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 fourth quarter and twelve months ended December 31, 2014.
“2014 was an exceptional year for Ocular Therapeutix, with accelerated
advancement of our sustained release drug delivery product candidates,
and this momentum is continuing into 2015,” said Amar Sawhney, Ph.D.,
President and Chief Executive Officer. “Earlier this morning, we
announced that we successfully achieved both primary efficacy measures
in our Phase 3a clinical trial evaluating OTX-DP for the treatment of
post-surgical ocular inflammation and pain. This is the first of our two
Phase 3 clinical trials of OTX-DP for this indication, and we believe
that this product candidate has the potential to meaningfully improve
upon the treatment modalities available to patients today. We are
advancing our business on multiple fronts and expect to be reporting on
a number of important milestones in 2015, the most imminent being Phase
3b clinical trial results and an NDA submission for OTX-DP for the
treatment of post-surgical ocular inflammation and pain. We also
anticipate the initiation of Phase 3 clinical trials of OTX-DP for
allergic conjunctivitis, results from our Phase 2 exploratory clinical
trial of OTX-DP for the treatment of inflammatory dry eye disease, and
results of a Phase 2b clinical trial of our OTX-TP product candidate for
glaucoma and ocular hypertension in 2015. Additionally, we will continue
to advance our preclinical development efforts for sustained-release
delivery of anti-VEGF drugs for the treatment of wet AMD using our
hydrogel depot, which we believe has potential to reduce the number of
annual intravitreal injections patients receive for their condition.”
Clinical Milestones and Corporate Developments
-
Earlier today, Ocular Therapeutix reported positive topline Phase 3a
clinical trial data of its Sustained Release Dexamethasone (OTX-DP)
for the treatment of ocular inflammation and pain following cataract
surgery in 247 patients, achieving statistically significant
improvement both in pain and in the reduction of inflammatory cells.
Statistically significant differences were shown in both primary
efficacy measures between treatment and control groups, the absence of
inflammatory cells at day 14 and the absence of pain at day 8. 33.7%
of OTX-DP treated patients showed an absence of inflammatory cells in
the anterior chamber of the eye on day 14 compared to 14.6% of those
receiving placebo (p=0.0015). In addition, 76.1% of patients receiving
OTX-DP reported absence of pain in the study eye at day 8 compared to
36.1% of those patients in the placebo group (p<0.0001).
-
In January 2015, the Company initiated patient enrollment in a Phase 2
exploratory clinical trial of OTX-DP for the treatment of inflammatory
dry eye disease, expanding the clinical program for its hydrogel
technology into a new indication.
-
In November 2014, the Company announced results from a Phase 2
clinical trial for OTX-DP for the treatment of allergic
conjunctivitis, achieving a statistically significant therapeutic
effect for ocular itching and conjunctival redness at multiple time
points with a single dose.
-
In November 2014, the Company initiated patient enrollment in a Phase
2b clinical trial of its Sustained Release Travoprost (OTX-TP) for the
treatment of glaucoma and ocular hypertension. The prospective,
multicenter, randomized, double-masked, parallel-arm, active
controlled study is designed to evaluate 80 patients at 10 clinical
sites in the U.S. for the safety and efficacy of OTX-TP as compared to
timolol eye drops. Fifty patients have been enrolled thus far, and the
Company is on track to complete the trial in the fourth quarter of
2015.
-
In October 2014, the Company signed an early stage feasibility
agreement with a fourth biopharmaceutical company to evaluate an
oncology drug for ophthalmic indications.
-
In July and August 2014, the Company raised net proceeds of
approximately $66.4 million in its IPO of 5,000,000 shares of its
common stock and the full exercise of the underwriters' option on an
additional 750,000 shares. On July 25, 2014, the Company’s shares
began trading on the NASDAQ Global Market under the symbol "OCUL".
-
In January 2014, the Company received approval from the U.S. Food and
Drug Administration (FDA) to commercialize the ReSure® Sealant in the
United States, with an indication for prevention of postoperative
fluid egress from incisions with a demonstrated wound leak following
cataract surgery. The ReSure® Sealant is the first and only sealant
that is FDA-approved for ophthalmic use.
Anticipated Clinical and Regulatory Milestones
-
Completion of the Phase 3b clinical trial of OTX-DP for the treatment
of ocular inflammation and pain following cataract surgery, with
topline results expected by the end March. This is the second of two
Phase 3 clinical trials of OTX-DP for this indication.
-
Submission of a New Drug Application (NDA) for OTX-DP for the
treatment of post-surgical ocular inflammation and pain anticipated in
the second quarter of 2015.
-
Advancement of feasibility work on the sustained delivery of anti-VEGF
drugs in a hydrogel depot for the treatment of back-of-the-eye
diseases, including wet age-related macular degeneration, expected in
the first half of 2015.
-
Completion of enrollment in the Phase 2b clinical trial evaluating
OTX-TP for the treatment of glaucoma and ocular hypertension, with
data expected in the fourth quarter of 2015.
-
Initiation of Phase 3 clinical trials of OTX-DP for the treatment of
allergic conjunctivitis expected in the middle of 2015.
-
Completion of a Phase 2 exploratory clinical trial of OTX-DP for the
treatment of inflammatory dry eye disease, with data expected in the
fourth quarter of 2015.
Fourth Quarter and Year Ended December 31, 2014 Financial Results
As of December 31, 2014, cash, cash equivalents and marketable
securities totaled $74.8 million. Cash used in operating activities was
$5.6 million in the fourth quarter of 2014 and $20.5 million for the
year ended December 2014. There was $15.0 million in outstanding debt as
of December 31, 2014, with an interest only period through September 30,
2015. The Company expects that cash, cash equivalents and marketable
securities will be sufficient to fund operating expenses, debt service
obligations and capital expenditures at least through the first half of
2016.
Ocular Therapeutix reported a net loss of approximately $8.0 million, or
$(0.37) per share, for the quarter ended December 31, 2014, compared to
a net loss of $3.5 million, or $(1.32) per share, for the quarter ended
December 31, 2013. The fourth quarter 2014 results include $1.0 million
in non-cash charges for stock-based compensation compared to $0.1
million in such non-cash charges in the fourth quarter of 2013. The
Company reported a net loss of approximately $28.7 million, or $(2.69)
per share, for the year ended December 31, 2014, compared to a net loss
of $13.3 million, or $(5.11) per share, for the year ended December 31,
2013. The 2014 results include $5.0 million in non-cash charges for
stock-based compensation compared to $0.5 million in such non-cash
charges in 2013.
Total operating expenses for the quarter ended December 31, 2014 were
$8.0 million as compared to $3.4 million for the quarter ended December
31, 2013. Research and development (R&D) expenses for the quarter ended
December 31, 2014 were $5.1 million, compared to $2.8 million for the
quarter ended December 31, 2013. This increase in operating expenses is
primarily related to clinical trial activities, the expansion of the
Company’s product development programs and costs incurred in connection
with operating as a public company.
The Company generated $0.5 million in revenue during the three months
ended December 31, 2014, including collaboration revenue from
feasibility agreements with pharmaceutical company partners and revenue
from sales of ReSure® Sealant. Sales of ReSure Sealant commenced in the
first quarter of 2014, and limited sales are anticipated in 2015 as the
Company expects to defer the hiring of a direct sales force until the
potential launch of its first sustained release drug delivery product,
OTX-DP for the treatment of post-surgical inflammation and pain.
As of December 31, 2014, there were approximately 21.3 million shares
outstanding.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast at 8:00 am Eastern Time on March 10, 2014 to
discuss the Company's financial results and provide a general business
update.
The live webcast and a replay may be accessed by visiting Ocular’s
website at investors.ocutx.com. Please
connect to the Company's website 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 live conference call.
The conference ID number for the live call is 98833560. Please dial in
approximately 10 minutes prior to the call. Following the webcast, an
archived version of the call will be available for three months.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. 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's lead product candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain, and
Phase 2 clinical development for glaucoma, allergic conjunctivitis, and
inflammatory dry eye disease. The Company is also evaluating
sustained-release injectable anti-VEGF drug depots for back-of-the-eye
diseases. Ocular Therapeutix's first product, ReSure® Sealant, is
FDA-approved to seal corneal incisions following cataract surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as the timing and
conduct of the Company’s Phase 3 clinical trials of OTX-DP for the
treatment of post-surgical ocular inflammation and pain, the potential
submission of an NDA for OTX-DP for this indication, the timing and
conduct of the Company's Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the Company’s Phase 3
clinical trials of OTX-DP for allergic conjunctivitis and the Company’s
Phase 2 exploratory clinical trial of OTX-DP for the treatment of
inflammatory dry eye disease, pre-commercial activities, the advancement
of the Company's earlier stage pipeline, including the timing and
conduct of feasibility studies for the Company’s hydrogel depot
delivering anti-VEGF drugs, future sales of ReSure Sealant 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 Ocular Therapeutix’
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 and expectations for
regulatory 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, the timing and costs involved
in commercializing ReSure® Sealant and other factors
discussed in the “Risk Factors” section contained in the Company’s most
recent Quarterly Report on Form 10-Q 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.
|
Statement of Operations and Comprehensive Loss
|
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
|
|
Year ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue
|
|
$
|
193
|
|
$
|
-
|
|
$
|
460
|
|
$
|
-
|
|
Collaboration revenue
|
|
|
312
|
|
|
-
|
|
|
312
|
|
|
-
|
|
Total revenue
|
|
|
505
|
|
|
-
|
|
|
772
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
30
|
|
|
-
|
|
|
91
|
|
|
-
|
|
Research and development
|
|
|
5,148
|
|
|
2,842
|
|
|
18,880
|
|
|
10,517
|
|
Selling and marketing
|
|
|
658
|
|
|
197
|
|
|
1,982
|
|
|
625
|
|
General and administrative
|
|
|
2,216
|
|
|
380
|
|
|
6,913
|
|
|
1,761
|
|
Total operating expenses
|
|
|
8,052
|
|
|
3,419
|
|
|
27,866
|
|
|
12,903
|
|
Loss from operations
|
|
|
(7,547)
|
|
|
(3,419)
|
|
|
(27,094)
|
|
|
(12,903)
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
-
|
|
|
2
|
|
|
7
|
|
|
13
|
|
Interest expense
|
|
|
(407)
|
|
|
(91)
|
|
|
(1,119)
|
|
|
(441)
|
|
Other (expense) income, net
|
|
|
-
|
|
|
3
|
|
|
(442)
|
|
|
14
|
|
Total other expense, net
|
|
|
(407)
|
|
|
(86)
|
|
|
(1,554)
|
|
|
(414)
|
|
Net loss and comprehensive loss
|
|
|
(7,954)
|
|
|
(3,505)
|
|
|
(28,648)
|
|
|
(13,317)
|
|
Accretion of redeemable convertible preferred stock to redemption
value
|
|
|
-
|
|
|
(5)
|
|
|
(11)
|
|
|
(27)
|
|
Net loss attributable to common stockholders
|
|
$
|
(7,954)
|
|
$
|
(3,510)
|
|
$
|
(28,659)
|
|
$
|
(13,344)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders per share,
basic and diluted
|
|
$
|
(0.37)
|
|
$
|
(1.32)
|
|
$
|
(2.69)
|
|
$
|
(5.11)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding, basic and diluted
|
|
|
21,289,378
|
|
|
2,659,726
|
|
|
10,652,865
|
|
|
2,609,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OCULAR THERAPEUTIX, INC.
|
|
|
|
|
|
|
BALANCE SHEETS
|
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
37,393
|
|
|
$
|
17,505
|
|
|
Marketable securities
|
|
|
37,435
|
|
|
|
-
|
|
|
Accounts receivable from related party
|
|
|
-
|
|
|
|
19
|
|
|
Accounts receivable
|
|
|
329
|
|
|
|
250
|
|
|
Inventory
|
|
|
133
|
|
|
|
-
|
|
|
Prepaid expenses and other current assets
|
|
|
893
|
|
|
|
240
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
76,183
|
|
|
|
18,014
|
|
|
Property and equipment, net
|
|
|
1,782
|
|
|
|
904
|
|
|
Restricted cash
|
|
|
228
|
|
|
|
228
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
78,193
|
|
|
$
|
19,146
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Convertible Preferred Stock and
Stockholders’ Equity (Deficit)
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,316
|
|
|
$
|
545
|
|
|
Accrued expenses
|
|
|
3,016
|
|
|
|
741
|
|
|
Deferred revenue
|
|
|
188
|
|
|
|
250
|
|
|
Notes payable, net of discount, current
|
|
|
1,354
|
|
|
|
1,806
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
5,874
|
|
|
|
3,342
|
|
|
Preferred stock warrants
|
|
|
-
|
|
|
|
254
|
|
|
Deferred rent, long-term
|
|
|
112
|
|
|
|
27
|
|
|
Notes payable, net of discount, long-term
|
|
|
13,511
|
|
|
|
651
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
19,497
|
|
|
|
4,274
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
Redeemable convertible preferred stock (Series A, B, C, D and
D-1), $0.001 par value; no shares and 33,979,025 shares authorized
at December 31, 2014 and 2013, respectively; no shares and
32,842,187 shares issued and outstanding at December 31, 2014 and
2013, respectively
|
|
|
-
|
|
|
|
74,344
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit):
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 and no shares
authorized at December 31, 2014 and 2013, respectively; no shares
issued or outstanding at December 31, 2014 and 2013
|
|
|
-
|
|
|
|
-
|
|
|
Common stock, $0.0001 par value; 100,000,000 and 45,000,000 shares
authorized at December 31, 2014 and 2013, respectively; 21,333,507
and 2,676,648 shares issued and outstanding at December 31, 2014 and
2013, respectively
|
|
|
2
|
|
|
|
-
|
|
|
Additional paid-in capital
|
|
|
148,122
|
|
|
|
1,308
|
|
|
Accumulated deficit
|
|
|
(89,428
|
)
|
|
|
(60,780
|
)
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit)
|
|
|
58,696
|
|
|
|
(59,472
|
)
|
|
|
|
|
|
|
|
Total liabilities, redeemable convertible preferred stock and
stockholders’ equity (deficit)
|
|
$
|
78,193
|
|
|
$
|
19,146
|
|
|
|
|
|
|
|
|
|
|
|
|
Copyright Business Wire 2015