-----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, QLZwqQhottqtiJNWvSTRvIGe2FkHWBRTrlwkBUAQmsxsJuq88+9aUl1lHu4n6Swf S3LdIcIjujYQQWig5OWt2w== 0001104659-09-016402.txt : 20090311 0001104659-09-016402.hdr.sgml : 20090311 20090311153804 ACCESSION NUMBER: 0001104659-09-016402 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090311 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090311 DATE AS OF CHANGE: 20090311 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: 09672442 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 a09-7481_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)

 

March 11, 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 dentification 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 March 11, 2009, the Company issued a press release reporting its financial results for the quarter and full year ended December 31, 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 March 11, 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:  March 11, 2009

 

3


 

EX-99.1 2 a09-7481_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Financial Results

 

SAN DIEGO — March 11, 2009 - Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced 2008 fourth quarter and full year financial results and accomplishments.

 

Optimer reported a net loss for the three months ended December 31, 2008 of $10.4 million, or $0.35 per common share, as compared to a net loss of $7.0 million, or $0.27 per common share, for the same period in 2007.  Optimer reported a net loss for the year ended December 31, 2008 of $35.6 million, or $1.24 per common share, as compared to a net loss of $46.1 million, or $2.12 per common share, for 2007. The decrease of $10.5 million was due primarily to 2007 expense related to a $20.0 million payment to Par Pharmaceutical Inc. to regain the rights to fidaxomicin in North America, and was partially offset by an increase in expenses related to fidaxomicin and prulifloxacin Phase 3 clinical trials in 2008.

 

As of December 31, 2008, Optimer held cash, cash equivalents and short-term investments of $39.3 million.  In March 2009, Optimer raised an additional $32.9 million of gross proceeds in a registered direct offering.

 

“In 2008, we took a first look at Phase 3 data from both of our lead drug programs, fidaxomicin and prulifloxacin, and both trials achieved their primary endpoints. 2008 was a revealing year for antibiotics and infectious disease, with increasing attention on the emergence of infections such as C. difficile and the need for new antibiotics to address these growing problems,” said Michael N. Chang, President and CEO of Optimer. “2009 will be a significant year for Optimer, with the anticipated completion of the second Phase 3 clinical trial of fidaxomicin, the potential partnering of fidaxomicin outside of North America and preparation of an MAA filing, and the anticipated submission of a New Drug Application for prulifloxacin.”

 

Optimer 2008 and Recent 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.

 

·                  Announced positive results from the first Phase 3 trial of fidaxomicin for CDI. 92.1% of patients treated with fidaxomicin (per protocol population) achieved clinical cure vs. 89.8% for Vancocin®.  In addition, only 13.3% of patients treated with fidaxomicin experienced a recurrence vs. 24.0% for Vancocin (p = 0.004). Patients treated with fidaxomicin had a global cure (cure with no recurrence within four weeks) of 77.7%, which was greater than Vancocin at 67.1% (p = 0.006). Fidaxomicin was well-tolerated.

 



·                  Announced positive results from both pivotal Phase 3 trials of prulifloxacin for the treatment of infectious diarrhea.  Both trials achieved the primary endpoint of median Time to Last Unformed Stool (TLUS). Median TLUS for patients treated with prulifloxacin in the first trial was 24.0 hours and 32.8 hours in the second trial. This was statistically significant from the TLUS for placebo with a p-value of less than 0.0001 in both trials. Prulifloxacin was generally well-tolerated and had a similar safety profile compared to placebo in both trials. These two pivotal Phase 3 clinical studies will be used to support an NDA submission with the U.S. Food and Drug Administration.

 

·                  Raised $32.9 million in gross proceeds in a registered direct offering in March 2009.  Also raised $14.8 million in gross proceeds in a registered direct offering in July 2008.

 

·                  Presented additional data from a Phase 2A clinical study of fidaxomicin finding a 42% prevalence of the super toxin-producing strain of C. difficile, known as BI/NAP1/027, in patients with CDI. The study also found that fidaxomicin produced similar cure rates in patients with the NAP1 strain compared to patients without the hyper-virulent strain. Data was presented at the Anaerobe Society of the Americas (ASA) in Long Beach, California.

 

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

 

·                  Sponsored educational symposia at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain and the joint meeting of the Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) in Washington, D.C., related to the treatment of CDI.

 

·                  Published Phase 1 clinical results of fidaxomicin in the peer-reviewed journal Antimicrobial Agents and Chemotherapy.

 

·                  Awarded a $1 million grant from the National Institutes of Health for the development of fidaxomicin.

 

2009 Financial Guidance

 

Optimer expects to use cash, cash equivalents and short-term investments of approximately $40 to $44 million for its operating activities in 2009, based on its current operating plans.

 

Scheduled Conference Call

 

The Company will host both a conference call and webcast to discuss the fourth quarter and full year 2008 financial results and to provide a corporate update today, Wednesday, March 11, 2009, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

 



The conference call may be accessed by dialing 877-874-1567 for domestic callers and 719-325-4808 for international callers.  Please specify to the operator that you would like to join the “Optimer Earnings Call.” The conference call will be webcast live under the Investors section of Optimer’s website at www.optimerpharma.com, where it will be archived for 30 days following the call.

 

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, anticipated uses of cash, cash equivalents and short term investments, the timing of clinical trials and anticipated results and regulatory submissions, and potential partnering 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, uncertainty regarding regulatory requirements for approval and the timing of regulatory submissions, an inability to enter into partnerships on favorable terms or at all, 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

 

 

 

Three Months Ended December 31,

 

Year Ended December 31,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Research grants

 

$

128,695

 

$

91,817

 

$

973,370

 

$

333,610

 

Collaborative research agreements

 

 

2,000

 

50,000

 

433,555

 

Total revenues

 

128,695

 

93,817

 

1,023,370

 

767,165

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

8,032,064

 

5,604,571

 

29,035,828

 

41,569,067

 

Marketing

 

755,791

 

809,510

 

2,451,191

 

2,048,002

 

General and administrative

 

1,879,459

 

1,381,105

 

6,682,881

 

5,350,800

 

Total operating expenses

 

10,667,314

 

7,795,186

 

38,169,900

 

48,967,869

 

Loss from operations

 

(10,538,619

)

(7,701,369

)

(37,146,530

)

(48,200,704

)

Interest income and other, net

 

135,548

 

669,796

 

1,561,934

 

2,061,527

 

Net loss

 

$

(10,403,071

)

$

(7,031,573

)

$

(35,584,596

)

$

(46,139,177

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.35

)

$

(0.27

)

$

(1.24

)

$

(2.12

)

Shares used to compute basic and diluted net loss per share

 

29,697,503

 

26,379,645

 

28,682,542

 

21,715,332

 

 

Optimer Pharmaceuticals, Inc.

Consolidated Balance Sheets

 

 

 

Year Ended December 31,

 

 

 

2008

 

2007

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

16,778,880

 

$

3,191,814

 

Short-term investments

 

22,547,515

 

55,613,785

 

Prepaid expenses and other current assets

 

744,670

 

967,994

 

Total current assets

 

40,071,065

 

59,773,593

 

Restricted cash

 

170,000

 

 

Property and equipment, net

 

694,183

 

705,374

 

Long-term investments

 

1,032,000

 

 

Other assets

 

328,250

 

306,573

 

Total assets

 

$

42,295,498

 

$

60,785,540

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,767,831

 

$

2,602,152

 

Accrued expenses

 

4,045,660

 

4,998,025

 

Total current liabilities

 

7,813,491

 

7,600,177

 

Deferred rent

 

251,504

 

281,894

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

34,230,503

 

52,903,469

 

Total liabilities and stockholders’ equity

 

$

42,295,498

 

$

60,785,540

 

 


 

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