Ophthotech Reports Second Quarter 2014 Financial Results and Provides Business Update
- Conference Call and Webcast, Today,
May 2014, the Company entered into an ex-US licensing and commercialization agreement with Novartis Pharma AGfocused on the treatment of wet age-related macular degeneration (AMD). Under the agreement, Ophthotechgranted Novartis exclusive rights to commercialize Ophthotech's lead product candidate, Fovista®, in markets outside the United Stateswhile Ophthotechretains sole rights to commercialize Fovista® in the United States.
Total payments to
Ophthotechunder the agreement could exceed $1 billionin upfront and milestone payments, not including future royalties.
The upfront payment and near-term milestones to
Ophthotechcould total up to $330 million. The Company received an upfront payment of $200 millionupon execution of the agreement and future Fovista® Phase 3 enrollment-based milestones could total up to $130 million.
Ophthotechis eligible to receive contingent future ex-US marketing approval milestones totaling up to $300 millionand ex-US sales milestones of up to $400 million.
- The upfront payment and near-term milestones to
Ophthotechis entitled to receive a mid-30 percent royalty on ex-US Fovista® sales.
- Total payments to
The Fovista® Phase 3 clinical program in wet age-related
macular degeneration (AMD) remains on track. As previously stated,
Ophthotechexpects to enroll a total of approximately 1,866 patients.
August 2014, Ophthotechannounced that it has initiated enrollment and dosed the first patient in the first of several planned expansion studies for Fovista® combination therapy. These expansion studies are designed to further investigate Fovista® in combination with anti-VEGF therapy in wet AMD patients and potentially may expand the market for Fovista®. The first expansion study is part of Ophthotech's program designed to investigate the possible role of Fovista® in reducing the formation and/or development of sub-retinal fibrosis in wet AMD.
The potential role of Fovista® (1.5mg) combination
therapy in reduction of sub-retinal fibrosis in a sub-group of wet
AMD patients with visual loss from the Phase 2b controlled trial
was evaluated by an independent third party. The findings from
this study have been accepted as an oral presentation at the 2014
Annual Meeting of the
American Academy of Ophthalmologyon October 21, 2014.
- The potential role of Fovista® (1.5mg) combination therapy in reduction of sub-retinal fibrosis in a sub-group of wet AMD patients with visual loss from the Phase 2b controlled trial was evaluated by an independent third party. The findings from this study have been accepted as an oral presentation at the 2014 Annual Meeting of the
- Planning for additional expansion trials of Fovista® in wet AMD is underway. These trials include the investigation of Fovista® administered with anti-VEGF therapy for the reduction in the treatment burden, treatment-resistance and reduction of sub-retinal fibrosis in wet AMD patients.
"During the second quarter we achieved a major milestone by executing
one of the largest ex-US partnering deals in the biotechnology industry
as we entered into a licensing and commercialization agreement with
Novartis for the treatment of wet AMD," said
For the six month period ended
The increases in operating expenses, and resulting increases in net
loss, for the three- and six-month periods ended
About the Fovista® Phase 3 Program
The Fovista® Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista®
anti-PDGF therapy, which
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
Six Months Ended
|Statement of Operations Data:||2014||2013||2014||2013|
|Costs and expenses:|
|Research and development||$||34,707||$||4,345||$||49,084||$||6,734|
|General and administrative||7,570||3,242||13,919||4,980|
|Total costs and expenses||42,277||7,587||63,003||11,714|
|Loss from operations||(42,277||)||(7,587||)||(63,003||)||(11,714||)|
|Interest income (expense)||72||(1,097||)||116||(1,454||)|
|Loss on extinguishment of debt||-||(1,196||)||-||(1,196||)|
|Net loss before income tax provision||(42,205||)||(10,006||)||(62,887||)||(14,624||)|
|Income tax provision||(10,294||)||-||(10,294||)||-|
|Add: accretion of preferred stock dividends||-||(1,858||)||-||(3,600||)|
Net loss attributable to common stockholders
Net loss attributable to common stockholders per share:
Basic and diluted
|Weighted average common shares outstanding:|
|Basic and diluted||33,373||1,470||32,830||1,470|
|Balance sheet data:|
|Cash, cash equivalents, and marketable securities||$||452,486||$||210,596|
|Royalty purchase liability||$||83,333||$||41,667|
|Deferred revenue, long-term||$||200,000||$||-|
|Additional paid-in capital||$||415,604||$||352,739|
|Deficit accumulated during the development stage||$||(256,231||)||$||(183,050||)|
|Total stockholders' equity||$||159,431||$||169,720|
Vice President, Investor Relations and Corporate Communications
News Provided by Acquire Media