would lead to a settlement of these lawsuits or what the terms or timing of any
such settlement might be, if it occurs at all.
We have undertaken a review of our various job classifications for legal compliance under
state and federal employment laws. Based on that review, we have identified certain job
classifications that may be subject to possible challenge and for which there is a reasonable
possibility that we could incur a liability, although we also believe that the present
classifications can be supported and defended. It is not possible based on the current available
information to reasonably estimate the scope of any potential liability.
Critical Accounting Estimates
Our condensed consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the U.S., or GAAP. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses. We base our estimates on historical experience and on various
other assumptions that we believe 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.
Our critical accounting policies include:
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revenue recognition; |
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accounting for stock-based compensation; |
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accounting for accounts receivable; |
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accounting for research and development expenses; and |
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accounting for the Mothers Work indemnification agreement. |
Revenue Recognition. Our revenues are currently generated principally through our
umbilical cord blood preservation and storage activities. We recognize revenue in accordance with
SEC Staff Accounting Bulletin No. 101 Revenue Recognition in Financial Statements, (SAB 101) as
amended by SAB 104, Revenue Recognition, corrected copy, and Emerging Issues Task Force (EITF)
Issue No. 00-21 Revenue Arrangements with Multiple Deliverables (EITF 00-21) for all revenue
transactions entered into in fiscal periods beginning after June 30, 2003. We receive fees for
collecting, testing, freezing and storing of umbilical cord blood units and recognize revenue upon
the successful completion of these processes. Storage revenue is deferred and recognized over the
storage period. We analyze our multiple element arrangements entered into after June 30, 2003 to
determine whether the elements can be separated and accounted for individually as separate units of
accounting in accordance with EITF No. 00-21 . We recognize fees received from collecting, testing
and freezing processes (collectively known as processing) as revenue if it has stand alone value
to the customer and the fair value of the undelivered storage services can be determined. We have
concluded that the collection, testing and freezing service has stand alone value to the customer.
The fair value of our processing service cannot be determined but we have objective evidence of the
fair value of the undelivered storage. The fair value of the storage is equal to the annual
storage fee charged to customers on a stand-alone basis. We charge an initial fee which covers
collection, testing, freezing, and, typically, one year of
storage. We defer the fair value of the revenue related to the future storage of the unit and
recognize the remainder of the revenue for processing under the residual method.
Accounting for Stock-Based Compensation. We have one stock-based employee compensation
plan. We have followed Statement of Financial Accounting Standards No. 123(R)
Share-Based Payment
(SFAS 123R) since our January 1, 2006 adoption using the modified prospective method, which
results
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in the provisions of SFAS 123R only being applied to the consolidated financial statements
on a going-forward basis (that is, the prior period results have not been restated). Under the fair
value recognition provisions of SFAS 123R, stock-based compensation expense is measured at the
grant date based on the value of the award and is recognized as expense over the requisite service
period.
We utilize the Black Scholes option pricing model to calculate the fair value of stock options
granted under SFAS 123(R). We are required to make significant estimates to note all required
inputs to the Black Scholes model including expected volatility and expected term. Changes in the
subjective input assumptions can materially affect the fair value estimate of stock-based
compensation expense. Our expected stock-price volatility assumption is based on both current
implied volatility and historical volatilities of the underlying stock which is obtained from
public data sources. Higher estimated volatility increases the fair value of a stock option, and
therefore increases the expense to be recognized for each stock option. We also determined the
weighted-average option life assumption based on the exercise behavior that different employee
groups exhibited historically, adjusted for specific factors that may influence future exercise
patterns. Longer expected term assumptions increase the fair value of the stock option, and
therefore increase the expense to be recognized for each stock option.
Accounting for accounts receivable. Accounts receivable consists of amounts primarily
due from customers that have used the ViaCord service offering. Accounts receivable are stated at
amounts due from customers, net of an allowance for doubtful accounts. We determine the allowance
by considering receivables that are past due, our previous loss history, and the customers current
ability to pay its obligations. We write off accounts receivable when they become uncollectible and
payments subsequently received on such accounts receivable are credited to the allowance for
doubtful accounts.
Accounting for research and development expenses. Our research and development expenses
consist primarily of costs associated with development of our stem cell product candidates,
including the recently completed Phase 1 clinical trial of our expanded umbilical cord blood
product candidate, CB001, and development of ViaCyte, our oocyte cryopreservation product
candidate. These expenses represent both preclinical and clinical development costs, and the costs
associated with non-clinical support activities such as toxicological testing, manufacturing,
process development and regulatory consulting services. Clinical development costs represent
internal costs for personnel, external costs incurred at clinical sites and contracted payments to
third party clinical research organizations to perform certain clinical trials. Our product
candidates do not currently have regulatory approval; accordingly, we expense license fees and
milestone payments when we incur the liability. We accrue research and development expenses for
activities occurring during the fiscal period prior to receiving invoices from clinical sites and
third party clinical research organizations. We accrue external costs for clinical studies based on
the progress of the clinical trials, including patient enrollment, progress by the enrolled
patients through the trial, and contracted costs with clinical sites. We record internal costs
primarily related to personnel in clinical development and external costs related to non-clinical
studies and basic research when incurred. Significant judgments and estimates must be made and used
in determining the accrued balance in any accounting period. Actual costs incurred may or may not
match the estimated costs for a given accounting period. We expect that our research and
development expenses will increase for the foreseeable future as we add personnel, expand our
clinical trial activities and increase our discovery research capabilities. The amount of these
potential increases is difficult to predict due to the uncertainty
inherent in the timing of clinical trials, progress in our discovery research program, the
rate of patient enrollment and the detailed design of future trials. In addition, the results from
our trials, as well as the results of trials of similar drugs under development by others, will
influence the number, size and duration of both planned and unplanned trials.
26
Accounting for the Mothers Work indemnification agreement. In August 2006, we entered into a
data license and marketing services agreement with Mothers Work, Inc., the worlds largest designer
and retailer of maternity apparel. Mothers Work operates several large maternity store retail
chains such as Motherhood Maternity ®, A Pea in the Pod ®,
Mimi Maternity ®, and Destination Maternity tm. Under the
terms of our agreement, Mothers Work has granted us an exclusive license within the field of
preserving stem cells from cord blood and other sources to market directly to those Mothers Work
customers who have affirmatively agreed to permit disclosure of their data and information. Mothers
Work has also agreed to provide certain in-store marketing services related to the ViaCord service
offering. The agreement can be terminated early by either company if the other company commits a
material breach of the agreement or under certain circumstances arising from claims by a third
party alleging that the third party has rights that supersede Mothers Works commitment to us. The
dispute between Mothers Work and the third party was the subject of an arbitration proceeding. In
February 2007, the arbitrator ruled in favor of Mothers Work. The arbitrator has denied a
challenge to his ruling by the third party. While there is no assurance that the third party will
not again challenge the ruling, we believe that reversal of the ruling is unlikely and that the
termination rights under our agreement with Mothers Work are unlikely to be triggered. As a
condition to commencing the agreement on January 1, 2007, we agreed to indemnify Mothers Work for
any damages that Mothers Work may be assessed in the event that Mothers Work is found to be in
breach of its agreement with the third party as a result of having entered into an agreement with
us. We also agreed to reimburse Mothers Work for certain legal fees if the fees exceed a specified
threshold. FASB Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45), requires us to record
a liability based on the estimated fair value of the indemnification provided. Our potential
obligation to Mothers Work under the indemnification agreement is unlimited. However, based on our
assessment of the amount of damages and legal fees that could be payable, and the low likelihood
that they might have to be paid given the arbitrators ruling, we concluded the fair value of our
indemnification obligation is not material and have not recorded a liability as of March 31, 2007.
Our assumptions involve judgments by management and are subject to change based on on-going
developments or binding results of the arbitration proceedings that could result in materially
different results than our current estimate.
Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and Financial
Liabilities Including an amendment of FASB Statement No. 115 (SFAS 159), which permits
entities to choose to measure many financial instruments and certain other items at fair value.
SFAS 159 will be effective for the first fiscal year that begins after November 15, 2007. We have
not yet completed our evaluation of the impact of adoption of SFAS 159 on our financial condition
or results of operations.
In September 2006, FASB issued Statement of Financial Accounting Standards No. 157,
Fair Value Measurements (SFAS No. 157) which defines fair value under GAAP, establishes a
framework for measuring fair value in accordance with GAAP, and expands disclosures about fair
value
measurements. Where applicable, SFAS No. 157 simplifies and codifies related guidance within
GAAP and does not require any new fair value measurements. SFAS No. 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and interim periods within
those fiscal years. We do not expect the adoption of SFAS No. 157 to have a significant
effect on our financial condition or results of operations.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Investment Risk
We own financial instruments that are sensitive to market risks as part of our investment
portfolio. We use this investment portfolio to preserve our capital until it is required to fund
operations, including our research and development activities. Our investment portfolio includes
only marketable securities with active secondary or resale markets to help ensure portfolio
liquidity, and we have implemented guidelines limiting the duration of investments. We invest in
highly-rated commercial paper with maturities of less than two years and money market funds. None
of these market-risk sensitive instruments is held for trading purposes. We do not own derivative
financial instruments in our investment portfolio.
Foreign Exchange Risk
Transactions by our German and Singapore subsidiaries are recorded in Euros and Singapore
dollars, respectively. Exchange gains or losses resulting from the translation of these
subsidiaries financial statements into U.S. dollars are included as a separate component of
stockholders equity. We hold Euro-based and Singapore dollar-based currency accounts to mitigate
foreign currency transaction risk. Since the expenses of these subsidiaries are denominated in
Euros and Singapore dollars, the fluctuations of exchange rates may adversely affect our results of
operations, financial condition and cash flows.
Interest Rate Risk
We invest our cash in a variety of financial instruments, principally securities issued by the
U.S. government and its agencies, investment grade corporate and money market instruments. These
investments are denominated in U.S. dollars. These bonds are subject to interest rate risk, and
could decline in value if interest rates fluctuate. Due to the conservative nature of these
instruments, we do not believe that we have a material exposure to interest rate risk.
ITEM 4. CONTROLS AND PROCEDURES
Under the supervision and with the participation of
our management, including our principal executive officer and principal financial officer, we have
evaluated the effectiveness of the design and operation of our disclosure controls and procedures
as of March 31, 2007 and, based on their evaluation, our principal executive officer and principal
financial officer have concluded that these controls and procedures are effective. Disclosure
controls and procedures are our controls and other procedures that are designed to ensure that
information required to be disclosed by us in the reports that we file or submit under the
Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported,
within the time periods specified in the Securities and Exchange Commissions rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by us in the reports that we file under the
Securities Exchange Act is
accumulated and communicated to our management, including our principal executive officer and
principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
There were no changes in our internal controls over financial reporting during the quarter
ended March 31, 2007 that have materially affected, or are reasonably likely to materially affect,
our internal controls over financial reporting.
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PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The section entitled Litigation in Notes to Condensed Consolidated
Financial Statements in Part I of this Quarterly Report on Form 10-Q is incorporated into this
item by reference.
ITEM 1A. RISK FACTORS
This report contains forward-looking statements, including statements about our current
projections as to future financial performance, our expectations as to events and potential results
related to our research and development programs, and our views as to the possible outcome of
pending litigation related to our intellectual property portfolio and other disputes. We have based
these forward-looking statements on our current expectations about such future events. While we
believe these expectations are reasonable, forward-looking statements are inherently subject to
risks and uncertainties, many of which are beyond our control. Our actual results may differ
materially from those suggested by these forward-looking statements for various reasons, including
those discussed in this Risk Factors section. Given these risks and uncertainties, you are
cautioned not to place substantial weight on forward-looking statements. The forward-looking
statements included in this report are made only as of the date of this report. We do not undertake
any obligation to update or revise any of these statements.
We may not achieve our goal of becoming cash flow positive, and may never become profitable.
We have generated operating losses since our inception. As of March 31, 2007, we had
cumulative net losses of approximately $201.2 million. These losses have resulted principally from
the costs of our research and development activities, which have totaled approximately $118.9
million since our inception. We expect that our research and development expenses will continue to
increase over the next several years as a result of increased costs and expenses associated with
our ViaCyte clinical trial and possible future clinical trials of other product candidates,
including our preclinical product candidate being studied as a potential treatment for cardiac
disease, if preclinical data supports moving forward. Future research and development expenses may
also include costs associated with product candidates that we might license or acquire, and, if our
programs are successful, costs and expenses associated with submissions for regulatory approvals
and the expansion of clinical and commercial scale manufacturing facilities. However, the amount of
these increases is difficult to predict, and will depend on a number of factors, such as results of
our clinical and preclinical programs, the design of future clinical trials, the results of our
efforts to acquire or license new technologies, and decisions made with respect to advancement of
our clinical and preclinical programs. Furthermore, we may make additional sales and marketing
investments in our Reproductive Health business, if deemed advisable to expand the market for our
ViaCord service offering or to market new products or service offerings that we may license or
acquire. Our ability to become cash flow positive and to achieve profitability, and the timing of
such events, will depend on many factors, including some or all of the following:
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our ability to increase sales of our ViaCord service offering
particularly in the face of significant competition; |
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continued acceptance in the marketplace for private cord blood banking; |
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the impact of any unexpected issues or failures related to the
collection, processing, or storage of umbilical cord blood by us or
others in the industry; |
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the impact of any potential adverse outcome in the patent infringement
lawsuits brought against us by PharmaStem, including legal expenses,
and the material impact on our business if PharmaStem were able to
obtain an injunction; |
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the level of our expenses, including as a result of difficulties or
delays related to our research and development programs, and any
unexpected expenses; and |
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the overall net impact on revenues and expenses of new licensing
deals, collaborations or other strategic efforts. |
We cannot assure you that we will ever become cash flow positive or profitable. Other factors
that may affect our ability to become cash flow positive and profitable are described in more
detail elsewhere in this Risk Factors section.
We may not be able to sustain our current level of revenues or our recent growth rates.
Revenues from sales of ViaCord were $14.4 million in the first quarter of 2007 and have grown
significantly over the past several years, from $7.1 million in 2001, to $20.1 million, $30.9
million, $36.8 million, $43.8 million and $54.1 million in 2002, 2003, 2004, 2005 and 2006,
respectively. We believe that this revenue growth is a result of our increased marketing efforts
and from increased awareness by the public generally of the concept of umbilical cord blood
preservation. We may not be able to sustain this growth rate or the current level of ViaCords
revenues in the future. The principal factors that may adversely affect our revenues include
competition from other private cord blood banks, any decline in the market or market acceptance for
cord blood banking, the impact of recommendations as to public banking over private banking from
physician groups, such as the policy statement issued by the American Academy of Pediatricians, the
risks associated with litigation, in particular, the pending PharmaStem litigation, the risk of
operational issues, the risks of not being able to maintain relationships with key third party
marketing partners, and the risks of reputational damage. These and other risks that may affect our
future revenues are described in more detail elsewhere in this Risk Factors section. If we are
unable to sustain our revenues, we may need to reduce our research and development activities or
raise additional funds earlier than anticipated or on unfavorable terms, and our stock price may be
adversely affected.
If we do not prevail in the PharmaStem litigation, we may be prevented from selling our ViaCord
service offering or may have to incur significant expenses.
In 2002, PharmaStem Therapeutics, Inc. filed suit against us and several other defendants in
the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patents No.
5,004,681 (681) and No. 5,192,553 (553), relating to certain aspects of the collection,
cryopreservation and storage of hematopoietic stem cells and progenitor cells from umbilical cord
blood. We believe that we do not infringe these patents and that the patents are invalid.
In 2003, a jury ruled against us and the other defendants, Cbr Systems Inc., CorCell, Inc., a
subsidiary of Cord Blood America Inc., and Cryo-Cell International Inc, who represent a majority of
the family cord blood preservation industry, finding that the patents were valid and enforceable
and that the
defendants infringed the patents. A judgment was entered against us for approximately $2.9
million, based on 6.125% royalties on our revenues from the processing and storage of umbilical
cord blood since
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April 2000. In 2004, the District Court judge in the case overturned the jurys
verdict and entered judgment in our favor and against PharmaStem, stating that PharmaStem had
failed to prove infringement. Consequently, we have not recorded a liability as of March 31, 2007.
PharmaStem has appealed the judges decision. We have appealed the jurys finding as to validity of
the patents. A hearing on the appeal was held at the U.S. Court of Appeals for the Federal Circuit
on April 4, 2006. A final ruling has not been issued in the appeal.
In July 2004, PharmaStem filed a second complaint against us. The second complaint was filed
in the U.S. District Court for the District of Massachusetts, alleging infringement of U.S. Patents
No. 6,461,645 (645) and 6,569,427 (427), which also relate to certain aspects of the collection,
cryopreservation and storage of hematopoietic stem cells and progenitor cells from umbilical cord
blood. We believe that the patents in this new action are invalid and that we do not infringe them.
On January 7, 2005, PharmaStem filed a Motion for Preliminary Injunction in the Massachusetts
litigation. That motion is currently stayed. We believe the issues presented in this case are
substantially the same as the issues presented in the original Delaware litigation. Accordingly, we
filed a motion to consolidate the Massachusetts case with six other actions against other
defendants in a single proceeding in the District of Delaware. On February 16, 2005, our request
was granted. The cases have been consolidated in Delaware.
On October 6, 2005, the Delaware court granted our motion to stay all discovery in the second
lawsuit pending decisions from the Federal Circuit on PharmaStems appeal of the District Court of
Delawares ruling in the original case and from the U.S. Patent and Trademark Office (U.S. PTO)
on the patent re-examinations described below.
In late 2006, the U.S. PTO issued final decisions in the existing re-examination of both the
553 method patent and the 681 composition patent at issue in the first case and the 645 and the
427 patents at issue in the second case based on prior art. The U.S. PTO had ordered a second
re-examination of the 427 patent in order to determine whether certain claims of the patent should
expire in 2008, rather than in 2010. The U.S. PTO issued notice of its intent to allow the
remaining claims of all of the patents.
In either of the pending cases, if we are ultimately found to infringe valid claims of the
PharmaStem patents, we could have a significant damages award entered against us. If we are found
to infringe at anytime during the course of either case, including if the court of appeals were to overturn
the district courts non-infringement ruling, we could also face an injunction which could prohibit
us from further engaging in the umbilical cord stem cell business absent a license from PharmaStem.
PharmaStem would be under no legal obligation to grant us a license or to do so on economically
reasonable terms, and previously informed us that it would not do so after October 15, 2004. While
we do not believe this outcome is likely, in the event of an injunction, if we are not able to
obtain a license under the disputed patents on economically reasonable terms or at all and we
cannot operate under an equitable doctrine known as intervening rights, we could be required to
stop preserving and storing cord blood and to cease using cryopreserved umbilical cord blood as a
source for stem cell products. We may enter into settlement negotiations with PharmaStem regarding
the litigation. We cannot predict whether any such negotiations would lead to a settlement of these
lawsuits or what the terms or timing of any such settlement might be, if it occurs at all.
A loss in either of the PharmaStem lawsuits could have a material adverse effect on our
ability to generate revenues from our ViaCord service offering, which is currently our only
commercialized product, and would have a significant adverse impact on our business, financial
condition, results of
operations and stock price. Even if we ultimately prevail, we are likely to incur significant
legal expenses during the course of the cases.
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A third party may again seek to challenge the arbitrators decision related to our agreement
with Mothers Work.
We have an agreement with Mothers Work related to the marketing of our ViaCord service
offering. The agreement can be terminated early by either company if the other company commits a
material breach of the agreement or under certain circumstances arising from claims by a third
party alleging that the third party has rights that supersede Mothers Works commitment to us. A
third party has claimed that it has rights under an agreement with Mothers Work that supersede
Mothers Works commitment to us. The dispute between Mothers Work and the third party was the
subject of an arbitration proceeding. In February 2007, the arbitrator ruled in favor of Mothers
Work. The arbitrator has denied a challenge to his ruling by the third party. While there is no
assurance that the third party will not again challenge the ruling, we believe that reversal of the
ruling is unlikely. If the third party were to be successful in efforts to overturn the
arbitrators decision, the termination rights under our agreement with Mothers Work could be
triggered. In addition, as a condition to commencing the agreement on January 1, 2007, we agreed to
indemnify Mothers Work for any damages that Mothers Work may be assessed in the event that Mothers
Work is found to be in breach of its agreement with the third party as a result of having entered
into an agreement with us. We also agreed to reimburse Mothers Work for certain legal fees if the
fees exceed a specified threshold. Our potential obligation to Mothers Work under the
indemnification agreement is unlimited. However, based on our assessment of the low likelihood that
we might have to pay damages or legal fees given the arbitrators ruling, we concluded the fair
value of our indemnification obligation is not material and have not recorded a liability as of
March 31, 2007.
If we are not able to successfully develop and commercialize new products, our future prospects may
be limited.
Drug
development in general involves a high degree of risk. As we obtain results and safety information
from preclinical or clinical trials of our product candidates, we may elect to discontinue
development or delay additional preclinical studies or clinical trials in order to focus our
resources on more promising product candidates. For example, in February 2007, we made the decision
not to advance CB001, one of our product candidates in the area of hematopoietic stem cell therapy,
in future clinical trials. We may also change the indication being pursued for a particular product
candidate or otherwise revise the development plan for that candidate. Moreover, product candidates
in later stages of clinical trials may fail to show the desired safety and efficacy traits despite
having progressed through earlier clinical testing.
The process of obtaining regulatory approval is lengthy, expensive and uncertain, and we may
never gain necessary approvals. Any difficulties that we encounter in developing our product
candidates and in obtaining regulatory approval may have a substantial adverse impact on our
financial condition, results of operations and cause our stock price to decline significantly. If
we are not able to successfully develop our product candidates and obtain regulatory approval, we
will not be able to commercialize such products, and therefore may not be able to generate
sufficient revenues to support our business.
Our cellular therapy product candidates are in the early stages of development. Very few companies have been successful in their efforts to develop and commercialize a stem
cell product. Stem cell products in general may be susceptible to various risks, including
undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic
efficacy or other characteristics that may prevent or limit their approval or commercial use.
The industry and the FDA have relatively little experience with therapeutics based on cellular
medicine generally. As a result, the pathway to regulatory approval for our stem cell-based product
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candidates may be more complex and lengthy than the pathway for approval of a new conventional
drug. Similarly, to obtain approval to market our stem cell products outside of the U.S., we will
need to submit clinical data concerning our products and receive regulatory approval from the
appropriate governmental agencies. Standards for approval outside the U.S. may differ from those
required by the FDA. We may encounter delays or rejections if changes occur in regulatory agency
policies during the period in which we develop a product candidate or during the period required
for review of any application for regulatory agency approval.
We expect that none of our cellular therapy product candidates will be commercially available
for at least several years, if at all. We will need to devote significant additional research and
development, financial resources and personnel to develop commercially viable products and obtain
regulatory approvals.
We may not be able to successfully develop our ViaCyte oocyte cryopreservation product candidate.
We are currently planning to conduct a single, pivotal clinical trial to study the safety and
efficacy of ViaCyte. The goal of the clinical trial is to generate data to submit to the FDA for a
510(k) application. In June 2006, the FDA gave us conditional approval of our Investigational
Device Exemption, or IDE, to allow our ViaCyte cryopreservation product candidate to be used in a
clinical trial. We subsequently satisfied all of the conditions imposed upon us by the FDA and, in
March 2007, we initiated the ViaCyte clinical trial. However, in April 2007, the FDA
disapproved a supplement to the IDE which is necessary to change our contract manufacturer for the
ViaCyte media to Invitrogen. The FDA has asked us to respond to questions related to the
specifications and sourcing of certain raw materials used in the manufacturing of the ViaCyte
media. We are currently working to address the questions raised by the FDA. We believe we will
ultimately be able to satisfy the FDA and obtain approval of the IDE supplement. However, there is
no assurance that we will be able to obtain approval on a timely basis or at all. Failure to
obtain approval on a timely basis could delay enrollment in the trial and may cause completion of
the trial to be significantly delayed. If we are unable to address the issues raised by the FDA,
we may need to change our manufacturing process. There is no assurance that we would be able to
make acceptable changes on a timely basis or at all. Changes in the manufacturing process could
result in significant delays in the trial or involve significant additional expense, and may not be
practical. Since we no longer use our original manufacturer, failure to obtain approval of the
IDE supplement would likely cause us to have to discontinue the trial. Even if we are successful
in our efforts to obtain approval of the IDE supplement, there is no assurance that we will be able
to show that our ViaCyte cryopreservation product candidate is safe and effective for its intended
use. While methods for preserving sperm and embryos are well-established and have been utilized for
in vitro fertilization procedures, methods for cryopreserving oocytes have not been widely employed
due to difficulties encountered in freezing this cell. We may not be able to generate the number of
live births needed to show that ViaCyte is effective. We may also encounter unexpected safety,
regulatory or manufacturing issues. Even if the results of the trial are favorable, there is no
assurance that the FDA will agree that we have met the standards for 510(k) clearance. The FDA
could at any time determine that some or all of the components used to cryopreserve the oocytes
will require pre-market approval, or PMA, and additional trials, which would involve additional
time and expense. Even if we are successful in our efforts to develop and gain approval for
ViaCyte, the FDA could ask for post-approval safety monitoring which would entail additional
expense. The FDA could also restrict the label for ViaCyte to limited patient populations which
could limit its commercial potential.
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We may not be able to raise additional funds necessary to fund our operations.
As of March 31, 2007, we had approximately $47.4 million in cash, cash equivalents and
short-term investments. In order to develop and bring new products to market, we must commit
substantial resources to costly and time-consuming research and development, preclinical testing
and clinical trials. While we anticipate that our existing cash, cash equivalents and investments
will be sufficient to fund our current operations for the next three years, we may need or want to
raise additional funding sooner, particularly if our business or operations change in a manner that
consumes available resources more rapidly than we anticipate. We expect to attempt to raise
additional funds well in advance of completely depleting our available funds.
Our future capital requirements will depend on many factors, including:
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the level of cash flows from sales of our ViaCord service offering; |
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the costs of increasing or expanding our ViaCord sales and marketing efforts; |
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the scope and results of our research and development programs; |
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the clinical pathway for each of our product candidates, including the
number, size, scope and cost of clinical trials required to establish safety
and efficacy; |
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the results of litigation and other disputes; |
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the costs associated with expanding our portfolio of product candidates
through licensing, collaborations or acquisitions; |
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the costs of research and development work focused on developing clinical
and commercial scale processes for manufacturing cellular products and, if
we advance our products, the costs of building and operating our
manufacturing facilities, both to support our clinical activities and also
in anticipation of growing our commercialization activities; |
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funds spent in connection with acquisitions of related technologies or
businesses, including contingent payments that may be made in connection
with our acquisition of Kourion Therapeutics; |
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the costs of maintaining, expanding and protecting our intellectual property
portfolio, including litigation costs and liabilities; and |
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our ability to establish and maintain collaborative arrangements and obtain
milestones, royalties and other payments from collaborators. |
We may seek additional funding through collaborative arrangements and public or private
financings. Additional funding may not be available to us on acceptable terms, or at all. If we
obtain additional capital through collaborative arrangements, these arrangements may require us to
relinquish
greater rights to our technologies or product candidates than we might otherwise have done. If
we raise additional capital through the sale of equity, or securities convertible into equity,
further dilution to our then existing stockholders will result. If we raise additional capital
through the incurrence of debt, our business may be affected by the amount of leverage we incur.
For instance, such borrowings could subject us to covenants restricting our business activities,
servicing interest would divert funds that would otherwise be available to support research and
development, clinical or commercialization activities, and
34
holders of debt instruments would have
rights and privileges senior to those of our equity investors. If we are unable to obtain adequate
financing on a timely basis, we may be required to delay, reduce the scope of or eliminate one or
more of our research and development programs, any of which could have a material adverse effect on
our business.
We depend on patents and other proprietary rights that may fail to protect our business.
Our success depends, in large part, on our ability to obtain and maintain intellectual
property protection for our product candidates, technologies and trade secrets. We own or have
exclusive licenses to U.S. patents and international patents. We also own or have exclusive
licenses to pending applications in the U.S. and pending applications in foreign countries. Our
pending patent applications may not issue, and we may not receive any additional patents. The
patent position of biotechnology companies is generally highly uncertain, involves complex legal
and factual questions and has been the subject of much litigation. Neither the U.S. PTO nor the
courts have a consistent policy regarding the breadth of claims allowed or the degree of protection
afforded under many biotechnology patents. The claims of our existing U.S. patents and those that
may issue in the future, or those licensed to us, may not offer significant protection of our
technologies. For example, our patent applications covering Unrestricted Somatic Stem Cells, or
USSC, claim these cells and/or their use in the treatment of many diseases. It is possible,
however, that these cells could be covered by other patents or patent applications which identify,
isolate or use the same cells by other markers, although we are not aware of any. Third parties may
challenge, narrow, invalidate or circumvent any patents we obtain based on our applications.
Interference proceedings brought by the U.S. PTO may be necessary to determine the priority of
inventions with respect to our patent applications or those of our collaborators or licensors.
Litigation or interference proceedings may fail and, even if successful, may result in substantial
costs and distraction to our management.
Competitors may infringe our patents or the patents of our collaborators or licensors.
Although we have not needed to take such action to date, we may be required to file infringement
claims to counter infringement or unauthorized use. This can be expensive, particularly for a
company of our size, and time-consuming. In addition, in an infringement proceeding, a court may
decide that a patent of ours is invalid or unenforceable, or may refuse to stop the other party
from using the technology at issue on the grounds that our patents do not cover its technology. An
adverse determination of any litigation or defense proceedings could put one or more of our patents
at risk of being invalidated or interpreted narrowly and could put our patent applications at risk
of not issuing. Furthermore, because of the substantial amount of discovery required in connection
with intellectual property litigation, there is a risk that some of our confidential information
could be compromised by disclosure during this type of litigation. In addition, during the course
of this kind of litigation, there could be public announcements of the results of hearings, motions
or other interim proceedings or developments. If investors perceive these results to be negative,
it could have a substantial adverse effect on the price of our common stock.
Furthermore, our competitors may independently develop similar technologies or duplicate any
technology developed by us in a manner that does not infringe our patents or other intellectual
property. Because of the extensive time required for development, testing and regulatory review of
a potential product, it is possible that, before any of our products can be commercialized, any
related patent may
expire or remain in force for only a short period following commercialization, thereby
reducing any advantages of the patent. Without patent protection, those products might have to
compete with identical products by competitors.
In an effort to protect our unpatented proprietary technology, processes and know-how as trade
secrets, we require our employees, consultants, collaborators and advisors to execute
confidentiality
35
agreements. These agreements, however, may not provide us with adequate protection
against improper use or disclosure of confidential information. These agreements may be breached,
and we may not have adequate remedies for any such breach. In addition, in some situations, these
agreements may conflict with, or be subject to, the rights of third parties with whom our
employees, consultants, collaborators or advisors have previous employment or consulting
relationships. Others may independently develop substantially equivalent proprietary information
and techniques or otherwise gain access to our trade secrets. We may not be able, alone or with our
collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in
countries where the laws may not protect such rights as fully as in the U.S.
Third parties may own or control patents or patent applications that are infringed by our
technologies or product candidates.
Our success depends in part on our not infringing other parties patents and proprietary
rights as well as not breaching any licenses relating to our technologies and product candidates.
In the U.S., patent applications filed in recent years are confidential for 18 months, while older
applications are not published until the patent issues. As a result, there may be patent
applications of which we are unaware that will result in issued patents in our field, and avoiding
patent infringement may be difficult. We may inadvertently infringe third party patents or patent
applications. These third parties could bring claims against us, our collaborators or our licensors
that, even if resolved in our favor, could cause us to incur substantial expenses and, if resolved
against us, could additionally cause us to pay substantial damages.
We may be required to pay substantial damages to a patent holder in an infringement case in
the event of a finding of infringement. Under some circumstances in the U.S., these damages could
be triple the actual damages the patent holder incurred, and we could be ordered to pay the costs
and attorneys fees incurred by the patent holder. If we have supplied infringing products to third
parties for marketing, or licensed third parties to manufacture, use or market infringing products,
we may be obligated to indemnify these third parties for any damages they may be required to pay to
the patent holder and for any losses the third parties may sustain themselves as the result of lost
sales or damages paid to the patent holder. Further, if patent infringement suits are brought
against us, our collaborators or our licensors, we or they could be forced to stop or delay
research, development, manufacturing or sales of any infringing product in the country or countries
covered by the patent we infringe, unless we can obtain a license from the patent holder. Such a
license may not be available on acceptable terms, or at all, particularly if the third party is
developing or marketing a product competitive with the infringing product. Even if we, our
collaborators or our licensors were able to obtain a license, the rights may be nonexclusive, which
would give our competitors access to the same intellectual property. In addition, payments under
such licenses would reduce the earnings otherwise attributable to the specific products.
Patent infringement cases often involve substantial legal expenses. For example, we are
involved in two patent infringement lawsuits filed against us by PharmaStem. As of March 31, 2007,
we have incurred total legal expenses of approximately $7.4 million related to these cases.
Depending upon the results of PharmaStems appeal of the District Courts decision to overturn the
jury verdict against us in this case, and the extent to which we are required to litigate the
second lawsuit brought by PharmaStem
and any related appeals, we estimate that we could incur at least an additional $1.0 million
to $5.0 million in litigation expenses.
Any successful infringement action brought against us may also adversely affect our ability to
market the infringing product in other markets not covered by the infringement action, as well as
our marketing of other products by us based on similar technology and may also delay the regulatory
approval process for future product candidates. Furthermore, we may suffer adverse consequences
from a
36
successful infringement action against us even if the action is subsequently reversed on
appeal, nullified through another action or resolved by settlement with the patent holder. The
damages or other remedies awarded, if any, may be significant. As a result, any infringement action
against us may harm our competitive position, be very costly and require significant time and
attention of our key management and technical personnel.
Our success will depend in part on establishing and maintaining effective strategic partnerships
and collaborations.
A key aspect of our business strategy is to establish strategic relationships in order to gain
access to technology and critical raw materials, to expand or complement our research, development
or commercialization capabilities, or to reduce the cost of developing or commercializing products
on our own. While we are continually in discussions with a number of companies, universities,
research institutions, cord blood banks and others to establish additional relationships and
collaborations, we may not reach definitive agreements with any of them. Even if we enter into
these arrangements, we may not be able to maintain these relationships or establish new ones in the
future on acceptable terms. Furthermore, these arrangements may require us to grant certain rights
to third parties, including exclusive marketing rights to one or more products, or may have other
terms that are burdensome to us, and may involve the acquisition of our securities. Our partners
may decide to develop alternative technologies either on their own or in collaboration with others
or commercialize or market competitive products in collaboration with others. If any of our
partners terminate their relationship with us or fail to perform their obligations in a timely
manner, the development or commercialization of our technology, potential products or existing
products may be substantially delayed or adversely impacted.
Our cell preservation activities are subject to regulations that may impose significant costs and
restrictions on us.
Cord blood preservation. The FDA has adopted good tissue practice regulations, or GTPs, that
establish a comprehensive regulatory program for human cellular and tissue-based products. Our
ViaCord service offering is subject to GTPs. We have registered with the FDA as an umbilical cord
blood preservation service and we are subject to FDA inspection. We believe that we comply with
GTPs, though we have not yet been inspected by the FDA. However, we may not be able to maintain
this compliance or comply with future regulatory requirements that may be imposed on us, including
product standards that may be developed. Unlike our business of private cord blood banking for
related use, the collection, processing and storage of umbilical cord blood stem cells intended to
be used in a recipient unrelated to the donor is regulated as biological products. In January 2007,
the FDA published draft guidance document for comment that would require public cord blood banks to
file Biologics License Applications. While the draft guidance does not currently apply to us, the
FDA could decide to impose these requirements or others on our business. Moreover, the cost of
compliance with government regulations may adversely affect our revenues and profitability. If the
FDA were to require companies that bank umbilical cord blood for related use to comply with the
recommendations set forth in the guidance, we would need to change certain of our processes. The
costs of such changes or the cost of compliance with any other new requirements that may be imposed
in the future could adversely affect our
revenues and profitability. Regulation of our cord blood preservation services in foreign
jurisdictions is still evolving.
We provide cord blood banking services in all 50 states. Several states require that cord
blood services be licensed, permitted or registered. We believe that we are currently licensed,
permitted or registered to operate in all states requiring us to be licensed, permitted or
registered. If other states adopt
37
requirements for the licensing, permitting or registration of
cord blood preservation services, we would have to obtain licenses, permits or registration to
continue providing services in those states.
Oocyte cryopreservation. There are no established precedents for U.S. and international
regulation of oocyte cryopreservation. The FDA has informed us that it will require a clinical
study to support approval of the technology used in oocyte cryopreservation. We are currently planning to conduct a single, pivotal clinical trial
to study the safety and efficacy of ViaCyte. In June 2006, the FDA
gave us conditional approval of an IDE to allow our ViaCyte cryopreservation product candidate to
be used in a clinical trial. We subsequently satisfied all of the conditions
imposed upon us by the FDA and, in March 2007, we initiated the ViaCyte clinical trial. However, in April
2007, the FDA disapproved a supplement to the IDE which is necessary to change our contract
manufacturer for the ViaCyte media to Invitrogen. The FDA has asked us to respond to questions
related to the specifications and sourcing of certain raw materials used in the manufacturing of
the ViaCyte media. We are currently working to address the questions raised by the FDA. We
believe we will ultimately be able to satisfy the FDA and obtain approval of the IDE supplement.
However, there is no assurance that we will be able to obtain approval on a timely basis or at all.
Failure to obtain approval on a timely basis could delay enrollment in the trial and may cause
completion of the trial to be significantly delayed. If we are unable to address the issues raised
by the FDA, we may need to change our manufacturing process. There is no assurance that we would
be able to make acceptable changes on a timely basis or at all. Changes in the manufacturing
process could result in significant delays in the trial or involve significant additional expense,
and may not be practical. Since we no longer use our original manufacturer, failure to obtain
approval of the IDE supplement would likely cause us to have to discontinue the trial. The goal of
the clinical trial is to generate data to submit to the FDA for a 510(k) application. There is no
assurance that we will be able to complete the clinical trial or that we will be able to show that
our ViaCyte cryopreservation product candidate is safe and effective for its intended use. We may
also encounter unexpected safety, regulatory or manufacturing issues, any of which could delay or cause us to
stop the trial. If we submit a new 510(k) and the FDA does not find the information adequate to
support 510(k) clearance, the FDA could require us to obtain PMA to market ViaCyte. This
requirement could substantially lengthen our planned developmental timeline and increase the costs
of developing and commercializing ViaCyte. We may not receive either 510(k) clearance or PMA for
ViaCyte. We believe that the time to conduct a clinical study, prepare a new 510(k), and receive
FDA clearance for our oocyte cryopreservation product candidate will take several years. We have
not investigated the regulations for the cryopreservation of oocytes in foreign jurisdictions. We
may not be able to generate sufficient data to receive approval to market ViaCyte in the U.S. or
any other jurisdictions.
We have only limited experience manufacturing cell therapy product candidates, and we may not be
able to manufacture our product candidates in quantities sufficient for clinical studies or for
commercial scale.
We currently produce limited quantities of stem cells using our technologies. We have not
built commercial scale manufacturing facilities, and have no experience in manufacturing cellular
products in the volumes that will be required for later stage clinical studies or
commercialization. If we obtain marketing approval for any cell therapy products, we may not be
able to produce sufficient quantities of our products at an acceptable cost. Commercial-scale
production of therapies made from live human cells
involves production in small batches and management of complex logistics. Cellular therapies are
inherently more difficult to manufacture at commercial-scale than chemical pharmaceuticals, which
are manufactured using standardized production technologies and operational methods. We may
encounter difficulties in production due to, among other things, quality control, quality assurance
and component supply. These difficulties could reduce sales of our products, increase our cost or
cause production delays, all of which could damage our reputation and hurt our profitability.
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We are dependent upon third parties to supply us with certain components of our cell therapy
product candidates, the loss of which may delay development of our product candidates
In order to produce cells for use in clinical studies and produce stem cell products for
commercial sale, certain biological components used in our production process will need to be
manufactured in compliance with current good manufacturing practices, or cGMP. To meet this
requirement, we will need to maintain supply agreements with third parties who manufacture these
components to cGMP standards. Once we engage these third parties, we may be dependent on them for
supply of cGMP grade components. If we are unable to obtain cGMP grade biological components for
our product candidates, we may not be able to market our stem cell product candidates.
Certain antibodies, growth factors and other reagents are critical components used in our stem
cell production process. We depend on our suppliers to perform their obligations in a timely
manner and in accordance with applicable government regulations. In the event that any of these
suppliers becomes unwilling or unable to continue to supply necessary components for the
manufacture of our stem cell products, we will need to repeat certain preclinical development work
to identify and demonstrate the equivalence of alternative components purchased from other
suppliers. If we are unable to demonstrate the equivalence of alternative components in a timely
manner, or purchase these alternative components on commercially reasonable terms, we may not be
able to advance the development of our preclinical stem cell product candidates.
The loss of our contract manufacturer for ViaCyte or our failure to respond to questions
raised by the FDA related to the specifications and sourcing of certain raw materials used in the
manufacturing of ViaCyte may delay or cause us to discontinue development of our ViaCyte product
candidate.
We are utilizing Invitrogen to manufacture, supply and package our ViaCyte product candidate
for our clinical trial. We are dependent on Invitrogen and our relationships with component and
testing service providers to satisfy all regulatory requirements and produce sufficient amounts of
cGMP-quality product on commercially reasonable terms for the trial. Manufacturing our ViaCyte
product candidate is highly complex. Due to its complexity, Invitrogen may be unable to
consistently manufacture ViaCyte to specifications. Invitrogen has the ability to terminate its
obligation to manufacture clinical supplies of ViaCyte under certain conditions including if it is
unable for reasons outside of its control to consistently meet specifications or if there is a
change in specifications it cannot meet or an uncured material breach by us. In June 2006, the FDA
gave us conditional approval of an IDE to allow our ViaCyte
cryopreservation product candidate to be used in a clinical trial. We subsequently satisfied all
of the conditions imposed upon us by the FDA and, in March 2007, we initiated the ViaCyte clinical
trial. However, in April 2007, the FDA disapproved a supplement to the IDE which is necessary to change our
contract manufacturer for the ViaCyte media to Invitrogen. The FDA has asked us to respond to
questions related to the specifications and sourcing of certain raw materials used in the
manufacturing of the ViaCyte media. We are currently working to address the questions raised by
the FDA. We believe we will ultimately be able to satisfy the FDA and obtain approval of the IDE
supplement. However, there is no assurance that we will be able to obtain approval on a timely
basis or at all. Failure to obtain approval on a timely basis could delay enrollment in the trial
and may cause
completion of the trial to be significantly delayed. If we are unable to address the issues raised
by the FDA, we may need to change our manufacturing process. There is no assurance that we would
be able to make acceptable changes on a timely basis or at all. Changes in the manufacturing
process could result in significant delays in the trial or involve significant additional expense,
and may not be practical. Since we no longer use our original manufacturer, failure to obtain
approval of the IDE supplement would likely cause us to have to discontinue the trial. If ViaCyte
is successfully developed, we will need
39
to establish similar relationships with third party contract manufacturers for our commercial
supply. In the event that we are unable to maintain a suitable contract manufacturer that is
willing to produce such products on commercially reasonable terms or the contract manufacturer
terminates or breaches its relationship with us or our contract manufacturers or we encounter
unexpected technical or manufacturing hurdles or delays, we may not be able to complete our
clinical trial or, if successfully developed, to commercialize our ViaCyte product candidate.
We are dependent on our existing suppliers to successfully commercialize our ViaCord service offering.
The loss of such suppliers may inhibit our ability to commercialize ViaCord.
We source a substantial portion of the components of our ViaCord collection kits and
processing and testing services from a concentrated group of third party contractors. The
production of the collection kits and the processing and testing of cord blood units require
successful coordination among ourselves and multiple third party providers. Our inability to
coordinate these efforts or any other problems with the operations of our third party contractors
could increase our costs, cause us to lose revenue or market share, and damage our reputation. Some
of the components of our ViaCord collection kits, including our Cell Sentinel
tm bag, are produced by single source providers. For other components, we make
every effort to qualify new vendors and to develop contingency plans so that our ViaCord business
is not impacted by short-term issues associated with single source providers. Our business could
be materially impacted by long-term or chronic issues associated with single source providers or
other vendors.
If our cord blood processing and storage facility or our clinical manufacturing facilities are
damaged or destroyed, our business, programs and prospects could be negatively affected.
We process and store our customers umbilical cord blood at our facility in Hebron, Kentucky.
If this facility or the equipment in the facility were to be significantly damaged or destroyed, we
could suffer a loss of some or all of the stored cord blood units. In addition, from time to time,
we transport large quantities of cord blood units from other storage facilities to our facility in
Hebron, Kentucky. If we encounter problems during transportation, some or all of the transported
units could be damaged. Depending on the extent of these losses, such an event could reduce our
ability to provide cord blood stem cells when requested, could expose us to significant liability
from cord blood banking customers and could affect our ability to continue to provide umbilical
cord blood preservation services.
We expect to manufacture all of our stem cell product candidates in our Cambridge
manufacturing facility for the next several years. If the Cambridge facility or the equipment in it
is significantly damaged or destroyed, we may not be able to quickly or inexpensively replace our
manufacturing capacity. In the event of a temporary or protracted loss of this facility or
equipment, we may be able to transfer manufacturing to a third party, but the shift would likely be
expensive, and the timing would depend on availability of third party resources and the speed with
which we could have a new facility approved by the FDA.
While we believe that we have insured against losses from damage to or destruction of our
facilities, and against damage to cord blood units being transported to our facility, consistent
with typical industry practices, if we have underestimated our insurance needs, we will not have
sufficient insurance to cover losses above and beyond the limits on our policies. Currently, we
maintain insurance coverage totaling
$22.2 million against damage to our property and equipment, and an additional $18.8 million to
cover incremental expenses and loss of profits resulting from such damage.
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Our competitors may have greater resources or capabilities or better technologies than we have, or
may succeed in developing better products or develop products more quickly than we do, and we may
not be successful in competing with them.
The private umbilical cord banking business is highly competitive. In private umbilical cord
blood banking, we compete with companies such as Cbr Systems, Inc., Cryo-Cell International, Inc.,
CorCell, Inc., a subsidiary of Cord Blood America Inc., and LifeBank USA, a division of Celgene
Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation. Any of these companies may
choose to invest more in sales, marketing, research and product development than we have. In cord
blood banking, we also compete with public cord blood banks such as the New York Blood Center
(National Cord Blood Program), University of Colorado Cord Blood Bank, Milan Cord Blood Bank,
Düsseldorf Cord Blood Bank, and other public cord blood banks around the world. Public cord blood
banks provide families with the option of donating their cord blood for public use at no cost. The
Stem Cell Therapeutic and Research Act of 2005, or the Stem Cell Therapeutic Act, provides
financing for a national system of public cord blood banks in the U.S. to encourage cord blood
donations from an ethnically diverse population. In addition, many states are evaluating the
feasibility of establishing cord blood repositories for transplantation purposes. An increase in
the number and diversity of publicly-available cord blood units from public banks would increase
the probability of finding suitably matched cells for a family member, which may result in a
decrease in the demand for private cord blood banking. If the science of human leukocyte antigens,
or HLA, typing advances, then unrelated cord blood transplantation may become safer and more
efficacious, similarly reducing the clinical advantage of related cord blood transplantation.
The pharmaceutical and biotechnology businesses are also highly competitive. We compete with
many organizations that are developing cell therapies for the treatment of a variety of human
diseases, including companies such as Aastrom Biosciences, Inc., Cellerant Therapeutics, Inc.,
Celgene Corporation, Cytori Therapeutics, Inc., Gamida-Cell Ltd., Genzyme Corporation, Bioheart,
Inc., and Osiris Therapeutics, Inc. We also face competition in the cell therapy field from
academic institutions and governmental agencies. We are also aware that some larger pharmaceutical
and biopharmaceutical companies have programs in the cell therapy area. Some of these competitors
and future competitors may have similar or better product candidates or technologies, greater
financial and human resources than we have, including more experience in research and development
and more established sales, marketing and distribution capabilities. In addition, public cord blood
banks may, as a result of the Stem Cell Therapeutic Act, be able to better compete with our
potential cell therapy products. An increase in the number and diversity of publicly-available cord
blood units from public banks could diminish the necessity for cord blood-derived therapeutics.
In oocyte cryopreservation, if our ViaCyte product candidate is successfully developed and
approved, we expect to compete with IVF centers and individual companies offering oocyte
cryopreservation, including Extend Fertility. Current and future competitors in this field may also
have greater financial and human resources than we have, and may have similar or better product
candidates or technologies, or product candidates which are brought to the market more quickly than
ours. Specifically,
several IVF centers are already performing oocyte cryopreservation on a limited basis and
Extend Fertility is offering related services, which may make it more difficult ViaCyte, if
successfully developed and approved, to achieve a significant market share.
We anticipate this competition to increase in the future as new companies enter the stem cell
therapy, cord blood preservation and oocyte cryopreservation markets. In addition, the health care
41
industry is characterized by rapid technological change. New product introductions or other
technological advancements could make some or all of our product candidates obsolete.
Due to the nature of our cell preservation activities, harm to our reputation could have a
significant negative impact on our financial condition. Damage to or loss of our customers
property held in our custody could potentially result in significant legal liability.
Our reputation among clients and the medical and birthing services community is extremely
important to the commercial success of our ViaCord service offering. This is due in significant
part to the nature of the service we provide. For instance, as part of our ViaCord service
offering, we are assuming custodial care of a childs umbilical cord blood stem cells entrusted to
us by the parents for potential future use as a therapeutic for the child or its siblings. We
believe that our reputation enables us to market ourselves as a premium provider of cord blood
preservation among our competitors. While we seek to maintain high standards in all aspects of our
provision of products and services, we cannot guarantee that we will not experience problems. Like
family cord blood banks generally, we face the risk that a customers cord blood unit could be lost
or damaged while in transit from the collection site to our storage facility, including while the
unit is in the possession of third party commercial carriers used to transport the units. There is
also risk of loss or damage to the unit during the preservation or storage process. Any such
problems, particularly if publicized in the media or otherwise, could negatively impact our
reputation, which could adversely affect our business and business prospects.
In addition to reputational damage, we face the risk of legal liability for loss of or damage
to cord blood units. We do not own the cord blood units banked by our ViaCord customers; instead,
we act as custodian on behalf of the child-donors guardian. Loss or damage to the units would be
loss or damage to the customers property. We cannot be sure to what extent we could be found
liable, in any given scenario, for damages suffered by an owner or donor as a result of harm or
loss of a cord blood unit, and if we are found liable, whether our insurance coverage will be
sufficient to cover such damages.
The manufacture and sale of products may expose us to product liability claims for which we could
have substantial liability.
We face an inherent business risk of exposure to product liability claims if our products or
product candidates are alleged or found to have caused injury. While we believe that our current
liability insurance coverage is adequate for our present clinical and commercial activities, we
will need to increase our insurance coverage if and when we begin commercializing additional
products. We may not be able to obtain insurance with adequate coverage for potential liability
arising from any such potential products on acceptable terms or may be excluded from coverage under
the terms of any insurance policy that we obtain. We may not be able to maintain insurance on
acceptable terms or at all. If we are unable to obtain insurance or any claims against us
substantially exceed our coverage, then our business could be adversely impacted.
Our success is dependent upon recruiting and retaining qualified management and other personnel.
Our success is highly dependent on the retention of the principal members of our scientific,
management and sales personnel. Marc D. Beer, our President and Chief Executive Officer, is
critical to our ability to execute our overall business strategy. Morey Kraus, our Chief Technology
Officer and co-founder, has significant and unique expertise in stem cell expansion and related
technologies. We maintain key man life insurance on the lives of Mr. Beer and Mr. Kraus.
Additionally, we have several other employees with scientific or other skills that we consider
important to the successful commercialization of our products and development of our technology.
Any of our key employees could
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terminate his or her relationship with us at any time and, despite
any non-competition agreement with us, work for one of our competitors. Furthermore, our future
growth will require hiring a significant number of qualified technical, commercial and
administrative personnel. Accordingly, recruiting and retaining such personnel in the future will
be critical to our success.
There is intense competition from other companies, universities and other research
institutions for qualified personnel in the areas of our activities. If we are not able to continue
to attract and retain, on acceptable terms, the qualified personnel necessary for the continued
development of our business, we may not be able to sustain our operations or achieve our business
objectives.
We may face difficulties in managing and maintaining the growth of our business.
We expect to continue expanding our reproductive health business and our research and
development activities. This expansion could put significant strain on our management, operational
and financial resources. To manage future growth, we would need to hire, train and manage
additional employees.
Our reporting obligations as a public company, as well as our need to comply with the
requirements of the Sarbanes-Oxley Act of 2002, the rules and regulations of the Securities and
Exchange Commission and the NASDAQ Global Market, place significant demands on our finance and
accounting staff, on our financial, accounting and information systems and on our internal
controls. We have increased the number of our accounting and finance personnel and have taken steps
to proactively monitor our networks and to improve our financial, accounting and information
systems and internal controls in order to fulfill our responsibilities as a public company and to
support growth in our business. We cannot assure you that our current and planned personnel,
systems procedures and controls will be adequate to support our anticipated growth or that
management will be able to hire, train, retain, motivate and manage required personnel.
Our failure to manage growth effectively could limit our ability to achieve our research and
development and commercialization goals or to satisfy our reporting and other obligations as a
public company.
Our business could be disrupted or harmed and we could be subject to liability if we are unable to
operate our information systems effectively, successfully implement new technologies and protect
the confidentiality of our or our customers data.
The efficient operation of our business is dependent on our information systems, including our
ability to operate them effectively and to successfully implement new technologies, systems,
controls and adequate disaster recovery systems. In addition, we must protect the confidentiality
of our and our customers data, including credit card information. The failure of our information
systems to perform as designed or our failure to implement and operate them effectively could
disrupt our business, harm our reputation and/or subject us to liability, any of which could impact
our financial condition and results of operations.
If we acquire other businesses or technologies the transactions may be dilutive and we may be
unable to integrate them successfully with our business, our financial performance could suffer.
If we are presented with appropriate opportunities, we may acquire other businesses. We have
had limited experience in acquiring and integrating other businesses. Since our incorporation in
1994, we have acquired three businesses: Viacord, Inc. in 2000, Cerebrotec, Inc. in 2001 and
Kourion Therapeutics
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AG in 2003. The integration process following any future acquisitions may
produce unforeseen operating difficulties and expenditures and may absorb significant management
attention that would otherwise be available for the ongoing development of our business. In any
future acquisitions, we may issue shares of stock dilutive to existing stockholders, incur debt,
assume contingent liabilities, or create additional expenses related to amortizing intangible
assets, any of which might harm our financial results and cause our stock price to decline. Any
financing we might need for future acquisitions may be available to us only on terms that restrict
our business or impose costs that increase our net loss.
The successful commercialization of products may depend on patients and physicians obtaining
reimbursement for products from third party payers.
If we successfully develop and obtain necessary regulatory approvals for our therapeutic
product candidates, we intend to sell such products initially in the U.S. and, potentially, outside
the U.S. In the U.S., the market for many pharmaceutical products is affected by the availability
of reimbursement from third party payers such as government health administration authorities,
private health insurers, health maintenance organizations and pharmacy benefit management
companies. Our potential cellular therapy products may be relatively expensive treatments due to
the higher cost of production and more complex logistics of cellular products compared with
standard pharmaceuticals. This, in turn, may make it more difficult for patients and physicians to
obtain adequate reimbursement from third party payers, particularly if we cannot demonstrate a
favorable cost-benefit relationship. Third-party payers may also deny coverage or offer inadequate
levels of reimbursement for our potential products if they determine that the product has not
received appropriate clearances from the FDA or other government regulators or is experimental,
unnecessary or inappropriate. In the countries of the European Union and in some other countries,
the pricing of prescription pharmaceutical products and services and the level of government
reimbursement are subject to governmental control.
Managing and reducing health care costs has been a concern generally of federal and state
governments in the U.S. and of foreign governments. Although we do not believe that any recently
enacted or presently proposed legislation should impact our business, we cannot be sure that we
will not be subject to future regulations that may materially restrict the price we receive for our
products. Cost control initiatives could decrease the price that we receive for any product we may
develop in the future. In addition, third party payers are increasingly challenging the price and
cost-effectiveness of medical products and services, and any of our potential products may
ultimately not be considered cost-effective by these payers. Any of these initiatives or
developments could materially harm our business. If our potential cell therapy products are not
reimbursed by government or third party insurers, the market for those products would be limited.
We cannot be sure that third party payers will reimburse sales of a product or enable us or our
partners to sell the product at prices that will provide a sustainable and profitable revenue
stream.
Although we are aware of a small fraction of ViaCord customers receiving reimbursement, we
believe our ViaCord service offering, like other private cord blood banking, is not generally
subject to reimbursement. We do not currently believe that our ViaCyte product candidate will be
subject to
reimbursement. In cases of preserving eggs for fertility preservation for cancer patients, it
is unknown at this time if it will be covered.
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We face potential liability related to the privacy of health information we obtain from research
collaborators or from providers who enroll patients and collect cord blood or human oocytes.
Our business relies on the acquisition, analysis, and storage of potentially sensitive
information about individuals health, both in our research activities and in our reproductive
health product and service offerings. These data are protected by numerous federal and state
privacy laws.
Most health care providers, including research collaborators from whom we obtain patient
information, are subject to privacy regulations promulgated under the Health Insurance Portability
and Accountability Act of 1996, or HIPAA. Although we ourselves are not directly regulated by
HIPAA, we could face substantial criminal penalties if we knowingly receive individually
identifiable health information from a health care provider who has not satisfied HIPAAs
disclosure standards. In addition, certain state privacy laws and genetic testing laws may apply
directly to our operations and impose restrictions on our use and dissemination of individuals
health information. Moreover, patients about whom we obtain information, as well as the providers
who share this information with us, may have contractual rights that limit our ability to use and
disclose the information. Claims that we have violated individuals privacy rights or breached our
contractual obligations, even if we are not found liable, could be expensive and time-consuming to
defend and could result in adverse publicity that could harm our business.
Ethical and other concerns surrounding the use of stem cell therapy may negatively affect
regulatory approval or public perception of our products and product candidates, thereby reducing
demand for our products and product candidates.
The use of embryonic stem cells for research and stem cell therapy has been the subject of
debate regarding related ethical, legal and social issues. Although we do not currently use
embryonic stem cells as a source for our research programs, the use of other types of human stem
cells for therapy could give rise to similar ethical, legal and social issues as those associated
with embryonic stem cells. The commercial success of our product candidates will depend in part on
public acceptance of the use of stem cell therapy, in general, for the prevention or treatment of
human diseases. Public attitudes may be influenced by claims that stem cell therapy is unsafe or
unethical, and stem cell therapy may not gain the acceptance of the public or the medical
community. Adverse events in the field of stem cell therapy that may occur in the future also may
result in greater governmental regulation of our product candidates and potential regulatory delays
relating to the testing or approval of our product candidates. In the event that our research
becomes the subject of adverse commentary or publicity, the market price for our common stock could
be significantly harmed.
Our business involves the use of hazardous materials that could expose us to environmental and
other liability.
We have facilities in Massachusetts and Kentucky that are subject to various local, state and
federal laws and regulations relating to safe working conditions, laboratory and manufacturing
practices, the experimental use of animals and the use and disposal of hazardous or potentially
hazardous substances, including chemicals, micro-organisms and various radioactive compounds used
in connection with our research and development activities. In the U.S., these laws include the
Occupational Safety and Health Act, the Toxic Test Substances Control Act and the Resource
Conservation and Recovery Act. Although we believe that our safety procedures for handling and
disposing of these materials comply with the
standards prescribed by these regulations, we cannot assure you that accidental contamination
or injury to employees and third parties from these materials will not occur. We do not have
insurance to cover claims arising from our use and disposal of these hazardous substances other
than limited clean-up expense coverage for environmental contamination due to an otherwise insured
peril, such as fire.
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Volatility of Our Stock Price.
The market price for our common stock is highly volatile, and likely will continue to
fluctuate due to a variety of factors, including:
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material public announcements; |
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the data, positive or negative, generated from the development of our product candidates; |
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setbacks or delays in any of our development programs; |
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the outcome of material litigation; |
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the financial results achieved by our cord blood preservation business; |
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the impact of competition; |
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unusual or unexpectedly high expenses; |
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developments related to patents and other proprietary rights; |
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market trends affecting stock prices in our industry; and |
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economic or other external factors. |
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Sales of Unregistered Securities
During the first quarter of 2007, we issued 187,437 shares of common stock to a warrant holder
upon the exercise of a warrant that we issued in connection with our Series D preferred stock
financing. In lieu of using cash to pay the exercise price, the warrant holder utilized a cashless
exercise procedure in which it forfeited warrants to purchase the shares of common stock that we
issued to them. There were no underwriters employed in connection with any of these transactions.
The warrant issuance and related stock issuance were exempt from registration under the Securities
Act under Regulation D and Section 4(2) thereunder because the exercise and issuance did not
involve a public offering.
Use of Proceeds from Registered Securities
We registered shares of our common stock in connection with our initial public offering under
the Securities Act. Our Registration Statement on Form S-1 (Reg. No. 333-114209) in connection with
our initial public offering was declared effective by the SEC on January 19, 2005. The offering
commenced as of January 20, 2005. 8,625,000 shares of our common stock registered were sold in the
offering. The offering did not terminate before any securities were sold. We completed the offering
on January 26, 2005. Credit Suisse and UBS Investment Bank were the managing underwriters.
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All 8,625,000 shares of our common stock registered in the offering were sold, with an initial
public offering price per share of $7.00. The aggregate purchase price of the offering was
$60,375,000, of a maximum potential registered aggregate offering price of $92,000,000. The net
offering proceeds to us after deducting total related expenses were approximately $53,300,000.
No payments for the above expenses nor other payments of proceeds were made directly or
indirectly to (i) any of our directors, officers or their associates, except as described below,
(ii) any person(s) owning 10% or more of any class of our equity securities or (iii) any of our
affiliates.
The net proceeds of the initial public offering, after payment of approximately $15.5 million
for all outstanding principal and interest on promissory notes held by funds affiliated with MPM
Asset Management LLC, the manager of which served on our board of directors until June 9, 2005, are
invested in investment grade securities with the weighted average days to maturity of the portfolio
less than six months and no security with an effective maturity in excess of 12 months. To date,
apart from the payment of promissory notes of $15.5 million and normal investing activities, we
have not used any of the net proceeds from the initial public offering and there has been no
material change in the planned use of proceeds from our initial public offering as described in our
final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities Act.
Issuer Purchase of Equity Securities
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
(a) None.
(b) None.
ITEM 6. EXHIBITS
See the Exhibit Index following the Signatures page below.
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized.
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VIACELL, INC. |
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May 10, 2007 |
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/s/ Marc D. Beer |
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Marc D. Beer
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Chief Executive Officer |
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(Principal Executive Officer) |
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May 10, 2007 |
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/s/ Stephen G. Dance |
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Stephen G. Dance
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Chief Financial Officer |
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(Principal Financial Officer) |
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EXHIBIT INDEX
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No. |
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Item |
10.1(1)
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Amended and restated employment agreement dated March 12, 2007
between ViaCell and Marc D. Beer.** |
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10.2(1)
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Amended and restated letter agreement dated March 12, 2007 between
ViaCell and Anne Marie Cook.** |
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10.3(1)
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Amended and restated letter agreement dated March 12, 2007 between
ViaCell and Jim Corbett.** |
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10.4(1)
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Amended and restated employment agreement dated March 12, 2007
between ViaCell and Morey Kraus.** |
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10.5(1)
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Amended and restated letter agreement dated March 12, 2007 between
ViaCell and Mary Thistle.** |
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31.1
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Certification of the Chief Executive Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
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31.2
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Certification of the Chief Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
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32.1
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Certification of the Chief Executive Officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 |
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32.2
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Certification of the Chief Financial Officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 |
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(1) |
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Incorporated by reference to the Companys current report on Form 8-K (No. 000-51110)
filed with the SEC on March 13, 2007. |
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** |
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Indicates a management contract or compensatory plan |
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