SAN DIEGO, March 10, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced 2010 fourth quarter and full year financial results and accomplishments.
Optimer reported a net loss for the three months ended December 31, 2010 of $11.9 million, or $0.31 per common share, as compared to a net loss of $9.4 million, or $0.28 per common share, for the same period in 2009. Optimer reported a net loss for the year ended December 31, 2010 of $47.3 million, or $1.25 per common share, as compared to a net loss of $42.1 million, or $1.30 per common share, for 2009. The increase of $5.2 million was due primarily to a $3.6 million increase in stock compensation expense, an increase in market research and pre-commercial launch efforts related to our fidaxomicin program, and increases in consulting, recruitment and compensation expenses. The increases were offset by a decrease in development and manufacturing set-up expenses reimbursable to Biocon, Inc. incurred in the prior year in connection with commercial manufacturing scale-up. The 2010 results include a $5 million milestone payment to Par for the successful completion of the second fidaxomicin Phase 3 trial and a $1.5 million regulatory filing fee for fidaxomicin.
As of December 31, 2010, Optimer held cash, cash equivalents and short-term investments of $49.4 million. In February 2011, Optimer raised an additional $73.1 million of net proceeds in a public offering of common stock. In March 2011, Optimer also received a $69.2 million upfront cash payment from Astellas Pharma under the terms of the collaboration agreement announced in February 2011.
"In 2010, we completed our second fidaxomicin Phase 3 clinical trial, submitted marketing applications for fidaxomicin in the EU and the U.S., and presented additional data showing that CDI patients treated with fidaxomicin experienced 47% fewer recurrences than patients treated with vancomycin," said Pedro Lichtinger, Optimer's President and CEO. "With the progress we made in 2010, we believe fidaxomicin, if approved, is positioned to become a first line treatment for CDI for patients at risk of recurrence. We expect 2011 to be a year of commercial execution marked by the potential launch of fidaxomicin."
"The rapid progress we've made so far in 2011 is a testament to the strength of the fidaxomicin program," added Lichtinger. "In 2011 we have signed a partnership agreement with Astellas to commercialize fidaxomicin in Europe and certain other countries in the Middle East, Africa and CIS, added key commercialization capabilities to our management team and published Phase 3 data in The New England Journal of Medicine."
The Company expects to provide 2011 financial guidance after obtaining further clarity on the outcome of the Advisory Committee Meeting and achieving an FDA registration.
Optimer 2010 and Recent Highlights
Scheduled Conference CallThe Company will host both a conference call and webcast to discuss the fourth quarter and full year 2010 financial results and to provide a corporate update today, Thursday, March 10, 2011 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
The conference call may be accessed by dialing (877) 280-7280 for domestic callers and (678) 825-8232 for international callers. Please specify to the operator that you would like to join the "Optimer Earnings Call." The conference call will be webcast live under the Investors section of Optimer's website at www.optimerpharma.com, where it will be archived for 30 days following the call.About Optimer PharmaceuticalsOptimer 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 anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Forward-looking StatementsStatements 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 and potential approval and commercialization of fidaxomicin, expectations of Optimer's capital requirements to fund future operations, the timing of any review of regulatory submissions, the timing of any financial guidance for 2011, and the potential commercialization of fidaxomicin or payment of milestones or royalties by Astellas. 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 and the timing of regulatory approvals, whether the FDA or other regulatory authorities will meet their goals for reviewing Optimer's regulatory submissions, Optimer's ability to recognize anticipated benefits from its collaboration with Astellas, the costs and timing of commercializing fidaxomicin in the U.S., if approved, and other risks detailed in Optimer's filings with the Securities and Exchange Commission.ContactsOptimer Pharmaceuticals, Inc.Christina Donaghy, Corporate Communications ManagerJohn D. Prunty, Chief Financial Officer & SVP Finance858-909-0736Canale CommunicationsJason I. Spark, Senior Vice President619-849-6005Optimer Pharmaceuticals, Inc. Consolidated Statements of Operations Three Months Ended December 31, Year Ended December 31, 2010200920102009Revenues:Research grants
792,644Collaborative research agreements
156,352208,6521,480,362892,644Operating expenses:Research and development
1,995,716194,8335,051,0061,049,760General and administrative
3,710,7392,074,19212,499,8778,024,138Total operating expenses
12,647,0199,842,27650,348,55543,490,881Loss from operations
(12,490,667)(9,633,624)(48,868,193)(42,598,237)Interest income and other, net
227,89955,025329,290363,998Consolidated net loss
$(12,262,768)$ (9,578,599)$(48,538,903)$(42,234,239)Net loss attributable to noncontrolling interest
316,766141,6821,199,161141,682 Net loss attributable to Optimer Pharmaceuticals, Inc. common stockholders
$(11,946,002)$ (9,436,917)$(47,339,742)$(42,092,557)Basic and diluted net loss per share attributable to common stockholders
(1.30)Shares used to compute basic and diluted net loss per share attributable to common stockholders
39,140,21433,117,09537,830,45232,468,702Optimer Pharmaceuticals, Inc.Consolidated Balance SheetsYear Ended December 31,20102009ASSETSCurrent assets:Cash and cash equivalents
$ 19,861,924$ 17,054,328Short-term investments
29,553,50621,131,145Prepaid expenses and other current assets
516,859416,859Total current assets
49,932,28938,602,332Property and equipment, net
$ 52,020,162$ 40,655,990LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable
2,307,820$ 2,625,240Accrued expenses
2,385,0465,025,669Total current liabilities
4,692,866$ 7,650,909Deferred rent
141,138253,474Commitments and contingencies
47,186,15832,751,607Total liabilities and stockholders’ equity
$ 52,020,162$ 40,655,990
|SOURCE Optimer Pharmaceuticals, Inc.|
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