Ophthotech Provides Business Update and Reports Third Quarter 2014 Financial Results
- Conference Call and Webcast, Today,
- Ophthotech Achieves Enrollment Milestone Triggering Third and Final Tranche in Royalty Financing with Novo A/S -
November 2014, Ophthotechachieved the final enrollment milestone related to the Phase 3 Fovista® program under the terms of the Company's $125 millionroyalty financing agreement with Novo A/S entered into in May 2013. This milestone triggers a payment of $41.7 millionto Ophthotech. The funding of this final tranche results in an additional royalty interest to Novo A/S based on worldwide Fovista® sales.
October 2014, Ophthotechreceived an initial $50 million enrollment milestone payment from Novartis Pharma AG related to the $130 milliontotal potential enrollment-based milestones under its ex-US licensing and commercialization agreement with Novartis entered into in May 2014. This payment was triggered upon Ophthotech reaching in September the first enrollment goal in its pivotal Fovista® Phase 3 clinical program.
August 2014, Ophthotechannounced the initiation of the first of several planned expansion Fovista® studies. The expansion studies are designed to further investigate the potential role of Fovista® combination therapy in the reduction of treatment burden, in the reduction of sub-retinal fibrosis, and in treatment resistant cases related to anti-VEGF monotherapy in wet age-related macular degeneration (AMD) patients. This first expansion trial is a Phase 2a open-label study investigating Fovista® in combination with anti-VEGF therapy in reducing sub-retinal fibrosis in wet AMD patients. Additional expansion programs are scheduled to commence in the near future.
"It was a solid quarter for
Research and Exclusive Option Agreement
The Company has entered into an exclusive research and option agreement
with AVEO Pharmaceuticals to license tivozanib, a small molecule
vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor, for
the treatment of non-oncologic conditions of the eye. Under the terms of
Under the agreement, upon completion of Ophthotech's initial analysis,
"While Fovista's development strategy continues to remain agnostic with
respect to the choice of the anti-VEGF agent administered in combination
with Fovista®, this agreement continues our quest to develop
multiple and flexible therapeutic options," said
Executive Management Appointments
Third Quarter 2014 Financial Results
September 30, 2014, the Company had $408.8 millionin cash, cash equivalents, and marketable securities.
$39.6 millionfor the three and nine months ended September 30, 2014and related to the $50.0 millionenrollment-based milestone that was achieved in September 2014under Ophthotech's agreement with Novartis. The balance of the milestone payment was recorded as deferred revenue. The Company did not have revenue during the comparable periods in 2013.
Research and development expenses were
$17.1 millionfor the three months ended September 30, 2014compared to $11.1 millionfor the same period in 2013. Research and development expenses were $66.2 millionfor the nine months ended September 30, 2014compared to $17.8 millionfor the same period in 2013. The increased research and development expense in each of the three and nine months ended September 30, 2014relates primarily to our Fovista® Phase 3 clinical program.
General and administrative expenses were
$8.8 millionfor the three months ended September 30, 2014compared to $4.2 millionfor the same period in 2013. General and administrative expenses were $22.7 millionfor the nine months ended September 30, 2014compared to $9.1 millionfor the same period in 2013. The increased general and administrative expense in each of the three and nine months ended September 30, 2014relates primarily to personnel-related expenses, including additional management and corporate staffing to support our public company infrastructure, and increased professional services and consulting fees.
The Company reported net income for the three months ended
September 30, 2014of $10.9 million, or $0.31per diluted share, compared to a net loss of $18.4 million, or ( $10.26) per diluted share for the same period in 2013. The Company reported a net loss for the nine months ended September 30, 2014of $62.3 million, or ( $1.88) per diluted share, compared to a net loss of $36.6 million, or ( $23.21) per diluted share for the same period in 2013.
About the Fovista® Phase 3 Program
The Fovista® Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista®
anti-PDGF therapy, which
Conference Call/Web Cast Information
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for
|Selected Financial Data (unaudited)|
|(in thousands, except per share data)|
Three Months Ended
Nine Months Ended
|Statement of Operations Data:|
|Costs and expenses:|
|Research and development||17,105||11,101||66,189||17,836|
|General and administrative||8,812||4,166||22,731||9,145|
|Total costs and expenses||25,917||15,267||88,920||26,981|
|Income (loss) from operations||13,658||(15,267||)||(49,345||)||(26,981||)|
|Interest income (expense)||73||-||189||(1,454||)|
|Gain (loss) on extinguishment of debt||-||105||-||(1,091||)|
|Income (loss) before income tax provision||13,731||(16,132||)||(49,156||)||(30,757||)|
|Income tax provision||2,867||-||13,161||-|
|Net income (loss)||10,864||(16,132||)||(62,317||)||(30,757||)|
|Add: accretion of preferred stock dividends||-||(2,292||)||-||(5,891||)|
Net income (loss) attributable to common
Net income (loss) attributable to common
|Weighted average common shares outstanding:|
|Balance sheet data:|
|Cash, cash equivalents, and marketable securities||$||408,782||$||210,596|
|Royalty purchase liability||$||83,333||$||41,667|
|Additional paid-in capital||$||421,193||$||352,739|
|Total stockholders' equity||$||175,895||$||169,720|
Vice President, Investor Relations and Corporate Communications
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