-----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, NUj9ZPmK2dEpy1FijClht0ZJJrsMzRk+cIhXRmN/ZteEjshzbvsMplNg1IJe7SqA Vg5cVWP1lNpOGdwXG73pAA== 0001104659-08-050289.txt : 20080806 0001104659-08-050289.hdr.sgml : 20080806 20080806144758 ACCESSION NUMBER: 0001104659-08-050289 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080806 DATE AS OF CHANGE: 20080806 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: 08994498 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 a08-20817_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)

August 6, 2008

 


 

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 August 6, 2008, the Company issued a press release announcing its unaudited financial results for the second quarter ended June 30, 2008.  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 August 6, 2008.

 

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:  August 6, 2008

 

3


EX-99.1 2 a08-20817_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports Second Quarter 2008 Financial Results

 

SAN DIEGO – August 6, 2008 - - Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced its financial results for the second quarter ended June 30, 2008. Optimer reported a net loss for the second quarter of 2008 of $8.1 million, or $0.29 per share, compared to a net loss of $8.1 million, or $0.35 per share, for the same period in 2007.  As of June 30, 2008, Optimer held cash, cash equivalents and investments of $44.2 million.

 

“In the past few months, we have made some exciting progress across our clinical programs,” said Michael N. Chang, Ph.D., Optimer’s President and CEO. “Recently, we reported positive top-line data from the first Prulifloxacin Phase 3 study for the treatment of infectious diarrhea.  We also completed enrollment in our first OPT-80 Phase 3 study for the treatment of Clostridium difficile infection. Last month we completed our most recent financing that provides us with additional capital to continue our development and commercialization programs while maintaining a prudent level of cash. As we head into the second half of the year, we look forward to the data from the first OPT-80 Phase 3 trial and the second Prulifloxacin Phase 3 trial.”

 

Financial Results

 

The net loss of $8.1 million for the second quarter of 2008 was consistent with the same period in 2007. Net loss per share decreased 17% to $0.29 per share in the second quarter of 2008 from $0.35 per share for the same period 2007.  The decrease in net loss per share was attributable to an additional 4.6 million shares of our common stock sold through a private placement completed in October 2007, in which the Company raised gross proceeds of approximately $35.9 million at $7.80 per share.

 

Collaboration and grant revenues of $169,000 in the second quarter of 2008 were relatively consistent with the $211,000 in the second quarter of 2007.

 

Research and development expenses in the second quarter of 2008 were $6.2 million compared to $7.0 million in the second quarter of 2007.  The decrease was primarily due to the purchase of $1.9 million of clinical supply material and active pharmaceutical ingredient in the second quarter of 2007 that was partially offset by an increase in expenses related to our OPT-80 and Prulifloxacin Phase 3 clinical trials.

 

Marketing expense for the second quarter of 2008 and 2007 was $914,000 and $299,000, respectively. The increase of $615,000 was primarily due to an increase in medical education and pre-launch marketing efforts related to OPT-80.

 

General and administrative expense of $1.5 million in the second quarter of 2008 was consistent with the $1.5 million of such expense in the second quarter of 2007.

 



 

Recent Corporate Highlights

 

·                  Raised $14.8 million in gross proceeds in a registered direct offering of 1,743,396 shares of common stock that closed on July 28, 2008.

 

·                  Completed enrollment in first of two Phase 3 studies of OPT-80 in patients with Clostridium difficile infection.

 

·                  Announced positive results from the first Phase 3 trial of Prulifloxacin for infectious diarrhea;  top-line analysis of data shows that the primary endpoint was achieved; median Time to Last Unformed Stool (TLUS) for patients treated with Prulifloxacin was approximately 24 hours. This was statistically different from the TLUS for placebo with a p-value of <0.0001.  Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo.

 

·                  OPT-80 polymorph patent was issued on May 27, 2008 by the United States Patent and Trademark Office.

 

·                  Presented additional data from a Phase 2A clinical study of OPT-80 finding a 42% prevalence of the super toxin-producing strain of C. difficile, known as BI/NAP1/027, in patients with Clostridium difficile infection. The study also found that OPT-80 produced similar cure rates in patients with the NAP1 strain compared to patients without the hypervirulent strain. Data was presented at the Anaerobe Society of the Americas (ASA), June 26, 2008.

 

·                  Also at ASA, Optimer’s Chief Medical Officer, Dr. Sherwood Gorbach, was one of two people honored with the Lifetime Achievement Award for his contributions to the study of anaerobic microbiology and the larger field of medicine.

 

About Optimer Pharmaceuticals

 

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates.  OPT-80 is being developed for the treatment of Clostridium difficile infection, the most common hospital-acquired diarrhea.  Prulifloxacin is an antibiotic being developed 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 OPT-80 and Prulifloxacin, and the timing of clinical trials and anticipated results and regulatory activities. 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 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

 

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,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Research grants

 

$

118,797

 

$

51,002

 

$

605,463

 

$

197,300

 

Collaborative research agreements

 

50,000

 

160,000

 

50,000

 

160,000

 

Total revenues

 

168,797

 

211,002

 

655,463

 

357,300

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

6,220,482

 

7,022,093

 

13,125,858

 

30,468,360

 

Marketing

 

913,916

 

299,071

 

1,279,484

 

851,068

 

General and administrative

 

1,521,446

 

1,513,175

 

3,258,497

 

2,607,643

 

Total operating expenses

 

8,655,844

 

8,834,339

 

17,663,839

 

33,927,071

 

Loss from operations

 

(8,487,047

)

(8,623,337

)

(17,008,376

)

(33,569,771

)

Interest income and other, net

 

433,750

 

495,280

 

1,015,034

 

937,501

 

Net loss

 

$

(8,053,297

)

$

(8,128,057

)

$

(15,993,342

)

$

(32,632,270

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.29

)

$

(0.35

)

$

(0.57

)

$

(1.75

)

 

 

 

 

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share

 

27,891,870

 

23,136,754

 

27,880,772

 

18,613,135

 

 

Optimer Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

 

 

 

 

June 30

 

December 31,

 

 

 

2008

 

2007

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

16,905,838

 

$

3,191,814

 

Short-term investments

 

26,177,939

 

55,613,785

 

Prepaid expenses and other current assets

 

976,595

 

967,994

 

Total current assets

 

44,060,372

 

59,773,593

 

Property and equipment, net

 

652,780

 

705,374

 

Long-term investments

 

1,150,000

 

 

Other assets

 

308,943

 

306,573

 

Total assets

 

$

46,172,095

 

$

60,785,540

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,800,225

 

$

2,602,152

 

Accrued expenses

 

4,134,009

 

4,998,025

 

Total current liabilities

 

7,934,234

 

7,600,177

 

Deferred rent

 

265,552

 

281,894

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

37,972,309

 

52,903,469

 

Total liabilities and stockholders’ equity

 

$

46,172,095

 

$

60,785,540

 

 


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