(Conference Call and Webcast Today, November 8,
2017, at 8:00 a.m. ET)
- Complement C5 Inhibitor, Zimura®, on Track to
Have Four Ophthalmic Clinical Programs Ongoing by Year End –
Ophthotech Corporation (Nasdaq: OPHT) today announced financial
and operating results for the third quarter ended September 30,
2017 and provided a business update.
“We are very excited to provide an update on the expansion of
our age related and orphan retina programs with our complement C5
inhibitor, Zimura,” stated Glenn P. Sblendorio, Chief Executive
Officer and President of Ophthotech. “Scientific literature
continues to strengthen our belief in the potential role of
complement C5 inhibition in the treatment of retinal diseases. We
have progressed in all of our clinical programs by initiating new
trials and modifying a current clinical trial. We remain on track
to have four trials ongoing by the end of the year.”
Zimura® Complement
Factor C5 Inhibitor Program
- Geographic Atrophy, a severe form of
Dry Age-related Macular Degeneration: Ophthotech has modified
its on-going Zimura (avacincaptad pegol) clinical trial for the
treatment of geographic atrophy (GA) secondary to dry age related
macular degeneration (AMD). This on-going randomized,
double-masked, sham controlled Phase 2b clinical trial is designed
to assess the safety and efficacy of Zimura monotherapy in patients
with GA. The Company has modified the design of the trial to
accelerate the anticipated timeline for obtaining top-line data.
The Company has reduced the number of patients it plans to enroll
in this trial to approximately 200 and has shortened the time point
for attaining the primary efficacy endpoint to 12 months. The
number of sites has been expanded within the United States and
globally to expedite enrollment. The primary efficacy endpoint is
the mean rate of change in GA over 12 months. Patients will be
treated and monitored for 18 months. The modified study design
incorporates patients that were already enrolled in the study prior
to these modifications. A range of Zimura dosing regimens will also
be assessed. The Company submitted a modified Phase 2b clinical
trial protocol to the U.S. Food and Drug Administration (FDA) early
in the fourth quarter of 2017. Initial, top-line data is expected
to be available during the second half of 2019.
- Wet Age-related Macular
Degeneration: During the third quarter of 2017, the Company
initiated a new dose-ranging, open-label Phase 2a clinical trial of
Zimura in combination with Lucentis® in patients with wet AMD who
have not been previously treated with any anti-VEGF agents.
Approximately 60 patients will be enrolled and treated for a
duration of 6 months. Based on the anticipated enrollment rate, the
Company expects initial top-line data from this trial to be
available by the end of 2018.
- Idiopathic Polypoidal Choroidal
Vasculopathy: The Company plans to initiate before year end an
open-label Phase 2a clinical trial evaluating Zimura in combination
with Eylea® for the treatment of idiopathic polypoidal choroidal
vasculopathy (IPCV) in treatment experienced patients.
Approximately 20 patients will be enrolled and treated for a
duration of 9 months. Initial top-line data is expected to be
available during the second half of 2019.
Ophthalmic Orphan Disease Program
- Autosomal Recessive Stargardt
Disease: Ophthotech remains on track to initiate a Phase 2b
randomized, double masked, sham controlled clinical trial in
autosomal recessive Stargardt disease (STGD1) before the end of
this year. This trial will assess the safety and efficacy of Zimura
monotherapy in patients with STGD1, an inherited orphan retinal
disease causing vision loss during childhood or adolescence. There
are currently no FDA or EMA approved treatments available for STGD1
and it remains a significant unmet medical need. The Company
expects to enroll approximately 120 patients in this trial, making
it one of the largest interventional clinical trials in Stargardt
disease to date. The Company plans to use an anatomic endpoint as
measured by spectral domain optical coherence tomography (SD-OCT)
as the primary endpoint, which will be assessed at 18 months.
Initial top-line data is expected to be available in 2020.
Third Quarter 2017 Financial
Highlights
- Cash Position: As of September
30, 2017, the Company had $180.2 million in cash and cash
equivalents. The Company expects a 2017 year end cash balance of
between $155 million and $165 million, excluding any potential
business development activities, and including the approximately $5
million to $7 million that remains committed to implementing a
reduction in personnel and winding-down the Fovista® (pegpleranib)
in combination with Eylea® or Avastin® clinical trial.
- Revenues: Collaboration revenue
was $206.7 million for the quarter ended September 30, 2017,
compared to $1.7 million for the same period in 2016. For the nine
months ended September 30, 2017, collaboration revenue was $210
million, compared to $45.6 million for the same period in 2016.
Collaboration revenue increased in both the quarter and nine months
ended September 30, 2017 as the Company completed all deliverables
required under its licensing and commercialization agreement with
Novartis Pharma AG and recognized all associated deferred revenue.
This increase in collaboration revenue had no impact on the
Company’s cash balance.
- R&D Expenses: Research and
development expenses were $10.7 million for the quarter ended
September 30, 2017, compared to $50.9 million for the same period
in 2016. For the quarter ended September 30, 2017, research and
development expenses included approximately $0.9 million in costs
related to the Company’s previously announced reduction in
personnel. For the nine months ended September 30, 2017, research
and development expenses were $58.3 million, compared to $136.9
million for the same period in 2016. For the nine months ended
September 30, 2017, research and development expenses included
approximately $6.8 million in costs related to the Company’s
previously announced reduction in personnel. Research and
development expenses decreased in both the quarter and nine months
ended September 30, 2017 primarily due to a decrease in expenses
related to the Company’s Fovista Phase 3 clinical program,
including a decrease in manufacturing activities.
- G&A Expenses: General and
administrative expenses were $7.1 million for the quarter ended
September 30, 2017, compared to $12.0 million for the same period
in 2016. For the quarter ended September 30, 2017, general and
administrative expenses included approximately $0.5 million in
costs related to the Company’s previously announced reduction in
personnel. For the nine months ended September 30, 2017, general
and administrative expenses were $28.8 million, compared to $37.2
million for the same period in 2016. For the nine months ended
September 30, 2017, general and administrative expenses included
approximately $5.1 million in costs related to the Company’s
previously announced reduction in personnel and its termination of
facilities leases. General and administrative expenses decreased in
both the quarter and nine months ended September 30, 2017 primarily
due to a decrease in costs to support the Company’s operations and
infrastructure.
- Net Income: The Company reported
net income for the quarter ended September 30, 2017 of $189.1
million, or $5.25 per diluted share, compared to a net loss of
$60.9 million, or ($1.71) per diluted share, for the same period in
2016. For the nine months ended September 30, 2017, the Company
reported net income of $123.7 million, or $3.44 per diluted share,
compared to a net loss of $127.1 million, or ($3.59) per diluted
share, for the same period in 2016.
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 November 8, 2017 at 8:00 a.m.
Eastern Time. To participate in this conference call, dial
800-239-9838 (USA) or +1 323-794-2551 (International), passcode
7300213. 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
7300213.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics for age-related and orphan
diseases of the eye. 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 development activities, 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 conduct of clinical trials, availability of data
from clinical trials, 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 September 30,
Nine Months Ended September 30, 2017
2016 2017 2016
Statements of Operations Data: Collaboration revenue $
206,654 $ 1,668 $ 209,977 $ 45,587 Operating expenses: Research and
development 10,707 50,854 58,343 136,886 General and administrative
7,059 12,024 28,770
37,209 Total operating expenses 17,766
62,878 87,113 174,095
Income (loss) from operations 188,888 (61,210 ) 122,864 (128,508 )
Interest income 391 409 1,113 1,301 Other loss (12 )
(20 ) (34 ) (88 ) Loss before income tax provision
189,267 (60,821 ) 123,943 (127,295 ) Income tax provision (benefit)
194 70 196 (158 )
Net income (loss) $ 189,073 $ (60,891 ) $ 123,747 $
(127,137 ) Net income (loss) per common share: Basic $ 5.26
$ (1.71 ) $ 3.45 $ (3.59 ) Diluted $ 5.25 $ (1.71 ) $
3.44 $ (3.59 ) Weighted average common shares outstanding:
Basic 35,971 35,594 35,878
35,415 Diluted 36,047
35,594 35,984 35,415
September 30, 2017 December 31, 2016 (in
thousands) Balance Sheets Data: Cash, cash equivalents,
and marketable securities $ 180,217 $ 289,278 Total assets 182,982
299,630 Deferred revenue - 209,976 Royalty purchase liability
125,000 125,000 Total liabilities 139,107 394,248 Additional
paid-in capital 519,051 504,517 Accumulated deficit (475,212 )
(598,959 ) Total stockholders' equity (deficit) $ 43,875 $ (94,618
)
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version on businesswire.com: http://www.businesswire.com/news/home/20171108005426/en/
InvestorsOphthotech CorporationKathy Galante,
212-845-8231Vice President, Investor Relations and Corporate
Communicationskathy.galante@ophthotech.comorMediaSmithSolve
LLC on behalf of Ophthotech CorporationAlex Van Rees,
973-442-1555 ext. 111alex.vanrees@smithsolve.com
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