Ophthotech Reports First Quarter 2015 Financial and Operating Results
- Conference Call and Webcast Today,
Recent Highlights
-
As announced today,
Ophthotech has completed patient recruitment in the Company's first Phase 3 trial of Fovista® in combination with Lucentis® (ranibizumab) in wet Age-Related Macular Degeneration (AMD). In addition to announcing this achievement, the Company also provided information pertaining to the overall Fovista® Phase 3 program including additional recruitment timelines. These announcements will be discussed during today's conference call/webcast (see press release issued earlier today and call in details below). -
In
March 2015 ,Ophthotech achieved a second $50 million enrollment milestone from Novartis Pharma AG related to the$130 million total potential enrollment-based milestones under its ex-US licensing and commercialization agreement with Novartis entered into inMay 2014 . Payment on this milestone was received inApril 2015 and was triggered upon Ophthotech reaching the second enrollment goal in its pivotal Fovista® Phase 3 clinical program. -
Ophthotech has expanded the clinical program for Fovista® beyond its pivotal Phase 3 program in wet AMD, and is advancing its second product candidate Zimura®, an inhibitor of complement factor C5, in both dry AMD and wet AMD.
-
Fovista® Expansion
Program:
- Ophthotech's study investigating the potential of Fovista® in combination with anti-VEGF therapy in reducing subretinal fibrosis in wet AMD patients continues to enroll well.
- During the first quarter of 2015, the Company dosed the first patient in its treatment burden reduction program which is investigating the potential of Fovista® combination therapy in reducing the treatment frequency associated with anti-VEGF monotherapy in wet AMD patients.
-
Ophthotech has initiated the planning process for a Fovista® combination therapy trial in anti-VEGF monotherapy resistant (failure) patients with wet AMD, which is expected to commence this year.
-
Zimura® Program:
During the first quarter of 2015,
Ophthotech dosed the first patient in a clinical trial of Zimura® in combination with anti-VEGF therapy for patients with polypoidal choroidal vasculopathy, a variant of wet AMD. The Company expects to advance Zimura® to a Phase 2/3 clinical trial for treatment of geographic atrophy, a form of dry AMD, in the second half of 2015.
"We remain focused on the execution of our ongoing Fovista®
Phase 3 program, which is highlighted by our successful completion of
patient recruitment of the first Phase 3 trial of Fovista® in
combination with Lucentis®," said
Management Appointments
During the first quarter of 2015,
Financial Results
-
As of
March 31, 2015 , the Company had$433.3 million in cash, cash equivalents, and marketable securities. -
Collaboration revenue was
$41.7 million for the quarter endedMarch 31, 2015 and primarily related to the$50.0 million enrollment-based milestone that was achieved under Ophthotech's agreement with Novartis. The balance of the milestone was recorded as deferred revenue. The Company did not have any collaboration revenue in the comparable period in 2014. -
Research and development expenses were
$24.6 million for the quarter endedMarch 31, 2015 compared to$14.4 million for the same period in 2014. The increase in research and development expense in the quarter endedMarch 31, 2015 relates primarily to the Company's Fovista® Phase 3 clinical program. -
General and administrative expenses were
$9.6 million for the quarter endedMarch 31, 2015 compared to$6.3 million for the same period in 2014. The increase in general and administrative expense in the quarterMarch 31, 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. -
The Company reported net income for the quarter ended
March 31, 2015 of$7.6 million , or$0.22 per diluted share, compared to a net loss of$20.7 million , or ($0.64 ) per diluted share for the same period in 2014.
Conference Call/Web Cast Information
About
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
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Selected Financial Data (unaudited) | ||||||||||||||
(in thousands, except per share data) | ||||||||||||||
Three Months Ended
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2015 | 2014 | |||||||||||||
Statement of Operations Data: | ||||||||||||||
Collaboration Revenue | $ | 41,678 | $ | - | ||||||||||
Costs and expenses: | ||||||||||||||
Research and development | 24,557 | 14,377 | ||||||||||||
General and administrative | 9,584 | 6,349 | ||||||||||||
Total costs and expenses | 34,141 | 20,726 | ||||||||||||
Income (loss) from operations | 7,537 | (20,726 | ) | |||||||||||
Interest income | 73 | 44 | ||||||||||||
Income (loss) before income tax provision | 7,610 | (20,682 | ) | |||||||||||
Income tax provision | - | - | ||||||||||||
Net income (loss) | $ | 7,610 | $ | (20,682 | ) | |||||||||
Net income (loss) per common share : | ||||||||||||||
Basic | $ | 0.22 | $ | (0.64 | ) | |||||||||
Diluted | $ | 0.22 | $ | (0.64 | ) | |||||||||
Weighted average common shares outstanding: | ||||||||||||||
Basic | 34,154 | 32,282 | ||||||||||||
Diluted | 35,239 | 32,282 | ||||||||||||
March 31, 2015 |
December 31, 2014 |
|||||||||||||
(in thousands) | ||||||||||||||
Balance sheet data: | ||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 433,286 | $ | 463,560 | ||||||||||
Due from |
$ | 50,249 | $ | 960 | ||||||||||
Total assets | $ | 517,425 | $ | 498,370 | ||||||||||
Royalty purchase liability | $ | 125,000 | $ | 125,000 | ||||||||||
Deferred revenue | $ | 217,946 | $ | 209,624 | ||||||||||
Total liabilities | $ | 355,832 | $ | 351,249 | ||||||||||
Additional paid-in capital | $ | 435,204 | $ | 428,390 | ||||||||||
Accumulated deficit | $ | (273,628 | ) | $ | (281,238 | ) | ||||||||
Total stockholders' equity | $ | 161,593 | $ | 147,121 | ||||||||||
Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
chris.vancheri@smithsolve.com
Source:
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