- Conference Call and Webcast Today, November
8th, at 8:00 a.m. ET -
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 CorporationSelected 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
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version on businesswire.com: http://www.businesswire.com/news/home/20161108005285/en/
InvestorsOphthotech CorporationKathy Galante,
212-845-8231Vice President, Investor Relations and Corporate
Communicationskathy.galante@ophthotech.comorMediaSmithSolve
LLC on behalf of Ophthotech CorporationJennifer Devine,
973-442-1555 ext. 102jennifer.devine@smithsolve.com
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