Ophthotech Reports Fourth Quarter and Full Year 2014 Financial and Operating Results
- Conference Call and Webcast Today,
Product Pipeline Highlights
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Ophthotech is on track with respect to the execution of its pivotal Fovista® Phase 3 program, evaluating the safety and efficacy of Fovista® administered in combination with anti-vascular endothelial growth factor (anti-VEGF) therapy for the treatment of wet age-related macular degeneration (AMD). The Company expects to have initial, top-line data from the Phase 3 program available in 2016. -
Ophthotech has expanded the clinical program for its lead product candidate Fovista® beyond its pivotal Phase 3 program in wet AMD, and is advancing its second product candidate ZimuraTM, an inhibitor of complement factor C5, in both dry AMD and wet AMD.-
Fovista®
Expansion Program
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Ophthotech commenced a study inAugust 2014 investigating the potential of Fovista® in combination with anti-VEGF therapy in reducing subretinal fibrosis in wet AMD patients. - The Company recently initiated its treatment burden reduction program to investigate the potential of Fovista® combination therapy in reducing the treatment frequency associated with anti-VEGF monotherapy in wet AMD patients.
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Ophthotech has initiated the planning process for a Fovista® combination therapy trial in monotherapy anti-VEGF resistant (failure) patients with wet AMD, which is expected to commence this year.
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Zimura™
Program:
Ophthotech has initiated a clinical trial of Zimura™ 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.
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Fovista®
Expansion Program
Research and Licensing Highlights
In
Recent Corporate Highlights
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In
October 2014 ,Ophthotech received an initial $50 million enrollment-based milestone payment from Novartis Pharma AG related to the potential$130 million total enrollment-based milestones under its ex-US licensing and commercialization agreement with Novartis entered into inMay 2014 .
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In
November 2014 ,Ophthotech achieved the final enrollment-based milestone related to the Phase 3 Fovista® program under the terms of the Company's$125 million royalty financing agreement with Novo A/S entered into inMay 2013 . Achievement of this milestone triggered a payment of$41.7 million toOphthotech . The funding of this final tranche resulted in an additional royalty interest to Novo A/S based on worldwide Fovista® sales. -
In
December 2014 ,Ophthotech was selected for addition to the NASDAQ Biotechnology Index, designed to track the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The listing went into effect onDecember 22, 2014 .
"Last year was truly a transformative one for Ophthotech," said
Financial Results
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As of
December 31, 2014 , the Company had$463.6 million in cash, cash equivalents, and marketable securities. -
Collaboration revenue under the Company's agreement with Novartis was
$1.7 million and$41.3 million for the quarter and year endedDecember 31, 2014 . The Company did not have revenue during the comparable periods in 2013. -
Research and development expenses were
$22.2 million for the quarter endedDecember 31, 2014 compared to$15.4 million for the same period in 2013. Research and development expenses were$88.4 million for the year endedDecember 31, 2014 compared to$33.2 million for the same period in 2013. The increase in research and development expense in the quarter and year endedDecember 31, 2014 relates primarily to the Company's Fovista® Phase 3 clinical program. -
General and administrative expenses were
$10.7 million for the quarter endedDecember 31, 2014 compared to$5.1 million for the same period in 2013. General and administrative expenses were$33.4 million for the year endedDecember 31, 2014 compared to$14.2 million for the same period in 2013. The increased general and administrative expense in the quarter and year endedDecember 31, 2014 relates primarily to an increase in costs to support the expanded operations and our public company infrastructure, including additional management, corporate staffing, professional services and consulting fees, and increased share-based compensation. -
The Company reported a net loss for the quarter ended
December 31, 2014 of$35.9 million , or ($1.06 ) per diluted share, compared to a net loss of$20.4 million , or ($0.65 ) per diluted share for the same period in 2013. The Company reported a net loss for the year endedDecember 31, 2014 of$98.2 million , or ($2.95 ) per diluted share, compared to a net loss of$57.0 million , or ($6.34 ) per diluted share for the same period in 2013.
About the Fovista® Phase 3 Program
The Fovista® Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista®
(anti-PDGF) therapy, which
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 |
Years Ended |
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2014 | 2013 | 2014 | 2013 | |||||||||||||
Statement of operations data: | ||||||||||||||||
Collaboration revenue | $ | 1,684 | $ | - | $ | 41,259 | $ | - | ||||||||
Costs and expenses: | ||||||||||||||||
Research and development | 22,196 | 15,379 | 88,385 | 33,215 | ||||||||||||
General and administrative | 10,656 | 5,065 | 33,387 | 14,210 | ||||||||||||
Total costs and expenses | 32,852 | 20,444 | 121,772 | 47,425 | ||||||||||||
Loss from operations | (31,168 | ) | (20,444 | ) | (80,513 | ) | (47,425 | ) | ||||||||
Interest income (expense) | 28 | - | 217 | (1,454 | ) | |||||||||||
Loss on extinguishment of debt | - | - | - | (1,091 | ) | |||||||||||
Other gain (loss) | - | 56 | - | (1,175 | ) | |||||||||||
Loss before income tax provision | (31,140 | ) | (20,388 | ) | (80,296 | ) | (51,145 | ) | ||||||||
Income tax provision | 4,731 | - | 17,892 | - | ||||||||||||
Net loss | (35,871 | ) | (20,388 | ) | (98,188 | ) | (51,145 | ) | ||||||||
Add: accretion of preferred stock dividends | - | - | - | (5,891 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (35,871 | ) | $ | (20,388 | ) | $ | (98,188 | ) | $ | (57,036 | ) | ||||
Net loss attributable to common stockholders per share : | ||||||||||||||||
Basic and diluted | $ | (1.06 | ) | $ | (0.65 | ) | $ | (2.95 | ) | $ | (6.34 | ) | ||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic and diluted | 33,803 | 31,355 | 33,258 | 9,003 | ||||||||||||
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(in thousands) | ||||||||||||||||
Balance sheet data: | ||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 463,560 | $ | 210,596 | ||||||||||||
Due from |
$ | 960 | $ | - | ||||||||||||
Total assets | $ | 498,370 | $ | 217,682 | ||||||||||||
Royalty purchase liability | $ | 125,000 | $ | 41,667 | ||||||||||||
Deferred revenue | $ | 209,624 | $ | - | ||||||||||||
Total liabilities | $ | 351,249 | $ | 47,962 | ||||||||||||
Additional paid-in capital | $ | 428,390 | $ | 352,739 | ||||||||||||
Accumulated deficit | $ | (281,238 | ) | $ | (183,050 | ) | ||||||||||
Total stockholders' equity | $ | 147,121 | $ | 169,720 |
Investors
Vice
President, Investor Relations and Corporate Communications
212-845-8231
kathy.galante@ophthotech.com
or
Media
973-442-1555
ext. 112
jarrod.aldom@smithsolve.com
Source:
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