Optimer Pharmaceuticals Reports Third Quarter 2009 Financial Results
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SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today reported financial results for the third quarter ended September 30, 2009. Optimer reported a net loss for the third quarter of 2009 of $9.4 million, or $0.28 per share, which was in line with the Company's expectations. This compares to a net loss for the third quarter of 2008 of $9.2 million, or $0.31 per share. Research and development expenses in the third quarter of 2009 were $7.2 million, compared to $7.9 million in the third quarter of 2008. The decrease was primarily due to the completion of the Pruvel(TM)(prulifloxacin) Phase 3 trials. The decrease was partially offset by an increase in expenses to prepare regulatory filings related to fidaxomicin and Pruvel.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090413/LA97352LOGO)
As of September 30, 2009, Optimer held cash, cash equivalents and short-term investments of $42.5 million.
"It's been another strong quarter for Optimer, marked by significant interaction with the medical community on the Phase 3 data profiling the characteristics and attributes of fidaxomicin and Pruvel," said Michael N. Chang, Ph.D., Optimer's President and Chief Executive Officer. "Additional data from the North American Phase 3 fidaxomicin trial were recently presented at the ICAAC and IDSA medical conferences further demonstrating why we believe fidaxomicin has the potential to be the optimal treatment for CDI."
Corporate Updates
-- Following discussions with the FDA, Optimer has elevated global cure to
a secondary endpoint from an exploratory endpoint in the second Phase 3
fidaxomicin trial. Given the significant problem with recurrence in CDI
patients, Optimer believes that the medical community is placing greater
emphasis on global cure, defined as a cure without a recurrence. The
global cure rate of fidaxomicin versus vancomycin was 77.7% versus 67.1%
(p=0.006) in Optimer's North American Phase 3 trial.
-- Optimer expects to complete enrollment of the second Phase 3 trial of
fidaxomicin in 2009, and anticipates reporting top-line data in the
first quarter of 2010. The Company continues to engage in partnering
discussions regarding fidaxomicin to maximize its value.
-- Optimer recently entered into a number of transactions involving OBI,
the Company's Taiwan subsidiary, to provide OBI with funding for the
development of two of Optimer's early-stage, non-core programs, OPT-88
and OPT-822/821, and to allow Optimer to focus on its late-stage
anti-infective programs, fidaxomicin and Pruvel. Pursuant to these
transactions, Optimer assigned to OBI certain patent rights, information
and know-how related to OPT-88, a preclinical product candidate for the
treatment of osteoarthritis, and OPT-822/821, a carbohydrate-based
cancer immunotherapy product candidate. Optimer is eligible to receive
up to $10 million in milestone payments and single-digit royalties on
net sales for any product developed and commercialized under the
programs. To provide capital for OBI's development of OPT-88 and
OPT-822/821, Optimer and a group of new investors purchased
approximately $3.7 million and $2.5 million, respectively, in new OBI
common shares. Also in connection with the transactions, Optimer sold
forty percent of its pre-transaction OBI common shares to the new
investors for proceeds of $2.1 million. Optimer maintains a sixty
percent ownership interest in OBI following the completion of these
transactions.
Recent Corporate Highlights
-- Three fidaxomicin-related abstracts from Optimer's North American Phase
3 study in patients with Clostridium difficile infection (CDI) were
presented at the 47th Annual Meeting of the Infectious Diseases Society
of America in October 2009. Clinical investigator Mark Miller, M.D.,
presented data showing that patients treated with fidaxomicin had a
faster time to resolution of diarrhea compared to those treated with
vancomycin. Faster time to resolution of diarrhea may reduce the spread
of CDI in healthcare facilities and improve patients' quality of life.
Clinical investigator Kate Mullane, D.O., presented data showing that
treatment with fidaxomicin compared to vancomycin in patients also
receiving concomitant antibiotics resulted in higher clinical cure
rates, lower recurrence rates and improved global cure rates.
-- Seven fidaxomicin-related abstracts from Optimer's North American Phase
3 study were presented at the 49th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in September 2009. The
additional data presented highlight fidaxomicin's unique profile as a
new antibiotic class with beneficial characteristics for treating CDI
such as lower recurrence rates, reduced risk of vancomycin-resistant
enteroccoci (VRE) acquisition, favorable pharmacokinetic profile, and a
safety profile comparable to that of vancomycin.
-- The full data analysis from the second Phase 3 clinical study for Pruvel
was presented at ICAAC in September 2009. Data presented by primary
investigator Robert Steffen, M.D., showed that Pruvel shortened recovery
time in adult travelers suffering from infectious diarrhea.
-- The United States Patent and Trademark Office recently issued a patent
which covers the composition of matter of CEM-101/(OP-1068).
CEM-101/(OP-1068) is a macrolide derivative originally developed by
Optimer and licensed to Cempra Pharmaceuticals who recently completed a
Phase 1 clinical trial for the treatment of respiratory infections.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Pruvel(TM) (prulifloxacin) is an antibiotic which has completed two Phase 3 clinical trials for the treatment of infectious diarrhea in travelers. Additional information can be found at http://www.optimerpharma.com.
Forward-looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the development of fidaxomicin and Pruvel and their potential efficacy as treatments for their intended indications, the timing and anticipated results of clinical trials and partnership discussions, and plans related to regulatory filings. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs, uncertainty regarding regulatory requirements for approval, the timing of regulatory submissions and the uncertainty regarding whether such submissions will be accepted or approved, Optimer's ability to enter into partnerships on favorable terms or at all, and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Contacts
Optimer Pharmaceuticals, Inc.
John Prunty, CFO & VP, Finance
Christina Donaghy, Corporate Communications Manager
858-909-0736
Porter Novelli Life Sciences
Jason I. Spark, Vice President
619-849-6005
Optimer Pharmaceuticals, Inc.
Consolidated Statements of Operations
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Research grants $176,202 $239,212 $583,992 $844,675
Collaborative
research
agreements - - 100,000 50,000
--- --- ------- ------
Total revenues 176,202 239,212 683,992 894,675
Operating expenses:
Research and
development 7,192,383 7,877,906 26,519,447 21,003,764
Marketing 393,864 415,916 1,179,212 1,695,400
General and
administrative 2,030,137 1,544,925 5,949,946 4,803,422
--------- --------- --------- ---------
Total operating
expenses 9,616,384 9,838,747 33,648,605 27,502,586
--------- --------- ---------- ----------
Loss from
operations (9,440,182) (9,599,535) (32,964,613) (26,607,911)
Interest income
and other, net 33,935 411,352 308,973 1,426,386
------ ------- ------- ---------
Net loss $(9,406,247) $(9,188,183) $(32,655,640) $(25,181,525)
=========== =========== ============ ============
Basic and diluted
net loss per share $(0.28) $(0.31) $(1.01) $(0.89)
====== ====== ====== ======
Shares used to
compute basic and
diluted net loss
per share 33,103,345 29,253,693 32,250,194 28,377,733
========== ========== ========== ==========
Optimer Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
September 30, December 31,
2009 2008
---- ----
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $19,240,782 $16,778,880
Short-term investments 23,243,958 22,547,515
Prepaid expenses and other current assets 579,134 744,670
------- -------
Total current assets 43,063,874 40,071,065
Property and equipment, net 697,328 694,183
Long-term investments 882,000 1,032,000
Other assets 498,644 498,250
------- -------
Total assets $45,141,846 $42,295,498
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $4,136,058 $3,767,831
Accrued expenses 3,890,438 4,045,660
--------- ---------
Total current liabilities $8,026,496 $7,813,491
Deferred rent 276,484 251,504
Commitments and contingencies - -
Stockholders' equity 36,838,866 34,230,503
---------- ----------
Total liabilities and stockholders' equity $45,141,846 $42,295,498
----------- -----------
SOURCE Optimer Pharmaceuticals, Inc.
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