Ocular Therapeutix™ Reports Second Quarter 2016 Financial Results and Provides Corporate Update
Conference call today at
“The second half of 2016 will be a busy time for
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
A New Drug Application (NDA) for DEXTENZA (dexamethasone insert) 0.4
mg, for intracanalicular use in the treatment of ocular pain occurring
after ophthalmic surgery is pending with the
U.S. Food and Drug Administration( FDA).
July 2016, Ocular Therapeutixreceived a complete response letter (CRL) from the FDAthat identified issues pertaining to deficiencies in the manufacturing process and controls, originally identified during a pre-NDA approval inspection of the Company’s manufacturing facility. The CRL for DEXTENZA did not identify efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA.
FDArecently issued a letter noting that the corrective actions detailed in the Company’s responses as a whole appear to address the ten inspectional observations raised in the Form 483 with one exception which relates to the proposed process for identity testing of an incoming inert gas component used in the DEXTENZA manufacturing process. The FDAalso requested that the Company provide evidence (e.g., a final report) when migration to automatic integration of analytical testing is complete, which is anticipated during the third quarter of 2016.
FDAgrant marketing approval for DEXTENZA for the treatment of ocular pain occurring after ophthalmic surgery by the end of 2016, the Company expects to apply for a pass-through reimbursement code used in the hospital and ambulatory surgery center setting and launch this product in the first half of 2017.
Ocular Therapeutixhas completed enrollment in a third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain.
- The Company expects topline results from the trial to be available in the fourth quarter of 2016.
If the Company obtains favorable results from this third Phase 3
trial and subject to approval of the NDA for post-surgical ocular
pain by the
FDA, the Company intends to submit an NDA supplement for DEXTENZA aiming to broaden the label to include a post-surgical inflammation indication.
DEXTENZA for the treatment of allergic conjunctivitis
To date, the Company has conducted two Phase 3 clinical trials for
DEXTENZA for the treatment of allergic conjunctivitis. The first trial
met the primary endpoint for ocular itching. In
June 2016, the Company reported that the second trial did not meet the single primary efficacy endpoint of ocular itching.
Following the second Phase 3 trial, a meeting was held with the
FDAto discuss the results. Pending receipt of written feedback from the FDA, the Company will provide further guidance on the clinical development path forward for this indication at a later time.
DEXTENZA for the treatment of dry eye disease
Ocular Therapeutixhas completed a Phase 2 clinical trial of DEXTENZA for the treatment of dry eye. In this trial, signs of total corneal staining decreased by a statistically significant level from baseline in the DEXTENZA group compared to placebo group.
- A range of objective and subjective measures (signs and symptoms, respectively) and potential clinical trial designs are being evaluated for additional clinical development in dry eye-related indications.
OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension
Ocular Therapeutixplans to initiate the first of two planned Phase 3 clinical trials for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension during the third quarter of 2016.
- The primary efficacy endpoint will be the reduction of intraocular pressure (IOP) from baseline in the OTX-TP treatment arm compared to a placebo arm.
- Importantly, the Phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm.
Second Quarter 2016 Financial Results
June 30, 2016, cash, cash equivalents and marketable securities totaled $83.9 million. Cash used in operating activities was $9.8 millionin the second quarter of 2016, compared to $8.5 millionfor the second quarter of 2015. There was $15.6 millionin outstanding debt as of June 30, 2016and no principal payments are due until January 2017. 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 third quarter of 2017.
Ocular Therapeutixreported a net loss of approximately $11.4 million, or $(0.46)per share, for the quarter ended June 30, 2016, compared to a net loss of $10.0 million, or $(0.45)per share, for the quarter ended June 30, 2015. The second quarter 2016 results include $1.5 millionin non-cash charges for stock-based compensation compared to $1.2 millionin such non-cash charges in the second quarter of 2015.
Total costs and operating expenses for the quarter ended
June 30, 2016were $11.5 million, as compared to $10.1 millionfor the quarter ended June 30, 2015. Research and development (R&D) expenses for the quarter ended June 30, 2016were $7.0 million, compared to $6.7 millionfor the quarter ended June 30, 2015. The increases in total costs and operating expenses primarily reflect activities associated with the third Phase 3 trial of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery and an increase in sales and marketing expenses as we prepare for the potential launch of DEXTENZA for ocular pain indication subject to FDAapproval of our NDA, as well as preclinical development of the Company’s anti-VEGF and TKI programs for the treatment of wet age-related macular degeneration and other back of the eye diseases.
Ocular Therapeutixgenerated $441,000in revenue during the three months ended June 30, 2016from product sales of ReSure® Sealant.
June 30, 2016, there were approximately 24.8 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the
The live webcast can be accessed by visiting the investor section of the
Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the conference call. The conference ID
number for the live call will be 58560807. An archive of the webcast
will be available until
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development and regulatory status of the Company’s product candidates,
such as the Company’s expectations and plans regarding regulatory
submissions for and the timing and conduct of clinical trials of
DEXTENZA™ for post-surgical ocular inflammation and pain, including our
expectations regarding the NDA filed with the
OCULAR THERAPEUTIX, INC.
STATEMENTS OF OPERATIONS and COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Three Months Ended
Six Months Ended
|Costs and operating expenses:|
|Cost of product revenue||105||80||204||136|
|Research and development||6,978||6,743||14,051||11,462|
|Selling and marketing||1,492||1,041||2,881||1,911|
|General and administrative||2,973||2,230||5,379||4,124|
|Total costs and operating expenses||11,548||10,094||22,515||17,633|
|Loss from operations||(11,107||)||(9,635||)||(21,616||)||(16,748||)|
|Other income (expense):|
|Other income (expense), net||—||3||—||3|
|Total other expense, net||(338||)||(374||)||(669||)||(839||)|
|Net loss per share, basic and diluted||$||(0.46||)||$||(0.45||
|Weighted average common shares outstanding, basic and diluted||24,770,059||22,167,274||24,761,498||21,765,087|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on marketable securities||10||(8||)||78||(8||)|
|Total other comprehensive income (loss)||10||(8||)||78||(8||)|
|Total comprehensive loss||$||(11,435||)||$||(10,017||)||$||(22,207||)||$||(17,595||)|
OCULAR THERAPEUTIX, INC.
(In thousands, except share and per share data)
|Cash and cash equivalents||$||48,170||$||30,784|
|Prepaid expenses and other current assets||715||1,592|
|Total current assets||84,974||106,983|
|Property and equipment, net||3,199||3,095|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||2,342||3,379|
|Notes payable, net of discount, current||2,466||—|
|Total current liabilities||6,419||5,378|
|Deferred rent, long-term||42||68|
|Notes payable, net of discount, long-term||12,992||15,272|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized at June 30, 2016 and December 31, 2015; no shares issued or outstanding at June 30, 2016 and December 31, 2015||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2016 and December 31, 2015 , respectively; 24,821,530 and 24,750,281 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively||2||2|
|Additional paid-in capital||221,897||218,830|
|Accumulated other comprehensive income (loss)||10||(68||)|
|Total stockholders’ equity||70,448||89,588|
|Total liabilities and stockholders’ equity||$||89,901||$||110,306|
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing