Full Press Release Details
Ocular Therapeutix Reports Third Quarter 2016 Financial Results and Provides
Preparing to Resubmit NDA for DEXTENZA for the Treatment of Ocular Pain Occurring After
Ophthalmic Surgery to FDA by the End of 2016
Began Enrollment in First Phase 3 Clinical Trial with OTX-TP (Sustained Release Travoprost) for
the Treatment of Glaucoma and Ocular Hypertension
Entered Into Strategic Collaboration with Regeneron to Develop Sustained Release Formulation
of Aflibercept for the Treatment of Wet AMD and Other Serious Retinal Diseases
Conference Call Today at 8:30 am Eastern Time
BEDFORD, Mass, November 9, 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 third quarter ended September 30, 2016 and provided a general business update.
Following productive discussions with the FDA, we are preparing for the resubmission of our NDA for DEXTENZA for post-surgical ocular pain by the
end of the year, said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. We are also pleased to have commenced patient enrollment in our first Phase 3 clinical trial with OTX-TP for the treatment of glaucoma and ocular
hypertension. We believe that this is the first Phase 3 clinical trial to be conducted with a non-invasive, sustained release drug candidate for the treatment of glaucoma, and our goal is to address the major issue of low patient compliance rates
associated with currently approved topical therapies. Further, we are excited to have entered into a strategic collaboration with Regeneron to develop a potential first-in-class sustained release protein-based anti-VEGF hydrogel injection for the
treatment of wet AMD and other serious retinal diseases.
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
treatment of allergic conjunctivitis
OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension
Sustained release intravitreal depots for the treatment of serious retinal diseases
Third 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 8:30 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 8389302. An archive of the webcast will be available until November 23, 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 has submitted an NDA
for post-surgical pain for its lead product candidate, DEXTENZA (dexamethasone insert), which is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis. OTX-TP (travoprost insert) is in Phase
3 clinical development for glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating injectable drug delivery depots for back-of-the-eye diseases. Ocular Therapeutix s first product, ReSure Sealant, is FDA-approved to seal corneal incisions following cataract surgery. For additional information about the Company, please visit www.ocutx.com.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company including 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 the treatment of post-surgical ocular inflammation and
pain, including our expectations regarding the NDA filed with the FDA and the resubmission of the NDA, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of inflammatory 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, the potential utility of any of the Company s product candidates, potential commercialization of the Company s
product candidates, the potential benefits and future operation of the collaboration with Regeneron, including any potential future payments thereunder, 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.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 477 | $ | 388 | $ | 1,334 | $ | 960 | ||||||||
| Collaboration revenue | 41 | 42 | 354 | |||||||||||||
| Total revenue: | 477 | 429 | 1,376 | 1,314 | ||||||||||||
| Costs and operating expenses: | ||||||||||||||||
| Cost of product revenue | 112 | 91 | 316 | 227 | ||||||||||||
| Research and development | 5,686 | 8,263 | 19,737 | 19,725 | ||||||||||||
| Selling and marketing | 1,294 | 798 | 4,175 | 2,709 | ||||||||||||
| General and administrative | 2,623 | 2,451 | 8,002 | 6,575 | ||||||||||||
| Total costs and operating expenses | 9,715 | 11,603 | 32,230 | 29,236 | ||||||||||||
| Loss from operations | (9,238 | ) | (11,174 | ) | (30,854 | ) | (27,922 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 69 | 53 | 236 | 121 | ||||||||||||
| Interest expense | (426 | ) | (406 | ) | (1,262 | ) | (1,316 | ) | ||||||||
| Other income (expense), net | (1 | ) | 3 | (1 | ) | 6 | ||||||||||
| Total other expense, net | (358 | ) | (350 | ) | (1,027 | ) | (1,189 | ) | ||||||||
| Net loss | (9,596 | ) | (11,524 | ) | (31,881 | ) | (29,111 | ) | ||||||||
| Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (0.47 | ) | $ | (1.29 | ) | $ | (1.28 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 24,853,880 | 24,713,597 | 24,792,087 | 22,757,646 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (9,596 | ) | $ | (11,524 | ) | $ | (31,881 | ) | $ | (29,111 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities | (5 | ) | (8 | ) | 73 | (16 | ) | |||||||||
| Total other comprehensive income (loss) | (5 | ) | (8 | ) | 73 | (16 | ) | |||||||||
| Total comprehensive loss | $ | (9,601 | ) | $ | (11,532 | ) | $ | (31,808 | ) | $ | (29,127 | ) |
Ocular Therapeutix, Inc.
thousands, except share and per share data)
| September 30, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,234 | $ | 30,784 | ||||
| Marketable securities | 23,513 | 74,280 | ||||||
| Accounts receivable | 243 | 193 | ||||||
| Inventory | 126 | 134 | ||||||
| Prepaid expenses and other current assets | 708 | 1,592 | ||||||
| Total current assets | 76,824 | 106,983 | ||||||
| Property and equipment, net | 3,795 | 3,095 | ||||||
| Restricted cash | 1,728 | 228 | ||||||
| Total assets | $ | 82,347 | $ | 110,306 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,680 | $ | 1,957 | ||||
| Accrued expenses and deferred rent | 2,791 | 3,379 | ||||||
| Deferred revenue | 42 | |||||||
| Notes payable, net of discount, current | 3,772 | |||||||
| Total current liabilities | 8,243 | 5,378 | ||||||
| Deferred rent, long-term | 32 | 68 | ||||||
| Notes payable, net of discount, long-term | 11,778 | 15,272 | ||||||
| Total liabilities | 20,053 | 20,718 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at September 30, 2016 and December 31, 2015, no shares issued or outstanding at September 30, 2016 and December 31, 2015 | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at September 30, 2016 and December 31, 2015, 24,879,887 and 24,750,281 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 223,344 | 218,830 | ||||||
| Accumulated deficit | (161,057 | ) | (129,176 | ) | ||||
| Accumulated other comprehensive income (loss) | 5 | (68 | ) | |||||
| Total stockholders equity | 62,294 | 89,588 | ||||||
| Total liabilities and stockholders equity | $ | 82,347 | $ | 110,306 |
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing