Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial
results for the third quarter ended September 30, 2016 and provided a general business update.
“Following productive discussions with the FDA, we are preparing for the
resubmission of our NDA for DEXTENZA™ for post-surgical ocular pain by
the end of the year,” said Amar Sawhney, Ph.D., President, Chief
Executive Officer and Chairman. “We are also pleased to have commenced
patient enrollment in our first Phase 3 clinical trial with OTX-TP for
the treatment of glaucoma and ocular hypertension. We believe that this
is the first Phase 3 clinical trial to be conducted with a non-invasive,
sustained release drug candidate for the treatment of glaucoma, and our
goal is to address the major issue of low patient compliance rates
associated with currently approved topical therapies. Further, we are
excited to have entered into a strategic collaboration with Regeneron to
develop a potential first-in-class sustained release protein-based
anti-VEGF hydrogel injection for the treatment of wet AMD and other
serious retinal diseases.”
Recent Highlights and Anticipated Near-Term
Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation
and pain
Ocular Therapeutix expects to resubmit its New Drug Application (NDA)
for DEXTENZA (dexamethasone insert) 0.4 mg, for intracanalicular use
in the treatment of ocular pain occurring after ophthalmic surgery by
the end of 2016.
Ocular Therapeutix continues to build its commercial organization
and infrastructure in preparation for the earliest possible launch
of DEXTENZA.
The Company recently appointed Andy Hurley to the newly created
position of chief commercial officer. Mr. Hurley has over two
decades of sales, marketing, market access and commercial
operations experience across the pharmaceutical industry and will
be responsible for leading Ocular’s commercial organization,
focusing on effective execution of the DEXTENZA launch and
potential future product launches.
Ocular Therapeutix expects topline results from its third Phase 3
clinical trial for DEXTENZA for post-surgical ocular inflammation and
pain to be available in the fourth quarter of 2016.
If the Company obtains favorable results from this third Phase 3
trial and subject to approval of the NDA for post-surgical ocular
pain by the FDA, the Company intends to submit an NDA supplement
for DEXTENZA to broaden the label to include a post-surgical
inflammation indication.
At the recent Ocular Surgery News (OSN) 2016 annual meeting in New
York City, Ocular Therapeutix reported positive results from a
patient-reported outcomes survey of patients who were administered
DEXTENZA. The survey population consists of patients from the first
two Phase 3 trials with DEXTENZA for the treatment of post-surgical
ocular inflammation and pain. In the trial, the majority of
participants preferred DEXTENZA over eye drops:
100% of participants stated the DEXTENZA insert was comfortable;
96% rated their overall experience with DEXTENZA as convenient or
very convenient;
88% of participants stated that if they were to undergo cataract
surgery again, they would request DEXTENZA; and
84% of participants stated they were willing to pay more for
DEXTENZA than eye drops.
DEXTENZA for the treatment of allergic conjunctivitis
The Company plans to conduct a non-significant risk (NSR) study to
confirm the effect on efficacy of the placebo insert used in previous
studies compared with a rapidly absorbing placebo insert. Pending
favorable results from this study, the Company plans to conduct an
additional Phase 3 clinical trial to further evaluate DEXTENZA for the
treatment of allergic conjunctivitis.
OTX-TP (sustained release travoprost) for the treatment of
glaucoma and ocular hypertension
Ocular Therapeutix has commenced enrollment in the first of two
planned Phase 3 clinical trials for OTX-TP (sustained release
travoprost) for the treatment of glaucoma and ocular hypertension.
The U.S.-based, prospective, multicenter, randomized,
parallel-arm, placebo-controlled study is expected to enroll
approximately 550 patients with open angle glaucoma or ocular
hypertension at 50 clinical sites.
Importantly, the Phase 3 study design does not include a timolol
comparator or validation arm, and does not have active or placebo
eye drops administered in either arm. The comparator arm utilizes
a non-drug eluting hydrogel-based intracanalicular insert.
The primary efficacy endpoint is statistically superior reduction
of intraocular pressure (IOP) from baseline with OTX-TP compared
to placebo at three diurnal time points (8am, 10am, 4pm) at 2, 6
and 12 weeks following insertion.
The Company’s most recent results from ongoing NSR investigational
device exemption (IDE) human clinical studies using the non-drug
eluting version of the OTX-TP insert demonstrate significantly
improved retention rates.
Sustained release intravitreal depots for the treatment of serious
retinal diseases
The Company entered into a strategic collaboration, option and license
agreement with Regeneron Pharmaceuticals for the development of a
sustained release formulation of aflibercept, the vascular endothelial
growth factor (VEGF) trap for the treatment of wet age-related macular
degeneration (wet AMD) and other serious retinal diseases.
Regeneron’s market share leading aflibercept is currently approved
by the FDA for certain indications under the brand name EYLEA®.
Under the terms of the agreement, Regeneron has the option to
obtain an exclusive license to use Ocular Therapeutix’s
hydrogel-based technology for the development and
commercialization of a sustained release formulation of
aflibercept and other biologics targeting VEGF for ophthalmic
indications.
Upon the exercise of the option, Ocular Therapeutix would receive
a payment of $10 million from Regeneron and would be eligible to
receive up to a total of $305 million in milestone payments,
including the option exercise payment, for a sustained release
version of aflibercept as well as tiered high single-digit to
low-to-mid teen-digit royalties on potential future net sales.
The Company has demonstrated up to 6 months of sustained release of a
few different anti-VEGF drugs using its hydrogel-based drug delivery
technology with a good safety profile in preclinical studies completed
to date.
Ocular Therapeutix retains all rights to develop its sustained-release
hydrogel-based drug delivery platform with all other non-VEGF
targeting compounds as well as with small molecule pharmaceuticals,
including tyrosine-kinase inhibitors (TKIs), for other retinal
diseases.
The Company also demonstrated minimal inflammatory response in vivo
through 26 weeks with both its anti-VEGF protein and TKI depots
currently in development.
Third Quarter 2016 Financial Results
As of September 30, 2016, cash, cash equivalents and marketable
securities totaled $75.7 million excluding $1.7 million in restricted
cash. Cash used in operating activities was $7.3 million in the third
quarter of 2016, compared to $9.7 million for the third quarter of
2015. The decrease in cash position in the third quarter of 2016 was
$8.1 million. There was $15.6 million in outstanding debt as of
September 30, 2016 and principal payments are due starting January
2017 over a 36-month period. The Company expects that cash, cash
equivalents and marketable securities will be sufficient to fund
operating expenses, debt service obligations and capital expenditures
into the fourth quarter of 2017.
Ocular Therapeutix reported a net loss of approximately $9.6 million,
or $(0.39) per share, for the quarter ended September 30, 2016,
compared to a net loss of $11.5 million, or $(0.47) per share, for the
quarter ended September 30, 2015. The third quarter 2016 results
include $1.4 million in non-cash charges for stock-based compensation
compared to $1.2 million in such non-cash charges in the third quarter
of 2015.
Total costs and operating expenses for the quarter ended September 30,
2016 were $9.7 million, as compared to $11.6 million for the quarter
ended September 30, 2015. Research and development (R&D) expenses for
the quarter ended September 30, 2016 were $5.7 million, compared to
$8.3 million for the quarter ended September 30, 2015. The decrease in
R&D expenses is primarily due to lower clinical trial costs. The
patient enrollment phase of the third Phase 3 trial of DEXTENZA for
the treatment of ocular inflammation and pain following ophthalmic
surgery was completed in the second quarter of 2016 and the first of
two planned Phase 3 trials of OTX-TP for the treatment of glaucoma and
ocular hypertension was initiated late in the third quarter of 2016
with the majority of costs expected to be incurred in future quarters.
The decrease in R&D expenses was partially offset by an increase in
sales and marketing expenses as we prepare for the potential launch of
DEXTENZA for ocular pain indication subject to FDA approval of our NDA.
As of September 30, 2016, there were approximately 24.9 million shares
issued and outstanding.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast today at 8:30 am Eastern Time to discuss the
Company’s financial results and provide a general business update.
The live webcast can be accessed by visiting the investor section of the
Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the conference call. The conference ID
number for the live call will be 8389302. An archive of the webcast will
be available until November 23, 2016 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix has submitted an NDA for
post-surgical pain for its lead product candidate, DEXTENZA™
(dexamethasone insert), which is in Phase 3 clinical development for
post-surgical ocular inflammation and pain and allergic conjunctivitis.
OTX-TP (travoprost insert) is in Phase 3 clinical development for
glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating
injectable drug delivery depots for back-of-the-eye diseases. Ocular
Therapeutix’s first product, ReSure® Sealant, is FDA-approved
to seal corneal incisions following cataract surgery. For additional
information about the Company, please visit www.ocutx.com.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for the treatment of
post-surgical ocular inflammation and pain, including our expectations
regarding the NDA filed with the FDA and the resubmission of the NDA,
DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the
treatment of inflammatory dry eye disease and OTX-TP for the treatment
of glaucoma and ocular hypertension, the ongoing development of the
Company’s sustained release hydrogel depot technology, the potential
utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, the potential
benefits and future operation of the collaboration with Regeneron,
including any potential future payments thereunder, the sufficiency of
the Company’s cash resources and 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,
constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
Company’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 timing and costs involved in
commercializing ReSure® Sealant or any product candidate that
receives regulatory approval, the initiation and conduct of clinical
trials, availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s scientific approach
and general development progress, the availability or commercial
potential of the Company’s product candidates, the sufficiency of cash
resources and need for additional financing or other actions and other
factors discussed in the “Risk Factors” section contained in the
Company’s quarterly and annual reports on file with the Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent the Company’s views as of the
date of this release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However, while
the Company may elect to update these forward-looking statements at some
point in the future, the Company specifically disclaims any obligation
to do so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
of this release.
Ocular Therapeutix, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2016
2015
2016
2015
Revenue:
Product revenue
$
477
$
388
$
1,334
$
960
Collaboration revenue
—
41
42
354
Total revenue:
477
429
1,376
1,314
Costs and operating expenses:
Cost of product revenue
112
91
316
227
Research and development
5,686
8,263
19,737
19,725
Selling and marketing
1,294
798
4,175
2,709
General and administrative
2,623
2,451
8,002
6,575
Total costs and operating expenses
9,715
11,603
32,230
29,236
Loss from operations
(9,238
)
(11,174
)
(30,854
)
(27,922
)
Other income (expense):
Interest income
69
53
236
121
Interest expense
(426
)
(406
)
(1,262
)
(1,316
)
Other income (expense), net
(1
)
3
(1
)
6
Total other expense, net
(358
)
(350
)
(1,027
)
(1,189
)
Net loss
(9,596
)
(11,524
)
(31,881
)
(29,111
)
Net loss per share, basic and diluted
$
(0.39
)
$
(0.47
)
$
(1.29
)
$
(1.28
)
Weighted average common shares outstanding, basic and diluted
24,853,880
24,713,597
24,792,087
22,757,646
Comprehensive loss:
Net loss
$
(9,596
)
$
(11,524
)
$
(31,881
)
$
(29,111
)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities
(5
)
(8
)
73
(16
)
Total other comprehensive income (loss)
(5
)
(8
)
73
(16
)
Total comprehensive loss
$
(9,601
)
$
(11,532
)
$
(31,808
)
$
(29,127
)
Ocular Therapeutix, Inc.
Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
September 30,
December 31,
2016
2015
Assets
Current assets:
Cash and cash equivalents
$ 52,234
$ 30,784
Marketable securities
23,513
74,280
Accounts receivable
243
193
Inventory
126
134
Prepaid expenses and other current assets
708
1,592
Total current assets
76,824
106,983
Property and equipment, net
3,795
3,095
Restricted cash
1,728
228
Total assets
$ 82,347
$ 110,306
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,680
$ 1,957
Accrued expenses and deferred rent
2,791
3,379
Deferred revenue
—
42
Notes payable, net of discount, current
3,772
—
Total current liabilities
8,243
5,378
Deferred rent, long-term
32
68
Notes payable, net of discount, long-term
11,778
15,272
Total liabilities
20,053
20,718
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at
September 30, 2016 and
December 31, 2015, no shares issued or outstanding at September
30, 2016 and December 31, 2015
—
—
Common stock, $0.0001 par value; 100,000,000 shares authorized at
September 30, 2016 and
December 31, 2015, 24,879,887 and 24,750,281 shares issued and
outstanding at
September 30, 2016 and December 31, 2015, respectively
2
2
Additional paid-in capital
223,344
218,830
Accumulated deficit
(161,057
)
(129,176
)
Accumulated other comprehensive income (loss)
5
(68
)
Total stockholders’ equity
62,294
89,588
Total liabilities and stockholders’ equity
$ 82,347
$ 110,306
The post Ocular Therapeutix Reports Third Quarter 2016 Financial Results and Provides Corporate Update appeared first on Investing News Network.