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(3.11.2010) SAN DIEGO, CAOptimer Pharmaceuticals Reports Fourth Quarter and Full Year 2009 Financial ResultsSAN DIEGO – March 11, 2010 - Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced 2009 fourth quarter and full year financial results and accomplishments. Optimer reported a net loss for the three months ended December 31, 2009 of $9.6 million, or $0.28 per common share, as compared to a net loss of $10.4 million, or $0.35 per common share, for the same period in 2008. Optimer reported a net loss for the year ended December 31, 2009 of $42.2 million, or $1.30 per common share, as compared to a net loss of $35.6 million, or $1.24 per common share, for 2008. The increase of $6.6 million was due primarily to an increase in development expenses, manufacturing scale-up expenses, and expenses to prepare regulatory filings related to fidaxomicin and Pruvel™ (prulifloxacin).
As of December 31, 2009, Optimer held cash, cash equivalents and short-term investments of $38.2 million. In March 2010, Optimer raised an additional $51.2 million of net proceeds in a public offering of common stock.
"Recently, we announced robust results from our second Phase 3 trial of fidaxomicin confirming the positive results of our first Phase 3 trial showing that fidaxomicin has the potential to be a first-in-class drug for the treatment of Clostridium difficile infection," said Michael N. Chang, President and CEO of Optimer. "2010 will be a significant year for Optimer, as we focus on completing fidaxomicin and Pruvel regulatory filings, publish existing data and continue to prepare for the commercialization of these product candidates.”
Optimer expects to use cash, cash equivalents and short-term investments of approximately $50 million for its operating activities in 2010, based on its current operating plans.
Optimer 2009 and Recent Highlights
· Raised $51.2 million in net proceeds in a public offering of common stock in March 2010. Also raised $32.9 million in gross proceeds in a registered direct offering in March 2009.
· Abstracts related to Optimer’s first Phase 3 study of fidaxomicin highlighted fidaxomicin’s unique profile as the first in a new antibiotic class with beneficial characteristics compared to vancomycin for treating CDI such as lower recurrence rates, reduced risk of vancomycin-resistant enteroccoci (VRE) acquisition, faster time to resolution of diarrhea, and improved outcomes for patients also receiving concomitant antibiotics. In addition, data presented on fidaxomicin showed a favorable pharmacokinetic profile, and a safety profile comparable to that of vancomycin. The data was presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September 2009 and at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in October 2009.
· Top-line data from Optimer’s first Phase 3 study of fidaxomicin showed the trial met its primary endpoint of achieving clinical cure compared to Vancocin® , that patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure compared to Vancocin (p=0.006). In addition, data was presented on CDI patient risk factors believed to be predictive of negative treatment outcomes. These risk factors include albumin levels, white blood cell (WBC) count and temperature and strain types of CDI. Overall, the data showed that fidaxomicin demonstrated a lower recurrence rate compared to Vancocin (p=0.004) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains. This data was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in May 2009 and at the Digestive Disease Week (DDW) conference in June 2009.
· Production patent for fidaxomicin issued by the United States Patent and Trademark Office.
· Appointed industry veterans Robert L. Zerbe, M.D., President and Chief Executive Officer at QuatRx Pharmaceuticals Company and Peter E. Grebow, Ph.D., Executive Vice President of Worldwide Technical Operations at Cephalon, Inc.(NASDAQ: CEPH), to Optimer’s Board of Directors.
· Entered into a number of transactions involving OBI, Optimer’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 fidaxomicin and Pruvel.
· The United States Patent and Trademark Office issued a patent which covers the composition of matter of CEM-101/(OP-1068), a macrolide derivative originally developed by Optimer and licensed to Cempra Pharmaceuticals, which recently completed a Phase 1 clinical trial for the treatment of respiratory infections.
Scheduled Conference Call
The Company will host both a conference call and webcast to discuss the fourth quarter and full year 2009 financial results and to provide a corporate update today, Thursday, March 11, 2010 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
The conference call may be accessed by dialing (877) 375-5161for domestic callers and (631) 291-4558for 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 Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infectives 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 first of a new class of antibiotics with narrow spectrum bactericidal activity targeted at the site of infection. Recently reported positive top-line results from the second Phase 3 trial confirmed the results from the first Phase 3 trial regarding fidaxomicin’s safety and efficacy in patients with Clostridium difficile infection. Optimer has also successfully completed two Phase 3 trials with Pruvel™, 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 Pruvel, anticipated uses of cash, cash equivalents and short term investments, the timing of anticipated regulatory submissions, and the future presentation of clinical data. 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 and the timing of regulatory submissions, an inability 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 Three Months Ended Year Ended December 31, December 31, ------------ ------------ 2009 2008 2009 2008 ---- ---- ---- ---- Revenues: Research grants $208,652 $128,695 $792,644 $973,370 Collaborative research agreements - - 100,000 50,000 --- --- ------- ------ Total revenues 208,652 128,695 892,644 1,023,370 Operating expenses: Research and development 7,195,983 8,032,064 33,715,430 29,035,828 Marketing 572,101 755,791 1,751,313 2,451,191 General and administrative 2,074,192 1,879,459 8,024,138 6,682,881 --------- --------- --------- --------- Total operating expenses 9,842,276 10,667,314 43,490,881 38,169,900 --------- ---------- ---------- ---------- Loss from operations (9,633,624) (10,538,619) (42,598,237) (37,146,530) Interest income and other, net 55,025 135,548 363,998 1,561,934 ------ ------- ------- --------- Net loss allocable to common stockholders (9,578,599) (10,403,071) (42,234,239) (35,584,596) Net loss attributable to noncontrolling interest, net of tax 141,682 - 141,682 - ------- --- ------- --- Net loss attributable to Optimer Pharmaceuticals, Inc. common stockholders $(9,436,917) $(10,403,071) $(42,092,557) $(35,584,596) =========== ============ ============ ============ Basic and diluted net loss per share attributable to common stockholders $(0.28) $(0.35) $(1.30) $(1.24) ====== ====== ====== ====== Shares used to compute basic and diluted net loss per share attributable to common stockholders 33,117,095 29,697,503 32,468,702 28,682,542 ========== ========== ========== ========== Optimer Pharmaceuticals, Inc. Consolidated Balance Sheets Year Ended December 31, ------------ 2009 2008 ---- ---- ASSETS Current assets: Cash and cash equivalents $17,054,328 $16,778,880 Short-term investments 21,131,145 22,547,515 Prepaid expenses and other current assets 416,859 744,670 ------- ------- Total current assets 38,602,332 40,071,065 Property and equipment, net 672,896 694,183 Long-term investments 882,000 1,032,000 Other assets 498,762 498,250 ------- ------- Total assets $40,655,990 $42,295,498 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $2,625,240 $3,767,831 Accrued expenses 5,025,669 4,045,660 --------- --------- Total current liabilities $7,650,909 $7,813,491 Deferred rent 253,474 251,504 Commitments and contingencies - - Stockholders' equity 32,751,607 34,230,503 ---------- ---------- Total liabilities and stockholders' equity $40,655,990 $42,295,498 =========== =========== |
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