Ocular Therapeutix™ Reports First Quarter 2017 Financial Results
PDUFA Target Action Date of
Enrollment Continues in First Phase 3 Clinical Trial of OTX-TP (travoprost insert) for the Treatment of Glaucoma and Ocular Hypertension
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Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
A New Drug Application (NDA) for DEXTENZA (dexamethasone insert) 0.4mg
for intracanalicular use is currently under review by the
U.S. Food and Drug Administration( FDA) for the treatment of ocular pain following ophthalmic surgery. The FDAhas set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017for a decision regarding the potential approval of DEXTENZA. Following a re-inspection of manufacturing operations by the FDAwhich was completed earlier this week, Ocular Therapeutixreceived an FDA Form 483 containing inspectional observations focused on procedures for manufacturing processes and analytical testing, related to manufacture of drug product for commercial production. The Company plans to evaluate and respond to the FDAwithin 15 days with corrective action plans to complete the inspection process. Adequate resolution of the outstanding Form 483 inspectional observations is a prerequisite to the approval of the NDA for DEXTENZA.
Subject to the approval of the NDA for post-surgical ocular pain
FDA, Ocular Therapeutixintends to submit an NDA supplement for DEXTENZA to broaden its label to include an indication for post-surgical ocular inflammation.
- Subject to the approval of the NDA for post-surgical ocular pain by the
Ocular Therapeutixplans to present additional data from its most recent Phase 3 study evaluating the efficacy and safety of DEXTENZA for the treatment of ocular pain and inflammation following cataract surgery, at the upcoming American Society of Cataract and Refractive Surgery(ASCRS) Annual Meeting, being held today through Tuesday, May 9, in Los Angeles, CA.
- Additional presentations will be made at the meeting regarding recent positive results of a patient experience study of DEXTENZA as well as the importance of the assessment of ocular pain.
In addition, DEXTENZA is in Phase 3 clinical development for the
treatment of allergic conjunctivitis. In
May 2017, the Company initiated a non-significant risk device study to confirm the effect on efficacy of the placebo insert used in previous studies compared with a rapidly resorbing placebo insert.
- Subject to favorable results from this study, the Company plans to conduct an additional Phase 3 clinical trial to further evaluate DEXTENZA for the treatment of allergic conjunctivitis.
OTX-TP (travoprost insert)
Ocular Therapeutixcontinues to enroll patients in its first Phase 3 clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension.
- The Company plans to commence its second Phase 3 clinical trial with OTX-TP for the treatment of glaucoma and ocular hypertension in the second half of 2017.
- If approved, OTX-TP may potentially become the first non-invasive, sustained release therapy for the treatment of glaucoma.
Sustained release intravitreal depots for the treatment of serious retinal diseases
In partnership with
Regeneron Pharmaceuticals, Ocular Therapeutixcontinues to advance the development of an extended release hydrogel-based formulation of Regeneron’s protein-based anti-vascular endothelial growth factor (VEGF) trap, aflibercept, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.
Regeneron’s aflibercept is currently approved by the
FDAfor certain indications under the brand name EYLEA®.
- Regeneron’s aflibercept is currently approved by the
Ocular Therapeutixcontinues to advance the development of its proprietary hydrogel platform technology for intravitreal drug delivery with tyrosine-kinase inhibitors (TKIs).
Ocular Therapeutixplans to present efficacy, tolerability and pharmacokinetics data with its OTX-TKI product candidate at the upcoming Association for Research in Vision and Ophthalmology(ARVO) Annual Meeting, being held May 7-11, in Baltimore, MD.
- The Company expects to enter Phase 1 clinical testing with OTX-TKI in the second half of 2017.
First Quarter 2017 Financial Results
March 31, 2017, cash, cash equivalents and marketable securities totaled $80.4 million. This includes the net proceeds from a recently completed registered underwritten public offering of $23.3 millionof shares of common stock pursuant to a shelf registration statement that was previously filed with and declared effective by the Securities and Exchange Commission. Cash used in operating activities was $14.6 millionin the first quarter of 2017, compared to $9.3 millionfor the first quarter of 2016. The Company expects that cash, cash equivalents and marketable securities will be sufficient to fund operating expenses, debt service obligations and capital expenditures through the second quarter of 2018. The Company will need to obtain additional capital to support the planned commercial launch of DEXTENZA, subject to FDAapproval.
$18.0 millionin outstanding debt as of March 31, 2017. In March 2017, the Company amended the terms of its existing credit facility to increase the total commitment to $38.0 million, including $18.0 millionfunded at closing, which was used primarily to pay-off outstanding balances as of the closing date, and options on two additional tranches of $10.0 million, the availability of each of which is based on the achievement of regulatory and commercial milestones. The interest-only payment period was extended through February 1, 2018, with provisions to further extend the interest-only period based on the achievement of certain regulatory and commercial milestones.
Ocular Therapeutixreported a net loss of approximately $(16.0) million, or $(0.58)per share, for the quarter ended March 31, 2017, compared to a net loss of $(10.8) million, or $(0.44)per share, for the quarter ended March 31, 2016. The first quarter 2017 results include $2.0 millionin non-cash charges for stock-based compensation and depreciation compared to $1.6 millionin such non-cash charges in the first quarter of 2016.
Total costs and operating expenses for the quarter ended
March 31, 2017were $16.1 million, as compared to $11.0 millionfor the quarter ended March 31, 2016. Research and development (R&D) expenses for the quarter ended March 31, 2017were $6.7 million, compared to $7.1 millionfor the quarter ended March 31, 2016. The Company continues to advance the clinical and preclinical development of its hydrogel platform technology and its portfolio of drug product candidates. Selling and marketing expenses for the quarter ended March 31, 2017were $6.0 million, compared to $1.4 millionfor the quarter ended March 31, 2016. The 2017 increase represents the costs of pre-commercial activities in preparation for the planned commercial launch of DEXTENZA, subject to FDAapproval.
Ocular Therapeutixgenerated $0.5 millionin revenue during the three-month period ended March 31, 2017from product sales of ReSure® Sealant.
March 31, 2017, there were approximately 28.9 million shares issued and outstanding.
Conference Call & Webcast Information
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About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company including the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA™ for the treatment of post-surgical ocular inflammation and pain, including our expectations regarding the NDA filed with the FDA and the FDA’s response to the resubmitted NDA and the potential impact of the re-inspection of manufacturing operations, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel technology, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, the potential benefits and future operation of the collaboration with
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended|
|Costs and operating expenses:|
|Cost of product revenue||115||99|
|Research and development||6,729||7,073|
|Selling and marketing||6,027||1,389|
|General and administrative||3,276||2,406|
|Total costs and operating expenses||16,147||10,967|
|Loss from operations||(15,672||)||(10,509||)|
|Other income (expense):|
|Total other expense, net||(351||)||(331||)|
|Net loss per share, basic and diluted||$||(0.58||)||$||(0.44||)|
|Weighted average common shares outstanding, basic and diluted||27,643,746||24,751,682|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on marketable securities||(4||)||68|
|Total other comprehensive income (loss)||(4||)||68|
|Total comprehensive loss||$||(16,027||)||$||(10,772||)|
(In thousands, except share and per share data)
|March 31,||December 31,|
|Cash and cash equivalents||$||54,682||$||32,936|
|Prepaid expenses and other current assets||2,557||1,390|
|Total current assets||83,276||69,898|
|Property and equipment, net||5,693||3,313|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||4,005||4,635|
|Notes payable, net of discount, current||897||1,549|
|Total current liabilities||8,656||8,300|
|Deferred rent, long-term||1,315||537|
|Notes payable, net of discount, long-term||16,821||14,094|
|Commitments and contingencies|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at
Common stock, $0.0001 par value; 100,000,000 shares authorized at
|Additional paid-in capital||253,813||225,889|
|Accumulated other comprehensive loss||(9||)||(5||)|
|Total stockholders’ equity||63,905||52,008|
|Total liabilities and stockholders’ equity||$||90,697||$||74,939|
Sandra Correa, 646-599-8637
Media and Business Group Director
Ocular Therapeutix, Inc.
Vice President of Marketing & Commercial Operations
Burns McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006