Ophthotech Reports First Quarter 2014 Financial Results and Provides Business Update
- Conference Call and Webcast, Today,
Review of First Quarter Accomplishments
-
In
January 2014 , the Company reached an enrollment milestone resulting in a second tranche payment of$41.7 million to the Company under its$125.0 million royalty financing agreement with Novo A/S . A potential third tranche of$41.7 million under this royalty agreement remains available to the Company based upon a further patient enrollment milestone. -
In
February 2014 ,Ophthotech completed a follow-on public offering of common stock resulting in net proceeds of approximately$55.4 million for the Company. -
The Company's Fovista™ Phase 3 clinical program in wet age-related
macular degeneration (AMD) remains on track.
- As scheduled, the Company activated initial trial sites for the third clinical trial with Fovista™ in combination with Avastin® (bevacizumab) and Eylea® (aflibercept).
-
Ophthotech announced its strategy to expand its Fovista anti-PDGF therapy program beyond the pivotal Phase 3 clinical trials in wet AMD and to advance its Zimura™ program in both dry and wet AMD. Zimura™ is an inhibitor of complement factor C5.- Plans are underway for multiple expansion trials of Fovista™ in wet AMD. These trials include the investigation of Fovista™ administered with anti-VEGF therapy for the potential reduction in the treatment burden for patients, the potential improvement of visual outcome for anti-VEGF treatment-resistant cases and the potential reduction of subretinal fibrosis to prevent sub-optimal visual outcome over the long-term. These studies are scheduled to commence this year.
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Ophthotech also expects to advance its second product candidate, ZimuraTM, to a Phase 2/3 clinical trial for treatment of geographic atrophy, a severe form of dry AMD, late this year or early in 2015. In addition, a Phase 2 clinical trial is planned for Zimura™ and FovistaTM in combination with anti-VEGF therapy for wet AMD patients believed to have complement-mediated inflammation. This trial is scheduled to initiate in 2015.
-
Ophthotech hosted its first R&D Day onMarch 7, 2014 . A panel of 10 leading retinal specialists gave their insight into the Fovista™ pivotal Phase 3 program and planned expansion clinical trials, the progress and challenges in the treatment of AMD, along with a look at the future of wet and dry AMD therapies.
"It has been a very productive first quarter which was highlighted by
our successful follow-on public offering and the achievement of the
second tranche payment under the company's royalty financing agreement
with Novo A/S," said
Financial Results
As of
About the FovistaTM Phase 3 Program
The FovistaTM 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
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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(A Development Stage Company) | ||||||||||||||
Selected Financial Data (unaudited) | ||||||||||||||
(in thousands, except per share data) | ||||||||||||||
Three months ended |
Period from
(Inception) to
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2014 | 2013 | 2014 | ||||||||||||
Statement of Operations Data: | (in thousands) | |||||||||||||
Operating Expenses: | ||||||||||||||
Research and development | 14,377 | 2,389 | 122,484 | |||||||||||
General and administrative | 6,349 | 1,738 | 47,908 | |||||||||||
Total operating expenses | 20,726 | 4,127 | 170,392 | |||||||||||
Loss from operations | (20,726 | ) | (4,127 | ) | (170,392 | ) | ||||||||
Interest income (expense) | 44 | (357 | ) | (1,438 | ) | |||||||||
Loss on extinguishment of debt | - | - | (1,091 | ) | ||||||||||
Other loss | - | (134 | ) | (1,546 | ) | |||||||||
Change in fair value related to investor rights liability | - | - | 683 | |||||||||||
Net loss before income tax benefit | (20,682 | ) | (4,618 | ) | (173,784 | ) | ||||||||
Income tax benefit | - | - | 1,327 | |||||||||||
Net loss | (20,682 | ) | (4,618 | ) | (172,457 | ) | ||||||||
Add: accretion of preferred stock dividends | - | (1,742 | ) | (33,046 | ) | |||||||||
Net loss attributable to common stockholders | $ | (20,682 | ) | $ | (6,360 | ) | $ | (205,503 | ) | |||||
Net loss attributable to common stockholders per share: | ||||||||||||||
Basic and diluted | $ | (0.64 | ) | $ | (4.33 | ) | ||||||||
Weighted average common shares outstanding: | ||||||||||||||
Basic and diluted | 32,282 | 1,470 | ||||||||||||
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(in thousands) | ||||||||||||||
Balance sheet data: | ||||||||||||||
Cash and cash equivalents | $ | 66,562 | $ | 210,596 | ||||||||||
Available for sale securities | $ | 224,263 | $ | - | ||||||||||
Total assets | $ | 297,093 | $ | 217,682 | ||||||||||
Royalty purchase liability | $ | 83,333 | $ | 41,667 | ||||||||||
Additional paid-in capital | $ | 410,886 | $ | 352,739 | ||||||||||
Deficit accumulated during the development stage | $ | (203,732 | ) | $ | (183,050 | ) | ||||||||
Total stockholders' equity | $ | 207,205 | $ | 169,720 |
Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
SmithSolve
jarrod.aldom@smithsolve.com
Source:
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