ThermoGenesis Holdings, Inc. - Quarter Report: 2010 March (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 March 31, 2010. |
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)
Rancho Cordova, California 95742
(Address of principal executive offices) (Zip Code)
(916) 858-5100
(Registrants telephone number, including area code)
(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 definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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 May 3, 2010 | |
Common stock, $.001 par value | 56,092,960 |
Table of Contents
PART I FINANCIAL INFORMATION
Item 1. | Financial Statements |
ThermoGenesis Corp.
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
March 31, | June 30, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 5,134,000 | $ | 6,655,000 | ||||
Short-term investments |
4,992,000 | 8,976,000 | ||||||
Accounts receivable, net of allowance for
doubtful accounts of $55,000 ($26,000 at June 30, 2009) |
5,080,000 | 4,235,000 | ||||||
Inventories |
5,459,000 | 5,233,000 | ||||||
Prepaid expenses and other current assets |
208,000 | 662,000 | ||||||
Total current assets |
20,873,000 | 25,761,000 | ||||||
Equipment at cost less accumulated depreciation of $3,677,000
($3,316,000 at June 30, 2009) |
1,831,000 | 1,784,000 | ||||||
Other assets |
188,000 | 110,000 | ||||||
$ | 22,892,000 | $ | 27,655,000 | |||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,290,000 | $ | 1,781,000 | ||||
Accrued payroll and related expenses |
444,000 | 881,000 | ||||||
Deferred revenue |
702,000 | 850,000 | ||||||
Other current liabilities |
1,571,000 | 1,326,000 | ||||||
Total current liabilities |
5,007,000 | 4,838,000 | ||||||
Deferred revenue |
34,000 | 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 |
121,176,000 | 120,757,000 | ||||||
Accumulated deficit |
(103,381,000 | ) | (98,359,000 | ) | ||||
Total stockholders equity |
17,851,000 | 22,454,000 | ||||||
$ | 22,892,000 | $ | 27,655,000 | |||||
See accompanying notes.
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ThermoGenesis Corp.
Condensed Consolidated Statements of Operations (Unaudited)
Condensed Consolidated Statements of Operations (Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Net revenues |
$ | 4,764,000 | $ | 5,148,000 | $ | 15,912,000 | $ | 15,776,000 | ||||||||
Cost of revenues |
3,363,000 | 3,354,000 | 10,943,000 | 10,489,000 | ||||||||||||
Gross profit |
1,401,000 | 1,794,000 | 4,969,000 | 5,287,000 | ||||||||||||
Expenses: |
||||||||||||||||
Selling, general and administrative |
1,722,000 | 1,917,000 | 5,975,000 | 7,037,000 | ||||||||||||
Research and development |
1,080,000 | 1,018,000 | 4,074,000 | 3,916,000 | ||||||||||||
Total operating expenses |
2,802,000 | 2,935,000 | 10,049,000 | 10,953,000 | ||||||||||||
Interest and other income, net |
36,000 | 49,000 | 58,000 | 200,000 | ||||||||||||
Net loss |
($1,365,000 | ) | ($1,092,000 | ) | ($5,022,000 | ) | ($5,466,000 | ) | ||||||||
Per share data: |
||||||||||||||||
Basic and diluted net loss per common
share |
($0.02 | ) | ($0.02 | ) | ($0.09 | ) | ($0.10 | ) | ||||||||
Shares used in computing per share data |
56,092,960 | 56,092,960 | 56,092,960 | 56,049,627 | ||||||||||||
See accompanying notes.
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ThermoGenesis Corp.
Condensed Consolidated Statements of Cash Flows (Unaudited)
Nine Months Ended March 31, 2010 and 2009
Condensed Consolidated Statements of Cash Flows (Unaudited)
Nine Months Ended March 31, 2010 and 2009
2010 | 2009 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
($5,022,000 | ) | ($5,466,000 | ) | ||||
Adjustments to reconcile net loss to net cash used
in operating activities: |
||||||||
Depreciation and amortization |
361,000 | 362,000 | ||||||
Stock based compensation expense |
419,000 | 370,000 | ||||||
Loss on impairment of equipment |
26,000 | | ||||||
Accretion of discount on short-term investments |
(2,000 | ) | (157,000 | ) | ||||
Net change in operating assets and liabilities: |
||||||||
Accounts receivable, net |
(782,000 | ) | 1,027,000 | |||||
Inventories |
(391,000 | ) | (470,000 | ) | ||||
Prepaid expenses and other current assets |
454,000 | 76,000 | ||||||
Other assets |
59,000 | (447,000 | ) | |||||
Accounts payable |
509,000 | (2,221,000 | ) | |||||
Accrued payroll and related expenses |
(437,000 | ) | 133,000 | |||||
Deferred revenue |
(477,000 | ) | (503,000 | ) | ||||
Other current liabilities |
248,000 | (123,000 | ) | |||||
Net cash used in operating activities |
(5,035,000 | ) | (7,419,000 | ) | ||||
Cash flows from investing activities: |
||||||||
Capital expenditures |
(469,000 | ) | (341,000 | ) | ||||
Purchase of investments |
(6,741,000 | ) | (16,981,000 | ) | ||||
Maturities of investments |
10,727,000 | 27,000,000 | ||||||
Net cash provided by investing activities |
3,517,000 | 9,678,000 | ||||||
Cash flows from financing activities: |
||||||||
Payments on capital lease obligations |
(3,000 | ) | (11,000 | ) | ||||
Net cash used in financing activities |
(3,000 | ) | (11,000 | ) | ||||
Net (decrease)increase in cash and cash equivalents |
(1,521,000 | ) | 2,248,000 | |||||
Cash and cash equivalents at beginning of period |
6,655,000 | 4,384,000 | ||||||
Cash and cash equivalents at end of period |
$ | 5,134,000 | $ | 6,632,000 | ||||
Supplemental non-cash flow information: |
||||||||
Transfer of equipment to other assets |
$ | 137,000 | $ | 51,000 | ||||
Transfer of equipment to receivables |
$ | 63,000 | | |||||
Transfer of inventories to equipment |
$ | 165,000 | | |||||
See accompanying notes.
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ThermoGenesis Corp.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 Corp., 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. In the opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included. Events subsequent
to the balance sheet date have been evaluated for inclusion in the accompanying condensed
consolidated financial statements through the date of issuance. Operating results for the
nine month period ended March 31, 2010 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,
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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 measures fair value in accordance with the provisions in Statement of Financial
Accounting Standard (SFAS) No. 157, Fair Value Measurements, as codified in ASC subtopic 820-10
(ASC 820-10). 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 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 assets or liabilitys
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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 March 31, 2010.
Assets measured at fair value on a recurring basis include the following as of March 31, 2010:
Fair Value Measurements at | ||||||||||||
March 31, 2010 Using | ||||||||||||
Significant | ||||||||||||
Quoted Prices | Other | Total Fair | ||||||||||
in Active | Observable | Value as of | ||||||||||
Markets | Inputs | March 31, | ||||||||||
(Level 1) | (Level 2) | 2010 | ||||||||||
Cash equivalents Money market funds |
$ | 1,059,000 | | $ | 1,059,000 | |||||||
Short-term investments Certificates of deposit |
| $ | 4,992,000 | $ | 4,992,000 |
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 3,917,619 and 3,653,106 as of March 31,
2010 and 2009, respectively.
Reclassifications
Certain amounts in the prior years financial statements have been reclassified to conform to the
2010 presentation.
Recently Adopted 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 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. ASC 808 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
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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 Staff Position No. FAS 107-1 and APB 28-1, Interim Disclosures
about Fair Value of Financial Instruments, as codified in ASC subtopic 825-10-65-1. ASC
825-10-65-1 requires disclosures about fair values of financial instruments for interim periods 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 January 2010, the FASB issued ASU No. 2010-06, Fair Value Measurements and Disclosures (Topic
820) Improving Disclosures about Fair Value Measurements (ASU 2010-06). ASU 2010-06 amends ASC
Topic 820, Fair Value Measurements and Disclosures (ASC 820) to require additional disclosures
regarding fair value measurements. Specifically, ASU 2010-06 requires entities to disclose
additional information regarding (i) the reconciliation of recurring Level 3 measurements about
purchases, sales, issuances and settlements on a gross basis, (ii) the amounts of significant
transfers between Level 1 and Level 2 of the fair value hierarchy and the reasons for these
transfers and (iii) the reasons for any transfers in or out of Level 3. In addition to these new
disclosure requirements, ASU 2010-06 also amends ASC 820 to further clarify existing guidance
pertaining to the level of disaggregation at which fair value disclosures should be made and the
requirements to disclose information about the valuation techniques and inputs used in estimating
Level 2 and Level 3 fair value measurements. Our adoption of the requirements of this guidance
on January 1, 2010, except for the requirement to separately disclose information about purchases,
sales, issuances, and settlements in the reconciliation of recurring Level 3 measurements on a
gross basis which becomes effective for fiscal years (and interim periods within those fiscal
years) beginning after December 15, 2010, did not have a material impact on the Companys results
of operations or financial condition.
In February 2010, the FASB issued ASU No. 2010-09, Subsequent Events (Topic 855) Amendments to
Certain Recognition and Disclosure Requirements (ASU 2010-09). ASU 2010-09 amends ASC Topic 855 to
remove the requirement for an SEC filer to disclose the date through which subsequent events have
been evaluated both in issued and revised financial statements. ASU 2010-09 was effective
immediately. The adoption of ASU 2010-09 did not have a material impact on the Companys results
of operations or financial condition.
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Recently Issued Accounting Pronouncements
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, as codified in FASB Accounting Standards Update (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. The Company is currently evaluating the potential impact of ASU
985 on the Companys results of operations or financial condition.
In October 2009, the FASB issued EITF 08-1, Revenue Arrangements with Multiple Deliverables,
which is also known as Accounting Standards Update (ASU) No. 2009-13, Revenue Recognition (Topic
605): Multiple-Deliverable Revenue Arrangements (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. The Company
is currently evaluating the potential impact of ASU 2009-13 on the Companys results of operations or financial condition.
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 | |||||||||||||
March 31, 2010 Certificates of deposit |
$ | 4,992,000 | | | $ | 4,992,000 | ||||||||||
Maturity Date: Less than 90 days |
$ | 4,992,000 | $ | 4,992,000 | ||||||||||||
June 30, 2009 Certificates of deposit |
$ | 8,976,000 | | | $ | 8,976,000 | ||||||||||
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3. Inventories
Inventories consisted of the following at:
March 31, 2010 | June 30, 2009 | |||||||
Raw materials |
$ | 1,430,000 | $ | 1,116,000 | ||||
Work in process |
1,300,000 | 1,871,000 | ||||||
Finished goods |
2,729,000 | 2,246,000 | ||||||
$ | 5,459,000 | $ | 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
various manufacturing and quality issues. The Supplier was instructed to suspend production, but
has incurred some costs under existing purchase orders. The parties have reached a tentative
settlement in which the Company has agreed to pay the Supplier $58,000. Accordingly, the Company
recorded an estimated loss contingency of $58,000 during the quarter ended December 31, 2009 as
management considers it probable that the payment will be made.
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 |
154,000 | |||
Settlements made during the period |
(157,000 | ) | ||
Changes in liability for pre-existing warranties during the
period, including expirations |
359,000 | |||
Balance at March 31, 2010 |
$ | 885,000 | ||
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. There was no change in
estimate for the quarter ended March 31, 2010.
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5. Stockholders Equity
Stock Based Compensation
The Company recorded stock-based compensation of $120,000 and $419,000 for the three and nine
months ended March 31, 2010 and $142,000 and $370,000 for the three and nine months ended March 31,
2009.
The following is a summary of option activity for the Companys stock option plans:
Weighted- Average | ||||||||||||||||
Number of | Weighted- Average | Remaining | Aggregate Intrinsic | |||||||||||||
Shares | Exercise Price | Contractual Life | Value | |||||||||||||
Outstanding at June 30, 2009 |
3,079,641 | $ | 1.65 | |||||||||||||
Granted |
1,175,000 | $ | 0.63 | |||||||||||||
Forfeited or Expired |
(356,522 | ) | $ | 2.24 | ||||||||||||
Exercised |
| | ||||||||||||||
Outstanding at March 31, 2010 |
3,898,119 | $ | 1.29 | 2.7 | $ | 171,000 | ||||||||||
Vested and Expected to Vest at
March 31, 2010 |
3,520,327 | $ | 1.34 | 2.7 | $ | 147,000 | ||||||||||
Exercisable at March 31, 2010 |
1,122,639 | $ | 2.38 | 1.9 | $ | 2,000 | ||||||||||
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 1,825,000
options that were in-the-money at March 31, 2010. There were no options exercised during the nine
months ended March 31, 2010 and 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 contained herein. 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 fiscal
year 2009.
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Overview
ThermoGenesis designs, develops and commercializes cell processing products that enable the
practice of regenerative medicine. 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. The Company was founded in 1986 and is located in Rancho Cordova,
California. 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.
Recent Developments
On April 30, 2010, the Company signed a non-exclusive distribution agreement
with GE Healthcare for its Res-Q system in the U.S. (except orthopedics), Canada and 19 countries in Europe. The agreement has a two and a
half year term, with automatic one year renewals.
On March 16, 2010, the Company signed a new distribution agreement with Fenwal, Inc. Under the
exclusive five-year agreement, Fenwal will market and distribute the AXP and BioArchive systems for
use in cord blood processing and storage in China, India and Japan.
On January 29, 2010, the Company and GEHC signed an amendment to their International Distribution
Agreement (the Agreement), effective February 1, 2010. Under the Agreement, which runs through
July 31, 2012, GEHC will continue to distribute the AXP product line, excluding certain countries
in Latin America, Asia, CIS, Eastern Europe and the Middle East. The Agreement provides incentives
for both the Company and GEHC related to sales success, product quality and delivery.
Additionally, the Agreement requires GEHC to fund additional marketing support for the first two
years. The Agreement will automatically renew for one year terms unless terminated at least six
months prior to the end of the then current term.
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 93% of the mononuclear cells. Self-powered and
microprocessor-controlled, the AXP contains flow control optical sensors which achieve precise
separation.
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 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 processing, reliable,
and easy-to-use product which achieves a high recovery of stem cells from bone marrow. The
key advantages of the Res-Q system include delivering a high number of target cells from a small
sample of bone marrow and
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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.
We currently manufacture the BioArchive device and outsource the manufacturing of the disposables.
It is our intent to explore outsourcing alternatives to in-house manufacturing for the BioArchive
device after completion of design upgrades.
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 component 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. During the quarter ended December 31, 2009, we completed the outsourcing of
manufacturing to a contract manufacturer for the Thermoline devices. We continue to evaluate our options to divest this product line.
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.
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.
Research and Development
In February 2010, the Company filed a Form 510(k) with the FDA seeking market clearance for the use
of the Res-Q technology in the preparation of platelet rich plasma, or PRP, from peripheral blood.
PRP therapy is used in regenerative medicine because its rich content of growth factors enhances
wound healing. The FDA has responded with an initial set of questions and we are in the process of
preparing our responses.
Critical Accounting Policies
Managements discussion and analysis of its financial condition and results of operations is 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 condensed 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
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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 March 31, 2010 as Compared to the Three Months
Ended March 31, 2009
Net Revenues:
Revenues for the three months ended March 31, 2010 were $4,764,000 compared to $5,148,000 for the
three months ended March 31, 2009, a decrease of $384,000 or 7%. The downturn in the economy
continues to impact our revenues, especially our capital equipment sales as customers are taking
longer to secure their funding sources. The decrease in revenues is primarily due to decreases
related to BioArchive devices of $476,000 as there were fewer BioArchive devices sold in the
current quarter and a decrease in ThermoLine freezer revenues of $290,000 due to a lack of sales of
our largest freezer in the current quarter. Offsetting these decreases were increases in AXP
device revenues of $192,000, as the devices were awaiting upgraded component parts during the first
and second quarters of fiscal 2010 and an increase in revenues from BioArchive disposables of
$176,000. We anticipate revenues from AXP disposables to increase as our second supplier will be
delivering product in the fourth quarter.
The following represents the Companys cumulative BioArchive devices sold into the following
geographies through the dates indicated:
March 31, | ||||||||
2010 | 2009 | |||||||
United States |
50 | 49 | ||||||
Asia |
70 | 64 | ||||||
Europe |
54 | 51 | ||||||
Rest of World |
41 | 35 | ||||||
215 | 199 | |||||||
The following represents the Companys revenues for disposables by product line for the three
months ended:
March 31, | ||||||||
2010 | 2009 | |||||||
AXP |
$ | 1,760,000 | $ | 1,918,000 | ||||
BioArchive |
1,007,000 | 831,000 | ||||||
Res-Q |
48,000 | | ||||||
MXP |
6,000 | 19,000 | ||||||
CryoSeal |
179,000 | 87,000 | ||||||
$ | 3,000,000 | $ | 2,855,000 | |||||
Percentage of total
Company revenues |
63 | % | 55 | % | ||||
Gross Profit:
The Companys gross profit was $1,401,000 or 29% of net revenues for the three months ended March
31, 2010, as compared to $1,794,000 or 35% for the corresponding fiscal 2009 period. The decrease
in
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gross profit is primarily due to higher warranty costs associated with the BioArchive device and
AXP disposable, the pricing mix on AXP disposables, and an increase in production rework costs,
offset by a release of inventory reserves associated with CryoSeal disposables of $148,000 as sales
were higher than previously estimated.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $1,722,000 for the three months ended March 31,
2010, compared to $1,917,000 for the comparable fiscal 2009 period, a decrease of $195,000 or 10%.
The decrease is primarily due to lower labeling/translation costs of $85,000 due to a large project
in fiscal 2009 and lower professional fees related to audit expenses.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses were $1,080,000 for the three months ended March 31, 2010,
compared to $1,018,000 for the comparable fiscal 2009 period, an increase of $62,000 or 6%. The
increase is primarily due to higher salaries and benefits of $125,000 primarily as a result of
hiring a new Vice President, Chief Quality and Regulatory Affairs Officer. This increase was
offset by a decrease in consulting expense due to the termination of the consulting agreement with
the former Chief Technology Architect effective October 1, 2009.
Results of Operations for the Nine Months Ended March 31, 2010 as Compared to the Nine Months Ended
March 31, 2009
Net Revenues:
Revenues for the nine months ended March 31, 2010 were $15,912,000, compared to $15,776,000 for the
nine months ended March 31, 2009, an increase of $136,000 or 1%. This increase is primarily due to
product revenue increases from the MXP and Res-Q product lines of approximately $955,000. MXP was
launched in December 2008 and Res-Q in the first quarter of the current fiscal year. This increase
was offset by a decrease in BioArchive device revenue of $855,000.
The following represents the Companys revenues for disposables by product line for the nine months
ended:
March 31, | ||||||||
2010 | 2009 | |||||||
AXP |
$ | 5,474,000 | $ | 5,281,000 | ||||
BioArchive |
2,976,000 | 2,808,000 | ||||||
MXP |
415,000 | 19,000 | ||||||
Res-Q |
300,000 | | ||||||
CryoSeal |
389,000 | 262,000 | ||||||
$ | 9,554,000 | $ | 8,370,000 | |||||
Percentage of total
Company revenues |
60 | % | 53 | % | ||||
Gross Profit:
The Companys gross profit was $4,969,000 or 31% of net revenues for the nine months ended March
31, 2010, as compared to $5,287,000 or 34% for the corresponding fiscal 2009 period. The decrease
in gross margin for the nine months ended March 31, 2010 is primarily due to the pricing mix of AXP
disposables, an increase in rework costs, higher warranty costs associated with the BioArchive
device and
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AXP disposables, and vendor qualification costs paid to our new contract manufacturers. These
costs were offset by the accrual for the voluntary recall of AXP bag sets during the six months
ended December 31, 2008 and a release of inventory reserves associated with CryoSeal disposables as
sales were higher than previously estimated during the three months ended March 31, 2010.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $5,975,000 for the nine months ended March 31,
2010, compared to $7,037,000 for the comparable fiscal 2009 period, a decrease of $1,062,000 or
15%. The decrease is primarily due to a severance accrual of $370,000 during the quarter ended
December 31, 2008 to the Companys former Chief Executive Officer, lower salaries and benefits of
$448,000, lower labeling/translation costs of $170,000 and lower legal fees of $110,000.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses were $4,074,000 for the nine months ended March 31, 2010,
compared to $3,916,000 for the comparable fiscal 2009 period, an increase of $158,000 or 4%. This
is primarily due to an increase in the costs incurred to complete development of the Res-Q product
of $265,000 and the termination of the consulting agreement with the Companys former Chief
Technology Architect effective October 1, 2009 for $240,000. These increases were offset by the
reduction of costs associated with the Vantus subsidiary during the six months ended December 31,
2008 of $290,000.
Liquidity and Capital Resources
At March 31, 2010, the Company had cash, cash equivalents and short-term investments of $10,126,000
and working capital of $15,866,000. 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 nine months ended March 31, 2010 was $5,035,000,
primarily due to the net loss of $5,022,000, offset by depreciation and stock based compensation
expense of $361,000 and $419,000, respectively. Accounts receivable utilized $782,000 of cash as a
result of increased revenues from the fourth quarter of fiscal 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 expect this trend to continue, we have reduced expenses without
sacrificing development plans we consider essential to our near term growth. Our ability to fund
our longer-term cash needs is subject to various risks, many of which are beyond our controlSee
Part I Item 1ARisk Factors set forth in our annual report on Form 10-K for the fiscal year ended
June 30, 2009. Should we require additional funding, such as additional capital investments, we
may need to raise the required additional funds through bank borrowings or public or private sales
of debt or equity securities. We cannot assure that such funding will be available in needed
quantities or on terms favorable to us, if at all.
Off-Balance Sheet Arrangements
As of March 31, 2010, the Company had no off-balance sheet arrangements.
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Backlog
The Companys cancelable backlog at March 31, 2010 was $4,651,000. Our backlog consists of product
orders for which a customer purchase order has been received and is scheduled for shipment within
the next twelve months. Orders are subject to cancellation or rescheduling by the customer,
sometimes with a cancellation charge. Due to timing of order placement, product lead times,
changes in product delivery schedules and cancellations, and because sales will often reflect
orders shipped in the same quarter received, our backlog at any particular date is not necessarily
indicative of sales for any succeeding period.
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 March 31, 2010 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 Chief Executive Officer along with the Companys
Chief 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 March 31, 2010 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.
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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 neither any 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 known material changes during the period ended March 31, 2010
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 or knowable 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. |
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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: May 6, 2010 | /s/ J. Melville Engle | |||
J. Melville Engle | ||||
Chief Executive Officer (Principal Executive Officer) | ||||
Dated: May 6, 2010 | /s/ Matthew T. Plavan | |||
Matthew T. Plavan | ||||
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
||||
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