Full Press Release Details
Ocular Therapeutix Reports First Quarter 2016 Financial Results and Provides Corporate Update
PDUFA target action date of July 24, 2016 for DEXTENZA NDA for the treatment of post-surgical ocular pain
Second Phase 3 clinical trial for DEXTENZA for the treatment of allergic conjunctivitis fully enrolled; topline results expected June 2016
First Phase 3 clinical trial for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension with
placebo control arm expected to commence in the third quarter of 2016
Conference call today at 8:00 am Eastern Time
BEDFORD, Mass, May 10, 2016 (BUSINESS WIRE): 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 first quarter ended March 31, 2016.
This is an exciting time for Ocular Therapeutix, as we anticipate multiple key milestones throughout the remainder of 2016, including the July 2016
PDUFA date for DEXTENZA for the treatment of post-surgical ocular pain, as well as expected read-outs from our second Phase 3 DEXTENZA clinical trial for the treatment of allergic conjunctivitis and our third Phase 3 clinical trial for the treatment
of post-surgical ocular inflammation and pain, said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. Following the completion of an End-of-Phase 2 review with the FDA last month, we are also gearing up to initiate
the first of two planned Phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension. We believe that successful outcomes for these milestones have the potential to affirm the growing value of our innovative
sustained-release platform in addressing diverse applications in ophthalmology.
Recent Highlights and Anticipated Near-Term Milestones for
Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
DEXTENZA for the treatment of allergic conjunctivitis
DEXTENZA for the treatment of dry eye disease
OTX-TP (sustained release
travoprost) for the treatment of glaucoma and ocular hypertension
First Quarter 2016 Financial Results
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:00 am Eastern Time to discuss the Company s
financial results and provide a general business update.
The live webcast can be accessed by visiting the investor section of the Company s website
at investors.ocutx.com. Please connect 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 conference call. The conference ID number for the live call will be 3038508. An archive of the webcast will be available until May 24, 2016 on the company s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
(NASDAQ: OCUL) 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
candidate, DEXTENZA (sustained release dexamethasone) Intracanalicular Depot, is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis, and in Phase 2 clinical development for dry eye
disease. A New Drug Application (NDA) for the post-operative ocular pain indication has been filed with FDA and has a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2016. A third Phase 3 clinical trial is being conducted
for post-surgical ocular inflammation and pain. For glaucoma and ocular hypertension, the Company has completed its End-of-Phase 2 review with the FDA, and the first of two planned OTX-TP (sustained release travoprost) Phase 3 clinical trials is
expected to be initiated in the third quarter of 2016. Ocular Therapeutix 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.
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the
development and regulatory status of the Company s product candidates, such as the Company s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA for post-surgical
ocular inflammation and pain, including our expectations regarding the pending PDUFA date for the NDA filed with the FDA, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and OTX-TP for the treatment of glaucoma
and ocular hypertension, the ongoing development of the Company s sustained release hydrogel depot technology and the advancement of the Company s other product candidates, the potential utility of any of the Company s product
candidates, the sufficiency of the Company s cash resources 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 the Company s 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 or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials
and expectations for regulatory submissions and 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 quarterly and annual reports 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.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing
OCULAR THERAPEUTIX, INC.
STATEMENTS OF OPERATIONS and COMPREHENSIVE LOSS
(In thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 416 | $ | 238 | ||||
| Collaboration revenue | 42 | 188 | ||||||
| Total revenue: | 458 | 426 | ||||||
| Cost and operating expenses: | ||||||||
| Cost of product revenue | 99 | 56 | ||||||
| Research and development | 7,073 | 4,719 | ||||||
| Selling and marketing | 1,389 | 870 | ||||||
| General and administrative | 2,406 | 1,894 | ||||||
| Total costs and operating expenses | 10,967 | 7,539 | ||||||
| Loss from operations | (10,509 | ) | (7,113 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 87 | 40 | ||||||
| Interest expense | (418 | ) | (505 | ) | ||||
| Total other expense, net | (331 | ) | (465 | ) | ||||
| Net loss | $ | (10,840 | ) | $ | (7,578 | ) | ||
| Net loss per share, basic and diluted | $ | (0.44 | ) | $ | (0.35 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 24,751,682 | 21,362,731 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (10,840 | ) | $ | (7,578 | ) | ||
| Other comprehensive income: | ||||||||
| Unrealized gains on marketable securities | 68 | |||||||
| Total other comprehensive income | 68 | |||||||
| Total comprehensive loss | $ | (10,772 | ) | $ | (7,578 | ) |
OCULAR THERAPEUTIX, INC.
thousands, except share and per share data)
| March 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,212 | $ | 30,784 | ||||
| Marketable securities | 49,244 | 74,280 | ||||||
| Accounts receivable | 227 | 193 | ||||||
| Inventory | 127 | 134 | ||||||
| Prepaid expenses and other current assets | 1,287 | 1,592 | ||||||
| Total current assets | 97,097 | 106,983 | ||||||
| Property and equipment, net | 3,107 | 3,095 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 100,432 | $ | 110,306 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,063 | $ | 1,957 | ||||
| Accrued expenses and deferred rent | 2,779 | 3,379 | ||||||
| Deferred revenue | 42 | |||||||
| Notes payable, net of discount, current | 1,161 | |||||||
| Total current liabilities | 6,003 | 5,378 | ||||||
| Deferred rent, long-term | 55 | 68 | ||||||
| Notes payable, net of discount, long-term | 14,204 | 15,272 | ||||||
| Total liabilities | 20,262 | 20,718 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at March 31, 2016 and December 31, 2015; no shares issued or outstanding at March 31, 2016 and December 31, 2015 | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2016 and December 31, 2015 , respectively; 24,758,786 and 24,750,281 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 220,184 | 218,830 | ||||||
| Accumulated deficit | (140,016 | ) | (129,176 | ) | ||||
| Accumulated other comprehensive loss | (68 | ) | ||||||
| Total stockholders equity | 80,170 | 89,588 | ||||||
| Total liabilities and stockholders equity | $ | 100,432 | $ | 110,306 |