Ophthotech Reports First Quarter 2016 Financial and Operating Results
- Conference Call and Webcast Today,
"During the first quarter, we continued to prepare for the exciting
opportunities that lie ahead in 2016," said
Initial, topline data from both pivotal Phase 3 trials of Fovista®
(pegpleranib) in combination with Lucentis® (ranibizumab)
in wet age-related macular degeneration (AMD) is expected in the
fourth quarter of this year. A third Phase 3 trial, which is
investigating Fovista® in combination with either Eylea®
(aflibercept) or Avastin® (bevacizumab), continues to
enroll patients and remains on track to complete enrollment in 2016. A
final payment of
$30 millionof the $130 millionenrollment-based milestone payments under the ex-US licensing and commercialization agreement with Novartis will be earned when the final Fovista® Phase 3 study completes enrollment.
Carmen A. Puliafito, M.D., M.B.A., one of the world's leading experts in ophthalmology and health management, was appointed Chief of Strategic Development at Ophthotech. Dr. Puliafitojoined the Company from the Keck School of Medicine of the Universityof Southern Californiawhere he most recently served as Dean, a position that he held from 2007 to 2016. Prior to USC, Dr. Puliafitoserved as Chair and Professor of the Department of Ophthalmologyat the Bascom Palmer Eye Instituteof the University of Miami Miller School of Medicine. Prior to his leadership at Bascom Palmer, he served as founding director of the New England Eye Centerand Chair and Professor of the Department of Ophthalmologyat Tufts University. Dr. Puliafitohas also been at the forefront of clinical innovation, including the introduction of Avastin® (bevacizumab) for the treatment of retinal disorders. Dr. Puliafitois on leave from his position as Professor of Ophthalmology and Health Management at the USC Roski Eye Institute.
- The Fovista® Expansion Studies are designed to further evaluate the potential of Fovista® in addressing a variety of unmet needs in wet AMD including investigating the potential role of Fovista® in combination with multiple anti-VEGF agents to reduce sub-retinal fibrosis and the potential role of Fovista® combination therapy to reduce the treatment burden for wet AMD patients. These studies are progressing well.
- During the first quarter of 2016, the first patient was dosed in a Phase 2/3 clinical trial of Zimura® (avacincaptad pegol sodium), an inhibitor of complement factor C5, in patients with geographic atrophy, an advanced form of dry AMD. The Phase 2 trial evaluating the potential role of Zimura® when administered in combination with anti-VEGF drugs for the treatment of wet AMD is on-going.
The Company had one oral presentation and two poster presentations
Association for Research in Vision and Ophthalmology(ARVO) Annual Meeting from May 1-5, 2016. Complete abstracts are available on the ARVOwebsite at: http://www.arvo.org/online_planner (Abstract 1347 - search Rezaei, Abstract 3343, Abstract 4418).
First Quarter 2016 Financial Highlights
Cash Position: As of
March 31, 2016, the Company had $356.1 millionin cash, cash equivalents, and available for sale securities.
Revenues: Collaboration revenue was
$15.7 millionfor the quarter ended March 31, 2016, compared to $41.7 millionfor the same period in 2015. Collaboration revenue recognized in the first quarter of 2015 related primarily to drug supply shipments the Company completed under the Novartis agreement. Revenue recognized in the prior year period related primarily to license fees attributable to the $50.0 millionenrollment-based milestone the Company achieved in March 2015under the same agreement. The balance of the milestone earned in the first quarter of 2015 was recorded as deferred revenue.
R&D Expenses: Research and development expenses were
$37.8 millionfor the quarter ended March 31, 2016, compared to $24.6 millionfor the same period in 2015. The increase in research and development expense in the quarter ended March 31, 2016was primarily due to the Company's Fovista® Phase 3 clinical program and Fovista® Expansion Studies, as well as increased personnel costs associated with additional management and research and development staffing, including share-based compensation expense.
G&A Expenses: General and administrative expenses were
$14.7 millionfor the quarter ended March 31, 2016compared to $9.6 millionfor the same period in 2015. The increase in general and administrative expenses in the quarter ended March 31, 2016relates primarily to an increase in costs to support the Company's expanded operations and public company infrastructure, including additional management, corporate staffing, pre-launch commercial activities, professional services and consulting fees, and increased share-based compensation.
Net Loss: The Company reported a net loss for the quarter ended
March 31, 2016of $36.3 million, or ( $1.03) per diluted share, compared to net income of $6.6 million, or $0.19per diluted share, for the same period in 2015.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
Three Months Ended
|Statements of Operations Data:|
|Research and development||37,770||24,557|
|General and administrative||14,696||9,584|
|Total operating expenses||52,466||34,141|
|Income (loss) from operations||(36,745||)||7,537|
|Other income (loss)||30||(52||)|
|Income (loss) before income tax provision||(36,269||)||7,610|
|Income tax provision||32||974|
|Net income (loss)||$||(36,301||)||$||6,636|
|Net income (loss) per common share:|
|Weighted average common shares outstanding:|
|Balance Sheets Data:|
|Cash, cash equivalents, and marketable securities||$||356,137||$||391,890|
|Royalty purchase liability||$||125,000||$||125,000|
|Additional paid-in capital||$||475,024||$||465,924|
|Total stockholders' equity||$||33,223||$||59,947|
Vice President, Investor Relations and Corporate Communications
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