– Conference Call and Webcast Today, November 8th,
at 8:00 a.m. ET –
NEW YORK–(BUSINESS WIRE)– Ophthotech Corporation (Nasdaq: OPHT) today announced financial results
for the third quarter ended September 30, 2016 and provided an update on
the Company’s business and product development programs.
-
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.
“This is an exciting time for Ophthotech as we prepare for data from two
trials of Fovista® in combination with Lucentis®
for the treatment of wet AMD,” said David R. Guyer, M.D., Chief
Executive Officer and Chairman of the Board of Ophthotech. “We look
forward to providing initial topline data in this fourth quarter.”
Financial Highlights
-
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.
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 November 8,
2016 at 8:00 a.m. Eastern Time. To participate in this conference call,
dial 888-684-1282 (USA) or 913-312-1458 (International), passcode
8738770. 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 8738770. 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 Selected Financial Data (unaudited) (in thousands, except per share data) |
|||||||||||||||||||||
Three Months Ended September 30, 2016 | Nine Months Ended September 30, 2016 | ||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||
Statements of Operations Data: | |||||||||||||||||||||
Collaboration revenue | $ | 1,668 | $ | 3,448 | $ | 45,587 | $ | 46,723 | |||||||||||||
Operating expenses: | |||||||||||||||||||||
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 | ) | |||||||||||||
Interest income | 409 | 320 | 1,301 | 584 | |||||||||||||||||
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 | $ | (60,891 | ) | $ | (39,573 | ) | $ | (127,137 | ) | $ | (70,068 | ) | |||||||||
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 | |||||||
Total assets | 350,585 | 428,851 | |||||||||
Deferred revenue | 211,768 | 213,066 | |||||||||
Royalty purchase liability | 125,000 | 125,000 | |||||||||
Total liabilities | 387,174 | 368,904 | |||||||||
Additional paid-in capital | 496,210 | 465,924 | |||||||||
Accumulated deficit | (532,676 | ) | (405,539 | ) | |||||||
Total stockholders’ equity (deficit) | $ | (36,589 | ) | $ | 59,947 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20161108005285/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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