Exhibit 99.1
Optimer Pharmaceuticals Reports First Quarter 2009 Financial Results
SAN DIEGO — May 7, 2009- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced its financial results for the first quarter ended March 31, 2009. Optimer reported a net loss for the first quarter of 2009 of $10.9 million, or $0.36 per share which was in line with the Company’s expectations. This compares to a net loss for the first quarter of 2008 of $7.9 million, or $0.28 per share. Research and development expenses in the first quarter of 2009 were $8.8 million compared to $6.9 million in the first quarter of 2008. The increase is primarily due to an increase in clinical development and regulatory expenses related to Optimer’s fidaxomicin and prulifloxacin programs.
As of March 31, 2009, Optimer held cash, cash equivalents and short-term investments of $62.6 million.
“We are off to a strong start in 2009,” said Michael N. Chang, Ph.D., Optimer’s President and CEO. “We announced plans to prepare a marketing application in Europe based on the results of the first fidaxomicin Phase 3 trial for Clostridium difficile infection. We also reported positive top-line results from the second prulifloxacin Phase 3 trial for the treatment of infectious diarrhea.”
Recent Corporate Highlights
· Announced plans to prepare a Marketing Authorization Application (MAA) for submission with the European Medicines Agency (EMEA) for approval of fidaxomicin as an oral treatment for Clostridium difficile infection (CDI) based on the results from the Company’s first Phase 3 fidaxomicin trial.
· Production patent for fidaxomicin issued by the United States Patent and Trademark Office.
· Announced positive results from the second pivotal Phase 3 trial of prulifloxacin for the treatment of infectious diarrhea. The trial achieved the primary endpoint of median Time to Last Unformed Stool (TLUS). Median TLUS for patients treated with prulifloxacin was 32.8 hours which was statistically significant compared to the TLUS for placebo with a p-value of less than 0.0001. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. This is the second of two pivotal Phase 3 clinical studies which will be used to support an NDA submission with the U.S. Food and Drug Administration.
· Raised $32.9 million in gross proceeds through the sale of 3.3 million shares and warrants to purchase 91,533 shares in a registered direct offering in March 2009.
· Appointed Francois-Xavier Frapaise, M.D., as Senior Vice President and Chief Scientific Officer and Peter E. Grebow, Ph.D., Executive Vice President of Worldwide Technical Operations at Cephalon, Inc. (NASDAQ: CEPH), to the company’s Board of Directors.
· Published in vitro data highlighting the antibacterial activity of prulifloxacin in the peer-reviewed journal Antimicrobial Agents and Chemotherapy.
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. Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials for the treatment of travelers’ diarrhea, a form of infectious diarrhea. 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 prulifloxacin, the timing of clinical trials and anticipated results, and plans related to regulatory filings, including a potential MAA for fidaxomicin. 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, 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 March 31, | |
| | 2009 | | 2008 | |
Revenues: | | | | | |
Research grants | | $ | 83,012 | | $ | 486,666 | |
Operating expenses: | | | | | |
Research and development | | 8,798,582 | | 6,905,376 | |
Marketing | | 310,286 | | 365,568 | |
General and administrative | | 2,048,500 | | 1,737,051 | |
Total operating expenses | | 11,157,368 | | 9,007,995 | |
Loss from operations | | (11,074,356 | ) | (8,521,329 | ) |
Interest income and other, net | | 186,968 | | 581,284 | |
Net loss | | (10,887,388 | ) | (7,940,045 | ) |
| | | | | |
Basic and diluted net loss per share | | $ | (0.36 | ) | $ | (0.28 | ) |
| | | | | |
Shares used to compute basic and diluted net loss per share | | 30,535,577 | | 27,869,675 | |
Optimer Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
| | March 31 | | December 31, | |
| | 2009 | | 2008 | |
| | (unaudited) | | | |
ASSETS | | | | | |
Current assets: | | | | | |
Cash and cash equivalents | | $ | 46,788,899 | | $ | 16,778,880 | |
Short-term investments | | 15,794,624 | | 22,547,515 | |
Prepaid expenses and other current assets | | 682,419 | | 744,670 | |
Total current assets | | 63,265,942 | | 40,071,065 | |
Restricted cash | | 170,000 | | 170,000 | |
Property and equipment, net | | 667,100 | | 694,183 | |
Long-term investments | | 982,000 | | 1,032,000 | |
Other assets | | 327,197 | | 328,250 | |
Total assets | | $ | 65,412,239 | | $ | 42,295,498 | |
| | | | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | |
Current liabilities: | | | | | |
Accounts payable | | $ | 4,049,160 | | $ | 3,767,831 | |
Accrued expenses | | 4,152,398 | | 4,045,660 | |
Total current liabilities | | 8,201,558 | | 7,813,491 | |
Deferred rent | | 268,166 | | 251,504 | |
Commitments and contingencies | | — | | — | |
Stockholders’ equity | | 56,942,515 | | 34,230,503 | |
Total liabilities and stockholders’ equity | | $ | 65,412,239 | | $ | 42,295,498 | |
