Ophthotech reports net loss of $20.4 million for fourth quarter 2013
Published on February 27, 2014 at 8:11 AM
Ophthotech Corporation (Nasdaq:OPHT) today announced financial results for the fourth quarter and full year ended December 31, 2013 and provided an update on the Company's business and product development programs.
Recent Corporate Highlights
As of December 31, 2013, the Company had $210.6 million in cash and cash equivalents.
In January 2014, the Company received an additional $41.7 million from a second tranche payment under the Company's $125.0 million royalty financing agreement with Novo A/S. A potential third tranche of $41.7 million under this royalty agreement remains available based upon a further patient enrollment milestone.
In February 2014, Ophthotech completed a follow-on public offering of common stock resulting in net proceeds of approximately $55.5 million for the Company.
With the follow-on public offering complete, Ophthotech is expanding the global clinical program for its lead product candidate Fovista™ beyond its pivotal Phase 3 program in wet age-related macular degeneration (AMD) and is advancing its second product candidate Zimura™, an inhibitor of complement factor C5 (formerly known as ARC1905), in both dry AMD and wet AMD.
Fovista™ program expansion: The Company is planning clinical trials of Fovista™ in combination with anti-VEGF therapy for the treatment of anti-VEGF resistant wet AMD patients and to assess possible reduction of treatment burden in wet AMD therapy. Ophthotech also plans to initiate a clinical trial to investigate the effect of Fovista™ in potentially inhibiting the formation of subretinal fibrosis in wet AMD patients treated with anti-VEGF therapies. Studies have shown that subretinal fibrosis is associated with severe vision loss in wet AMD patients. These trials are scheduled to commence in 2014. In addition, the National Eye Institute is scheduled to conduct a clinical trial with Fovista™ in von Hippel-Lindau disease starting in 2014, and the Company is planning to initiate in 2015 a clinical trial of Fovista™ in proliferative vitreoretinopathy.
Zimura™ program: The Company is expected to advance to a Phase 2/3 clinical trial for treatment of geographic atrophy, a severe form of dry AMD, in late 2014 or early 2015. In addition, a Phase 2 clinical trial is planned for Zimura™ and Fovista™ in combination with anti-VEGF therapy for the treatment of anti-VEGF resistant wet AMD patients believed to have complement mediated inflammation. This trial is scheduled to initiate in 2015.
In late February, the Company received written confirmation from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) indicating that the CHMP and the Company are now in agreement regarding the Company's trial design and dosing regimens for the Fovista™ Phase 3 program.
"It has been a very busy and exciting time for Ophthotech following our IPO in September," said David Guyer, M.D., Chief Executive Officer of Ophthotech. "Our lead product Fovista™ being developed as a first-in-class anti-PDGF agent for wet AMD combination therapy, is on track as we continue to expect initial, topline data and an NDA filing in 2016. In addition, recent science-driven findings along with net proceeds of approximately $55.5 million from a public offering in February of this year provide us with the foundation to expand our Fovista™ and Zimura™ clinical programs to address the unmet medical needs in AMD and other ophthalmic diseases and conditions. We are extremely pleased with the progress we have made and look forward to the expansion of our programs with our plan for 10 clinical trials ongoing or initiating in 2014 and 2015 and data expected to begin in 2015."
Operating expenses for the quarter ended December 31, 2013 were $20.4 million, with $15.4 million attributable to research and development. This compares to operating expenses of $3.5 million and research and development expenses of $2.0 million for the same period in 2012. The Company reported a net loss for the quarter ended December 31, 2013 of $20.4 million, or $0.65 per share.
Operating expenses for the year ended December 31, 2013 were $47.4 million, with $33.2 million attributable to research and development. This compares to operating expenses of $13.7 million and research and development expenses of $6.8 million for 2012. The Company reported a net loss for the year ended December 31, 2013 of $57.0 million, or $6.34 per share.