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| KOOL > SEC Filings for KOOL > Form 10-K on 11-Sep-2009 | All Recent SEC Filings |
11-Sep-2009
Annual Report
CERTAIN STATEMENTS CONTAINED IN THIS SECTION AND OTHER PARTS OF THIS REPORT ON
FORM 10-K WHICH ARE NOT HISTORICAL FACTS ARE FORWARD-LOOKING STATEMENTS AND ARE
SUBJECT TO CERTAIN RISKS AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS MAY
DIFFER SIGNIFICANTLY FROM THE PROJECTED RESULTS DISCUSSED IN THE FORWARD-LOOKING
STATEMENTS. FACTORS THAT MIGHT AFFECT ACTUAL RESULTS INCLUDE, BUT ARE NOT
LIMITED TO, THOSE DISCUSSED IN ITEM 7A "RISK FACTORS" AND OTHER FACTORS
IDENTIFIED FROM TIME TO TIME IN THE COMPANY'S REPORTS FILED WITH THE U.S.
SECURITIES AND EXCHANGE COMMISSION.
The following discussion should be read in conjunction with the Company's
consolidated financial statements contained in this report.
(a) Overview
ThermoGenesis develops, manufactures, and sells medical products that enable the
practice of regenerative medicine. The Company was founded in 1986 and is
located in Rancho Cordova, California. Our products automate the volume
reduction and cryopreservation process of adult stem cell concentrates from cord
blood and bone marrow for use in laboratory and point of care settings. Our
growth strategy is to expand our offerings in regenerative medicine and partner
with other pioneers in the stem cell arena to accelerate our worldwide
penetration in this potentially explosive market.
Critical Accounting Policies:
The Company's discussion and analysis of its financial condition and results of
operations are based upon the Company's consolidated financial statements, which
have been prepared in accordance with accounting principles generally accepted
in the U.S. The preparation of these consolidated financial statements requires
the Company to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses and related disclosure of contingent
assets and liabilities. On an on-going basis, the Company evaluates its
estimates, including those related to stock-based compensation, 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 consolidated
financial statements.
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 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 or income tax expense, which could have a material impact on the
Company's financial position and results of operations.
Revenue Recognition:
The Company recognizes revenue including multiple element arrangements, in
accordance with the provisions of the SEC's 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 collectability 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 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 collectability
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.
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.
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.
Inventory Reserve:
The Company states inventories at lower of cost or market value determined on a
first-in, first-out basis. The Company provides inventory allowances when
conditions indicate that the selling price could be less than cost due to
physical deterioration, obsolescence, changes in price levels, or other causes,
which it includes as a component of cost of product and other revenues.
Additionally, the Company provides reserves for excess and slow-moving inventory
on hand that are not expected to be sold to reduce the carrying amount of
slow-moving inventory to its estimated net realizable value. The reserves are
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 inventories. As a result, actual
demand may differ from forecasts and the Company may be required to record
additional inventory reserves that could adversely impact our gross margins.
Conversely, favorable changes in demand could result in higher gross margins
when products previously reserved are sold.
(b) Results of Operations
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 periods included in the accompanying consolidated
financial statements.
Results of Operations for the Year Ended June 30, 2009 as Compared to the Year
Ended June 30, 2008
Net Revenues:
Net revenues for the year ended June 30, 2009 were $19,799,000 compared to
$21,946,000 for the year ended June 30, 2008, a decrease of $2,147,000 or 10%.
Our decrease in revenues is primarily a result of the slowing global economy
which has impacted the majority of our product lines. The CryoSeal product line
decreased $1,477,000 from the year ended June 30, 2008. Revenues from the
BioArchive product line decreased approximately $1,000,000 as there were six
fewer devices sold in fiscal 2009 as compared to fiscal 2008. The AXP product
line decreased $560,000 primarily due to the timing of bag set orders.
Offsetting these decreases was an increase in revenues of $367,000 due to the
launch of the MXP in fiscal 2009 and Freezer sales increased $370,000 primarily
due to the sale of ten freezers to two different customers.
Sales analysis for the year ending June 30:
2009 2008
Disposable revenues:
AXP/MXP $ 6,531,000 $ 6,828,000
BioArchive 3,766,000 3,757,000
CryoSeal 297,000 1,143,000
10,594,000 54 % 11,728,000 53 %
Non-disposable revenues:
BioArchive 4,262,000 22 % 5,564,000 25 %
Thermoline 2,361,000 12 % 2,058,000 9 %
AXP/MXP 722,000 4 % 594,000 3 %
CryoSeal 37,000 - 481,000 2 %
Milestone payments and license fees 676,000 3 % 866,000 5 %
Other 1,147,000 5 % 655,000 3 %
Total Company revenues $ 19,799,000 100 % $ 21,946,000 100 %
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The following represents the Company's cumulative BioArchive System placements in the following geographies:
June 30
2009 2008
Asia 64 58
United States 49 46
Europe 51 47
Rest of World 38 30
202 181
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Gross Profit:
The Company's gross profit was $5,693,000 or 29% of net revenues for the year
ended June 30, 2009, as compared to $6,970,000 or 32% for the year ended
June 30, 2008. The lower gross profit was due to a lower volume of disposable
products and additional inventory allowances and reserves for obsolete inventory
at AXP bag set suppliers, excess AXP device inventory given the planned
transition to an upgraded AXP device and excess CryoSeal inventory. These were
offset by lower warranty costs for the BioArchive and CryoSeal products and
lower material costs on the AXP bag sets.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $9,249,000 for the year ended
June 30, 2009, compared to $10,165,000 for the year ended June 30, 2008, a
decrease of $916,000 or 9%. The decrease is primarily due to lower salaries and
benefits of $580,000 as there were four management positions open during the
year, and lower legal fees of $325,000, as there was $300,000 of legal fees
incurred in fiscal 2008 associated with the GEHC distribution agreement
negotiations and for consultation during the voluntary recall effort. Recruiting
costs decreased $275,000 in fiscal 2009 as there were expenses paid in fiscal
2008 in searches for new board members and executive officers. Additionally,
stock compensation expense decreased $220,000. These decreases were offset by an
increase in severance expense of $500,000 in fiscal 2009 primarily due to the
severance accruals for the Company's former Chief Executive Officer and vice
presidents of sales and marketing.
Research and Development Expenses:
Research and development expenses for the year ended June 30, 2009 were
$5,222,000 compared to $7,172,000 for fiscal 2008, a decrease of $1,950,000 or
27%. The decrease is primarily due to a decrease in stock compensation expense
of $1,230,000 as the restricted stock awarded to the company's former Chief
Technology Architect (CTA) fully vested in April 2008, a decrease of $330,000 in
expenses associated with the Vantus subsidiary which was formed in February 2008
and a reduction of $460,000 of expenses for new product development.
Management believes that product development and refinement are essential to
maintaining the Company's market position. Therefore, the Company considers
these costs as continuing costs of doing business. No assurances can be given
that the products or markets recently developed or under development will be
successful.
Results of Operations for the Year Ended June 30, 2008 as Compared to the Year
Ended June 30, 2007
Net Revenues:
Net revenues for the year ended June 30, 2008 were $21,946,000 compared to
$16,751,000 for the year ended June 30, 2007, an increase of $5,195,000 or 31%.
The increase is primarily due to revenues from AXP disposables, which increased
$4,271,000 due to higher sales volume from existing customers. Additionally,
revenues from BioArchive devices and accessories increased $1,111,000 as there
were 27 shipments of devices in fiscal 2008 compared to 20 shipments in fiscal
2007. These increases were offset by a decrease in development milestone
payments and license fees of approximately $800,000.
The following represents the Company's cumulative BioArchive Systems in the
following geographies:
June 30
2008 2007
Asia 58 56
United States 46 33
Europe 47 40
Rest of World 30 26
181 155
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The following represents the Company's revenues for disposables by product line:
June 30
2008 2007
AXP $ 6,828,000 $ 2,557,000
BioArchive 3,757,000 3,290,000
TPD 257,000 493,000
CryoSeal 886,000 365,000
$ 11,728,000 $ 6,705,000
Percentage of total Company revenues 53 % 40 %
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Gross Profit:
The Company's gross profit was $6,970,000 or 32% of net revenues for the year
ended June 30, 2008, as compared to $5,197,000 or 31% for the year ended
June 30, 2007. The gross margin for fiscal 2008 was impacted by the costs
associated with the voluntary recall of AXP disposable bag sets. The incremental
costs of $386,000 were for testing, materials and the destruction of bag sets
which were not considered resalable. No bag set lots have failed the requisite
testing performed on the recalled inventory. This was offset by lower warranty
costs for the CryoSeal and BioArchive devices.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $10,165,000 for the year ended
June 30, 2008, compared to $9,630,000 for the year ended June 30, 2007, an
increase of $535,000 or 6%. The increase is due to increased legal costs
primarily related to the discussions with GEHC regarding the distribution
agreement and consultation during the voluntary AXP recall effort.
Research and Development Expenses:
Research and development expenses for the year ended June 30, 2008 were
$7,172,000 compared to $4,108,000 for fiscal 2007, an increase of $3,064,000 or
75%. The increase is primarily due to stock compensation, salaries and
consulting fees of approximately $1,800,000 related to the CTA, a position
filled by the Company's former Chief Executive Officer as of August 1, 2007.
Effective May 1, 2008, the CTA resigned to become a consultant to the Company.
Also adding to the increase in research and development was $620,000 in expenses
associated with the Vantus subsidiary, a $350,000 increase in operating supplies
for cell therapy research projects and payments made to UC Davis of $130,000 in
connection with an agreement to develop stem cell treatments.
(c) Liquidity and Capital Resources
At June 30, 2009, the Company had a cash, cash equivalents, and short-term
investments balance of $15,631,000 and working capital of $20,884,000. This
compares to a cash and short-term investments balance of $25,287,000 and working
capital of $29,978,000 at June 30, 2008. 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 million, net of
expenses, through common and preferred stock financings and option and warrant
exercises.
Net cash used in operating activities for the year ended June 30, 2009 was
$8,757,000, primarily due to the net loss of $8,550,000, which included the
accretion of discount on short-term investments of $161,000, offset by
depreciation and stock based compensation expense of $474,000 and $479,000,
respectively. Accounts payable used $2,405,000 of cash due to paying vendors for
purchases made late in the prior fiscal year, primarily for disposable products.
Accounts receivable generated $1,741,000 in cash for the year ended June 30,
2009. Investing activities generated $11,041,000 of cash primarily due to
short-term investments maturing.
We believe that our currently available cash, cash equivalents and short-term
investments, and cash generated from operations will be sufficient to satisfy
our operating and working capital requirements for at least the next twelve
months. We have experienced some slowing in our customers' spending as a result
of deterioration in credit markets. As we anticipate this trend to continue into
fiscal 2010, we have reduced expenses without sacrificing development plans we
consider essential to our near term revenue growth and do no anticipate we will
have to seek additional debt or equity capital.
The Company generally does not require extensive capital equipment to produce or
sell its current products. In fiscal 2007, the Company spent $621,000 primarily
for office furniture for the new leased
facility, manufacturing equipment for the AXP product line and laboratory
equipment. In fiscal 2008, the Company spent $514,000 for development of the
Company's website, laboratory equipment and manufacturing equipment. In fiscal
2009, the Company spent $1,047,000 for quality system software, centrifuges to
be placed at MXP customer sites, tooling for new products or additional vendors
and computer equipment.
During the fiscal year ended June 30, 2009, revenues from one significant
customer, GEHC, totaled $7,735,000 or 39% of net revenues. During the fiscal
year ended June 30, 2008, revenues from one significant customer, GEHC, totaled
$13,310,000 or 61% of net revenues. During the fiscal year ended June 30, 2007,
revenues from one significant customer, GEHC, totaled $7,502,000 or 45% of net
revenues.
At June 30, 2009, the Company had two customers that individually accounted for
43% and 19% of accounts receivable. At June 30, 2008, the Company had two
customers that individually accounted for 60% and 14% of accounts receivable.
The Company manages the concentration of credit risk with these customers
through a variety of methods including, letters of credit with financial
institutions, pre-shipment deposits, credit reference checks and credit limits.
Although management believes that these customers are sound and creditworthy, a
severe adverse impact on their business operations could have a corresponding
material effect on their ability to pay timely and therefore on our net
revenues, cash flows and financial condition.
Off Balance Sheet Arrangements:
As of June 30, 2009, the Company had no off-balance sheet arrangements.
Contractual Obligations:
As of June 30, 2009, the Company had the following contractual obligations and
commercial commitments:
Contractual Obligations Payments Due by Period
Less than After 5
Total 1 year 1-3 years 4-5 years years
Capital Lease Obligations $ 9,000 $ 5,000 $ 4,000 - -
Operating Leases 1,623,000 642,000 981,000 - -
Total Contractual Cash Obligations $ 1,632,000 $ 647,000 $ 985,000 - -
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