(Exact name of registrant as specified in its charter)
Delaware
52-1841431
(State or other jurisdiction of
incorporation or organization)
(IRS Employer Id. No.)
777 Old Saw Mill River Road Tarrytown, NY10591
(Address of principal executive offices)
Registrant’s telephone number, including area code: (914) 606-3500
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (section 232.405 of this chapter) during the preceding 12
months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated
filer,”“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o
Accelerated filer o
Non-accelerated filer o
Smaller reporting company þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
EpiCept Corporation and Subsidiaries
Condensed Consolidated Statement of Stockholders’ Deficit
For the Six Months Ended June 30, 2009
(In thousands, except share amounts)
(Unaudited)
EpiCept Corporation (“EpiCept” or the “Company”) is a specialty pharmaceutical company focused
on the clinical development and commercialization of pharmaceutical products for the treatment of
cancer and pain. The Company’s strategy is to focus its clinical development efforts on innovative
cancer therapies and topically delivered analgesics targeting peripheral nerve receptors. The
Company’s lead product is Ceplene®, which when used concomitantly with interleukin-2 is
intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for
adult patients who are in their first complete remission. On October 8, 2008, the European
Commission issued a formal marketing authorization for Ceplene® in the European Union.
In June 2009 the Company launched a Named Patient Program for Ceplene®in Europe through
a partnership with IDIS. In August 2009, the Company filed a New Drug Submission (“NDS”) for
Ceplene® with Health Canada for the treatment of AML in Canada and in January 2009, the
Company received permission to proceed with a New Drug Application (“NDA”) filing with the United
States Food and Drug Administration (“FDA”). In addition to Ceplene®, the Company has
two oncology compounds and a pain product candidate for the treatment of peripheral neuropathies in
clinical development. The Company believes this portfolio of oncology and pain management product
candidates lessens its reliance on the success of any single product or product candidate.
The Company’s cancer portfolio includes crinobulin, or EPC2407, a novel small molecule
vascular disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid
tumors and lymphomas. The Company has completed its first Phase I clinical trial for crinobulin.
AzixaTM, an apoptosis inducer with VDA activity licensed by the Company to Myriad
Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement, is
currently in Phase II clinical trials in patients with primary glioblastoma and cancer that has
metastasized to the brain.
The Company’s late-stage pain product candidate, EpiCeptTM NP-1 cream, which the
Company refers to as NP-1, is a prescription topical analgesic cream designed to provide effective
long-term relief of pain associated with peripheral neuropathies. In February 2008, the Company
concluded a Phase II clinical study of NP-1 in patients suffering from diabetic peripheral
neuropathy, or DPN. In January 2009, the Company concluded a second Phase II clinical trial of
NP-1 in which the Company studied its safety and efficacy in patients suffering from post-herpetic
neuralgia, or PHN, compared to gabapentin and placebo. Both studies support the advancement of NP-1
into a registration-sized trial. NP-1 utilizes a proprietary formulation to administer FDA
approved pain management therapeutics, or analgesics, directly on the skin’s surface at or near the
site of the pain, targeting pain that is influenced, or mediated, by nerve receptors located just
beneath the skin’s surface. Peripheral neuropathy affects over 15 million people in the United
States of America.
Ceplene® has been granted full marketing authorization by the European Commission
for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia
in first remission. None of the Company’s other drug candidates has received FDA or foreign
regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory
agencies must conclude that the Company and its collaborators’ clinical data establish the safety
and efficacy of its drug candidates. Furthermore, the Company’s strategy includes entering into
collaborative arrangements with third parties to participate in the clinical development and
commercialization of its products. In the event that third parties have control over the
preclinical development or clinical trial process for a product candidate, the estimated completion
date would largely be under control of that third party rather than under the Company’s control.
The Company cannot forecast with any degree of certainty which of its drug candidates will be
subject to future collaborations or how such arrangements would affect the Company’s development
plan or capital requirements.
The Company is subject to a number of risks associated with companies in the specialty
pharmaceutical industry as discussed in this report and in Part I “Item 1A. Risk Factors” in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2008. Principal among these
are risks associated with the Company’s ability to obtain regulatory approval for its product
candidates, its ability to adequately fund its operations, dependence on collaborative
arrangements, the development by the Company or its competitors of new technological innovations,
the dependence on key personnel, the protection of proprietary technology and the compliance with
the FDA and other governmental regulations. The Company has yet to generate product revenues from
any of its product candidates. The Company has financed its operations primarily through the
proceeds from the sales of common stock, warrants, debt instruments, cash proceeds from
collaborative relationships and investment income earned on cash balances and short-term
investments.
The Company has prepared its consolidated financial statements under the assumption that it is
a going concern. The Company has devoted substantially all of its cash resources to research and
development programs and general and administrative expenses, and to date it has not generated any
meaningful revenues from the sale of products. Since inception, the Company has incurred
significant net losses each year. As a result, the Company has an accumulated deficit of $225.8
million as of June 30, 2009. The Company’s recurring losses from operations and the accumulated
deficit raise substantial doubt about its ability to continue as a going concern. The Company’s
consolidated financial statements do not include any adjustments that might result from the outcome
of this uncertainty. The Company’s losses have resulted principally from costs incurred in
connection with its development activities and from general and administrative expenses. Even if
the Company succeeds in developing and commercializing one or more of its product candidates, the
Company may never become profitable. The Company expects to continue to incur significant expenses
over the next several years as it:
•
seeks to conclude a European marketing partnership in preparation for the commercial
launch of Ceplene®;
•
continues to conduct clinical trials for its product candidates;
•
seeks regulatory approvals for its product candidates;
•
develops, formulates, and commercializes its product candidates;
•
implements additional internal systems and develops new infrastructure;
•
acquires or in-licenses additional products or technologies or expands the use of its
technologies;
•
maintains, defends and expands the scope of its intellectual property; and
•
hires additional personnel.
The Company believes that its existing cash and cash equivalents will be sufficient to fund
its operations and debt service requirements into the second quarter of 2010. Future funding is
anticipated to be derived from sales of Ceplene®in Europe; fees from the Company’s
strategic partners, including a marketing partner for Ceplene® in Europe that is
expected to be concluded in 2009, or funding through public or private financings, strategic
relationships or other arrangements.
The condensed consolidated balance sheets as of June 30, 2009, the condensed consolidated
statements of operations for the three months and six months ended June 30, 2009 and 2008, the
condensed consolidated statement of stockholders’ deficit for the six months ended June 30, 2009
and the condensed consolidated statements of cash flows for the six months ended June 30, 2009 and
2008 and related disclosures contained in the accompanying notes are unaudited. The condensed
consolidated balance sheet as of December 31, 2008 is derived from the audited consolidated
financial statements included in the annual report filed on Form 10-K with the U.S. Securities and
Exchange Commission (the “SEC”). The condensed consolidated financial statements are presented on
the basis of accounting principles that are generally accepted in the United States of America for
interim financial information and in accordance with the instructions of the SEC on Form 10-Q and
Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and footnotes
required by accounting principles generally accepted in the United States of America for a complete
set of financial statements. In the opinion of management, all adjustments (which include only
normal recurring adjustments) necessary to present fairly the condensed consolidated balance sheet
as of June 30, 2009 and the results of operations and cash flows for the periods ended June 30,2009 and 2008 have been made. The results for the three and six months ended June 30, 2009 are not
necessarily indicative of the results to be expected for the year ending December 31, 2009 or for
any other period. The condensed consolidated financial statements should be read in conjunction
with the audited consolidated financial statements and the accompanying notes for the year ended
December 31, 2008 included in the Company’s Annual Report on Form 10-K filed with the SEC. The
Company has evaluated all subsequent events through August 6, 2009, the date these financial
statements were issued.
3. Summary of Significant Accounting Policies
Consolidation
The accompanying condensed consolidated financial statements include the accounts of the
Company and its wholly-owned subsidiaries. All significant intercompany transactions and balances
have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the condensed consolidated
financial statements. Estimates also affect the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
The Company recognizes revenue relating to its collaboration agreements in accordance with the
Securities and Exchange Commission’s Staff Accounting Bulletin No. 104, Revenue Recognition, and
Emerging Issues Task Force (“EITF”) Issue 00-21, “Revenue Arrangements with Multiple Deliverables.”
Revenue under collaborative arrangements may result from license fees, milestone payments, research
and development payments and royalty payments.
The Company’s application of these standards requires subjective determinations and requires
management to make judgments about value of the individual elements and whether they are separable
from the other aspects of the contractual relationship. The Company evaluates its collaboration
agreements to determine units of accounting for revenue recognition purposes. To date, the Company
has determined that its upfront non-refundable license fees cannot be separated from its ongoing
collaborative research and development activities and, accordingly, do not treat them as a separate
element. The Company recognizes revenue from non-refundable, upfront licenses and related payments,
not specifically tied to a separate earnings process, either on the proportional performance method
or ratably over either the development period in which the Company is obligated to participate on a
continuing and substantial basis in the research and development activities outlined in the
contract, or the later of (1) the conclusion of the royalty term on a jurisdiction by jurisdiction
basis or (2) the expiration of the last EpiCept licensed patent. Ratable revenue recognition is
only utilized if the research and development services are performed systematically over the
development period. Proportional performance is measured based on costs incurred compared to total
estimated costs to be incurred over the development period which approximates the proportion of the
value of the services provided compared to the total estimated value over the development period.
The Company periodically reviews its estimates of cost and the length of the development period
and, to the extent such estimates change, the impact of the change is recorded at that time.
EpiCept recognizes milestone payments as revenue upon achievement of the milestone only if (1)
it represents a separate unit of accounting as defined in EITF Issue 00-21; (2) the milestone
payments are nonrefundable; (3) substantive effort is involved in achieving the milestone; and (4)
the amount of the milestone is reasonable in relation to the effort expended or the risk associated
with the achievement of the milestone. If any of these conditions is not met, EpiCept will
recognize milestones as revenue in accordance with its accounting policy in effect for the
respective contract. For current agreements, EpiCept recognizes revenue for milestone payments
based upon the portion of the development services that are completed to date and defers the
remaining portion and recognizes it over the remainder of the development services on the
proportional or ratable method, whichever is applicable. Deferred revenue represents the excess of
cash received compared to revenue recognized to date under licensing agreements.
Foreign Currency Translation
The financial statements of the Company’s foreign subsidiary are translated into U.S. dollars
using the period-end exchange rate for all balance sheet accounts and the average exchange rates
for expenses. Adjustments resulting from translation have been reported in other comprehensive
loss.
Gains or losses from foreign currency transactions relating to inter-company debt are recorded
in the consolidated statements of operations in other income (expense).
Stock Based Compensation
The Company has various stock-based compensation plans for employees and outside directors,
which are described more fully in Note 9 “Stock Options and Warrants.”
Income Taxes
The Company files income tax returns in the U.S. federal jurisdiction and various state and
foreign jurisdictions. The Company’s income tax returns for tax years after 2004 are still subject
to review. The Company does not believe there will be any material changes in its unrecognized tax
positions over the next 12 months.
The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax
benefits as a component of operating expense. The Company did not have any accrued interest or
penalties associated with any unrecognized tax benefits, nor
was any interest expense recognized during the quarter. The tax expense is primarily due to
minimal state and local income taxes.
The Company considers all highly liquid investments with a maturity of 90 days or less when
purchased to be cash equivalents.
Restricted Cash
The Company has lease agreements for the premises it occupies. Letters of credit in lieu of
lease deposits for leased facilities totaling $0.1 million are secured by restricted cash in the
same amount at June 30, 2009. During 2008, the Company failed to make certain payments on its lease
agreement for the premises located in San Diego, California. As a result, the landlord exercised
their right to draw down the full letter of credit, amounting to approximately $0.3 million, and
applied approximately $0.2 million to unpaid rent. The remaining balance of $0.1 million is
classified as prepaid rent.
On February 4, 2009, the Company issued $25.0 million in principal aggregate amount of 7.5556%
convertible subordinated notes due 2014. In connection with the issuance of these notes, the
Company was required to deposit approximately $9.4 million in escrow for up to twenty-four months
for the purposes of paying the interest on the notes and the make-whole payments upon conversion or
redemption. As the result of the conversion of $24.5 million of these notes, $0.2 million remained
in escrow for payment of the interest on these notes and was accordingly classified as restricted
cash at June 30, 2009.
Inventory
Inventories are valued at the lower of cost (first-in, first-out) or market. The Company
periodically evaluates its inventories and will reduce inventory to its net realizable value
depending on certain factors, such as product demand, remaining shelf life, future marketing
plans, obsolescence and slow-moving inventories.
Identifiable Intangible Asset
Intangible asset consists of the assembled workforce acquired in the merger with Maxim in
January 2006. The assembled workforce is being amortized on the greater of the straight-line basis
or actual assembled workforce turnover over six years. The gross carrying amount of the assembled
workforce is $0.5 million and $0.5 million of accumulated amortization has been recorded as of June30, 2009. Approximately $0.2 million of amortization was recorded in the second quarter of 2009
due to the layoff of substantially all the Company’s remaining employees at its research facility
in San Diego, California. Assembled workforce amortization is recorded in research and development
expense. During the six months ended June 30, 2009 and 2008, the Company recorded amortization
expense of $0.2 million and $41,000, respectively.
Deferred Rent and Other Noncurrent Liabilities
Deferred rent and other noncurrent liabilities represents deferred rent expense on our
facilities in Tarrytown, NY and San Diego, CA. During the second quarter of 2009, the Company
ceased use of its discovery research facility in San Diego, CA as a result of the Company’s
previously announced decision to discontinue its drug discovery activities. In accordance with FAS
No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“FAS 146”), the
Company recorded a liability of $0.8 million on the cease-use date based on the fair value of the
costs that are expected to be incurred under the lease of the facility. The fair value of the
liability at the cease-use date was determined based on the remaining rental payments, reduced by
estimated sublease rental income that could be reasonably obtained for the property.
Deferred Financing Cost
Deferred financing costs represent legal and other costs and fees incurred to negotiate and
obtain debt financing. Deferred financing costs are capitalized and amortized using the effective
interest method over the life of the applicable financing. During the first quarter of 2009, the
Company incurred approximately $1.6 million in deferred financing costs from the issuance of $25.0
million in principal aggregate amount of 7.5556% convertible subordinated notes due 2014. As a
result of the conversion of $24.5 million of these notes, amortization of the deferred financing
costs was accelerated and amortization expense of $1.6 million was recorded at June 30, 2009. As
of June 30, 2009 and 2008, deferred financing costs were approximately $0.1 and $0.2 million,
respectively. Amortization expense was $1.8 million and $0.2 million for the six months ended June30, 2009 and 2008, respectively.
Basic and diluted loss per share is computed by dividing loss attributable to common
stockholders by the weighted average number of shares of common stock outstanding during the
period. Diluted weighted average shares outstanding excludes shares underlying stock options,
restrictive stock and warrants, since the effects would be anti-dilutive. Accordingly, basic and
diluted loss per share is the same. Such excluded shares are summarized as follows:
Interest and amortization of debt discount and expense
$
(19,833
)
$
(850
)
Interest and amortization of debt discount and expense for the six months ended June 30, 2009
included $10.5 million in amortization of debt issuance costs and discount and $9.3 million in
interest expense, which was paid from escrowed cash, as a result of the conversion of $24.5 million
of the Company’s 7.5556% convertible subordinated notes due 2014 into approximately 27.2 million
shares of the Company’s common stock.
Depreciation expense was approximately $0.1 million for each of the six months ended June 30,2009 and 2008.
Other Comprehensive Loss
For the six months ended June 30, 2009 and 2008, the Company’s only element of comprehensive
loss other than net loss was foreign currency translation loss of $0.1 million and $0.6 million,
respectively.
Recent Accounting Pronouncements
In June 2009, the FASB issued FAS No. 168, “The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles — a replacement of FASB Statement No. 162”
(“FAS 168”). FAS 168 provides for the FASB Accounting Standards Codification (the “Codification”)
to become the single official source of authoritative, nongovernmental U.S. generally accepted
accounting principles (GAAP). The Codification did not change GAAP but reorganizes the literature.
FAS 168 is effective for interim and annual periods ending after September 15, 2009. The adoption
of this pronouncement is not expected to have a material effect on the Company’s consolidated
financial statements.
In May 2009, the FASB issued FAS No. 165, “Subsequent Events” (“FAS 165”). The objective of
this statement is to establish principles and requirements for subsequent events. In particular,
FAS 165 sets forth the period after the balance sheet date during which management of a reporting
entity shall evaluate events or transactions that may occur for potential recognition or disclosure
in the financial statements, the circumstances under which an entity shall recognize events or
transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity shall make about events or transactions that occurred after the balance
sheet date. FAS No. 165 is effective for interim or annual financial statements issued after June15, 2009. The adoption of this pronouncement did not have a material effect on the Company’s
consolidated financial statements.
In March 2008, the FASB issued FAS No. 161, “Disclosures about Derivative Instruments and
Hedging Activities — an amendment of FASB Statement No. 133” (“FAS 161”). FAS 161 requires that
an entity provide enhanced disclosures related to derivative and hedging activities. FAS 161 is
effective for financial statements issued for fiscal years beginning after December 15, 2008. The
adoption of this pronouncement did not have a material effect on the Company’s consolidated
financial statements.
In December 2007, the FASB issued FAS No. 141(R), “Business Combinations” (“FAS 141R”). FAS
141R establishes guidelines for the recognition and measurement of assets, liabilities and equity
in business combinations. FAS 141R is effective for financial statements issued for fiscal years
beginning after December 15, 2008. The adoption of this pronouncement did not have a material
effect on the Company’s consolidated financial statements.
In December 2007, the SEC staff issued Staff Accounting Bulletin (“SAB”) 110, “Share-Based
Payment,” which amends SAB 107, “Share-Based Payment,” to permit public companies, under certain
circumstances, to use the simplified method in SAB 107 for employee option grants after December31, 2007. Use of the simplified method after December 2007 is permitted only for companies whose
historical data about their employees’ exercise behavior does not provide a reasonable basis for
estimating the expected term of the options. The Company adopted SAB 110 on January 1, 2008. The
adoption of this pronouncement did not have a material effect on the Company’s consolidated
financial statements.
In December 2007, the FASB issued EITF Issue No. 07-1, “Accounting for Collaborative
Arrangements” (“EITF 07-1”), which is effective for fiscal years beginning after December 15, 2008.
The Task Force clarified the manner in which costs, revenues and
sharing payments made to, or received by a partner in a collaborative arrangements should be
presented in the statement of operations and set forth certain disclosures that should be required
in the partners’ financial statements. The adoption of this pronouncement did not have a material
effect on the Company’s consolidated financial statements.
In connection with its merger with Maxim on January 4, 2006, EpiCept acquired a license
agreement with Myriad Genetics Inc. (“Myriad”) under which the Company licensed the MX90745 series
of caspase-inducer anti-cancer compounds to Myriad. Under the terms of the agreement, Maxim granted
to Myriad a research license to develop and commercialize any drug candidates from the series of
compounds during the Research Term (as defined in the agreement) with a non-exclusive, worldwide,
royalty-free license, without the right to sublicense the technology. Myriad is responsible for the
worldwide development and commercialization of any drug candidates from the series of compounds.
Maxim also granted to Myriad a worldwide royalty bearing development and commercialization license
with the right to sublicense the technology. The agreement requires that Myriad make licensing,
research and milestone payments to the Company totaling up to $27 million, of which $3 million was
paid and recognized as revenue by Maxim prior to the merger on January 4, 2006, assuming the
successful commercialization of the compound for the treatment of cancer, as well as pay a royalty
on product sales. In March 2008, the Company received a milestone payment of $1.0 million
following dosing of the first patient in a Phase II registration sized clinical trial, which has
been deferred and is being recognized as revenue ratably over the life of the last to expire patent
that expires in July 2024. For the six months ended June 30, 2009 and 2008, the Company recorded
revenue from Myriad of approximately $31,000 and $20,000, respectively.
DURECT Corporation (DURECT)
On December 20, 2006, the Company entered into a license agreement with DURECT Corporation,
pursuant to which it granted DURECT the exclusive worldwide rights to certain of its intellectual
property for a transdermal patch containing bupivacaine for the treatment of back pain. Under the
terms of the agreement, EpiCept received a $1.0 million payment which has been deferred and is
being recognized as revenue ratably over the life of the last to expire patent that expires in
March 2020. In September 2008, the Company amended its license agreement with DURECT. Under the
terms of the amended agreement, the Company granted DURECT royalty-free, fully paid up, perpetual
and irrevocable rights to the intellectual property licensed as part of the original agreement in
exchange for a cash payment of $2.25 million from DURECT, which has also been deferred and is being
recognized as revenue ratably over the last patent life. For the six months ended June 30, 2009
and 2008, the Company recorded revenue from DURECT of approximately $0.1 million and $38,000,
respectively.
Endo Pharmaceuticals Inc. (Endo)
In December 2003, the Company entered into a license agreement with Endo Pharmaceuticals Inc.
(“Endo”) under which it granted Endo (and its affiliates) the exclusive (including as to the
Company and its affiliates) worldwide right to commercialize LidoPAIN BP. The Company also granted
Endo worldwide rights to use certain of its patents for the development of certain other
non-sterile, topical lidocaine containing patches, including Lidoderm®, Endo’s topical
lidocaine-containing patch for the treatment of chronic lower back pain. Upon the execution of the
Endo agreement, the Company received a non-refundable payment of $7.5 million, which has been
deferred and is being recognized as revenue on the proportional performance method. For the six
months ended June 30, 2009 and 2008, the Company recorded revenue from Endo of approximately
$13,000 and $12,000, respectively. The Company is eligible to receive payments of up to $52.5
million upon the achievement of various milestones relating to product development and regulatory
approval for both the Company’s LidoPAIN BP product and licensed Endo products, including
Lidoderm®, so long as, in the case of Endo’s product candidate, the Company’s patents
provide protection thereof. The Company is also entitled to receive royalties from Endo based on
the net sales of LidoPAIN BP. These royalties are payable until generic equivalents to the LidoPAIN
BP product are available or until expiration of the patents covering LidoPAIN BP, whichever is
sooner. The Company is also eligible to receive milestone payments from Endo of up to approximately
$30.0 million upon the achievement of specified net sales milestones for licensed Endo products,
including Lidoderm®, so long as the Company’s patents provide protection thereof. The
future amount of milestone payments the Company is eligible to receive under the Endo agreement is
$82.5 million.
There is no certainty that any of these milestones will be achieved or any royalty earned.
Based on the current level of activity, we do not expect to receive milestones under this agreement
for at least the next twelve months.
Under the terms of the license agreement, the Company is responsible for continuing and
completing the development of
LidoPAIN BP, including the conduct of all clinical trials and the supply of the clinical
products necessary for those trials and the preparation and submission of the NDA in order to
obtain regulatory approval for LidoPAIN BP. Endo remains responsible for continuing and completing
the development of Lidoderm® for the treatment of chronic lower back pain, including the
conduct of all clinical trials and the supply of the clinical products necessary for those trials.
The Company has the option to negotiate a co-promotion arrangement with Endo for LidoPAIN BP
or similar product in any country in which an NDA (or foreign equivalent) filing has been made
within thirty days of such filing. The Company also has the right to terminate its license to Endo
with respect to any territory in which Endo has failed to commercialize LidoPAIN BP within three
years of the receipt of regulatory approval permitting such commercialization.
6. Other Accrued Liabilities
Other accrued liabilities consist of the following:
During the second quarter of 2009, as a result of the decision to close the Company’s research
facility in San Diego, the Company expensed $0.8 million related to the lease on this facility and
$0.2 million in severance payments for the employees affected by the closing. The severance
expense and the current portion of the facility expense is recorded in other accrued liabilities.
The long-term portion of the facility expense of $0.7 million is recorded in deferred rent and
other noncurrent liabilities.
7. Notes, Loans and Financing
The Company is a party to several loan agreements in the following amounts:
Total notes and loans payable, before debt discount
2,556
3,645
Less: Debt discount
170
93
Total notes and loans payable
2,386
3,552
Less: Notes and loans payable, current portion
962
3,275
Notes and loans payable, long-term
$
1,424
$
277
(1)
In August 1997, EpiCept GmbH, a wholly-owned subsidiary of EpiCept, entered into a ten-year
non-amortizing loan in the amount of €1.5 million with Technologie-Beteiligungs Gesellschaft
mbH der Deutschen Ausgleichsbank (“tbg”). The loan initially bore interest at 6% per annum.
Tbg was also entitled to receive additional compensation equal to 9% of the annual surplus
(income before taxes, as defined in the agreement) of EpiCept GmbH, reduced by any other
compensation received from EpiCept GmbH by virtue of other loans to or investments in EpiCept
GmbH provided that tbg is an equity investor in EpiCept GmbH during that time period. The
Company considered the additional compensation element based on the surplus of EpiCept GmbH to
be a derivative. The Company assigned no value to the derivative at each reporting period as
no surplus of EpiCept GmbH was anticipated over the term of the agreement. In addition, any
additional compensation as a result of surplus would be reduced by the additional interest
noted below.
At the demand of tbg, additional amounts could have been due at the end of the loan term
up to 30% of the loan amount, plus 6% of the principal balance of the note for each year
after the expiration of the fifth complete year of the loan period, such payments to be
offset by the cumulative amount of all payments made to the lender from the annual surplus
of EpiCept GmbH. The Company was accruing these additional amounts as additional interest
up to the maximum amount due over the term of the loan.
On December 20, 2007, EpiCept GmbH entered into a repayment agreement with tbg, whereby
EpiCept GmbH paid tbg approximately €0.2 million ($0.2 million) in January 2008,
representing all interest payable to tbg as of December 31, 2007. The loan balance of €1.5
million ($2.0 million), plus accrued interest at a rate of 7.38% per annum beginning
January 1, 2008 was to be repaid to tbg no later than June 30, 2008. Tbg waived any
additional interest payments of approximately €0.5 million ($0.7 million). EpiCept GmbH
considered this a substantial modification to the original debt agreement and has recorded
the new debt at its fair value in accordance with EITF Issue No. 96-19, “Debtor’s
Accounting for a Modification of Debt Instruments” (“EITF 96-19”). As a result of the
modification to the original debt agreement, EpiCept GmbH recorded a gain on the
extinguishment of debt of $0.5 million in December 2007.
On May 14, 2008, EpiCept GmbH entered into a prolongation of the repayment agreement with
tbg, whereby the loan balance of €1.5 million ($2.1 million) was required to be repaid to
tbg no later than December 31, 2008. Interest continued to accrue at a rate of 7.38% per
annum and all the provisions of the repayment agreement dated December 20, 2007 continued
to apply without change.
On November 26, 2008, EpiCept GmbH entered into a second amendment to the repayment
agreement with tbg, whereby the loan balance of €1.5 million ($2.1 million) was required to
be repaid to tbg no later than June 30, 2009. Interest continued to accrue at a rate of
7.38% per annum and all the provisions of the repayment agreement dated December 20, 2007
continued to apply without change.
On June 25, 2009, EpiCept GmbH entered into a third amendment to the repayment agreement with
tbg, whereby €0.3 million of the loan balance of €1.5 million ($2.1 million) plus accrued
interest of €56,000 ($0.1 million) was repaid to tbg on June 30, 2009. The remaining loan
balance of €1.2 million ($1.7 million) plus accrued interest will be paid in four semi-annual
installments of €0.3 million ($0.4 million) beginning December 31, 2009. Interest will continue
to accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated
December 20, 2007 will continue to apply without change.
(2)
In July 2006, the Company entered into a six-year non-interest bearing promissory note in the
amount of $0.8 million with Pharmaceutical Research Associates, Inc., (“PRA”) as compensation
for PRA assuming liability on a lease of premises in San Diego, CA. The fair value of the note
(assuming an imputed 11.6% interest rate) was $0.6 million and broker fees amounted to $0.2
million at issuance. The note is payable in seventy-two equal installments of $11,000 per
month. The Company terminated its lease of certain property in San Diego, CA as part of its
exit plan upon the completion of the merger with Maxim on January 4, 2006. The loan balance
at June 30, 2009 was $0.3 million.
(3)
In August 2006, the Company entered into a term loan in the amount of $10.0 million with
Hercules Technology Growth Capital, Inc., (“Hercules”). The interest rate on the loan was
initially 11.7% per year. In addition, the Company issued five year common stock purchase
warrants to Hercules granting them the right to purchase 0.5 million shares of the Company’s
common stock at an exercise price of $2.65 per share. As a result of certain anti-dilution
adjustments resulting from a financing consummated by the Company in December 2006 and an
amendment entered into in January 2007, the terms of the warrants issued to Hercules were
adjusted to grant Hercules the right to purchase an aggregate of 0.9 million shares of the
Company’s common stock at an exercise price of $1.46 per share. Hercules exercised 0.4 million
warrants in August 2007 and had 0.5 million warrants remaining as of this date. The basic
terms of the loan required monthly payments of interest only through March 1, 2007, with 30
monthly payments of principal and interest which commenced on April 1, 2007. Any outstanding
balance of the loan and accrued interest was to be repaid on August 30, 2009. In connection
with the terms of the loan agreement, the Company granted Hercules a security interest in
substantially all of the Company’s personal property including its intellectual property.
The Company allocated the $10.0 million in proceeds between the term loan and the warrants
based on their relative fair values. The Company calculated the fair value of the warrants at
the date of the transaction at approximately $0.9 million with a corresponding amount recorded
as a debt discount. The debt discount was being accreted over the life of the outstanding term
loan using the effective interest method. At the date of the transaction, the fair value of the
warrants of $0.9 million was determined utilizing the Black-Scholes option pricing model
utilizing the following assumptions: dividend yield of 0%, risk free interest rate of 4.72%,
volatility of 69% and an expected life of five years. During 2008 and 2007, the Company
recognized approximately $0.1 million and $0.4 million, respectively, of non-cash interest
expense related to the accretion of the debt
discount. Since inception of the term loan, the Company recognized approximately $0.8 million of
non-cash interest expense related to the accretion of the debt discount.
On May 5, 2008, the Company entered into the first amendment to the loan agreement. Under
this agreement the Company paid an amendment fee of $50,000, agreed to maintain, subject to
certain exceptions, a minimum cash balance of $0.5 million in the Company’s bank accounts
that are subject to the security interest maintained by Hercules under the loan agreement
and to deliver an amendment to the warrant agreement. On May 7, 2008, in connection with a
second amendment to the warrant agreement with Hercules, the terms of the warrants issued
to Hercules were adjusted to grant Hercules the right to purchase an aggregate of 2.2
million shares of the Company’s common stock at an exercise price of $0.30 per share. As a
result of this amendment, these warrants no longer met the requirements to be accounted for
as equity in accordance with EITF Issue No. 00-19, “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock”(“EITF 00-19”).
Therefore, the warrants were reclassified as a liability from equity for approximately $0.4
million at the date of the amendment to the loan agreement. The value of the warrant
shares were being marked to market at each reporting period as a derivative gain or loss.
At June 30, 2008, the warrants met the requirements to be accounted for as equity in
accordance with EITF 00-19 and were reclassified as equity from a liability for $0.3
million. The Company recognized a change in the fair value of warrants and derivatives of
approximately $0.1 million, as a gain on the consolidated statement of operations. The
warrants issued under this amendment were exercised in full during the third quarter of
2008.
On June 23, 2008, the Company entered into the second amendment to the loan agreement.
Under this amendment, the Company paid Hercules a $0.3 million restructuring fee and $0.5
million from the restricted cash account toward the last principal installments owed on the
loan. The applicable interest rate on the balance of the loan was increased from 11.7% to
15.0% and the repayment schedule was modified and accelerated. In addition, the Company
was required to make contingent payments of $0.5 million resulting from the approval of
Ceplene®, which was paid in September 2008, and $0.3 million for achieving
statistically significant results of the primary endpoints of the Phase II trial for NP-1,
which we paid in February 2009. Hercules was permitted to convert up to $1.9 million of
the outstanding principal balance into up to 3.7 million shares of the Company’s common
stock at a price of $0.515 per share. In October 2008 and December 2008, Hercules
converted $1.9 million of the outstanding principal balance into approximately 3.6 million
shares of the Company’s common stock, resulting in a reduction of the outstanding principal
balance to $8,000 at December 31, 2008.
Finally, in connection with the second amendment to the loan agreement, the Company issued to
Hercules warrants to purchase an aggregate of 3.8 million shares of the Company’s common
stock at an exercise price of $0.39 per share and an aggregate of 1.0 million shares of the
Company’s common stock at an exercise price of $0.41 per share. The Company considered
this a substantial modification to the original debt agreement and recorded the new debt at
its fair value in accordance with EITF 96-19. As a result of the modification to the
original debt agreement, the Company recorded a loss on the extinguishment of debt of $2.0
million in June 2008.
In February 2009, the Company repaid the remaining principal amount and all fees due under
its loan agreement with Hercules. The Company has no further obligations under this
agreement.
(4)
In December 2008, the Company completed the sale of subordinated convertible notes due April10, 2009 for aggregate proceeds of $1.0 million. The notes were convertible into shares of the
Company’s common stock at any time upon the election of the purchasers at $1.00 per share. The
notes were subordinated to the senior secured loan discussed in (4) below. The notes were
issued as an original issue discount obligation in lieu of periodic interest payments and
therefore no interest payments were made under these notes. Accordingly, the aggregate
principal face amount of the notes was $1.1 million. In April 2009, the Company repaid the
remaining balance of these notes.
(5)
On February 4, 2009, the Company issued $25.0 million principal aggregate amount of 7.5556%
convertible subordinated notes due February 2014 and five and-a-half year warrants to purchase
approximately 12.5 million shares of common stock at an exercise price of $1.035 per share.
Each $1,000 in principal aggregate amount of the notes is initially convertible into
approximately 1,111 shares of Common Stock, at the option of the holders or upon specified
events, including a change of control, and if the Company’s common stock trades at or greater
than $1.70 a share for 20 out of 30 days, beginning February 9, 2010. Upon any conversion or
redemption of the notes, the holders will receive a make-whole payment in an amount equal to
the interest payable through the scheduled maturity of the converted or redeemed notes, less
any interest paid before such conversion or redemption. Interest is due and payable on the
notes semi-annually in arrears on June 30 and December 31, beginning on June 30, 2009.
The Company allocated the $25.0 million in proceeds between the convertible subordinated
notes and the warrants based on their relative fair values. The Company calculated the fair
value of the warrants at the date of the transaction at approximately $8.8 million with a
corresponding amount recorded as a debt discount. The debt discount is being accreted over
the life of the outstanding convertible subordinated notes using the effective interest
method. At the date of the transaction, the fair value of the warrants of $8.8 million was
determined utilizing the Black-Scholes option pricing model under the following
assumptions: dividend yield of 0%, risk free interest rate of 1.99%, volatility of 118% and
an expected life of five years. During the first six months of 2009, the Company
recognized approximately $8.6 million of non-cash interest expense related to the accretion
of the debt discount as a result of the conversion of $24.5 million of the convertible
subordinated notes into approximately 27.2 million shares of the Company’s common stock.
As of June 30, 2009, after giving effect to the conversions into common stock, the remaining
principal aggregate amount of the notes due 2014 outstanding is $0.5 million.
On June 23, 2009, the Company raised $9.6 million in gross proceeds, $8.9 million net of $0.7
million in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Company’s common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Company’s securities. Approximately
12.0 million shares of the Company’s common stock were sold at a price of $0.80 per share. Two and
one-half year common stock purchase warrants were issued to investors granting them the right to
purchase approximately 4.2 million shares of the Company’s common stock at an exercise price of
$0.90 per share. The Company allocated the $9.6 million in gross proceeds between the common stock
and the warrants based on their relative fair values. $2.0 million of this amount was allocated to
the warrants. The warrants did not meet the requirements of being accounted for as equity in
accordance with EITF 00-19 since the Company did not have an adequate number of authorized shares
to reserve for the exercise of the warrants. Therefore, the value of the warrant shares were
classified as a liability and were marked to market at June 30, 2009 as a derivative loss. On July2, 2009, the warrants were reclassified from liability to equity as a result of shareholders
approving an increase in the number of authorized shares of the Company’s common stock. A charter
amendment to increase the number of authorized shares of common stock was filed on July 8, 2009.
On August 11, 2008, the Company raised $4.0 million in gross proceeds, $3.7 million net of
$0.3 million in transactions costs, through a public offering of common stock and common stock
purchase warrants registered pursuant to a shelf registration statement on Form S-3 registering the
issuance and sale of up to $50.0 million of the Company’s common stock, preferred stock, debt
securities, convertible debt securities and/or warrants to purchase the Company’s securities.
Approximately 5.2 million shares of the Company’s common stock were sold at a price of $0.7589 per
share. Five year common stock purchase warrants were issued to investors granting them the right
to purchase approximately 2.6 million shares of the Company’s common stock at an exercise price of
$0.63 per share and approximately 0.3 million shares of the Company’s common stock at an exercise
price of $0.95 per share. In addition, in consideration of the receipt of $1.3 million in
connection with the exercise of all of the warrants issued in connection with the Company’s public
offering announced on August 1, 2008, the Company agreed to issue to the investors in that offering
new warrants to purchase up to approximately 2.8 million shares of Common Stock of the Company with
an exercise price of $0.693 per share. Such warrants are exercisable until August 11, 2013. The
Company allocated the $3.7 million in gross proceeds between the common stock and the warrants
based on their relative fair values. $1.7 million of this amount was allocated to the warrants. The
warrants meet the requirements of and are being accounted for as equity in accordance with EITF
00-19.
On August 1, 2008, the Company raised $3.0 million in gross proceeds, $2.8 million net of $0.2
million in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Company’s common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Company’s securities. Approximately
5.5 million shares of the Company’s common stock were sold at a price of $0.54 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 2.8 million shares of the Company’s common stock at an exercise price of $0.48 per
share and approximately 0.3 million shares of the Company’s common stock at an exercise price of
$0.68 per share. The Company allocated the $3.0 million in gross proceeds between the common stock
and the warrants based on their relative fair values. $0.9 million of this amount was allocated to
the warrants. The warrants meet the requirements of and are being accounted for as equity in
accordance with EITF 00-19.
On July 15, 2008, the Company raised $0.5 million in gross proceeds, $0.5 million net of
$50,000 in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form
S-3 registering the issuance and sale of up to $50.0 million of the Company’s common stock,
preferred stock, debt securities, convertible debt securities and/or warrants to purchase the
Company’s securities. Approximately 2.0 million shares of the Company’s common stock were sold at
a price of $0.25 per share. Five year common stock purchase warrants were issued to investors
granting them the right to purchase approximately 2.1 million shares of the Company’s common stock
at an exercise price of $0.39 per share. The Company allocated the $0.5 million in gross proceeds
between the common stock and the warrants based on their relative fair values. $0.2 million of this
amount was allocated to the warrants. The warrants meet the requirements of and are being accounted
for as equity in accordance with EITF 00-19.
On June 23, 2008, the Company raised $2.0 million in gross proceeds, $1.8 million net of $0.2
million in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Company’s common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Company’s securities. Approximately
8.0 million shares of the Company’s common stock were sold at a price of $0.25 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 8.3 million shares of the Company’s common stock at an exercise price of $0.39 per
share. The Company allocated the $2.0 million in gross proceeds between the common stock and the
warrants based on their relative fair values. $0.8 million of this amount was allocated to the
warrants. The warrants meet the requirements of and are being accounted for as equity in accordance
with EITF 00-19.
On March 6, 2008, the Company raised $5.0 million in gross proceeds, $4.7 million net of $0.3
million in transaction costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Company’s common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Company’s securities. Approximately
5.4 million shares of the Company’s common stock were sold at a price of $0.9225 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 3.0 million shares of the Company’s common stock at an exercise price of $0.86 per
share. The Company allocated the $5.0 million in gross proceeds between the common stock and the
warrants based on their relative fair values. $1.3 million of this amount was allocated to the
warrants. The warrants meet the requirements of and are being accounted for as equity in accordance
with EITF 00-19.
On August 30, 2006, the Company entered into a senior secured term loan in the amount of $10.0
million with Hercules. Five year common stock purchase warrants were issued to Hercules granting
them the right to purchase 0.5 million shares of the Company’s common stock at an exercise price of
$2.65 per share. The fair value of the warrants was determined utilizing the Black-Scholes option
pricing model utilizing the following assumptions: dividend yield of 0%, risk free interest rate of
4.72%, volatility of 69% and an expected life of five years. The value of the warrant shares was
being marked to market each reporting period as a derivative gain or loss. As a result of certain
anti-dilution adjustments resulting from the issuance of common stock consummated on December 21,2006 and an amendment to the warrants on January 26, 2007, the warrants issued to Hercules were
adjusted to grant Hercules the right to purchase an aggregate of 0.9 million shares of the
Company’s common stock at an exercise price of $1.46 per share. As a result of the January 2007
amendment to the warrants, the warrants issued to Hercules met the requirements of and were being
accounted for as equity in accordance with EITF 00-19. The fair value of the warrants as of the
date of the amendment was $0.8 million. Accordingly, the Company reclassified this amount from a
liability to warrants in stockholders’ deficit at that date. During 2007, the Company recognized
the change in the value of warrants and derivatives of approximately $0.8 million as a loss on the
consolidated statement of operations.
In July 2007, the Company entered into a release and settlement agreement to compensate
Hercules for its inability to sell registered shares following an April 2007 planned exercise of a
portion of the warrants issued by the Company to Hercules. The Company agreed to pay Hercules a
fee of $0.3 million and to compensate Hercules up to $1.1 million on its exercise and sale of a
portion of the warrants, provided such exercise and sale occurred prior to November 1, 2007, to the
extent the market value of the Company’s common stock on the date of exercise was less than the
market value of the Company’s stock at the time Hercules planned to sell the shares issued pursuant
to the exercise of the warrants. Such compensation, if any, was payable in cash up to $0.6
million, the amount EpiCept received from the mandatory cash exercise of the warrants, with the
remainder payable at the Company’s option in cash or in the Company’s common stock based on the
fair value of the stock on the date the compensation was paid. The Company considered the
contingent amount a derivative and marked the derivative to market at each reporting date. The 0.4
million warrants relating to the release and settlement agreement were reclassified as a liability
from equity for $0.7 million at the date of the derivative agreement. In August 2007, Hercules
exercised and sold the warrants relating to the release and settlement agreement, resulting in a
total liability to the Company of $1.1 million. The Company paid Hercules $0.6 million in cash
during the third quarter of 2007 and paid the remaining liability of $0.5 million at its option in
its common stock on November 1, 2007.
On May 7, 2008, in connection with a second amendment to the warrant agreement with Hercules,
the terms of the warrants issued to Hercules were adjusted to grant Hercules the right to purchase
an aggregate of 2.2 million shares of the Company’s common stock at an exercise price of $0.30 per
share.
On June 23, 2008, the Company entered into the second amendment to the loan agreement with
Hercules. Under this amendment, the Company issued Hercules warrants to purchase an aggregate of
3.8 million shares of the Company’s common stock at an exercise price of $0.39 per share and an
aggregate of 1.0 million shares of the Company’s common stock at an exercise price of $0.41 per
share.
The following table summarizes information about warrants outstanding at June 30, 2009:
February 9, 2009 convertible subordinated note due 2014 (See Note 7)
2014
11,111,111
1.04
February 9, 2009 convertible subordinated note due 2014 (See Note 7)
2014
1,388,889
1.29
June 2009 stock issuance (See Note 8)
2011
4,200,000
0.90
June 2009 stock issuance (See Note 8)
2011
600,000
1.00
Total
40,173,547
$
1.23
For the six months ended June 30, 2009, the Company received proceeds of $3.1 million related
to the exercise of approximately 8.9 million warrants.
9. Stock Options and Warrants
The Company records stock-based compensation expense at fair value in accordance with the FAS
123R. The Company utilizes the Black-Scholes valuation method to recognize compensation expense
over the vesting period. Certain assumptions need to be made with respect to utilizing the
Black-Scholes valuation model, including the expected life, volatility, risk-free interest rate and
anticipated forfeiture of the stock options. The expected life of the stock options was calculated
using the method allowed by the provisions of FAS 123R and interpreted by an SEC issued Staff
Accounting Bulletin No. 107, or SAB 107, as amended by SAB 110. In accordance with SAB 107, the
simplified method for “plain vanilla” options may be used where the expected term is equal to the
vesting term plus the original contract term divided by two. Due to limited Company specific
historical volatility data, the Company has based its estimate of expected volatility of stock
awards upon historical volatility rates of comparable public companies to the extent it was not
materially lower than its actual volatility. The risk-free interest rate is based on the rates paid
on securities issued by the U.S. Treasury with a term approximating the expected life of the
options. Estimates of pre-vesting option forfeitures are based on our experience. The Company will
adjust its estimate of forfeitures over the requisite service period based on the extent to which
actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated
forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future periods.
The Company accounts for stock-based transactions with non-employees in which services are
received in exchange for the equity instruments based upon the fair value of the equity instruments
issued, in accordance with SFAS No. 123 and EITF Issue No.
96-18, “Accounting for Equity Instruments that are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services.” The two factors that most affect
charges or credits to operations related to stock-based compensation are the estimated fair market
value of the common stock underlying stock options for which stock-based compensation is recorded
and the estimated volatility of such fair market value. The value of such options is periodically
remeasured and income or expense is recognized during the vesting terms.
2005 Equity Incentive Plan
The 2005 Equity Incentive Plan (the “2005 Plan”) was adopted on September 1, 2005, approved by
stockholders on September 5, 2005 and became effective on January 4, 2006. The 2005 Plan provides
for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue
Code, to EpiCept’s employees and its subsidiary corporations’ employees, and for the grant of
nonstatutory stock options, restricted stock, restricted stock units, performance-based awards and
cash awards to its employees, directors and consultants and its subsidiary corporations’ employees
and consultants. Options are granted and vest as determined by the Board of Directors. A total of
13.0 million shares of EpiCept’s common stock are reserved for issuance pursuant to the 2005 Plan.
No optionee may be granted an option to purchase more than 1.5 million shares in any fiscal year.
Options issued pursuant to the 2005 Plan have a maximum maturity of 10 years and generally vest
over 4 years from the date of grant. The Company records stock-based compensation expense at fair
value. During the six months ended June 30, 2009, the Company issued approximately 1.9 million
options to purchase common stock to certain of its employees and members of its board of directors.
The Company estimated $0.9 million of share-based compensation will be recognized as compensation
expense over the vesting periods. During the six months ended June 30, 2009, the Company granted
0.8 million stock options that contained a performance condition.
Following the departure of a former director, the Company agreed to extend the period during
which he would be entitled to exercise certain vested stock options to purchase the Company’s
common stock from three months following the effective date of his resignation, February 3, 2009,
to six months following such effective date. The Company recorded compensation expense related to
the modification of the exercise period of $3,000 in the first quarter of 2009.
The following table presents the total employee, former employee, board of directors and third
party stock-based compensation expense resulting from stock options, restricted stock and
restricted stock units included in the consolidated statement of operations for the three and six
months ended June 30, 2009 and 2008:
There were no stock option exercises during the six months ended June 30, 2009 and 2008. The
total intrinsic value of options exercised during 2009 and 2008 was $0. Intrinsic value is measured
using the fair market value at the date of exercise (for shares
exercised) or at June 30, 2009 (for outstanding options), less the applicable exercise price.
The weighted average grant-date fair value of options granted for the six months ended June 30,2009 and 2008 was $0.50 and $1.19, respectively.
As of June 30, 2009, the total remaining unrecognized compensation cost related to the
non-vested stock options amounted to $1.7 million, which will be amortized over the
weighted-average remaining requisite service period of 2.14 years. Summarized Black-Scholes option
pricing model assumptions for stock option grants to employees and directors for six months ended
June 30, 2009 and 2008 are as follows:
Restricted stock was issued to certain employees in January 2007, which entitle the holder to
receive a specified number of shares of the Company’s common stock over a four year, monthly
vesting term. This restricted stock grant is accounted for at fair value at the date of grant and
an expense is recognized during the vesting term. There were no restricted stock grants prior to
2007. Summarized information for restricted stock grants for the six months ended June 30, 2009 is
as follows:
Restricted stock units were issued to certain employees and non-employee members of the
Company’s Board of Directors in 2009 and 2008, which entitle the holder to receive a specified
number of shares of the Company’s common stock at the end of the respective vesting term. This
restricted stock unit grant is accounted for at fair value at the date of grant and an expense is
recognized during the vesting term. Summarized information for restricted stock unit grants for the
six months ended June 30, 2009 is as follows:
Following the departure of a former director, the Company agreed to accelerate the vesting of
certain restricted stock units. The Company issued 12,500 shares of the Company’s common stock as
a result of accelerating the vesting period and recorded compensation expense related to the
modification of the vesting period of $5,000 in the first quarter of 2009.
1995 Stock Options
The EpiCept Corporation 1995 Stock Option Plan as amended in 1997 and 1999 (the “1995 Plan”)
provides for the granting of incentive stock options and non-qualified stock options to purchase
the Company’s stock through the year 2005. A total of 0.8 million shares of the Company’s common
stock are authorized under the 1995 Plan. All stock options granted after December 31, 2005 were
from the 2005 Plan. Under the terms of the 1995 Plan, which terminated on November 14, 2005, 0.3
million options remain vested and outstanding as of June 30, 2009.
The 2005 Employee Stock Purchase Plan (the “2005 ESPP”) was adopted on September 1, 2005 and
approved by the stockholders on September 5, 2005. The 2005 ESPP became effective upon the
completion of the merger with Maxim on January 4, 2006 and a total of 500,000 shares of common
stock were reserved for sale. The Company commenced the administration of the 2005 ESPP in November
2007. The 2005 ESPP is implemented by offerings of rights to all eligible employees from time to
time. Unless otherwise determined by the Company’s Board of Directors, common stock is purchased
for accounts of employees participating in the 2005 ESPP at a price per share equal to the lower of
(i) 85% of the fair market value of a share of the Company’s common stock on the first day the
offering or (ii) 85% of the fair market value of a share of the Company’s common stock on the last
trading day of the purchase period. The initial period commenced November 16, 2007, and ended June30, 2008. Each subsequent offering period will have a six month duration.
The number of shares to be purchased at each balance sheet date is estimated based on the
current amount of employee withholdings and the remaining purchase dates within the offering
period. The fair value of share options expected to vest is estimated using the Black-Scholes
option-pricing model. Share options for employees entering the ESPP were estimated using the
Black-Scholes option-pricing model and the assumptions noted on the table below.
As of June 30, 2009, 500,000 shares were issued under the 2005 ESPP, therefore there are
currently no shares available for issuance under the 2005 ESPP. For the six months ended June 30,2009 and 2008, the Company recorded an expense of $0 based on the estimated number of shares to be
purchased.
2009 Employee Stock Purchase Plan
The 2009 Employee Stock Purchase Plan (the “2009 ESPP”) was adopted by the Board of Directors
on December 19, 2008, subject to stockholder approval, and was approved by the stockholders at the
Company’s 2009 Annual Meeting held on June 2, 2009. The 2009 ESPP was effective on January 1, 2009
and a total of 1,000,000 shares of common stock have been reserved for sale. The 2009 ESPP is
implemented by offerings of rights to all eligible employees from time to time. Unless otherwise
determined by the Company’s Board of Directors, common stock is purchased for accounts of employees
participating in the 2009 ESPP at a price per share equal to the lower of (i) 85% of the fair
market value of a share of the Company’s common stock on the first day the offering or (ii) 85% of
the fair market value of a share of the Company’s common stock on the last trading day of the
purchase period. The initial period commenced January 1, 2009 and ended on June 30, 2009. Each
subsequent offering period will have a six-month duration.
As of June 30, 2009, 103,424 shares were issued under the 2009 ESPP. For the six months ended
June 30, 2009 and 2008, the Company recorded an expense of $27,000 and $0, respectively, based on
the estimated number of shares to be purchased.
The Company operates as one business segment: the clinical development and commercialization
of pharmaceutical products. The Company maintains clinical development operations in the United
States and Germany.
Geographic information for the three and six months ended June 30, 2009 and 2008 are as follows:
In July 2009, the Company amended its certificate of incorporation to increase the number of
authorized shares of common stock from 175,000,000 to 225,000,000 shares.
On August 3, 2009, the Company received a letter from the Nasdaq Listing Qualifications
Department stating that the Company had not regained compliance with the minimum bid price
requirement under Listing Rule 5550(a)(2) by July 28, 2009 and, as a result, its common stock would
be subject to delisting from The Nasdaq Capital Market unless the
Company requests an appeal before
the Nasdaq Hearings Panel (the “Panel”). The Company intends to request a hearing
before the Panel, which will stay the delisting of its common stock pending the issuance of a
decision by the Panel following the hearing. The Company expects that the hearing will be
scheduled for September 2009. At the hearing, the Company will request continued listing on The
Nasdaq Capital Market based upon its plan for demonstrating compliance with the applicable listing
requirements. Pursuant to the Nasdaq Marketplace Rules, the Panel has the authority to grant the
Company up to an additional 180 days from August 3, 2009 (i.e. January 30, 2010) to implement its
plan of compliance. There can be no assurance that the Panel will grant the Company’s request for
continued listing on The Nasdaq Stock Market.
In August 2009, the Company filed a New Drug Submission (“NDS”) for Ceplene® with
Health Canada for the treatment of AML in Canada.
The Company has evaluated all subsequent events through August 6, 2009, the date these
financial statements were issued.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
This discussion and analysis of EpiCept’s condensed consolidated financial condition and
results of operations contains forward-looking statements that involve risks and uncertainties. The
Company has based these forward-looking statements on its current expectations and projections of
future events. Such statements reflect the Company’s current views with respect to future events
and are subject to unknown risks, uncertainties and other factors that may cause results to differ
materially from those contemplated in such forward looking statements. Statements made in this
document related to the development, commercialization and market expectations of the Company’s
drug candidates, to the establishment of corporate collaborations, and to the Company’s operational
projections are forward-looking and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. Among the factors that could result in a materially
different outcome are the inherent uncertainties accompanying new product development, action of
regulatory authorities and the results of further trials. Additional economic, competitive,
governmental, technological, marketing and other factors identified in EpiCept’s filings with the
SEC could affect such results. This report refers to trademarks of the Company as well as
trademarks of third parties. All trademarks referenced herein are property of their respective
owners. Lidoderm® is a registered trademark of Hind Health Care Inc. Azixa™ is a
trademark of Myriad Genetics, Inc.
Overview
We are a specialty pharmaceutical company focused on the clinical development and
commercialization of pharmaceutical products for the treatment of cancer and pain. Our strategy is
to focus our clinical development efforts on innovative cancer therapies and topically delivered
analgesics targeting peripheral nerve receptors. Our lead product is Ceplene®, which
when used concomitantly with interleukin-2 is intended as remission maintenance therapy in the
treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete
remission. On October 8, 2008, the European Commission issued a formal marketing authorization for
Ceplene®in the European Union. In June 2009 the Company launched a Named Patient
Program for Ceplene®in Europe through a partnership with IDIS. In August 2009, we
filed a New Drug Submission, or NDS, for Ceplene® with Health Canada for the treatment
of AML in Canada and in January 2009, we received permission to proceed with a New Drug
Application, or NDA, filing with the United States Food and Drug Administration, or FDA. In
addition to Ceplene®, we have two oncology compounds and a pain product candidate for
the treatment of peripheral neuropathies in clinical development. We believe this portfolio of
oncology and pain management product candidates lessens our reliance on the success of any single
product or product candidate.
Our cancer portfolio includes crinobulin, or EPC2407, a novel small molecule vascular
disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid tumors and
lymphomas. We have completed our first Phase I clinical trial for crinobulin. AzixaTM,
or MPC-6827, an apoptosis inducer with VDA activity licensed by us to Myriad Genetics, Inc., or
Myriad, as part of an exclusive, worldwide development and commercialization agreement, is
currently in Phase II clinical trials in patients with primary glioblastoma, melanoma that has
metastasized to the brain and non-small-cell lung cancer that has spread to the brain.
Our late-stage pain product candidate, EpiCeptTM NP-1 cream, which we refer to as
NP-1, is a prescription topical analgesic cream designed to provide effective long-term relief of
pain associated with peripheral neuropathies. In February 2008, we concluded a Phase II clinical
study of NP-1 in patients suffering from diabetic peripheral neuropathy, or DPN. In January 2009,
we concluded a second Phase II clinical trial of NP-1 in which we studied its safety and efficacy
in patients suffering from post-herpetic neuralgia, or PHN, compared to gabapentin and placebo.
Both studies support the advancement of NP-1 into a registration-sized trial. NP-1 utilizes a
proprietary formulation to administer FDA approved pain management therapeutics, or analgesics,
directly on the skin’s surface at or near the site of the pain, targeting pain that is influenced,
or mediated, by nerve receptors located just beneath the skin’s surface.
We are subject to a number of risks associated with companies in the specialty pharmaceutical
industry as discussed in this report and in Part I “Item 1A. Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2008. Principal among these are risks associated with our
ability to obtain regulatory approval for our product candidates, our ability to adequately fund
our operations, dependence on collaborative arrangements, the development by us or our competitors
of new technological innovations, dependence on key personnel, protection of proprietary technology
and compliance with the FDA and other governmental regulations. We have yet to generate product
revenues from any of our product candidates. We have financed our operations primarily through the
proceeds from the sale of common stock, warrants, debt instruments, cash proceeds from
collaborative relationships and investment income earned on cash balances and short-term
investments.
Ceplene® has been granted full marketing authorization by the European Commission
for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia
in first remission. None of our other drug candidates has received FDA or foreign regulatory
marketing approval. In order to grant marketing approval, the FDA or foreign regulatory agencies
must conclude
that we and our collaborators’ clinical data establish the safety and efficacy of our drug
candidates. Furthermore, our strategy includes entering into collaborative arrangements with third
parties to participate in the development and commercialization of our products. In the event that
third parties have control over the preclinical development or clinical trial process for a product
candidate, the estimated completion date would largely be under control of that third party rather
than under our control. We cannot forecast with any degree of certainty which of our drug
candidates will be subject to future collaborations or how such arrangements would affect our
development plan or capital requirements.
We have prepared our consolidated financial statements under the assumption that we are a
going concern. We have devoted substantially all of our cash resources to research and development
programs and general and administrative expenses, and to date it not generated any meaningful
revenues from the sale of products. Since inception, we have incurred significant net losses each
year. As a result, we have an accumulated deficit of $225.8 million as of June 30, 2009. Our
recurring losses from operations and the accumulated deficit raise substantial doubt about our
ability to continue as a going concern. The consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty. Our losses have resulted
principally from costs incurred in connection with our development activities and from general and
administrative expenses. Even if we succeed in developing and commercializing one or more of our
product candidates, we may never become profitable. We expect to continue to incur significant
expenses over the next several years as we:
•
seek to conclude a European marketing partnership in preparation for the commercial
launch of Ceplene®;
•
continue to conduct clinical trials for our product candidates;
•
seek regulatory approvals for our product candidates;
•
develop, formulate, and commercialize our product candidates;
•
implement additional internal systems and develop new infrastructure;
•
acquire or in-licenses additional products or technologies or expand the use of our
technologies;
•
maintain, defend and expand the scope of our intellectual property; and
•
hire additional personnel.
We believe that our existing cash and cash equivalents will be sufficient to fund our
operations and debt service requirements into the second quarter of 2010. Future funding is
anticipated to be derived from sales of Ceplene®in Europe; fees from our strategic
partners, including a marketing partner for Ceplene® in Europe that is expected to be
concluded in 2009, or funding through public or private financings, strategic relationships or
other arrangements.
Recent Events
In July 2009, we amended our certificate of incorporation to increase the number of authorized
shares of common stock from 175,000,000 to 225,000,000 shares.
In August 2009, we filed a New Drug Submission (“NDS”) for Ceplene® with Health
Canada for the treatment of AML in Canada.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on
our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these financial statements
requires that we make estimates and judgments that affect the reported amounts of assets,
liabilities and expenses and related disclosure of contingent assets and liabilities. We review our
estimates on an ongoing basis. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances. Actual results may differ
from these estimates under different assumptions or conditions. While our significant accounting
policies are described in more detail in the notes to our consolidated financial statements
included in our Annual Report filed on Form 10-K, we believe the following accounting policies to
be critical to the judgments and estimates used in the preparation of its financial statements.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements. Estimates also affect the reported amounts of
revenues and expenses during the reporting period, stock-based compensation, contingent
interest and warrant liability. Actual results could differ from those estimates.
We recognize revenue relating to our collaboration agreements in accordance with the SEC Staff
Accounting Bulletin (“SAB”) 104, Revenue Recognition, and Emerging Issues Task Force Issue 00-21,
“Revenue Arrangements with Multiple Deliverables.” (“EITF 00-21”). Revenue under collaborative
arrangements may result from license fees, milestone payments, research and development payments
and royalties.
Our application of these standards involves subjective determinations and requires management
to make judgments about value of the individual elements and whether they are separable from the
other aspects of the contractual relationship. We evaluate our collaboration agreements to
determine units of accounting for revenue recognition purposes. For collaborations containing a
single unit of accounting, we recognize revenue when the fee is fixed or determinable,
collectibility is assured and the contractual obligations have occurred or been rendered. For
collaborations involving multiple elements, our application requires management to make judgments
about value of the individual elements and whether they are separable from the other aspects of the
contractual relationship. To date, we have determined that its upfront non-refundable license fees
cannot be separated from its ongoing collaborative research and development activities to the
extent such activities are required under the agreement and, accordingly, do not treat them as a
separate element. We recognize revenue from non-refundable, up-front licenses and related payments,
not specifically tied to a separate earnings process, either on the proportional performance method
with respect to our license with Endo, or ratably over either the development period or the later
of (1) the conclusion of the royalty term on a jurisdiction by jurisdiction basis; and (2) the
expiration of the last EpiCept licensed patent as we do with respect to our license with DURECT,
Myriad and GNI, Ltd., or GNI.
Proportional performance is measured based on costs incurred compared to total estimated costs
over the development period which approximates the proportion of the value of the services provided
compared to the total estimated value over the development period. The proportional performance
method currently results in revenue recognition at a slower pace than the ratable method as many of
our costs are incurred in the latter stages of the development period. We periodically review our
estimates of cost and the length of the development period and, to the extent such estimates
change, the impact of the change is recorded at that time. During each of the years 2009 and 2008
we increased the estimated development period by an additional twelve months to reflect additional
time required to obtain clinical data from our partner.
We will recognize milestone payments as revenue upon achievement of the milestone only if (1)
it represents a separate unit of accounting as defined in EITF 00-21; (2) the milestone payments
are nonrefundable; (3) substantive effort is involved in achieving the milestone; and (4) the
amount of the milestone is reasonable in relation to the effort expended or the risk associated
with the achievement of the milestone. If any of these conditions are not met, we will recognize
milestones as revenue in accordance with our accounting policy in effect for the respective
contract. At the time of a milestone payment receipt, we will recognize revenue based upon the
portion of the development services that are completed to date and defer the remaining portion and
recognize it over the remainder of the development services on the proportional or ratable method,
whichever is applicable. When payments are specifically tied to a separate earnings process,
revenue will be recognized when the specific performance obligation associated with the payment has
been satisfied. Deferred revenue represents the excess of cash received compared to revenue
recognized to date under licensing agreements.
Royalty Expense
Upon receipt of marketing approval and commencement of commercial sales, some of which may not
occur for several years, we will owe royalties to licensors of certain patents generally based upon
net sales of the respective products. Under a license agreement with respect to NP-1, we are
obligated to pay royalties based on annual net sales derived from the products incorporating the
licensed technology. Under a license agreement with respect to crinobulin, we are required to
provide a portion of any sublicensing payments we receive if we relicense the series of compounds
or make milestone payments, assuming the successful commercialization of the compound by us for the
treatment of a cancer indication, as well as pay a royalty on product sales. Under a royalty
agreement with respect to Ceplene®, we are obligated to pay royalties based on annual
net sales derived from the products incorporating the licensed technology. In each case, our
royalty obligation ends the later of (1) the conclusion of the royalty term on a jurisdiction by
jurisdiction basis; and (2) the expiration of the last EpiCept licensed patent.
We record stock-based compensation expense at fair value in accordance with the Financial
Accounting Standards Board, or FASB, issued FAS 123R, “Share-Based Payment”, or FAS 123R. We
utilize the Black-Scholes valuation method to recognize compensation expense over the vesting
period. Certain assumptions need to be made with respect to utilizing the Black-Scholes valuation
model, including the expected life, volatility, risk-free interest rate and anticipated forfeiture
of the stock options. The expected life of the stock options was calculated using the method
allowed by the provisions of FAS 123R and interpreted by an SEC issued Staff Accounting Bulletin
No. 107, or SAB 107, as amended by SAB 110. In accordance with SAB 107, the simplified method for
“plain vanilla” options may be used where the expected term is equal to the vesting term plus the
original contract term divided by two. Due to limited Company specific historical volatility data,
we have based our estimate of expected volatility of stock awards upon historical volatility rates
of comparable public companies to the extent it was not materially lower than our actual
volatility. The risk-free interest rate is based on the rates paid on securities issued by the U.S.
Treasury with a term approximating the expected life of the options. Estimates of pre-vesting
option forfeitures are based on our experience. We will adjust our estimate of forfeitures over the
requisite service period based on the extent to which actual forfeitures differ, or are expected to
differ, from such estimates. Changes in estimated forfeitures will be recognized through a
cumulative catch-up adjustment in the period of change and will also impact the amount of
compensation expense to be recognized in future periods.
We account for stock-based transactions with non-employees in which services are received in
exchange for the equity instruments based upon the fair value of the equity instruments issued, in
accordance with SFAS No. 123 and EITF Issue No. 96-18, “Accounting for Equity Instruments that are
Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”
The two factors that most affect charges or credits to operations related to stock-based
compensation are the estimated fair market value of the common stock underlying stock options for
which stock-based compensation is recorded and the estimated volatility of such fair market value.
The value of such options is periodically remeasured and income or expense is recognized during the
vesting terms.
Accounting for stock-based compensation granted by us requires fair value estimates of the
equity instrument granted or sold. If our estimate of the fair value of stock-based compensation is
too high or too low, it will have the effect of overstating or understating expenses. When
stock-based grants are granted in exchange for the receipt of goods or services, we estimate the
value of the stock-based compensation based upon the value of our common stock.
During each of the six months ended June 30, 2009 and 2008, we issued approximately 1.9
million stock options, with varying vesting provisions to certain of our employees and directors.
Based on the Black-Scholes valuation method (volatility — 114%-118%, risk free rate — 1.67-2.52%,
dividends — zero, weighted average life — 5 years; forfeiture — 10%), for the grants issued in
2009, we estimated $0.9 million of share-based compensation will be recognized as compensation
expense over the vesting period, which will be amortized over the weighted average remaining
requisite service period of 2.55 years. During the six months ended June 30, 2009 and 2008, we
recognized total share-based compensation of approximately $0.7 million and $1.3 million,
respectively, related to the options granted during 2009, 2008, 2007, 2006 and the unvested
outstanding Maxim options as of January 4, 2006 that were converted into EpiCept options based on
the vesting of those options during 2006. Future grants of options will result in additional
charges for stock-based compensation that will be recognized over the vesting periods of the
respective options.
Following the departure of a former director, we agreed to extend the period during which he
would be entitled to exercise certain vested stock options to purchase our common stock from three
months following the effective date of his resignation, February 3, 2009, to six months following
such effective date. We recorded compensation expense related to the modification of the exercise
period of $3,000 in the first quarter of 2009. We also agreed to accelerate the vesting of certain
restricted stock units. We issued 12,500 shares of our common stock as a result of accelerating
the vesting period and recorded compensation expense related to the modification of the vesting
period of $5,000 in the first quarter of 2009.
Deferred Financing Costs
Deferred financing costs represent legal and other costs and fees incurred to negotiate and
obtain debt financing. These costs are capitalized and amortized using the effective interest rate
method over the life of the applicable financing.
As a result of certain financings, derivative instruments were created that we have measured
at fair value and mark to market at each reporting period. Fair value of the derivative instruments
will be affected by estimates of various factors that may affect the
respective instrument, including our cost of capital, risk free rate of return, volatility in
the fair value of our stock price, future foreign exchange rates of the U.S. dollar to the euro and
future profitability of our German subsidiary. At each reporting date, we review applicable
assumptions and estimates relating to fair value and record any changes in the statement of
operations.
Foreign Exchange Gains and Losses
We have a 100%-owned subsidiary in Germany, EpiCept GmbH, that performs certain research and
development activities on our behalf pursuant to a research collaboration agreement. EpiCept GmbH
has been unprofitable since its inception. Its functional currency is the euro. The process by
which EpiCept GmbH’s financial results are translated into U.S. dollars is as follows: income
statement accounts are translated at average exchange rates for the period and balance sheet asset
and liability accounts are translated at end of period exchange rates. Translation of the balance
sheet in this manner affects the stockholders’ equity account, referred to as the cumulative
translation adjustment account. This account exists only in EpiCept GmbH’s U.S. dollar balance
sheet and is necessary to keep the foreign balance sheet stated in U.S. dollars in balance.
Certain of our debt instruments, originally expressed in German deutsche marks, are now
denominated in euros. Changes in the value of the euro relative to the value of the U.S. dollar
could affect the U.S. dollar value of our indebtedness at each reporting date as substantially all
of our assets are held in U.S. dollars. These changes are recognized by us as a foreign currency
transaction gain or loss, as applicable, and are reported in other expense or income in our
consolidated statements of operations.
Research and Development Expenses
We expect that a large percentage of our future research and development expenses will be
incurred in support of current and future preclinical and clinical development programs. These
expenditures are subject to numerous uncertainties in timing and cost to completion. We test our
product candidates in numerous preclinical studies for toxicology, safety and efficacy. We then
conduct early stage clinical trials for each drug candidate. As we obtain results from clinical
trials, we may elect to discontinue or delay clinical trials for certain product candidates or
programs in order to focus resources on more promising product candidates or programs. Completion
of clinical trials may take several years but the length of time generally varies according to the
type, complexity, novelty and intended use of a drug candidate. The cost of clinical trials may
vary significantly over the life of a project as a result of differences arising during clinical
development, including:
•
the number of sites included in the trials;
•
the length of time required to enroll suitable patients;
•
the number of patients that participate in the trials;
•
the number of doses that patients receive;
•
the duration of follow-up with the patient;
•
the product candidate’s phase of development; and
•
the efficacy and safety profile of the product.
Expenses related to clinical trials are based on estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and clinical research
organizations that conduct clinical trials on the our behalf. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may result in uneven
payment flows. If timelines or contracts are modified based upon changes in the clinical trial
protocol or scope of work to be performed, estimates of expenses are modified accordingly on a
prospective basis.
Ceplene® has been granted full marketing authorization by the European Commission
for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid
Leukemia in first remission. None of our other drug candidates has received FDA or foreign
regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory
agencies must conclude that we and our collaborators’ clinical data establishes the safety and
efficacy of our drug candidates. Furthermore, our strategy includes entering into collaborations
with third parties to participate in the development and commercialization of our products. In the
event that third parties have control over the preclinical development or clinical trial process
for a product candidate, the estimated completion date would largely be under control of that third
party rather than under our control. We cannot forecast with any degree of certainty which of our
drug candidates will be subject to future collaborations or how such arrangements would affect our
development plan or capital requirements.
In June 2009, the FASB issued FAS No. 168, “The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles — a replacement of FASB Statement No. 162”
(“FAS 168”). FAS 168 provides for the FASB Accounting Standards Codification (the “Codification”)
to become the single official source of authoritative, nongovernmental U.S. generally accepted
accounting principles (GAAP). The Codification did not change GAAP but reorganizes the literature.
FAS 168 is effective for interim and annual periods ending after September 15, 2009. The adoption
of this pronouncement is not expected to have a material effect on our consolidated financial
statements.
In May 2009, the FASB issued FAS No. 165, “Subsequent Events” (“FAS 165”). The objective of
this statement is to establish principles and requirements for subsequent events. In particular,
FAS 165 sets forth the period after the balance sheet date during which management of a reporting
entity shall evaluate events or transactions that may occur for potential recognition or disclosure
in the financial statements, the circumstances under which an entity shall recognize events or
transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity shall make about events or transactions that occurred after the balance
sheet date. FAS No. 165 is effective for interim or annual financial statements issued after June15, 2009. The adoption of this pronouncement did not have a material effect on our consolidated
financial statements.
In March 2008, the FASB issued FAS No. 161, “Disclosures about Derivative Instruments and
Hedging Activities — an amendment of FASB Statement No. 133” (“FAS 161”). FAS 161 requires that
an entity provide enhanced disclosures related to derivative and hedging activities. FAS 161 is
effective for financial statements issued for fiscal years beginning after December 15, 2008. The
adoption of this pronouncement did not have a material effect on our consolidated financial
statements.
In December 2007, the FASB issued FAS No. 141(R), “Business Combinations” (“FAS 141R”). FAS
141R establishes guidelines for the recognition and measurement of assets, liabilities and equity
in business combinations. FAS 141R is effective for financial statements issued for fiscal years
beginning after December 15, 2008. The adoption of this pronouncement did not have a material
effect on our consolidated financial statements.
In December 2007, the SEC staff issued Staff Accounting Bulletin 110 (“SAB 110”), “Share-Based
Payment,” which amends SAB 107, “Share-Based Payment,” to permit public companies, under certain
circumstances, to use the simplified method in SAB 107 for employee option grants after December31, 2007. Use of the simplified method after December 2007 is permitted only for companies whose
historical data about their employees’ exercise behavior does not provide a reasonable basis for
estimating the expected term of the options. We adopted SAB 110 on January 1, 2008. The adoption
of this pronouncement did not have a material effect on our consolidated financial statements.
In December 2007, the FASB issued EITF Issue No. 07-1, “Accounting for Collaborative
Arrangements” (“EITF 07-1”), which is effective for fiscal years beginning after December 15, 2008.
The Task Force clarified the manner in which costs, revenues and sharing payments made to, or
received by a partner in a collaborative arrangements should be presented in the statement of
operations and set forth certain disclosures that should be required in the partners’ financial
statements. The adoption of this pronouncement did not have a material effect on our consolidated
financial statements.
Revenues. During the three months ended June 30, 2009 and 2008, we recognized revenue of
approximately $0.1 million and $42,000, respectively, from the upfront licensing fees and milestone
payments received from Myriad, Endo and DURECT and royalties with respect to acquired Maxim
technology. We recognize revenue from our agreement with Endo using the proportional performance
method with respect to LidoPAIN BP and on a straight line method over the life of the last to
expire patent with Myriad and DURECT. We recognized revenue of $0 for each of the three months
ended June 30, 2009 and 2008 from royalties with respect to acquired Maxim technology.
The current portion of deferred revenue as of June 30, 2009 of $0.4 million represents our
estimate of revenue to be recognized over the next twelve months primarily related to the upfront
payments from Myriad, Endo and DURECT.
General and administrative expense. General and administrative expense decreased by 23%, or
$0.5 million. from $2.2 million for the three months ended June 30, 2008 to $1.7 million for the
three months ended June 30, 2009. The decrease was primarily attributable to lower non-cash
compensation of $0.4 million and lower legal fees of $0.1 million for the three months ended June30, 2009 as compared to the same period in 2008.
Research and development expense. Research and development expense increased by 15%, or $0.5
million, from $3.3 million for the three months ended June 30, 2008 to $3.8 million for the three
months ended June 30, 2009. The increase was primarily attributable to a $0.8 million facility
expense and $0.2 million in severance expense related to closing our research facility in San Diego
for the six months ended June 30, 2009 as compared to the same period in 2008, partially offset by
lower clinical trial expenses. During the second quarter of 2009, our clinical efforts were
focused on the initiation of an open label trial of Ceplene® that will meet our post-approval
requirements with the EMEA and a Phase Ib clinical trial for crinobulin. During the second quarter
of 2008, our clinical efforts were focused on the completion of the clinical trials of NP-1 and
preparation for the reexamination of the negative determination issued by the CHMP, the scientific
committee of the EMEA, regarding our marketing application for Ceplene®.
Other income (expense). Our other income (expense) consisted of the following:
Interest and amortization of debt discount and expense
$
(1,714
)
$
(377
)
Change in value of warrants and derivatives
(305
)
113
Interest income
8
5
Loss on extinguishment of debt
—
(1,975
)
Foreign exchange gain (loss)
382
(11
)
Other expense, net
$
(1,629
)
$
(2,245
)
For the three months ended June 30, 2009, we recorded other expense, net of $1.6 million as
compared to other expense, net of $2.2 million for the three months ended June 30, 2008. The $0.6
million decrease in other expense, net was primarily related to a loss on extinguishment of debt of
$2.0 million that was recorded for the three months ended June 30, 2008 and a $0.4 million
favorable foreign exchange gain for the three months ended June 30, 2009, which was partially
offset by higher interest expense of $1.3 million primarily related to conversions of our February
2009 debt and a $0.4 million decrease in the fair value of certain warrants and derivatives. On
June 23, 2008, we entered into a second amendment to our senior secured term loan agreement. Under
this amendment, we paid the lender a $0.3 million restructuring fee in the second quarter of 2008
and $0.5 million from the restricted cash account toward the last principal installments owed on
the loan. The applicable interest rate on the balance of the loan was increased from 11.7% to
15.0%. In addition, we were required to make contingent payments of $0.5 million if Ceplene® was
approved and $0.3 million if the NP-1 trial yielded statistically significant results of the
primary endpoints. We also permitted Hercules to convert up to $1.9 million of the outstanding
principal balance into shares of our common stock at a price above the market price of our common
stock on the date of the amendment. Finally, we issued Hercules warrants to purchase an aggregate
of 3.8 million shares of our common stock at an exercise price of $0.39 per share and an aggregate
of 1.0 million shares our common stock at an exercise price of $0.41 per share. We considered the
amendment a substantial modification to the original debt agreement and we recorded the new debt at
its fair value in accordance with EITF 96-19, “Debtor’s Accounting for a Modification of Debt
Instruments.” As a result of the modification to the original debt agreement, we recorded a loss on
the extinguishment of debt of $2.0 million in June 2008.
Revenues. During the six months ended June 30, 2009 and 2008, we recognized revenue of
approximately $0.2 million and $0.1 million, respectively, from the upfront licensing fees and
milestone payments received from Myriad, Endo and DURECT and royalties with respect to acquired
Maxim technology. We recognize revenue from our agreement with Endo using the proportional
performance method with respect to LidoPAIN BP and on a straight line method over the life of the
last to expire patent with Myriad and DURECT. We recognized revenue of $20,000 and $19,000 for the
six months ended June 30, 2009 and 2008, respectively, from royalties with respect to acquired
Maxim technology.
The current portion of deferred revenue as of June 30, 2009 of $0.4 million represents our
estimate of revenue to be recognized over the next twelve months primarily related to the upfront
payments from Myriad, Endo and DURECT.
General and administrative expense. General and administrative expense decreased by 22%, or
$1.1 million, from $4.8 million for the six months ended June 30, 2008 to $3.7 million for the six
months ended June 30, 2009. The decrease was primarily attributable to lower non-cash compensation
of $0.7 million and lower legal fees of $0.3 million for the six months ended June 30, 2009 as
compared to the same period in 2008.
Research and development expense. Research and development expense decreased by 12%, or $0.8
million, from $6.8 million for the six months ended June 30, 2008 to $6.0 million for the six
months ended June 30, 2009. The decrease was primarily attributable to lower clinical trial
expenses for the six months ended June 30, 2009 as compared to the same period in 2008, partially
offset by a $0.8 million facility expense and $0.2 million in severance expense related to closing
our research facility in San Diego. During the six months ended June 30, 2009, our clinical
efforts were focused on the initiation of an open label trial of Ceplene® that will meet our
post-approval requirements with the EMEA and a Phase Ib clinical trial for crinobulin. During the
six months ended 2008, our clinical efforts were focused on the completion of the clinical trials
of NP-1, preparation for the Oral Explanation meeting with the CHMP, the scientific committee of
the EMEA, regarding the remaining outstanding issues on the MAA for Ceplene® and preparation for
the reexamination of the negative determination issued by the CHMP regarding our marketing
application for Ceplene®.
Other income (expense). Our other income (expense) consisted of the following for the six
months ended June 30, 2009 and 2008:
Interest and amortization of debt discount and expense
$
(19,833
)
$
(850
)
Change in value of warrants and derivatives
(305
)
113
Interest income
15
20
Loss on extinguishment of debt
—
(1,975
)
Foreign exchange gain
92
384
Other expense, net
$
(20,031
)
$
(2,308
)
For the six months ended June 30, 2009, we recorded other expense, net of $20.0 million as
compared to other expense, net of $2.3 million for the six months ended June 30, 2008. The $17.7
million increase in other expense, net was primarily related to $10.5 million in amortization of
debt issuance costs and discount and $9.3 million in interest expense, which was paid from
restricted cash, as a result of the conversion of $24.5 million of our 7.5556% convertible
subordinated notes due 2014 into approximately 27.2 million shares of our common stock, a $0.4
million decrease in the fair value of certain warrants and derivatives and a smaller foreign
exchange gain of $0.3 million, partially offset by a loss on extinguishment of debt of $2.0 million
for the six months ended June 30, 2008. On June 23, 2008, we entered into a second amendment to
our senior secured term loan agreement. Under this amendment, we paid the lender, Hercules, a $0.3
million restructuring fee and $0.5 million from the restricted cash account toward the last
principal installments owed on the loan. The applicable interest rate on the balance of the loan
was increased from 11.7% to 15.0%. In addition, we were required to make contingent payments of
$0.5 million if Ceplene® was approved and $0.3 million if the NP-1 trial yields statistically
significant results of the primary endpoints. We also permitted Hercules to convert up to $1.9
million of the outstanding principal balance into shares of our common stock at a price above the
market price of our common stock on the date of the amendment. Finally, we issued Hercules
warrants to purchase an aggregate of 3.8 million shares of our common stock at an exercise price of
$0.39 per share and an aggregate of 1.0 million shares our common stock at an exercise price of
$0.41 per share. We considered the amendment a substantial modification to the original debt
agreement and we recorded the new debt at its fair value in accordance with EITF 96-19, “Debtor’s
Accounting for a Modification of Debt Instruments.” As a result of the modification to the
original debt agreement, we recorded a loss on the extinguishment of debt of $2.0 million in
June 2008.
We have devoted substantially all of our cash resources to research and development programs
and general and administrative expenses. To date, we have not generated any meaningful revenues
from the sale of products and may not generate any such revenues for a number of years, if at all.
As a result, we have incurred an accumulated deficit of $225.8 million as of June 30, 2009, and we
anticipate that we will continue to incur operating losses in the future. Our recurring losses from
operations and our stockholders’ deficit raise substantial doubt about our ability to continue as a
going concern. Should we be unable to generate sufficient revenue from the sale of Ceplene®or raise adequate financing in the future, operations will need to be scaled back or
discontinued. Since our inception, we have financed our operations primarily through the proceeds
from the sales of common and preferred securities, debt, revenue from collaborative relationships,
investment income earned on cash balances and short-term investments and the sales of a portion of
our New Jersey net operating loss carryforwards.
At June 30, 2009, we had working capital of $7.6 million consisting of current assets of $15.6
million and current liabilities of $8.0 million. This represents an increase in working capital of
approximately $16.1 million from the working capital deficit of $8.5 million at December 31, 2008,
consisting of current assets of $1.2 million and current liabilities of $9.7 million. We funded our
working capital deficit and the cash portion of our 2009 operating loss with the cash proceeds from
our June 2009, February 2009 and December 2008 financings. We believe that our existing cash
resources will be sufficient to meet our projected operating and debt service requirements into the
second quarter of 2010. Future funding is anticipated to be derived from sales of Ceplene®in Europe; fees from our strategic partners, including a marketing partner for
Ceplene® in Europe that is expected to be concluded in 2009, or funding through public
or private financings, strategic relationships or other arrangements.
Cash and Cash Equivalents
At June 30, 2009, our cash and cash equivalents totaled $14.1 million. At December 31, 2008,
cash and cash equivalents totaled $0.8 million. Our cash and cash equivalents consist primarily of
an interest bearing money market account. In June 2009, we sold approximately 12.0 million shares
of common stock and warrants to purchase 4.2 million shares of common stock for gross proceeds of
$9.6 million, $8.9 million net of $0.7 million in transaction costs. In February 2009, we received
net proceeds of approximately $14.0 million, after $1.6 million in transaction costs and
establishing a restricted cash account of $9.4 million for make-whole interest, from the issuance
of $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes due
February 2014 and five and one-half year warrants to purchase approximately 12.5 million shares of
the Company’s common stock at an exercise price of $1.035 per share.
In December 2008, we received $1.0 million in net proceeds from the issuance of convertible
subordinated notes due April 2009. On August 11, 2008, we sold approximately 5.2 million shares of
common stock and warrants to purchase 2.9 million shares of common stock for gross proceeds of $4.0
million, $3.7 million net of $0.3 million in transactions costs. In addition, in consideration of
the receipt of $1.3 million in connection with the exercise of all of the warrants issued in
connection with our August 1, 2008 public offering, we issued to the investors in that offering new
warrants to purchase up to approximately 2.8 million shares of our Common Stock. On August 1, 2008,
we sold approximately 5.5 million shares of common stock and warrants to purchase 3.1 million
shares of common stock for gross proceeds of $3.0 million, $2.8 million net of $0.2 million in
transactions costs. In July 2008, we sold approximately 2.0 million shares of common stock and
warrants to purchase 2.1 million shares of common stock for gross proceeds of $0.5 million, $0.5
million net of $50,000 in transactions costs. In June 2008, we sold approximately 8.0 million
shares of common stock and warrants to purchase 8.0 million shares of common stock for gross
proceeds of $2.0 million, $1.8 million net of $0.2 million
in transaction costs. In March 2008, we sold approximately 5.4 million shares of common stock
and warrants to purchase 2.7 million shares of common stock for gross proceeds of $5.0 million,
$4.7 million net of $0.3 million in transactions costs.
During 2008, we raised gross proceeds of $15.5 million, $14.3 million net of $1.2 million in
transaction costs. In June 2009, we raised gross proceeds of $9.6 million, $8.9 million net of
$0.7 million in transaction costs, from the sale of common stock and warrants and in February 2009,
we issued $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes
due February 2014 and five and one-half year warrants to purchase approximately 12.5 million shares
of our common stock at an exercise price of $1.035 per share, netting us $14.0 million after $1.6
million in transaction costs and the restriction of $9.4 million to establish an escrow account to
make interest payments. For the six months ended June 30, 2009, a total of 8.9 million shares of
our common stock were issued upon the exercise of common stock purchase warrants, resulting in
proceeds to the Company of approximately $3.1 million. Our cash at June 30, 2009 of $14.1 million
is expected to meet our projected operating requirements into the second quarter of 2010. Future
funding is anticipated to be derived from sales of Ceplene®in Europe; fees from our
strategic partners, including a marketing partner for Ceplene® in Europe that is
expected to be concluded in 2009, or funding through public or private financings, strategic
relationships or other arrangements.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include, but are not limited to, the following:
•
revenues generated from the sale of Ceplene®in Europe, including payments
from our marketing partner;
•
progress in our research and development programs, as well as the magnitude of these
programs;
•
the timing, receipt and amount of milestone and other payments, if any, from present
and future collaborators, if any;
•
the ability to establish and maintain additional collaborative arrangements;
•
the resources, time and costs required to successfully initiate and complete our
preclinical and clinical trials, obtain regulatory approvals, protect our intellectual
property;
•
the cost of preparing, filing, prosecuting, maintaining and enforcing patent claims;
and
•
the timing, receipt and amount of sales and royalties, if any, from our potential
products.
If, at any time, our prospects for financing our clinical development programs decline, we may
decide to reduce research and development expenses by delaying, discontinuing or reducing our
funding of development of one or more product candidates. Alternatively, we might raise funds
through public or private financings, strategic relationships or other arrangements. There can be
no assurance that the funding, if needed, will be available on attractive terms, or at all.
Furthermore, any additional equity financing may be dilutive to stockholders and debt financing, if
available, may involve restrictive covenants and increased interest expense. Similarly, financing
obtained through future co-development arrangements may require us to forego certain commercial
rights to future drug candidates. Our failure to raise capital as and when needed could have a
negative impact on our consolidated financial condition and our ability to pursue our business
strategy.
Our ability to raise additional capital will depend on financial, economic and market
conditions and other factors, many of which are beyond our control. We cannot be certain that such
additional funding will be available upon acceptable terms, or at all. To the extent that we raise
additional capital by issuing equity securities, our then-existing stockholders may experience
further dilution. Our sales of equity have generally included the issuance of warrants, and if
these warrants are exercised in the future, stockholders may experience significant additional
dilution. We may not be able to raise additional capital through the sale of our securities which
would severely limit our ability to fund our operations. Debt financing, if available, may subject
us to restrictive covenants that could limit our flexibility in conducting future business
activities. Given our available cash resources, existing indebtedness and results of operations,
obtaining debt financing may not be possible. To the extent that we raise additional capital
through collaboration and licensing arrangements, it may be necessary for us to relinquish valuable
rights to our product candidates that we might otherwise seek to develop or commercialize
independently.
In December 2006, we entered into a Standby Equity Distribution Agreement, or SEDA, with YA
Global Investments, L.P. Pursuant to this agreement, YA Global Investments, L.P. has committed to
purchase up to $15.0 million of shares of our common stock from us through December 2009 at a
discount to be calculated at the time of issuance. Under the terms of the agreement, we will
determine, at our sole discretion, the exact timing and amount of any SEDA financings, subject to
certain conditions. We have not drawn on the SEDA to date.
Net cash used in operating activities for the first six months of 2009 was $21.0 million as
compared to $7.8 million in the first six months of 2008. Cash was primarily used to fund our net
loss for the applicable period for research and development and general and administrative
expenses. The 2009 net loss was partially offset by non-cash charges of $10.5 million in
amortization of deferred financing costs and discount on loans, $0.7 million of FAS 123R
stock-based compensation and $0.3 million of depreciation and amortization expense. Deferred
revenue decreased by $0.2 million to account for the portion of the Myriad, Endo and DURECT
deferred revenue recognized as revenue. The 2008 net loss was partially offset by non-cash charges
of $1.7 million related to the extinguishment of debt, $1.3 million of FAS 123R stock-based
compensation and $0.1 million of depreciation and amortization expense. Deferred revenue increased
by $1.0 million as a result of receiving a $1.0 million milestone payment from our partner, Myriad,
following dosing of the first patient in a Phase II registration sized clinical trial for
AzixaTM. This was partially offset by $0.1 million to account for the portion of the
Myriad, Endo and DURECT deferred revenue recognized as revenue.
Investing Activities
Net cash used in investing activities for the first six months of 2009 was $0.1 million
compared with net cash provided by investing activities of $0.3 million for the first six months of
2008. During the first six months of 2009, cash was used to establish restricted cash for a $9.4
million make-whole interest payment resulting from the issuance of $25.0 million principal
aggregate amount of 7.5556% convertible senior subordinated notes, the release of $9.3 million
from restricted cash to pay for interest on the 7.5556% notes as the result of the conversion of
$24.5 million in aggregate principal amount of the 7.5556% notes, $0.1 million in proceeds from the
sale of equipment in our San Diego research facility and $16,000 for the purchase of equipment.
Net cash provided by investing activities for the six months of 2008 consisted of the release of
restricted cash amounting to $0.3 million and proceeds from the sale of property and equipment
amounting to $0.1 million.
Financing Activities
Net cash provided by financing activities for the first six months of 2009 was $34.3 million
compared to $3.8 million for the first six months of 2008. During the first six months of 2009, we
issued $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes,
netting us $14.0 million after $1.6 million in transaction costs and establishing a restricted cash
account of $9.4 million for make-whole interest. In June 2009, we raised $9.6 million gross
proceeds, $8.9 million net of $0.7 million in transaction costs, in connection with the issuance of
common stock and warrants. We also received proceeds of $3.1 million related to the exercise of
approximately 8.9 million warrants in the first six months of 2009. We repaid the outstanding loan
balance with Hercules of approximately $8,000 and deferred financing costs of $0.2 million,
resulting in our having no further obligations under this loan agreement. We also repaid $0.8
million of the subordinated convertible notes due April 10, 2009. Net cash provided by financing
activities for the six months of 2008 was $3.8 million. In June 2008, we raised $2.0 million gross
proceeds less $0.2 million in transaction related costs in connection with the issuance of common
stock and warrants. In March 2008, we raised $5.0 million gross proceeds less $0.3 million in
transaction related costs in connection with the issuance of common stock and warrants. The
increase in cash provided by financing was partially offset by loan repayments of $2.7 million.
As of June 30, 2009, the annual amounts of future minimum payments under debt obligations,
interest, lease obligations and other long term obligations consisting of research, development,
consulting and license agreements (including maintenance fees) are as follows (in thousands of U.S.
dollars, using exchange rates where applicable in effect as of June 30, 2009):
Less than
More than
1 Year
1 – 3 Years
3 – 5 Years
5 Years
Total
Long-term debt
$
962
$
1,094
$
500
$
—
$
2,556
Interest expense
144
76
—
—
220
Operating leases
1,079
1,996
1,050
—
4,125
Severance
239
—
—
—
239
Other obligations
1,543
950
200
200
2,893
Total
$
3,967
$
4,116
$
1,750
$
200
$
10,033
Our current commitments of debt consist of the following:
€1.5 Million Due 2009. In August 1997, our subsidiary, EpiCept GmbH entered into a ten-year
non-amortizing loan in the amount of €1.5 million with Technologie-Beteiligungs Gesellschaft mbH
der Deutschen Ausgleichsbank, or tbg. This loan is referred to in this report as the “tbg I” loan.
Proceeds must be directed toward research, development, production and distribution of
pharmaceutical products. The tbg I loan initially bore interest at 6% per annum. Tbg was also
entitled to receive additional compensation equal to 9% of the annual surplus (income before taxes,
as defined in the debt agreement) of EpiCept GmbH, reduced by any other compensation received from
EpiCept GmbH by virtue of other loans to or investments in EpiCept GmbH provided that tbg is an
equity investor in EpiCept GmbH during that time period. We considered the additional compensation
element based on the surplus of EpiCept GmbH to be a derivative. We assigned no value to the
derivative at each reporting period as no surplus of EpiCept GmbH was anticipated over the term of
the agreement. In addition, any additional compensation as a result of surplus would be reduced by
the additional interest noted below.
At the demand of tbg, additional amounts could have been due at the end of the loan term up to
30% of the loan amount, plus 6% of the principal balance of the loan for each year after the
expiration of the fifth complete year of the loan period, such payments to be offset by the
cumulative amount of all payments made to tbg from the annual surplus of EpiCept GmbH. We were
accruing these additional amounts as additional interest up to the maximum amount due over the term
of the loan.
On December 20, 2007, EpiCept GmbH entered into a repayment agreement with tbg, whereby
EpiCept GmbH paid tbg approximately €0.2 million ($0.2 million) in January 2008, representing all
interest payable to tbg as of December 31, 2007. The loan balance of €1.5 million ($2.0 million),
plus accrued interest at a rate of 7.38% per annum beginning January 1, 2008 was required to be
repaid to tbg no later than June 30, 2008. Tbg waived any additional interest payments of
approximately €0.5 million ($0.7 million). EpiCept GmbH considered this a substantial modification
to the original debt agreement and has recorded the new debt at its fair value in accordance with
EITF 96-19. As a result of the modification to the original debt agreement, EpiCept GmbH recorded a
gain on the extinguishment of debt of $0.5 million in December 2007.
On May 14, 2008, EpiCept GmbH entered into a prolongation of the repayment agreement with tbg,
whereby the loan balance of €1.5 million ($2.0 million) was required to be repaid to tbg no later
than December 31, 2008. Interest continued to accrue at a rate of 7.38% per annum and all the
provisions of the repayment agreement dated December 20, 2007 continued to apply without change.
On November 26, 2008, EpiCept GmbH entered into a second amendment to the repayment agreement
with tbg, whereby the loan balance of €1.5 million ($2.0 million) was required to be repaid to tbg
no later than June 30, 2009. Interest continued to accrue at a rate of 7.38% per annum and all the
provisions of the repayment agreement dated December 20, 2007 continued to apply without change.
On June 25, 2009, EpiCept GmbH entered into a third amendment to the repayment agreement with
tbg, whereby €0.3 million ($0.4 million) of the loan balance of €1.5 million ($2.1 million) plus
accrued interest of €56,000 ($0.1 million) was repaid to tbg on June 30, 2009. The remaining loan
balance of €1.2 million ($1.7 million) plus accrued interest will be paid in four semi-annual
installments of €0.3 million ($0.4 million) beginning December 31, 2009. Interest will continue to
accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated
December 20, 2007 will continue to apply without change.
$0.8 million Due 2012. In July 2006, Maxim, our wholly-owned subsidiary, issued a six-year
non-interest bearing promissory note in the amount of $0.8 million to Pharmaceutical Research
Associates, Inc., or PRA, as compensation for PRA assuming the liability on a lease in San Diego,
CA. The note is payable in seventy-two equal installments of approximately $11,000 per month. We
terminated our lease of certain property in San Diego, CA as part of our exit plan upon the
completion of the merger with Maxim on January 4, 2006. Our loan balance at June 30, 2009 is $0.3
million.
Senior Secured Term Loan. In August 2006, we entered into a senior secured term loan in the
amount of $10.0 million with Hercules Technology Growth Capital, Inc., or Hercules. The interest
rate on the loan was initially 11.7% per year. In addition, we issued five year common stock
purchase warrants to Hercules granting them the right to purchase 0.5 million shares of our common
stock at an exercise price of $2.65 per share. As a result of certain anti-dilution adjustments
resulting from a financing consummated by us in December 2006 and an amendment entered into in
January 2007, the terms of the warrants issued to Hercules were adjusted to grant Hercules the
right to purchase an aggregate of 0.9 million shares of our common stock at an exercise price of
$1.46 per share. Hercules exercised 0.4 million warrants in August 2007 and had 0.5 million
warrants remaining as of this date. The basic terms of the loan required monthly payments of
interest only through March 1, 2007, with 30 monthly payments of principal and interest which
commenced on April 1, 2007. Any outstanding balance of the loan and accrued interest was to be
repaid on August 30, 2009. In connection with the terms of the loan agreement, we granted Hercules
a security interest in substantially all of the Company’s personal property including its
intellectual property.
We allocated the $10.0 million in proceeds between the term loan and the warrants based on
their relative fair values. We calculated the fair value of the warrants at the date of the
transaction at approximately $0.9 million with a corresponding amount recorded as a debt discount.
The debt discount was being accreted over the life of the outstanding term loan using the effective
interest method. At the date of the transaction, the fair value of the warrants of $0.9 million was
determined utilizing the Black-Scholes option pricing model utilizing the following assumptions:
dividend yield of 0%, risk free interest rate of 4.72%, volatility of 69% and an expected life of
five years. During 2008 and 2007, we recognized approximately $0.1 million and $0.4 million,
respectively, of non-cash interest expense related to the accretion of the debt discount. Since
inception of the term loan, we recognized approximately $0.8 million of non-cash interest expense
related to the accretion of the debt discount.
On May 5, 2008, we entered into the first amendment to the loan agreement. Under this
agreement we paid an amendment fee of $50,000, agreed to maintain, subject to certain exceptions, a
minimum cash balance of $0.5 million in our bank accounts that are subject to the security interest
maintained by Hercules under the loan agreement and to deliver an amendment to the warrant
agreement. On May 7, 2008, in connection with a second amendment to the warrant agreement with
Hercules, the terms of the warrants issued to Hercules were adjusted to grant Hercules the right to
purchase an aggregate of 2.2 million shares of our common stock at an exercise price of $0.30 per
share. As a result of this amendment, these warrants no longer met the requirements to be accounted
for as equity in accordance with EITF Issue No. 00-19, “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock” (“EITF 00-19”).
Therefore, the warrants were reclassified as a liability from equity for approximately $0.4 million
at the date of the amendment to the loan agreement. The value of the warrants shares were being
marked to market at each reporting period as a derivative gain or loss. At June 30, 2008, the
warrants met the requirements to be accounted for as equity in accordance with EITF 00-19 and were
reclassified as equity from a liability for $0.3 million. We recognized a change in the fair value
of warrants and derivatives of approximately $0.1 million as a gain on the consolidated statement
of operations. The warrants issued under this amendment were exercised in full during the third
quarter of 2008.
On June 23, 2008, we entered into the second amendment to the loan agreement. Under this
amendment, we paid Hercules a $0.3 million restructuring fee and $0.5 million from the restricted
cash account toward the last principal installments owed on the loan. The applicable interest rate
on the balance of the loan was increased from 11.7% to 15.0% and the repayment schedule was
modified and accelerated. In addition, we were required to make contingent payments of $0.5
million resulting from the approval of Ceplene®, which was paid in September 2008, and
$0.3 million for achieving statistically significant results of the primary endpoints of the Phase
II trial for NP-1, which was paid in February 2009. Hercules was permitted to convert up to $1.9
million of the outstanding principal balance into up to 3.7 million shares of our common stock at a
price of $0.515 per share. In October 2008 and December 2008, Hercules converted $1.9 million of
the outstanding loan balance into approximately 3.6 million shares of our common stock, resulting
in a reduction of the outstanding principal balance to $8,000 at December 31, 2008.
Finally, we issued Hercules warrants to purchase an aggregate of 3.8 million shares of our
common stock at an exercise price of $0.39 per share and an aggregate of 1.0 million shares of our
common stock at an exercise price of $0.41 per share. We considered this a substantial
modification to the original debt agreement and recorded the new debt at its fair value in
accordance with EITF 96-19. As a result of the modification to the original debt agreement, we
recorded a loss on the extinguishment of debt of $2.0 million in June 2008. Approximately 1.3
million of the warrants issued as a result of this amendment remain outstanding at June 30, 2009.
In February 2009, we repaid the remaining principal amount and all fees due under our loan
agreement with Hercules. We have no further obligations under this agreement.
$1.1 million Due 2009. In December 2008, we completed the sale of subordinated convertible
notes due April 10, 2009 for aggregate proceeds of $1.0 million. The notes are convertible into
shares of our common stock at any time upon the election of the Purchasers at $1.00 per share. The
notes were subordinated to the senior secured loan. The notes were issued as an original issue
discount obligation in lieu of periodic interest payments and therefore no interest payments were
made under these notes. Accordingly, the aggregate principal face amount of the notes was $1.1
million. We repaid $0.8 million of these notes in January 2009, and repaid the remaining balance
of these notes in April 2009. We have no further obligations under this agreement.
Other Commitments. Our long-term commitments under operating leases shown above consist of
payments relating to our facility leases in Tarrytown, New York, which expires in February 2012,
and Munich, Germany, which expires in July 2010. Long-term commitments under operating leases for
facilities leased by Maxim and retained by EpiCept relate primarily to the research and development
site at 6650 Nancy Ridge Drive in San Diego, which is leased through October 2013. In June 2008, we
defaulted on our lease agreement for the premises located in San Diego, California by failing to
make the monthly rent payment. As a result, the landlord exercised their right to draw down the
full letter of credit, amounting to approximately $0.3 million, and applied approximately $0.2
million to unpaid rent. The remaining balance of $0.1 million is classified as prepaid rent. At
June 30, 2009, we are current with our lease payments on this facility. In July 2006, we terminated
our lease of certain property in San Diego, CA. In connection with the lease termination, we issued
a six year non-interest bearing note payable in the amount of $0.8 million to the new tenant. These
payments are reflected in the long-term debt section of the above table.
We have a number of research, consulting and license agreements that require us to make
payments to the other party to the agreement upon us attaining certain milestones as defined in the
agreements. As of June 30, 2009, we may be required to make future milestone payments totaling
approximately $2.9 million under these agreements, depending upon the success and timing of future
clinical trials and the attainment of other milestones as defined in the respective agreement. Our
current estimate as to the timing of other research, development and license payments, assuming all
related research and development work is successful, is listed in the table above in “Other
obligations.”
We are also obligated to make future royalty payments to four of our collaborators under
existing license agreements, based on net sales of Ceplene®, EpiCept NP-1 and crinobulin, to the
extent revenues on such products are realized. We can not reasonably determine the amount and
timing of such royalty payments and they are not include in the table above.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The financial currency of our German subsidiary is the euro. As a result, we are exposed to
various foreign currency risks. First, our consolidated financial statements are in U.S. dollars,
but a portion of our consolidated assets and liabilities is denominated in euros. Accordingly,
changes in the exchange rate between the euro and the U.S. dollar will affect the translation of
our German subsidiary’s financial results into U.S. dollars for purposes of reporting consolidated
financial results. We also bear the risk that interest on our euro-denominated debt, when
translated from euros to U.S. dollars, will exceed our current estimates and that principal
payments we make on those loans may be greater than those amounts currently reflected on our
consolidated balance sheet. Historically, fluctuations in exchange rates resulting in transaction
gains or losses have had a material effect on our consolidated financial results. We have not
engaged in any hedging activities to minimize this exposure, although we may do so in the future.
Our exposure to interest rate risk is limited to interest income sensitivity, which is
affected by changes in the general level of U.S. interest rates, particularly because the majority
of our investments are in short term debt securities and bank deposits. The primary objective of
our investment activities is to preserve principal while at the same time maximizing the income we
receive without significantly increasing risk. To minimize risk, we maintain our portfolio of cash
and cash equivalents and marketable securities in a variety of interest-bearing instruments,
primarily bank deposits and money market funds, which may also include U.S. government and agency
securities, high-grade U.S. corporate bonds and commercial paper. Due to the nature of our
short-term and restricted investments, we believe that we are not exposed to any material interest
rate risk. We do not have any relationships with unconsolidated entities or financial partnerships,
such as entities often referred to as structured finance or special purpose entities, which would
have been established for the purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts. Therefore, we are not materially exposed to any financing,
liquidity, market or credit risk that could arise if we had engaged in these relationships. All of
our debt arrangements have a fixed interest rate, so we are not exposed to interest rate risk on
our debt instruments. We do not have
relationships or transactions with persons or entities that derive benefits from their
non-independent relationship with us or related parties.
Item 4. Controls and Procedures.
Our management, including the Chief Executive Officer and Chief Financial Officer, conducted
an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the
period covered by this Quarterly Report on Form 10-Q. Based upon that evaluation, the Chief
Executive Officer and the Chief Financial Officer concluded that such disclosure controls and
procedures were effective as of the end of the period covered by this Quarterly Report on From 10-Q
in alerting them on a timely basis to material information relating to us required to be included
in our periodic filings under the Exchange Act. There have been no changes that have materially
affected, or are reasonably likely to materially affect, our internal control over financial
reporting that have occurred during the period covered by this Quarterly Report on Form 10-Q.
In addition to the other information set forth in this report, you should carefully consider
the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for
the year ended December 31, 2008, which could materially affect our business, financial condition
or future results. To the extent that the risk factors set forth below appear in our Annual Report
on Form 10-K, the risk factors set forth below amend and supplement those risk factors with the
same titles contained in such previously filed reports.
Risks Related to our Financial Condition and Business
We have limited liquidity and, as a result, may not be able to meet our obligations.
We believe that our existing cash resources will be sufficient to meet our projected operating
and debt service requirements into the second quarter of 2010 but may not be sufficient to meet our
obligations thereafter. If our anticipated fees and royalties from our prospective partner for the
sales of Ceplene®in Europe do not meet our expectations and we do not raise additional
funds prior to or during the second quarter of 2010, we will be unable to meet our obligations,
which would materially and adversely affect our business, financial condition, results of
operations, the value of our securities and our ability to raise capital and could result in the
termination of our collaborative and licensing arrangements.
We may not be able to continue as a going concern.
Our recurring losses from operations and our stockholders’ deficit raise substantial doubt
about our ability to continue as a going concern and, as a result, our independent registered
public accounting firm included an explanatory paragraph in its report on our consolidated
financial statements for the year ended December 31, 2008, which is incorporated herein by
reference, with respect to this uncertainty. We will need to generate significant revenue from the
sale of Ceplene® or raise additional capital to continue to operate as a going concern.
In addition, the perception that we may not be able to continue as a going concern may cause others
to choose not to deal with us due to concerns about our ability to meet our contractual obligations
and may adversely affect our ability to raise additional capital.
Risks Relating to our Common Stock
Our common stock may be delisted from The Nasdaq Capital Market or the OMX Nordic Exchange, which
may make it more difficult for you to sell your shares.
In April 2008, we received a letter from the Nasdaq Listing Qualifications Department stating
that we had not regained compliance with the continued listing requirements of The Nasdaq Capital
Market because the market value of our listed securities at that time was below $35,000,000 for 10
consecutive trading days and we were unable to regain compliance. As a result, Nasdaq determined
that our common stock would be delisted from The Nasdaq Capital Market on May 16, 2008. We appealed
that determination which stayed the delisting of our common stock. In addition, we also received a
letter from Nasdaq stating that we were not in compliance with the continued listing requirements
of The Nasdaq Capital Market because the bid price of our common stock closed below the minimum of
$1.00 per share requirement for 30 consecutive business days. Nasdaq requested that we also address
this requirement in our appeal. The hearing for our appeal was held on June 12, 2008. On August 6,2008, we received a determination that the Nasdaq Hearings Panel granted our request for continued
listing, subject to our ability to (i) maintain a market value of listed securities above $35
million for 10 consecutive trading days, on or before August 29, 2008, (ii) comply with the
requirement to maintain a minimum bid price of $1.00 per share by October 13, 2008 and (iii) comply
with all requirements for continued listing on The Nasdaq Stock Market.
On August 27, 2008, we received a letter from the Nasdaq Hearings Panel stating that we
maintained a market value of listed securities above $35 million for 10 consecutive trading days.
On October 22, 2008, we received a letter from Nasdaq stating that given the extraordinary market
conditions, Nasdaq determined on October 16, 2008 to suspend enforcement of the bid price and
market value of publicly held shares requirements through Friday, January 16, 2009. On December 23,2008 that suspension period was
extended until April 20, 2009. On March 24, 2009 that suspension period was extended until
July 20, 2009. On July 13, 2009 that suspension period was extended until July 31, 2009. As a
result, all companies presently in a bid price or market value of publicly held shares compliance
period will remain at that same stage of the process and will not be subject to being delisted for
these concerns. However, since we had no calendar days remaining in our compliance period as of
October 16, 2008, Nasdaq stated it would determine, upon reinstatement of the rules, whether (i) we
maintained a minimum bid price of $1.00 per share for a minimum of 10 consecutive trading days, in
which case we will regain compliance, or (ii) we met The Nasdaq Capital Market initial listing
criteria, except for the bid price requirement, in which case we will be granted an additional 180
calendar day compliance period.
On August 3, 2009, we received a letter from the Nasdaq Listing Qualifications Department
stating that we had not regained compliance with the minimum bid price requirement under Listing
Rule 5550(a)(2) by July 28, 2009 and, as a result, our common stock would be subject to delisting
from The Nasdaq Capital Market unless the Company requests an appeal
before the Nasdaq Hearings Panel (the “Panel”). We intend to request a hearing before the Panel, which will
stay the delisting of our common stock pending the issuance of a decision by the Panel following
the hearing. We expect that the hearing will be scheduled for September 2009. At the hearing, we
will request continued listing on The Nasdaq Capital Market based upon our plan for demonstrating
compliance with the applicable listing requirements. Pursuant to the Nasdaq Marketplace Rules, the
Panel has the authority to grant us up to an additional 180 days from August 3, 2009 (i.e. January30, 2010) to implement our plan of compliance. There can be no assurance that the Panel will grant
our request for continued listing on The Nasdaq Stock Market.
We also received a notice from the OMX Nordic Exchange that our common stock was moved to the
observation segment effective June 2, 2008 due to the fact that there was a material adverse
uncertainty regarding our financial situation. On June 26, 2009, the OMX Nordic Exchange announced
our common stock was removed from the observation segment and transferred back to its ordinary
position on the Exchange effective June 29, 2009. The OMX Nordic Exchange cited our announcement
on June 19, 2009 of a public offering resulting in approximately $8.9 million in net proceeds,
which we expect will be sufficient to fund our operations into the second quarter of 2010.
Risks Relating to Commercialization
We may not be able to successfully market and sell Ceplene® or find a collaborative
partner to help market and sell Ceplene®.
Even though Ceplene® was granted full marketing authorization by the European
Commission for remission maintenance and prevention of relapse in adult patients with Acute Myeloid
Leukemia in first remission, we may not be able to effectively market and sell Ceplene®.
Our strategy for commercializing Ceplene® currently anticipates that we will enter into
collaborative arrangements with one or more pharmaceutical companies that have product development
resources and expertise, established distribution systems and direct sales forces to successfully
market Ceplene® in the European Union. If so, we will be reliant on one or more of these
strategic partners to generate revenue on our behalf.
We expect to incur substantial net losses, in the aggregate and on a per share basis, for the
foreseeable future as we attempt to market and sell Ceplene®. We are unable to predict
the extent of these future net losses, or when we may attain profitability, if at all. These net
losses, among other things, have had and will continue to have an adverse effect on our
stockholders’ deficit. We anticipate that for the foreseeable future our ability to generate
revenues and achieve profitability will be dependent on the successful commercialization of
Ceplene®. If we are unable to generate significant revenue from Ceplene®, or
attain profitability, we may not be able to sustain our operations.
We may not be successful in marketing and selling Ceplene® in Europe, or may be
delayed in doing so, in which case we would not receive revenue or royalties on the timeframe and
to the extent that we currently anticipate.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Item 4. Submissions of Matters to Vote of Security Holders.
Our Annual Meeting of Stockholders was held on June 2, 2009, was adjourned with respect to
voting on one proposal, and was reconvened on July 2, 2009 as permitted by the majority of
stockholders who voted at the meeting. Holders of an aggregate of 118,143,166 shares of our Common
Stock were entitled to vote at the meeting, of which 69,102,630 were present in person or
represented by proxy. At the Annual Meeting on June 2, 2009, our stockholders voted as follows:
Proposal One. The election of two directors to serve for the ensuing three years until their
respective successors are elected and qualified.
Name of Nominee
Total Votes For
Total Votes Withheld
Guy C. Jackson
68,220,125
830,085
Wayne P. Yetter
68,267,441
782,769
The Stockholders reelected, by a plurality of the votes cast, Guy C. Jackson and Wayne P.
Yetter to the Board of Directors of EpiCept. They will serve until the Annual Meeting of
Stockholders in 2012 and until their successors are elected and qualify.
Proposal Two. The ratification of the selection by the Audit Committee of EpiCept’s Board of
Directors of Deloitte & Touche LLP as the independent registered public accounting firm for the
year ending December 31, 2009.
Total Votes For
Total Votes Against
Total Votes Abstained
Broker Non-Votes
55,808,046
632,292
12,662,292
—
The appointment of Deloitte & Touche LLP was ratified. A majority of votes cast was required
for approval.
Proposal Four. Amend the 2005 Equity Incentive Plan to increase the number of available
shares to 13,000,000 shares.
Total Votes For
Total Votes Against
Total Votes Abstained
Broker Non-Votes
30,902,620
17,054,759
14,232,805
6,912,446
The amendment to our 2005 Equity Incentive Plan was approved. A majority of votes cast was
required for approval.
Proposal Five. Approve the 2009 Employee Stock Purchase Plan (the “ESPP”) and authorize the
issuance of up to 1,000,000 shares pursuant to the ESPP.
Total Votes For
Total Votes Against
Total Votes Abstained
Broker Non-Votes
43,063,872
5,281,591
13,792,301
6,912,446
The 2009 ESPP was approved. A majority of votes cast was required for approval.
At the reconvened Annual Meeting on July 2, 2009, our stockholders voted as follows:
Proposal Three. Amend the certificate of incorporation to increase the number of authorized
shares of common stock to 225,000,000 shares.
Total Votes For
Total Votes Against
Total Votes Abstained
Broker Non-Votes
64,029,552
7,296,059
3,498,699
—
The amendment to our certificate of incorporation was approved. A favorable vote of a majority
of outstanding shares of common stock was required for approval.
Amendment to the Third Amended and Restated Certificate of
Incorporation (incorporated by reference to Exhibit 3.1 to EpiCept
Corporation’s Current Report on Form 8-K filed July 9, 2009).
Placement Agent Agreement, dated June 18, 2009 (incorporated by
reference to Exhibit 10.3 to EpiCept Corporation’s Current Report
on Form 8-K filed June 19, 2009)
10.4
Amendment to the Repayment Agreement, dated June 25, 2009 (English
translation from the original German) (incorporated by reference to
Exhibit 10.1 to EpiCept Corporation’s Current Report on Form 8-K
filed June 30, 2009).
31.1
*
Certification of Chief Executive Officer pursuant to
Exchange Act Rules 13a- 14(a) and 15(d)-14(a), adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
*
Certification of Chief Financial Officer pursuant to
Exchange Act Rules 13a- 14(a) and 15(d)-14(a), adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
*
Certification of Chief Executive Officer pursuant to 18
U.S.C. Section 1350, adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
32.2
*
Certification of Chief Financial Officer pursuant to 18
U.S.C. Section 1350, adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
Certification of Chief Executive Officer pursuant to
Exchange Act Rules 13a- 14(a) and 15(d)-14(a), adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Chief Financial Officer pursuant to
Exchange Act Rules 13a- 14(a) and 15(d)-14(a), adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certification of Chief Executive Officer pursuant to 18
U.S.C. Section 1350, adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
32.2
Certification of Chief Financial Officer pursuant to 18
U.S.C. Section 1350, adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
44
Dates Referenced Herein and Documents Incorporated by Reference