Ophthotech Reports First Quarter 2018 Financial and Operating Results
(Conference Call and Webcast Today,
“We continue to build on our Zimura program with on-going clinical
trials in wet age related macular degeneration (AMD) with patient
recruitment completed and topline data expected by the end of 2018, in
geographic atrophy secondary to dry AMD where recruitment is on-track
for topline data in the second half of 2019 and in autosomal recessive
Stargardt disease which began enrolling patients earlier in the year,”
Recent Key Highlights
Zimura® Complement Factor C5 Inhibitor Program
April 2018, the Company completed patient recruitment in its dose-ranging, open-label, multi-center Phase 2a clinical trial of Zimura® (avacincaptad pegol) in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis® (ranibizumab) in patients with wet age-related macular degeneration (AMD) who have not been previously treated with any anti-VEGF agents. This uncontrolled trial is designed to assess safety at different dosages and to detect a potential efficacy signal. The Company will evaluate data at month six.
- The Company’s ongoing Zimura clinical trial for the treatment of geographic atrophy secondary to dry AMD is on track for initial top-line data to be available during the second half of 2019.
January 2018, the first patient was enrolled in the Company’s Phase 2b randomized, double-masked, sham-controlled clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1). Initial top-line data is expected to be available in 2020.
Scientific details for two of the Company’s ongoing Zimura clinical
trials were presented at medical conferences:
The scientific details of the geographic atrophy secondary to dry
AMD clinical trial were presented at the 41st Annual
Macula Society Meeting in
Beverly Hills, California, February 21-24, 2018.
The scientific details of the STGD1 clinical trial were presented
at the 2018 Annual Meeting of the
Association for Research in Vision and Ophthalmologyin Honolulu, Hawaii, April 29-May 3, 2018and at the International Symposium on Ocular Pharmacology and Therapeutics in Tel-Aviv, Israel, March 1-3, 2018.
- The scientific details of the geographic atrophy secondary to dry AMD clinical trial were presented at the 41st Annual Macula Society Meeting in
Gene Therapy Program
February 2018, the Company initiated an innovative gene therapy program focused on applying novel gene therapy technology to discover and develop new therapies for ocular diseases.
February 2018, the Company announced its first gene therapy collaboration, as it entered into a series of sponsored research agreements with the University of Massachusetts Medical School(UMMS) and its Horae Gene Therapy Centerto utilize their “minigene” therapy approach and other novel gene delivery methods to target retinal diseases. UMMS has granted Ophthotechan option to obtain an exclusive license to any patent or patent applications that result from this research.
2018 Operational Update
The Company’s estimates its year end 2018 cash and cash equivalents will
First Quarter 2018 Financial Highlights
- Revenues: Collaboration revenue was $0 for the quarter ended
March 31, 2018, compared to $1.7 millionfor the same period in 2017. Collaboration revenue decreased due to the completion of the Company’s licensing and commercialization agreement with Novartis Pharma AGand the recognition of all associated deferred revenue during the third quarter of 2017.
- R&D Expenses: Research and development expenses were
$7.7 millionfor the quarter ended March 31, 2018, compared to $32 millionfor the same period in 2017. As the Company pursues its ongoing and planned Zimura development programs, research and development expenses decreased primarily due to decreases in expenses related to the discontinuation of the Company’s FovistaPhase 3 clinical program and decreases in costs associated with the Company’s 2017 reduction in personnel program.
- G&A Expenses: General and administrative expenses were
$5.6 millionfor the quarter ended March 31, 2018, compared to $13.2 millionfor the same period in 2017. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure and decreases in costs associated with its 2017 reduction in personnel program, which included facilities lease termination expenses incurred during the first quarter of 2017.
- Net Loss: The Company reported a net loss for the quarter ended
March 31, 2018of $13.1 million, or ($.36)per diluted share, compared to a net loss of $43.1 million, or ($1.20)per diluted share, for the same period in 2017.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech’s future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech’s strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
|Three Months Ended March 31,|
|Statements of Operations Data:|
|Research and development||7,686||31,979|
|General and administrative||5,645||13,159|
|Total operating expenses||13,331||45,138|
|Loss from operations||(13,331||)||(43,476||)|
|Loss before income tax provision||(12,874||)||(43,119||)|
|Income tax provision||199||3|
|Net loss per common share:|
|Basic and diluted||$||(0.36||)||$||(1.20||)|
|Weighted average common shares outstanding:|
|Basic and diluted||36,153||35,804|
|March 31, 2018||December 31, 2017|
|Balance Sheets Data:|
|Cash, cash equivalents, and marketable securities||$||154,911||$||166,972|
|Royalty purchase liability||125,000||125,000|
|Additional paid-in capital||525,868||522,759|
|Total stockholders' equity||$||28,077||$||38,041|
Kathy Galante, 212-845-8231
Vice President, Investor Relations and Corporate Communications
SmithSolve LLC on behalf of Ophthotech Corporation
Alex Van Rees, 973-442-1555 ext. 111