Press Release
Ocular Therapeutix Announces Second Quarter 2014 Financial Results
“The past several months have been transformational for Ocular
Therapeutix,” said
Second Quarter 2014 Financial Results
Ocular reported a net loss attributable to common stockholders of
approximately
Total operating expenses for the quarter ended
Ocular generated
As of
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 theNASDAQ 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 ofBrad 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 effectiveJuly 1, 2014 . -
In
January 2014 , Ocular received approval from theU.S. Food and Drug Administration (FDA ) to commercialize the ReSure® Sealant inthe 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 isFDA -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 inOrlando, Florida , fromMay 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 , fromApril 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
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
|
Statements of Operations and Comprehensive Loss |
|||||||||||||||||||
|
(In thousands, except share and per share data) |
|||||||||||||||||||
|
(Unaudited) |
|||||||||||||||||||
|
Three Months Ended June 30, |
Six Months Ended June 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), |
74,355 | 74,344 | ||||||||||
| Stockholders’ deficit: | ||||||||||||
|
Common stock, $0.0001 par value; 47,500,000 and 45,000,000 |
— | — | ||||||||||
| 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 | ||||||||
Source:
Investors:
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media:
Scott
Corning
Vice President of Sales and Marketing
scorning@ocutx.com
