EX-99.1 2 a10-15272_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports Second Quarter 2010 Financial Results

 

SAN DIEGO — August 4, 2010 - Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today reported financial results for the second quarter ended June 30, 2010.  Optimer reported a net loss for the second quarter of 2010 of $10.4 million, or $0.27 per share, which was in line with the Company’s expectations. This compares to a net loss for the second quarter of 2009 of $12.4 million, or $0.37 per share.  The decrease in net loss was primarily due to lower research and development expenses offset by an increase in general and administrative expenses.

 

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.

 



 

Contacts

 

Optimer Pharmaceuticals, Inc.

Christina Donaghy, Corporate Communications Manager

John D. Prunty, Chief Financial Officer & VP Finance

858-909-0736

 

Canale Communications, Inc.

Jason I. Spark, Senior Vice President

619-849-6005

 

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

 

672,896

 

Long-term investments

 

882,000

 

882,000

 

Other assets

 

503,741

 

498,762

 

Total assets

 

$

69,564,792

 

$

40,655,990

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,447,820

 

$

2,625,240

 

Accrued expenses

 

2,113,604

 

5,025,669

 

Total current liabilities

 

5,561,424

 

7,650,909

 

Deferred rent

 

200,179

 

253,474

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

63,803,189

 

32,751,607

 

Total liabilities and stockholders’ equity

 

$

69,564,792

 

$

40,655,990