Ophthotech Reports Third Quarter 2018 Financial and Operating Results
- Conference Call and Webcast to Discuss Q3 2018 Results and Two Pipeline Deals Announced Today -
The following announcements will be discussed during today’s conference call/webcast (see full detailed press releases issued earlier today and call in information below).
As announced today,
Ophthotechhas acquired Inception 4, Inc., a privately held company backed by Versant Ventures, expanding Ophthotech’s therapeutic pipeline in age-related retinal indications. Through this acquisition, Ophthotechgains worldwide development and commercialization rights to Inception 4’s small molecule inhibitors of HtrA1 (high temperature requirement A serine peptidase 1 protein). As a major new investor with substantial geographic reach, Versant Ventureshas agreed to help Ophthotechidentify exceptional opportunities to expand the pipeline. As a result of the closing of the acquisition, Ophthotechobtained approximately $6.1 millionin cash through Inception 4. As upfront consideration in the transaction, Ophthotechagreed to issue approximately 5.2 million shares to the shareholders of Inception 4. After giving effect to the transaction, Versant Ventures, through its affiliated investment funds, owns approximately 12.5% of the outstanding shares of Ophthotech’s common stock. In addition, Inception 4 equity holders will be entitled to receive post-closing payments upon the achievement of certain clinical and marketing approval milestones in certain AMD indications. Ophthotechalso announced today that it expanded its gene therapy pipeline with a novel product candidate to treat Best vitelliform macular dystrophy, also known as Best disease. The Company entered into its second series of gene therapy agreements with the University of Pennsylvaniaand the University of Florida, including an exclusive option agreement for rights to negotiate to acquire an exclusive global license to develop and commercialize novel adeno-associated virus (AAV) gene therapy product candidates for the treatment of Best disease.
Therapeutic Program Highlights
Complement Factor C5 Inhibitor Program: Zimura®
- Wet Age-related Macular Degeneration: The Company
expects initial top-line data by the end of this year from its
randomized, dose-ranging, open-label, uncontrolled, 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 AMD who have not been previously treated with anti-VEGF therapies.
This trial is designed to assess the safety of Zimura combination
therapy at different dosages and to detect a potential efficacy signal
at month six. The Company completed patient recruitment for this trial
- Geographic Atrophy, an Advanced Form of Dry Age-related Macular
October 2018, the Company completed patient enrollment for its ongoing randomized, double-masked, sham controlled, multi-center Phase 2b clinical trial of Zimura for the treatment of geographic atrophy secondary to dry AMD. The Company expects initial top-line data for this trial to be available in the fourth quarter of 2019.
- Autosomal Recessive Stargardt Disease: Patient enrollment in the Phase 2b randomized, double-masked, sham-controlled, multi-center clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1) is currently on-going. Initial top-line data is expected to be available in 2020.
Gene Therapy Program Highlights
- Rhodopsin-mediated Autosomal Dominant Retinitis Pigmentosa:
August 2018, Ophthotechannounced that proof-of-concept study results of its adeno-associated virus (AAV) gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) in a naturally occurring canine model were published in the journal Proceedings of the National Academy of Sciences of the USA(PNAS). Ophthotechobtained a license for rights to develop and commercialize this AAV gene therapy product candidate in June 2018. This publication entitled: “Mutation-independent Rhodopsin Gene Therapy by Knockdown and Replacement with a Single AAV vector” was published by scientists at the University of Pennsylvaniaand University of Florida. Based on current timelines and subject to regulatory review, Ophthotechexpects to initiate a Phase 1/2 clinical trial in RHO-adRP in 2020.
2018 Operational Update
2018 Financial Highlights
- Revenues: The Company did not have any collaboration revenue
for the quarter and nine months ended
September 30, 2018, compared to $206.7 millionand $210.0 millionfor the same periods 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
$9.4 millionfor the quarter ended September 30, 2018, compared to $10.7 millionfor the same period in 2017. For the nine months ended September 30, 2018, research and development expenses were $25.6 millioncompared to $58.3 millionfor 2017. The Company continues to pursue its ongoing Zimura development programs and gene therapy research and 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.
- G&A Expenses: General and administrative expenses were
$6 millionfor the quarter ended September 30, 2018, compared to $7.1 millionfor the same period in 2017. For the nine months ended September 30, 2018, general and administrative expenses were $17.9 millioncompared to $28.8 millionfor 2017. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s reduced operations and infrastructure and decreases in costs associated with its 2017 reduction in personnel, which included facilities lease termination expenses incurred during the first quarter of 2017.
- Net Income: The Company reported a net loss for the quarter
September 30, 2018of $14.7 million, or ($.41)per diluted share, compared to net income of $189.1 million, or $5.25per diluted share, for the same period in 2017. For the nine months ended September 30, 2018, the Company reported a net loss of $41 million, or ($1.13)per diluted share, compared to net income of $123.7 million, or $3.44per diluted share, for the same period in 2017.
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech’s future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech’s strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Statements of Operations Data:|
|Research and development||9,407||10,707||25,609||58,343|
|General and administrative||5,968||7,059||17,945||28,770|
|Total operating expenses||15,375||17,766||43,554||87,113|
|Income (loss) from operations||(15,375||)||188,888||(43,554||)||122,864|
|Income (loss) before income tax provision (benefit)||(14,739||)||189,267||(41,860||)||123,943|
|Income tax provision (benefit)||6||194||(833||)||196|
|Net income (loss)||$||(14,745||)||$||189,073||$||(41,027||)||$||123,747|
|Net income (loss) per common share:|
|Weighted average common shares outstanding:|
|September 30, 2018||December 31, 2017|
|Balance Sheets Data:|
|Cash and cash equivalents||$||135,208||$||166,972|
|Royalty purchase liability||125,000||125,000|
|Additional paid-in capital||531,172||522,759|
|Total stockholders' equity||$||5,427||$||38,041|
Vice President, Investor Relations and Corporate Communications
Alex Van Rees, 973-442-1555 ext. 111
SmithSolve LLC on behalf of Ophthotech Corporation