Full Press Release Details
Ocular Therapeutix Reports Fourth Quarter and Full Year 2014 Financial Results
Both primary efficacy measures successfully achieved in the first of two Phase 3 clinical trials of OTX-DP for the treatment of post-surgical ocular inflammation and pain
NDA submission for OTX-DP for the treatment of
post-surgical ocular inflammation and pain expected in 2Q 2015
Initiation of Phase 3 clinical trials of OTX-DP for the treatment of
allergic conjunctivitis expected in the middle of 2015
Phase 2b clinical data on OTX-TP for glaucoma and ocular hypertension
anticipated in 4Q 2015
Conference Call Today at 8:00 am Eastern Time
BEDFORD, MA, March 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 fourth quarter and twelve months ended December 31, 2014.
2014 was an exceptional year for Ocular Therapeutix, with accelerated advancement of our sustained release drug delivery product candidates, and this
momentum is continuing into 2015, said Amar Sawhney, Ph.D., President and Chief Executive Officer. Earlier this morning, we announced that we successfully achieved both primary efficacy measures in our Phase 3a clinical trial evaluating
OTX-DP for the treatment of post-surgical ocular inflammation and pain. This is the first of our two Phase 3 clinical trials of OTX-DP for this indication, and we believe that this product candidate has the potential to meaningfully improve upon the
treatment modalities available to patients today. We are advancing our business on multiple fronts and expect to be reporting on a number of important milestones in 2015, the most imminent being Phase 3b clinical trial results and an NDA submission
for OTX-DP for the treatment of post-surgical ocular inflammation and pain. We also anticipate the initiation of Phase 3 clinical trials of OTX-DP for allergic conjunctivitis, results from our Phase 2 exploratory clinical trial of OTX-DP for the
treatment of inflammatory dry eye disease, and results of a Phase 2b clinical trial of our OTX-TP product candidate for glaucoma and ocular hypertension in 2015. Additionally, we will continue to advance our preclinical development efforts for
sustained-release delivery of anti-VEGF drugs for the treatment of wet AMD using our hydrogel depot, which we believe has potential to reduce the number of annual intravitreal injections patients receive for their condition.
Clinical Milestones and Corporate Developments
Anticipated Clinical and Regulatory Milestones
Fourth Quarter and Year Ended December 31, 2014 Financial Results
As of December 31, 2014, cash, cash equivalents and marketable securities totaled $74.8 million. Cash used in operating activities was $5.6 million in the
fourth quarter of 2014 and $20.5 million for the year ended December 2014. There was $15.0 million in outstanding debt as of December 31, 2014, with an interest only period through September 30, 2015. The Company expects that cash, cash
equivalents and marketable securities will be sufficient to fund operating expenses, debt service obligations and capital expenditures at least through the first half of 2016.
Ocular Therapeutix reported a net loss of approximately $8.0 million, or $(0.37) per share, for the quarter ended December 31, 2014, compared to a net
loss of $3.5 million, or $(1.32) per share, for the quarter ended December 31, 2013. The fourth quarter 2014 results include $1.0 million in non-cash charges for stock-based compensation compared to $0.1 million in such non-cash charges in the
fourth quarter of 2013. The Company reported a net loss of approximately $28.7 million, or $(2.69) per share, for the year ended December 31, 2014, compared to a net loss of $13.3 million, or $(5.11) per share, for the year ended
December 31, 2013. The 2014 results include $5.0 million in non-cash charges for stock-based compensation compared to $0.5 million in such non-cash charges in 2013.
Total operating expenses for the quarter ended December 31, 2014 were $8.0 million as compared to $3.4 million for the quarter ended December 31,
2013. Research and development (R&D) expenses for the quarter ended December 31, 2014 were $5.1 million, compared to $2.8 million for the quarter ended December 31, 2013. This increase in operating expenses is primarily related to
clinical trial activities, the expansion of the Company s product development programs and costs incurred in connection with operating as a public company.
The Company generated $0.5 million in revenue during the three months ended December 31, 2014, including collaboration revenue from feasibility
agreements with pharmaceutical company partners and revenue from sales of ReSure Sealant. Sales of ReSure Sealant commenced in the first quarter of 2014, and limited sales are anticipated in
2015 as the Company expects to defer the hiring of a direct sales force until the potential launch of its first sustained release drug delivery product, OTX-DP for the treatment of post-surgical inflammation
As of December 31, 2014, there were approximately 21.3 million shares outstanding.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast at 8:00 am Eastern Time on March 10, 2014 to discuss
the Company s financial results and provide a general business update.
The live webcast and a replay may be accessed by visiting Ocular s
website at investors.ocutx.com. Please connect to the Company s website 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 is 98833560. Please dial in approximately 10 minutes prior to the call. Following the webcast, an archived version
of the call will be available for three months.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. 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 Phase 2 clinical development for glaucoma, allergic
conjunctivitis, 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.
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 timing and conduct of the Company s Phase 3 clinical trials of OTX-DP for the treatment of post-surgical ocular inflammation and pain, the
potential submission of an NDA for OTX-DP for this indication, 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 OTX-DP
for allergic conjunctivitis and the Company s Phase 2 exploratory clinical trial of OTX-DP for the treatment of inflammatory dry eye disease, pre-commercial activities, the advancement of the Company s earlier stage pipeline, including the
timing and conduct of feasibility studies for the Company s hydrogel depot delivering anti-VEGF drugs, future sales of ReSure Sealant 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 Ocular Therapeutix 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 initiation and conduct of clinical trials,
availability of data from clinical trials and expectations for regulatory 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, the timing and costs involved in commercializing ReSure Sealant and other factors discussed in the Risk
Factors section contained in the Company s most recent Quarterly Report on Form 10-Q 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.
Statement of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months ended December 31, | Year ended December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Product revenue | $ | 193 | $ | $ | 460 | $ | ||||||||||
| Collaboration revenue | 312 | 312 | ||||||||||||||
| Total revenue | 505 | 772 | ||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Cost of product revenue | 30 | 91 | ||||||||||||||
| Research and development | 5,148 | 2,842 | 18,880 | 10,517 | ||||||||||||
| Selling and marketing | 658 | 197 | 1,982 | 625 | ||||||||||||
| General and administrative | 2,216 | 380 | 6,913 | 1,761 | ||||||||||||
| Total operating expenses | 8,052 | 3,419 | 27,866 | 12,903 | ||||||||||||
| Loss from operations | (7,547 | ) | (3,419 | ) | (27,094 | ) | (12,903 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 2 | 7 | 13 | |||||||||||||
| Interest expense | (407 | ) | (91 | ) | (1,119 | ) | (441 | ) | ||||||||
| Other (expense) income, net | 3 | (442 | ) | 14 | ||||||||||||
| Total other expense, net | (407 | ) | (86 | ) | (1,554 | ) | (414 | ) | ||||||||
| Net loss and comprehensive loss | (7,954 | ) | (3,505 | ) | (28,648 | ) | (13,317 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (5 | ) | (11 | ) | (27 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (7,954 | ) | $ | (3,510 | ) | $ | (28,659 | ) | $ | (13,344 | ) | ||||
| Net loss per share attributable to common stockholders per share, basic and diluted | $ | (0.37 | ) | $ | (1.32 | ) | $ | (2.69 | ) | $ | (5.11 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 21,289,378 | 2,659,726 | 10,652,865 | 2,609,020 |
OCULAR THERAPEUTIX, INC.
thousands, except share and per share data)
| December 31, | ||||||||
| 2014 | 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 37,393 | $ | 17,505 | ||||
| Marketable securities | 37,435 | |||||||
| Accounts receivable from related party | 19 | |||||||
| Accounts receivable | 329 | 250 | ||||||
| Inventory | 133 | |||||||
| Prepaid expenses and other current assets | 893 | 240 | ||||||
| Total current assets | 76,183 | 18,014 | ||||||
| Property and equipment, net | 1,782 | 904 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 78,193 | $ | 19,146 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,316 | $ | 545 | ||||
| Accrued expenses | 3,016 | 741 | ||||||
| Deferred revenue | 188 | 250 | ||||||
| Notes payable, net of discount, current | 1,354 | 1,806 | ||||||
| Total current liabilities | 5,874 | 3,342 | ||||||
| Preferred stock warrants | 254 | |||||||
| Deferred rent, long-term | 112 | 27 | ||||||
| Notes payable, net of discount, long-term | 13,511 | 651 | ||||||
| Total liabilities | 19,497 | 4,274 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock (Series A, B, C, D and D-1), $0.001 par value; no shares and 33,979,025 shares authorized at December 31, 2014 and 2013, respectively; no shares and 32,842,187 shares issued and outstanding at December 31, 2014 and 2013, respectively | 74,344 | |||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 and no shares authorized at December 31, 2014 and 2013, respectively; no shares issued or outstanding at December 31, 2014 and 2013 | ||||||||
| Common stock, $0.0001 par value; 100,000,000 and 45,000,000 shares authorized at December 31, 2014 and 2013, respectively; 21,333,507 and 2,676,648 shares issued and outstanding at December 31, 2014 and 2013, respectively | 2 | |||||||
| Additional paid-in capital | 148,122 | 1,308 | ||||||
| Accumulated deficit | (89,428 | ) | (60,780 | ) | ||||
| Total stockholders equity (deficit) | 58,696 | (59,472 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders equity (deficit) | $ | 78,193 | $ | 19,146 |