– Conference Call and Webcast Today, November 13, at 8:30 a.m. ET –
New York, NY, November 13, 2013 – Ophthotech Corporation (Nasdaq: OPHT) today announced financial results for the third quarter and nine months ended September 30, 2013 and provided an update on the Company’s business, and product development programs.
Recent Corporate Highlights
- Ophthotech closed its $192 million initial public offering (IPO) on September 30, 2013 and began trading on the NASDAQ Global Select Market under the symbol OPHT on September 25, 2013.
- As of September 30, 2013, the Company had $236.1 million in cash and cash equivalents. This reflects the proceeds from the Company’s IPO completed in the third quarter. In addition, the Company had an additional $83.3 million of potential funding available under the company’s royalty purchase and sale agreement with Novo A/S, providing a total of $319.4 million of potential available funds.
- Ophthotech expanded its management team to advance the global Phase 3 clinical program for its lead compound FovistaTM. Richard L. Beckman, M.D. has joined Ophthotech as Chief Medical Officer; Douglas G. Brooks, Ph.D. as Vice President, Manufacturing Development; Kathy Galante as Vice President, Investor Relations; Douglas K. Kollmorgen as Senior Vice President, Quality Assurance; Jeffrey Nau as Vice President, Clinical and Medical Affairs and Barbara Wood as Senior Vice President and General Counsel.
Operating expenses for the quarter ended September 30, 2013 were $15.3 million, with $11.1 million attributable to research and development. This compares to operating expenses of $3.9 million and research and development expenses of $1.6 million for the same period last year. The Company reported a net loss for the quarter ended September 30, 2013 of $18.4 million, or $10.26 per share, compared to a net loss of $5.9 million, or $4.07 per share, for the same period last year.
Operating expenses for the nine month period ended September 30, 2013 were $27.0 million, with $17.8 million attributable to research and development. This compares to operating expenses of $10.1 million and research and development expenses of $4.8 million for the same period last year. The Company reported a net loss for the nine month period ended September 30, 2013 of $36.6 million, or $23.21 per share compared to a net loss of $16.0 million, or $11.07 per share for the same period last year.
Product Development Update
The FovistaTM Phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista™ (anti-PDGF) therapy, which Ophthotech is developing for use in combination with anti-VEGF drugs for the treatment of wet age-related macular degeneration. Two of the trials will evaluate FovistaTM in combination with Lucentis® and the other will evaluate FovistaTM in combination with each of Eylea® or Avastin®. The three trials are planned to enroll a total of approximately 1,866 patients in approximately 225 centers worldwide.
In July 2013, protocols for the three clinical trials were submitted to the Food and Drug Administration (FDA). In August 2013, enrollment in the United States was initiated in the two Lucentis® combination trials. The third trial is targeted for initiation in the United States in the first quarter of 2014.
Ex-U.S., the Company has made regulatory submissions in selected countries to initiate the planned Phase 3 clinical trials of Fovista™ in combination with Lucentis® and has begun to receive approvals to initiate the trials. In the European Union, in addition to filing in selected individual countries with regulatory agencies (National Competent Authorities), which are responsible for approving clinical trial applications (CTA), the Company is also continuing its interactions with the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) following recent advice CHMP provided to the Company on the proposed Fovista™ Phase 3 clinical program and related regulatory submission plans.
The Company expects to have initial, topline data from the Fovista™ Phase 3 clinical program available in 2016, as previously stated. The Company will provide additional information during the conference call described below regarding the Fovista™ Phase 3 program, including regulatory status.
The Company has initiated the process to manufacture clinical supplies and is developing protocols for the use of this complement inhibitor in AMD.
“It has been a productive and exciting time for Ophthotech as we expanded our management team and completed our IPO, which was one of the largest for the sector this year,” said David Guyer, M.D., Chief Executive Officer of Ophthotech. “We have made meaningful progress in our clinical programs including advancing FovistaTM into Phase 3 pivotal trials and greatly expanded our financial resources to allow us to continue our development efforts.”
Conference Call/Web Cast Information
Ophthotech will host a conference call/audio web cast to discuss the Company’s financial and operating results, its product development programs and provide a general business update. The call is scheduled for November 13, at 8:30 a.m., Eastern Time. To participate in this conference call, dial 888-211-0353 (USA) or 913-312-6664 (International), passcode 2669908 shortly before 8:30 a.m. Eastern Time. A replay of the call will be available from 11:30 a.m. ET through Thursday, November 21, 2013 at 11:30 a.m. ET. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 2669908. The audio web cast can be accessed at: www.ophthotech.com.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the eye. The company has initiated a pivotal Phase 3 clinical program for its most advanced product candidate, Fovista™ anti-PDGF therapy, which it is developing for use in combination with anti-VEGF drugs that represent the standard of care for the treatment of wet age-related macular degeneration.
Any statements in this press release about Ophthotech’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about Ophthotech’s strategy, future operations, future financial position and future expectations and plans and prospects for Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward-looking statements include statements about the conduct of the FovistaTM Phase 3 program, the anticipated initiation of the third trial in the FovistaTM Phase 3 program, obtaining top-line data from the FovistaTM Phase 3 program and seeking marketing approval for FovistaTM, the potential of FovistaTM to provide meaningful added benefit to patients and the sufficiency of Ophthotech’s financial resources. Such forward-looking statements involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials, expectations for regulatory approvals or other actions, the availability or commercial potential of product candidates and other factors discussed in the “Risk Factors” section contained in Ophthotech’s final prospectus from its initial public offering which is on file with the Securities and Exchange Commission (SEC), and in the quarterly and annual reports that the company files with the SEC. Any forward-looking statements represent Ophthotech’s views only as of the date of this press release. Ophthotech anticipates that subsequent events and developments will cause its views to change. While Ophthotech may elect to update these forward-looking statements at some point in the future, Ophthotech specifically disclaims any obligation to do so.
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