Full Press Release Details
Ocular Therapeutix Reports Third Quarter 2015 Financial Results
Advances in Clinical Programs Include NDA Submission for DEXTENZATM (sustained release
dexamethasone, 0.4mg) for the Treatment of Post-Surgical Ocular Pain
Results Reported for Phase 3 Allergic Conjunctivitis and Phase
2b Glaucoma Programs
Conference Call Today at 5:00 pm Eastern Time
BEDFORD, Mass. November 10, 2015 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, 2015.
Our product development programs advanced meaningfully during the third quarter with an NDA submission to the Food and Drug Administration for our lead
product candidate, DEXTENZA for a post-surgical ocular pain indication, as well as the reporting of clinical trial results of DEXTENZA in our Phase 3 allergic conjunctivitis program and our Phase 2b glaucoma program, said Amar Sawhney, Ph.D.,
President and Chief Executive Officer. We are pleased by the productivity of our research and clinical teams, who are dedicated to developing sustained-release ophthalmic therapies with proprietary tailored hydrogels that offer
perservative-free, one-time administration or once in every few months therapy with potentially greater compliance and better patient outcomes.
Clinical and Corporate Updates during the Third Quarter 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 and inflammatory dry eye disease
OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma
American Academy of Ophthalmology (AAO) and Ophthalmology Innovation Summit (OIS) Meetings
Expansion and Strengthening of the Board of Directors
The Company strengthened its Board of Directors with two appointments:
Third Quarter 2015 Financial Results
Conference Call & Webcast Information
of the Ocular Therapeutix management team will host a live conference call and webcast today at 5:00 pm 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 71925202. An archive of the webcast will be available until November 24, 2015 on the company s website.
About Ocular Therapeutix, Inc.
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 candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis, and Phase 2 clinical development for glaucoma and inflammatory dry eye disease. 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 Company s plans for regulatory submissions and the design and conduct of a third clinical trial of DEXTENZATM for post-surgical inflammation and
pain, the timing and conduct of the Company s additional development work and clinical trials of OTX-TP for the treatment of glaucoma and ocular hypertension, the timing and conduct of a second Phase 3 clinical trial of DEXTENZA for the
treatment of allergic conjunctivitis and the Company s exploratory Phase 2 clinical trial of DEXTENZA for the treatment of inflammatory dry eye disease, the ongoing development of the
Company s sustained release hydrogel depot technology, the advancement of the Company s other product candidates, the potential utility of any of the Company s product candidates
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, 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
Minarovich, 212-213-0006
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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 388 | $ | 143 | $ | 960 | $ | 267 | ||||||||
| Collaboration revenue | 41 | 354 | ||||||||||||||
| Total revenue: | 429 | 143 | 1,314 | 267 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product revenue | 91 | 32 | 227 | 61 | ||||||||||||
| Research and development | 8,263 | 4,482 | 19,725 | 13,732 | ||||||||||||
| Selling and marketing | 798 | 479 | 2,709 | 1,324 | ||||||||||||
| General and administrative | 2,451 | 1,926 | 6,575 | 4,697 | ||||||||||||
| Total operating expenses | 11,603 | 6,919 | 29,236 | 19,814 | ||||||||||||
| Loss from operations | (11,174 | ) | (6,776 | ) | (27,922 | ) | (19,547 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 53 | 5 | 121 | 7 | ||||||||||||
| Interest expense | (406 | ) | (412 | ) | (1,316 | ) | (712 | ) | ||||||||
| Other income (expense), net | 3 | (111 | ) | 6 | (442 | ) | ||||||||||
| Total other expense, net | (350 | ) | (518 | ) | (1,189 | ) | (1,147 | ) | ||||||||
| Net loss | (11,524 | ) | (7,294 | ) | (29,111 | ) | (20,694 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (11 | ) | ||||||||||||||
| Net loss attributable to common stockholders | $ | (11,524 | ) | $ | (7,294 | ) | $ | (29,111 | ) | $ | (20,705 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.47 | ) | $ | (0.48 | ) | $ | (1.28 | ) | $ | (2.93 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 24,713,597 | 15,165,612 | 22,757,646 | 7,068,399 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (11,524 | ) | $ | (7,294 | ) | $ | (29,111 | ) | $ | (20,694 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on marketable securities | (8 | ) | (16 | ) | ||||||||||||
| Total other comprehensive loss | (8 | ) | (16 | ) | ||||||||||||
| Total comprehensive loss | $ | (11,532 | ) | $ | (7,294 | ) | $ | (29,127 | ) | $ | (20,694 | ) |
OCULAR THERAPEUTIX, INC.
thousands, except share and per share data)
| September 30, 2015 | December 31, 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 41,198 | $ | 37,393 | ||||
| Marketable securities | 72,445 | 37,435 | ||||||
| Accounts receivable | 189 | 329 | ||||||
| Inventory | 147 | 133 | ||||||
| Prepaid expenses and other current assets | 1,919 | 893 | ||||||
| Total current assets | 115,898 | 76,183 | ||||||
| Property and equipment, net | 3,193 | 1,782 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 119,319 | $ | 78,193 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,624 | $ | 1,316 | ||||
| Accrued expenses | 3,591 | 3,016 | ||||||
| Deferred revenue | 83 | 188 | ||||||
| Notes payable, net of discount, current | 5,883 | 1,354 | ||||||
| Total current liabilities | 11,181 | 5,874 | ||||||
| Deferred rent, long-term | 81 | 112 | ||||||
| Notes payable, net of discount, long-term | 9,249 | 13,511 | ||||||
| Total liabilities | 20,511 | 19,497 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 authorized at September 30, 2015 and December 31, 2014; no shares issued or outstanding at September 30, 2015 and December 31, 2014 | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at September 30, 2015 and December 31, 2014; 24,730,061 and 21,333,507 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 217,361 | 148,122 | ||||||
| Accumulated deficit | (118,539 | ) | (89,428 | ) | ||||
| Accumulated other comprehensive loss | (16 | ) | ||||||
| Total stockholders equity | 98,808 | 58,696 | ||||||
| Total liabilities and stockholders equity | $ | 119,319 | $ | 78,193 |