the product candidates in terms of purpose (fracture
repair, diabetic foot ulcer healing, etc.) each product candidate is focused on
accelerating and enhancing tissue repair.
Chrysalin
Product Platform Status
|
·
|
We
believe that the results of our efforts to date support that Chrysalin may
have potential therapeutic value in tissues and diseases exhibiting
endothelial dysfunction.
|
|
·
|
We
are continuing pre-clinical experiments tying Chrysalin to potential
modulation of the health of endothelial tissue in blood vessels and other
mechanism-of-action studies.
|
|
·
|
We
are focusing our efforts on vascular product candidates and are not
currently planning additional pre-clinical or clinical studies in fracture
repair, wound healing, spine fusion, cartilage defect repair, dental bone
repair or tendon repair.
|
|
·
|
Although
we do not currently plan to re-enter clinical trials with Chrysalin,
evaluations are ongoing as to the appropriate pre-clinical and clinical
studies which would serve to strengthen our portfolio and partnering
possibilities.
|
|
·
|
In
2008 we will continue to explore the science behind and potential of
Chrysalin.
|
AZX100
AZX100,
our second peptide, is a novel synthetic pre-clinical 24-amino acid peptide.
AZX100
relaxes smooth muscle, which modulates blood pressure and the function of blood
vessels, airways, sphincters, the gastrointestinal tract and the genitourinary
tract. Sustained abnormal contraction of any of these muscles is
called spasm. Any disorders known to be associated with excessive
constriction or inadequate dilation of smooth muscle represent potential
applications for AZX100.
AZX100
may also inhibit the fibrotic phenotype of fibroblasts and smooth muscle cells
in a mechanism similar to that which causes vasorelaxation. Through
phenotypic modulation of fibroblasts and smooth muscle cells, AZX100 may inhibit
the scarring that results from wound healing and disease states in the dermis,
blood vessels, lungs, liver and other organs.
We are
executing a development plan for this peptide which included the filing of an
IND for a dermal indication in 2007 and includes the intention to commence a
Phase 1 safety study in dermal scarring in the first quarter of
2008. The first safety study will include approximately 30 healthy
subjects and is expected to be completed in mid 2008. Pending
favorable results, we will initiate further safety and dose-ranging studies for
dermal scarring.
We
continue to explore other biopharmaceutical compounds that can complement our
research activity internally and broaden our potential pipeline for successful
products.
Critical
Accounting Policies and Estimates
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires that management make
a number of assumptions and estimates that affect the reported amounts of
assets, liabilities, and expenses in our financial statements and accompanying
notes. Management bases its estimates on historical experience and
various other assumptions believed to be reasonable. Although these
estimates are based on management’s best knowledge of current events and actions
that may impact the Company in the future, actual results may differ from these
estimates and assumptions. Our critical accounting policies are those
that affect, or could affect, our financial statements materially and involve a
significant level of judgment by management.
Income Taxes: SFAS
No. 109 “Accounting for Income Taxes” requires that a valuation allowance be
established when it is more likely than not that all or a portion of a deferred
tax asset will not be realized. Changes in valuation allowances from
period to period are included in the tax provision in the period of
change. In determining whether a valuation allowance is required, we
take into account all evidence with regard to the utilization of a deferred tax
asset included in past earnings history, expected future earnings, the character
and jurisdiction of such earnings, unsettled circumstances that, if unfavorably
resolved, would adversely affect utilization of a deferred tax asset, carryback
and carryforward periods, and tax strategies that could potentially enhance the
likelihood of realization of a deferred asset. We have evaluated the
available evidence about future taxable income and other possible sources of
realization of deferred tax assets and have established a valuation allowance of
approximately $39 million at December 31, 2007. The valuation
allowance includes approximately $6 million for net operating loss carry
forwards that relate to stock option compensation expense for income tax
reporting purposes. Any utilization of these net operating loss carry
forwards would be recorded as an increase to additional paid-in
capital. The valuation allowance reduces deferred tax assets to an
amount that management believes will more likely than not be
realized. The results of our Phase 3 Chrysalin fracture repair human
clinical trial resulted in a change in our planned clinical pathway and timeline
for our Chrysalin fracture repair indication. This change, when
factored with our current significant net operating loss carryovers and current
period net loss, resulted in a revision of our estimate of the need for a
valuation allowance for the previously recorded deferred tax asset related to a
Alternative Minimum Tax credit carryover. Due to the uncertainty that
the deferred tax asset will be realized, we recorded a valuation allowance for
the full amount of the deferred tax asset ($1,106,000) in 2006.
We have
accumulated approximately $89 million in federal and $77 million in state net
operating loss carryforwards (“NOLs”) and approximately $4 million of general
business and alternative minimum tax credit carryforwards. The
federal NOLs expire from 2023 and the state NOL’s expire from 2019 and their
availability for use to offset future taxable income would be limited should a
change in ownership, as defined in Section 382 of the Internal Revenue Code,
occur.
We
adopted the provisions of Financial Accounting Standards Board (“FASB”)
Interpretation NO. 48, “Accounting for Uncertainty in Income Taxes – an
interpretation of SFAS No. 109” (“FIN 48”), on January 1, 2007. FIN
48 clarifies the accounting for uncertainty in income taxes recognized in an
enterprise’s financial statements in accordance with SFAS Statement 109,
“Accounting for Income Taxes”, and prescribes a recognition threshold and
measurement process for financial statement recognition and measurement of a tax
position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition classification, interest and penalties,
accounting in interim periods, disclosure and transition.
We may
from time to time be assessed interest or penalties by major tax jurisdictions,
although any such assessments historically have been minimal and immaterial to
our financial results. In the event we have received an assessment
for interest and/or penalties, it has been classified in the financial
statements as income tax expense.
Patents: On November 2, 2006, we
announced that we have no immediate plans to re-enter clinical trials for
Chrysalin-based product candidates and a strategic shift in our development
approach to our Chrysalin product platform. We currently intend to
pursue development partnering or licensing opportunities for our Chrysalin-based
product candidates, a change from its previous development history of
independently conducting human clinical trials necessary to advance our
Chrysalin-based product candidates to market. SFAS No. 142 requires
an impairment loss be recognized for an amortizable intangible asset whenever
the net cash in-flow to be generated from an asset is less than its carrying
cost. We are unable to determine the timing or amount of net cash
in-flow to be generated from Chrysalin-based product
candidates. Accordingly, due to this uncertainty, we recognized an
impairment loss for the amount of unamortized Chrysalin product platform patent
costs of $2,100,000 in 2006. The impairment loss is included in research and
development expenses in 2006.
Stock based
compensation: Effective January 1, 2006, we adopted SFAS No.
123 (revised 2004), “Share-Based Payment”, (SFAS 123(R)). SFAS 123(R)
requires all share-based payments, including grants of stock options, restricted
stock units and employee stock purchase rights, to be recognized in our
financial statements based on their respective grant date fair values. Under
this standard, the fair value of each employee stock option and employee stock
purchase right is estimated on the date of grant using an option pricing model
that meets certain requirements. We currently use the Black-Scholes
option pricing model to estimate the fair value of our share-based
payments. The determination of the fair value of share-based payment
awards utilizing the Black-Scholes model is affected by our stock price and a
number of assumptions, including expected volatility, expected life, risk-free
interest rate and expected dividends. We use the historical
volatility adjusted for future expectations. The expected life of the stock
options is based on historical data and future expectations. The
risk-free interest rate assumption is based on observed interest rates
appropriate for the terms of our stock options and stock purchase
rights. The dividend yield assumption is based on our history and
expectation of dividend payouts. The fair value of our restricted
stock units is based on the fair market value of our common stock on the date of
grant. Stock-based compensation expense recognized in our financial
statements in 2006 and thereafter is based on awards that are ultimately
expected to vest. The amount of stock-based compensation expense in
2006 and thereafter will be reduced for estimated
forfeitures. Forfeitures are required to be estimated at the time of
grant and revised, if necessary, in subsequent periods if actual forfeitures
differ from those estimates. We will evaluate the assumptions used to
value stock awards on a quarterly basis. If factors change and we
employ different assumptions, stock-based compensation expense may differ
significantly from what we have recorded in the past. To the extent
that we grant additional equity securities to employees, our stock-based
compensation expense will be increased by the additional compensation resulting
from those additional grants.
Results
of Operations Comparing Years Ended December 31, 2007 and 2006.
General and Administrative
(“G&A”) Expenses: G&A expenses related to our ongoing
development operations decreased by $2,820,000 to $3,738,000 in the year ended
December 31, 2007 from $6,558,000 in 2006. Our administrative
expenses during the year ended December 31, 2007 were lower than 2006, primarily
as a result of a decrease of non-cash stock compensation expense of $1,433,000,
reduced costs in 2007 reflecting management changes and staff reductions which
occurred in the first half of 2006, and general cost containment
efforts.
Research and Development
Expenses: Research and development expenses were $9,641,000
for the year ended December 31, 2007 compared to $19,661,000 in
2006. Our research and development expenses decreased $10,020,000 in
the year ended December 31, 2007 compared to 2006, primarily due to a $5.5
million decline in clinical costs related to our fracture repair Phase 3 and
Phase 2b clinical trials, which were substantially completed as of December 31,
2006 and a Chrysalin product platform patent impairment loss of $2.1 million
recorded in 2006. Given the overlapping nature of our research efforts it is not
possible to clearly separate research expenditures between Chrysalin and AZX100;
however, currently we anticipate that the substantial majority of our research
and development expenses in 2008 will be directed towards AZX100 development
efforts.
Interest and Other Income,
Net: Interest and other income net decreased from $3,883,000
in the year ended December 31, 2006 to $3,278,000 in 2007, due to a reduction in
the cash and investments available for investment during 2007.
Net Loss: We
incurred a net loss in 2007 of $10.1 million compared to a net loss of $31.9
million in 2006. The $21.8 million decrease in the net loss in the
year ended December 31, 2007 compared to the same period in 2006, results
primarily from $8.5 million purchased in-process research and development costs
in 2006, a decrease of $2.0 million in non-cash stock compensation expense,
reduced costs in 2007 reflecting management changes and staff reductions which
occurred in the first half of 2006, a $5.5 million decline in
clinical costs related to our fracture repair Phase 3 and Phase 2b clinical
trials, which were substantially completed as of December 31, 2006, a Chrysalin
product platform patent impairment loss of $2.1 million recorded in 2006, and
the recognition in 2006 of income tax expense related to the recording of a
valuation allowance of $1.1 million for a deferred tax asset related to a
Alternative Minimum Tax credit carryover.
Results
of Operations Comparing Years Ended December 31, 2006 and 2005.
General and Administrative
(“G&A”) Expenses: G&A expenses related to our ongoing
development operations increased by $1,648,000 from $4,910,000 in 2005 to
$6,558,000 in 2006. Our administrative expenses during 2006 were
higher than 2005, primarily as a result of stock compensation expense of
$1,946,000, as disclosed in Note 8 to the financial statements, a reduction in
the allocation of general and administrative expenses to research and
development due to the decline in clinical activity, partially offset by a
general reduction of expenses due to cost containment efforts.
Research and Development
Expenses: Research and development expenses were
$19,661,000 in 2006 compared to $25,444,000 in 2005. Our research and
development expenses decreased $5,783,000 in 2006 over the same period in 2005
primarily due to the substantial completion of our Phase 3 human clinical trial
for fracture repair and the temporary interruption and later termination of our
Phase 2b dose-ranging human clinical trial for fracture repair. This decrease in
clinical trial costs was partially offset by recognition of a $2,100,000
Chrysalin product platform patent impairment loss and stock compensation expense
of $835,000. The primary focus of our research and development work was our
Chrysalin-based fracture repair indication. On November 2, 2006, we announced
that we have no immediate plans to re-enter clinical trials for Chrysalin-based
product candidates and a strategic shift in our development approach to our
Chrysalin Product Platform. During 2006 we commenced pre-clinical
work on AZX100; however, the substantial majority of expenditures in 2006 were
related to our Chrysalin product platform development efforts.
Interest and Other
Income, Net: Interest and other income,
net increased from $2,640,000 in 2005 to $3,883,000 in 2006 due primarily to the
increase in interest rates between the two periods.
Net Loss: We incurred a net loss
in 2006 of $31.9 million compared to a net loss of $27.2 million in
2005. The $4.7 million increase in the net loss in 2006 compared to
the same period in 2005, results primarily from $2.8 million of stock
compensation expense, recognition of a $2.1 million Chrysalin product platform
patent impairment loss, $8.4 million of in-process research and development
costs related to the acquisition of the AZX100 technology platform and
recognition of income tax expense related to the recording of a valuation
allowance of $1.1 million for a deferred tax asset related to a Alternative
Minimum Tax credit carryover. These items were partially offset by the decrease
in fracture repair human clinical trial activity compared to the same period in
2005 and a general reduction of expenses due to cost containment
efforts.
Liquidity
and Capital Resources
We have
historically financed our operations through operating cash flows and the public
and private sales of equity securities. However, with the sale of our
Bone Device Business in November 2003, we sold all of our revenue producing
operations. Since that time, we have relied on our cash and
investments to finance all our operations, the focus of which was research and
development of our Chrysalin Product Platform. We received
approximately $93.0 million in cash from the sale of our Bone Device
Business. On December 1, 2005, we received the additional $7.2
million, including interest, from the escrow balance related to the sale of the
Bone Device Business. On February 27, 2006, we entered into an
agreement with Quintiles (see Note 15 to the financial statements), which
provided an investment by Quintiles in our common stock, of which
$2,000,000 was received on February 27, 2006 and $1,500,000 was received on July
3, 2006. We also received net proceeds of $4,612,000 from the
exercise of stock options during our development stage period. At December 31,
2007, we had cash and cash equivalents of $20.9 million, short-term investments
of $18.2 million and long-term investments of $21.5 million.
We
announced that we have no immediate plans to re-enter clinical trials for
Chrysalin-based product candidates and a strategic shift in our development
approach to our Chrysalin Product Platform. We currently intend to
pursue development partnering or licensing opportunities for our Chrysalin-based
product candidates, a change from our previous development history of
independently conducting human clinical trials necessary to advance our
Chrysalin-based product candidates to market. We will continue to
explore Chrysalin’s therapeutic value in tissues and diseases exhibiting
endothelial dysfunction as well as the science behind and potential of
Chrysalin. We will also continue research and development expenditures for
further pre-clinical studies supporting multiple indications for AZX100 and plan
to commence a Phase 1 dermal scarring human clinical trial in the first quarter
of 2008.
Our
future research and development expenses may vary significantly from prior
periods depending on the Company’s decisions on its future Chrysalin and AZX100
development plans.
We
anticipate that our cash and short-term investments will be sufficient to meet
our presently projected cash and working capital requirements for the next year.
However, the timing and amounts of cash used will depend on many factors,
including our ability to continue to control our expenditures related to our
research and development programs, including our planned AZX100 dermal scarring
clinical trials. If we decide to expand our clinical trials or if we
consider other opportunities in the market, our expense levels may change, which
could require us to seek other sources of capital. If additional
funding is required, we would be required to seek new sources of funds,
including raising capital through the sales of securities or licensing
agreements. These sources of funds may not be available or could only
be available at terms that would have a material adverse impact on our existing
stockholders’ interests.
The
following table sets forth all known commitments as of December 31, 2007 and the
year in which these commitments become due or are expected to be
settled:
|
|
Payments
due by period:
|
|
|
|
Total
|
|
|
Less
than 1 year
|
|
|
1 -
3 years
|
|
|
3
to 5 years
|
|
Operating
lease obligation
|
|
$ |
1,360,000 |
|
|
$ |
263,000 |
|
|
$ |
527,000 |
|
|
$ |
570,000 |
|
Research
and clinical obligation
|
|
|
627,000 |
|
|
|
627,000 |
|
|
|
- |
|
|
|
- |
|
Consulting
contracts
|
|
|
236,000 |
|
|
|
205,000 |
|
|
|
31,000 |
|
|
|
- |
|
Open
purchase order for supplies
|
|
|
18,000 |
|
|
|
18,000 |
|
|
|
- |
|
|
|
- |
|
|
|
$ |
2,241,000 |
|
|
$ |
1,113,000 |
|
|
$ |
558,000 |
|
|
$ |
570,000 |
|
|
(1)
|
A
lease commitment of $1.4 million refers to our real property lease in
Tempe, Arizona. We occupy approximately 17,000 square feet of
space in the building under a five year lease which commenced March 1,
2008.
|
|
(2)
|
We
anticipate paying all our liabilities with our cash
resources.
|
|
Quantitative
and Qualitative Disclosures about Market
Risk
|
We had no
debt and no derivative instruments at December 31, 2007. Our
investment portfolio is used to preserve our capital until it is required to
fund our operations. Our investment instruments are classified as
held-to-maturity. We do not own derivative financial instruments in
our investment portfolio. We maintain a non-trading investment
portfolio of investment grade securities that limits the amount of credit
exposure of any one issue, issuer or type of instrument. Due to the
short duration and conservative nature of these instruments, we do not believe
that we have a material exposure to interest rate risk.
A summary
of the maturity of our long-term investments, which consist primarily of U.S.
Government Obligations, is as follows:
2009
|
|
$ |
19,238,000 |
|
2010
|
|
|
2,221,000 |
|
|
|
$ |
21,459,000 |
|
|
Financial
Statements and Supplementary Data
|
Balance
sheets, as of December 31, 2007 and December 31, 2006, and statements of
operations, stockholders’ equity and cash flows for each of the three years in
the period ended December 31, 2007, and for the statement of operations and cash
flow for the period of August 5, 2004 through December 31, 2007, together with
the related notes and the reports of Ernst & Young, LLP and Deloitte &
Touche LLP, independent registered public accounting firms, are set forth on the
“F” pages of the Form 10-K.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
None.
Conclusion
Regarding the Effectiveness of Disclosure Controls and Procedures
Under the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we conducted an
evaluation of our disclosure controls and procedures, as such term is defined
under Rules 13a-15(e) and 15d – 15(e) promulgated under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our
principal executive officer and our principal financial officer concluded that
our disclosure controls and procedures were effective as of the end of the
period covered by this annual report.
Management’s
Annual Report on Internal Control Over Financial Reporting
The
management of OrthoLogic Corp. (a development stage company) is responsible for
establishing and maintaining adequate internal control over financial reporting,
as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision
and with the participation of our management, including our principal executive
officer and principal financial officer, we conducted an evaluation of the
effectiveness of our internal control over financial reporting based on the
framework in Internal Control - Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission. Based on our evaluation
under the framework in Internal Control - Integrated Framework, our management
concluded that our internal control over financial reporting was effective as of
December 31, 2007.
Ernst
& Young LLP, the independent registered public accounting firm that audited
the financial statements of the Company included in this Annual Report on Form
10-K, has issued a report on the effectiveness of the Company’s internal control
over financial reporting as of December 31, 2007. The report, which
expresses an unqualified opinion on the effectiveness of the Company’s internal
control over financial reporting as of December 31, 2007, is included herein
under the heading “Report of Independent Registered Public Accounting Firm”
following Item 9B.
Management’s
Annual Report on Changes in Internal Controls
There
have not been any changes in our internal controls over financial reporting
during the fiscal quarter ended December 31, 2007, that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
None
Report
of Independent Registered Public Accounting Firm
The Board
of Directors and Stockholders of OrthoLogic Corp.
We have
audited OrthoLogic Corp.’s internal control over financial reporting as of
December 31, 2007, based on criteria established in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). OrthoLogic Corp.’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
included in the accompanying Management’s Annual Report on Internal Control Over
Financial Reporting. Our responsibility is to express an opinion on the
Company’s 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, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based
on the assessed risk, 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
company’s 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 company’s 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 company’s
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, OrthoLogic Corp. (a development stage company) maintained, in all
material respects, effective internal control over financial reporting as of
December 31, 2007, based on the COSO criteria.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the balance sheet of OrthoLogic Corp. (a
development stage company) as of December 31, 2007 and 2006 and the related
statements of operations, stockholders’ equity, and cash flows for the years
then ended, and for the period August 5, 2004 (inception of development stage)
through December 31, 2007 and our report dated March 3, 2008 expressed an
unqualified opinion thereon.
|
/s/
Ernst & Young LLP
|
Phoenix,
Arizona
|
|
March
3, 2008
|
|
|
Directors,
Executive Officers and Corporate
Governance
|
The
information required herein is incorporated by reference pursuant to General
Instruction G(3) of Form 10-K, since the Registrant will file its definitive
proxy statement with the Securities and Exchange Commission for the 2008 Annual
Meeting of Stockholders to be held on May 9, 2008, no later than 120 days after
the close of its fiscal year ended December 31, 2007.
The
information required herein is incorporated by reference pursuant to General
Instruction G(3) of Form 10-K, since the Registrant will file its definitive
proxy statement with the Securities and Exchange Commission for the 2008 Annual
Meeting of Stockholders to be held on May 9, 2008, no later than 120 days after
the close of its fiscal year ended December 31, 2007.
|
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholders
Matters
|
The
information required herein is incorporated by reference pursuant to General
Instruction G(3) of Form 10-K, since the Registrant will file its definitive
proxy statement with the Securities and Exchange Commission for the 2008 Annual
Meeting of Stockholders to be held on May 9, 2008, no later than 120 days after
the close of its fiscal year ended December 31, 2007.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
The
information required herein is incorporated by reference pursuant to General
Instruction G(3) of Form 10-K, since the Registrant will file its definitive
proxy statement with the Securities and Exchange Commission for the 2008 Annual
Meeting of Stockholders to be held on May 9, 2008, no later than 120 days after
the close of its fiscal year ended December 31, 2007.
|
Principal
Accountant Fees and Services
|
The
information required herein is incorporated by reference pursuant to General
Instruction G(3) of Form 10-K, since the Registrant will file its definitive
proxy statement with the Securities and Exchange Commission for the 2008 Annual
Meeting of Stockholders to be held on May 9, 2008, no later than 120 days after
the close of its fiscal year ended December 31, 2007.
|
Exhibits
and Financial Statement Schedules
|
(a)
|
The following
documents are filed as part of this
report:
|
The
following financial statements of OrthoLogic Corp. and Reports of Independent
Registered Public Accounting Firms are presented in the “F” pages of this
report:
Reports
of Independent Registered Public Accounting Firms
Balance
Sheets - December 31, 2007 and 2006
Statements
of Operations - Each of the three years in the period ended December 31, 2007
and for the period of August 5, 2004 through December 31, 2007
Statements
of Stockholders’ Equity - Each of the three years in the period ended December
31, 2007
Statements
of Cash Flows - Each of the three years in the period ended December 31, 2007
and for the period of August 5, 2004 through December 31, 2007
Notes to
Financial Statements
2.
|
Financial
Statement Schedule II Valuation and Qualifying Accounts. The information
for Schedule II as well as other Schedules has been omitted since they are
not applicable.
|
3.
|
All
management contracts and compensatory plans and arrangements are
specifically identified on the attached Exhibit
Index.
|
See the
Exhibit Index following the signature page of this report, which Index is
incorporated herein by reference.
(c)
|
Financial Statements
and Schedules - See Item 15(a)(1) and Item 15(a)(2)
above.
|
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.
|
ORTHOLOGIC
CORP. |
|
|
|
|
Date: March
5, 2008
|
By
|
/s/ John M. Holliman,
III
|
|
|
John
M. Holliman, III
|
|
|
Executive
Chairman
|
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
|
|
|
|
|
Executive
Chairman
|
March
5, 2008
|
/s/ John M. Holliman,
III
|
(Principal
Executive Officer)
|
|
John
M. Holliman, III
|
and
Director
|
|
|
|
|
/s/ Fredric J.
Feldman
|
|
March
5, 2008
|
Fredric
J. Feldman, Ph.D.
|
Director
|
|
|
|
|
/s/ Elwood D. Howse,
Jr.
|
|
March
5, 2008
|
Elwood
D. Howse, Jr.
|
Director
|
|
|
|
|
/s/ William M.
Wardell
|
|
March
5, 2008
|
William
M. Wardell, MD, Ph.D.
|
Director
|
|
|
|
|
/s/ Augustus A. White,
III
|
|
March
5, 2008
|
Augustus
A. White III, MD.
|
Director
|
|
|
|
|
/s/ Randolph C.
Steer
|
President
|
|
Randolph
C. Steer, MD, Ph.D.
|
|
March
5, 2008
|
|
|
|
/s/ Les M.
Taeger
|
Senior
Vice President and Chief
|
March
5, 2008
|
Les
M. Taeger
|
Financial
Officer (Principal Financial and Accounting
Officer)
|
|
|
|
|
Exhibit
Index to Annual Report on Form 10-K
For
the Year Ended December 31, 2007
Exhibit
No.
|
|
Description
|
|
Incorporated by
Reference To:
|
|
Filed
Herewith
|
|
|
|
|
|
|
|
2.1
|
|
Asset
Purchase Agreement and Plan of Reorganization by and between OrthoLogic
Corp. and Chrysalis Biotechnology, dated April 28, 2004
(*)
|
|
Exhibit 2.1
to the Company’s Registration Statement on Form S-4 filed with the
SEC on June 3, 2004 (“June 2004 S-4”)
|
|
|
2.2
|
|
Amendment
No. 1 to Asset Purchase Agreement and Plan of Reorganization by and
between OrthoLogic Corp. and Chrysalis Biotechnology, dated June 1,
2004 (*)
|
|
Exhibit 2.2
to the Company’s June 2004 S-4
|
|
|
2.3
|
|
Amendment
No. 2 to Asset Purchase Agreement and Plan of Reorganization between
OrthoLogic Corp. and Chrysalis Biotechnology, Inc., dated August 5,
2004 (*)
|
|
Exhibit 2.1
to the Company’s Current Report on Form 8-K filed on August 6,
2004
|
|
|
2.4
|
|
Asset
Purchase Agreement and Plan of Reorganization by and between OrthoLogic
Corp. and AzERx, Inc., dated February 23, 2006 (*)
|
|
Exhibit
10.1 to the Company’s Registration Statement on Form S-3 filed with the
SEC on April 25, 2006
|
|
|
3.1
|
|
Restated
Certificate of Incorporation, executed April 15, 2005
|
|
Exhibit
3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2005, filed with the SEC on May 10, 2005 (“March 2005
10-Q”)
|
|
|
3.2
|
|
Amended
and Restated Certificate of Designation of Series A Preferred Stock,
executed June 19, 2007
|
|
Exhibit
3.1 to the Company’s Current Report on Form 8-K filed with the SEC on June
25, 2007 (the “June 25th
2007 8-K”)
|
|
|
3.3
|
|
Bylaws
of the Company
|
|
Exhibit
3.4 to the Company’s Amendment No. 2 to Registration Statement
on Form S-1 (No. 33-47569) filed with the SEC on January 25,
1993 (“January 1993 S-1”)
|
|
|
4.1
|
|
Class
A Warrant Agreement dated February 24, 2006, between OrthoLogic Corp. and
PharmaBio Development Inc. (d/b/a NovaQuest)
|
|
Exhibit
4.1 to the Company’s Current Report on Form 8-K filed with the SEC on
March 3, 2006
|
|
|
4.2
|
|
Form
of Additional Class A Warrant Agreement related to the Common Stock and
Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc.
|
|
Exhibit
4.8 to the Company’s Registration Statement on Form S-3 filed with the SEC
on April 13, 2006 (“April 2006 S-3”)
|
|
|
4.3
|
|
Class
A Warrant Agreement dated June 30, 2006 by and between OrthoLogic Corp.
and PharmaBio Development, Inc
|
|
Exhibit
4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July
6, 2006
|
|
|
4.4
|
|
Amended
and Restated Class B Warrant Agreement dated February 24,
2006, and amended and restated as of June 30, 2006, related to the Common
Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc. (2)
|
|
Exhibit
4.5 to the Company’s Amendment No. 1 to Registration Statement on Form S-3
filed with the SEC on September 22, 2006 (“September 2006
S-3/A”)
|
|
|
4.5
|
|
Amended
and Restated Class C Warrant Agreement dated February 24, 2006,
and amended and restated as of June 30, 2006, related to the Common Stock
and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc.
|
|
Exhibit
4.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2007, filed with the SEC on May 7, 2007
|
|
|
|
|
Amended
and Restated Class D Warrant Agreement dated February 24, 2006, and
amended and restated as of June 30, 2006, related to the Common Stock and
Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc.
|
|
|
|
X
|
4.7
|
|
Rights
Agreement, dated as of June 19, 2007, between OrthoLogic Corp. and the
Bank of New York
|
|
Exhibit
4.1 to the June 25th
2007 8-K
|
|
|
10.1
|
|
Form
of Indemnification Agreement(**)
|
|
Exhibit 10.16
to the Company’s January 1993 S-1
|
|
|
10.2
|
|
1997
Stock Option Plan of the Company, as amended and approved by the
stockholders (1)
|
|
Exhibit
4.3 to the Company’s Registration Statement on Form S-8, filed with the
SEC on March 2, 2005
|
|
|
10.3
|
|
Single-tenant
Lease dated June 12, 1997, by and between the Company and Chamberlain
Development, L.L.C.
|
|
Exhibit 10.2
to the Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 1997
|
|
|
10.4
|
|
Patent
License Agreement between the Board of Regents of The University of Texas
System through its component institution The University of Texas Medical
Branch at Galveston and Chrysalis Biotechnology, Inc., dated
April 27, 2004 and exhibits thereto (2)
|
|
Exhibit 10.1
to the Company’s Amendment No. 1 to its Registration Statement on
Form S-4, filed July 14, 2004
|
|
|
10.5
|
|
Form
of Incentive Stock Option Grant Letter for use in connection with the
Company’s 1997 Stock Option Plan (***)
|
|
Exhibit 10.1
to the Company’s Current Report on Form 8-K filed on January 4,
2005
|
|
|
10.6
|
|
Form
of Non-qualified Stock Option Grant Letter for use in connection with the
Company’s 1997 Stock Option Plan (***)
|
|
Exhibit 10.1
to the Company’s Current Report on Form 8-K filed on January 19,
2006
|
|
|
10.7
|
|
Patent
Assignment Agreement dated June 28, 2005, between the Company and the
University of Texas
|
|
Exhibit
10.3 to the Company’s Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 2005, filed with the SEC on August 9, 2005 (the
“June 2005 10-Q”)
|
|
|
10.8
|
|
Director
Compensation Plan, effective June 10, 2005 (1)
|
|
Exhibit
10.2 to the June 2005 10-Q
|
|
|
10.9
|
|
Letter
of Stock Option Grant to Dr. James M. Pusey for 200,000
shares of the Company’s common stock, dated March 3, 2005
(1)
|
|
Exhibit
10.3 to the March 4th,
2005 8-K
|
|
|
10.10
|
|
Letter
of Stock Option Grant to Dr. James M. Pusey for 300,000
shares of the Company’s common stock, dated March 3, 2005
(1)
|
|
Exhibit
10.4 to the March 4th,
2005 8-K
|
|
|
10.11
|
|
Employment
Agreement between the Company and Dana Shinbaum dated October 17,
2005 (1)
|
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
October 27, 2005
|
|
|
10.12
|
|
Employment
Agreement dated January 10, 2006 between the Company and Les M. Taeger
(1)
|
|
Exhibit
10.1 to the Company’s Form 8-K filed with the SEC on January 11, 2006 (the
“January 11th
8-K”)
|
|
|
10.13
|
|
Intellectual
Property, Confidentiality and Non-Competition Agreement between the
Company and Les M. Taeger dated January 10, 2006 (1)
|
|
Exhibit
10.2 to the January 11th
8-K
|
|
|
10.14
|
|
Separation
Agreement and Release dated April 5, 2006 by and between OrthoLogic Corp.
and James M. Pusey (1)
|
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
April 11, 2006
|
|
|
10.15
|
|
Common
Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc., dated February 24, 2006.
|
|
Exhibit
10.1 to the Company’s April 2006 S-3
|
|
|
10.16
|
|
Registration
Rights Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc., dated February 24, 2006
|
|
Exhibit
10.2 to the Company’s April 2006 S-3
|
|
|
10.17
|
|
Registration
Rights Agreement by and between OrthoLogic Corp., AzERx, Inc., and Certain
Shareholders, dated February 27, 2006
|
|
Exhibit
10.3 to the Company’s April 2006 S-3
|
|
|
10.18
|
|
Amended
and Restated License Agreement dated February 23, 2006 by and between
OrthoLogic Corp. and Arizona Science Technology Enterprises,
LLC
|
|
Exhibit
10.5 to the Company’s Registration Statement on Form S-3 filed with the
SEC on April 25, 2006
|
|
|
10.19
|
|
2005
Equity Incentive Plan (2005 Plan) (1)
|
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May
18, 2006
|
|
|
10.20
|
|
Form
of Incentive Stock Option Grant Letters for Grants under the 2005
Plan (***)
|
|
Exhibit
10.1 to the Company’s Report on Form 10-Q for the quarterly period ended
June 30, 2006, filed on August 8, 2006 (“June 2006 10-Q”)
|
|
|
10.21
|
|
Form
of Non-Qualified Stock Options Grant Letter for Grants under the 2005
Plan (***)
|
|
Exhibit
10.2 to the Company’s June 2006 10-Q
|
|
|
10.22
|
|
Form
of Restricted Stock Grant Letters for Grants under the 2005
Plan
|
|
Exhibit
10.4 to the Company’s Current Report on Form 8-K filed with the SEC on May
18, 2006
|
|
|
10.23
|
|
Amendment
to Employment Agreement dated January 10, 2006 between OrthoLogic Corp.
and Les Taeger (1)
|
|
Exhibit
10.3 to the Company’s June 2006 10-Q
|
|
|
10.24
|
|
Employment
Agreement between Randolph C. Steer, MD, Ph.D., President, and OrthoLogic
Corp., effective May 12, 2006 (1)
|
|
Exhibit
10.7 to the Company’s June 2006 10-Q
|
|
|
10.25
|
|
Management
Service Agreement between Valley Venture III, Management LLC, John M.
Holliman, III, Executive Chairman and OrthoLogic Corp., effective May 12,
2006 (1)
|
|
Exhibit
10.8 to the Company’s June 2006 10-Q
|
|
|
10.26
|
|
Amendment
No.1 to Registration Rights Agreement dated June 30, 2006 by and between
PharmaBio Development, Inc., and OrthoLogic Corp.
|
|
Exhibit
10.4 to the Company’s September 2006 S-3/A
|
|
|
10.27
|
|
Separation
Agreement and Release dated November 17, 2006 by and between OrthoLogic
Corp., and James T. Ryaby, Ph.D. (1)
|
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
November 24, 2006 (“November 24th 8-K”)
|
|
|
10.28
|
|
Consulting
Agreement dated November 17, 2006 by and between James T. Ryaby,
Ph.D., and OrthoLogic Corp. (1)
|
|
Exhibit
10.2 to the Company’s November 24th 8-K
|
|
|
10.29
|
|
Lease
Agreement dated July 19, 2007, by and between the Company and Phoenix
Investors #13, L.L.C.
|
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
July 23, 2007
|
|
|
|
|
Amendment
#1 to Employment Agreement dated May 21, 2007, between Randolph C. Steer,
MD, Ph.D., President, and OrthoLogic Corp.
|
|
|
|
X
|
|
|
Amendment
#2 to Employment Agreement dated February 21, 2008, between Randolph C.
Steer, MD, Ph.D., President, and OrthoLogic Corp.
|
|
|
|
X
|
16.1
|
|
Letter
from Deloitte and Touche, LLP, to the SEC dated June 19,
2006
|
|
Exhibit
16.1 to the Company’s Current Report on Form 8-K filed with the SEC on
June 20, 2006
|
|
|
|
|
List
of subsidiaries
|
|
|
|
|
|
|
Consent
of independent registered public accounting firm.
|
|
|
|
X
|
|
|
Consent
of independent registered public accounting firm.
|
|
|
|
X
|
|
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
X
|
|
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
|
|
X
|
|
|
Certification
of Principal Executive Officer and Chief Financial Officer Pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. (****)
|
|
|
|
|
(1)
|
Management
contract or compensatory plan or
arrangement.
|
(2)
|
Portions
of this agreement have been redacted and filed under confidential
treatment request with the
|
Securities
and Exchange Commission.
*
Upon the request of the Securities and Exchange Commission, OrthoLogic Corp.
agrees to furnish supplementally a copy of any schedule to the Asset Purchase
Agreement and Plan of Reorganization between the Company and Chrysalis
Biotechnology, Inc., dated as of April 28, 2004, as amended and the Asset
Purchase Agreement and Plan of Reorganization by and between the Company and
AzERx, Inc., dated February 23, 2006.
**
OrthoLogic has entered into separate indemnification agreements with each
of its current directors and executive officers that differ only in party names
and dates. Pursuant to the instructions accompanying Item 601 of
Regulation S-K, OrthoLogic has filed the form of such indemnification
agreement.
***
OrthoLogic from time to time issues stock options to its
employees, officers and directors pursuant to its 1997 and 2005 Stock Option
Plan, as amended. The incentive stock option grant letters and
non-qualified stock option grant letters that evidence these issuances differ
only in such terms as the identity of the recipient, the grant date, the number
of securities covered by the award, the price(s) at which the recipient may
acquire the securities and the vesting schedule. Pursuant to the
instructions accompanying Item 601 of Regulation S-K, OrthoLogic has filed the
form of such incentive stock option grant letter and non-qualified stock option
grant letter.
****
Furnished herewith.
Report of Independent Registered
Public Accounting Firm
The Board
of Directors and Stockholders of OrthoLogic Corp.
We have
audited the accompanying balance sheets of OrthoLogic Corp. (a development stage
company) as of December 31, 2007 and 2006, and the related statements of
operations, stockholders’ equity, and cash flows for the years then ended, and
for the period August 5, 2004 (inception of development stage) through December
31, 2007. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audits. The financial statements as of December 31,
2005, and for the period August 5, 2004 (inception) through December 31, 2005,
were audited by other auditors whose report dated March 9, 2006 expressed an
unqualified opinion on those statements. Our opinion on the
statements of operations, stockholders’ equity and cash flows for the period
August 5, 2004 (inception) through December 31, 2007, insofar as it relates to
the amounts for prior periods through December 31, 2005, is based solely on the
report of other auditors.
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 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 financial statements referred to above present fairly, in all
material respects, the financial position of OrthoLogic Corp. (a development
stage company) as of December 31, 2007 and 2006 and the results of its
operations and its cash flows for the years then ended and the period from
August 5, 2004 (inception of development stage) through December 31, 2007, in
conformity with U.S. generally accepted accounting
principles.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), OrthoLogic Corp’s internal control over
financial reporting as of December 31, 2007, based on criteria established
in Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated March 3, 2008,
expressed an unqualified opinion thereon.
As
discussed in Note 1 to the financial statements, effective January 1,
2006, the Company adopted the provisions of Statement of Financial Accounting
Standards No. 123 (revised 2004), Share-Based
Payment.
|
/s/
Ernst & Young LLP
|
|
|
Phoenix,
Arizona
|
|
March
3, 2008
|
|
FINANCIAL
STATEMENTS
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of OrthoLogic Corp.
We have
audited the accompanying statements of operations, stockholders' equity, and
cash flows of OrthoLogic Corp. (a development stage company) (the “Company”) for
the year ended December 31, 2005, and for the period of August 5, 2004
(inception) through December 31, 2005 (the financial statements for the period
from August 5, 2004 (inception) to December 31, 2005 are not presented
separately herein). These financial statements are the responsibility of
the Company’s management. Our responsibility is to express an opinion
on these 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, such financial statements present fairly, in all material respects, the
results of the Company’s operations, it’s changes in stockholders’ equity and
its cash flows for the year ended December 31, 2005, and for the period of
August 5, 2004 (inception) through December 31, 2005, in conformity with
accounting principles generally accepted in the United States of
America.
The
Company is in the development stage at December 31, 2005. As
discussed in Note 1 to the financial statements, the Company has not yet
completed product development.
/s/
DELOITTE & TOUCHE LLP
Phoenix,
Arizona
March 9,
2006
ORTHOLOGIC
CORP
(A
Development Stage Company)
BALANCE
SHEETS
(in
thousands, except share and per share data)
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
20,943 |
|
|
$ |
18,047 |
|
Short-term
investments
|
|
|
18,236 |
|
|
|
35,977 |
|
Prepaids
and other current assets
|
|
|
906 |
|
|
|
1,950 |
|
Total
current assets
|
|
|
40,085 |
|
|
|
55,974 |
|
|
|
|
|
|
|
|
|
|
Furniture
and equipment, net
|
|
|
318 |
|
|
|
409 |
|
Long-term
investments
|
|
|
21,459 |
|
|
|
16,206 |
|
Total
assets
|
|
$ |
61,862 |
|
|
$ |
72,589 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
702 |
|
|
$ |
1,621 |
|
Accrued
compensation
|
|
|
658 |
|
|
|
584 |
|
Accrued
clinical
|
|
|
1 |
|
|
|
133 |
|
Accrued
severance and other restructuring costs
|
|
|
166 |
|
|
|
366 |
|
Other
accrued liabilities
|
|
|
874 |
|
|
|
737 |
|
Total
current liabilities
|
|
|
2,401 |
|
|
|
3,441 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
|
|
|
|
Common
Stock $.0005 par value; 100,000,000 shares authorized;
41,758,065 and 41,564,291 shares issued and
outstanding
|
|
|
21 |
|
|
|
21 |
|
Additional
paid-in capital
|
|
|
189,013 |
|
|
|
188,236 |
|
Accumulated
deficit
|
|
|
(129,573 |
) |
|
|
(119,109 |
) |
Total
stockholders' equity
|
|
|
59,461 |
|
|
|
69,148 |
|
Total
liabilities and stockholders' equity
|
|
$ |
61,862 |
|
|
$ |
72,589 |
|
See
notes to financial statements
ORTHOLOGIC
CORP.
(A
Development Stage Company)
STATEMENTS
OF OPERATIONS
(in
thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
As
a
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
Stage
Company
|
|
|
|
Years
Ended December 31,
|
|
|
August
5, 2004 -
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
December
31, 2007
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
General
and administrative
|
|
$ |
3,738 |
|
|
$ |
6,558 |
|
|
$ |
4,910 |
|
|
$ |
17,084 |
|
Research
and development
|
|
|
9,641 |
|
|
|
19,661 |
|
|
|
25,444 |
|
|
|
62,826 |
|
Purchased
in-process research and development
|
|
|
- |
|
|
|
8,471 |
|
|
|
- |
|
|
|
34,311 |
|
Other
gains
|
|
|
- |
|
|
|
- |
|
|
|
(250 |
) |
|
|
(375 |
) |
Total
operating expenses
|
|
|
13,379 |
|
|
|
34,690 |
|
|
|
30,104 |
|
|
|
113,846 |
|
Interest
and other income, net
|
|
|
(3,278 |
) |
|
|
(3,883 |
) |
|
|
(2,640 |
) |
|
|
(10,552 |
) |
Loss
from continuing operations before taxes
|
|
|
10,101 |
|
|
|
30,807 |
|
|
|
27,464 |
|
|
|
103,294 |
|
Income
tax expense (benefit)
|
|
|
- |
|
|
|
1,106 |
|
|
|
(108 |
) |
|
|
356 |
|
Loss
from continuing operations
|
|
|
10,101 |
|
|
|
31,913 |
|
|
|
27,356 |
|
|
|
103,650 |
|
Discontinued
operations - net gain on the sale of the bone devicebusiness, net of taxes
of $0, $0, $96, ($267), respectively
|
|
|
- |
|
|
|
- |
|
|
|
(154 |
) |
|
|
(2,202 |
) |
NET
LOSS
|
|
$ |
10,101 |
|
|
$ |
31,913 |
|
|
$ |
27,202 |
|
|
$ |
101,448 |
|
Per
Share Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss, basic and diluted
|
|
$ |
0.24 |
|
|
$ |
0.78 |
|
|
$ |
0.72 |
|
|
|
|
|
Basic
and diluted shares outstanding
|
|
|
41,644 |
|
|
|
40,764 |
|
|
|
38,032 |
|
|
|
|
|
See
notes to financial statements
ORTHOLOGIC
CORP.
(A
Development Stage Company)
STATEMENTS
OF STOCKHOLDERS’ EQUITY
(in
thousands)
|
|
Common
Stock
|
|
|
Additional
|
|
|
Accumulated
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid
in Capital
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
December 31, 2004
|
|
|
38,012 |
|
|
$ |
19 |
|
|
$ |
170,905 |
|
|
$ |
(59,994 |
) |
|
$ |
110,930 |
|
Exercise
of common stock options
|
|
|
113 |
|
|
|
- |
|
|
|
288 |
|
|
|
- |
|
|
|
288 |
|
Compensation
earned on stock awards
|
|
|
- |
|
|
|
- |
|
|
|
162 |
|
|
|
- |
|
|
|
162 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(27,202 |
) |
|
|
(27,202 |
) |
Balance
December 31, 2005
|
|
|
38,125 |
|
|
|
19 |
|
|
|
171,355 |
|
|
|
(87,196 |
) |
|
|
84,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
of common stock options
|
|
|
670 |
|
|
|
- |
|
|
|
2,962 |
|
|
|
- |
|
|
|
2,962 |
|
Sales
of common stock
|
|
|
1,263 |
|
|
|
1 |
|
|
|
3,375 |
|
|
|
- |
|
|
|
3,376 |
|
Stock
option compensation cost
|
|
|
- |
|
|
|
- |
|
|
|
2,150 |
|
|
|
- |
|
|
|
2,150 |
|
Compensation
earned on stock awards
|
|
|
151 |
|
|
|
- |
|
|
|
631 |
|
|
|
- |
|
|
|
631 |
|
Acquisition
of AzERx
|
|
|
1,355 |
|
|
|
1 |
|
|
|
7,763 |
|
|
|
- |
|
|
|
7,764 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(31,913 |
) |
|
|
(31,913 |
) |
Balance
December 31, 2006
|
|
|
41,564 |
|
|
|
21 |
|
|
|
188,236 |
|
|
|
(119,109 |
) |
|
|
69,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adoption
of FIN 48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(363 |
) |
|
|
(363 |
) |
Stock
option compensation cost
|
|
|
- |
|
|
|
- |
|
|
|
534 |
|
|
|
- |
|
|
|
534 |
|
Compensation
earned on stock awards
|
|
|
194 |
|
|
|
- |
|
|
|
243 |
|
|
|
- |
|
|
|
243 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(10,101 |
) |
|
|
(10,101 |
) |
Balance
December 31, 2007
|
|
|
41,758 |
|
|
$ |
21 |
|
|
$ |
189,013 |
|
|
$ |
(129,573 |
) |
|
$ |
59,461 |
|
See
notes to financial statements
ORTHOLOGIC
CORP.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
As
a
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
Stage
Company
|
|
|
|
Years
Ended December 31,
|
|
|
August
5, 2004 -
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
December
31, 2007
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(10,101 |
) |
|
$ |
(31,913 |
) |
|
$ |
(27,202 |
) |
|
$ |
(101,448 |
) |
Non
Cash items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax expense
|
|
|
- |
|
|
|
1,106 |
|
|
|
- |
|
|
|
770 |
|
Depreciation
and amortization
|
|
|
169 |
|
|
|
2,833 |
|
|
|
392 |
|
|
|
3,434 |
|
Non-cash
stock compensation
|
|
|
777 |
|
|
|
2,781 |
|
|
|
162 |
|
|
|
3,720 |
|
Gain
on sale of bone device business
|
|
|
- |
|
|
|
- |
|
|
|
(250 |
) |
|
|
(2,298 |
) |
In-process
research and development
|
|
|
- |
|
|
|
8,471 |
|
|
|
- |
|
|
|
34,311 |
|
Change
in other operating items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
Prepaids
and other current assets
|
|
|
1,044 |
|
|
|
(1,094 |
) |
|
|
424 |
|
|
|
803 |
|
Accounts
payable
|
|
|
(919 |
) |
|
|
334 |
|
|
|
203 |
|
|
|
(269 |
) |
Accrued
liabilities
|
|
|
(384 |
) |
|
|
(1,422 |
) |
|
|
(294 |
) |
|
|
(1,317 |
) |
Cash
flows used in operating activities
|
|
|
(9,414 |
) |
|
|
(18,904 |
) |
|
|
(26,565 |
) |
|
|
(62,294 |
) |
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenditures
for furniture and equipment, net
|
|
|
(178 |
) |
|
|
(196 |
) |
|
|
(268 |
) |
|
|
(693 |
) |
Proceeds
from sale of assets
|
|
|
- |
|
|
|
- |
|
|
|
7,000 |
|
|
|
7,000 |
|
Cash
paid for assets of AzERx/CBI
|
|
|
- |
|
|
|
(390 |
) |
|
|
- |
|
|
|
(4,058 |
) |
Cash
paid for patent assignment rights
|
|
|
- |
|
|
|
(250 |
) |
|
|
(400 |
) |
|
|
(650 |
) |
Purchases
of investments
|
|
|
(51,395 |
) |
|
|
(56,509 |
) |
|
|
(48,823 |
) |
|
|
(197,289 |
) |
Maturities
of investments
|
|
|
63,883 |
|
|
|
52,847 |
|
|
|
65,502 |
|
|
|
215,532 |
|
Cash
flows provided by (used in) investing activities
|
|
|
12,310 |
|
|
|
(4,498 |
) |
|
|
23,011 |
|
|
|
19,842 |
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from stock option exercises
|
|
|
- |
|
|
|
2,962 |
|
|
|
288 |
|
|
|
4,612 |
|
Net
proceeds from sale of stock
|
|
|
- |
|
|
|
3,376 |
|
|
|
- |
|
|
|
3,376 |
|
Cash
flows provided by financing activities
|
|
|
- |
|
|
|
6,338 |
|
|
|
288 |
|
|
|
7,988 |
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
2,896 |
|
|
|
(17,064 |
) |
|
|
(3,266 |
) |
|
|
(34,464 |
) |
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
18,047 |
|
|
|
35,111 |
|
|
|
38,377 |
|
|
|
55,407 |
|
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
|
$ |
20,943 |
|
|
$ |
18,047 |
|
|
$ |
35,111 |
|
|
$ |
20,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure of Non-Cash Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AzERx
/ CBI Acquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets acquired
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
29 |
|
Patents
acquired
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,142 |
|
Liabilities
acquired, and accrued acquisition costs
|
|
|
- |
|
|
|
(317 |
) |
|
|
- |
|
|
|
(457 |
) |
Original
investment reversal
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(750 |
) |
In-process
research and development acquired
|
|
|
- |
|
|
|
8,471 |
|
|
|
- |
|
|
|
34,311 |
|
Common
stock issued for acquisitions
|
|
|
- |
|
|
|
(7,764 |
) |
|
|
- |
|
|
|
(31,217 |
) |
Cash
paid for acquisitions
|
|
$ |
- |
|
|
$ |
390 |
|
|
$ |
- |
|
|
$ |
4,058 |
|
See
notes to financial statements
ORTHOLOGIC
CORP.
(A
Development Stage Company)
NOTES TO
FINANCIAL STATEMENTS
YEARS
ENDED DECEMBER 31, 2007, 2006 and 2005
1.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Description of the
business
OrthoLogic
is a biotechnology company committed to developing a pipeline of novel peptides
and other molecules aimed at helping patients with under-served
conditions. We are focused on the development and commercialization
of two product platforms: Chrysalin® (TP508) and AZX100.
Chrysalin
(TP508), a novel synthetic 23-amino acid peptide, is believed to produce
angiogenic and other tissue repair effects by activating or upregulating nitric
oxide synthase (NOS) and the production of nitric oxide in endothelial cells,
and if so, it may have potential therapeutic value in tissues and diseases
exhibiting endothelial dysfunction. We have primarily investigated
Chrysalin in two indications, fracture repair and diabetic foot ulcer healing
and we are initiating study of other potential vascular
indications. The Company owns exclusive worldwide rights to
Chrysalin.
AZX100 is
a novel synthetic pre-clinical 24-amino acid peptide and is believed to have
smooth muscle relaxation and anti-fibrotic properties. AZX100 is currently being
evaluated for medically and commercially significant applications, such as
prevention of dermal scarring, pulmonary fibrosis, the treatment of asthma, and
vascular intimal hyperplasia. We filed an IND for a dermal scarring
indication in 2007 and plan to start a Phase 1 clinical trial in dermal scarring
in early 2008. OrthoLogic has an exclusive worldwide license to
AZX100.
We
continue to explore other biopharmaceutical compounds that can complement our
research activity internally and broaden our potential pipeline for successful
products.
Company
History
Prior to
November 26, 2003, we developed, manufactured and marketed proprietary,
technologically advanced orthopedic products designed to promote the healing of
musculoskeletal bone and tissue, with particular emphasis on fracture healing
and spine repair. Our product lines included bone growth stimulation
and fracture fixation devices including the OL1000 product line, SpinaLogic® and
OrthoFrame/Mayo, which we sometimes refer to as our “Bone Device
Business.”
On
November 26, 2003, we sold our Bone Device Business. Our principal
business remains focused on tissue repair, although through biopharmaceutical
approaches rather than through the use of medical devices.
On August
5, 2004, we purchased substantially all of the assets and intellectual property
of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide
license for Chrysalin for all medical indications. We became a development stage
entity commensurate with the acquisition. Subsequently, our efforts
were focused on research and development of our Chrysalin Product Platform, with
the goal of commercializing our products.
On
February 27, 2006, the Company purchased certain assets and assumed certain
liabilities of AzERx, Inc. Under the terms of the transaction, OrthoLogic
acquired an exclusive license for the core intellectual property relating to
AZX100.
Our
development activities for the Chrysalin Product Platform and AZX100 represent a
single operating segment as they share the same product development path and
utilize the same Company resources. As a result, we have determined
that it is appropriate to reflect our operations as one reportable segment.
Through December 31, 2007, we have incurred $101 million in net losses as a
development stage company.
In these
notes, references to “we”, “our” and the “Company” refer to OrthoLogic
Corp. References to our Bone Device Business refer to our former
business line of bone growth stimulation and fracture fixation devices,
including the OL1000 product line, SpinaLogic®, OrthoFrame® and
OrthoFrame/Mayo.
Use of
estimates. The preparation of financial statements in
accordance with accounting principles generally accepted in the United States of
America requires that management make a number of assumptions and estimates that
affect the reported amounts of assets, liabilities, and expenses in our
financial statements and accompanying notes. Management bases its
estimates on historical experience and various other assumptions believed to be
reasonable. Although these estimates are based on management’s
assumptions regarding current events and actions that may impact the Company in
the future, actual results may differ from these estimates and
assumptions.
The
significant estimates include the Chrysalis Biotechnology, Inc. and AzERx
purchase price allocations, valuation of intangibles, income taxes,
contingencies, litigation, accrued clinical reserves and accounting for
stock-based compensation.
Cash and cash equivalents.
Cash and cash equivalents consist of cash on hand and cash deposited with
financial institutions, including money market accounts, and investments
purchased with a remaining maturity of three months or less when
acquired.
Furniture and
equipment. Furniture and equipment are stated at cost.
Depreciation is calculated on a straight-line basis over the estimated useful
lives of the various assets, which range from three to seven
years. Leasehold improvements are amortized over the life of the
asset or the period of the respective lease using the straight-line method,
whichever is the shortest.
Patents. Patent
costs relate to the acquisition of CBI and rights associated with the Chrysalin
platform and the costs were being amortized over the estimated life of the
patents, 6 – 17 years. On November 2, 2006, the Company announced
that it has no immediate plans to re-enter clinical trials for Chrysalin-based
product candidates and a strategic shift in its development approach to its
Chrysalin product platform. The Company currently intends to pursue
development partnering or licensing opportunities for its Chrysalin-based
product candidates, a change from its previous development history of
independently conducting human clinical trials necessary to advance its
Chrysalin-based product candidates to market. SFAS No. 142 requires
an impairment loss be recognized for an amortizable intangible asset whenever
the net cash in-flow to be generated from an asset is less that it’s carrying
cost. The Company was unable to determine the timing or amount of net
cash in-flow to be generated from Chrysalin-based product
candidates. Accordingly, due to this uncertainty, the Company
recognized an impairment loss for the amount of unamortized Chrysalin product
platform patent costs of $2,100,000 in 2006. The impairment loss is included in
research and development expenses in the Statements of Operations in
2006. Subsequent to the recognition of the impairment loss, the
Company incurred and expensed $250,000 in 2006 for payments made under existing
agreements for additional patent rights. Patent amortization costs
charged to research and development totaled $2,473,000 in 2006.
Research and
development. Research and development represents both costs
incurred internally for research and development activities, as well as costs
incurred to fund the research activities with which we have contracted and
certain milestone payments regarding the continued clinical testing of Chrysalin
and AZX100. All research and development costs are expensed when
incurred.
Accrued
Clinical. Accrued clinical represents the liability recorded
on a per patient basis of the costs incurred for our human clinical
trials. Total patient costs are based on the specified clinical trial
protocol, recognized over the period of time service is provided to the
patient. We have no active clinical trials at December 31,
2007.
Stock-based compensation. At December 31, 2005, we
had two stock-based employee compensation plans described more fully in Note
8. Prior to January 1, 2006, we accounted for those plans
under the recognition and measurement principles of Accounting Principles Board
(“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations. Stock-based employee compensation cost was normally
not recognized, as all options granted under our stock plans had an exercise
price equal to the market value of the underlying common stock on the date of
grant. For non-employees this expense is recognized as the service is
provided in accordance with guidance in 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.
Effective
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment”,
(SFAS 123(R)). SFAS 123(R) requires all share-based payments,
including grants of stock options, restricted stock units and employee stock
purchase rights, to be recognized in our financial statements based on their
respective grant date fair values. Under this standard, the fair value of each
employee stock option and employee stock purchase right is estimated on the date
of grant using an option pricing model that meets certain
requirements. We currently use the Black-Scholes option pricing model
to estimate the fair value of our share-based payments. The
determination of the fair value of share-based payment awards utilizing the
Black-Scholes model is affected by our stock price and a number of assumptions,
including expected volatility, expected life, risk-free interest rate and
expected dividends. We use the historical volatility adjusted for
future expectations. The expected life of the stock options is based on
historical data and future expectations. The risk-free interest rate
assumption is based on observed interest rates appropriate for the terms of our
stock options and stock purchase rights. The dividend yield
assumption is based on our history and expectation of dividend
payouts. The fair value of our restricted stock units is based on the
fair market value of our common stock on the date of
grant. Stock-based compensation expense recognized in our financial
statements in 2006 and thereafter is based on awards that are ultimately
expected to vest. We recognize compensation cost for an award with
only service conditions that has a graded vesting schedule on a straight line
basis over the requisite service period as if the award was, in-substance, a
multiple award. However, the amount of compensation cost recognized
at any date must at least equal the portion of grant-date fair value of the
award that is vested at that date. The amount of stock-based compensation
expense in 2006 and thereafter will be reduced for estimated
forfeitures. Forfeitures are required to be estimated at the time of
grant and revised, if necessary, in subsequent periods if actual forfeitures
differ from those estimates. We will evaluate the assumptions used to
value stock awards on a quarterly basis. If factors change and we
employ different assumptions, stock-based compensation expense may differ
significantly from what we have recorded in the past. The Company
chose the modified-prospective transition alternatives in adopting SFAS
123(R). Under the modified-prospective transition method,
compensation cost is recognized in financial statements issued subsequent to the
date of adoption for all stock-based payments granted, modified or settled after
the date of adoption, as well as for any unvested awards that were granted prior
to the date of adoption. Because the Company previously adopted only
the pro forma disclosure provisions of SFAS 123, we recognize compensation cost
relating to the unvested portion of awards granted prior to January 1, 2006, the
date of adoption, using the same estimate of the grant-date fair value and the
same attribution method used to determine the pro forma disclosure under SFAS
123, except that a forfeiture rate will be estimated for all options, as
required by SFAS 123(R).
SFAS
123(R) requires the benefits associated with tax deductions that are realized in
excess of recognized compensation cost to be reported as a financing cash flow
rather than as an operating cash flow as previously
required. Subsequent to the adoption of SFAS 123(R) on January 1,
2006, we have not recorded any excess tax benefit generated from option
exercises, due to our net operating loss carryforwards, which cause such excess
to be unrealized.
We have
provided the required additional disclosures below which illustrates the effect
on net loss and loss per share if the Company had applied the fair value
recognition provisions of SFAS No. 123(R), to stock-based employee
compensation (in thousands, except per share data) prior to January 1, 2006, the
date of adoption of SFAS No. 123(R).
|
|
Year
Ended
|
|
|
|
December
31, 2005
|
|
Net
loss attributable to common stockholders:
|
|
|
|
As
reported
|
|
$ |
(27,202 |
) |
Stock
based compensation included in net loss
|
|
|
162 |
|
Stock
based compensation expense, net of tax
|
|
|
(932 |
) |
Pro
forma
|
|
$ |
(27,972 |
) |
Basic
and diluted net loss per share:
|
|
|
|
|
As
reported
|
|
$ |
(0.72 |
) |
Pro
forma
|
|
$ |
(0.74 |
) |
Black
Scholes model assumptions:
|
|
|
|
|
Risk
free interest rate
|
|
|
4.29 |
% |
Expected
volatility
|
|
|
51 |
% |
Expected
term (from vesting date)
|
|
2.6
Years
|
|
Dividend
yield
|
|
|
0 |
% |
Estimated
weighted-average fair value of options granted during the
year
|
|
$ |
3.07 |
|
The
Company recorded stock option based compensation of $534,000 in 2007 and
$2,150,000 in 2006. Net loss for the years ended December 31, 2007
and 2006 increased by $534,000 and $2,150,000, respectively, and loss per
weighted average basic and diluted shares outstanding increased by $0.01 per
share in 2007 and $0.05 per share in 2006 due to the adoption of SFAS 123(R) in
2006.
Loss per common
share. Loss per common share is computed on the weighted
average number of common or common and equivalent shares outstanding during each
year. Basic earnings per share is computed as net loss divided by the
weighted average number of common shares outstanding during the
period. Diluted earnings per share reflects the potential dilution
that could occur from common shares issuable through stock options, warrants,
and non-vested restricted stock when the effect would be dilutive. At
December 31, 2007, options and warrants to purchase 164,889 shares were excluded
from the calculations of diluted earnings per share because they were
anti-dilutive.
Discontinued operations. Under
SFAS No. 144, “Accounting for the impairment and Disposal of Long-Lived Assets,”
discontinued operations are reported if a component of the entity is held for
sale or sold during the period. The Bone Device Business qualified as
a component of the entity under the standard. Therefore, the gains on
the sale of the Bone Device Business have been presented as discontinued
operations in the financial statements.
Income Taxes. Under SFAS No. 109,
“Accounting for Income Taxes,” income taxes are recorded based on current year
amounts payable or refundable, as well as the consequences of events that give
rise to deferred tax assets and liabilities. We base our estimate of
current and deferred taxes on the tax laws and rates that are estimated to be in
effect in the periods in which deferred tax liabilities or assets are expected
to be settled or realized. Pursuant to SFAS No. 109, we have
determined that the deferred tax assets at December 31, 2007 require a full
valuation allowance given that it is not “more likely than not” that the assets
will be recovered.
We
adopted the provisions of Financial Accounting Standards Board (“FASB”)
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes-an
interpretation of FASB Statement No. 109” (“FIN 48”), on January 1, 2007. FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an
enterprise’s financial statements in accordance with SFAS No. 109, and
prescribes a recognition threshold and measurement process for financial
statement recognition and measurement of a tax position taken or expected to be
taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition.
An
evaluation was performed for the tax years ended December 31, 2003, 2004, 2005,
2006 and 2007, the tax years which remain subject to examination by major tax
jurisdictions as of December 31, 2007. Based on our evaluation, we have
concluded that, in accordance with FIN No. 48, the
Company recognized a cumulative-effect adjustment of $363,000, increasing its
liability for unrecognized tax benefits, interest, and penalties and increasing
accumulated deficit. A reconciliation of the beginning and ending
amount of unrecognized tax benefits is as follows:
Balance
at January 1, 2007
|
|
$ |
1,001,000 |
|
Additions
based on tax positions related to the current year
|
|
|
- |
|
Additions
for tax positions of prior years
|
|
|
- |
|
Reductions
for tax positions of prior years
|
|
|
- |
|
Settlements
|
|
|
- |
|
Reductions
due to lapse in statute of limitations
|
|
|
- |
|
Balance
at December 31, 2007
|
|
$ |
1,001,000 |
|
The gross
amount of unrecognized tax benefits which, if ultimately recognized, could
favorably affect the effective tax rate in a future period is approximately
$683,000 as of January 1, 2007 and December 31, 2007.
We may,
from time-to-time, be assessed interest or penalties by major tax jurisdictions,
although any such assessments historically have been minimal and immaterial to
our financial results. The Company recognizes accrued interest and penalties, if
applicable, related to unrecognized tax benefits in income tax expense. During
the year ended December 31, 2007, the Company did not recognize a material
amount in interest and penalties.
New Accounting
Pronouncements
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurements,
which clarifies the definition of fair value, establishes a framework for
measuring fair value, and expands the disclosures about fair value
measurements. SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007. The Company does not expect SFAS No. 157 to
have a material impact on the Company’s results of operations and financial
condition.
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Statements and Financial Liabilities, which provides companies with an
option to report selected financial assets and liabilities at fair
value. SFAS No. 159 requires companies to provide additional
information that will help investors and other users of financial statements to
more easily understand the effect of the company’s choice to use fair value on
its earnings. It also requires entities to display the fair value of
those assets and liabilities for which the company has chosen to use fair value
on the face of the balance sheet. The new Statement does not
eliminate disclosure requirements included in other accounting standards,
including requirements for disclosures about fair value measurements included in
FASB Statements No. 157, Fair
Value Measurements, and No. 107, Disclosures about Fair Value of
Financial Instruments. The Company does not expect SFAS No. 159 to have a
material impact on the Company’s results of operations and financial condition
upon adoption.
In June
2007, the EITF reached a consensus on EITF 07-03, Accounting for Nonrefundable Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities. EITF 07-03 concludes that non-refundable advance
payments for future research and development activities should be deferred and
capitalized until the goods have been delivered or the related services have
been performed. If an entity does not expect the goods to be
delivered or services to be rendered, the capitalized advance payment should be
charged to expense. This consensus is effective for financial
statements issued for fiscal years beginning after December 15, 2007, and
interim periods within those fiscal years. Earlier adoption is not
permitted. The effect of applying the consensus will be prospective
for new contracts entered into on or after that date. The Company
does not expect EITF 07-03 to have a material impact on the Company’s results of
operations and financial condition upon adoption.
In
December 2007, the FASB issued SFAS No. 141R, Business Combinations, which
replaces SFAS No. 141 and establishes principles and requirements for how an
acquirer in a business combination recognizes and measures in its financial
statements the identifiable assets acquired, the liabilities assumed and any
controlling interest. It also established principles and requirements
for how an acquirer in a business combination recognizes and measures the
goodwill acquired in the business combination or a gain from a bargain purchase,
and determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. The Company does not expect SFAS No. 141R to have a
material impact on the Company’s results of operations and financial condition
upon adoption.
2.
|
ASSET
ACQUISITION OF CHRYSALIS BIOTECHNOLOGY,
INC
|
In
January 1998, we acquired a minority equity investment (less than 10%) in
Chrysalis BioTechnology, Inc. (“CBI”) for $750,000. As part of the transaction,
we were awarded a worldwide exclusive option to license the orthopedic
applications of Chrysalin, a patented 23-amino acid synthetic peptide that had
shown promise in accelerating the healing process.
On August
5, 2004, we purchased substantially all of the assets and intellectual property
of CBI, including its exclusive worldwide license for Chrysalin for all medical
indications for $2.5 million in cash, excluding acquisition costs, and $25.0
million in OrthoLogic common stock issued. We issued 3,462,124 shares of OrthoLogic
common stock to CBI for this transaction based on the 10-day average closing
price of $7.221. Pursuant to the terms of the definitive agreement,
we must issue an additional number of shares of OrthoLogic common stock valued
at $7.0 million upon the occurrence of certain trigger events, which include the
sale or other transactions that result in a change of control of OrthoLogic or
the acceptance by the U.S. Food and Drug Administration of a new drug
application for a product based on Chrysalin, if either such trigger occurs
within five years of closing. The largest portion of the purchase price and
acquisition costs was expensed as in-process research and development of $25.8
million. The remainder of the purchase price was allocated to patents
totaling $2.1 million, liabilities of $140,000 and other assets of
$29,000.
The
initial $750,000 investment was recognized as part of the purchase price of the
transaction. In return for the initial investment in CBI, we received
214,234 shares of OrthoLogic common stock as the prorated share of the purchase
price, in accordance with the liquidation plan adopted by CBI at the time of the
asset acquisition. The shares of OrthoLogic common stock, valued at
$1.5 million, were accumulated with the other 41,800 shares of treasury stock
previously outstanding and reverted back into the authorized but unissued common
stock during the third quarter of 2004.
Pursuant
to the Asset Purchase Agreement, fifteen percent of the shares of OrthoLogic
common stock issued for the acquisition of CBI were placed in escrow for 18
months from the closing date to cover indemnifications for the representations
and warranties made by CBI. No indemnification claims were made and in February
2006 the shares were released from escrow. We assumed the CBI lease for the
location in Galveston, Texas, with approximately 4,400 sq. ft. of office space
and laboratory space. We hired eight of the eleven full time CBI
employees, and retained the President and founder of the company through a
two-year consulting agreement.
The CBI
acquisition has been accounted for using the purchase method of accounting
whereby the total purchase price has been allocated to tangible and intangible
assets acquired and liabilities assumed based on their estimated fair market
values as of the acquisition date.
The
components of the purchase price are as follows (in thousands):
Cash
paid, including acquisition costs
|
|
$ |
3,668 |
|
Common
stock issued (less treasury stock received)
|
|
|
23,453 |
|
Original investment in CBI
|
|
|
750 |
|
Total
purchase price
|
|
$ |
27,871 |
|
|
|
|
|
|
The
fair value of CBI net assets acquired:
|
|
|
|
|
Patents
|
|
$ |
2,142 |
|
In-process
research and development
|
|
|
25,840 |
|
Furniture,
equipment and other
|
|
|
29 |
|
Liabilities acquired
|
|
|
(140 |
) |
Fair
value of the assets purchased
|
|
$ |
27,871 |
|
3.
|
ASSET
SALE OF THE BONE DEVICE BUSINESS – DISCONTINUED
OPERATIONS
|
On
November 26, 2003, we completed the sale of the Bone Device Business assets and
related liabilities (including the rights to produce and market the OL1000,
OL1000 SC, SpinaLogic and OrthoFrame/Mayo) to dj Orthopedics,
LLC. Pursuant to the asset purchase agreement, we sold substantially
all of the assets of the Bone Device Business (other than our Medicare accounts
receivable, which were $1.2 million in the aggregate), including substantially
all of the related machinery, equipment, inventory, work in process, licenses,
customer lists, intellectual property, certain agreements and
contracts. dj Orthopedics paid $93.0 million in cash at closing and
assumed substantially all of the Bone Device Business trade payables and other
current liabilities less payables in an amount approximately equal to the amount
of retained Medicare receivables. Upon the closing of the sale, we
assigned and dj Orthopedics agreed to assume and perform the obligations
outstanding on November 26, 2003, related to the operation of the Bone Device
Business (including various liabilities related to the Company’s
employees). The net gain on the sale of the Bone Device Business was
$72.7 million, recognized in fiscal year 2003, at the time of the
sale.
Of the
$93.0 million we received in the sale, $7.5 million was placed in an escrow
account. The funds were divided into two accounts: $7.0 million from
which dj Orthopedics, LLP was eligible for indemnity and breach of contract
claims, if any, and $0.5 million from which a portion of the agreed upon
incentive stay bonuses was paid by dj Orthopedics to former OrthoLogic
executives on November 26, 2004, the first anniversary of the
closing. The funds in the $7.0 million escrow account, in excess of
the amount of any pending claims, was to be released to us on the second
anniversary of the closing. The amount reserved for the potential
liability at closing was $1.9 million related to the fair value of the
representation and warranties in the Asset Purchase Agreement. We
received updated information during the third quarter of 2004 that eliminated
most of the potential exposure of the representations and warranties in the
Asset Purchase Agreement. This decrease in the reserve combined with
a tax benefit is shown as gain recognized on the sale of the Bone Device
Business in discontinued operations in the statement of
operations. The Company received the amounts in escrow during fiscal
year 2005.
The sale
of the Bone Device Business was considered an accelerating event for our
stock-based compensation plans. Terminated employees’ unvested
options vested immediately upon the sale. Our directors and employees
who were retained had 75% of their unvested options vest upon the sale, with the
remainder vesting over a 12 month period or on their regular vesting period,
whichever was earlier.
The sale
of the Bone Device Business is accounted for as discontinued
operations. The income from the divested business and related tax
effects is summarized as discontinued operations in the statement of
operations.
4.
|
CPM
DIVESTITURE IN 2001 AND RELATED
GAINS
|
In 2001,
we sold our continuous passive motion (“CPM”) business to OrthoRehab,
Inc. We received $12.0 million in cash, with OrthoRehab, Inc.
assuming approximately $2.0 million in liabilities in connection with the sale
of certain CPM related assets that we had recorded in our financial statements
at a carrying value of approximately $20.7 million. We recorded a
$6.9 million charge to write down the CPM assets to their fair value less direct
costs of selling the assets. Under the CPM Asset Purchase Agreement,
we were eligible to receive up to an additional $2.5 million of cash if certain
objectives were achieved by OrthoRehab, Inc.
We
settled litigation over the $2.5 million payment and other matters in April
2003. OrthoRehab, Inc. agreed to pay $1.2 million to settle the contingent
payment due to us, and all outstanding claims between the two
companies. All payments due had been received as of December 31,
2005.
The
combination of settlement payments and additional collection of the divested
receivables is included in the “Other gains” line item in the 2005 Statement of
Operations.
5.
|
INVESTMENTS
AND FAIR VALUE DISCLOSURES
|
At
December 31, 2007, investments consisted of municipal and corporate commercial
paper or bonds and were classified as held-to-maturity
securities. Such classification requires these securities to be
reported at amortized cost unless they are deemed to be permanently impaired in
value.
A summary
of the fair market value and unrealized gains and losses on these securities is
as follows (in thousands):
Investments
with maturities – Short-term
|
|
December
31
|
|
|
|
2007
|
|
|
2006
|
|
Amortized
cost
|
|
$ |
18,236 |
|
|
$ |
35,977 |
|
Gross
unrealized gain (loss)
|
|
|
117 |
|
|
|
(29 |
) |
Fair
value
|
|
$ |
18,353 |
|
|
$ |
35,948 |
|
Investments
with maturities – Long term
|
|
December
31
|
|
|
|
2007
|
|
|
2006
|
|
Amortized
cost
|
|
$ |
21,459 |
|
|
$ |
16,206 |
|
Gross
unrealized gain (loss)
|
|
|
610 |
|
|
|
(1 |
) |
Fair
value
|
|
$ |
22,069 |
|
|
$ |
16,205 |
|
For our
cash and cash equivalents and short-term investments, the carrying amount is
assumed to be the fair market value because of the liquidity of these
instruments. The carrying amount is assumed to be the fair value for
other current assets, accounts payable and other accrued expenses because of
their short maturity. Our long-term investments carry a market
interest rate and the fair market value of the investments approximated the
carrying values (as shown above) at December 31, 2007.
Our
long-term investments are comprised primarily of U.S. Government obligations
with the following maturities:
2009
|
|
$ |
19,238,000 |
|
|
|
|
|
|
2010
|
|
|
2,221,000 |
|
|
|
$ |
21,459,000 |
|
6.
|
FURNITURE
AND EQUIPMENT
|
The
components of furniture and equipment are as follows (in
thousands):
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
|
|
Machinery
and equipment
|
|
$ |
1,258 |
|
|
$ |
1,757 |
|
Furniture
and fixtures
|
|
|
144 |
|
|
|
140 |
|
Leasehold
improvements
|
|
|
- |
|
|
|
1,411 |
|
|
|
|
1,402 |
|
|
|
3,308 |
|
Less
accumulated depreciation and amortization
|
|
|
(1,084 |
) |
|
|
(2,899 |
) |
Total
|
|
$ |
318 |
|
|
$ |
409 |
|
Depreciation
expense for the years ended December 31, 2007, 2006, 2005, and for the period of
August 5, 2004 through December 31, 2007 was $166,000, $370,000, $222,000, and
$813,000, respectively.
The
components of deferred income taxes at December 31 are as follows (in
thousands):
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
|
|
Other
accruals and reserves
|
|
$ |
328 |
|
|
$ |
20 |
|
Valuation
allowance
|
|
|
(328 |
) |
|
|
(20 |
) |
Total
current
|
|
|
- |
|
|
|
- |
|
NOL,
AMT and general business credit carryforwards
|
|
|
38,357 |
|
|
|
32,873 |
|
Difference
in basis of fixed assets
|
|
|
93 |
|
|
|
61 |
|
Other
accruals and reserves
|
|
|
756 |
|
|
|
684 |
|
Difference
in basis of intangibles
|
|
|
35 |
|
|
|
142 |
|
Valuation
allowance
|
|
|
(39,241 |
) |
|
|
(33,760 |
) |
Total
non current
|
|
|
- |
|
|
|
- |
|
Total
deferred income taxes
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
As
a
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
Stage
Company
|
|
|
|
Years
Ended December 31
|
|
|
August
5, 2004 -
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
December
31, 2007
|
|
The
provisions (benefits) for income taxes are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(108 |
) |
|
$ |
(750 |
) |
Deferred
|
|
|
|
|
|
|
1,106 |
|
|
|
- |
|
|
|
1,106 |
|
Income
tax provision (benefit)
|
|
$ |
- |
|
|
$ |
1,106 |
|
|
$ |
(108 |
) |
|
$ |
356 |
|
SFAS No.
109 requires that a valuation allowance be established when it is more likely
than not that all or a portion of a deferred tax asset will not be
realized. Changes in valuation allowances from period to period are
included in the tax provision in the period of change. In determining
whether a valuation allowance is required, we take into account all evidence
with regard to the utilization of a deferred tax asset including past earnings
history, expected future earnings, the character and jurisdiction of such
earnings, unsettled circumstances that, if unfavorably resolved, would adversely
affect utilization of a deferred tax asset, carryback and carryforward periods,
and tax strategies that could potentially enhance the likelihood of realization
of a deferred tax asset. Management has evaluated the available
evidence about future taxable income and other possible sources of realization
of deferred tax assets and has established a valuation allowance of
approximately $39 million at December 31, 2007. The valuation
allowance includes approximately $6.1 million for net operating loss carry
forwards that relate to stock option compensation expense for income tax
reporting purposes. The results of the Company’s Phase 3 Chrysalin
fracture repair human clinical trial, which was received in 2006, resulted in a
change in our planned clinical pathway and timeline for our Chrysalin fracture
repair indication. This potential change, when factored with our
current significant net operating loss carryovers and current period net loss,
resulted in a revision of our estimate of the need for a valuation allowance for
the previously recorded deferred tax asset related to a Alternative Minimum Tax
credit carryover. Due to the uncertainty that the deferred tax asset
will be realized, we recorded a valuation allowance for the full amount of the
deferred tax asset ($1,106,000) in 2006. The valuation allowance reduces
deferred tax assets to an amount that management believes will more likely than
not be realized.
We have
accumulated approximately $89 million in federal and $77 million in state net
operating loss carryforwards (“NOLs”) and approximately $4 million of general
business and alternative minimum tax credit carryforwards. The
federal NOLs expire from 2023 and the state NOL’s expire from 2019 and their
availability to offset future taxable income would be limited should a change in
ownership, as defined in Section 382 of the Internal Revenue Code,
occur.
The AzERx
and CBI acquisitions were treated as tax free reorganizations under Internal
Revenue Code Section 368 and therefore resulted in a carryover basis and no
income tax benefit for the related acquisition costs, including in-process
research and development costs.
A
reconciliation of the difference between the provision (benefit) for income
taxes and income taxes at the statutory U.S. federal income tax rate is as
follows for the year ended December 31, and for the period of August 5, 2004
through December 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
As
a
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
Stage
Company
|
|
|
|
Years
Ended December 31,
|
|
|
August
5, 2004 -
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
December
31, 2007
|
|
Income
tax (benefit) as statutory rate
|
|
$ |
(3,434 |
) |
|
$ |
(10,474 |
) |
|
$ |
(9,336 |
) |
|
$ |
(35,117 |
) |
State
income taxes (benefit)
|
|
|
(465 |
) |
|
|
(990 |
) |
|
|
(975 |
) |
|
|
(3,647 |
) |
Purchased
in-process research and development
|
|
|
- |
|
|
|
2,843 |
|
|
|
- |
|
|
|
12,533 |
|
Research
credits
|
|
|
(1,516 |
) |
|
|
- |
|
|
|
(545 |
) |
|
|
(3,301 |
) |
Other
|
|
|
(291 |
) |
|
|
844 |
|
|
|
126 |
|
|
|
1,024 |
|
Change
in valuation allowance
|
|
|
5,706 |
|
|
|
8,883 |
|
|
|
10,622 |
|
|
|
28,864 |
|
Net
provision (benefit)
|
|
$ |
- |
|
|
$ |
1,106 |
|
|
$ |
(108 |
) |
|
$ |
356 |
|
The
number of common shares reserved for issuance under the OrthoLogic 1987 option
plan was 4,160,000 shares. This plan expired during October 1997. In
May 1997, the stockholders adopted a new stock option plan (the “1997
Plan”). The 1997 Plan reserved for issuance 1,040,000 shares of
Common Stock. Subsequent to its original adoption, the Board and
Shareholders approved amendments to the 1997 Plan that increased the number of
shares of common stock reserved for issuance to 4,190,000. The 1997
Plan expired in March 2007. In May 2006, the stockholders approved
the 2005 Equity Incentive Plan (2005 Plan) and reserved 2,000,000 shares of our
common stock for issuance. At December 31, 2007, 436,026 shares
remained available to grant under the 2005 Plan. Two types of options
may be granted under the Plans: options intended to qualify as incentive stock
options under Section 422 of the Internal Revenue Code (“Code”) and other
options not specifically authorized or qualified for favorable income tax
treatment by the Code. All eligible employees may receive more than
one type of option. Any director or consultant who is not an employee
of the Company shall be eligible to receive only nonqualified stock options
under the Plans.
The Plans
provide that in the event of a takeover or merger of the Company in which 100%
of the equity of the Company is purchased or a sale of all or substantially all
of OrthoLogic’s assets (an “Accelerating Event”), 75% of all unvested employee
options will vest and the remaining 25% vest over the following twelve month
period. If an employee or holder of stock options is terminated as a
result of or subsequent to the acquisition, 100% of that individual’s stock
option will vest immediately upon employment termination.
Stock
Options issued prior to December 31, 2005:
Unrecognized
non-cash stock compensation expense related to unvested options outstanding as
of December 31, 2005 was approximately $1 million (includes 328,124 shares
valued at $500,000 unvested and cancelled on April 5, 2006 upon the resignation
of James M. Pusey, MD). Because of the significant expected forfeiture rate
(58%) caused by the options cancelled at the time of Dr. Pusey’s
resignation, the expected compensation cost for unvested options at December 31,
2005, was approximately $388,000. Compensation cost recorded for the
years ended December 31, 2007 and 2006, for the options outstanding and
unvested at December 31, 2005, was $18,000 and $203,000, respectively. At
December 31, 2007 the remaining expected compensation cost related to
unvested options outstanding at December 31, 2005, is approximately
$13,000, which will be recognized over the remaining vesting period of
approximately two years, with an estimated weighted average period of one
year.
2006
Stock Options
On June
2, 2006, the Board of Directors granted options to purchase 800,000 shares of
the Company’s common stock, at an exercise price of $1.70 per share, to certain
Company employees. These options vest pro rata over a two-year
period.
On May
12, 2006, The Board of Directors granted each Director a fully vested option to
purchase 25,000 shares of the Company’s common stock at an exercise price of
$1.75.
As part
of their service agreements, on May 12, 2006, the Board of Directors granted
options to John M. Holliman, III, Executive Chairman, and Randolph C. Steer, MD,
Ph.D., President, to each purchase 200,000 shares of the Company’s common stock,
at an exercise price of $1.75 per share. The options vest pro rata
over a two-year period.
During
the three months ended March 31, 2006, the Board of Directors granted employees
options to purchase 584,000 shares of the Company’s common stock at exercise
prices ranging from $4.73 to $5.39 per share. These options vest over
a four-year period. On January 1, 2006, the Board of Directors also
granted each Director a fully vested option to purchase 10,000 shares of the
Company’s common stock at an exercise price of $4.90 per share.
The
Company used the Black-Scholes model with the following assumptions to determine
the total fair market value of $3,555,000 for options to purchase 1,994,000
shares of the Company’s common stock issued during the year ended December 31,
2006:
|
Three
months ended
|
Three
months ended
|
|
March
31, 2006
|
June
30, 2006
|
Risk
free interest rate
|
4.8%
|
5.2%
|
Volatility
|
73%
|
70%
|
Expected
term from vesting
|
2.9
years
|
2.9
years
|
Dividend
yield
|
0%
|
0%
|
Compensation
cost recorded for the year ended December 31, 2006, for options issued in 2006,
was $1,946,000. Using an estimated forfeiture rate of 12%, compensation
cost recorded for the year ended December 31, 2007, for options issued in 2006,
was $404,000. The options granted generally vest over a two to
four-year period from the date of grant and, accordingly, the remaining expected
unamortized cost at December 31, 2007 of approximately $254,000 will
be amortized ratably over the periods ending December 31, 2009, with an
estimated weighted average period of seven months.
2007
Stock Options
On
January 1, 2007, the Board of Directors granted each Director a fully vested
option to purchase 10,000 shares of the Company’s common stock at an exercise
price of $1.43. Additionally, during the three months ended March 31,
2007, the Company granted a fully vested option to purchase 13,889 shares of the
Company’s common stock to a consultant at an exercise price of $1.44 and an
option to purchase 5,000 shares that vests over a four-year period, to an
employee, at an exercise price of $1.45. On May 21, 2007, the Company
granted an option to Dr. Steer to purchase 50,000 shares of the Company’s common
stock at $1.53, which vests pro-rata over a two-year period.
During
the three months ended September 30, 2007, the Company granted options to
purchase 86,000 shares of the Company’s common stock to the members of its
Scientific Advisory Board at an average exercise price of $1.43 per
share. The options vested 25% on the date of grant, with the
remaining options vesting pro-rata over a three year period. The cost
of the options will be determined based upon the fair market value of the
options by using the Black Scholes model, revalued at each Company reporting
date until fully vested.
The
Company used the Black-Scholes model with the following assumptions to determine
the total fair value of $52,000 for options to purchase 78,889 shares of the
Company’s common stock issued during the three months ended March 31, 2007, the
fair value of $33,000 for options to purchase 50,000 shares of the Company’s
common stock issued during the three months ended June 30, 2007, and the fair
value of $87,000 for options to purchase 86,000 shares of the Company’s common
stock issued during the three months ended September 30, 2007.
|
Three
months ended
|
Three
months ended
|
Three
months ended
|
|
March
31, 2007
|
June
30, 2007
|
September
30, 2007
|
Risk
free interest rate
|
4.6%
|
4.87%
|
4.24%
|
Volatility
|
66%
|
61%
|
59%
|
Expected
term from vesting
|
2.8
Years
|
2.8
Years
|
2.9
Years
|
Dividend
yield
|
0%
|
0%
|
0%
|
Using an
estimated forfeiture rate of 16%, compensation cost recorded for the year ended
December 31, 2007, for options issued in 2007, was $114,000. The
options granted, that did not vest on the grant date, vest over two to four year
periods from the date of grant and, accordingly, the remaining unamortized cost
at December 31, 2007 of approximately $32,000 will be amortized ratably over the
period ending December 31, 2010, with an estimated weighted average period of
one year.
2006
Awards of Shares of Common Stock
On May
12, 2006, the Shareholders of the Company approved the 2005 Equity Incentive
Plan, which reserves an additional 2,000,000 shares of the Company’s common
stock for equity incentive awards. In conjunction with the approval,
on May 12, 2006, the Board of Directors of the Company awarded 117,750 shares of
restricted stock, which were fully vested at December 31, 2006. All
of the restricted stock awards had been conditionally awarded in 2005, subject
to shareholder approval of the 2005 Equity Incentive Plan. Of the
restricted shares awarded, 62,750 shares related to annual awards to the Board
of Directors, and 55,000 shares were performance based awards to officers of the
Company. The total fair market value of the grants, determined using
the closing price of the Company’s common stock on the date of grant, was
$206,000, which has been recognized as compensation cost in the year ended
December 31, 2006.
In
connection with the employment of James M. Pusey, MD, President and
CEO, in March 2005, the Company granted Dr. Pusey 200,000 shares of restricted
stock, which vested if certain milestones were reached. In March
2006, 100,000 shares of restricted stock vested resulting in total compensation
expense of $588,000, of which $426,000 was recorded in the quarter ended March
31, 2006 and $162,000 in fiscal year 2005, as general and administrative
expenses. The compensation cost was determined using the closing
price of the Company’s common stock on March 3, 2005, the date of
grant. The remaining unvested 100,000 shares of restricted stock were
cancelled upon Dr. Pusey’s resignation on April 5, 2006 of his employment
with the Company.
2007 Awards
of Shares of Common Stock
On
January 1, 2007, the Board of Directors of the Company awarded 104,898 shares of
restricted stock (17,843 shares to each director), which vest on January 1,
2008. The total fair value of the grants, determined using the
closing price of the Company’s common stock on the date of grant, was $150,000,
which included $25,000 (17,843 shares) that were subsequently forfeited due to
Mr. Casey’s decision to not seek re-election to the Board of Directors on May
10, 2007. The net fair value of the awards of $125,000, has been
recognized as compensation cost in the year ended December 31,
2007.
On May
10, 2007, the Board of Directors of the Company awarded total compensation of
$115,000 to various executives, to be paid through the issuance of shares of the
Company’s common stock. The total number of shares of stock issued
was 76,159.
Summary
Non-cash
stock compensation cost for the year ended December 31, 2006 totaled $2,781,000.
In the Statements of Operations for the year ended December 31, 2006, non-cash
stock compensation expense of $1,946,000 was recorded as a general and
administrative expense and $835,000 was recorded as a research and development
expense.
Non-cash
stock compensation cost for the year ended December 31, 2007, totaled
$777,000. In the Statements of Operations for the year ended December
31, 2007, non-cash stock compensation expense of $513,000 was recorded as a
general and administrative expense and $264,000 was recorded as research and
development expense.
During
the year ended December 31, 2006, options to purchase 670,400 shares of the
Company’s common stock were exercised resulting in the receipt by the Company of
net cash proceeds of $2,962,000. The intrinsic value of options
exercised in 2006 was $689,000. No options were exercised in the year
ended December 31, 2007.
A summary
of option activity under our stock option plans for the years ended December 31,
2007, 2006 and 2005, is as follows:
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
average
|
|
|
average
|
|
|
|
|
|
average
|
|
|
|
|
|
average
|
|
|
|
|
|
|
exercise
|
|
|
remaining
|
|
|
|
|
|
exercise
|
|
|
|
|
|
exercise
|
|
|
|
Number
of
|
|
|
price
|
|
|
contractual
term
|
|
|
Number
of
|
|
|
price
|
|
|
Number
of
|
|
|
price
|
|
|
|
Options
|
|
|
$
|
|
|
(years)
|
|
|
Options
|
|
|
$
|
|
|
Options
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at the beginning of the year:
|
|
|
3,438,126 |
|
|
|
3.69 |
|
|
|
|
|
|
3,040,785 |
|
|
|
5.23 |
|
|
|
2,507,850 |
|
|
|
5.04 |
|
Granted
|
|
|
214,889 |
|
|
|
1.45 |
|
|
|
|
|
|
1,994,000 |
|
|
|
2.85 |
|
|
|
650,000 |
|
|
|
5.21 |
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
(670,400 |
) |
|
|
4.42 |
|
|
|
(113,100 |
) |
|
|
2.54 |
|
Forfeited
|
|
|
(452,890 |
) |
|
|
4.47 |
|
|
|
|
|
|
(926,259 |
) |
|
|
6.57 |
|
|
|
(3,965 |
) |
|
|
5.81 |
|
Outstanding
at end of year
|
|
|
3,200,125 |
|
|
|
3.43 |
|
|
|
6.54 |
|
|
|
3,438,126 |
|
|
|
3.69 |
|
|
|
3,040,785 |
|
|
|
5.17 |
|
Options
exercisable at year-end
|
|
|
2,581,336 |
|
|
|
3.54 |
|
|
|
6.09 |
|
|
|
2,148,420 |
|
|
|
4.19 |
|
|
|
2,487,041 |
|
|
|
5.17 |
|
Options
vested and expected to vest at December 31, 2007
|
|
|
2,942,863 |
|
|
|
3.44 |
|
|
|
6.34 |
|
|
|
3,379,249 |
|
|
|
3.70 |
|
|
|
|
|
|
|
|
|
A summary
of the status of the Company’s unvested shares as of December 31, 2007 and 2006,
and changes during the years ended December 31, 2007 and 2006, is presented
below:
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
average
|
|
|
|
Number
of
|
|
|
Grant
date
|
|
Unvested
Shares
|
|
Options
|
|
|
Fair
Value
|
|
|
|
|
|
|
$
|
|
Unvested
shares at December 31, 2005
|
|
|
200,000 |
|
|
|
5.88 |
|
Granted
|
|
|
117,750 |
|
|
|
1.75 |
|
Vested
|
|
|
(217,750 |
) |
|
|
3.65 |
|
Canceled/forfeited
|
|
|
(100,000 |
) |
|
|
5.88 |
|
Unvested
shares at December 31, 2006
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
181,057 |
|
|
|
1.46 |
|
Vested
|
|
|
(163,574 |
) |
|
|
1.47 |
|
Canceled/forfeited
|
|
|
(17,483 |
) |
|
|
1.43 |
|
Unvested
shares at December 31, 2007
|
|
|
- |
|
|
|
|
|
It is the
Company’s policy to issue options from stockholder approved incentive plans.
However, if the options are issued as an inducement for an individual to join
the Company, the Company may issue stock options outside of stockholder approved
plans. The options granted under shareholder approved incentive plans
have a ten-year term and vest over a two to four-year period of
service. All options and stock purchase rights are granted with an
exercise price equal to the current market value on the date of grant and,
accordingly, options or stock purchase rights have no intrinsic value on the
date of grant. Based on the closing market price of the Company’s
common stock at December 31, 2007 of $1.35, stock options exercisable or
expected to vest at December 31, 2007, have no intrinsic value.
Warrants
At
December 31, 2007, the Company has warrants outstanding to purchase 46,706
shares of the Company’s common stock with an exercise price of $6.39 per share
which expire in February 2016, and warrants outstanding to purchase 117,423
shares of the Company’s common stock with an exercise price of $1.91 per share
which expire in July 2016.
Additionally,
as described in Note 15, performance based warrants to purchase 240,000 shares
of the Company’s common stock with an exercise price of $1.91, which expire in
February 2016, are outstanding but unvested at December 31, 2007. The
total cost of the performance based warrants will be charged to expense over the
period of performance. The costs will be determined based on the fair market
value of the warrants determined by using the Black-Scholes model, revalued at
each Company reporting date until fully vested. The fair market value
of the milestone warrants using the Black-Scholes model, 58% volatility, 0%
dividend yield, expected term of 8.2 years, and 3.4% interest rate was $187,000
at December 31, 2007. No costs were charged to expense at December
31, 2007 as it is not yet probable that any milestone warrants will
vest.
During
1998 through 2007, we were obligated under a non-cancelable operating lease
agreement for a Tempe, Arizona office and research facility. Rent
expense for the years ended December 31, 2007, 2006, 2005 and for the period of
August 5, 2004 through December 31, 2007 was $999,000, $1,174,000, $1,135,000
and $3,779,000, respectively. We subleased portions of the Tempe
facility to other tenants and approximately 45% of the Tempe facility was
subleased through December 2007, which offset our lease expense. The
Company recorded approximately $744,000, $745,000, $517,000, and $2,299,000 of
sublease income for the years ended December 31, 2007, 2006, 2005, and for the
period of August 5, 2004 through December 31, 2007, respectively.
On July
19, 2007, the Company entered into a new lease, which became effective upon the
expiration of its previous lease, for 17,000 square feet of space in the same
Tempe, Arizona facility. The new lease calls for monthly rental
payments of $22,000, plus a proportionate share of building operating expenses
and property taxes. The term of the new lease is sixty months from
March 1, 2008, with an option to extend the lease for an additional twenty-four
months with monthly rental payments set at $24,000, plus a proportionate share
of building operating expenses and property taxes, during the extension
period. The Company also has the right to terminate the new lease at
the end of thirty-six months upon payment of an early termination fee of
approximately $158,000. Total base rent for the initial sixty-month
term is approximately $1,316,000, due approximately $263,000 per year for years
2008 through 2012 and $44,000 in year 2013.
The
Company, along with similar affected property owners or lessees, contested
certain property taxes levied by Maricopa County on Salt River Project leasehold
improvements. In September 2006, the Superior Court of Arizona ruled
in favor of the Company and in November of 2006, Maricopa County informed the
Company it did not intend to appeal the decision. The property tax
bills subject to the court’s decision, totaled $466,000 and covered tax years
2004 and 2005. The Company has also been billed $240,000 for tax year
2006 for the same taxes, of which $120,000 had been paid at December 31, 2006.
The Company recorded a receivable from Maricopa County in the amount of $690,000
at December 31, 2006. The Company treated the recovery as a reduction
of current period property tax expense of which $462,000 was recorded as a
reduction of research and development expense, and $228,000 was recorded as a
reduction of general and administrative expenses in the statement of operations
for 2006. The Company received a refund of these taxes paid, plus
interest at 10% on the amounts from the dates paid, in February
2007. During 2006, the Arizona State Legislature repealed the
property tax which is the subject of the dispute.
The
Company is involved in various legal proceedings that arise in the ordinary
course of business. In management’s opinion, the ultimate resolution
of these other legal proceedings are not likely to have a material adverse
effect on the financial position, results of operations or cash flows of the
Company.
We
adopted a 401(k) plan (the “Plan”) for our employees on July 1,
1993. We may make matching contributions to the Plan on behalf of all
Plan participants, the amount of which is determined by the Board of Directors.
We matched approximately $40,000, $48,000 and $34,000 in 2007, 2006, and 2005,
respectively.
12.
|
CONDENSED QUARTERLY RESULTS
(UNAUDITED)
|
|
|
First
Quarter
|
|
|
Second
Quarter
|
|
|
Third
Quarter
|
|
|
Fourth
Quarter
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
|
(in
thousands, except for per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
$ |
3,797 |
|
|
$ |
17,243 |
|
|
$ |
3,180 |
|
|
$ |
6,303 |
|
|
$ |
3,258 |
|
|
$ |
7,067 |
|
|
$ |
3,144 |
|
|
$ |
4,077 |
|
Loss
from continuing operations
|
|
$ |
2,913 |
|
|
$ |
16,481 |
|
|
$ |
2,339 |
|
|
$ |
6,542 |
|
|
$ |
2,425 |
|
|
$ |
5,817 |
|
|
$ |
2,423 |
|
|
$ |
3,073 |
|
Net
loss
|
|
$ |
2,913 |
|
|
$ |
16,481 |
|
|
$ |
2,339 |
|
|
$ |
6,542 |
|
|
$ |
2,425 |
|
|
$ |
5,817 |
|
|
$ |
2,423 |
|
|
$ |
3,073 |
|
Net
loss per share basic and diluted
|
|
$ |
0.07 |
|
|
$ |
0.42 |
|
|
$ |
0.06 |
|
|
$ |
0.16 |
|
|
$ |
0.06 |
|
|
$ |
0.14 |
|
|
$ |
0.06 |
|
|
$ |
0.07 |
|
In
February of 2006, we acquired certain assets of AzERx resulting in a $8.4
million expense for in-process research and development. Cross footing the
quarterly data may not result in the yearly totals due to rounding.
13.
|
AUTHORIZED
PREFERRED STOCK
|
We have
2,000,000 shares of authorized preferred stock, the terms of which may be fixed
by our Board of Directors. We presently have no outstanding shares of
preferred stock. While we have no present plans to issue any
additional shares of preferred stock, our Board of Directors has the authority,
without stockholder approval, to create and issue one or more series of such
preferred stock and to determine the voting, dividend and other rights of
holders of such preferred stock. The issuance of any of such series
of preferred stock may have an adverse effect on the holders of common
stock.
On June
19, 2007, the Company entered into a new Rights Agreement (the “New Rights
Agreement”) with the Bank of New York. In connection with the New
Rights Agreement, we declared a dividend distribution of one Right for each
outstanding share of our common stock to stockholders of record as of July 2,
2007 and designated 1,000,000 shares of preferred stock as Series A Preferred
Stock. The Right, exercisable upon a Triggering Event as defined in
the New Rights Agreement, allows the holder of each share of the Company’s
common stock to purchase 1/100 of a share of Series A Preferred Stock for $6.00.
(Each 1/100 of a share of Series A Preferred Stock is convertible into $12 of
the Company’s common stock). The new rights replace similar rights
that the Company issued under its previous Rights Agreement. The New
Rights Agreement and the exercise of rights to purchase Series A Preferred Stock
pursuant to the terms thereof may delay, defer or prevent a change in control
because the terms of any issued Series A Preferred Stock would potentially
prohibit our consummation of certain extraordinary corporate transactions
without the approval of the Board of Directors. In addition to the
anti-takeover effects of the rights granted under the New Rights Agreement, the
issuance of preferred stock, generally, could have a dilutive effect on our
stockholders. The New Rights Agreement will expire June 19,
2010.
14.
|
ACQUISITION
OF AZX100 - A NEW CLASS OF
MOLECULES
|
On
February 27, 2006, the Company purchased certain assets and assumed certain
liabilities of AzERx, Inc. for $390,000 in cash and the issuance of 1,355,000
shares of the Company’s common stock. Under the terms of the transaction,
OrthoLogic acquired an exclusive license for the core intellectual property
relating to AZX100, a 24-amino acid synthetic peptide.
The
acquisition provides the Company with a new technology platform that diversifies
the portfolio, and may provide more than one potential
product. AZX100 is currently being evaluated for medically important
and commercially significant applications such as the prevention or treatment of
keloid scarring, pulmonary fibrosis, asthma and intimal
hyperplasia. Preclinical and human in vitro studies have shown that
this novel compound has the ability to relax smooth muscle in multiple tissue
types.
The
Company deemed the cost of the acquisition to be in-process research and
development costs and, accordingly, charged the acquisition costs to research
and development expense in the year ended December 31, 2006.
The costs
associated with the acquisition were as follows:
Cash
|
|
$ |
390,000 |
|
Fair
market value of the Company's common stock issued (1)
|
|
|
7,764,000 |
|
Transaction
costs
|
|
|
242,000 |
|
Liabilities
assumed
|
|
|
75,000 |
|
In-process
research and development costs
|
|
$ |
8,471,000 |
|
(1) The
fair market value of the Company’s common stock ($5.73) was determined by
reference to the closing market price of the Company’s common stock for a
reasonable period before and after February 24, 2006.
Valley
Ventures III, L.P., an investment fund affiliated with the Executive Chairman of
OrthoLogic, John M. Holliman, III, is a minority stockholder of
AzERx. Mr. Holliman did not participate in the evaluation or approval
of this transaction on behalf of OrthoLogic.
15.
|
SALE
OF SHARES OF COMPANY STOCK, ISSUANCE OF WARRANTS AND ENTRY INTO MASTER
SERVICES AGREEMENT
|
On
February 24, 2006, the Company entered into agreements with PharmaBio
Development Inc., (dba NovaQuest), an affiliate of Quintiles, Inc., and
Quintiles, Inc. (collectively “Quintiles”), which provided for the
purchase of $2,000,000 of the Company’s common stock, with the number of shares
(359,279) determined by the 15-day average closing stock price prior to February
24, 2006 ($5.56). The transaction was completed (closed) on February 27, 2006.
Additionally, under the terms of the agreements, at the election of the Company,
Quintiles would have been required to purchase $1,500,000 of the Company’s
common stock on June 30, 2006, (Second Closing) with the number of shares
determined by the 15-day average closing stock price prior to June 30, 2006, and
would have been required to purchase $1,500,000 of the Company’s common stock on
September 29, 2006, with the number of shares determined by the 15-day average
closing stock price prior to September 29, 2006 (Third Closing). Each stock
purchase would include the issuance of fully vested warrants, exercisable for a
ten-year period from the date of issuance, for an amount of shares equal to 13%
of the shares purchased and with the exercise price set at 115% of the share
price of each respective share purchase. (For the February 27, 2006 investment,
warrants to purchase 46,706 shares at $6.39 were issued).
On July
3, 2006, the Company closed the transaction contemplated by the agreements on
the Second Closing Date. Pursuant to the agreements, on July 3, 2006,
the Company issued a total of 903,252 shares of its common stock to Quintiles
for a purchase price of $1,500,000 and issued a fully vested warrant to purchase
117,423 shares of the Company’s common stock at $1.91 a share.
On
September 14, 2006, the Company notified Quintiles that the Company would not
offer for sale or issue to Quintiles the shares contemplated in the Third
Closing. Accordingly, the Company has no further right to request Quintiles
purchase shares of its common stock and Quintiles has no further obligation to
purchase such shares under the agreements.
Summary
of the stock sale transactions:
|
|
February
27, 2006
|
|
|
July
3, 2006
|
|
Capital
stock and additional paid-in capital
|
|
$ |
1,913,000 |
|
|
$ |
1,463,000 |
|
Accrued
transaction costs
|
|
|
87,000 |
|
|
|
37,000 |
|
Cash
proceeds
|
|
$ |
2,000,000 |
|
|
$ |
1,500,000 |
|
Accrued
transaction costs represent direct costs of the transaction (legal and
accounting fees) and are treated as reduction of additional paid-in
capital.
As part
of the transaction, the Company and Quintiles also entered into a Master
Services Agreement whereby Quintiles agreed to become the Company’s exclusive
contract research organization service provider for the Company’s Chrysalin
Product Platform and to provide certain other technical assistance. The Company
may enter into a variety of contracts over the five-year term of the agreement
as determined by the development and clinical progress of its Chrysalin
products. In return for this agreement, the Company has granted Quintiles the
right of first negotiation to promote Chrysalin with a specialty sales force
under a fee-for-service or risk-based structure. Additionally, the Company has
granted Quintiles warrants to purchase up to 240,000 shares of the Company’s
common stock, with the exercise price set at 115% of the Second Closing stock
price ($1.91). The shares will be exercisable for a ten-year period
from February 27, 2006 and the warrants will vest based on the achievement of
certain milestones (milestone warrants).
The total
cost of the milestone warrants will be charged to expense over the period of
performance. The costs will be determined based on the fair market value of the
milestone warrants determined by using the Black-Scholes model, revalued at each
Company reporting date until fully vested. The fair market value of
the milestone warrants using the Black-Scholes model, 58% volatility, 0%
dividend yield, expected term of 8.2 years, and 3.4% interest rate was $187,000
at December 31, 2007. No costs were charged to expense at December
31, 2007 as it is not yet probable that any milestone warrants will
vest.
F- 25