EXHIBIT 99.2
FOR IMMEDIATE RELEASE
Contact:
DOV Pharmaceutical, Inc.
(201) 968-0980
Barbara Duncan Alan Beckhard
Chief Financial Officer Manager, Investor Relations and Corporate
Communications
DOV Pharmaceutical, Inc. Announces Second Quarter
2005 Results
Hackensack, NJ, August 9, 2005. DOV Pharmaceutical, Inc. (Nasdaq: DOVP) today
announced results for the second quarter ending June 30, 2005.
Second Quarter 2005 Performance
For the second quarter of 2005, the Company reported a net loss of $11.2
million, or $0.49 per share, compared with $8.3 million, or $0.43 per share, for
the comparable period last year. For the six months ended June 30, 2005, the
Company reported a net loss of $20.3 million, or $0.90 per share, compared with
$16.0 million, or $0.89 per share, for the comparable period last year. At June
30, 2005, cash and cash equivalents and marketable securities totaled $125.9
million.
The comparative increase in net loss of $2.9 million for the second quarter was
primarily the result of an increase in loss from operations of $3.9 million
offset by an increase in interest income of $805,000 and a decrease in interest
expense of $244,000. The increase in loss from operations is primarily due to an
increase of $6.0 million in research and development expenses and an increase of
$1.7 million in general and administrative expense offset by an increase in
revenue recognized of $3.8 million. The increase in research and development is
primarily due to increased expenditures associated with bicifadine's clinical
development and an overall increase in preclinical and research expenditures.
The increase in general and administrative expense is primarily related to
severance expense of $790,000 for the termination of the employment agreement
with Dr. Lippa as Chief Executive Officer and President of the Company and an
increase in professional fees. Revenue in the second quarter consisted of $1.8
million of amortization of the $35.0 million fee the Company received on the
signing of the license, research and development agreement for its collaboration
with Merck over the estimated research and development period and the
recognition of a $2.0 million milestone received from Neurocrine Biosciences,
Inc., or Neurocrine, upon the acceptance of the New Drug Application, or NDA, by
the U.S. Food and Drug Administration, or FDA, for indiplon tablets in the
treatment of insomnia.
The comparative increase in net loss for the six months ended June 30, 2005 of
$4.3 million was primarily the result of an increase in loss from operations of
$6.5 million offset by an increase in interest income of $1.5 million and a
decrease in interest expense of $688,000. The increase in loss from operations
is primarily due to an increase of $10.4 million in research and development
expenses and an increase of $2.0 million in general and administrative expense
offset by an increase in revenue recognized of $5.9 million. The increase in
research and development is primarily due to increased expenditures associated
with bicifadine's clinical development and an overall increase in preclinical
and research expenditures. The increase in general and administrative expense is
primarily related to severance expense for Dr. Lippa as discussed above and an
increase in professional fees. Revenue recognized in the six months ended June
30, 2005 consisted of $3.9 million of amortization of the Merck up-front payment
and the recognition of the $2.0 million milestone from Neurocrine as discussed
above.
The increase in interest income for the three and six months ended June 30, 2005
is primarily related to an increase in higher average cash balances and an
increase in interest rate yields. The decrease in interest expense for the three
and six months ended June 30, 2005 is primarily related to the conversion of
certain debt into common stock of the Company offset by an increase of $1.0
million related to the $80.0 million of convertible debentures placed in
December 2004 and January 2005.
Recent Highlights:
May 2005
The Company:
o Held its annual meeting of shareholders, on May 23, 2005 at which
the Company's shareholders approved the re-election of Dr. Arnold
Lippa and Mr. Patrick Ashe to its Board of Directors and approved an
amendment to its 2000 stock option and grant plan to increase by
750,000 the total number of shares of common stock authorized for
issuance under the plan. In addition, shareholders approved the
selection of PricewaterhouseCoopers LLP as independent registered
public accounting firm of the Company for its fiscal year ending
December 31, 2005.
o Received notice from its partner Neurocrine that data presented at
the 2005 American Psychiatric Association Annual Meeting showed that
nightly administration of indiplon capsules resulted in significant
and sustained improvement in sleep onset and sleep maintenance in
patients with chronic insomnia over the entire treatment period.
Data also showed there was no evidence of tolerance over the three
months or withdrawal upon discontinuation of treatment --
complications often seen with extended use of older-generation sleep
medications.
o Received notice from its partner Neurocrine that it had completed
submission of a NDA to the FDA for indiplon tablets for the
treatment of insomnia in both adult and elderly patients.
June 2005
The Company:
o Received notice from Neurocrine that the FDA had accepted its NDA
for indiplon capsules for review for the treatment of insomnia in
both adult and elderly patients.
o Received notice from Neurocrine that U.S. Patent No. 6,903,106 (the
'106 patent) covering a novel polymorphic form (different crystal
structure) of its proprietary compound indiplon for the treatment of
insomnia had been issued. Neurocrine filed for the '106 patent in
2003 based on the novel properties of this polymorphic form. The
'106 patent will provide Neurocrine with patent protection for
indiplon until the year 2023.
o Received notice from Neurocrine that data presented at the 2005
Associated Professional Sleep Societies' Annual Meeting showed that
indiplon safely and effectively helps elderly patients with chronic
insomnia fall asleep faster and stay asleep throughout the night.
o Modified the protocol in its ongoing phase III clinical trial with
ocinaplon, the Company's novel anxiolytic, to permit the enrollment
of normal volunteers for whom the protocol safety measures, but not
the psychiatric scale information, will be obtained. This amendment
is expected to help speed enrollment and obtain more rapid
information demonstrating the expected level of safety in liver
enzyme function test and other safety measures. The Company expects
to have the required safety information on the 373 subjects
including patients and normals as agreed with the FDA by the end of
2005. At that time, the Company intends to request a further
amendment to the protocol to allow for less frequent liver enzyme
testing.
o Announced that Dr. Leslie Hudson would become the Company's chief
executive officer and president and that its co-founder, Dr. Arnold
Lippa, currently chairman, CEO and president, would continue to
serve as chairman of the board.
o Completed a Phase I clinical trial for bicifadine, the Company's
novel analgesic, to investigate possible effects of subject age on
pharmacokinetic parameters.
July 2005
The Company:
o Received notice from Neurocrine that the FDA accepted its NDA for
indiplon tablets for review for the treatment of insomnia in both
adult and elderly patients.
o Filed a provisional patent application covering novel uses of
bicifadine.
o Filed provisional composition of matter patent applications covering
novel reuptake inhibitors.
o Completed dosing in the FDA-required two-year carcinogenicity
studies for ocinaplon in two animal species.
o Completed enrollment in its pivotal, Phase III, U.S. clinical trial
of bicifadine in 328 patients with moderate to severe acute pain
following bunionectomy surgery. The Company expects to report
results of this clinical trial in September 2005.
o Amended the protocol in its ongoing pivotal, Phase III, U.S.
multi-center clinical trial to evaluate the long-term safety of
bicifadine in patients with chronic lower back pain. The amendment
includes, among other changes, an additional dosage regimen of a
total daily dose of 1200 mg to support the maximum intended dosage
strength for the NDA filing for the management of acute pain.
August 2005
The Company:
o Initiated a Phase III clinical trial with bicifadine in
approximately 200 patients with post-operative acute pain following
vaginal hysterectomy.
o Completed enrollment of 50% (300) patients in its pivotal, Phase
III, U.S. clinical trial with bicifadine in patients with moderate
to severe chronic lower back pain and intends to complete the
interim futility analysis in the fourth quarter of 2005. Enrollment
in the trial is expected to be completed by year end 2005.
o Announced that DOV and Merck have amended their 2004 license
agreement covering the clinical and commercial development
activities of DOV 21,947 and DOV 216,303. The amendment will allow
certain development contemplated by the license agreement for DOV
21,947 to be undertaken by the Company and permit expansion of the
parties' relationship to include an additional triple reuptake
inhibitor from the Company's preclinical pipeline.
DOV is a biopharmaceutical company focused on the discovery, acquisition,
development and commercialization of novel drug candidates for central nervous
system and other disorders, including cardiovascular, that involve alterations
in neuronal processing. Its product candidates address some of the largest
pharmaceutical markets in the world including insomnia, pain, anxiety, and
depression. In addition, its partner Neurocrine has filed two NDAs for the
treatment of indiplon in insomnia.
Cautionary Note
Statements in this press release that are not historical facts constitute
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act, each as amended,
including statements regarding our expectations with respect to the progress of
and level of expenses for our clinical trial programs. You can also identify
forward-looking statements by the following words: may, will, should, expect,
intend, plan, anticipate, believe, estimate, predict, potential, continue or the
negative of these terms or other comparable terminology. We caution you that
forward-looking statements are inherently uncertain and are simply point-in-time
estimates based on a combination of facts and factors currently known by us
about which we cannot be certain. Actual results or events will surely differ
and may differ materially from our forward-looking statements as a result of
many factors, some of which we may not be able to predict or may not be within
our control. Such factors may also materially adversely affect our ability to
achieve our objectives and to successfully develop and commercialize our product
candidates, including our ability to:
o demonstrate the safety and efficacy of product candidates at each
stage of development;
o meet our development schedule for our product candidates, including
with respect to clinical trial initiation, enrollment and
completion;
o develop an acceptable development plan under and otherwise achieve
the results contemplated by the recent amendment to the existing
license agreement with Merck;
o meet applicable regulatory standards and receive required regulatory
approvals on our anticipated time schedule or at all;
o meet obligations and required milestones under our license and other
agreements;
o obtain and maintain collaborations as required with pharmaceutical
partners;
o obtain substantial additional funds;
o obtain and maintain all necessary patents or licenses; and
o produce drug candidates in commercial quantities at reasonable costs
and compete successfully against other products and companies.
Factors that may cause our actual results to differ materially from our
forward-looking statements include (i) one or more of our product candidates
could be shown to cause harmful side effects, (ii) one or more of our product
candidates may not exhibit the expected therapeutic results, (iii) we or the FDA
may suspend one or more of our clinical trials, (iv) patient recruitment may be
slower than expected or patients may drop out of our clinical trials, (v)
regulatory approval for our product candidates may not be received or may be
delayed, and (vi) performance of our licensees and collaborative partners on
whom our success depends may not fulfill their obligations to us. You should
also refer to the risks discussed in our other filings with the Securities and
Exchange Commission including those contained in our annual report on Form 10-K
filed on March 15, 2005. We qualify all our forward-looking statements by these
cautionary statements. There may be other factors that may materially affect our
forward-looking statements and our future results. Readers should not,
therefore, place undue reliance on our forward-looking statements. We do not
undertake any obligation and do not intend to update any forward-looking
statement.
DOV PHARMACEUTICAL, INC.
CONSOLIDATED BALANCE SHEET DATA
December 31, June 30,
2004 2005
------------ ------------
(Unaudited) (Unaudited)
Cash and cash equivalents .............. $ 28,934,473 $ 6,183,417
Marketable securities .................. 103,287,600 119,752,943
Working capital ........................ 91,334,455 95,065,648
Total assets ........................... 136,722,553 132,006,835
Long-term debt ......................... 65,000,000 80,000,000
Total stockholders' equity ............. 27,936,332 12,558,062
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Six Months Ended
June 30, June 30,
2004 2005 2004 2005
------------ ------------ ------------ ------------
(Unaudited) (Unaudited)
Revenue ....................... $ -- $ 3,831,866 $ -- $ 5,890,689
Operating expenses:
Research and development
expense ................... 6,161,352 12,241,167 11,670,644 22,047,769
General and administrative
expense ................... 1,446,965 3,132,560 2,704,347 4,728,484
------------ ------------ ------------ ------------
Loss from operations ...... (7,608,317) (11,541,861) (14,374,991) (20,885,564)
Interest income ............... 182,321 987,729 340,214 1,866,543
Interest expense .............. (908,780) (664,926) (1,990,145) (1,301,720)
Other income (expense), net ... (7,211) 1,176 (6,757) (4,755)
------------ ------------ ------------ ------------
Net loss .................. $(8,341,987) $(11,217,882) $(16,031,679) $(20,325,496)
============ ============ ============ ============
Basic and diluted net loss per
share ....................... $ (0.43) $ (0.49) $ (0.89) $ (0.90)
============ ============ ============ ============
Weighted average shares used in
computing basic and diluted
net loss per share .......... 19,404,059 22,776,359 18,052,399 22,658,345