Ophthotech Reports First Quarter 2015 Financial and Operating Results
- Conference Call and Webcast Today,
As announced today,
Ophthotechhas 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).
March 2015, Ophthotechachieved a second $50 million enrollment milestone from Novartis Pharma AG related to the $130 milliontotal potential enrollment-based milestones under its ex-US licensing and commercialization agreement with Novartis entered into in May 2014. Payment on this milestone was received in April 2015and was triggered upon Ophthotech reaching the second enrollment goal in its pivotal Fovista® Phase 3 clinical program.
Ophthotechhas 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.
- 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.
Ophthotechhas 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.
During the first quarter of 2015,
Ophthotechdosed 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
During the first quarter of 2015,
March 31, 2015, the Company had $433.3 millionin cash, cash equivalents, and marketable securities.
Collaboration revenue was
$41.7 millionfor the quarter ended March 31, 2015and primarily related to the $50.0 millionenrollment-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 millionfor the quarter ended March 31, 2015compared to $14.4 millionfor the same period in 2014. The increase in research and development expense in the quarter ended March 31, 2015relates primarily to the Company's Fovista® Phase 3 clinical program.
General and administrative expenses were
$9.6 millionfor the quarter ended March 31, 2015compared to $6.3 millionfor the same period in 2014. The increase in general and administrative expense in the quarter March 31, 2015relates 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, 2015of $7.6 million, or $0.22per diluted share, compared to a net loss of $20.7 million, or ( $0.64) per diluted share for the same period in 2014.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
Three Months Ended
|Statement of Operations Data:|
|Costs and expenses:|
|Research and development||24,557||14,377|
|General and administrative||9,584||6,349|
|Total costs and expenses||34,141||20,726|
|Income (loss) from operations||7,537||(20,726||)|
|Income (loss) before income tax provision||7,610||(20,682||)|
|Income tax provision||-||-|
|Net income (loss)||$||7,610||$||(20,682||)|
|Net income (loss) per common share :|
|Weighted average common shares outstanding:|
|Balance sheet data:|
|Cash, cash equivalents, and marketable securities||$||433,286||$||463,560|
|Royalty purchase liability||$||125,000||$||125,000|
|Additional paid-in capital||$||435,204||$||428,390|
|Total stockholders' equity||$||161,593||$||147,121|
Vice President, Investor Relations and Corporate Communications
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