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): August 5, 2015
OPHTHOTECH CORPORATION
(Exact Name of Company as Specified in Charter)
Delaware |
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001-36080 |
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20-8185347 |
(State or Other Jurisdiction |
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(Commission |
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(IRS Employer |
of Incorporation) |
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File Number) |
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Identification No.) |
One Penn Plaza, 19th Floor
New York, NY 10119
(Address of Principal Executive Offices) (Zip Code)
Companys telephone number, including area code: (212) 845-8200
Not Applicable
(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 5, 2015, Ophthotech Corporation announced its financial results for the quarter ended June 30, 2015. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it 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:
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
99.1 Press Release dated August 5, 2015.
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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OPHTHOTECH CORPORATION | |
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Date: August 5, 2015 |
By: |
/s/ Barbara A. Wood |
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Barbara A. Wood |
Exhibit 99.1
Ophthotech Reports Second Quarter 2015 Financial and Operating Results
- Conference Call and Webcast Today, August 5, 2015, at 8:00 a.m. ET -
New York, NY, August 5, 2015 Ophthotech Corporation (Nasdaq: OPHT) today announced financial results for the second quarter ended June 30, 2015 and provided an update on the Companys business and product development programs.
Program Highlights
In May 2015, Ophthotech provided updates on the Companys two Phase 3 trials of Fovista® in combination with Lucentis® (ranibizumab) in patients with wet Age-Related Macular Degeneration (AMD). Completion of enrollment of the first Phase 3 trial was announced. In addition, guidance was provided for the approximate completion of enrollment of the second Phase 3 trial by the end of the third quarter of 2015, subject to delays related to the summer season and/or the initiation of competing trials.
The Company currently anticipates that enrollment of the second Phase 3 trial should be completed in the fourth quarter of 2015. The Companys timing projections for completion of enrollment assume no additional impact related to the summer season and/or competing trials. The Company continues to expect to report initial, topline data from both Phase 3 trials of Fovista® in combination with Lucentis® by the end of 2016. This timeline could be subject to an adjustment to a slightly later time point if the recruitment rate is on the lower end of the Companys projected enrollment scenario. The initial, topline data are expected one year after the enrollment of the last patient in the second Phase 3 Fovista® in combination with Lucentis® trial, plus the customary time required for database closure and analysis.
The third Phase 3 trial, which is investigating Fovista® in combination with either Eylea® (aflibercept) or Avastin® (bevacizumab) continues to enroll patients and the recruitment is on track. This third Phase 3 trial was initiated approximately nine months after the Fovista® in combination with Lucentis® trials.
The Fovista® Expansion Studies (FES) investigating the rationale for Fovista® in combination with multiple anti-VEGF agents to reduce retinal fibrosis and treatment burden in wet AMD patients are progressing well. The Company expects initial interim data from the Fovista® retinal fibrosis study by the end of 2015. The planning process for a study in monotherapy anti-VEGF resistant patients with wet AMD is on track, with the study expected to commence this year.
During the first half of 2015, Ophthotech achieved several significant milestones, particularly with regard to the execution of our ongoing Fovista® Phase 3 program with the completion of patient recruitment of the first Phase 3 trial of Fovista® in combination with Lucentis®, said David Guyer, M.D., Chief Executive Officer and Chairman of the Board of Ophthotech. We remain focused on the continued execution of the Fovista® Phase 3 program. We look forward to the completion of enrollment of the second Phase 3 Fovista® in combination with Lucentis® trial, the release of initial interim data from of our Fovista® retinal fibrosis study, and the initiation of our Phase 2/3 dry AMD program with Zimura®.
Management Highlights
In July 2015, Ophthotech announced the appointment of three industry veterans to its senior management team. Dr. David T. Shima joins as Chief Scientific Officer, Henric Bjarke as Chief Commercial Officer, and Dr. Satish C. Tripathi as Senior Vice President of Global Regulatory Affairs. Dr. Shima is a pioneer, world leader and expert in ocular angiogenesis and vascular cell biology and joins the Company from Roche, where he recently served as Global Head and Vice President of Ophthalmology Discovery and Biomarkers. Mr. Bjarke joins the Company from Alexion where he successfully managed commercial operations in the U.S. and Canada. He has extensive commercial experience in the retina and ophthalmology market, and has participated in the launch of multiple blockbuster drugs in diverse settings. Dr. Tripathi joins the Company from InterMune/Roche-Genentech and has over 25 years of combined R&D and global regulatory strategy experience.
We are very excited to welcome these well accomplished and talented new members to Ophthotechs senior leadership team, stated Samir Patel, M.D., President and Vice-Chairman of the Board of Ophthotech. All three bring relevant experience and proven track records to Ophthotech.
Financial Results
· As of June 30, 2015, the Company had $449.0 million in cash, cash equivalents, and marketable securities.
· Collaboration revenue was $1.6 million for the quarter ended June 30, 2015. For the six months ended June 30, 2015, collaboration revenue was $43.3 million and primarily related to the $50.0 million enrollment-based milestone that was achieved in March 2015 under Ophthotechs agreement with Novartis. The balance of the milestone was recorded as deferred revenue. The Company did not have any collaboration revenue in the comparable periods in 2014.
· Research and development expenses were $32.1 million for the quarter ended June 30, 2015 compared to $34.7 million for the same period in 2014. For the six months ended June 30, 2015 research and development expenses were $56.6 million compared to $49.1 million for the same period in 2014. Both prior year periods included a $19.8 million milestone payment the Company paid in connection with the Novartis Agreement. Excluding this milestone payment, research and development expense increased in both the quarter and six months ended June 30, 2015 primarily due to the Companys Fovista® Phase 3 clinical program.
· General and administrative expenses were $12.0 million for the quarter ended June 30, 2015 compared to $7.6 million for the same period in 2014. For the six months ended June 30, 2015, general and administrative expenses were $21.5 million compared to $13.9 million for the same period in 2014. The increase in general and administrative expenses in the quarter and six months ended June 30, 2015 relates primarily to an increase in costs to support the Companys expanded operations and public company infrastructure, including additional management, corporate staffing, professional services and consulting fees, and increased share-based compensation.
· The Company reported a net loss for the quarter ended June 30, 2015 of $37.1 million, or ($1.08) per diluted share, compared to a net loss of $73.0 million, or ($2.19) per diluted share for the same period in 2014. For the six months ended June 30, 2015, the Company reported a net loss of $30.5 million, or ($0.89) per diluted share, compared to a net loss of $93.7 million, or ($2.85) per diluted share, for the same period in 2014.
Conference Call/Web Cast Information
Ophthotech will host a conference call/audio web cast to discuss this announcement. The call is scheduled for August 5, 2015 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 888-337-8169 (USA) or 719-325-2455 (International), passcode 8617835. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is (888) 203-1112 (USA Toll Free), passcode 8617835. The audio webcast can be accessed at: www.ophthotech.com.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat back of the eye diseases, with a focus on developing innovative therapies for age-related macular degeneration (AMD). Ophthotechs most advanced product candidate, Fovista® anti-PDGF therapy, is in Phase 3 clinical trials for use in combination with anti-VEGF therapy that represents the current standard of care for the treatment of wet AMD. Ophthotechs second product candidate, Zimura®, an inhibitor of complement factor C5, is being developed for the treatment of geographic atrophy, a form of dry AMD. For more information, please visit www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotechs 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 Ophthotechs strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words anticipate, believe, estimate, expect, intend, goal, may, might, plan, predict, project, target, potential, will, would, could, should, continue, and similar expressions. In this press release, Ophthotechs forward looking statements include statements about, the timing and progress of the Fovista® Phase 3 clinical program and Fovista® expansion studies, including the timing of completion of enrollment these trials, obtaining initial, topline data or interim data from these clinical trials, as applicable and seeking marketing approval for Fovista®, the potential of Fovista® as a wet AMD combination therapy, and the initiation of additional clinical trials for Fovista® and Zimura®. Such forward-looking statements involve substantial risks and uncertainties that could cause Ophthotechs 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 and expectations for regulatory approvals or other actions and other factors discussed in the Risk Factors section contained in the quarterly and annual reports that Ophthotech files with the SEC. Any forward-looking statements represent Ophthotechs 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 except as required by law.
Contacts: Investors
Kathy Galante
Ophthotech Corporation
Vice President, Investor Relations and Corporate Communications
212-845-8231
kathy.galante@ophthotech.com
Media
Jennifer Devine
SmithSolve LLC on behalf of Ophthotech Corporation
973-442-1555
jennifer.devine@smithsolve.com
Ophthotech Corporation
Selected Financial Data (unaudited)
(in thousands, except per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2015 |
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2014 |
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2015 |
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2014 |
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Statement of Operations Data: |
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Collaboration revenue |
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$ |
1,597 |
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$ |
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$ |
43,275 |
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$ |
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Costs and expenses: |
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Research and development |
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32,059 |
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34,707 |
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56,616 |
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49,084 |
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General and administrative |
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11,959 |
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7,570 |
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21,543 |
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13,919 |
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Total costs and expenses |
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44,018 |
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42,277 |
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78,159 |
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63,003 |
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Loss from operations |
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(42,421 |
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(42,277 |
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(34,884 |
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(63,003 |
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Interest income |
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218 |
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72 |
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291 |
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116 |
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Loss before income tax provision |
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(42,203 |
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(42,205 |
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(34,593 |
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(62,887 |
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Income tax (benefit) provision |
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(5,072 |
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30,785 |
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(4,098 |
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30,785 |
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Net loss |
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$ |
(37,131 |
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$ |
(72,990 |
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$ |
(30,495 |
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$ |
(93,672 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(1.08 |
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$ |
(2.19 |
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$ |
(0.89 |
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$ |
(2.85 |
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Weighted average common shares outstanding: |
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Basic and diluted |
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34,353 |
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33,373 |
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34,254 |
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32,830 |
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June 30, 2015 |
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December 31, 2014 |
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(in thousands) |
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Balance sheet data: |
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Cash, cash equivalents, and marketable securities |
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$ |
449,040 |
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$ |
463,560 |
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Total assets |
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$ |
471,049 |
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$ |
479,786 |
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Royalty purchase liability |
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$ |
125,000 |
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$ |
125,000 |
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Deferred revenue |
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$ |
216,348 |
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$ |
209,624 |
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Total liabilities |
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$ |
357,273 |
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$ |
351,249 |
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Additional paid-in capital |
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$ |
444,034 |
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$ |
428,390 |
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Accumulated deficit |
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$ |
(330,317 |
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$ |
(299,822 |
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Total stockholders equity |
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$ |
113,776 |
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$ |
128,537 |
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