Ophthotech Reports Third Quarter 2015 Financial and Operating Results
– Conference Call and Webcast Today, November 5, 2015, 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, 2015 and provided an update on
the Company’s business and product development programs.
“We have achieved many significant milestones that have us on track to
reach our goal to provide initial, topline data from both Phase 3 trials
of Fovista® in combination with Lucentis in the fourth
quarter of 2016,” said David R. Guyer, M.D., Chief Executive Officer and
Chairman of the Board of Ophthotech.
Ophthotech Highlights
-
In October 2015, Ophthotech announced the completion of patient
recruitment in its second Phase 3 trial of Fovista®
(pegpleranib) in combination with Lucentis® (ranibizumab)
for the treatment of wet age-related macular degeneration (AMD). The
Company expects to announce initial, topline data from both Phase 3
trials of Fovista® in combination with Lucentis®
in the fourth quarter of 2016. A third Phase 3 trial, which is
investigating Fovista® in combination with either Eylea®
(aflibercept) or Avastin® (bevacizumab), continues to
enroll patients and is on track. -
Recruitment has been completed in two of the Fovista®
Expansion Studies. These trials are investigating the optimal regimen
for Fovista® administration in combination with multiple
anti-VEGF agents to potentially reduce sub-retinal fibrosis and
treatment burden in wet AMD patients. Both trials are ongoing and
progressing well.
“This is an exciting time for Ophthotech as we approach the end of
2015,” stated Samir Patel, M.D., President and Vice-Chairman of the
Board of Ophthotech. “We continue to make excellent progress on our
Fovista® expansion studies and, in particular, in our
anti-fibrosis program with respect to which we look forward to reporting
interim data by the end of the year. Additionally, our plans to initiate
a Phase 2/3 dry AMD program with Zimura® by the end of the
year continue to be on track.”
Third Quarter Financial Highlights
-
Cash Position: As of September 30, 2015, the Company had $426.0
million in cash, cash equivalents, and marketable securities. -
Revenues: Collaboration revenue was $3.4 million for the
quarter ended September 30, 2015, compared to $39.6 million for the
prior year period. For the nine months ended September 30, 2015,
collaboration revenue was $46.7 million compared to $39.6 million for
the same period in 2014. Collaboration revenue recognized in 2015 and
2014 consists of license fee revenue primarily attributable to the
$50.0 million enrollment-based milestones the Company achieved in
March 2015 and September 2014 under the Company’s Licensing and
Commercialization Agreement with Novartis Pharma AG, as well as
revenue associated with research and development activities the
Company performs under the same agreement. -
R&D Expenses: Research and development expenses were $40.5
million for the quarter ended September 30, 2015 compared to $17.1
million for the same period in 2014. For the nine months ended
September 30, 2015 research and development expenses were $97.1
million compared to $66.2 million for the same period in 2014. The
nine months ended September 30, 2014 included a $19.8 million
milestone payment the Company paid in connection with entering into
the agreement with Novartis. Excluding this milestone payment,
research and development expense increased in both the quarter and
nine months ended September 30, 2015 primarily due to the Company’s
Fovista® Phase 3 clinical program and 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
$10.4 million for the quarter ended September 30, 2015 compared to
$8.8 million for the same period in 2014. For the nine months ended
September 30, 2015, general and administrative expenses were $32.0
million compared to $22.7 million for the same period in 2014. The
increase in general and administrative expenses in the quarter and
nine months ended September 30, 2015 relates primarily to an increase
in costs to support the Company’s expanded operations and public
company infrastructure, including 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, 2015 of $39.6 million, or ($1.14) per diluted share.
During September 2014, the Company achieved a $50.0 million
enrollment-based milestone under Ophthotech’s agreement with Novartis
which resulted in the Company recording net income of $8.6 million, or
$0.25 per diluted share for the quarter ended September 30, 2014.
Conference Call/Web Cast Information
Ophthotech will host a conference call/audio webcast to discuss this
announcement. The call is scheduled for November 5, 2015 at 8:00 a.m.
Eastern Time. To participate in this conference call, dial 888-539-3678
(USA) or 719-457-2661 (International), passcode 270112. 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 270112. 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. 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 and
Fovista® expansion studies, including the
timing of completion of enrollment for these trials, the timing of
obtaining initial, topline data or interim data from these trials, the
timing of seeking marketing approval for Fovista®, the
potential of Fovista® as a wet AMD combination
therapy, and the initiation of additional trials for Fovista® and
Zimura®. 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 |
Nine Months Ended |
||||||||||||||||||||||||||||||||
2015 |
2014 |
2015 | 2014 | ||||||||||||||||||||||||||||||
Statement of Operations Data: | |||||||||||||||||||||||||||||||||
Collaboration revenue | $ | 3,448 | $ | 39,575 | $ | 46,723 | $ | 39,575 | |||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||
Research and development | 40,479 | 17,105 | 97,095 | 66,189 | |||||||||||||||||||||||||||||
General and administrative | 10,412 | 8,812 | 31,955 | 22,731 | |||||||||||||||||||||||||||||
Total operating expenses |
50,891 |
25,917 | 129,050 | 88,920 | |||||||||||||||||||||||||||||
Income (loss) from operations | (47,443 | ) | 13,658 | (82,327 | ) | (49,345 | ) | ||||||||||||||||||||||||||
Interest income and other | 339 | 73 | 630 | 189 | |||||||||||||||||||||||||||||
Income (loss) before income tax provision | (47,104 | ) | 13,731 | (81,697 | ) | (49,156 | ) | ||||||||||||||||||||||||||
Income tax (benefit) provision | (7,531 | ) | 5,179 | (11,629 | ) | 35,964 | |||||||||||||||||||||||||||
Net income (loss) | $ | (39,573 | ) | $ | 8,552 | $ | (70,068 | ) | $ | (85,120 | ) | ||||||||||||||||||||||
Net income (loss) per common share: | |||||||||||||||||||||||||||||||||
Basic | $ | (1.14 | ) | $ |
0.26 |
|
$ | (2.03 | ) | $ | (2.57 | ) | |||||||||||||||||||||
Diluted | $ | (1.14 | ) | $ | 0.25 | $ | (2.03 | ) | $ | (2.57 | ) | ||||||||||||||||||||||
Weighted average common shares outstanding: | |||||||||||||||||||||||||||||||||
Basic | 34,782 | 33,531 | 34,432 | 33,074 | |||||||||||||||||||||||||||||
Diluted | 34,782 | 34,859 | 34,432 | 33,074 | |||||||||||||||||||||||||||||
September |
December |
||||||||||||||||||||||||||||||||
(in thousands) | |||||||||||||||||||||||||||||||||
Balance sheet data: | |||||||||||||||||||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 425,986 | $ | 463,560 | |||||||||||||||||||||||||||||
Total assets | $ | 450,751 | $ | 479,786 | |||||||||||||||||||||||||||||
Royalty purchase liability | $ | 125,000 | $ | 125,000 | |||||||||||||||||||||||||||||
Deferred revenue | $ | 214,710 | $ | 209,624 | |||||||||||||||||||||||||||||
Total liabilities | $ | 367,640 | $ | 351,249 | |||||||||||||||||||||||||||||
Additional paid-in capital | $ | 452,887 | $ | 428,390 | |||||||||||||||||||||||||||||
Accumulated deficit | $ | (369,890 | ) | $ | (299,822 | ) | |||||||||||||||||||||||||||
Total stockholders’ equity | $ | 83,111 | $ | 128,537 | |||||||||||||||||||||||||||||
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
jennifer.devine@smithsolve.com