Ophthotech Reports Fourth Quarter and Full Year 2013 Financial and Operating Results
Conference Call and Webcast Today,
Recent Corporate Highlights
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Cash Resources:
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As of
December 31, 2013 , the Company had$210.6 million in cash and cash equivalents. -
In
January 2014 , the Company received an additional$41.7 million from a second tranche payment under the Company's$125.0 million royalty financing agreement with Novo A/S. A potential third tranche of$41.7 million under this royalty agreement remains available 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$55.5 million for the Company.
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As of
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With the follow-on public offering complete,
Ophthotech is expanding the global clinical program for its lead product candidate Fovista™ beyond its pivotal Phase 3 program in wet age-related macular degeneration (AMD) and is advancing its second product candidate Zimura™,an inhibitor of complement factor C5 (formerly known as ARC1905), in both dry AMD and wet AMD.-
Fovista™ program expansion: The Company is planning clinical
trials of Fovista™ in combination with anti-VEGF therapy for the
treatment of anti-VEGF resistant wet AMD patients and to assess
possible reduction of treatment burden in wet AMD therapy.
Ophthotech also plans to initiate a clinical trial to investigate the effect of Fovista™ in potentially inhibiting the formation of subretinal fibrosis in wet AMD patients treated with anti-VEGF therapies. Studies have shown that subretinal fibrosis is associated with severe vision loss in wet AMD patients. These trials are scheduled to commence in 2014. In addition, theNational Eye Institute is scheduled to conduct a clinical trial with Fovista™ invon Hippel-Lindau disease starting in 2014, and the Company is planning to initiate in 2015 a clinical trial of Fovista™ in proliferative vitreoretinopathy. - Zimura™ program: The Company is expected to advance to a Phase 2/3 clinical trial for treatment of geographic atrophy, a severe form of dry AMD, in late 2014 or early 2015. In addition, a Phase 2 clinical trial is planned for Zimura™ and Fovista™ in combination with anti-VEGF therapy for the treatment of anti-VEGF resistant wet AMD patients believed to have complement mediated inflammation. This trial is scheduled to initiate in 2015.
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Fovista™ program expansion: The Company is planning clinical
trials of Fovista™ in combination with anti-VEGF therapy for the
treatment of anti-VEGF resistant wet AMD patients and to assess
possible reduction of treatment burden in wet AMD therapy.
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In late February, the Company received written confirmation from the
European Medicine Agency's
Committee for Medicinal Products for Human Use (CHMP) indicating that theCHMP and the Company are now in agreement regarding the Company's trial design and dosing regimens for the Fovista™ Phase 3 program.
"It has been a very busy and exciting time for
Financial Results
Operating expenses for the quarter ended
Operating expenses for the year ended
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/Webcast 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 | ||||||||||||||||||||
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Three Months Ended |
Years Ended |
Period from |
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| Statement of Operations Data: | 2013 | 2012 | 2013 | 2012 | 2013 | |||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| Costs and expenses: | ||||||||||||||||||||
| Research and development | $ | 15,379 | $ | 1,998 | $ | 33,215 | $ | 6,792 | $ | 108,107 | ||||||||||
| General and administrative | 5,065 | 1,548 | 14,210 | 6,889 | 41,559 | |||||||||||||||
| Total costs and expenses | 20,444 | 3,546 | 47,425 | 13,681 | 149,666 | |||||||||||||||
| Loss from operations | (20,444 | ) | (3,546 | ) | (47,425 | ) | (13,681 | ) | (149,666 | ) | ||||||||||
| Interest expense, net | - | (251 | ) | (1,454 | ) | (507 | ) | (1,482 | ) | |||||||||||
| Loss on extinguishment of debt | - | - | (1,091 | ) | - | (1,091 | ) | |||||||||||||
| Other gain (loss) | 56 | (33 | ) | (1,175 | ) | (374 | ) | (1,546 | ) | |||||||||||
| Change in fair value related to investor rights liability | - | - | - | - | 683 | |||||||||||||||
| Net loss before income tax benefit | (20,388 | ) | (3,830 | ) | (51,145 | ) | (14,562 | ) | (153,102 | ) | ||||||||||
| Income tax benefit | - | - | - | - | 1,327 | |||||||||||||||
| Net loss | (20,388 | ) | (3,830 | ) | (51,145 | ) | (14,562 | ) | (151,775 | ) | ||||||||||
| Add: accretion of preferred stock dividends | - | (1,776 | ) | (5,891 | ) | (7,063 | ) | (33,046 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (20,388 | ) | $ | (5,606 | ) | $ | (57,036 | ) | $ | (21,625 | ) | $ | (184,821 | ) | |||||
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Net loss attributable to common stockholders per share: |
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Basic and diluted |
$ | (0.65 | ) | $ | (3.81 | ) | $ | (6.34 | ) | $ | (14.89 | ) | ||||||||
| Weighted average common shares outstanding: | ||||||||||||||||||||
| Basic and diluted | 31,355 | 1,470 | 9,003 | 1,452 | ||||||||||||||||
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As of |
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| 2013 | 2012 | |||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| Balance sheet data: | ||||||||||||||||||||
| Cash and cash equivalents | $ | 210,596 | $ | 4,304 | ||||||||||||||||
| Total assets | $ | 217,682 | $ | 4,879 | ||||||||||||||||
| Royalty purchase liability | $ | 41,667 | $ | - | ||||||||||||||||
| Total liabilities | $ | 47,962 | $ | 14,410 | ||||||||||||||||
| Preferred stock | $ | - | $ | 113,939 | ||||||||||||||||
| Additional paid-in capital | $ | 352,739 | $ | - | ||||||||||||||||
| Deficit accumulated during the development stage | $ | (183,050 | ) | $ | (126,471 | ) | ||||||||||||||
| Total stockholders' equity (deficit) | $ | 169,720 | $ | (123,470 | ) | |||||||||||||||
Investors
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
jarrod.aldom@smithsolve.com
Source:
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