Ophthotech Reports Second Quarter 2015 Financial and Operating Results
Conference Call and Webcast Today,
Program Highlights
In
The Company currently anticipates that enrollment of the second Phase 3 trial should be completed in the fourth quarter of 2015. The Company's timing projections for completion of enrollment assume no additional impact related to the summer season and/or competing trials. The Company continues to expect to report initial, topline data from both Phase 3 trials of Fovista® in combination with Lucentis® by the end of 2016. This timeline could be subject to an adjustment to a slightly later time point if the recruitment rate is on the lower end of the Company's projected enrollment scenario. The initial, topline data are expected one year after the enrollment of the last patient in the second Phase 3 Fovista® in combination with Lucentis® trial, plus the customary time required for database closure and analysis.
The third Phase 3 trial, which is investigating Fovista® in combination with either Eylea® (aflibercept) or Avastin® (bevacizumab) continues to enroll patients and the recruitment is on track. This third Phase 3 trial was initiated approximately nine months after the Fovista® in combination with Lucentis® trials.
The Fovista® Expansion Studies (
"During the first half of 2015,
Management Highlights
In
"We are very excited to welcome these well accomplished and talented new
members to Ophthotech's senior leadership team," stated
Financial Results
-
As of
June 30, 2015 , the Company had$449.0 million in cash, cash equivalents, and marketable securities. -
Collaboration revenue was
$1.6 million for the quarter endedJune 30, 2015 . For the six months endedJune 30, 2015 , collaboration revenue was$43.3 million and primarily related to the$50.0 million enrollment-based milestone that was achieved inMarch 2015 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 periods in 2014. -
Research and development expenses were
$32.1 million for the quarter endedJune 30, 2015 compared to$34.7 million for the same period in 2014. For the six months endedJune 30, 2015 research and development expenses were$56.6 million compared to$49.1 million for the same period in 2014. Both prior year periods included a$19.8 million milestone payment the Company paid in connection with the Novartis Agreement. Excluding this milestone payment, research and development expense increased in both the quarter and six months endedJune 30, 2015 primarily due to the Company's Fovista® Phase 3 clinical program. -
General and administrative expenses were
$12.0 million for the quarter endedJune 30, 2015 compared to$7.6 million for the same period in 2014. For the six months endedJune 30, 2015 , general and administrative expenses were$21.5 million compared to$13.9 million for the same period in 2014. The increase in general and administrative expenses in the quarter and six months endedJune 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. -
The Company reported a net loss for the quarter ended
June 30, 2015 of$37.1 million , or ($1.08 ) per diluted share, compared to a net loss of$73.0 million , or ($2.19 ) per diluted share for the same period in 2014. For the six months endedJune 30, 2015 , the Company reported a net loss of$30.5 million , or ($0.89 ) per diluted share, compared to a net loss of$93.7 million , or ($2.85 ) per diluted share, for the same period in 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
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Selected Financial Data (unaudited) | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Three Months Ended |
Six Months Ended |
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2015 | 2014 | 2015 | 2014 | |||||||||||||
Statement of Operations Data: | ||||||||||||||||
Collaboration Revenue | $ | 1,597 | $ | - | $ | 43,275 | $ | - | ||||||||
Costs and expenses: | ||||||||||||||||
Research and development | 32,059 | 34,707 | 56,616 | 49,084 | ||||||||||||
General and administrative | 11,959 | 7,570 | 21,543 | 13,919 | ||||||||||||
Total costs and expenses | 44,018 | 42,277 | 78,159 | 63,003 | ||||||||||||
Loss from operations | (42,421 | ) | (42,277 | ) | (34,884 | ) | (63,003 | ) | ||||||||
Interest income | 218 | 72 | 291 | 116 | ||||||||||||
Loss before income tax provision | (42,203 | ) | (42,205 | ) | (34,593 | ) | (62,887 | ) | ||||||||
Income tax (benefit) provision | (5,072 | ) | 30,785 | (4,098 | ) | 30,785 | ||||||||||
Net loss | $ | (37,131 | ) | $ | (72,990 | ) | $ | (30,495 | ) | $ | (93,672 | ) | ||||
Net loss per common share: | ||||||||||||||||
Basic and diluted | $ | (1.08 | ) | $ | (2.19 | ) | $ | (0.89 | ) | $ | (2.85 | ) | ||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic and diluted | 34,353 | 33,373 | 34,254 | 32,830 | ||||||||||||
June 30, |
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(in thousands) | ||||||||||||||||
Balance sheet data: | ||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 449,040 | $ | 463,560 | ||||||||||||
Total assets | $ | 471,049 | $ | 479,786 | ||||||||||||
Royalty purchase liability | $ | 125,000 | $ | 125,000 | ||||||||||||
Deferred revenue | $ | 216,348 | $ | 209,624 | ||||||||||||
Total liabilities | $ | 357,273 | $ | 351,249 | ||||||||||||
Additional paid-in capital | $ | 444,034 | $ | 428,390 | ||||||||||||
Accumulated deficit | $ | (330,317 | ) | $ | (299,822 | ) | ||||||||||
Total stockholders' equity | $ | 113,776 | $ | 128,537 | ||||||||||||
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Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
jennifer.devine@smithsolve.com
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