SAN DIEGO, July 31, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the Company's financial results for the quarter ended June 30, 2012.
Second Quarter 2012 Financial Highlights:
"July marked the one-year anniversary of the launch of DIFICID, and we are very proud of our accomplishments. We've generated $51.1 million in net sales and shipped almost 21,000 treatments of DIFICID since launch through the end of June this year," stated Pedro Lichtinger, President and Chief Executive Officer of Optimer. "Both demand for, and access to, DIFICID continue to grow, as scientific and health economic understanding is being expanded through more than 90 publications to date. We are confident in DIFICID's potential to meet our expectations in 2012 and also maintain expectations for reaching break-even within 3 years of launch."
Total revenues for the three months ended June 30, 2012 and 2011 were $49.8 million and $33,000, respectively, an increase of $49.8 million. Second quarter contract revenues included $19.9 million from an up-front payment from Astellas Pharmaceuticals, Inc. of Japan and $12.6 million from a milestone payment from Astellas Pharmaceuticals Europe, Ltd. (APEL) in association with the first sales of DIFICLIR, currently available in the UK, Austria, Sweden, Denmark, Finland, Norway, the Netherlands and Portugal, in an APEL territory. In addition, we recognized $15.2 million of net product revenue from sales of DIFICID. We launched DIFICID in the U.S. in July 2011 and in Canada in June 2012. We recognize product sales of DIFICID upon delivery of product to our wholesalers.
We reported a net loss for the second quarter of 2012 of $296,000, or $0.01 per share, on both a basic and diluted basis, as compared to a net loss for the second quarter 2011 of $24.2 million, or $0.52 per share, on both a basic and diluted basis.
Selling, general and administrative expense for the three months ended June 30, 2012 and 2011 was $28.9 million and $14.8 million, respectively, an increase of $14.1 million. The increase was primarily due to our commercialization efforts on DIFICID. We had higher headcount during the 2012 period and thus incurred higher salary expense. We also incurred higher advertising and promotion expense as well as higher legal, consulting and other outside services.
Co-promotion expenses with Cubist for the three months ended June 30, 2012 were $5.0 million, representing certain expenses that may be due Cubist under our April 2011 DIFICID co-promotion agreement. Based on the level of sales to date we achieved the first-year sales target and have accrued $10.4 million representing the quarterly service fee and a pro-rated portion of the $5.0 million bonus payment as well as a portion of gross profits. We did not incur similar expenses in the quarter ended June 30, 2011.
Research and development expense for the three months ended June 30, 2012 and 2011 was $11.6 million and $10.3 million, respectively, an increase of $1.3 million. The increase was primarily due to higher health economics and outcomes research costs.
As of June 30, 2012, we held cash, cash equivalents and short-term investments of $130.6 million. This amount includes the $53.6 million milestone payment from Astellas Pharmaceuticals Europe recognized in the fourth quarter of 2011. We had 47,531,412 shares outstanding on June 30, 2012.
DIFICID Launch Update
DIFICID net sales of $15.2 million in the second quarter of 2012 reflected a 6% increase over the first quarter of 2012.
Gross sales to our wholesalers of $18.0 million in the second quarter of 2012 represent 6,415 treatments shipped and a 9% increase over the $16.5 million in gross sales for the first quarter of 2012. Further, 6,131 DIFICID treatments were shipped from wholesalers to hospitals, retail pharmacies and long-term care facilities in the second quarter, reflecting an 11% increase over the prior quarter.
Additionally, as of June 30, 2012:
We continue to improve patient access to DIFICID:
Global Commercialization Initiatives
"In addition to making progress on DIFICID sales in the U.S., our efforts to make DIFICID available globally also have continued to gain traction," continued Mr. Lichtinger. "Earlier this month we announced the launch of DIFICID by our Canadian subsidiary after receiving approval from Health Canada under a priority review, and the product was recently approved in Taiwan. We also recently announced first sales of the product in Europe through our collaboration with Astellas Pharma Europe, and we engaged with Specialised Therapeutics Australia for commercialization in Australia and New Zealand."
Recent progress in our efforts to facilitate access to fidaxomicin includes:
Conference Call and Webcast
Optimer will host a conference call and webcast including supplemental slides to discuss its second quarter financial results and to provide a corporate update today at 5:00 p.m. Eastern time (2:00 p.m. Pacific time).
The conference call may be accessed by dialing (877) 280-7280 for domestic callers and +1 (678) 825-8232 for international callers. Please specify to the operator that you would like to join "Optimer's Financial Results Call." The conference call will be webcast live under the Investors section of Optimer's website at www.optimerpharma.com, where it and accompanying slides will be archived for 30 days following the call.
About DIFICID® (fidaxomicin) Tablets
DIFICID is the first antibacterial drug indicated for Clostridium difficile-associated diarrhea (CDAD) to be approved in more than 25 years in the U.S. It is indicated in the U.S. for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily.
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer developed DIFICID® (fidaxomicin) tablets, an FDA-approved macrolide antibacterial drug for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older and is commercializing DIFICID in the US and Canada. Optimer also received marketing authorization for fidaxomicin tablets in the European Union where its partner, Astellas Pharma Europe, is commercializing fidaxomicin under the trade name DIFICLIR™. The company is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem, including Asia. 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 statements related to Optimer's expectations of future sales and adoption of DIFICID, projections regarding the results and trends of the DIFICID launch, Optimer's expectations under its co-promotion agreement with Cubist, and Optimer's expectations regarding patient access to DIFICID, commercialization and availability of fidaxomicin outside the United States, the timeframe within which Optimer may reach profitability, continued clinical development of DIFICID, including for new potential FDA approved indications and development related to FDA post marketing requirements and commitments. Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will," 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. These forward-looking statements are based on management's expectations on the date of this release. 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: Optimer's ability to continue driving adoption and use of DIFICID, the implementation and success of DIFICID growth initiatives and entry into new markets, whether healthcare professionals will prescribe DIFICID, the extent to which DIFICID receives reimbursement coverage from healthcare payers and government agencies, the extent to which DIFICID will be accepted on additional hospital formularies and the timing of hospital formulary decisions, Optimer's ability to successfully coordinate commercialization efforts with Cubist Pharmaceuticals under its co-promotion agreement, whether Optimer will be able to realize expected benefits under its co-promotion agreement with Cubist and its collaboration agreements with Astellas, the fact that past results may not be predictive of future results or performance, the possibility of alternative means of preventing or treating CDAD impacting adoption and sales of DIFICID, Optimer's ability, through its third party manufacturers and logistics providers, to maintain a sufficient supply of DIFICID to meet demand, DIFICID's ability to compete against lower-priced generic products and other risks detailed in Optimer's filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this release, and Optimer undertakes no obligation to update or revise these statements, except as may be required by law.Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
OPTIMER and DIFICID are trademarks of Optimer Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.Optimer Pharmaceuticals, Inc.Consolidated Statements of Operations(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2012201120122011Revenues:Product sales, net
49,757,57233,29464,140,21969,309,933Cost and expenses:Cost of product sales
2,269,331-4,553,591-Cost of contract revenue
1,744,182-1,744,1824,273,532Research and development
11,557,21710,290,76022,625,18418,668,769Selling , general and administrative
28,856,92914,760,72354,379,21126,566,998Co-promotion expenses with Cubist
5,001,583-15,083,166-Total operating expenses
49,429,24225,051,48398,385,33449,509,299Income (loss) from operations
328,330(25,018,189)(34,245,115)19,800,634Gain on deconsolidation of OBI
--23,782,229-Equity in net loss of OBI
(668,852)-(1,154,821)-Interest income and other, net
44,31895,860120,705119,102Consolidated net income (loss)
(296,204)$ (24,922,329)$ (11,497,002)$ 19,919,736Net loss attributable to noncontrolling interest
-683,483280,344974,288Net income (loss) attributable to Optimer Pharmaceuticals, Inc.
(296,204)$ (24,238,846)$ (11,216,658)$ 20,894,024Net income (loss) per share - basic
.47Net income (loss) per share - diluted
.46Weighted average number of shares used to compute net income (loss) per share - basic
47,234,37146,479,39546,978,49744,581,010Weighted average number of shares used to compute net income (loss) per share - diluted
47,234,37146,479,39546,978,49745,447,261Comprehensive income (loss)
(177,625)$ (23,954,597)$ (10,084,685)$ 21,417,416 Optimer Pharmaceuticals, Inc.Condensed Consolidated Balance SheetsJune 30,December 31,20122011(unaudited)ASSETSCurrent assets:Cash and cash equivalents
$ 99,703,307$ 31,787,512Short-term investments
30,934,77478,791,066Trade accounts receivable, net
5,312,4326,563,645Accounts receivable, other
7,962,1123,947,380Prepaid expenses and other current assets
2,326,1223,781,830Total current assets
149,420,067177,160,723Equity investment in OBI
29,013,792-Property and equipment, net
$ 184,420,555$ 182,023,172LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:Accounts payable
245,319-Total current liabilities
147,055,778150,564,025Total liabilities and stockholders' equity
$ 184,420,555$ 182,023,172
|SOURCE Optimer Pharmaceuticals, Inc.|
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