Ophthotech Reports Fourth Quarter and Full Year 2015 Financial and Operating Results
- Conference Call and Webcast Today,
"We are well positioned to build on the strong momentum that we achieved
in 2015," said
- The Company completed patient recruitment in both of its pivotal Phase 3 trials of Fovista® (pegpleranib) in combination with Lucentis® (ranibizumab). Initial, topline data from both Phase 3 trials of Fovista® in combination with Lucentis® is expected in the fourth quarter. A third Phase 3 trial, which is investigating Fovista® in combination with either Eylea® (aflibercept) or Avastin® (bevacizumab), continues to enroll patients and remains on track to complete enrollment in 2016.
In late 2015,
Genentech, a Roche wholly-owned subsidiary, exercised its option to participate in the financial arrangements relating to Novartis' rights under the Ophthotech/Novartis ex-US licensing and commercialization agreement for Fovista® to treat wet AMD. Ophthotech's agreement with Novartis, including its financial terms, remains unchanged. Ophthotechcontinues to retain sole rights to Fovista® in the United States.
Ophthotechachieved a second $50 million enrollment milestone from Novartis related to the $130 milliontotal potential enrollment-based milestones under the ex-US licensing and commercialization agreement with Novartis. A $30 millionenrollment milestone remains which will be earned when the final Fovista® Phase 3 study completes enrollment.
Recruitment has been completed in two of the Company's Fovista®
Expansion Studies. One of these Phase 2a trials is investigating the
potential role of Fovista® in combination with multiple
anti-VEGF agents to reduce sub-retinal fibrosis and the other is
investigating the potential role of Fovista® combination
therapy to reduce the treatment burden for wet AMD patients. The
Company presented encouraging initial interim data from the Fovista®
anti-fibrosis study at its R&D Investor Day in
- Results from Ophthotech's Phase 1 Fovista® combination therapy study in wet AMD patients were published during the fourth quarter of 2015 (Jaffe GJ, Eliott D, Wells JA, Prenner JL, Papp A, Patel S. A Phase 1 Study of Intravitreous E10030 in Combination with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2016 Jan;123(1):78-85.)
- In Q4 2015, the Company initiated a Phase 2 trial of Zimura® (avacincaptad pegol sodium), an inhibitor of complement factor C5, in combination with anti-VEGF therapy in wet AMD patients to potentially address the treatment burden associated with wet AMD. The Company also initiated in Q4 a Phase 2/3 clinical trial of Zimura® in patients with geographic atrophy, an advanced form of dry AMD.
Year-end and Fourth Quarter 2015 Financial Highlights
Cash Position: As of
December 31, 2015, the Company had $391.9 millionin cash, cash equivalents, and available for sale securities.
Revenues: Collaboration revenue was
$4.8 millionfor the quarter ended December 31, 2015, compared to $1.7 millionfor the prior year period. For the year ended December 31, 2015, collaboration revenue was $51.5 millioncompared to $41.3 millionfor the same period in 2014. Collaboration revenue recognized in 2015 and 2014 consists of license fee revenue primarily attributable to the $50.0 millionenrollment-based milestones the Company achieved in March 2015and September 2014under the Novartis Agreement, as well as revenue associated with research and development activities and drug supply shipments the Company completed under the same agreement.
R&D Expenses: Research and development expenses were
$33.9 millionfor the quarter ended December 31, 2015compared to $22.2 millionfor the same period in 2014. For the year ended December 31, 2015research and development expenses were $131.0 millioncompared to $88.4 millionfor the same period in 2014. The year ended December 31, 2014included a $19.8 millionmilestone payment the Company paid in connection with the Novartis Agreement. Excluding this milestone payment, research and development expense increased in both the quarter and year ended December 31, 2015primarily due to the Company's Fovista® Phase 3 clinical program and increased personnel costs associated with additional management and research and development staffing, including share-based compensation expense.
G&A Expenses: General and administrative expenses were
$12.1 millionfor the quarter ended December 31, 2015compared to $10.7 millionfor the same period in 2014. For the year ended December 31, 2015, general and administrative expenses were $44.0 millioncompared to $33.4 millionfor the same period in 2014. The increase in general and administrative expenses in the quarter and year ended December 31, 2015relates primarily to an increase in costs to support the Company's expanded operations and public company infrastructure, including additional management, corporate staffing, pre-launch commercial activities, professional services and consulting fees, and increased share-based compensation.
Net Loss: The Company reported a net loss for the quarter ended
December 31, 2015of $35.6 million, or ( $1.02) per diluted share, compared to a net loss of $31.7 million, or ( $0.94) per diluted share for the same period in 2014. For the year ended December 31, 2015, the Company reported a net loss of $105.7 million, or ( $3.06) per diluted share, compared to a net loss of $116.8 million, or ( $3.51) per diluted share, for the same period in 2014.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
Three Months Ended
|Statements of Operations Data:|
|Research and development||33,917||22,196||131,012||88,385|
|General and administrative||12,066||10,656||44,021||33,387|
|Total operating expenses||45,983||32,852||175,033||121,772|
|Loss from operations||(41,201)||(31,168)||(123,528)||(80,513)|
|Loss before income tax provision||(40,807)||(31,140)||(122,504)||(80,296)|
|Income tax (benefit) provision||(5,158)||512||(16,787)||36,476|
|Net loss per common share:|
|Basic and diluted||$||(1.02)||$||(0.94)||$||(3.06)||$||(3.51)|
|Weighted average common shares outstanding:|
|Basic and diluted||35,022||33,803||34,580||33,258|
|Balance sheets data:|
|Cash, cash equivalents, and marketable securities||$||391,890||$||463,560|
|Royalty purchase liability||$||125,000||$||125,000|
|Additional paid-in capital||$||465,924||$||428,390|
|Total stockholders' equity||$||59,947||$||128,537|
Vice President, Investor Relations and Corporate Communications
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