EX-99.1 2 a09-21047_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports Second Quarter 2009 Financial Results

 

SAN DIEGO — August 5, 2009- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today reported financial results for the second quarter ended June 30, 2009.  Optimer reported a net loss for the second quarter of 2009 of $12.4 million, or $0.37 per share, which was in line with the Company’s expectations. This compares to a net loss for the second quarter of 2008 of $8.1 million, or $0.29 per share.  The increase in net loss was primarily due to higher research and development expenses.  Research and development expenses in the second quarter of 2009 were $10.5 million, compared to $6.2 million in the second quarter of 2008.  The increase was primarily due to manufacturing scale-up expenses and expenses to prepare regulatory filings related to the Company’s fidaxomicin and prulifloxacin programs.

 

As of June 30, 2009, Optimer held cash, cash equivalents and short-term investments of $51.2 million.

 

“During the second quarter we had the first oral presentations of our North American Phase 3 fidaxomicin data at major scientific conferences showing that fidaxomicin is more effective than oral vancomycin when it comes to reducing recurrence of CDI, even in high risk patient populations,” said Michael N. Chang, Ph.D., Optimer’s President and Chief Executive Officer.  “As we head into the second half of this year, we look forward to presenting additional data from this study at ICAAC and IDSA and we are focused on completing our second fidaxomicin Phase 3 trial and preparing regulatory filings for fidaxomicin and prulifloxacin.”

 

Recent Corporate Highlights

 

·                  Clinical investigator, Thomas J. Louie, M.D., presented top-line data from Optimer’s fidaxomicin North American Phase 3 clinical study for patients with Clostridium difficile infection at the European Congress of Clinical Microbiology and Infectious Diseases meeting which showed the trial met its primary endpoint of achieving clinical cure compared to Vancocin®.  In addition, the top-line data showed that patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to Vancocin (p=0.006).

 

·                  Clinical investigator, Mark A. Miller, M.D., presented additional data from Optimer’s fidaxomicin North American Phase 3 clinical study at the Digestive Disease Week 2009 Conference focusing on patient risk factors believed to be predictive of CDI recurrence following treatment.  These risk factors include albumin levels, white blood cell (WBC) count and temperature and strain types of CDI. The data showed that fidaxomicin overall 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.

 



 

·                  The United States Patent and Trademark Office issued Optimer a production patent covering steps used in the manufacture of fidaxomicin.

 

About Optimer Pharmaceuticals

 

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products 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 only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection.  Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials 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 prulifloxacin, the timing of clinical trials and anticipated results, 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, the timing and status of its preclinical and clinical development of potential drugs, 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.

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

(unaudited)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Research grants

 

$

324,778

 

$

118,797

 

$

407,790

 

$

605,463

 

Collaborative research agreements

 

100,000

 

50,000

 

100,000

 

50,000

 

Total revenues

 

424,778

 

168,797

 

507,790

 

655,463

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

10,528,482

 

6,220,482

 

19,327,064

 

13,125,858

 

Marketing

 

475,062

 

913,916

 

785,348

 

1,279,484

 

General and administrative

 

1,871,309

 

1,521,446

 

3,919,809

 

3,258,497

 

Total operating expenses

 

12,874,853

 

8,655,844

 

24,032,221

 

17,663,839

 

Loss from operations

 

(12,450,075

)

(8,487,047

)

(23,524,431

)

(17,008,376

)

Interest income and other, net

 

88,070

 

433,750

 

275,038

 

1,015,034

 

Net loss

 

$

(12,362,005

)

$

(8,053,297

)

$

(23,249,393

)

$

(15,993,342

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.37

)

$

(0.29

)

$

(0.73

)

$

(0.57

)

 

 

 

 

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share

 

33,083,447

 

27,891,870

 

31,816,553

 

27,880,772

 

 

Optimer Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

 

 

 

June 30,

 

December 31,

 

 

 

 

 

 

 

2009

 

2008

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,217,128

 

$

16,778,880

 

 

 

 

 

Short-term investments

 

24,935,778

 

22,547,515

 

 

 

 

 

Prepaid expenses and other current assets

 

810,556

 

744,670

 

 

 

 

 

Total current assets

 

51,963,462

 

40,071,065

 

 

 

 

 

Property and equipment, net

 

623,892

 

694,183

 

 

 

 

 

Long-term investments

 

882,000

 

1,032,000

 

 

 

 

 

Other assets

 

498,171

 

498,250

 

 

 

 

 

Total assets

 

$

53,967,525

 

$

42,295,498

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,091,178

 

$

3,767,831

 

 

 

 

 

Accrued expenses

 

4,099,069

 

4,045,660

 

 

 

 

 

Total current liabilities

 

8,190,247

 

7,813,491

 

 

 

 

 

Deferred rent

 

284,828

 

251,504

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ equity

 

45,492,450

 

34,230,503

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

53,967,525

 

$

42,295,498