Ophthotech Reports First Quarter 2014 Financial Results and Provides Business Update
- Conference Call and Webcast, Today,
Review of First Quarter Accomplishments
January 2014, the Company reached an enrollment milestone resulting in a second tranche payment of $41.7 millionto the Company under its $125.0 millionroyalty financing agreement with Novo A/ S. A potential third tranche of $41.7 millionunder this royalty agreement remains available to the Company based upon a further patient enrollment milestone.
February 2014, Ophthotechcompleted a follow-on public offering of common stock resulting in net proceeds of approximately $55.4 millionfor the Company.
The Company's Fovista™ Phase 3 clinical program in wet age-related
macular degeneration (AMD) remains on track.
- As scheduled, the Company activated initial trial sites for the third clinical trial with Fovista™ in combination with Avastin® (bevacizumab) and Eylea® (aflibercept).
Ophthotechannounced its strategy to expand its Fovista anti-PDGF therapy program beyond the pivotal Phase 3 clinical trials in wet AMD and to advance its Zimura™ program in both dry and wet AMD. Zimura™ is an inhibitor of complement factor C5.
- Plans are underway for multiple expansion trials of Fovista™ in wet AMD. These trials include the investigation of Fovista™ administered with anti-VEGF therapy for the potential reduction in the treatment burden for patients, the potential improvement of visual outcome for anti-VEGF treatment-resistant cases and the potential reduction of subretinal fibrosis to prevent sub-optimal visual outcome over the long-term. These studies are scheduled to commence this year.
Ophthotechalso expects to advance its second product candidate, ZimuraTM,to a Phase 2/3 clinical trial for treatment of geographic atrophy, a severe form of dry AMD, late this year or early in 2015. In addition, a Phase 2 clinical trial is planned for Zimura™ and FovistaTM in combination with anti-VEGF therapy for wet AMD patients believed to have complement-mediated inflammation. This trial is scheduled to initiate in 2015.
Ophthotechhosted its first R&D Day on March 7, 2014. A panel of 10 leading retinal specialists gave their insight into the Fovista™ pivotal Phase 3 program and planned expansion clinical trials, the progress and challenges in the treatment of AMD, along with a look at the future of wet and dry AMD therapies.
"It has been a very productive first quarter which was highlighted by
our successful follow-on public offering and the achievement of the
second tranche payment under the company's royalty financing agreement
with Novo A/S," said
About the FovistaTM Phase 3 Program
The FovistaTM Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista™ anti-PDGF
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
|(A Development Stage Company)|
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
Three months ended
|Statement of Operations Data:||(in thousands)|
|Research and development||14,377||2,389||122,484|
|General and administrative||6,349||1,738||47,908|
|Total operating expenses||20,726||4,127||170,392|
|Loss from operations||(20,726||)||(4,127||)||(170,392||)|
|Interest income (expense)||44||(357||)||(1,438||)|
|Loss on extinguishment of debt||-||-||(1,091||)|
|Change in fair value related to investor rights liability||-||-||683|
|Net loss before income tax benefit||(20,682||)||(4,618||)||(173,784||)|
|Income tax benefit||-||-||1,327|
|Add: accretion of preferred stock dividends||-||(1,742||)||(33,046||)|
|Net loss attributable to common stockholders||$||(20,682||)||$||(6,360||)||$||(205,503||)|
|Net loss attributable to common stockholders per share:|
|Basic and diluted||$||(0.64||)||$||(4.33||)|
|Weighted average common shares outstanding:|
|Basic and diluted||32,282||1,470|
|Balance sheet data:|
|Cash and cash equivalents||$||66,562||$||210,596|
|Available for sale securities||$||224,263||$||-|
|Royalty purchase liability||$||83,333||$||41,667|
|Additional paid-in capital||$||410,886||$||352,739|
|Deficit accumulated during the development stage||$||(203,732||)||$||(183,050||)|
|Total stockholders' equity||$||207,205||$||169,720|
Vice President, Investor Relations and Corporate Communications
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