Ocular Therapeutix (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, 2014, and provided an update
on current business developments.
“Since our IPO in July, Ocular has made substantial headway towards both
our business and financial goals for 2014,” said Amar Sawhney, Ph.D.,
President and CEO. “This has been an exciting period for us, marked by
continued progress with our lead clinical development programs. We have
achieved several clinical milestones. Today, we reported that in our
Phase 2 trial for our OTX-DP product candidate in allergic
conjunctivitis OTX-DP treated subjects presented statistically
significant lower ocular itching and conjunctival redness scores than
the placebo vehicle control group at all three time points measured on
Days 14, 28, and 42 after insertion of the punctum plug. We also
completed patient enrollment in two Phase 3 trials for our OTX-DP
product candidate in post-operative ocular inflammation and pain, and we
enrolled our first patients in a Phase 2b clinical trial for our OTX-TP
product candidate for the treatment of glaucoma and ocular hypertension.
The completion of our IPO provides us with resources to continue to
advance our business further. We look forward to reporting on our
upcoming milestones and finishing 2014 on a strong note.”
Third Quarter 2014 Financial Results
Ocular Therapeutix reported a net loss of approximately $7.3 million, or
$(0.48) per share, for the quarter ended September 30, 2014, compared to
a net loss of $3.5 million, or $(1.34) per share, for the quarter ended
September 30, 2013. The third quarter 2014 results include $0.6 million
in non-cash charges for stock-based compensation compared to $0.1
million in such non-cash charges in the third quarter of 2013.
Total operating expenses for the quarter ended September 30, 2014 were
$6.9 million as compared to $3.4 million for the quarter ended September
30, 2013. Research and development (R&D) expenses for the quarter ended
September 30, 2014 were $4.5 million, compared to $2.8 million for the
quarter ended September 30, 2013. This increase is primarily related to
clinical trials of the OTX-DP product candidate for the treatment of
post- operative ocular inflammation and pain, as well as allergic
conjunctivitis, and the OTX-TP product candidate for the treatment of
glaucoma and ocular hypertension.
Ocular Therapeutix generated $143,000 in revenue during the three months
ended September, 30, 2014 from sales of ReSure® Sealant. Sales of ReSure
Sealant commenced in the first quarter of 2014 and limited sales are
anticipated during 2014 as the company seeks to build awareness of this
product through a network of independent medical device distributors
across the United States.
As of September 30, 2014, cash and cash equivalents totaled $80.9
million. Cash used in operating activities was $14.9 million for the
nine months ended September 2014. There was $15 million in outstanding
debt as of September 30, 2014, with an interest only period through
September 30, 2015.
As of October 31, 2014 there were approximately 21.3 million shares
outstanding.
Recent Highlights for Key Development Programs
-
Completion of enrollment in the company’s Phase 3 clinical trials of
its OTX-DP product candidate, which incorporates the FDA approved
corticosteroid dexamethasone as an active pharmaceutical ingredient,
for the treatment of post-operative ocular inflammation and pain.
-
Presentation of data from the Phase 2 clinical trial of OTX-DP for the
treatment of post-operative ocular inflammation and pain at the
American Academy of Ophthalmology (AAO) in October 2014, showing a
statistically significant difference in the absence of inflammatory
cells and pain at various time points following cataract surgery.
-
Enrollment of the first patients in the Phase 2b trial for OTX-TP for
the treatment of glaucoma and ocular hypertension.
-
Announcement of top line Phase 2 clinical trial results for OTX-DP in
allergic conjunctivitis, in which we achieved a statistically
significant mean difference between the OTX-DP treatment group and the
placebo vehicle control group for both ocular itching and conjunctival
redness at all three time points measured on Days 14, 28, and 42. We
also achieved a mean difference between the OTX-DP treatment group and
the vehicle group of more than 0.5 units on a five point scale at all
three time points measured on Day 14 for both ocular itching and
conjunctival redness. The trial did not, however, achieve a mean
difference of at least 1.0 unit on the five point scale at the
majority of time points at Day 14 for either ocular itching or
conjunctival redness. OTX-DP was well-tolerated in all patients, and
no serious treatment related adverse events were observed.
Anticipated Near-Term Milestones
-
Completion of feasibility studies for the hydrogel depot delivering
anti-VEGF drugs in collaboration with several pharmaceutical partners,
expected in the first quarter of 2015.
-
Phase 3 results of OTX-DP for the treatment of post-operative ocular
inflammation and pain, expected in the first quarter of 2015, and
assuming favorable results the submission of an NDA to the FDA,
expected in the second quarter of 2015.
Conference Call/Web Cast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast at 8:00 a.m. on November 12, 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 27170246.
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
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-operative ocular inflammation and pain,
and Phase 2 clinical development for glaucoma, ocular hypertension and
chronic allergic conjunctivitis. 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 trial of OTX-DP for the
treatment of post-operative ocular inflammation and pain and the
Company's Phase 2b clinical trial of OTX-TP for the treatment of
glaucoma and ocular hypertension, 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 timing and costs involved in
commercializing ReSure® Sealant, 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 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.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
|
|
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|
|
|
|
|
|
|
|
|
|
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Three Months Ended September 30,
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Nine Months Ended September 30,
|
|
2014
|
|
|
2013
|
|
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
$
|
143
|
|
|
$
|
—
|
|
|
|
|
$
|
267
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Operating expenses:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cost of revenue
|
|
32
|
|
|
|
—
|
|
|
|
|
|
61
|
|
|
|
—
|
|
Research and development
|
|
4,482
|
|
|
|
2,784
|
|
|
|
|
|
13,732
|
|
|
|
7,675
|
|
Selling and marketing
|
|
479
|
|
|
|
148
|
|
|
|
|
|
1,324
|
|
|
|
428
|
|
General and administrative
|
|
1,926
|
|
|
|
503
|
|
|
|
|
|
4,697
|
|
|
|
1,381
|
|
Total operating expenses
|
|
6,919
|
|
|
|
3,435
|
|
|
|
|
|
19,814
|
|
|
|
9,484
|
|
Loss from operations
|
|
(6,776
|
)
|
|
|
(3,435
|
)
|
|
|
|
|
(19,547
|
)
|
|
|
(9,484
|
)
|
Other income (expense):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
5
|
|
|
|
3
|
|
|
|
|
|
7
|
|
|
|
11
|
|
Interest expense
|
|
(412
|
)
|
|
|
(94
|
)
|
|
|
|
|
(712
|
)
|
|
|
(350
|
)
|
Other income (expense), net
|
|
(111
|
)
|
|
|
4
|
|
|
|
|
|
(442
|
)
|
|
|
11
|
|
Total other expense, net
|
|
(518
|
|
|
|
(87
|
)
|
|
|
|
|
(1,147
|
)
|
|
|
(328
|
)
|
Net loss and comprehensive loss
|
|
(7,294
|
)
|
|
|
(3,522
|
)
|
|
|
|
|
(20,694
|
)
|
|
|
(9,812
|
)
|
Accretion of redeemable convertible preferred stock to redemption
value
|
|
—
|
|
|
|
(5
|
)
|
|
|
|
|
(11
|
)
|
|
|
(22
|
)
|
Net loss attributable to common stockholders
|
$
|
(7,294
|
)
|
|
$
|
(3,527
|
)
|
|
|
|
$
|
(20,705
|
)
|
|
$
|
(9,834
|
)
|
Net loss per share attributable to common stockholders, basic and
diluted
|
$
|
(0.48
|
)
|
|
$
|
(1.34
|
)
|
|
|
|
$
|
(2.93
|
)
|
|
$
|
(3.79
|
)
|
Weighted average common shares outstanding, basic and diluted
|
|
15,165,612
|
|
|
|
2,624,040
|
|
|
|
|
|
7,068,399
|
|
|
|
2,591,932
|
|
Ocular Therapeutix, Inc.
Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
September 30,
|
|
|
|
December 31,
|
|
|
|
|
|
2014
|
|
|
|
2013
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
80,892
|
|
|
|
$
|
17,505
|
|
Accounts receivable from related party
|
|
|
|
|
1
|
|
|
|
|
19
|
|
Accounts receivable
|
|
|
|
|
53
|
|
|
|
|
250
|
|
Inventory
|
|
|
|
|
117
|
|
|
|
|
—
|
|
Prepaid expenses and other current assets
|
|
|
|
|
1,211
|
|
|
|
|
240
|
|
Total current assets
|
|
|
|
|
82,274
|
|
|
|
|
18,014
|
|
Property and equipment, net
|
|
|
|
|
1,376
|
|
|
|
|
904
|
|
Restricted cash
|
|
|
|
|
228
|
|
|
|
|
228
|
|
Total assets
|
|
|
|
$
|
83,878
|
|
|
|
$
|
19,146
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Convertible Preferred Stock and
Stockholders’ Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$
|
649
|
|
|
|
$
|
545
|
|
Accrued expenses
|
|
|
|
|
2,480
|
|
|
|
|
741
|
|
Deferred revenue
|
|
|
|
|
250
|
|
|
|
|
250
|
|
Notes payable, net of discount, current
|
|
|
|
|
—
|
|
|
|
|
1,806
|
|
Total current liabilities
|
|
|
|
|
3,379
|
|
|
|
|
3,342
|
|
Preferred stock warrants
|
|
|
|
|
—
|
|
|
|
|
254
|
|
Deferred rent, long-term
|
|
|
|
|
121
|
|
|
|
|
27
|
|
Notes payable, net of discount, long-term
|
|
|
|
|
14,776
|
|
|
|
|
651
|
|
Total liabilities
|
|
|
|
|
18,276
|
|
|
|
|
4,274
|
|
Commitments and contingencies (Note 11)
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, 2014 and December
31, 2013, respectively, respectively; no
shares and 32,842,187 shares issued
and outstanding at September 30, 2014 and December 31, 2013, respectively;
aggregate liquidation preference of $74,436 at December 31, 2013
|
|
|
|
|
—
|
|
|
|
|
74,344
|
|
Stockholders’ equity (deficit):
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 and 0 shares
authorized at September 30, 2014 and December 31, 2013,
respectively; no shares issued or outstanding at September 30,
2014 and December 31, 2013
|
|
|
|
|
—
|
|
|
|
|
—
|
|
Common stock, $0.0001 par value; 100,000,000 and 45,000,000 shares
authorized at September 30, 2014 and December 31, 2013,
respectively; 21,322,433 and 2,676,648 shares issued and outstanding
at September 30, 2014 and December 31, 2013, respectively
|
|
|
|
|
2
|
|
|
|
|
—
|
|
Additional paid-in capital
|
|
|
|
|
147,074
|
|
|
|
|
1,308
|
|
Accumulated deficit
|
|
|
|
|
(81,474
|
)
|
|
|
|
(60,780
|
)
|
Total stockholders’ equity (deficit)
|
|
|
|
|
65,602
|
|
|
|
|
(59,472
|
)
|
Total liabilities, redeemable convertible preferred stock and
stockholders’ equity (deficit)
|
|
|
|
$
|
83,878
|
|
|
|
$
|
19,146
|
|
Copyright Business Wire 2014