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Research and development expenses in the second quarter of 2010 were $6.4 million, compared to $10.7 million in the second quarter of 2009.
The decrease was primarily due to a decrease in fidaxomicin and Pruvel development expenses. Additionally, the prior year's expenses included certain expenses that were reimbursed to Biocon Limited (NSE: BIOCON). The increase in general and administrative expenses of $1.8 million was due to higher compensation expenses, including a $1.3 million increase in non-cash stock compensation expenses compared to the second quarter of 2009.
As of June 30, 2010, Optimer held cash, cash equivalents and short-term investments of $66.6 million.
"Last quarter, we achieved key milestones in our pre-approval activities for fidaxomicin by securing a commercial manufacturing agreement with Biocon and by submitting a Marketing Authorization Application for European marketing approval," said Pedro Lichtinger, Optimer's President and Chief Executive Officer. "We expect another strong presence at ICAAC and IDSA with additional data from our fidaxomicin Phase 3 studies. As we head into the second half of this year, we are focused on completing our New Drug Applications with the FDA for both fidaxomicin and Pruvel."
Recent Corporate Highlights
- Submitted a Marketing Authorization Application to the European Medicines Agency for marketing approval of fidaxomicin for the treatment of Clostridium difficile infection.
- Optimer and Biocon Limited, entered into a long-term supply agreement for the commercial manufacture of the active pharmaceutical ingredient in fidaxomicin.
- Received a $500,000 milestone payment from Cempra Pharmaceuticals as a result of Cempra's continuing development of a next-generation macrolide (CEM-101) for the treatment of respiratory infections. Cempra licensed CEM-101 from Optimer, and has successfully completed a Phase 1 study.
- Pedro Lichtinger succeeded Michael N. Chang, Ph.D. as Optimer's President and Chief Executive Officer and also was appointed to the Board of Directors. Dr. Chang has remained on the Board of Directors as the Chairman and is serving as a consultant. Mr. Lichtinger joined Optimer with more than 30 years of global experience in the pharmaceutical industry. He served as an executive of Pfizer, Inc. from 1995 to 2009, most recently as President of Pfizer's Global Primary Care Business Unit, where he oversaw operations in North America, Europe, Korea, and Australia with revenues of $23 billion and 15,000 employees.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). In two Phase 3 trials completed by Optimer to study the safety and efficacy of fidaxomicin for the treatment of CDI, fidaxomicin was statistically superior to vancomycin in global cure rate (defined as cure with no recurrence within four weeks of completing therapy) as well as statistically superior in reducing recurrences of CDI by up to 50% when compared with vancomycin, the only FDA approved product for CDI. Pruvel is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Optimer has also successfully completed two Phase 3 trials with Pruvel. 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 the timing and plans related to regulatory filings and presentations of clinical trial results. 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, 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.
Optimer Pharmaceuticals, Inc. | ||||||||
Consolidated Statements of Operations | ||||||||
(unaudited) | ||||||||
Three Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
2010 | 2009 | 2010 | 2009 | |||||
Revenues: | ||||||||
Research grants | $ 357,436 | $ 324,778 | $ 654,873 | $ 407,790 | ||||
Collaborative research agreements | - | 100,000 | - | 100,000 | ||||
Total revenues | 357,436 | 424,778 | 654,873 | 507,790 | ||||
Operating expenses: | ||||||||
Research and development | 6,419,251 | 10,737,277 | 17,780,830 | 19,651,349 | ||||
Marketing | 656,464 | 266,267 | 925,058 | 461,063 | ||||
General and administrative | 3,686,442 | 1,871,309 | 6,075,154 | 3,919,809 | ||||
Total operating expenses | 10,762,157 | 12,874,853 | 24,781,042 | 24,032,221 | ||||
Loss from operations | (10,404,721) | (12,450,075) | (24,126,169) | (23,524,431) | ||||
Interest income and other, net | 53,719 | 88,070 | 78,497 | 275,038 | ||||
Consolidated net loss | $(10,351,002) | $ (12,362,005) | $(24,047,672) | $(23,249,393) | ||||
Net loss attributable to noncontrolling interest | 290,105 | - | 491,020 | - | ||||
Net loss attributable to Optimer Pharmaceuticals, Inc. | $(10,060,897) | $ (12,362,005) | $(23,556,652) | $(23,249,393) | ||||
Basic and diluted net loss per share attributable to | ||||||||
Optimer Pharmaceuticals, Inc. common stockholders | $ (0.27) | $ (0.37) | $ (0.66) | $ (0.73) | ||||
Shares used to compute basic and diluted net | ||||||||
loss per share attributable to common stockholders | 38,306,910 | 33,083,447 | 36,663,380 | 31,816,553 | ||||
Optimer Pharmaceuticals, Inc. | ||||
Condensed Consolidated Balance Sheets | ||||
June 30 | December 31, | |||
2010 | 2009 | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 31,377,616 | $ 17,054,328 | ||
Short-term investments | 35,180,463 | 21,131,145 | ||
Prepaid expenses and other current assets | 816,983 | 416,859 | ||
Total current assets | 67,375,062 | 38,602,332 | ||
Property and equipment, net | 803,989 | |||
