UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): April 6, 2012
OPTIMER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-33291 |
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33-0830300 |
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10110 Sorrento Valley Road, Suite C San Diego, California |
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92121 |
Registrant’s telephone number, including area code: (858) 909-0736
Not Applicable.
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
In this report, “Optimer Pharmaceuticals,” “Optimer,” “Company,” “we,” “us” and “our” refer to Optimer Pharmaceuticals, Inc., unless the context otherwise provides.
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Item 2.02 |
Results of Operations and Financial Condition. |
On April 9, 2012, we issued a press release announcing certain preliminary operating results relating to gross revenues during the first quarter ended March 31, 2012. A copy of this press release is attached hereto as Exhibit 99.1.
This information under this Item 2.02 and the exhibit 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, (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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Item 5.02 |
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On April 6, 2012, the employment of each of John D. Prunty, our Senior Vice President, Chief Financial Officer and Corporate Secretary, and Youe-Kong Shue, Ph.D., our Vice President, was terminated effective immediately. A copy of the press release announcing the terminations is attached hereto as Exhibit 99.1.
In connection with Mr. Prunty’s termination, our Board of Directors appointed Kurt M. Hartman, our General Counsel, Chief Compliance Officer and Senior Vice President, Access, as our acting Chief Financial Officer while we engage in a search for a permanent Chief Financial Officer. In his role as acting Chief Financial Officer, Mr. Hartman will also serve as our principal financial officer and principal accounting officer.
Mr. Hartman has served as our General Counsel and Senior Vice President, Access since December 2010 and in February 2011 he was appointed Chief Compliance Officer. Prior to joining us, Mr. Hartman held the position of Executive Director, Value and Access at Eisai, Inc., a research-based human health care company that discovers, develops and markets products throughout the world, where Mr. Hartman served as a Chairperson of Eisai’s U.S. Pricing Committee and led the areas of Strategic Pricing and Contracting, Reimbursement Support Services, and Eisai’s National Field Reimbursement Team. From 2007 to 2008, Mr. Hartman served as a Director of Patient Reimbursement Support and Assistance for Roche Laboratories, a research-focused healthcare company that develops and provides innovative diagnostic and therapeutic products and services that deliver significant benefits to patients and healthcare professionals. From 2004 to 2007, Mr. Hartman held strategic positions at Boehringer Ingelheim, a pharmaceutical company, including Associate Director, Contract Analysis and prior to that position, Associate Director, Managed Markets Marketing. Mr. Hartman received a bachelor’s degree from University of California at Los Angeles and received his J.D. from Pepperdine University School of Law.
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Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated April 9, 2012. |
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.
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OPTIMER PHARMACEUTICALS, INC. |
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By: |
/s/ Pedro Lichtinger |
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Pedro Lichtinger |
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President and Chief Executive Officer |
Date: April 9, 2012
Exhibit 99.1
Optimer Pharmaceuticals Announces Personnel Changes
—Reports Preliminary First Quarter 2012 Gross Revenues of Approximately $16.45 Million, 36%
Increase in Growth Compared to Fourth Quarter 2011—
SAN DIEGO, April 9, 2012— Optimer Pharmaceuticals [NASDAQ: OPTR] (“the Company” or “Optimer”) today announced its Board of Directors has appointed Hank McKinnell as its new Chairman. Dr. McKinnell was previously appointed Lead Independent Director at the February 29, 2012 Board meeting. The Company also announced that Kurt Hartman — who currently serves as General Counsel, Chief Compliance Officer and Senior Vice President — has been appointed acting CFO and a search for a permanent CFO has commenced.
The appointments were made after the Optimer Board of Directors removed Dr. Michael Chang as Chairman and terminated John D. Prunty, Chief Financial Officer, and Dr. Youe-Kong Shue, Vice President. The Board, excluding Dr. Chang, unanimously approved the personnel changes. The Company said that Dr. Chang remains as a Director of the Company, but that the Board has requested his resignation.
The changes are not expected to materially impact the Company’s revenues or operations, including the commercialization and launch of DIFICID®, but were related to certain lapses in corporate governance practices and the Company’s relationship with Optimer Biotechnology, Inc. (“OBI”), its 43%-owned independent, Taiwanese-based affiliate.
Separately, the Company announced that, based upon preliminary results, it expects to report gross revenues of approximately $16.45 million for the first quarter of 2012, an increase of approximately 36% over gross revenues for the fourth quarter of 2011.
Dr. Chang’s removal as Chairman resulted from the Board’s views as to his actions in his capacity as Optimer’s representative on the Board of Directors of OBI as well as his failure to identify and effectively manage compliance, record keeping and conflict of interest issues in connection with OBI’s grant to Dr. Chang, potentially for the benefit of a third party, of 1.5 million shares of OBI. The terminations of Mr. Prunty and Dr. Shue were related to the belief of Optimer’s Independent Directors that both individuals failed to follow proper procedures when they became aware of the issues related to the issuance of the OBI shares to Dr. Chang.
The Company said it has disclosed the matter to the relevant U.S. authorities and is cooperating with those authorities in reviewing the matter.
Optimer’s Board has determined to remove Dr. Chang from OBI’s Board of Directors and to appoint Dr. McKinnell to replace Dr. Chang as Optimer’s representative on the OBI Board.
Dr. McKinnell stated, “Clearly, we are disappointed that we had to take these actions. However, the Board believes they reflect the importance to the Company of good corporate governance practices and that they are in the best interests of the Company and its
stakeholders. Importantly, the issues surrounding the Board’s decision relate solely to the Company’s relationship with OBI.”
Comments on Preliminary Results for 2012 First Quarter
Commenting upon the Company’s first quarter results, Mr. Lichtinger said: “We are pleased that the Company continues to perform well in the marketplace and, based upon preliminary results, we expect to report that gross revenues for the first quarter of 2012 increased to approximately $16.45 million, approximately 36% over gross revenues of $12.22 million for the fourth quarter of 2011.
“We are especially pleased with these results since it demonstrates continuing momentum in our business. Indeed, after a successful 2011 highlighted by the FDA approval and U.S. launch of DIFICID as well as European approval of the drug, Optimer is delivering strong growth into 2012 and continues to advance key drivers of growth. Our recently announced collaboration and license agreement with Astellas to develop and commercialize DIFICID in Japan is another sign of our continuing momentum.”
Mr. Lichtinger added, “The strong growth is also being driven by Optimer’s recently launched Long Term Care (LTC) strategy, which resulted in a significant acceleration in prescriptions with 160 reported in last week’s National Prescription Audit published by IMS Health. The formulary inclusion of DIFICID in three of the four key GPOs effective in April combined with a significant improvement in Medicare Part D coverage applicable to the LTC setting are expected to continue to generate increased growth.
“In addition, the increase in formulary Medicare Part D coverage from 13 million to 23 million lives that became effective as of April 2 is also expected to reduce the at least 30% of estimated prescription losses being experienced at the retail level as a result of lack of coverage or patient inability to pay the required co-insurance. Hospital performance continued to progress with over 700 hospitals now on formulary, motivating Optimer to rebalance its hospital field activities to increase pull through (number of prescriptions in hospitals where DIFICID is on formulary). In support of Optimer’s first line focus on patients at high risk of lower sustained clinical cure and high cost, publications focusing on oncology and renally impaired patients were presented, respectively, at the recent ECCMID London conference, and Society of Hospital Medical conference in San Diego, showing improved performance across cure, recurrence and sustained clinical cure when compared to vancomycin,” he concluded.
The Company said that it expects to report its first quarter 2012 results on May 3, 2012.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer developed and commercialized DIFICID® (fidaxomicin) tablets, an FDA-approved antibacterial drug for the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD). Optimer has also received marketing authorization for fidaxomicin
tablets in the European Union under the trade name DIFICLIR™. The company is seeking marketing authorization for fidaxomicin in Canada and is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem, including Asia. 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 statements related to the expected impact of Optimer’s recent personnel changes, Optimer’s expected financial results for the first quarter of 2012, Optimer’s expectations as to the future growth of its business and potential drivers of future growth and the expected impact of the increase in formulary Medicare Part D coverage. Words such as “believes,” “would,” “anticipates,” “plans,” “expects,” “may,” “intend,” “will” 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. These forward-looking statements are based on management’s expectations on the date of this release. 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: Optimer’s ability to continue driving adoption and use of DIFICID, the implementation and success of DIFICID growth initiatives and entry into new markets, whether healthcare professionals will prescribe DIFICID, the extent to which DIFICID receives reimbursement coverage from healthcare payers and government agencies, the extent to which DIFICID will be accepted on additional hospital formularies and the timing of hospital formulary decisions, Optimer’s ability to successfully coordinate commercialization efforts with Cubist Pharmaceuticals under its co-promotion agreement, whether Optimer will be able to realize expected benefits under its co-promotion agreement with Cubist and its collaboration agreements with Astellas, the possibility of alternative means of preventing or treating DIFICID impacting adoption and sales of DIFICID, Optimer’s ability, through its third party manufacturers and logistics providers, to maintain a sufficient supply of DIFICID to meet demand, the effects of changes in Optimer’s management, changes in Optimer’s relationship with OBI and other risks detailed in Optimer’s filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this release, and Optimer undertakes no obligation to update or revise these statements, except as may be required by law.
Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
858-909-0736
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
619-849-6005