Ophthotech Reports Third Quarter 2017 Financial and Operating Results

(Conference Call and Webcast Today, November 8, 2017, at 8:00 a.m. ET)
Related Biotechnology, Pharmaceutical and Healthcare News
- 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 FovistaPhase 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
|
)
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20171108005426/en/
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
SmithSolve
LLC on behalf of Ophthotech Corporation
Alex Van Rees,
973-442-1555 ext. 111
alex.vanrees@smithsolve.com
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