-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GLaddhor1fa22oItRrh+nGYagmCQ+VlXQhz5LXbuqi2JwQtXcC/3gCM8g9GD2ADg 2hVZq31SoSJjNOqRwLOAiQ== 0001104659-09-030383.txt : 20090507 0001104659-09-030383.hdr.sgml : 20090507 20090507132441 ACCESSION NUMBER: 0001104659-09-030383 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090507 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090507 DATE AS OF CHANGE: 20090507 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OPTIMER PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001142576 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330830300 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33291 FILM NUMBER: 09804547 BUSINESS ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8589090736 MAIL ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a09-12861_18k.htm 8-K

 

 
 
UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)

 

May 7, 2009

 


 

OPTIMER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-33291

 

33-0830300

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

10110 Sorrento Valley Road, Suite C

San Diego, CA  92121

(Address of principal executive offices, including zip code)

 

(858) 909-0736

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02    Results of Operations and Financial Condition.

 

On May 7, 2009, the Company issued a press release announcing its unaudited financial results for the first quarter ended March 31, 2009.  A copy of this press release is attached hereto as Exhibit 99.1.

 

This information and the exhibits hereto are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01     Financial Statements and Exhibits.

 

(d)  Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated May 7, 2009.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 
OPTIMER PHARMACEUTICALS, INC.
 
 

 

By:

/s/ John D. Prunty

 

 

John D. Prunty
Chief Financial Officer (Duly Authorized Officer and
Principal Financial and Accounting Officer)

 

Date:  May 7, 2009

 

3


EX-99.1 2 a09-12861_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports First Quarter 2009 Financial Results

 

SAN DIEGO — May 7, 2009- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced its financial results for the first quarter ended March 31, 2009. Optimer reported a net loss for the first quarter of 2009 of $10.9 million, or $0.36 per share which was in line with the Company’s expectations.  This compares to a net loss for the first quarter of 2008 of $7.9 million, or $0.28 per share.  Research and development expenses in the first quarter of 2009 were $8.8 million compared to $6.9 million in the first quarter of 2008.  The increase is primarily due to an increase in clinical development and regulatory expenses related to Optimer’s fidaxomicin and prulifloxacin programs.

 

As of March 31, 2009, Optimer held cash, cash equivalents and short-term investments of $62.6 million.

 

 “We are off to a strong start in 2009,” said Michael N. Chang, Ph.D., Optimer’s President and CEO. “We announced plans to prepare a marketing application in Europe based on the results of the first fidaxomicin Phase 3 trial for Clostridium difficile infection.  We also reported positive top-line results from the second prulifloxacin Phase 3 trial for the treatment of infectious diarrhea.”

 

Recent Corporate Highlights

 

·                  Announced plans to prepare a Marketing Authorization Application (MAA) for submission with the European Medicines Agency (EMEA) for approval of fidaxomicin as an oral treatment for Clostridium difficile infection (CDI) based on the results from the Company’s first Phase 3 fidaxomicin trial.

 

·                  Production patent for fidaxomicin issued by the United States Patent and Trademark Office.

 

·                  Announced positive results from the second pivotal Phase 3 trial of prulifloxacin for the treatment of infectious diarrhea.  The trial achieved the primary endpoint of median Time to Last Unformed Stool (TLUS). Median TLUS for patients treated with prulifloxacin was 32.8 hours which was statistically significant compared to the TLUS for placebo with a p-value of less than 0.0001. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. This is the second of two pivotal Phase 3 clinical studies which will be used to support an NDA submission with the U.S. Food and Drug Administration.

 

·                  Raised $32.9 million in gross proceeds through the sale of 3.3 million shares and warrants to purchase 91,533 shares in a registered direct offering in March 2009.

 



 

·                  Appointed Francois-Xavier Frapaise, M.D., as Senior Vice President and Chief Scientific Officer and Peter E. Grebow, Ph.D., Executive Vice President of Worldwide Technical Operations at Cephalon, Inc. (NASDAQ: CEPH), to the company’s Board of Directors.

 

·                  Published in vitro data highlighting the antibacterial activity of prulifloxacin in the peer-reviewed journal Antimicrobial Agents and Chemotherapy.

 

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, including a potential MAA for fidaxomicin. 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 March 31,

 

 

 

2009

 

2008

 

Revenues:

 

 

 

 

 

Research grants

 

$

83,012

 

$

486,666

 

Operating expenses:

 

 

 

 

 

Research and development

 

8,798,582

 

6,905,376

 

Marketing

 

310,286

 

365,568

 

General and administrative

 

2,048,500

 

1,737,051

 

Total operating expenses

 

11,157,368

 

9,007,995

 

Loss from operations

 

(11,074,356

)

(8,521,329

)

Interest income and other, net

 

186,968

 

581,284

 

Net loss

 

(10,887,388

)

(7,940,045

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.36

)

$

(0.28

)

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share

 

30,535,577

 

27,869,675

 

 

Optimer Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

 

 

 

March 31

 

December 31,

 

 

 

2009

 

2008

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

46,788,899

 

$

16,778,880

 

Short-term investments

 

15,794,624

 

22,547,515

 

Prepaid expenses and other current assets

 

682,419

 

744,670

 

Total current assets

 

63,265,942

 

40,071,065

 

Restricted cash

 

170,000

 

170,000

 

Property and equipment, net

 

667,100

 

694,183

 

Long-term investments

 

982,000

 

1,032,000

 

Other assets

 

327,197

 

328,250

 

Total assets

 

$

65,412,239

 

$

42,295,498

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,049,160

 

$

3,767,831

 

Accrued expenses

 

4,152,398

 

4,045,660

 

Total current liabilities

 

8,201,558

 

7,813,491

 

Deferred rent

 

268,166

 

251,504

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

56,942,515

 

34,230,503

 

Total liabilities and stockholders’ equity

 

$

65,412,239

 

$

42,295,498

 

 


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