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Conference Call Today at 5:00pm Eastern Time
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the second quarter ended June 30, 2017, and provided a corporate update.
“This is an important time for Ocular Therapeutix as we focus our efforts on the resubmission of our NDA for DEXTENZA™ for the treatment of post-surgical ocular pain while continuing to advance our pipeline programs,” said Antony Mattessich, Chief Executive Officer. “My goal as CEO is to fully realize the opportunities for Ocular Therapeutix by deepening the Company’s expertise in biopharmaceuticals. I believe our hydrogel technology represents an important innovation in the field of ophthalmology and has great potential to improve outcomes across a wide range of diseases of the eye by improving the performance of both small and large molecules. We are focused on execution and working as diligently as possible to achieve our vision.”
Recent Updates and Anticipated Near-Term Milestones Across Key Development Programs
DEXTENZA™ for the treatment of post-surgical ocular inflammation and pain
OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension
OTX-TIC (travoprost intracameral injection) for the treatment of moderate to severe glaucoma and ocular hypertension
Sustained release intravitreal depots for the treatment of serious retinal diseases
Second Quarter 2017 Financial Results
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 5:00pm Eastern Time to review the Company's financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors 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 live conference call. The conference ID number for the live call will be 59980638. An archive of the webcast will be available until August 22, 2017 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development, manufacturing 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™ (dexamethasone insert) 0.4 mg for intracanalicular use has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery. 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.
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 product development efforts and regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA for the treatment of post-surgical ocular inflammation and pain, including with respect to the manufacturing deficiencies identified by the FDA and the prospects for approvability of DEXTENZA for these indications, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release intravitreal depot, the potential utility of any of the Company’s product candidates, potential commercialization 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 manufacturing operations, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the availability 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||Six Months Ended|
|June 30,||June 30,|
|Costs and operating expenses:|
|Cost of product revenue||104||105||219||204|
|Research and development||8,117||6,978||14,846||14,051|
|Selling and marketing||6,832||1,492||12,859||2,881|
|General and administrative||3,724||2,973||7,000||5,379|
|Total costs and operating expenses||18,777||11,548||34,924||22,515|
|Loss from operations||(18,339||)||(11,107||)||(34,011||)||(21,616||)|
|Other income (expense):|
|Total other expense, net||(355||)||(338||)||(706||)||(669||)|
|Net loss per share, basic and diluted||$||(0.64||)||$||(0.46||)||$||(1.22||)||$||(0.90||)|
|Weighted average common shares outstanding, basic and diluted||29,026,259||24,770,059||28,352,348||24,761,498|
|Other comprehensive income (loss):|
|Unrealized gain on marketable securities||9||10||5||78|
|Total other comprehensive income||9||10||5||78|
|Total comprehensive loss||$||(18,685||)||$||(11,435||)||$||(34,712||)||$||(22,207||)|
(In thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||63,049||$||32,936|
|Prepaid expenses and other current assets||1,978||1,390|
|Total current assets||68,328||69,898|
|Property and equipment, net||9,619||3,313|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||4,379||4,635|
|Notes payable, net of discount, current||2,444||1,549|
|Total current liabilities||13,130||8,300|
|Deferred rent, long-term||3,146||537|
|Notes payable, net of discount, long-term||15,374||14,094|
|Commitments and contingencies (Note 11)|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized at June 30, 2017 and December 31, 2016; no shares issued or outstanding at June 30, 2017 and December 31, 2016||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2017 and December 31, 2016; 29,055,460 and 25,024,100 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively||3||3|
|Additional paid-in capital||256,618||225,889|
|Accumulated other comprehensive loss||—||(5||)|
|Total stockholders’ equity||48,025||52,008|
|Total liabilities and stockholders’ equity||$||79,675||$||74,939|
Steve Klass, 212-213-0006
Interim Chief Financial Officer
Vice President of Marketing & Commercial Operations
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