- Conference Call and Webcast Today, February
26, 2019, at 8:00 a.m. ET -
Ophthotech Corporation (Nasdaq: OPHT) today announced financial
and operating results for the fourth quarter and full year ended
December 31, 2018 and provided a business update.
“2018 was a significant year for transforming the Company by
executing multiple business development transactions that resulted
in the addition of four gene therapy research and development
programs targeting orphan inherited retinal diseases and an
age-related therapeutic development program to our retina
portfolio,” stated Glenn P. Sblendorio, Chief Executive Officer and
President of Ophthotech. “We welcomed Versant Ventures as a major
shareholder of Ophthotech through the acquisition of Inception 4
and expanded our Board of Directors by adding three industry
leaders. We look forward to topline data from our Phase 2b clinical
trial of Zimura for the treatment of geographic atrophy secondary
to dry age-related macular degeneration in the fourth quarter of
2019. We are committed to advancing and potentially expanding our
pipeline of therapies for retinal diseases and creating value for
our shareholders.”
Gene Therapy Program Highlights of
2018
In 2018, the Company initiated multiple innovative gene therapy
collaborations to discover and develop next-generation therapies
for the treatment of inherited retinal diseases.
- In June 2018, the Company entered into
an exclusive global license agreement with the University of
Florida Research Foundation (UFRF), Incorporated and the Trustees
of the University of Pennsylvania (Penn) for rights to develop and
commercialize a novel adeno-associated virus (AAV) gene therapy
product candidate for the treatment of rhodopsin-mediated autosomal
dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic
retinal disease. The novel AAV gene therapy construct is designed
to knock down toxic rhodopsin and deliver a transgene for healthy
rhodopsin via a single AAV vector in a mutation independent manner.
The Company expects to initiate a Phase 1/2 clinical trial in
RHO-adRP in 2020.
- In August, proof-of-concept study
results of this product candidate in a naturally occurring canine
disease model were published in the prestigious journal Proceedings
of the National Academy of Sciences of the USA. This publication
entitled: “Mutation-independent Rhodopsin Gene Therapy by Knockdown
and Replacement with a Single AAV vector” was published by
scientists at Penn and University of Florida.
- In October 2018, the Company entered
into its second series of gene therapy agreements with Penn and
UFRF, including an exclusive option agreement for rights to
negotiate to acquire an exclusive global license to develop and
commercialize novel AAV gene therapy product candidates for the
treatment of diseases impacted by the bestrophin, or BEST1, gene.
The Company expects to initiate a Phase 1/2 clinical trial in
2021.
- In February 2018, the Company entered
into a series of sponsored research agreements with the University
of Massachusetts Medical School (UMMS) and its Horae Gene Therapy
Center. The research seeks to utilize a minigene strategy to create
novel AAV gene therapy product candidates for Leber Congenital
Amaurosis type 10 due to CEP290 mutations (the most common type of
LCA), and autosomal recessive Stargardt disease due to ABCA4
mutations, both of which are orphan inherited retinal diseases, and
to evaluate different AAV gene delivery methods for application in
the eye.
Therapeutic Program Highlights of
2018
Complement Factor C5 Inhibitor Program:
Zimura®
- In October 2018, the Company completed
patient enrollment for its ongoing randomized, double-masked, sham
controlled, multi-center Phase 2b clinical trial of Zimura for the
treatment of geographic atrophy secondary to dry AMD. The Company
expects initial top-line data for this trial to be available in the
fourth quarter of 2019.
- Patient enrollment in the Phase 2b
randomized, double-masked, sham-controlled, multi-center clinical
trial assessing the efficacy and safety of Zimura in patients with
autosomal recessive Stargardt disease (STGD1) is completed and
initial top-line data is expected to be available in the second
half of 2020.
Corporate Highlights of
2018
- In October 2018, Ophthotech acquired
Inception 4, Inc., a privately held company backed by Versant
Ventures. Ophthotech gained worldwide development and
commercialization rights to Inception 4’s small molecule inhibitors
of HtrA1 (high temperature requirement A serine peptidase 1
protein). In addition, Versant Ventures agreed to help Ophthotech
identify opportunities to expand the pipeline. Ophthotech obtained
approximately $6.1 million in cash through its acquisition of
Inception 4 and issued approximately 5.2 million shares to the
shareholders of Inception 4. After giving effect to the
transaction, funds affiliated with Versant Ventures own
approximately 12.5% of the outstanding shares of Ophthotech’s
common stock.
- During 2018, the Company expanded its
Board of Directors by adding leading industry experts: Adrienne L.
Graves, Ph.D., former Chief Executive Officer of Santen, Inc., and
Jane Pritchett Henderson, Chief Financial Officer of Turnstone
Biologics and former Chief Financial Officer and Senior Vice
President of Corporate Development at Voyager Therapeutics.
Effective January 1, 2019, Calvin W. Roberts, M.D., Senior Vice
President and Chief Medical Officer, Eye Care at Bausch Health
Companies and Clinical Professor of Ophthalmology at Weill Medical
College of Cornell University was elected to Ophthotech’s Board of
Directors.
2019 Operational Update
As of December 31, 2018, the Company had $131.2 million in cash
and cash equivalents. The Company estimates its year end 2019 cash
and cash equivalents will range between $80 million and $85 million
based on its current 2019 business plan, including expansion of the
Company’s gene therapy research and development programs, expansion
of its HtrA1 development program, and the continuation of its
clinical development programs for Zimura® (avacincaptad pegol
sodium). This estimate does not reflect any additional expenditures
resulting from the potential in-licensing or acquisition of
additional product candidates or technologies or associated
development that the Company may pursue.
2018 Financial
Highlights
- Gain on Extinguishment of Royalty
Purchase Liability: The Company recognized a gain on
extinguishment of its royalty purchase liability of $125 million
for the quarter and year ended December 31, 2018, due to the
December 2018 termination of the Company’s royalty purchase and
sale agreement with Novo Holdings A/S. The termination of the
agreement relieved the Company of any obligation to pay Novo
Holdings A/S future product royalties on sales of certain platelet
derived growth factor (PDGF) antagonists and did not impact the
Company’s cash balance.
- Revenues: The Company did not
have any collaboration revenue for the quarters ended December 31,
2018 and 2017 or during the year ended December 31, 2018, compared
to $210 million for the year ended December 31, 2017. Collaboration
revenue decreased for 2018 as compared to 2017 as the Company had
recognized all deferred revenue associated with the completion of
the Company’s licensing and commercialization agreement with
Novartis Pharma AG during the third quarter of 2017 and had no
collaboration revenue in 2018.
- R&D Expenses: Research and
development expenses were $16.1 million for the quarter ended
December 31, 2018, compared to $7.9 million for the same period in
2017. Research and development expenses increased primarily due to
$6.9 million in charges associated with the Company’s October 2018
acquisition of Inception 4 and its HtrA1 inhibitor program and
increases in costs associated with the Company’s ongoing Zimura and
gene therapy development programs. For the year ended December 31,
2018, research and development expenses were $41.7 million compared
to $66.3 million for 2017. Research and development expenses
decreased primarily due to decreases in expenses related to the
discontinuation of the Company’s Fovista Phase 3 clinical program
and decreases in costs associated with the Company’s 2017 reduction
in personnel program partially offset by charges associated with
the Company’s October 2018 acquisition of Inception 4 and its HtrA1
inhibitor program and increases in costs associated with the
Company’s ongoing Zimura and gene therapy development
programs.
- G&A Expenses: General and
administrative expenses were $5.7 million for the quarter ended
December 31, 2018, compared to $6.9 million for the same period in
2017. For the year ended December 31, 2018, general and
administrative expenses were $23.6 million compared to $35.7
million for 2017. General and administrative expenses decreased
primarily due to decreases in costs to support the Company’s
operations and infrastructure and decreases in costs associated
with its 2017 reduction in personnel program, which included
facilities lease termination expenses incurred during the first
quarter of 2017.
- Net Income: The Company reported
net income for the quarter ended December 31, 2018 of $104.1
million, or $2.62 per diluted share, compared to net loss of $9.5
million, or ($0.26) per diluted share, for the same period in 2017.
For the year ended December 31, 2018, the Company reported net
income of $63.1 million, or $1.70 per diluted share, compared to
net income of $114.2 million, or $3.17 per diluted share, for the
same period in 2017.
Conference Call/Web Cast
Information
Ophthotech will host a conference call/webcast to discuss the
Company’s financial and operating results and provide a business
update. The call is scheduled for February 26, 2019 at 8:00 a.m.
Eastern Time. To participate in this conference call, dial
888-224-1005 (USA) or 323-994-2093 (International), passcode
6840989. A live, listen-only audio webcast of the conference call
can be accessed on the Investor Relations section of the Ophthotech
website at: www.ophthotech.com. A replay will be available
approximately two hours following the live call for two weeks. The
replay number is 888-203-1112 (USA Toll Free), passcode
6840989.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of transformative gene therapies and novel therapeutics
to treat retinal diseases, with a focus on orphan and age related
indications. For more information, please visit www.ophthotech.com.
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 Ophthotech, and any other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,”
“may”, “might,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. In this press release, Ophthotech’s forward
looking statements include statements about the implementation of
its strategic plan, Ophthotech's projected use of cash and cash
balances, the timing, progress and results of clinical trials and
other research and development activities, the potential utility of
its product candidates and the potential for its business
development strategy, including any potential in-license or
acquisition opportunities. Such forward-looking statements involve
substantial risks and uncertainties that could cause Ophthotech’s
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, those related to the
initiation and the conduct and design of research programs and
clinical trials, availability of data from these programs,
expectations for regulatory matters, need for additional financing
and negotiation and consummation of in-license and/or acquisition
transactions and other factors discussed in the “Risk Factors”
section contained in the quarterly and annual reports that
Ophthotech files with the Securities and Exchange Commission. Any
forward-looking statements represent Ophthotech’s views only as of
the date of this press release. Ophthotech anticipates that
subsequent events and developments will cause its views to change.
While Ophthotech may elect to update these forward-looking
statements at some point in the future, Ophthotech specifically
disclaims any obligation to do so except as required by law.
OPHT-G
Ophthotech Corporation Selected
Financial Data (unaudited) (in thousands, except per share
data) Three months ended December 31, Year
ended December 31, 2018 2017 2018
2017 Statements of Operations Data:
Collaboration revenue $ - $ - $ - $ 209,977 Operating expenses:
Research and development 16,128 7,946 41,737 66,289 General and
administrative 5,667 6,913
23,612 35,683 Total operating expenses
21,795 14,859 65,349
101,972 Income (loss) from operations (21,795 ) (14,859 )
(65,349 ) 108,005 Interest income 677 409 2,389 1,522 Gain on
extinguishment of Royalty Purchase Liability 125,000 - 125,000 -
Other income (expense) 1 - (16 )
(34 ) Income (loss) before income tax benefit 103,883
(14,450 ) 62,024 109,493 Income tax benefit (231 )
(4,908 ) (1,063 ) (4,712 ) Net income (loss) $
104,114 $ (9,542 ) $ 63,087 $ 114,205 Net
income (loss) per common share: Basic $ 2.62 $ (0.26 ) $
1.70 $ 3.18 Diluted $ 2.62 $ (0.26 ) $ 1.70
$ 3.17 Weighted average common shares outstanding:
Basic 39,673 36,041 37,061
35,919 Diluted 39,687
36,041 37,088 36,007
December 31, 2018 December 31, 2017 (in
thousands) Balance Sheets Data: Cash and cash
equivalents $ 131,201 $ 166,972 Total assets 137,165 175,576
Royalty purchase liability - 125,000 Total liabilities 13,206
137,535 Additional paid-in capital 545,585 522,759 Accumulated
deficit (421,667 ) (484,754 ) Total stockholders' equity $ 123,959
$ 38,041
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version on businesswire.com: https://www.businesswire.com/news/home/20190226005394/en/
InvestorsKathy GalanteOphthotech CorporationVice
President, Investor Relations and Corporate
Communications212-845-8231kathy.galante@ophthotech.com
MediaAlex Van Rees, 973-442-1555 ext. 111SmithSolve
LLC on behalf of Ophthotech
Corporationalex.vanrees@smithsolve.com
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