Ocular Therapeutix™ Reports Second Quarter 2015 Financial Results
Clinical Programs Advance with Patient Enrollment Finalized in Three Clinical Trials: Phase 3 Allergic Conjunctivitis Trial, Phase 2b Glaucoma Trial and Phase 2 Inflammatory Dry Eye Trial
Follow-on Public Offering of 4 Million Shares Completed
Conference Call Today at
“We continued to make strong progress in our development programs this
quarter and look forward to several significant clinical milestones
expected during the second half of 2015. For our lead product candidate,
DEXTENZA™ (sustained release dexamethasone, 0.4mg), we remain on track
to submit an NDA to the
Dr. Sawhney further commented, “On the corporate development front, we
also made important progress during this quarter, highlighted by the
closing of a
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
- Submission of an NDA for DEXTENZA for a post-surgical ocular pain indication expected in the fourth quarter of 2015.
Initiation of a third Phase 3 clinical trial for DEXTENZA for
post-surgical ocular inflammation and pain expected in the fourth
quarter of 2015 with modifications to the trial design based on
learnings from the previously completed Phase 3 trials, made
subsequent to a pre-NDA meeting with the
Food and Drug Administrationin April 2015.
- Submission of an NDA supplement for DEXTENZA expected in the second half of 2016 to broaden the indication to include treatment of post-surgical ocular inflammation, subject to favorable results from the third Phase 3 clinical trial and the approval of the NDA for DEXTENZA for the pain indication.
DEXTENZA for the treatment of allergic conjunctivitis and inflammatory dry eye disease
- DEXTENZA is being investigated for the treatment of allergic conjunctivitis, and has completed enrollment in a Phase 3 clinical trial. Topline efficacy data from the Phase 3 trial is expected in the fourth quarter of 2015, for which the primary endpoints are ocular itching and conjunctival redness. Ocular itching is the labeling for many currently marketed prescription eye drops for allergic conjunctivitis.
- DEXTENZA is also being investigated for the treatment of inflammatory dry eye disease and is in an exploratory Phase 2 clinical trial which is now fully enrolled, with topline efficacy data expected in the fourth quarter of 2015.
OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma
The Company’s OTX-TP product candidate for the treatment of glaucoma
and ocular hypertension is being evaluated in a Phase 2b clinical
trial at multiple sites in
the United States. Enrollment is now closed and the company expects to report topline efficacy data in the fourth quarter of 2015. This trial has been designed to further assist in the Phase 3 clinical design and to estimate treatment effect relative to timolol, determine the duration of effect up to 3 months and to assess patients’ ability to self-assess the presence of the drug product.
Second Quarter 2015 Financial Results
Ocular Therapeutixreported a net loss of approximately $10.0 million, or $(0.45)per share, for the quarter ended June 30, 2015, compared to a net loss of $6.4 million, or $(2.10)per share, for the quarter ended June 30, 2014. The second quarter 2015 results include $1.2 millionin non-cash charges for stock-based compensation compared to $0.6 millionin non-cash charges for stock-based compensation.
Total operating expenses for the quarter ended
June 30, 2015were $10.1 millionas compared to $6.0 millionfor the quarter ended June 30, 2014. Research and development (R&D) expenses for the quarter ended June 30, 2015were $6.7 million, compared to $4.3 millionfor the quarter ended June 30, 2014. The increase is primarily related to personnel costs and clinical trials of DEXTENZA and OTX-TP product candidates.
Ocular Therapeutixgenerated $0.5 millionin revenue during the three months ended June 30, 2015from product sales of ReSure® Sealant and from collaborations with corporate partners.
June 30, 2015, cash and cash equivalents and marketable securities totaled $123.7 million. Cash used in operating activities was $15.4 millionfor the six months ended June 30, 2015.
$15.0 millionin outstanding debt as of June 30, 2015, with an interest only period through September 30, 2015.
August 7, 2015, there were approximately 24.7 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 98596258. 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 of the Company’s product candidates, such as the Company’s
plans for regulatory submissions and the design, initiation and conduct
of a third clinical trial of DEXTENZA™ for post-surgical inflammation
and pain, the ongoing development of the Company’s sustained release
hydrogel depot technology, the timing and conduct of the Company’s Phase
2b clinical trial of OTX-TP for the treatment of glaucoma and ocular
hypertension, the Company’s Phase 3 clinical trials of DEXTENZA for
allergic conjunctivitis and the Company’s Phase 2 clinical trial of
OTX-DP for the treatment of inflammatory dry eye disease, the
advancement of the Company's other 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
Ocular Therapeutix, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
Three Months Ended
Six Months Ended
|Cost of product revenue||80||20||136||29|
|Research and development||6,743||4,292||11,462||9,250|
|Selling and marketing||1,041||535||1,911||845|
|General and administrative||2,230||1,196||4,124||2,771|
|Total operating expenses||10,094||6,043||17,633||12,895|
|Loss from operations||(9,635||)||(5,946||)||(16,748||)||(12,771||)|
|Other income (expense):|
|Other income (expense), net||3||(190||)||3||(331||)|
|Total other expense, net||(374||)||(446||)||(840||)||(629||)|
|Accretion of redeemable convertible preferred stock to redemption value||—||(5||)||—||(11||)|
|Net loss attributable to common stockholders||$||(10,009||)||$||(6,397||)||$||(17,587||)||$||(13,411||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.45||)||$||(2.10||)||$||(0.81||)||$||(4.54||)|
|Weighted average common shares outstanding, basic and diluted||22,167,274||3,044,605||21,765,087||2,952,689|
|Other comprehensive loss:|
|Unrealized loss on marketable securities||(8||)||—||(8||)||—|
|Total other comprehensive loss||(8||)||—||(8||)||—|
|Total comprehensive loss||$||(10,017||)||$||(6,392||)||$||(17,595||)||$||(13,411||)|
OCULAR THERAPEUTIX, INC.
(In thousands, except share and per share data)
|Cash and cash equivalents||$||78,686||$||37,393|
|Prepaid expenses and other current assets||2,608||893|
|Total current assets||126,639||76,183|
|Property and equipment, net||2,603||1,782|
|Liabilities and Stockholders’ Equity|
|Notes payable, net of discount, current||4,370||1,354|
|Total current liabilities||9,591||5,874|
|Deferred rent, long-term||94||112|
|Notes payable, net of discount, long-term||10,673||13,511|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 authorized at June 30, 2015 and December 31, 2014; no shares issued or outstanding at June 30, 2015 and December 31, 2014||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2015 and December 31, 2014; 24,719,225 and 21,333,507 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively||2||2|
|Additional paid-in capital||216,133||148,122|
|Accumulated other comprehensive loss||
|Total stockholders’ equity||109,112||58,696|
|Total liabilities and stockholders’ equity||$||129,470||$||78,193|
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing