e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
|
|
|
þ |
|
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2009. |
or
|
|
|
o |
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition from to . |
Commission File Number: 333-82900
ThermoGenesis Corp.
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
94-3018487 |
(State of incorporation)
|
|
(I.R.S. Employer Identification No.) |
2711 Citrus Road
Rancho Cordova, California 95742
(Address of principal executive offices) (Zip Code)
(916) 858-5100
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or such shorter period that the
registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company þ |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
|
|
|
Class |
|
Outstanding at November 2, 2009 |
Common stock, $.001 par value
|
|
56,092,960 |
ThermoGenesis Corp.
INDEX
i
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ThermoGenesis Corp.
Condensed Consolidated Balance Sheets (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,743,000 |
|
|
$ |
6,655,000 |
|
Short-term investments |
|
|
10,377,000 |
|
|
|
8,976,000 |
|
Accounts receivable, net of allowance for
doubtful accounts of $34,000 ($26,000 at June 30, 2009) |
|
|
4,463,000 |
|
|
|
4,235,000 |
|
Inventories |
|
|
5,290,000 |
|
|
|
5,233,000 |
|
Prepaid expenses and other current assets |
|
|
403,000 |
|
|
|
662,000 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
23,276,000 |
|
|
|
25,761,000 |
|
|
|
|
|
|
|
|
|
|
Equipment at cost less accumulated depreciation of $3,427,000
($3,316,000 at June 30, 2009) |
|
|
1,903,000 |
|
|
|
1,784,000 |
|
Other assets |
|
|
108,000 |
|
|
|
110,000 |
|
|
|
|
|
|
|
|
|
|
$ |
25,287,000 |
|
|
$ |
27,655,000 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
1,567,000 |
|
|
$ |
1,781,000 |
|
Accrued payroll and related expenses |
|
|
672,000 |
|
|
|
881,000 |
|
Deferred revenue |
|
|
841,000 |
|
|
|
850,000 |
|
Other current liabilities |
|
|
1,562,000 |
|
|
|
1,326,000 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,642,000 |
|
|
|
4,838,000 |
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
218,000 |
|
|
|
363,000 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 2,000,000 shares authorized;
none outstanding |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 80,000,000 shares
authorized; 56,092,960 issued and outstanding
(56,092,960 at June 30, 2009) |
|
|
56,000 |
|
|
|
56,000 |
|
Paid in capital in excess of par |
|
|
120,919,000 |
|
|
|
120,757,000 |
|
Accumulated deficit |
|
|
(100,548,000 |
) |
|
|
(98,359,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
20,427,000 |
|
|
|
22,454,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
25,287,000 |
|
|
$ |
27,655,000 |
|
|
|
|
|
|
|
|
See accompanying notes.
Page 3
ThermoGenesis Corp.
Condensed Consolidated Statements of Operations (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
Net revenues |
|
$ |
5,193,000 |
|
|
$ |
4,502,000 |
|
Cost of revenues |
|
|
3,636,000 |
|
|
|
3,222,000 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,557,000 |
|
|
|
1,280,000 |
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
2,163,000 |
|
|
|
2,447,000 |
|
Research and development |
|
|
1,594,000 |
|
|
|
1,600,000 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
3,757,000 |
|
|
|
4,047,000 |
|
Interest and other income, net |
|
|
11,000 |
|
|
|
88,000 |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,189,000 |
) |
|
$ |
(2,679,000 |
) |
|
|
|
|
|
|
|
Per share data: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common
share |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
Shares used in computing per share data |
|
|
56,092,960 |
|
|
|
56,027,960 |
|
|
|
|
|
|
|
|
See accompanying notes.
Page 4
ThermoGenesis Corp.
Condensed Consolidated Statements of Cash Flows (Unaudited)
Three Months Ended September 30, 2009 and 2008
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,189,000 |
) |
|
$ |
(2,679,000 |
) |
Adjustments to reconcile net loss to net cash used
in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
111,000 |
|
|
|
120,000 |
|
Stock based compensation expense |
|
|
162,000 |
|
|
|
123,000 |
|
Loss on impairment of equipment |
|
|
26,000 |
|
|
|
|
|
Accretion of discount on short-term investments |
|
|
(1,000 |
) |
|
|
(76,000 |
) |
Net change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(228,000 |
) |
|
|
1,800,000 |
|
Inventories |
|
|
(57,000 |
) |
|
|
(856,000 |
) |
Prepaid expenses and other current assets |
|
|
259,000 |
|
|
|
1,000 |
|
Other assets |
|
|
2,000 |
|
|
|
6,000 |
|
Accounts payable |
|
|
(214,000 |
) |
|
|
(1,555,000 |
) |
Accrued payroll and related expenses |
|
|
(209,000 |
) |
|
|
(149,000 |
) |
Deferred revenue |
|
|
(154,000 |
) |
|
|
(240,000 |
) |
Other current liabilities |
|
|
237,000 |
|
|
|
569,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(2,255,000 |
) |
|
|
(2,936,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(256,000 |
) |
|
|
(105,000 |
) |
Purchase of investments |
|
|
(1,499,000 |
) |
|
|
(3,982,000 |
) |
Maturities of investments |
|
|
99,000 |
|
|
|
9,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(1,656,000 |
) |
|
|
4,913,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments on capital lease obligations |
|
|
(1,000 |
) |
|
|
(3,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(1,000 |
) |
|
|
(3,000 |
) |
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(3,912,000 |
) |
|
|
1,974,000 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
6,655,000 |
|
|
|
4,384,000 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
2,743,000 |
|
|
$ |
6,358,000 |
|
|
|
|
|
|
|
|
See accompanying notes.
Page 5
ThermoGenesis Corp.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation and Summary of Significant Accounting Policies
Organization and Basis of Presentation
ThermoGenesis Corp. (the Company) develops, manufactures, and sells medical products that enable
the practice of regenerative medicine. The Company was founded in 1986 and is located in Rancho
Cordova, California. Our products automate the volume reduction and cryopreservation process of
adult stem cell concentrate from cord blood and bone marrow for use in laboratory and point of care
settings.
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of the
parent company, ThermoGenesis, and its wholly-owned subsidiary, Vantus. All significant
intercompany balances and transactions have been eliminated in consolidation.
Interim Reporting
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States for interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
certain information and footnote disclosures normally included in annual financial statements
prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such Securities
and Exchange Commission (SEC) rules and regulations and accounting principles applicable for
interim periods. All sales, domestic and foreign, are denominated in U.S. dollars and, therefore,
currency fluctuations are believed to have no impact on the Companys net revenues. In the opinion
of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included. Operating results for the three month period ended September
30, 2009 are not necessarily indicative of the results that may be expected for the year ending
June 30, 2010. These unaudited condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and the notes thereto included in the Annual
Report on Form 10-K for the fiscal year ended June 30, 2009.
Revenue Recognition
The Company recognizes revenue including multiple element arrangements, in accordance with the
provisions of the SEC Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition and the
Financial Accounting Standards Boards (FASB) Emerging Issues Task Force (EITF) 00-21, Revenue
Agreements with Multiple Deliverables (EITF 00-21), as codified in the FASBs Accounting Standards
Codification (ASC) subtopic 605-25. Revenues from the sale of the Companys products are
recognized when persuasive evidence of an arrangement exists, delivery has occurred (or services
have been rendered), the price is fixed or determinable, and collectibility is reasonably assured.
The Company generally ships products F.O.B. shipping point. There is no conditional evaluation on
any product sold and recognized as revenue. All foreign sales are denominated in U.S. dollars.
Amounts billed in excess of revenue recognized are recorded as deferred revenue on the balance
sheet.
The Companys foreign sales are generally through distributors. There is no right of return
provided for distributors. For sales of products made to distributors, the Company considers a
number of factors in determining whether revenue is recognized upon transfer of title to the
distributor, or when payment is received. These factors include, but are not limited to, whether
the payment terms offered to the distributor are considered to be non-standard, the distributor
history of adhering to the terms of its contractual arrangements with the Company, the level of
inventories maintained by the distributor,
Page 6
whether the Company has a pattern of granting concessions for the benefit of the distributor, and
whether there are other conditions that may indicate that the sale to the distributor is not
substantive. The Company currently recognizes revenue primarily on the sell-in method with its
distributors.
Revenue arrangements with multiple elements are divided into separate units of accounting if
certain criteria are met, including whether the delivered item has value to the customer on a
stand-alone basis and whether there is objective and reliable evidence of the fair value of any
undelivered items. Revenue is recognized as specific elements indicated in sales contracts are
executed. If an element is essential to the functionality of an arrangement, the entire
arrangements revenue is deferred until that essential element is delivered. The fair value of
each undelivered element that is not essential to the functionality of the system is deferred until
performance or delivery occurs. The fair value of an undelivered element is based on vendor
specific objective evidence or third party evidence of fair value as appropriate. Costs associated
with inconsequential or perfunctory elements in multiple element arrangements are accrued at the
time of revenue recognition. The Company accounts for training and installation as a separate
element of a multiple element arrangement. The Company therefore recognizes the fair value of
training and installation services upon their completion when the Company is obligated to perform
such services.
Service revenue generated from contracts for providing maintenance of equipment is amortized over
the life of the agreement. All other service revenue is recognized at the time the service is
completed.
Milestone payments the Company receives under research and development arrangements are recognized
as revenue upon achievement of the milestone events, which represent the culmination of the
earnings process, and when collectibility is reasonably assured. Milestone payments are triggered
by the results of the Companys development efforts. Accordingly, the milestone payments are
substantially at risk at the inception of the contract, and the amounts of the payments assigned
thereto are commensurate with the milestone achieved. Upon the achievement of a milestone event,
which may include acceptance by the counterparty, the Company has no future performance obligations
related to that milestone as the milestone payments received by the Company are nonrefundable.
For licensing agreements pursuant to which the Company receives up-front licensing fees for
products or technologies that will be provided by the Company over the term of the arrangements,
the Company defers the up-front fees and recognizes the fees as revenue on a straight-line method
over the term of the respective license. For license agreements that require no continuing
performance on the Companys part, license fee revenue is recognized immediately upon grant of the
license.
Shipping and handling fees billed to customers are included in net revenues, while the related
costs are included in cost of revenues.
Fair Value of Financial Instruments
The carrying values of cash and cash equivalents, short term investments, accounts receivable,
accounts payable and accrued liabilities approximate fair value due to their short duration.
The Company adopted Statement of Financial Accounting Standard No. 157, Fair Value Measurements, as
codified in ASC subtopic 820-10 (ASC 820-10), effective July 1, 2008 for financial assets and
liabilities measured on a recurring basis. ASC 820-10 applies to all financial assets and
financial liabilities that are measured and reported on a fair value basis and requires disclosure
that establishes a framework for measuring fair value and expands disclosure about fair value
measurements. There was no impact for adoption of ASC 820-10 to the Companys consolidated
financial statements.
ASC 820-10 establishes a valuation hierarchy for disclosure of the inputs to valuation used to
measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows.
Level 1 inputs are
Page 7
quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs
are quoted prices for similar assets and liabilities in active markets or inputs that are
observable for the asset or liability, either directly or indirectly through market corroboration,
for substantially the full term of the financial instrument. Level 3 inputs are unobservable
inputs based on managements own assumptions used to measure assets and liabilities at fair value.
A financial asset or liabilitys classification within the hierarchy is determined based on the
lowest level input that is significant to the fair value measurement. The Company has no Level 3
financial assets or liabilities as of September 30, 2009.
Assets measured at fair value on a recurring basis include the following as of September 30,
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at |
|
|
|
|
September 30, 2009 Using |
|
|
|
|
|
|
|
|
Significant |
|
|
|
|
Quoted Prices |
|
Other |
|
Total Fair |
|
|
in Active |
|
Observable |
|
Value as of |
|
|
Markets |
|
Inputs |
|
September 30, |
|
|
(Level 1) |
|
(Level 2) |
|
2009 |
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
1,059,000 |
|
|
|
|
|
|
$ |
1,059,000 |
|
Certificates of deposit |
|
|
|
|
|
$ |
500,000 |
|
|
$ |
500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
|
|
|
$ |
10,377,000 |
|
|
$ |
10,377,000 |
|
Segment Reporting
The Company operates in a single segment providing medical devices and disposables to hospitals and
blood banks throughout the world which utilize the equipment to process blood components.
Net Loss per Share
Net loss per share is computed by dividing the net loss to common stockholders by the weighted
average number of common shares outstanding. The calculation of the
basic and diluted net loss per
share is the same for all periods presented, as the effect of the potential common stock
equivalents is anti-dilutive due to the Companys net loss position for all periods presented.
Anti-dilutive securities, which consist of stock options and common stock restricted awards that
were not included in diluted net loss per common share were 3,720,296 and 3,124,437 as of September
30, 2009 and 2008, respectively.
Subsequent Events
The Company has evaluated its subsequent events through November 6, 2009, the filing date of the
Companys Quarterly Report on Form 10-Q for the period ended September 30, 2009.
Reclassifications
Certain amounts in the prior years financial statements have been reclassified to conform with the
2010 presentation.
Recent Accounting Pronouncements
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, as codified in ASC topic 808 (ASC 808). ASC 808 defines collaborative arrangements
and establishes reporting requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangement and third parties. ASC 808 also
establishes the
Page 8
appropriate income statement presentation and classification for joint operating activities and
payments between participants, as well as the sufficiency of the disclosures related to these
arrangements. EITF 07-1 is effective for fiscal years beginning after December 15, 2008. ASC 808
shall be applied retrospectively to all prior periods presented for all collaborative arrangements
existing as of the effective date. The adoption of ASC 808 did not have a material impact on the
Companys results of operations or financial condition.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, as codified in ASC topic
805 (ASC 805). The statement retains the purchase method of accounting for acquisitions, but
requires a number of changes, including changes in the way assets and liabilities are recognized in
the purchase accounting. It also changes the recognition of assets acquired and liabilities
assumed arising from contingencies, requires the capitalization of in-process research and
development at fair value and requires the expensing of acquisition-related costs as incurred. ASC
805 is effective for business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December 15, 2008. The
Company will assess the potential impact of the adoption of ASC 805 if and when a future
acquisition occurs.
In April
2009, the FASB issued ASC 825-10-65-1 Financial Instruments (formerly FASB Staff Position No. FAS 107-1 and APB
28-1 (FSP 107-1), Interim Disclosures about Fair Value of
Financial Instruments). ASC 825-10-65-1 requires disclosures
about fair values of financial instruments for interim perioids of
publicly traded companies. These disclosures include fair value
methods and significant assumptions used. The adoption of ASC
825-10-65-1 did not have a material impact on the Companys
results of operations or financial condition.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principlesa replacement of FASB Statement No. 162, as
codified in FASB ASC topic 105, Generally Accepted Accounting Principles (ASC 105). The statement
confirmed that the FASB Accounting Standards Codification (the Codification) will become the
single official source of authoritative U.S. GAAP (other than guidance issued by the Securities and
Exchange Commission (the SEC), superseding existing FASB, American Institute of Certified Public
Accountants, EITF, and related literature. After that date, only one level of authoritative U.S.
GAAP will exist. All other literature will be considered non-authoritative. The Codification does
not change U.S. GAAP; instead, it introduces a new structure that is organized in an easily
accessible, user-friendly online research system. The Codification, which changes the referencing
of financial standards, becomes effective for interim and annual periods ending on or after
September 15, 2009. The adoption of ASC 105 did not have a
material impact on the Companys results of operations or
financial condition.
In September 2009, the EITF reached final consensus on a new revenue recognition standard, Issue
No. 09-3, Applicability of AICPA Statement of Position 97-2 to Certain Arrangements That Contain
Software Elements (ASU 985). ASU 985 amends the scope of AICPA Statement of Position 97-2,
Software Revenue Recognition to exclude tangible products that include software and non-software
components that function together to deliver the products essential functionality. This Issue
shall be applied on a prospective basis for revenue arrangements entered into or materially
modified in fiscal years beginning on or after June 15, 2010.
Early adoption is permitted, provided that the guidance is retroactively applied at the beginning of the year of adoption.
We are currently evaluating the
potential impact of ASU 985 on the Companys results of operations or
financial condition.
In October
2009, FASB issued Accounting Standards Update (ASU) No. 2009-13,
Revenue Recognition (Topic 605): Multiple-Deliverable Revenue
Arrangements a consensus of the FASB Emerging Issues Task
Force (ASU 2009-13). ASU 2009-13 addresses the accounting for
multiple-deliverable arrangements to enable vendors to account for
products or services separately rather than as a combined unit and
modifies the manner in which the transaction consideration is
allocated across the separately identified deliverables. ASU 2009-13
significantly expands the disclosure requirements for
multiple-deliverable revenue arrangements. ASU 2009-13 will be
effective for the first annual reporting period beginning on or after
June 15, 2010, and may be applied retrospectively for all periods
presented or prospectively to arrangements entered into or materially
modified after the adoption date. Early adoption is permitted,
provided that the guidance is retroactively applied to the beginning
of the year of adoption. We are currently evaluating the impact this
update will have on the Companys results of operations or
financial condition.
Page 9
2. Investments
The Company intends and has the ability to hold its Certificates of deposit to maturity, and
therefore classifies its investments as held-to-maturity and carries such investments at amortized
cost in accordance with the provisions of Financial Accounting Standards No. 115, Accounting for
Certain Investments in Debt and Equity Securities, as codified in ASC topic 320, Investments-Debt
and Equity Securities (ASC 320).
The following is a summary of held-to-maturity securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
$ |
10,377,000 |
|
|
|
|
|
|
|
|
|
|
$ |
10,377,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturity Date: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 90 days |
|
$ |
8,877,000 |
|
|
|
|
|
|
|
|
|
|
$ |
8,878,000 |
|
Due in 91-365 days |
|
|
1,499,000 |
|
|
|
|
|
|
|
|
|
|
|
1,499,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,376,000 |
|
|
|
|
|
|
|
|
|
|
$ |
10,377,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
$ |
8,976,000 |
|
|
|
|
|
|
|
|
|
|
$ |
8,976,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. Inventories
Inventories consisted of the following at:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009 |
|
|
June 30, 2009 |
|
Raw materials |
|
$ |
1,278,000 |
|
|
$ |
1,116,000 |
|
Work in process |
|
|
2,279,000 |
|
|
|
1,871,000 |
|
Finished goods |
|
|
1,733,000 |
|
|
|
2,246,000 |
|
|
|
|
|
|
|
|
|
|
$ |
5,290,000 |
|
|
$ |
5,233,000 |
|
|
|
|
|
|
|
|
4. Commitments and Contingencies
Vendor Purchase Commitments
A product manufacturing supplier made purchases of raw materials based on company provided
forecasts, which the Company may be required to pay for as part of normal manufacturing processes,
including scrap and obsolete parts that result from the Companys product design changes, and or
discontinuation of manufacturing by a particular vendor. These are normal and standard
manufacturing terms, and upon the contract end date, May 2009, the Company recorded an estimated
loss contingency of $160,000 as management considers it probable that the payment will be made.
The
Company has initiated discussions with a product manufacturing supplier (Supplier) regarding a mutual
termination of their contract manufacturing and supply agreement, primarily due to quality issues.
The Supplier is currently on hold, but has likely incurred some costs under existing purchase orders.
As part of the termination discussions, the Company anticipates that
the Supplier will seek reimbursement
for their costs incurred to fulfill the purchase orders and the Company intends to seek reimbursement for
our costs incurred
Page 10
due to
past quality issues and returned product from customers. Additionally, the Company intends to sell
inventory, if any, which it agrees to purchase from the Supplier to other suppliers as an additional cost
offset. The Company has determined the contract termination is probable and the range of loss is
between $0 and $650,000. However, the Company has not recorded an
expense related to the potential termination because any potential
loss is not reasonably estimable under SFAS No. 5 Accounting
for Contingencies, as codified in ASC 450.
Warranty
The Company offers a one-year warranty on all of its products. The Company warrants disposable
products through their expiration date. The Company periodically assesses the adequacy of its
recorded warranty liabilities and adjusts the amounts as necessary.
Changes in the Companys product liability during the period are as follows:
|
|
|
|
|
July 1, 2009 balance |
|
$ |
529,000 |
|
Warranties issued during the period |
|
|
46,000 |
|
Settlements made during the period |
|
|
(60,000 |
) |
Changes in liability for pre-existing warranties during the
period, including expirations |
|
|
313,000 |
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
828,000 |
|
|
|
|
|
As a
result of various quality issues experienced by high usage customers
of the AXP disposable bag sets, the Company made revisions to its
estimated warranty liability for the three month period ended
September 30, 2009. The Company recorded a change in estimate, which
increased the Companys cost of revenues and net loss (no net
loss per share impact) by $190,000.
As a
result of a product recall in the second quarter of fiscal 2009, the
Company made revisions to its estimated warranty liability for the
three months ended September 30, 2008. The Company recorded a change
in estimate, which increased the Companys cost of revenues and
net loss by $520,000 and net loss per share of $0.01.
5. Stockholders Equity
Stock Based Compensation
The Company recorded stock-based compensation of $162,000 and $123,000 for the three months ended
September 30, 2009 and 2008, respectively.
The following is a summary of option activity for the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Life |
|
|
Value |
|
|
|
|
|
|
Outstanding at June 30, 2009 |
|
|
3,079,641 |
|
|
$ |
1.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
860,000 |
|
|
$ |
0.64 |
|
|
|
|
|
|
|
|
|
Forfeited or Expired |
|
|
(238,845 |
) |
|
$ |
2.16 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009 |
|
|
3,700,796 |
|
|
$ |
1.38 |
|
|
|
3.1 |
|
|
$ |
32,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Expected to Vest at
September 30, 2009 |
|
|
3,336,640 |
|
|
$ |
1.44 |
|
|
|
3.1 |
|
|
$ |
27,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2009 |
|
|
887,944 |
|
|
$ |
2.96 |
|
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value is calculated as the difference between the exercise price of
the underlying awards and the quoted price of the Companys common stock. There were no options
exercised during the three months ended September 30, 2009 and 2008.
Page 11
6. Subsequent Event
In
October 2009, the Company and a consultant, the Companys
former Chief Technology Architect (Consultant),
entered into a Mutual Termination Agreement (the Agreement) to terminate their consulting agreement
effective October 1, 2009. Under the terms of the Agreement, the Company shall pay $104,000 in
October 2009 and $136,000 in January 2010. As there is no further obligation for the Consultant to
perform under the Agreement, the entire $240,000 was expensed in October 2009.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking Statements
This report contains forward-looking statements. The forward-looking statements
involve risks and uncertainties that could cause actual results to differ materially from the
forward-looking statements. When used in this report, the words anticipate, believe,
estimate, expect and similar expressions as they relate to the Company or its management are
intended to identify such forward-looking statements. The Companys actual results, performance or
achievements could differ materially from the results expressed in, or implied by these
forward-looking statements. The Company wishes to caution readers of the important factors, among
others, that in some cases have affected, and in the future could affect the Companys actual
results and could cause actual results for fiscal year 2010, and beyond, to differ materially from
those expressed in any forward-looking statements made by, or on behalf of, the Company. These
factors include without limitation, the ability to obtain capital and other financing in the
amounts and at the times needed to complete clinical trials and product marketing for new products,
market acceptance of new products, regulatory approval and time frames for such approval of new
products and new claims for existing products, realization of forecasted income and expenses,
initiatives by competitors, price pressures, failure to meet FDA
regulations governing our products and operations and recalls
associated with such regulations, the risks associated with initiating manufacturing for
new products, and the risk factors listed from time to time in the Companys SEC reports,
including, in particular, the factors and discussion in the Companys Form 10-K for its last fiscal
year.
Overview
ThermoGenesis develops, manufactures, and sells medical products that enable the practice of
regenerative medicine. The Company was founded in 1986 and is located in Rancho Cordova,
California. Our products automate the volume reduction and cryopreservation process of adult
stem cell concentrates from cord blood and bone marrow for use in laboratory and point of care
settings. Our growth strategy is to expand our offerings in regenerative medicine and partner with
other pioneers in the stem cell arena to accelerate our worldwide penetration in this potentially
explosive market.
Our Products
The AutoXpress Platform or AXP® is a medical device with an accompanying disposable bag
set that isolates and retrieves stem cells from umbilical cord blood. The AXP provides cord blood
banks with a system to isolate and capture adult stem cells with lower labor costs and a reduced
risk of contamination, under GMPs. Our market for the AXP includes both private and public cord
blood banks. At a private bank, an individual pays to have cord blood stem cells from their
offspring collected and stored, while a public bank owns cord blood stem cells donated by
individuals, which are then available to the public for transplantation. The product is an
automated, closed, sterile system that volume-reduces cord blood to a user defined volume in 30
minutes, able to retain over 97% of the mononuclear cells. Self-powered and
microprocessor-controlled, the AXP contains flow control optical sensors which achieve precise
separation.
Page 12
The MarrowXpress or MXP, an extension of the AXP, defines a new processing standard for
isolating and retrieving stem cells from bone marrow aspirate. It is an automated, closed, sterile
system that volume-reduces blood to a user-defined volume while retaining over 90% of the
mononuclear cells. Self-powered and microprocessor-controlled, the MarrowXpress Platform contains
flow control optical sensors which achieve precise separation. In June 2008, we received the
CE-Mark, enabling commercial sales in Europe. In July 2008, we received authorization from the FDA
to begin marketing the MXP for use in the clinical laboratory or intraoperatively at the
point-of-care for preparation of a cell concentrate from bone marrow. In September 2008, the
Company announced an agreement with Celling Technologies, a subsidiary of Spine-Smith, LLC, to
distribute the MXP for orthopedic applications. The product was launched in December 2008.
The Res-Q product is also used for bone marrow stem cell processing. Launched in July 2009, the
Res-Q can be used in a clinical laboratory or can be used inter-operatively at the point of care.
The technology is a next generation, centrifuge-based disposable device designed for the isolation
and extraction of specific stem cell populations at the point of care. Res-Q is a rapid, reliable,
and easier-to-use product which achieves a high recovery rate of stem cells from bone marrow.
The key advantages of the Res-Q include (a) delivering a high number of target cells from a small
sample of bone marrow, and (b) providing a disposable that is highly portable and packaged for the
sterile field. These features allow the physician to process bone marrow and return the cells to
the patient in as little as 15 minutes. As cell processing for regenerative medicine applications
becomes more readily accepted, we believe the features and benefits of the Res-Q position the
product for broad-based adoption.
The BioArchive® System is an automated cryogenic system used in stem
cell therapy to cryopreserve and archive stem cells for future transplant and treatment. Launched
in fiscal 1998, over 200 BioArchive Systems have been purchased by over 90 umbilical cord blood
stem cell banks in over 30 countries worldwide to archive, cryopreserve and store stem cell
preparations extracted from human placentas and umbilical cords for future use. The BioArchive
System can store over 3,600 stem cell samples. It is the only fully-automated system commercially
available that integrates controlled-rate freezing, sample management and long term cryogenic
storage in liquid nitrogen. The robotic storage and retrieval of these stem cell units improves
cell viability, provides precise inventory management and minimizes the possibility of human error.
The Thermoline product line includes the ultra-rapid plasma Thermoline Freezer and ultra-rapid
plasma Thermoline Thawer. The Thermoline freezer optimizes plasma freezing through its unique
liquid heat transfer and uniform freezing technologies that can freeze units of blood plasma in
approximately 30 minutes. These products are suited for medium to large laboratories. We also
offer three models of blood components thawers which vary primarily by capacity. The products
unique flexible membrane technology allows for a closed thawing system. These instruments can be
used for rapid (less than 12 minutes) homogeneous thawing of plasma and glycerolized frozen red
blood cells.
The CryoSeal® Fibrin Sealant (CryoSeal) System is an automated system used to prepare an
autologous hemostatic surgical sealant from a patients own blood or from a single donor in
approximately one hour. We received FDA approval to market the CryoSeal in liver resection
surgeries in July 2007. The CryoSeal serves the wound care market. Our intention is to divest
this product line in fiscal 2010.
The following is Managements discussion and analysis of certain significant factors which have
affected the Companys financial condition and results of operations during the period included in
the accompanying consolidated financial statements.
Page 13
Critical Accounting Policies
Managements discussion and analysis of its financial condition and results of operations are based
upon the Companys condensed consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States. The preparation of
these consolidated financial statements requires the Company to make estimates and judgments that
affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of
contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates,
including those related to bad debts, inventories, warranties, contingencies and litigation. The
Company bases its estimates on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or
conditions. For a full discussion of our accounting estimates and assumptions that the Company has
identified as critical in the preparation of our condensed consolidated financial statements,
please refer to our 2009 Annual Report on Form 10-K.
Results of Operations for the Three Months Ended September 30, 2009 as Compared to the Three Months
Ended September 30, 2008
Net Revenues:
Revenues for the three months ended September 30, 2009 were $5,193,000 compared to $4,502,000 for
the three months ended September 30, 2008, an increase of $691,000 or 15%. The increase is
primarily due to revenues of $470,000 from the MXP product line which was launched in December 2008
and an increase in AXP disposable revenues of $460,000 due to volume increases. The increases were
offset by a decline in Thermoline Freezer revenues of $330,000.
The following represents the Companys revenues for disposables by product line for the three
months ended:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
AXP |
|
$ |
1,626,000 |
|
|
$ |
1,166,000 |
|
BioArchive |
|
|
994,000 |
|
|
|
850,000 |
|
MXP/Res-Q |
|
|
330,000 |
|
|
|
|
|
CryoSeal |
|
|
80,000 |
|
|
|
83,000 |
|
|
|
|
|
|
|
|
|
|
$ |
3,030,000 |
|
|
$ |
2,099,000 |
|
|
|
|
|
|
|
|
Percentage of total
Company revenues |
|
|
58 |
% |
|
|
47 |
% |
|
|
|
|
|
|
|
The following represents the Companys cumulative BioArchive devices sold into the following
geographies through the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2009 |
|
2008 |
Asia |
|
|
66 |
|
|
|
62 |
|
United States |
|
|
50 |
|
|
|
48 |
|
Europe |
|
|
51 |
|
|
|
47 |
|
Rest of World |
|
|
39 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
206 |
|
|
|
187 |
|
|
|
|
|
|
|
|
|
|
Page 14
Gross Profit:
The Companys gross profit was $1,557,000 or 30% of net revenues for the three months ended
September 30, 2009, as compared to $1,280,000 or 28% for the corresponding fiscal 2009 period. The
increase in gross profit is primarily due to the $520,000 accrual for the voluntary recall of AXP
bag sets in the quarter ended September 30, 2008, offset by an increase in warranty for BioArchive
devices and AXP disposables.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $2,163,000 for the three months ended September
30, 2009, compared to $2,447,000 for the comparable fiscal 2009 period, a decrease of $284,000 or
12%. The decrease is primarily due to lower salaries and benefits of $220,000 as there were five
fewer positions employed during the quarter ended September 30, 2009 as compared to the quarter
ended September 30, 2008.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses were $1,594,000 for the three months ended September 30, 2009,
compared to $1,600,000 for the corresponding fiscal 2009 period, a decrease of $6,000. Spending in
research and development has remained consistent as the increase in costs to complete development
of the Res-Q product, $260,000, was offset by a decrease in costs associated with the Vantus
subsidiary during the three months ended September 30, 2008.
Liquidity and Capital Resources
At September 30, 2009, the Company had cash, cash equivalents and short-term investments of
$13,120,000 and working capital of $18,634,000. This compares to cash, cash equivalents and
short-term investments of $15,631,000 and working capital of $20,923,000 at June 30, 2009. The
cash was used to fund operations, capital expenditures and other strategic initiatives of the
Company. In addition to product revenues, the Company has primarily financed operations through
the private and public placement of equity securities and has raised approximately $108,000,000,
net of expenses, through common and preferred stock financings and option and warrant exercises.
Net cash used in operating activities for the three months ended September 30, 2009 was $2,255,000,
primarily due to the net loss of $2,189,000, offset by depreciation and stock based compensation
expense of $111,000 and $162,000, respectively. Accounts receivable utilized $228,000 of cash as a
result of higher sales during the current quarter versus the prior quarter. Other current
liabilities generated $237,000 in cash for the quarter ended September 30, 2009.
We believe that our currently available cash, cash equivalents and short-term investments, will be
sufficient to satisfy our operating and working capital requirements for at least the next twelve
months. We have experienced some slowing in our customers spending as a result of deterioration
in credit markets. As we anticipate this trend to continue, we have reduced expenses without
sacrificing development plans we consider essential to our near term revenue growth and do not
anticipate we will have to seek additional debt or equity capital.
Off-Balance Sheet Arrangements
As of September 30, 2009, the Company has no off-balance sheet arrangements.
Backlog
The Companys cancelable backlog at September 30, 2009 was $895,000.
Page 15
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Market risk represents the risk of changes in the value of market risk sensitive instruments caused
by fluctuations in interest rates, foreign exchange rates and commodity prices. There have been no
material changes in the Companys exposure to market risk since the 2009 fiscal year end.
Our exposure to interest rate risk at September 30, 2009 is related to the investment of our excess
cash into highly liquid, short-term financial investments. We invest in money market funds,
certificates of deposit or U.S. Treasury obligations in accordance with our investment policy. The
primary objectives of our investment policy are to preserve principal, maintain proper liquidity to
meet operating needs and maximize yields. Our investment policy specifies credit quality standards
for our investments. We do not hold auction-rate or mortgage-backed securities. Due to the
short-term nature of our investments, we have assessed that there is no material exposure to
interest rate risk arising from them.
All sales, including those involving foreign entities, are denominated in U.S. dollars and as a
result, we have experienced no significant foreign exchange gains and losses to date. We have not
engaged in foreign currency hedging activities to date, and have no intention of doing so. Our
future revenues may be negatively impacted in periods of a strengthening U.S. dollar. We have not
entered into any derivative financial instruments or derivative commodity instruments.
Item 4. Controls and Procedures
The Company carried out an evaluation, under the supervision and with the participation of the
Companys management, including the Companys Principal Executive Officer along with the Companys
Principal Financial Officer, of the effectiveness of the design and operation of the Companys
disclosure controls and procedures (as defined by Exchange Act Rule 13a-15(e) and 15d-15(e)) as of
the end of our fiscal quarter pursuant to Exchange Act Rule 13a-15. Based upon that evaluation, the
Companys Chief Executive Officer and Chief Financial Officer concluded that the Companys
disclosure controls and procedures are effective.
There were no changes in the Companys internal controls over financial reporting that occurred
during the three months ended September 30, 2009 that have materially affected, or are reasonably
likely to materially affect, its internal controls over financial reporting. The Company believes
that a control system, no matter how well designed and operated, cannot provide absolute assurance
that the objectives of the control system are met, and no evaluation of controls can provide
absolute assurance that all control issues and instances of fraud, if any, within any company have
been detected.
Page 16
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
In the normal course of operations, the Company may have disagreements or disputes
with distributors, vendors or employees. Such potential disputes are seen by the Companys
management as a normal part of business.
There
are currently no pending actions
nor any threatened actions that management believes would have a significant
material impact on the Companys financial position, results of operations or cash
flows.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully
consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual
Report on Form 10-K for the year ended June 30, 2009, which could materially affect
our business, financial condition or future results. There have been no material
changes from those risk factors. The risks described in our Annual Report on Form
10-K are not the only risks facing our Company. Additional risks and uncertainties
not currently known to us or that we currently deem to be immaterial also may
materially adversely affect our business, financial condition and/or operating
results.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
None.
Item 5. Other Information.
None.
Item 6. Exhibits:
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
Certification by the Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
Certification by the Principal Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
|
|
|
|
32 |
|
|
Certification of Principal Executive Officer and Principal
Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002. |
Page 17
ThermoGenesis Corp.
Signatures
Pursuant to the requirements 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.
|
|
|
|
|
|
ThermoGenesis Corp.
(Registrant)
|
|
Dated: November 5, 2009 |
/s/ J. Melville Engle
|
|
|
J. Melville Engle |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Dated: November 5, 2009 |
/s/ Matthew T. Plavan
|
|
|
Matthew T. Plavan |
|
|
Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer) |
|
Page 18