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
- 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.”
Statements of Operations and
Comprehensive Loss
(In thousands, except share and per
share data)
(Unaudited)
Three Months EndedJune 30, Six Months
EndedJune 30, 2014 2013 2014
2013 Revenue $ 97 $ — $ 124 $ —
Operating expenses: Cost of revenue 20 — 29 — Research and
development 4,292 2,404 9,250 4,891 Selling and marketing 535 143
845 280 General and administrative 1,196 442
2,771 878 Total operating
expenses 6,043 2,989 12,895
6,049 Loss from operations
(5,946 ) (2,989 ) (12,771 ) (6,049 )
Other income (expense): Interest income 1 3 2 8 Interest expense
(257 ) (107 ) (300 ) (256 ) Other income (expense), net (190
) 3 (331 ) 7 Total other income
(expense), net (446 ) (101 ) (629 )
(241 ) Net loss and comprehensive loss (6,392 ) (3,090 )
(13,400 ) (6,290 ) Accretion of redeemable convertible preferred
stock to redemption value (5 ) (9 ) (11 )
(17 ) Net loss attributable to common stockholders $
(6,397 ) $ (3,099 ) $ (13,411 ) $ (6,307 ) Net loss per
share attributable to common stockholders, basic and diluted $
(2.10 ) $ (1.19 ) $ (4.54 ) $ (2.45 ) Weighted average
common shares outstanding, basic and diluted 3,044,605 2,595,771
2,952,689
2,575,612
Ocular Therapeutix, Inc.
Balance Sheets
(In thousands, except share and per
share data)
(Unaudited)
June 30,
December 31,
2014 2013 Assets Current assets: Cash and cash
equivalents $ 19,944 $ 17,505 Accounts receivable from related
party 1 19 Accounts receivable 60 250 Inventory 109 — Deferred
offering costs 2,197 — Prepaid expenses and other current assets
283 240 Total current assets 22,594 18,014
Property and equipment, net 1,152 904 Restricted cash 228
228 Total assets $ 23,974 $ 19,146
Liabilities, Redeemable Convertible Preferred Stock and
Stockholders’ Deficit Current liabilities: Accounts payable
$1,525 $545 Accrued expenses 1,629 741 Deferred revenue 250 250
Notes payable, net of discount, current 1,085 1,806
Total current liabilities 4,489 3,342 Preferred stock warrants 852
254 Deferred rent, long-term 119 27 Notes payable, net of discount,
long-term 13,594 651 Total liabilities 19,054
4,274 Commitments and contingencies (Note 11)
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 atJune 30, 2014 and December 31, 2013,
respectively; 32,842,187shares issued and outstanding at June 30,
2014 and December 31,2013; aggregate liquidation preference of
$74,436 at June 30, 2014and December 31, 2013
74,355 74,344 Stockholders’ deficit:
Common stock, $0.0001 par value;
47,500,000 and 45,000,000shares 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
— — 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 $ 19,146
Investors:Ocular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixKimberly Minarovich,
212-213-0006kminarovich@burnsmc.comorMedia:Scott CorningVice
President of Sales and Marketingscorning@ocutx.com
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