– Conference Call and Webcast Today, May 4th,
at 8:00 a.m. ET –
NEW YORK–(BUSINESS WIRE)– Ophthotech Corporation (Nasdaq:OPHT) today announced financial results
for the first quarter ended March 31, 2016 and provided an update on the
Company’s business and product development programs.
“During the first quarter, we continued to prepare for the exciting
opportunities that lie ahead in 2016,” said David R. Guyer, M.D., Chief
Executive Officer and Chairman of the Board of Ophthotech. “We look
forward to providing initial, topline data from our two pivotal Phase 3
trials of Fovista® in combination with Lucentis®
in the fourth quarter of this year, completing patient recruitment of
the Phase 3 Fovista® in combination with Eylea® or
Avastin® trial, continuing progress in our Fovista®
Expansion Studies, and advancing our Zimura® programs.
Recently, we had the privilege of welcoming Dr. Carmen Puliafito as
Chief of Strategic Development to Ophthotech. As one of the world’s
leading experts in ophthalmology and health management, we are delighted
to have Carmen join our company during this exciting period for
Ophthotech.”
Highlights
-
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 million of the $130 million enrollment-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. -
In April, 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. Puliafito joined the
Company from the Keck School of Medicine of the University of Southern
California where he most recently served as Dean, a position that he
held from 2007 to 2016. Prior to USC, Dr. Puliafito served as Chair
and Professor of the Department of Ophthalmology at the Bascom Palmer
Eye Institute of 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 Center and Chair and Professor of the
Department of Ophthalmology at Tufts University. Dr. Puliafito has
also been at the forefront of clinical innovation, including the
introduction of Avastin® (bevacizumab) for the treatment of
retinal disorders. Dr. Puliafito is 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
during the Association for Research in Vision and Ophthalmology (ARVO)
Annual Meeting from May 1-5, 2016. Complete abstracts are available on
the ARVO website 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
million in cash, cash equivalents, and available for sale securities. -
Revenues: Collaboration revenue was $15.7 million for the
quarter ended March 31, 2016, compared to $41.7 million for 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 million enrollment-based milestone the Company achieved in
March 2015 under 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
million for the quarter ended March 31, 2016, compared to $24.6
million for the same period in 2015. The increase in research and
development expense in the quarter ended March 31, 2016 was 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 million for the quarter ended March 31, 2016 compared to $9.6
million for the same period in 2015. The increase in general and
administrative expenses in the quarter ended March 31, 2016 relates
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, 2016 of $36.3 million, or ($1.03) per diluted share,
compared to net income of $6.6 million, or $0.19 per diluted share,
for the same period in 2015.
Conference Call/Web Cast Information
Ophthotech will host a conference call/audio web cast to discuss the
Company’s financial and operating results, its development programs and
provide a general business update. The call is scheduled for May 4, 2016
at 8:00 a.m. Eastern Time. To participate in this conference call, dial
888-359-3624 (USA) or 719-785-1765 (International), passcode 2126947. A
live, listen-only audio webcast of the conference call can be accessed
on the Investor Relations section of the Ophthotech website at: www.ophthotech.com.
A replay will be available approximately two hours following the live
call for two weeks. The replay number is (888) 203-1112 (USA Toll Free),
passcode 2126947. The audio webcast can be accessed at: www.ophthotech.com.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics to treat back of the eye diseases,
with a focus on developing innovative therapies for age-related macular
degeneration (AMD). Ophthotech’s most advanced product candidate, Fovista®
anti-PDGF therapy, is in Phase 3 clinical trials for use in combination
with anti-VEGF therapy that represents the current standard of care for
the treatment of wet AMD. Ophthotech’s second product candidate, Zimura®,
an inhibitor of complement factor C5, is being developed for the
treatment of geographic atrophy, a form of dry AMD, and in combination
with anti-VEGF therapy in wet AMD patients. For more information, please
visit www.ophthotech.com.
Forward-looking Statements
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 Ophthotech, and any other
statements containing the words “anticipate,” “believe,” “estimate,”
“expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions. In this press release, Ophthotech’s
forward looking statements include statements about the timing and
progress of the Fovista® Phase 3 clinical
program, the Fovista® Expansion Studies, and
Ophthotech’s Zimura® development programs for
geographic atrophy and, in combination with anti-VEGF drugs, for wet
AMD. Such forward-looking statements involve substantial risks and
uncertainties that could cause Ophthotech’s clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, those
related to the initiation and conduct of clinical trials, availability
of data from clinical trials and expectations for regulatory approvals
or other actions and other factors discussed in the “Risk Factors”
section contained in the quarterly and annual reports that Ophthotech
files with the SEC. Any forward-looking statements represent
Ophthotech’s views only as of the date of this press release. Ophthotech
anticipates that subsequent events and developments will cause its views
to change. While Ophthotech may elect to update these forward-looking
statements at some point in the future, Ophthotech specifically
disclaims any obligation to do so except as required by law.
OPHT-G
Ophthotech Corporation |
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Selected Financial Data (unaudited) | ||||||||||
(in thousands, except per share data) | ||||||||||
Three Months Ended March 31, |
||||||||||
2016 | 2015 | |||||||||
Statements of Operations Data: | ||||||||||
Collaboration revenue | $ | 15,721 | $ | 41,678 | ||||||
Operating expenses: | ||||||||||
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 | |||||||
Interest income | 446 | 125 | ||||||||
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: | ||||||||||
Basic | $ | (1.03 | ) | $ | 0.19 | |||||
Diluted | $ | (1.03 | ) | $ | 0.19 | |||||
Weighted average common shares outstanding: | ||||||||||
Basic | 35,256 | 34,154 | ||||||||
Diluted | 35,256 | 35,239 | ||||||||
March 31, 2016 | December 31, 2015 | |||||||||
Balance Sheets Data: | ||||||||||
Cash, cash equivalents, and marketable securities | $ | 356,137 | $ | 391,890 | ||||||
Total assets | $ | 398,845 | $ | 428,851 | ||||||
Deferred revenue | $ | 211,608 | $ | 213,066 | ||||||
Royalty purchase liability | $ | 125,000 | $ | 125,000 | ||||||
Total liabilities | $ | 365,622 | $ | 368,904 | ||||||
Additional paid-in capital | $ | 475,024 | $ | 465,924 | ||||||
Accumulated deficit | $ | (441,840 | ) | $ | (405,539 | ) | ||||
Total stockholders’ equity | $ | 33,223 | $ | 59,947 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160504005404/en/
Contacts
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
SmithSolve
LLC on behalf of Ophthotech Corporation
Jennifer Devine,
973-442-1555 ext. 102
jennifer.devine@smithsolve.com
Source: Ophthotech Corporation
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