ThermoGenesis Holdings, Inc. - Quarter Report: 2007 December (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 December 31, 2007.
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 (State of incorporation) |
94-3018487 (I.R.S. Employer Identification No.) |
2711 Citrus Road
Rancho Cordova, California 95742
Rancho Cordova, California 95742
(Address of principal executive offices) (Zip Code)
(916) 858-5100
(Registrant’s 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.
þ
Yes o No
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):
| o Large accelerated filer | þ Accelerated filer | o Non-accelerated filer (Do not check if a smaller reporting company) |
o Smaller reporting company |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
o
Yes þ No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of
the latest practicable date.
| Class | Outstanding at January 31, 2008 | |
| Common stock, $.001 par value | 55,701,175 |
ThermoGenesis Corp.
INDEX
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| EXHIBIT 31.1 | ||||||||
| EXHIBIT 31.2 | ||||||||
| EXHIBIT 32 | ||||||||
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
ThermoGenesis Corp.
Condensed Balance Sheets (Unaudited)
Condensed Balance Sheets (Unaudited)
| December 31, | June 30, | |||||||
| (in thousands, except share and per share amounts) | 2007 | 2007 | ||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 3,796 | $ | 5,730 | ||||
Short-term investments |
26,695 | 27,649 | ||||||
Accounts receivable, net of allowance for
doubtful accounts of $29 ($50 at June 30, 2007) |
3,103 | 3,226 | ||||||
Inventories, net |
5,105 | 5,046 | ||||||
Other current assets |
211 | 415 | ||||||
Total current assets |
38,910 | 42,066 | ||||||
Equipment at cost less accumulated depreciation of $2,764
($2,605 at June 30, 2007) |
1,694 | 1,602 | ||||||
Other assets |
77 | 122 | ||||||
| $ | 40,681 | $ | 43,790 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,640 | $ | 2,074 | ||||
Accrued payroll and related expenses |
516 | 525 | ||||||
Deferred revenue |
766 | 761 | ||||||
Other current liabilities |
1,250 | 947 | ||||||
Total current liabilities |
4,172 | 4,307 | ||||||
Deferred revenue |
1,310 | 1,647 | ||||||
Long-term portion of capital lease obligations |
17 | 24 | ||||||
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; 55,701,175 issued and outstanding
(55,500,524 at June 30, 2007) |
56 | 56 | ||||||
Paid in capital in excess of par |
119,771 | 118,384 | ||||||
Accumulated deficit |
(84,645 | ) | (80,628 | ) | ||||
Total stockholders’ equity |
35,182 | 37,812 | ||||||
| $ | 40,681 | $ | 43,790 | |||||
See accompanying notes to financial statements.
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ThermoGenesis Corp.
Condensed Statements of Operations (Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| (in thousands, except share and per share amounts) | 2007 | 2006 | 2007 | 2006 | ||||||||||||
Product and other revenues |
$ | 5,208 | $ | 3,281 | $ | 8,591 | $ | 7,100 | ||||||||
Milestone payments and license fees |
279 | 435 | 528 | 921 | ||||||||||||
Net revenues |
5,487 | 3,716 | 9,119 | 8,021 | ||||||||||||
Cost of product and other revenues |
3,553 | 2,866 | 5,908 | 5,395 | ||||||||||||
Cost of milestone payments and license
fees |
24 | 61 | 92 | 125 | ||||||||||||
Cost of revenues |
3,577 | 2,927 | 6,000 | 5,520 | ||||||||||||
Gross profit |
1,910 | 789 | 3,119 | 2,501 | ||||||||||||
Expenses: |
||||||||||||||||
Selling, general and administrative |
2,357 | 2,300 | 4,777 | 4,612 | ||||||||||||
Research and development |
1,617 | 973 | 3,113 | 1,935 | ||||||||||||
Total operating expenses |
3,974 | 3,273 | 7,890 | 6,547 | ||||||||||||
Interest and other income, net |
347 | 454 | 754 | 920 | ||||||||||||
Net loss |
$ | (1,717 | ) | $ | (2,030 | ) | $ | (4,017 | ) | $ | (3,126 | ) | ||||
Per share data: |
||||||||||||||||
Basic and diluted net loss per common
share |
$ | (0.03 | ) | $ | (0.04 | ) | $ | (0.07 | ) | $ | (0.06 | ) | ||||
Shares used in computing per share data |
55,701,175 | 55,140,675 | 55,680,342 | 55,022,221 | ||||||||||||
See accompanying notes to financial statements.
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ThermoGenesis Corp.
Condensed Statements of Cash Flows (Unaudited)
Six Months Ended December 31, 2007 and 2006
Condensed Statements of Cash Flows (Unaudited)
Six Months Ended December 31, 2007 and 2006
| (in thousands) | 2007 | 2006 | ||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (4,017 | ) | $ | (3,126 | ) | ||
Adjustments to reconcile net loss to net cash used
in operating activities: |
||||||||
Depreciation and amortization |
265 | 228 | ||||||
Stock based compensation expense |
1,121 | 582 | ||||||
Accretion of discount on short-term investments |
(564 | ) | (690 | ) | ||||
Net change in operating assets and liabilities: |
||||||||
Accounts receivable, net |
123 | 376 | ||||||
Inventories, net |
(191 | ) | (1,542 | ) | ||||
Other current assets |
204 | 138 | ||||||
Other assets |
45 | (15 | ) | |||||
Accounts payable |
(434 | ) | 618 | |||||
Accrued payroll and related expenses |
(9 | ) | 74 | |||||
Deferred revenue |
(332 | ) | (373 | ) | ||||
Other current liabilities |
304 | 109 | ||||||
Net cash used in operating activities |
(3,485 | ) | (3,621 | ) | ||||
Cash flows from investing activities: |
||||||||
Capital expenditures |
(225 | ) | (165 | ) | ||||
Purchase of investments |
(23,482 | ) | (25,533 | ) | ||||
Maturities of investments |
25,000 | 36,000 | ||||||
Net cash provided by investing activities |
1,293 | 10,302 | ||||||
Cash flows from financing activities: |
||||||||
Payments on capital lease obligations |
(8 | ) | (11 | ) | ||||
Exercise of stock options and warrants |
266 | 1,028 | ||||||
Net cash provided by financing activities |
258 | 1,017 | ||||||
Net
(decrease) increase in cash and cash equivalents |
(1,934 | ) | 7,698 | |||||
Cash and cash equivalents at beginning of period |
5,730 | 3,527 | ||||||
Cash and cash equivalents at end of period |
$ | 3,796 | $ | 11,225 | ||||
Supplemental non-cash flow information: |
||||||||
Transfer of inventory to equipment |
$ | 150 | $ | 67 | ||||
Transfer of equipment to inventory |
$ | 18 | $ | 20 | ||||
See accompanying notes to financial statements
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ThermoGenesis Corp.
Notes to Condensed Financial Statements (Unaudited)
Notes to Condensed Financial Statements (Unaudited)
1. Summary of Significant Accounting Policies
Interim Reporting
The accompanying unaudited 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, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. All sales, domestic and foreign, are made in U.S. dollars and therefore currency fluctuations are believed to have no impact on ThermoGenesis Corp’s (the “Company”) 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 six month period ended December 31, 2007 are not necessarily indicative of the results that may be expected for the year ending June 30, 2008. These financial statements should be read in conjunction with the financial statements and the notes thereto included in the Annual Report on Form 10-K for the fiscal year ended June 30, 2007.
The accompanying unaudited 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, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. All sales, domestic and foreign, are made in U.S. dollars and therefore currency fluctuations are believed to have no impact on ThermoGenesis Corp’s (the “Company”) 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 six month period ended December 31, 2007 are not necessarily indicative of the results that may be expected for the year ending June 30, 2008. These financial statements should be read in conjunction with the financial statements and the notes thereto included in the Annual Report on Form 10-K for the fiscal year ended June 30, 2007.
The balance sheet at June 30, 2007, has been derived from the audited financial statements at that
date but does not include all the information and footnotes required by U.S. generally accepted
accounting principles for complete financial statements.
Revenue Recognition
The Company recognizes revenue including multiple element arrangements, in accordance with the provisions of the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue Recognition and the Financial Accounting Standards Board’s (“FASB”) Emerging Issues Task Force (“EITF”) 00-21, Revenue Agreements with Multiple Deliverables. Revenues from the sale of the Company’s 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 Company recognizes revenue including multiple element arrangements, in accordance with the provisions of the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue Recognition and the Financial Accounting Standards Board’s (“FASB”) Emerging Issues Task Force (“EITF”) 00-21, Revenue Agreements with Multiple Deliverables. Revenues from the sale of the Company’s 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 Company’s 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, 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 the
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
arrangement’s 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
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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 collaborative 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 Company’s 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. The direct costs,
primarily labor, of product development contracts are deferred until the development revenue is
recognized.
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 Company’s part, license fee revenue is recognized immediately upon grant of the
license.
Shipping and handling fees billed to customers are included in product and other revenues, while
the related costs are included in cost of product and other revenues.
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.
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 earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities, which consist of stock options, warrants and common stock restricted awards that were not included in diluted net loss per common share were 3,492,232 and 2,647,133 as of December 31, 2007 and 2006.
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 earnings per share is the same for all periods presented, as the effect of the potential common stock equivalents is anti-dilutive due to the Company’s net loss position for all periods presented. Anti-dilutive securities, which consist of stock options, warrants and common stock restricted awards that were not included in diluted net loss per common share were 3,492,232 and 2,647,133 as of December 31, 2007 and 2006.
Recent Accounting Pronouncements
In September 2006, the FASB issued Statement of Financial Accounting Standard (“SFAS”) No. 157, Fair Value Measurements (“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework for measuring fair value under GAAP and expands disclosure about fair value measurements. SFAS No. 157 applies under other accounting standards that require or permit fair value measurements. Accordingly, SFAS No. 157 does not require any new fair value measurement. SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007. The Company is currently evaluating the impact of the provisions of SFAS No. 157 on its financial statements.
In September 2006, the FASB issued Statement of Financial Accounting Standard (“SFAS”) No. 157, Fair Value Measurements (“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework for measuring fair value under GAAP and expands disclosure about fair value measurements. SFAS No. 157 applies under other accounting standards that require or permit fair value measurements. Accordingly, SFAS No. 157 does not require any new fair value measurement. SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007. The Company is currently evaluating the impact of the provisions of SFAS No. 157 on its financial statements.
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In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities (“SFAS No. 159”). SFAS No. 159 allows entities to voluntarily choose to
measure many financial assets and financial liabilities at fair value. SFAS No. 159 is effective
for financial statements issued for fiscal years beginning after November 15, 2007. The Company is
currently evaluating the impact of the provisions of SFAS No. 159 on its financial statements.
2. Investments
The following is a summary of held-to-maturity securities:
| Gross | Gross | |||||||||||||||
| Amortized | Unrealized | Unrealized | Estimated | |||||||||||||
| (in thousands) | Cost | Gains | Losses | Fair Value | ||||||||||||
December 31, 2007 |
||||||||||||||||
Mortgage-backed securities
of government sponsored
enterprises |
$ | 26,695 | $ | 17 | — | $ | 26,712 | |||||||||
Maturity Date: |
||||||||||||||||
Less than 90 days |
$ | 12,927 | $ | 12,937 | ||||||||||||
Due in 91-365 days |
13,768 | 13,775 | ||||||||||||||
| $ | 26,695 | $ | 26,712 | |||||||||||||
June 30, 2007 |
||||||||||||||||
Mortgage-backed securities
of government sponsored
enterprises |
$ | 27,649 | $ | 2 | $ | 10 | $ | 27,641 | ||||||||
The Company has no unrealized losses on short-term investments at December 31, 2007.
3. Inventories
Inventories consisted of the following at:
| (in thousands) | December 31, 2007 | June 30, 2007 | ||||||
Raw materials |
$ | 2,458 | $ | 2,380 | ||||
Work in process |
1,825 | 1,334 | ||||||
Finished goods |
1,698 | 2,247 | ||||||
Reserve |
(876 | ) | (915 | ) | ||||
| $ | 5,105 | $ | 5,046 | |||||
Included in the Company’s inventory reserve at December 31, 2007 and June 30, 2007 were $623 and
$638, respectively, related to CryoSeal® FS System inventory products, which are based
on inventory levels in excess of forecasted demand for the product. The remainder of the reserve
relates to inventory for other product lines which have been identified as slow-moving or
potentially obsolete.
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4. Commitments and Contingencies
Warranty
The Company offers a one-year warranty for parts only on all of its non-disposable products. In addition, the Company’s one-year warranty for the BioArchive® System includes labor and travel. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary.
The Company offers a one-year warranty for parts only on all of its non-disposable products. In addition, the Company’s one-year warranty for the BioArchive® System includes labor and travel. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary.
Changes in the Company’s product liability during the period are as follows:
(in thousands) |
||||
July 1, 2007 balance |
$ | 302 | ||
Warranties issued during the period |
170 | |||
Settlements made during the period |
(171 | ) | ||
Changes in liability for pre-existing warranties during the period, including expirations |
249 | |||
Balance at December 31, 2007 |
$ | 550 | ||
As a
result of various quality issues experienced by high usage customers
of the AXP devices and docking stations, the Company made revisions
to its estimated warranty liability for the six month period ended
December 31, 2007. The Company recorded a change in estimate,
which increased the Company’s cost of product and other revenues
and net loss (no net loss per share impact) by $249. The Company did
not record any significant change in estimate during the quarter and
six-month period ended December 31, 2006.
Import/Export Bonds The Company imports and exports products and components as a routine part of its business,
and must comply with the rules and regulations of both the US Food and Drug Administration and the US Department of Homeland Security Bureau of Customs and Border Protection (CBP). With products and components that require FDA approval
but prior to the receipt of such approval, the Company enters the components into the United States under certain temporary import provisions and must provide documentation of re-export of such product or its destruction within specified time periods. If components or products have not
been exported or destroyed within the period provided for by the regulations, the Port Director may make a demand in writing under the bond for the payment of defined damages. The Company utilizes a continuous import bond in the face amount of $50 for these
activities, which would provide payment of any damages up to the face amount of the bond. The Company was recently notified by CBP at the Port of San Francisco that it may be in breach of the temporary import agreement for components sold within the US to our strategic partners who then export such components for use outside the United States. The matter is currently under review. However, the Company may be exposed to damages up to
a maximum of the face amount of our continuous import bond for each year the non-compliant imports occurred, and the bond was in effect. For the quarter ended December 31, 2007, the Company has recorded an estimated loss contingency in the amount of $100, which is based on the face amounts of the bond described above. The estimated loss contingency is included in Selling, General & Administrative expenses in the condensed statements of operations.
5. Stockholder’s Equity
Stock Based Compensation
(in thousands)
The Company recorded stock-based compensation of $493 and $1,121 for the three and six months ended December 31, 2007 and $240 and $582 for the three and six months ended December 31, 2006.
The Company recorded stock-based compensation of $493 and $1,121 for the three and six months ended December 31, 2007 and $240 and $582 for the three and six months ended December 31, 2006.
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The following is a summary of option activity for the Company’s stock option plans:
| Weighted- | ||||||||||||||||
| Weighted- | Average | |||||||||||||||
| Average | Remaining | Aggregate | ||||||||||||||
| (in thousands, except shares, | Number of | Exercise | Contractual | Intrinsic | ||||||||||||
| share price and term) | Shares | Price | Life | Value | ||||||||||||
Outstanding at June 30, 2007 |
2,470,917 | $ | 2.89 | 2.6 | $ | 1,046 | ||||||||||
Granted |
958,000 | $ | 2.34 | |||||||||||||
Forfeited or Expired |
(310,534 | ) | $ | 3.39 | ||||||||||||
Exercised |
(200,651 | ) | $ | 1.33 | ||||||||||||
Outstanding at December 31, 2007 |
2,917,732 | $ | 2.77 | 2.6 | — | |||||||||||
Vested and Expected to Vest at
December 31, 2007 |
2,830,997 | $ | 2.76 | 2.6 | — | |||||||||||
Exercisable at December 31,
2007 |
1,634,069 | $ | 2.70 | 2.0 | — | |||||||||||
The aggregate intrinsic value is calculated as the difference between the exercise price of the
underlying awards and the quoted price of the Company’s common stock. There were no options that
were in-the-money at December 31, 2007. During the six months ended December 31, 2007 and 2006,
the aggregate intrinsic value of options exercised under the Company’s stock option plans were $248
and $83, respectively, determined as of the date of option exercise.
6. Income Taxes
Effective July 1, 2007, we adopted the provisions of Financial Accounting Standards Board
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (FIN 48), an interpretation of
FASB Statement No. 109 (SFAS 109). There was no impact on our financial statements upon adoption.
Because of our historical significant net operating losses, we have not been subject to income tax
since inception. The tax years 1993-2007 remain open to examination by the major taxing
jurisdictions to which we are subject. The Company’s policy is to recognize interest and penalties
related to the underpayment of income taxes as a component of income tax expense. To date, there
have been no interest or penalties charged to the Company in relation to the underpayment of income
taxes. There were no unrecognized tax benefits during all the periods presented.
We maintain deferred tax assets that reflect the net tax effects of temporary differences between
the carrying amounts of assets and liabilities for financial reporting purposes and the amounts
used for income tax purposes. These deferred tax assets include net operating loss carryforwards,
research credits and deferred revenue. The net deferred tax asset has been fully offset by a
valuation allowance because of our history of losses. Utilization of operating losses and credits
may be subject to annual limitation due to ownership change provisions of the Internal Revenue Code
of 1986 and similar state provisions. The annual limitation may result in the expiration of net
operating losses and credits before utilization.
7. Subsequent Event
In February 2008, the Company announced the formation of a wholly-owned subsidiary, Vantus
Veterinary Stem Cell Laboratories (Vantus). Vantus involves a formal collaboration with the Center
for Equine Health and Stem Cell Regenerative Medicine Group at the University of California, Davis, School of Veterinary Medicine.
Its initial focus will be the harvesting, processing and preservation of equine stem cells for use in treatment of orthopedic injuries in the performance equine market.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking Statements
This report contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 Company’s 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 Company’s actual results and could cause actual results for fiscal year 2008, 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, the risks associated with initiating manufacturing for new products, and the risk factors listed from time to time in the Company’s Securities and Exchange Commission (“SEC”) reports, including, in particular, the factors and discussion in the Company’s Form 10-K for its last fiscal year.
This report contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 Company’s 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 Company’s actual results and could cause actual results for fiscal year 2008, 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, the risks associated with initiating manufacturing for new products, and the risk factors listed from time to time in the Company’s Securities and Exchange Commission (“SEC”) reports, including, in particular, the factors and discussion in the Company’s Form 10-K for its last fiscal year.
Overview
We are principally a leading supplier of innovative products that process, cryopreserve, store and administer therapeutic doses of adult stem cells for treatment of disease and injury. These stem cells typically originate from the blood or tissue from donated cord blood or the bone marrow of the patient to be treated. The Stem Cell therapy market is a broad, rapidly growing field of medicine that involves the collection, purification, manipulation and administration of stem cells, to treat malignant or genetic blood diseases, tailored to individual patients. This methodology of personalized treatment is considerably different than practices with generic conventional pharmaceutical drugs. Pharmaceutical drugs are produced in large quantities and are effective on most patients with similar underlying medical conditions. Additionally, these drugs typically consist of inert materials that can be stored in medicine cabinets at room temperature. In contrast, “personalized” cell therapies are manufactured one at a time, are intended for a single patient and must be used immediately or, if stored, require precision freezing and extremely low storage temperatures (-196°C in some cases) in order to preserve the viability of the cells.
We are principally a leading supplier of innovative products that process, cryopreserve, store and administer therapeutic doses of adult stem cells for treatment of disease and injury. These stem cells typically originate from the blood or tissue from donated cord blood or the bone marrow of the patient to be treated. The Stem Cell therapy market is a broad, rapidly growing field of medicine that involves the collection, purification, manipulation and administration of stem cells, to treat malignant or genetic blood diseases, tailored to individual patients. This methodology of personalized treatment is considerably different than practices with generic conventional pharmaceutical drugs. Pharmaceutical drugs are produced in large quantities and are effective on most patients with similar underlying medical conditions. Additionally, these drugs typically consist of inert materials that can be stored in medicine cabinets at room temperature. In contrast, “personalized” cell therapies are manufactured one at a time, are intended for a single patient and must be used immediately or, if stored, require precision freezing and extremely low storage temperatures (-196°C in some cases) in order to preserve the viability of the cells.
In February 2008, the Company formed a wholly-owned subsidiary, Vantus Veterinary Stem Cell
Laboratories (Vantus). Vantus involves a formal collaboration with the Center for Equine Health and
Stem Cell Regenerative Medicine Group at the University of California, Davis, School of Veterinary
Medicine. Its initial focus will be the harvesting, processing and preservation of equine stem
cells for use in treatment of orthopedic injuries in the performance equine market.
Historically, our focus was on our core ultra-rapid freezing technology, applied principally to
freezers for blood and blood components and plasma thawers, which are our legacy products. Through
our research programs we developed more advanced product platforms directed at stem cell therapies
and wound care. Our stem cell products have been the principal drivers of our revenue growth over
the past few years, and our legacy products have become an increasingly smaller component of
revenue and are no longer strategically relevant to our growth.
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Our Products
The BioArchive System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE Healthcare is the global distribution partner for the BioArchive System. The BioArchive System has initially been configured to automate the cryopreservation and archiving in liquid nitrogen of units of stem cells sourced from umbilical cord blood.
The BioArchive System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE Healthcare is the global distribution partner for the BioArchive System. The BioArchive System has initially been configured to automate the cryopreservation and archiving in liquid nitrogen of units of stem cells sourced from umbilical cord blood.
The
AXP(™) AutoXpress Platform (AXP) is an innovative product which automates the
isolation and concentration of stem cells from cord blood into a fixed 20 ml volume in a
functionally closed sterile environment. It includes a compact battery powered device and a
proprietary disposable bag set. The AXP has been commercially available since March 2006, marketed
under a Master File with the FDA. In October 2007, the Company received 510k clearance from the
FDA for the use of the AXP in the processing of cord blood for cryopreservation. The AXP Platform
replaces the current clinical process which is typically an 18-step manual method over a ninety
(90) minute period with a semi-automated process requiring only thirty (30) minutes. The manual
process requires the introduction of sedimentation agents or density gradient media into the cord
blood and requires a clean room along with trained technicians to accomplish. The AXP Platform
completes its processing without these agents or media with a higher cell recovery rate in a
functionally closed bag set in thirty (30) minutes. Included in the set is a 25 ml freezing bag
which can be archived in the BioArchive System.
The Company is developing an extension of the AXP, the MarrowXpressä Platform. This is a
proprietary, automated device and companion sterile blood processing disposable for isolating stem
cells from bone marrow in a close system at or near the point of care. The initial focus will be
in the use of bone marrow stem cells in the treatment of critical limb ischemia and myocardial
ischemia. We are in the process of preparing a 510 (k) submission and CE Mark application. The
Company plans to sell the MarrowXpress directly to global customers.
The CryoSeal FS System (CryoSeal) produces a second-generation surgical sealant which harvests the
two interactive protein component solutions of a fibrin sealant: (1) the wound healing proteins of
fibrinogen, fibronectin, Factor VIII, von Willebrands Factor and Factor XIII and (2) the activating
enzyme, thrombin from the patient’s own blood. When combined at the bleeding wound site, the two
components form an adhesive gel that stops bleeding and bonds tissue. This advanced surgical
sealant may be manufactured in either hospitals or blood centers and competes with conventional
fibrin sealants, sourced from “pools” of plasma purchased from up to ten thousand individuals.
On July 30, 2007, the Company announced that it had received FDA clearance to market the CryoSeal
FS System’s autologous fibrin sealant, as an adjunct to hemostasis in liver resection surgery. In
Japan, our distributor, Asahi has completed enrollment in their pivotal clinical trial and filed
their PMA equivalent in March 2005 with approval expected during fiscal 2009. The Company has
received CE Mark approval for the system enabling its sale and use in Europe. However, we have not
been able to meaningfully penetrate the market with this product and revenues have lagged
expectations. Over the last several years while marketing the CryoSeal in numerous European
countries, we and our distributors have faced substantial country specific regulatory,
cost-reimbursement and product registration requirements that have negatively impacted our ability
to sell the product and grow revenues. Compliance with these requirements has been more
complicated than we anticipated, requiring far more time and the consumption of more of our
resources than we originally projected.
With a better appreciation today for the country specific expertise required to successfully market
the CryoSeal, we are assessing strategic alternatives beyond our own regulatory and marketing
capabilities to help us better navigate the regulatory and reimbursement pathways in each of our
markets throughout the world. We are targeting to increase our market penetration for this product
in Europe and in other areas of the world including Brazil, Korea, Mexico, Russia and Taiwan where
our distributors may now register the CryoSeal following our recently received FDA approval.
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We believe that there is a market for our 100% autologous CryoSeal System due to its safety
advantages over conventional, non-autologous fibrin sealants that carry the risk of contamination
by blood-borne pathogens from other donors, and that this market may extend beyond the typical
wound care applications to include use of the technology in the delivery of stem cells for cell
therapeutics. Therefore, we are evaluating alternatives for commercialization of our CryoSeal
System including new strategic partnering and licensing, distribution channel partners, and the
potential use of the technology in the delivery of stem cells.
The Thrombin Processing Device™ (TPD), a product line extension of the CryoSeal System, is a small
stand alone disposable that isolates and captures activated autologous thrombin from approximately
11 ml of patient blood plasma. Thrombin is used as a topical hemostatic agent for minor bleeding
sites, to treat pseudoaneurysms and to release growth factors from platelets.
The Company’s legacy is in its ThermoLine™ products for ultra rapid freezing and thawing of blood
components, which the Company distributes to blood banks and hospitals. We are currently
evaluating our divestiture options for the ThermoLine consistent with our strategic direction
emphasizing the cell therapy and surgical wound care market.
The following is Management’s discussion and analysis of certain significant factors which have
affected the Company’s financial condition and results of operations during the period included in
the accompanying financial statements.
Critical Accounting Policies
The Company’s discussion and analysis of its financial condition and results of operations are based upon the Company’s financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these 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.
The Company’s discussion and analysis of its financial condition and results of operations are based upon the Company’s financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these 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.
The Company believes the following critical accounting policies affect its more significant
judgments and estimates used in the preparation of its financial statements.
Revenue Recognition:
The Company recognizes revenue including multiple element arrangements, in accordance with the provisions of the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue Recognition and the Financial Accounting Standards Board’s (“FASB”) Emerging Issues Task Force (“EITF”) 00-21, Revenue Agreements with Multiple Deliverables. Revenues from the sale of the Company’s 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 Company recognizes revenue including multiple element arrangements, in accordance with the provisions of the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue Recognition and the Financial Accounting Standards Board’s (“FASB”) Emerging Issues Task Force (“EITF”) 00-21, Revenue Agreements with Multiple Deliverables. Revenues from the sale of the Company’s 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.
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The Company’s 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, 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 the
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
arrangement’s 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 collaborative 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 Company’s 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. The direct costs,
primarily labor, of product development contracts are deferred until the development revenue is
recognized.
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 Company’s part, license fee revenue is recognized immediately upon grant of the
license.
Stock-Based Compensation:
The Company accounts for stock-based employee compensation arrangements in accordance with the provisions of Statement of Financial Accounting Standards No. 123(R), Shared-Based Payments (“FAS 123(R)”). Under FAS 123(R), compensation cost is calculated on the date of the grant using the Black Scholes-Merton option-pricing formula. The compensation expense is then amortized over the vesting period. The Company uses the Black-Scholes-Merton option-pricing formula in determining the fair value of the Company’s options at the grant date and applies judgment in estimating the key assumptions that are critical to the model such as the expected term, volatility and forfeiture rate of an option. The Company’s estimate of these key assumptions is based on historical information and judgment regarding
The Company accounts for stock-based employee compensation arrangements in accordance with the provisions of Statement of Financial Accounting Standards No. 123(R), Shared-Based Payments (“FAS 123(R)”). Under FAS 123(R), compensation cost is calculated on the date of the grant using the Black Scholes-Merton option-pricing formula. The compensation expense is then amortized over the vesting period. The Company uses the Black-Scholes-Merton option-pricing formula in determining the fair value of the Company’s options at the grant date and applies judgment in estimating the key assumptions that are critical to the model such as the expected term, volatility and forfeiture rate of an option. The Company’s estimate of these key assumptions is based on historical information and judgment regarding
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market factors and trends. If actual results are not consistent with the Company’s assumptions and
judgments used in estimating the key assumptions, the Company may be required to record additional
compensation expense, which could have a material impact on the Company’s financial position and
results of operations.
Allowance for Doubtful Accounts:
The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. If the financial condition of the Company’s customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required, which would be charged against earnings.
The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. If the financial condition of the Company’s customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required, which would be charged against earnings.
Warranty:
The Company provides for the estimated cost of product warranties at the time revenue is recognized. While the Company engages in extensive product quality programs and processes, including actively monitoring and evaluating the quality of its component suppliers, the Company’s warranty obligation is affected by product failure rates, material usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, material usage or service delivery costs differ from the Company’s estimates, revisions to the estimated warranty liability could have a material impact on the Company’s financial position, cash flows or results of operations.
The Company provides for the estimated cost of product warranties at the time revenue is recognized. While the Company engages in extensive product quality programs and processes, including actively monitoring and evaluating the quality of its component suppliers, the Company’s warranty obligation is affected by product failure rates, material usage and service delivery costs incurred in correcting a product failure. Should actual product failure rates, material usage or service delivery costs differ from the Company’s estimates, revisions to the estimated warranty liability could have a material impact on the Company’s financial position, cash flows or results of operations.
Inventory Reserve:
The Company plans inventory procurement and production based on orders received, forecasted demand and supplier requirements. The Company writes down its inventories for estimated obsolescence or unmarketable inventories equal to the difference between the cost of inventories and its net realizable value based upon estimates about future demand from our customers and distributors and market conditions. Because some of the Company’s products are highly dependent on government and third-party funding, current customer use and validation, and completion of regulatory and field trials, there is a risk that we will forecast incorrectly and purchase or produce excess inventory. As a result, actual demand may differ from forecasts, and such a difference may have a material adverse effect on future results of operations due to required write-offs of excess or obsolete inventory. This inventory risk may be further compounded for the CryoSeal family of products because they are at initial market introduction and market acceptance will depend upon the customer accepting the products as clinically useful, reliable, accurate and cost effective compared to existing and future products and completion of required clinical or field acceptance trials.
The Company plans inventory procurement and production based on orders received, forecasted demand and supplier requirements. The Company writes down its inventories for estimated obsolescence or unmarketable inventories equal to the difference between the cost of inventories and its net realizable value based upon estimates about future demand from our customers and distributors and market conditions. Because some of the Company’s products are highly dependent on government and third-party funding, current customer use and validation, and completion of regulatory and field trials, there is a risk that we will forecast incorrectly and purchase or produce excess inventory. As a result, actual demand may differ from forecasts, and such a difference may have a material adverse effect on future results of operations due to required write-offs of excess or obsolete inventory. This inventory risk may be further compounded for the CryoSeal family of products because they are at initial market introduction and market acceptance will depend upon the customer accepting the products as clinically useful, reliable, accurate and cost effective compared to existing and future products and completion of required clinical or field acceptance trials.
Results of Operations for the Three Months Ended December 31, 2007 as Compared to the Three Months
Ended December 31, 2006
Net Revenues:
Revenues for the three months ended December 31, 2007 were $5,487,000 compared to $3,716,000 for the three months ended December 31, 2006, an increase of $1,771,000 or 48%. This is primarily due to an increase in BioArchive device shipments, eight in the current quarter versus three in the second quarter of fiscal 2007, which contributed to an increase in revenues of approximately $900,000. Revenues from AXP disposables were $1,384,000, for the three months ended December 31, 2007 compared to $589,000 for the three months ended December 31, 2006. We have continued to improve the quality output from our supplier and were able to fulfill more of our AXP disposable backlog in the current quarter.
Revenues for the three months ended December 31, 2007 were $5,487,000 compared to $3,716,000 for the three months ended December 31, 2006, an increase of $1,771,000 or 48%. This is primarily due to an increase in BioArchive device shipments, eight in the current quarter versus three in the second quarter of fiscal 2007, which contributed to an increase in revenues of approximately $900,000. Revenues from AXP disposables were $1,384,000, for the three months ended December 31, 2007 compared to $589,000 for the three months ended December 31, 2006. We have continued to improve the quality output from our supplier and were able to fulfill more of our AXP disposable backlog in the current quarter.
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The following represents the Company’s cumulative BioArchive devices sold into the following
geographies through the dates indicated:
| December 31, | ||||||||
| 2007 | 2006 | |||||||
United States |
37 | 30 | ||||||
Asia |
57 | 53 | ||||||
Europe |
45 | 37 | ||||||
Rest of World |
27 | 25 | ||||||
| 166 | 145 | |||||||
The following represents the Company’s revenues for disposables by product line for the three
months ended:
| December 31, | ||||||||
| 2007 | 2006 | |||||||
BioArchive |
$ | 774,000 | $ | 950,000 | ||||
AXP |
1,384,000 | 589,000 | ||||||
CryoSeal |
289,000 | 138,000 | ||||||
TPD |
113,000 | 117,000 | ||||||
| $ | 2,560,000 | $ | 1,794,000 | |||||
Percentage of total
Company revenues |
47 | % | 48 | % | ||||
Gross Profit:
The Company’s gross profit was $1,910,000 or 35% of net revenues for the three months ended December 31, 2007, as compared to $789,000 or 21% for the corresponding fiscal 2007 period. The increase in gross profit is primarily due to costs of $500,000 that were charged in the second quarter of the prior year for the destruction of lots and product testing as part of the quality assurance program of the AXP bagset disposables. There were no similar charges in the second quarter of fiscal 2008. Additionally, as our production volume of the AXP bagset disposables increased we absorbed overhead costs of approximately $200,000.
The Company’s gross profit was $1,910,000 or 35% of net revenues for the three months ended December 31, 2007, as compared to $789,000 or 21% for the corresponding fiscal 2007 period. The increase in gross profit is primarily due to costs of $500,000 that were charged in the second quarter of the prior year for the destruction of lots and product testing as part of the quality assurance program of the AXP bagset disposables. There were no similar charges in the second quarter of fiscal 2008. Additionally, as our production volume of the AXP bagset disposables increased we absorbed overhead costs of approximately $200,000.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $2,357,000 for the three months ended December 31, 2007, compared to $2,300,000 for the comparable fiscal 2007 period, an increase of $57,000 or 2%. The increase is primarily due to an increase in salary and benefits for additional sales and marketing personnel.
Selling, general and administrative expenses were $2,357,000 for the three months ended December 31, 2007, compared to $2,300,000 for the comparable fiscal 2007 period, an increase of $57,000 or 2%. The increase is primarily due to an increase in salary and benefits for additional sales and marketing personnel.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses for the three months ended December 31, 2007, were $1,617,000
compared to $973,000 for the corresponding fiscal 2007 period, an increase of $644,000 or 66%. The
increase is primarily due to stock compensation, salaries and benefits of approximately $500,000
related to the Chief Technology Architect, a new position filled by the Company’s former Chief
Executive Officer as of August 1, 2007 as part of the succession plan.
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Results of Operations for the Six Months Ended December 31, 2007 as Compared to the Six Months
Ended December 31, 2006
Net Revenues:
Revenues for the six months ended December 31, 2007 were $9,119,000, compared to $8,021,000 for the six months ended December 31, 2006, an increase of $1,098,000 or 14%. The increase is primarily due to revenues from AXP disposables which were $2,102,000, for the six months ended December 31, 2007 compared to $590,000 for the six months ended December 31, 2006. As discussed above, the revenue increase is due to higher AXP disposables sales volume. This was offset by a decrease in development milestone payments and license fees of approximately $400,000.
Revenues for the six months ended December 31, 2007 were $9,119,000, compared to $8,021,000 for the six months ended December 31, 2006, an increase of $1,098,000 or 14%. The increase is primarily due to revenues from AXP disposables which were $2,102,000, for the six months ended December 31, 2007 compared to $590,000 for the six months ended December 31, 2006. As discussed above, the revenue increase is due to higher AXP disposables sales volume. This was offset by a decrease in development milestone payments and license fees of approximately $400,000.
The following represents the Company’s revenues for disposables by product line for the six months
ended:
| December 31, | ||||||||
| 2007 | 2006 | |||||||
BioArchive |
$ | 1,583,000 | $ | 1,737,000 | ||||
AXP |
2,102,000 | 590,000 | ||||||
CryoSeal |
580,000 | 255,000 | ||||||
TPD |
203,000 | 212,000 | ||||||
| $ | 4,468,000 | $ | 2,794,000 | |||||
Percentage of total
Company revenues |
49 | % | 35 | % | ||||
Gross Profit:
The Company’s gross profit was $3,119,000 or 34% of net revenues for the six months ended December 31, 2007, as compared to $2,501,000 or 31% for the corresponding fiscal 2007 period. The increase in gross profit is primarily due to $500,000 in costs that were charged in the second quarter of the prior year for the destruction of lots and product testing as part of the quality assurance program of the AXP bagset disposables, offset by approximately $90,000 in similar costs in the first quarter of the current year. This increase was offset by an accrual of $300,000 to retrofit AXP devices and docking stations to address various quality issues experienced by high usage customers.
The Company’s gross profit was $3,119,000 or 34% of net revenues for the six months ended December 31, 2007, as compared to $2,501,000 or 31% for the corresponding fiscal 2007 period. The increase in gross profit is primarily due to $500,000 in costs that were charged in the second quarter of the prior year for the destruction of lots and product testing as part of the quality assurance program of the AXP bagset disposables, offset by approximately $90,000 in similar costs in the first quarter of the current year. This increase was offset by an accrual of $300,000 to retrofit AXP devices and docking stations to address various quality issues experienced by high usage customers.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $4,777,000 for the six months ended December 31, 2007, compared to $4,612,000 for the comparable fiscal 2007 period, an increase of $165,000 or 4%. The increase is primarily due to an increase in salary and benefits for additional sales and marketing personnel as well as year over year merit increases.
Selling, general and administrative expenses were $4,777,000 for the six months ended December 31, 2007, compared to $4,612,000 for the comparable fiscal 2007 period, an increase of $165,000 or 4%. The increase is primarily due to an increase in salary and benefits for additional sales and marketing personnel as well as year over year merit increases.
Research and Development Expenses:
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Included in this line item are Engineering, Regulatory Affairs, Scientific and Clinical Affairs.
Research and development expenses for the six months ended December 31, 2007, were $3,113,000
compared to $1,935,000 for the corresponding fiscal 2007 period, an increase of $1,178,000 or 61%.
The increase is primarily due to stock compensation, salaries and benefits of approximately $860,000 related to the Chief
Technology Architect, a new position filled by the Company’s former Chief Executive Officer as of
August 1, 2007 as part of the succession plan and payments made to UC Davis in connection with a
collaboration agreement to develop stem cell treatments.
Liquidity and Capital Resources
At December 31, 2007, the Company had cash, cash equivalents and short-term investments of $30,491,000 and working capital of $34,738,000. This compares to cash, cash equivalents and short-term investments of $33,379,000 and working capital of $37,759,000 at June 30, 2007. The cash was used to fund operations and other cash needs 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. As of December 31, 2007, the Company has no off-balance sheet arrangements.
At December 31, 2007, the Company had cash, cash equivalents and short-term investments of $30,491,000 and working capital of $34,738,000. This compares to cash, cash equivalents and short-term investments of $33,379,000 and working capital of $37,759,000 at June 30, 2007. The cash was used to fund operations and other cash needs 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. As of December 31, 2007, the Company has no off-balance sheet arrangements.
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Net cash used in operating activities for the six months ended December 31, 2007 was $3,485,000,
primarily due to the net loss of $4,017,000 which included the accretion of discount on short-term
investments of $564,000, offset by depreciation and stock based compensation expense of $265,000
and $1,121,000, respectively. Accounts payable utilized $434,000 of cash primarily due to paying
vendors for purchases made at the end of fiscal 2007. Deferred revenue utilized $332,000 of cash
as a result of the amortization of previously received license fees.
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. However, if we experience significant growth in the future, we may be required to raise
additional cash through the issuance of new debt or additional equity.
Backlog
The Company’s cancelable backlog at December 31, 2007 was $3,910,000.
The Company’s cancelable backlog at December 31, 2007 was $3,910,000.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
All sales, domestic and foreign, are made in U.S. dollars and therefore material fluctuations in
foreign currency rates are believed to have no impact on the Company’s net revenues. The Company
has no long-term investments or long-term debt, other than a capital lease, and therefore is not
subject to interest rate risk. Management does not believe that inflation has had or will have a
significant impact on the Company’s results of operations. The Company is not exposed to any
market risk involving activities in derivative financial instruments, other 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
Company’s management, including the Company’s Principal Executive Officer along with the Company’s
Principal Financial Officer, of the effectiveness of the design and operation of the Company’s
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
Company’s Chief Executive Officer along with the Company’s Chief Financial Officer concluded that
the Company’s disclosure controls and procedures are effective in ensuring that information
required to be disclosed by us in reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the Securities
and Exchange Commission’s rules and forms.
There were no changes in the Company’s internal controls over financial reporting that occurred
during the three months ended December 31, 2007 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.
In the normal course of operations, the Company may have disagreements or disputes
with distributors, vendors or employees. These disputes are seen by the Company’s
management as a normal part of business, and there are no pending actions currently
or no threatened actions that management believes would have a significant material
impact on the Company’s 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, 2007, 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.
An Annual Meeting of Stockholders was held on December 14, 2007. The following
matters were voted on:
Proposal 1: Election of five directors to serve until the next Annual Meeting of
Stockholders and until their successors are duly elected and qualified.
Proposal 2: Ratification to appoint Ernst & Young LLP as the Company’s independent
registered public accounting firm for the 2008 fiscal year.
Proposal 3: Stockholder Proposal to amend the Company’s Bylaws and Certificate of
Incorporation; and
A summary of the voting for each proposal submitted is as follows:
Proposal #1
| Election of Directors | For | Withhold | ||||||
Philip H. Coelho |
33,295,314 | 13,500,494 | ||||||
Hubert E. Huckel, M.D. |
43,475,070 | 3,320,738 | ||||||
Patrick McEnany |
40,521,640 | 6,274,168 | ||||||
Woodrow A. Myers, M.D. |
40,254,561 | 6,541,247 | ||||||
William R. Osgood, Ph.D. |
43,108,437 | 3,699,471 | ||||||
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| Proposal #2 | Ratification of Auditors |
| For | Against | Abstain | Not Voted | |||
46,346,198
|
346,315 | 128,112 |
| Proposal #3 | Stockholder Proposal |
| For | Against | Abstain | Not Voted | |||
| 19,189,554 | 9,744,288 | 200,467 | 17,686,316 |
| 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: February 5, 2008 | /s/ William R. Osgood | |||||
| Chief Executive Officer (Principal Executive Officer) |
||||||
| /s/ Matthew T. Plavan | ||||||
| Chief Financial Officer | ||||||
| (Principal Financial Officer and Principal Accounting Officer) |
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Exhibit Index
| 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. |