Ophthotech Reports Third Quarter 2016 Financial and Operating Results
- Conference Call and Webcast Today,
The Company expects to announce initial topline data from two Phase 3
trials of Fovista® (pegpleranib) in combination with
Lucentis® (ranibizumab) for the treatment of wet
age-related macular degeneration (AMD) in this fourth quarter. A third
Phase 3 trial investigating Fovista® in combination with
either Eylea® (aflibercept) or Avastin®
(bevacizumab) completed patient recruitment in
June 2016. The Company expects initial topline data from this third Phase 3 trial to be available in the second half of 2017.
Results from Ophthotech's Phase 2b Fovista® combination
therapy study in wet AMD patients were published in
October 2016in Ophthalmology®, the journal of the American Academy of Ophthalmology. The published article, "Dual Antagonism of PDGF and VEGF in Neovascular Age-related Macular Degeneration," can be accessed online under "Articles in Press" at: http://www.aaojournal.org/inpress.
Ophthotechcontinues to enroll patients in its Phase 2/3 trial of Zimura® in patients with geographic atrophy, an advanced form of dry AMD. In addition, its Phase 2 trial evaluating the potential role of Zimura® when administered in combination with anti-VEGF drugs for the treatment of wet AMD has been activated.
"This is an exciting time for
Cash Position: As of
September 30, 2016, the Company had $321.2 millionin cash, cash equivalents, and marketable securities.
Revenues: Collaboration revenue was
$1.7 millionfor the quarter ended September 30, 2016, compared to $3.4 millionfor the prior year period. For the nine months ended September 30, 2016, collaboration revenue was $45.6 millioncompared to $46.7 millionfor the same period in 2015. Collaboration revenue was in connection with the Company's Licensing and Commercialization Agreement with Novartis Pharma AG.
R&D Expenses: Research and development expenses were
$50.9 millionfor the quarter ended September 30, 2016compared to $40.5 millionfor the same period in 2015. For the nine months ended September 30, 2016, research and development expenses were $136.9 millioncompared to $97.1 millionfor the same period in 2015. Research and development expense increased in both the quarter and nine months ended September 30, 2016primarily due to the Company's Fovista® Phase 3 clinical program, including manufacturing expenses and personnel costs which include share-based compensation expense.
G&A Expenses: General and administrative expenses were
$12.0 millionfor the quarter ended September 30, 2016compared to $10.4 millionfor the same period in 2015. For the nine months ended September 30, 2016, general and administrative expenses were $37.2 millioncompared to $32.0 millionfor the same period in 2015. The increase in general and administrative expenses in the quarter and nine months ended September 30, 2016relates primarily to an increase in costs to support the Company's expanded operations and infrastructure, which consists of additional management, corporate staffing, professional services and consulting fees, and increased share-based compensation.
Net Loss: The Company reported a net loss for the quarter ended
September 30, 2016of $60.9 million, or ( $1.71) per diluted share, compared to a net loss of $39.6 million, or ( $1.14) per diluted share, for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $127.1 million, or ( $3.59) per diluted share, compared to a net loss of $70.1 million, or ( $2.03) per diluted share, for the same period in 2015.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
Selected Financial Data (unaudited)
(in thousands, except per share data)
Three Months Ended
Nine Months Ended
|Statements of Operations Data:|
|Research and development||50,854||40,479||136,886||97,095|
|General and administrative||12,024||10,412||37,209||31,955|
|Total operating expenses||62,878||50,891||174,095||129,050|
|Loss from operations||(61,210||)||(47,443||)||(128,508||)||(82,327||)|
|Other income (loss)||(20||)||19||(88||)||46|
|Loss before income tax (benefit) provision||(60,821||)||(47,104||)||(127,295||)||(81,697||)|
|Income tax (benefit) provision||70||(7,531||)||(158||)||(11,629||)|
|Net loss per common share:|
|Basic and diluted||$||(1.71||)||$||(1.14||)||$||(3.59||)||$||(2.03||)|
|Weighted average common shares outstanding:|
|Basic and diluted||35,594||34,782||35,415||34,432|
|Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$||321,156||$||391,890|
|Royalty purchase liability||125,000||125,000|
|Additional paid-in capital||496,210||465,924|
|Total stockholders' equity (deficit)||$||(36,589||)||$||59,947|
Vice President, Investor Relations and Corporate Communications
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