[August 28, 2014] |
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Ocular Therapeutix Announces Second Quarter 2014 Financial Results
BEDFORD, Mass. --(Business Wire)--
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 second quarter ended June 30, 2014.
"The past several months have been transformational for Ocular
Therapeutix," said Amar Sawhney, Ph.D., President and Chief Executive
Officer. "With the closing of our IPO in July, our solid balance sheet
should enable the Company to progress with its robust clinical
development programs in pain and inflammation, glaucoma and ocular
hypertension, and chronic allergic conjunctivitis." Dr. Sawhney
continued, "We look forward to advancing our pipeline further in the
second half of 2014 with the anticipated initiation of a Phase 2b
clinical trial of our OTX-TP product candidate for the treatment of
glaucoma and ocular hypertension. We are also continuing to advance our
Phase 3 clinical trials of our OTX-DP product candidate for the
treatment of post-surgical ocular inflammation and pain."
Second Quarter 2014 Financial Results
Ocular reported a net loss attributable to common stockholders of
approximately $6.4 million, or $2.10 per share, for the quarter ended
June 30, 2014, compared to $3.1 million, or $1.19 per share, for the
quarter ended June 30, 2013. The second quarter 2014 results include
$3.4 million in non-cash charges for stock-based compensation and
licensing and consultant fees paid in common stock compared to $0.2
million in such non-cash charges in the second quarter of 2013.
Total operating expenses for the quarter ended June 30, 2014 were $6.0
million as compared to $3.0 million for the quarter ended June 30, 2013.
Research and development (R&D) expenses for the quarter ended June 30,
2014 were $4.3 million, compared to $2.4 million for the second quarter
of 2013. This increase is primarily related to the clinical development
of the Company's product pipeline, including the Phase 3 clinical trials
of its OTX-DP product candidate for the treatment of post-surgical
ocular inflammation and pain, the Phase 2 clinical trials of its OTX-DP
product candidate for the treatment of chronic allergic conjunctivitis
and a Phase 2a clinical trial of its OTX-TP product candidate for the
treatment of glaucoma and ocular hypertension.
Ocular generated $0.1 million of revenue during the three months ended
June 30, 2014 from initial 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 June 30, 2014, cash, cash equivalents, and short-term investments
totaled $19.9 million. Subsequent to the end of the second quarter,
Ocular completed an initial public offering (IPO) of its common stock
and received $66.5 million in net proceeds.
Summary of Year-to-Date 2014 Accomplishments
-
Ocular received net proceeds of approximately $66.5 million from the
issuance and sale of 5,750,000 shares of its common stock in its IPO,
including shares issued upon the exercise in full of the underwriters'
over-allotment option.
-
On July 25, 2014, Ocular's shares began trading on the NASDAQ Global
Market under the symbol "OCUL".
-
Ocular strengthened its leadership team with the appointment of Bruce
Peacock, a seasoned executive with significant experience in the
biopharmaceutical industry, to the Board of Directors, and with the
appointment of Brad Smith, an executive with experience with both
public and private life sciences companies, as Chief Financial Officer.
-
The American Medical Association (AMA) CPT Editorial Panel granted
Ocular a Category III CPT code 0356T for the insertion of a
drug-eluting implant in the punctum, a natural opening in the eyelid
near the tear ducts. The new Category III CPT code, designated for
emerging technologies, services, and procedures, became effective July
1, 2014.
-
In January 2014, Ocular received approval from the U.S. Food and Drug
Administration (FDA) to commercialize the ReSure® Sealant
in the United States, indicated for prevention of postoperative fluid
egress from corneal incisions with a demonstrated wound leak following
cataract surgery. The ReSure® Sealant is the first and only surgical
sealant that is FDA-approved for ophthalmic use.
Recent Clinical Highlights
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Ocular completed a 41-patient Phase 2a clinical trial of OTX-TP for
the treatment of glaucoma and ocular hypertension. One of the two
OTX-TP dosing arms of the study appeared to show reduction of
intraocular pressure similar to comparator Timolol eye drops, although
the trial was not powered to measure any endpoints with statistical
significance. The results of this clinical trial provided valuable
information for the design of a Phase 2b clinical trial of this
product.
-
In March, Ocular initiated a Phase 3 clinical program to evaluate the
safety and efficacy 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. Ocular has designed OTX-DP to provide a
sustained, tapered release of dexamethasone over a period of
approximately 30 days.
-
Ocular presented six posters at the Association for Research in Vision
and Ophthalmology (ARVO) Annual Meeting in Orlando, Florida, from May
4-8, 2014.
-
Ocular presented eleven podium and posters, including clinical data on
its ReSure® Sealant and sustained release dexamethasone, at the
American Society of Cataract and Refractive Surgery (ASCRS) Annual
Symposium in Boston, Massachusetts, from April 25-29, 2014.
Anticipated Clinical Milestones and Development Plans
-
During the fourth quarter of 2014, Ocular intends to initiate a Phase
2b clinical trial of OTX-TP for the treatment of glaucoma and ocular
hypertension.
-
During the fourth quarter of 2014, Ocular expects to release Phase 2
clinical trial data of OTX-DP for the treatment of chronic allergic
conjunctivitis. A total of 60 patients have been randomized 1:1 to
receive either OTX-DP or a proprietary placebo punctum plug, using a
Modified Conjunctival Allergen Challenge Model (CAC™). OTX-DP is
administered as a one-time sustained release corticosteroid with a
four-week release. Primary endpoints of the Phase 2 trial include
ocular itching and conjunctival redness.
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-surgical 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 inflammation and pain following cataract
surgery and the Company's Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the expected timing to
release data relating to the Company's Phase 2 clinical trial of OTX-DP
for the treatment of chronic allergic conjunctivitis, pre-commercial
activities, the advancement of the company's earlier stage pipeline,
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, including
statements about the clinical trials of our product candidates. 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 of the
final prospectus for the Company's IPO, which is 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."
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Statements of Operations and Comprehensive Loss
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(In thousands, except share and per share data)
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(Unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2014
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2013
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2014
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2013
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Revenue
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$
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97
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$
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-
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$
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124
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$
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-
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Operating expenses:
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Cost of revenue
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20
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-
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29
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-
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Research and development
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4,292
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2,404
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9,250
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4,891
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Selling and marketing
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535
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143
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845
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280
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General and administrative
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1,196
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442
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2,771
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878
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Total operating expenses
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6,043
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2,989
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12,895
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6,049
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Loss from operations
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(5,946
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)
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(2,989
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)
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(12,771
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)
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(6,049
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)
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Other income (expense):
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Interest income
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1
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3
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2
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8
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Interest expense
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(257
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)
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(107
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)
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(300
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)
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(256
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)
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Other income (expense), net
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(190
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)
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3
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(331
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)
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7
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Total other income (expense), net
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(446
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)
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(101
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)
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(629
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)
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|
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(241
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)
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Net loss and comprehensive loss
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(6,392
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)
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(3,090
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)
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(13,400
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)
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(6,290
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)
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Accretion of redeemable convertible preferred stock to redemption
value
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(5
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)
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|
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(9
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)
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|
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(11
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)
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(17
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)
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Net loss attributable to common stockholders
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$
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(6,397
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)
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$
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(3,099
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)
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$
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(13,411
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)
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$
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(6,307
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)
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Net loss per share attributable to common stockholders, basic and
diluted
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$
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(2.10
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)
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$
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(1.19
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)
|
|
$
|
(4.54
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)
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$
|
(2.45
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)
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Weighted average common shares outstanding, basic and diluted
|
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3,044,605
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2,595,771
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2,952,689
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2,575,612
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Ocular Therapeutix, Inc.
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Balance Sheets
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(In thousands, except share and per share data)
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(Unaudited)
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June 30,
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December 31,
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2014
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2013
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Assets
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Current assets:
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Cash and cash equivalents
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$
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19,944
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$
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17,505
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Accounts receivable from related party
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|
1
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|
19
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Accounts receivable
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|
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|
60
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|
|
|
250
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Inventory
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|
|
109
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|
-
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Deferred offering costs
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2,197
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-
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Prepaid expenses and other current assets
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|
283
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240
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Total current assets
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22,594
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18,014
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Property and equipment, net
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1,152
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|
904
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Restricted cash
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|
|
|
|
|
|
228
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|
|
|
228
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|
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|
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|
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|
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Total assets
|
|
|
|
|
|
$
|
23,974
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$
|
19,146
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|
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Liabilities, Redeemable Convertible Preferred Stock and
Stockholders' Deficit
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Current liabilities:
|
|
|
|
|
|
|
|
|
|
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|
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Accounts payable
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|
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|
|
|
|
$1,525
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|
|
|
$545
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Accrued expenses
|
|
|
|
|
|
|
1,629
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|
|
|
741
|
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Deferred revenue
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|
250
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|
|
|
250
|
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Notes payable, net of discount, current
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|
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|
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|
1,085
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|
|
|
1,806
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Total current liabilities
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|
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|
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|
|
4,489
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|
|
|
3,342
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Preferred stock warrants
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|
|
|
|
|
|
852
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|
|
|
254
|
|
Deferred rent, long-term
|
|
|
|
|
|
|
119
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|
|
|
27
|
|
Notes payable, net of discount, long-term
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|
|
|
|
|
|
13,594
|
|
|
|
651
|
|
Total liabilities
|
|
|
|
|
|
|
19,054
|
|
|
|
4,274
|
|
Commitments and contingencies (Note 11)
|
|
|
|
|
|
|
|
|
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|
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Redeemable convertible preferred stock (Series A, B, C, D and D-1), $0.001
par value; 34,229,025 and 33,979,025 shares authorized at June
30, 2014 and December 31, 2013, respectively; 32,842,187 shares
issued and outstanding at June 30, 2014 and December 31, 2013;
aggregate liquidation preference of $74,436 at June 30, 2014 and
December 31, 2013
|
|
|
|
|
|
|
74,355
|
|
|
|
74,344
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Stockholders' deficit:
|
|
|
|
|
|
|
|
|
|
|
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Common stock, $0.0001 par value; 47,500,000 and 45,000,000 shares
authorized at June 30, 2014 and December 31, 2013, respectively;
3,129,285 and 2,676,648 shares issued and outstanding at June 30,
2014 and December 31, 2013, respectively
|
|
|
|
|
|
|
-
|
|
|
|
-
|
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Additional paid-in capital
|
|
|
|
|
|
|
4,745
|
|
|
|
1,308
|
|
Accumulated deficit
|
|
|
|
|
|
|
(74,180
|
)
|
|
|
(60,780
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders' deficit
|
|
|
|
|
|
|
(69,435
|
)
|
|
|
(59,472
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities, redeemable convertible preferred stock and
stockholders' deficit
|
|
|
|
|
|
$
|
23,974
|
|
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$
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19,146
|
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