Full Press Release Details
Ocular TherapeutixTM 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 5:00 pm Eastern Time
BEDFORD, MA, August 10, 2015 (BUSINESS WIRE): 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 second quarter ended June 30, 2015.
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 FDA for a post-surgical ocular pain indication and initiate a third Phase 3 clinical
trial for the treatment of post-surgical ocular inflammation and pain in the fourth quarter of 2015. In addition, we have completed patient enrollment in a Phase 3 clinical trial with DEXTENZA for the treatment of allergic conjunctivitis and for our
exploratory Phase 2 clinical trial for the treatment of inflammatory dry eye, as part of our strategy to expand clinical indications for DEXTENZA, said Amar Sawhney, Ph.D., President and Chief Executive Officer. We have also closed
patient enrollment in our Phase 2b clinical trial of OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension and expect topline efficacy data in the fourth quarter.
Dr. Sawhney further commented, On the corporate development front, we also made important progress during this quarter, highlighted by the closing
of a $101 million follow-on public offering, which resulted in approximately $66 million in net proceeds to the Company. These proceeds will be used to further the clinical development of DEXTENZA for post-operative pain and inflammation, expanded
indications for DEXTENZA and OTX-TP for the treatment of glaucoma and ocular hypertension, as well as preclinical development of our sustained release hydrogel depot for the intravitreal delivery of anti-VEGF drugs for the treatment of wet AMD. We
believe we are well-positioned to further execute on our vision of leading the development of sustained ophthalmic therapies with proprietary tailored hydrogels to improve patient experience and outcomes.
Recent Highlights 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
Second 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 98596258. An archive of the webcast will be available until August 24, 2015 on the company s website.
Ocular Therapeutix, Inc.
Ocular Therapeutix, 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, 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
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
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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 334 | $ | 97 | $ | 572 | $ | 124 | ||||||||
| Collaboration revenue | 125 | 313 | ||||||||||||||
| Total revenue: | 459 | 97 | 885 | 124 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| 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): | ||||||||||||||||
| Interest income | 28 | 1 | 68 | 2 | ||||||||||||
| Interest expense | (405 | ) | (257 | ) | (910 | ) | (300 | ) | ||||||||
| Other income (expense), net | 3 | (190 | ) | 3 | (331 | ) | ||||||||||
| Total other expense, net | (374 | ) | (446 | ) | (840 | ) | (629 | ) | ||||||||
| Net loss | (10,009 | ) | (6,392 | ) | (17,587 | ) | (13,400 | ) | ||||||||
| 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 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (10,009 | ) | $ | (6,392 | ) | $ | (17,587 | ) | $ | (13,411 | ) | ||||
| 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.
thousands, except share and per share data)
| June 30, 2015 | December 31, 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 78,686 | $ | 37,393 | ||||
| Marketable securities | 45,036 | 37,435 | ||||||
| Accounts receivable | 164 | 329 | ||||||
| Inventory | 145 | 133 | ||||||
| Prepaid expenses and other current assets | 2,608 | 893 | ||||||
| Total current assets | 126,639 | 76,183 | ||||||
| Property and equipment, net | 2,603 | 1,782 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 129,470 | $ | 78,193 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,812 | $ | 1,316 | ||||
| Accrued expenses | 2,284 | 3,016 | ||||||
| Deferred revenue | 125 | 188 | ||||||
| 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 | ||||||
| Total liabilities | 20,358 | 19,497 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| 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 deficit | (107,015 | ) | (89,428 | ) | ||||
| Accumulated other comprehensive loss | (8 | ) | ||||||
| Total stockholders equity | 109,112 | 58,696 | ||||||
| Total liabilities and stockholders equity | $ | 129,470 | $ | 78,193 |