- 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 2016 in 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.
- Ophthotech continues 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.
- Cash Position: As of September 30, 2016, the Company had $321.2 million in cash, cash equivalents, and marketable securities.
- Revenues: Collaboration revenue was $1.7 million for the quarter ended September 30, 2016, compared to $3.4 million for the prior year period. For the nine months ended September 30, 2016, collaboration revenue was $45.6 million compared to $46.7 million for 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 million for the quarter ended September 30, 2016 compared to $40.5 million for the same period in 2015. For the nine months ended September 30, 2016, research and development expenses were $136.9 million compared to $97.1 million for the same period in 2015. Research and development expense increased in both the quarter and nine months ended September 30, 2016 primarily 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 million for the quarter ended September 30, 2016 compared to $10.4 million for the same period in 2015. For the nine months ended September 30, 2016, general and administrative expenses were $37.2 million compared to $32.0 million for the same period in 2015. The increase in general and administrative expenses in the quarter and nine months ended September 30, 2016 relates 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, 2016 of $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 ($2.03) per diluted share, for the same period in 2015.
|Ophthotech Corporation Selected Financial Data (unaudited) (in thousands, except per share data)|
|Three Months Ended September 30, 2016||Nine Months Ended September 30, 2016|
|Statements of Operations Data:|
|Research and development||50,854||40,479||136,886||97,095|
|General and administrative||12,024||10,412||37,209||31,955|
|Total operating expenses||62,878||50,891||174,095||129,050|
|Loss from operations||(61,210||)||(47,443||)||(128,508||)||(82,327||)|
|Other income (loss)||(20||)||19||(88||)||46|
|Loss before income tax (benefit) provision||(60,821||)||(47,104||)||(127,295||)||(81,697||)|
|Income tax (benefit) provision||70||(7,531||)||(158||)||(11,629||)|
|Net loss per common share:|
|Basic and diluted||$||(1.71||)||$||(1.14||)||$||(3.59||)||$||(2.03||)|
|Weighted average common shares outstanding:|
|Basic and diluted||35,594||34,782||35,415||34,432|
|September 30, 2016||December 31, 2015|
|Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$||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|