Ophthotech Reports Third Quarter 2015 Financial and Operating Results
- Conference Call and Webcast Today,
"We have achieved many significant milestones that have us on track to
reach our goal to provide initial, topline data from both Phase 3 trials
of Fovista® in combination with Lucentis in the fourth
quarter of 2016," said
Ophthotech Highlights
-
In
October 2015 ,Ophthotech announced the completion of patient recruitment in its second Phase 3 trial of Fovista® (pegpleranib) in combination with Lucentis® (ranibizumab) for the treatment of wet age-related macular degeneration (AMD). The Company expects to announce initial, topline data from both Phase 3 trials of Fovista® in combination with Lucentis® in the fourth quarter of 2016. A third Phase 3 trial, which is investigating Fovista® in combination with either Eylea® (aflibercept) or Avastin® (bevacizumab), continues to enroll patients and is on track. - Recruitment has been completed in two of the Fovista® Expansion Studies. These trials are investigating the optimal regimen for Fovista® administration in combination with multiple anti-VEGF agents to potentially reduce sub-retinal fibrosis and treatment burden in wet AMD patients. Both trials are ongoing and progressing well.
"This is an exciting time for
Third Quarter Financial Highlights
-
Cash Position: As of
September 30, 2015 , the Company had$426.0 million in cash, cash equivalents, and marketable securities. -
Revenues: Collaboration revenue was
$3.4 million for the quarter endedSeptember 30, 2015 , compared to$39.6 million for the prior year period. For the nine months endedSeptember 30, 2015 , collaboration revenue was$46.7 million compared to$39.6 million for the same period in 2014. Collaboration revenue recognized in 2015 and 2014 consists of license fee revenue primarily attributable to the$50.0 million enrollment-based milestones the Company achieved inMarch 2015 andSeptember 2014 under the Company's Licensing and Commercialization Agreement withNovartis Pharma AG , as well as revenue associated with research and development activities the Company performs under the same agreement. -
R&D Expenses: Research and development expenses were
$40.5 million for the quarter endedSeptember 30, 2015 compared to$17.1 million for the same period in 2014. For the nine months endedSeptember 30, 2015 research and development expenses were$97.1 million compared to$66.2 million for the same period in 2014. The nine months endedSeptember 30, 2014 included a$19.8 million milestone payment the Company paid in connection with entering into the agreement with Novartis. Excluding this milestone payment, research and development expense increased in both the quarter and nine months endedSeptember 30, 2015 primarily due to the Company's Fovista® Phase 3 clinical program and increased personnel costs associated with additional management and research and development staffing, including share-based compensation expense. -
G&A Expenses: General and administrative expenses were
$10.4 million for the quarter endedSeptember 30, 2015 compared to$8.8 million for the same period in 2014. For the nine months endedSeptember 30, 2015 , general and administrative expenses were$32.0 million compared to$22.7 million for the same period in 2014. The increase in general and administrative expenses in the quarter and nine months endedSeptember 30, 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. -
Net Loss: The Company reported a net loss for the quarter ended
September 30, 2015 of$39.6 million , or ($1.14 ) per diluted share. DuringSeptember 2014 , the Company achieved a$50.0 million enrollment-based milestone under Ophthotech's agreement with Novartis which resulted in the Company recording net income of$8.6 million , or$0.25 per diluted share for the quarter endedSeptember 30, 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
OPHT-G
|
|||||||||||||||||||||||||||||||||
Selected Financial Data (unaudited) | |||||||||||||||||||||||||||||||||
(in thousands, except per share data) | |||||||||||||||||||||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||||||||||||||||||||
2015 |
2014 |
2015 | 2014 | ||||||||||||||||||||||||||||||
Statement of Operations Data: | |||||||||||||||||||||||||||||||||
Collaboration revenue | $ | 3,448 | $ | 39,575 | $ | 46,723 | $ | 39,575 | |||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||
Research and development | 40,479 | 17,105 | 97,095 | 66,189 | |||||||||||||||||||||||||||||
General and administrative | 10,412 | 8,812 | 31,955 | 22,731 | |||||||||||||||||||||||||||||
Total operating expenses |
50,891 |
25,917 | 129,050 | 88,920 | |||||||||||||||||||||||||||||
Income (loss) from operations | (47,443 | ) | 13,658 | (82,327 | ) | (49,345 | ) | ||||||||||||||||||||||||||
Interest income and other | 339 | 73 | 630 | 189 | |||||||||||||||||||||||||||||
Income (loss) before income tax provision | (47,104 | ) | 13,731 | (81,697 | ) | (49,156 | ) | ||||||||||||||||||||||||||
Income tax (benefit) provision | (7,531 | ) | 5,179 | (11,629 | ) | 35,964 | |||||||||||||||||||||||||||
Net income (loss) | $ | (39,573 | ) | $ | 8,552 | $ | (70,068 | ) | $ | (85,120 | ) | ||||||||||||||||||||||
Net income (loss) per common share: | |||||||||||||||||||||||||||||||||
Basic | $ | (1.14 | ) | $ |
0.26 |
|
$ | (2.03 | ) | $ | (2.57 | ) | |||||||||||||||||||||
Diluted | $ | (1.14 | ) | $ | 0.25 | $ | (2.03 | ) | $ | (2.57 | ) | ||||||||||||||||||||||
Weighted average common shares outstanding: | |||||||||||||||||||||||||||||||||
Basic | 34,782 | 33,531 | 34,432 | 33,074 | |||||||||||||||||||||||||||||
Diluted | 34,782 | 34,859 | 34,432 | 33,074 | |||||||||||||||||||||||||||||
September |
December |
||||||||||||||||||||||||||||||||
(in thousands) | |||||||||||||||||||||||||||||||||
Balance sheet data: | |||||||||||||||||||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 425,986 | $ | 463,560 | |||||||||||||||||||||||||||||
Total assets | $ | 450,751 | $ | 479,786 | |||||||||||||||||||||||||||||
Royalty purchase liability | $ | 125,000 | $ | 125,000 | |||||||||||||||||||||||||||||
Deferred revenue | $ | 214,710 | $ | 209,624 | |||||||||||||||||||||||||||||
Total liabilities | $ | 367,640 | $ | 351,249 | |||||||||||||||||||||||||||||
Additional paid-in capital | $ | 452,887 | $ | 428,390 | |||||||||||||||||||||||||||||
Accumulated deficit | $ | (369,890 | ) | $ | (299,822 | ) | |||||||||||||||||||||||||||
Total stockholders' equity | $ | 83,111 | $ | 128,537 | |||||||||||||||||||||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20151105005165/en/
Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
jennifer.devine@smithsolve.com
Source:
News Provided by Acquire Media