PRINCETON, N.J., May 7 /PRNewswire-FirstCall/ -- Pharmacopeia today announced results for the quarter ended March 31, 2008.
Recent company developments have included the following:
-- Pharmacopeia announced the completion of enrollment in a multi-center
Phase 2a clinical trial evaluating PS433540, its first-in-class Dual
Acting Receptor Antagonist (DARA). The objective of the Phase 2a
randomized, double-blind, placebo-controlled, parallel-group study is
to evaluate the efficacy and safety of DARA in patients with Stage 1
and Stage 2 hypertension. After a lead-in period, approximately 100
patients were randomized into three study arms receiving placebo and
two active arms of PS433540 (200mg and 500mg) once daily for 28 days.
The data is being analyzed and the company expects to announce topline
results from this Phase 2a study in a late-breaker presentation on May
16 during the American Society of Hypertension (ASH) 23rd Annual
Scientific Meeting and Exposition in New Orleans, LA. Pharmacopeia also
plans to host an investor event at 7:00 am CDT (8:00 am EDT) on May 16
to review the DARA Phase 2a study results. A live webcast of the
presentation can be accessed at http://www.pharmacopeia.com/.
-- Pharmacopeia announced the initiation of a Phase 2b clinical study of
PS433540 in patients with Stage 1 and Stage 2 hypertension. After a
lead-in period, this multi-center trial is expected to randomize
approximately 375 patients into five study arms receiving PS433540 (200
mg, 400 mg or 800 mg); irbesartan (300 mg), an angiotensin II receptor
antagonist; or placebo. All doses will be administered once daily for
12 weeks. The trial's primary objective is to compare the change from
baseline in mean seated systolic blood pressure for each dose of
PS433540 with placebo. Additional study objectives include comparisons
of changes in blood pressure for each dose of PS433540 with irbesartan.
The company expects to announce results from this study by the end of
2008.
-- Pharmacopeia received a $5 million payment from GlaxoSmithKline (GSK).
This payment was triggered by Pharmacopeia's completion of certain
early discovery activities under its agreement with GSK. With this
payment, Pharmacopeia has received over $16 million in connection with
the ongoing product development and commercialization alliance with
GSK.
-- Celgene Corporation advanced an inflammatory disease compound into
Phase 1 clinical development. This compound was discovered through a
collaboration between Celgene Corporation and Pharmacopeia. With two
internal Pharmacopeia programs and six partnered programs in clinical
development, the company now has eight clinical programs -- three in
Phase 2 and five in Phase 1.
-- Pharmacopeia announced the nomination of a development compound from
its internal CCR1 discovery program. The compound, PS031291, is a
potent and highly selective antagonist at the CCR1 chemokine receptor,
which research has implicated as critically important in the
pathogenesis of inflammatory processes associated with multiple human
diseases. Based on our research to date, PS031291 possesses certain
properties which we believe may make it superior to other compounds
targeting the CCR1 chemokine receptor that have not progressed in
clinical development. PS031291 has potential for the oral treatment of
various inflammatory diseases including rheumatoid arthritis.
-- In April, Pharmacopeia announced that Leslie J. Browne, Ph.D., resigned
as President and Chief Executive Officer and as a member of the Board
of Directors in order to pursue other interests. Dr. Browne's
resignation was effective April 9, 2008. Joseph A. Mollica, Ph.D.,
Chairman of the Board and former Chief Executive Officer of
Pharmacopeia, has assumed day-to-day leadership responsibilities on an
interim basis until a successor is appointed.
"The company has seen continued progress in both internal and partnered programs this year," stated Joseph Mollica, Ph.D., Chairman and interim President and Chief Executive Officer. "Looking forward to the end of 2009, Pharmacopeia could have four of its current proprietary programs in or approaching clinical development with each program having the potential to address major markets. Two of those programs, DARA and SARM, should have progressed to or beyond proof of concept Phase 2 testing." Dr. Mollica added, "Pharmacopeia will continue with its strategy of developing pharmaceutical products for its own account and for its partners while seeking the best allocation of its resources to maximize shareholder value."
First Quarter 2008 Financial Results
At March 31, 2008, Pharmacopeia had cash, cash equivalents and marketable securities of $61.5 million, compared to $71.3 million at December 31, 2007. The balance at March 31, 2008 includes $5 million received from GSK during the quarter. As of March 31, 2008, Pharmacopeia had deferred revenue of $48.5 million relating to research and development activities that are to be performed by the company subsequent to March 31, 2008.
Pharmacopeia expects to end 2008 with cash, cash equivalents and marketable securities in excess of $55 million. The company's actual ending cash balance will be contingent on several factors, including its ability to structure an alliance around any of its internal programs that will maximize the program's future potential and retain significant commercial upside for Pharmacopeia. The company will revise this guidance as necessary during the year.
Pharmacopeia reported a net loss of $11.7 million, or ($.0.40) per share, for the quarter ended March 31, 2008, compared to a net loss of $10.0 million, or ($0.50) per share, for the quarter ended March 31, 2007.
Pharmacopeia's net revenue was $6.2 million for the quarter ended March 31, 2008, compared to $6.3 million for the quarter ended March 31, 2007, a decrease of 2%. The decrease in net revenue was primarily due to lower milestone revenue during the quarter ended March 31, 2008, offset by increased research revenue under the company's agreements with Schering-Plough, GSK and Bristol-Myers Squibb (BMS).
Collaborative research and development expense was $7.9 million for the quarter ended March 31, 2008, compared to $5.2 million for the quarter ended March 31, 2007, an increase of 51%. This increase was due to increased resources allocated to Pharmacopeia's alliances with Schering-Plough and GSK, coupled with chemistry resources working with BMS under the discovery collaboration agreement Pharmacopeia entered into in connection with the acquisition of the SARM program. The chemistry resources collaborating with BMS are for a BMS program unrelated to the SARM program.
Proprietary research and development expense was $8.8 million for the quarter ended March 31, 2008, compared to $7.4 million for the quarter ended March 31, 2007, an increase of 18%. This increase was primarily due to increased costs related to clinical development studies for the DARA program.
General and administrative expense was $3.4 million for the quarter ended March 31, 2008, compared to $2.7 million for the quarter ended March 31, 2007, an increase of 26%. The increase in general and administrative expense was due to increased compensation, consulting and patent prosecution costs.
First Quarter Conference Call and Webcast Information
Further details regarding Pharmacopeia's first quarter financial results will be presented in a conference call today, May 7, 2008 at 5:00 p.m. Eastern Time. Dr. Joseph A. Mollica, Chairman and interim President and Chief Executive Officer, Mr. Brian M. Posner, Executive Vice President and Chief Financial Officer, and Dr. Rene Belder, Senior Vice President, Clinical and Regulatory Affairs, will host the call. Forward-looking and material information may be discussed on this conference call.
Date: May 7, 2008
Time: 5:00 p.m. EDT
Webcast: Accessible via the company's website at http://www.pharmacopeia.com/
US/Canadian participants: 800-211-3767
International participants: 719-785-9438
Confirmation code: 9717744
Name of conference: Pharmacopeia's First Quarter 2008 Financial Results
Conference Call
A replay of the conference call can be accessed by dialing toll-free (888) 203-1112 in the U.S., or (719) 457-0820 outside the U.S. The access code for the replay is 9717744. Replay of the webcast will also be accessible on Pharmacopeia's website on the Investors page at http://www.pharmacopeia.com/. The replays will be available for two weeks.
About Pharmacopeia
Pharmacopeia is a clinical development stage biopharmaceutical company dedicated to discovering and developing novel small molecule therapeutics to address significant medical needs. The company has a broad portfolio of clinical and preclinical candidates under development internally or by partners including eight clinical programs in Phase 2 or Phase 1 development addressing multiple indications including hypertension, diabetic nephropathy, muscle wasting, inflammation and respiratory disease. The company is leveraging its fully integrated drug discovery platform to sustain the growth of its development pipeline. Pharmacopeia has established strategic agreements with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, Celgene, Cephalon, GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more information please visit the company's website at http://www.pharmacopeia.com/.
Contacts:
Amy P. Sharpless
Pharmacopeia, Inc.
(609) 452-3643
ir_pr@pcop.com
Carney Noensie
Burns McClellan
(212) 213-0006
cnoensie@burnsmc.com
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 2 and Phase 1 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS178990, a product candidate from its SARM program, Pharmacopeia's Phase 1 clinical studies with respect to PS178990, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS031291, a product candidate from its chemokine receptor CCR1 program, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, PS178990 and PS031291, Pharmacopeia's ability to successfully perform under its collaborations with Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov/ and from Pharmacopeia at http://www.pharmacopeia.com/. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
Tables to Follow
PHARMACOPEIA, INC.
SELECTED FINANCIAL DATA
(Dollars in thousands, except share and per share data)
Consolidated Statements of Operations
For the Three Months
Ended March 31,
2008 2007
Revenue
Net revenue $6,204 $6,349
Operating Expenses
Collaborative research and development
expense 7,920 5,237
Proprietary research and development
expense 8,764 7,418
General and administrative expense 3,387 2,688
Total operating expenses 20,071 15,343
Operating loss (13,867) (8,994)
Interest and other income 643 696
Interest and other expense (100) -
Decrease (increase) in warrant liability 1,606 (1,706)
Loss before income taxes (11,718) (10,004)
Provision for income taxes - -
Net loss $(11,718) $(10,004)
Net loss per share:
- Basic and diluted $(0.40) $(0.50)
Weighted average number of common stock
shares outstanding:
- Basic and diluted 29,642,134 20,134,514
PHARMACOPEIA, INC.
SELECTED FINANCIAL DATA
(Dollars in thousands)
Consolidated Balance Sheets
March 31, December 31,
2008 2007
Cash, cash equivalents and marketable
securities $61,465 $71,315
Other assets, net 18,582 19,083
Total assets $80,047 $90,398
Current liabilities $37,676 $37,471
Long-term liabilities 30,193 29,843
Total stockholders' equity 12,178 23,084
Total liabilities and stockholders' equity $80,047 $90,398
Pharmacopeia
