Press Release
Ocular Therapeutix™ Reports Third Quarter 2016 Financial Results and Provides Corporate Update
Preparing to Resubmit NDA for DEXTENZA™ for the Treatment of Ocular
Pain Occurring After Ophthalmic Surgery to
Began Enrollment in First Phase 3 Clinical Trial with OTX-TP (Sustained Release Travoprost) for the Treatment of Glaucoma and Ocular Hypertension
Entered Into Strategic Collaboration with Regeneron to Develop Sustained Release Formulation of Aflibercept for the Treatment of Wet AMD and Other Serious Retinal Diseases
Conference Call Today at
“Following productive discussions with the
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
-
Ocular Therapeutix expects to resubmit its New Drug Application (NDA) for DEXTENZA (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery by the end of 2016.-
Ocular Therapeutix continues to build its commercial organization and infrastructure in preparation for the earliest possible launch of DEXTENZA. -
The Company recently appointed
Andy Hurley to the newly created position of chief commercial officer. Mr. Hurley has over two decades of sales, marketing, market access and commercial operations experience across the pharmaceutical industry and will be responsible for leading Ocular’s commercial organization, focusing on effective execution of the DEXTENZA launch and potential future product launches.
-
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Ocular Therapeutix expects topline results from its third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain 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 to broaden the label to include a post-surgical inflammation indication.
-
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
-
At the recent
Ocular Surgery News (OSN) 2016 annual meeting inNew York City ,Ocular Therapeutix reported positive results from a patient-reported outcomes survey of patients who were administered DEXTENZA. The survey population consists of patients from the first two Phase 3 trials with DEXTENZA for the treatment of post-surgical ocular inflammation and pain. In the trial, the majority of participants preferred DEXTENZA over eye drops:- 100% of participants stated the DEXTENZA insert was comfortable;
- 96% rated their overall experience with DEXTENZA as convenient or very convenient;
- 88% of participants stated that if they were to undergo cataract surgery again, they would request DEXTENZA; and
- 84% of participants stated they were willing to pay more for DEXTENZA than eye drops.
DEXTENZA for the treatment of allergic conjunctivitis
- The Company plans to conduct a non-significant risk (NSR) study to confirm the effect on efficacy of the placebo insert used in previous studies compared with a rapidly absorbing placebo insert. Pending 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 (sustained release travoprost) for the treatment of glaucoma and ocular hypertension
-
Ocular Therapeutix has commenced enrollment in the first of two planned Phase 3 clinical trials for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension.- The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled study is expected to enroll approximately 550 patients with open angle glaucoma or ocular hypertension at 50 clinical sites.
- Importantly, the Phase 3 study design does not include a timolol comparator or validation arm, and does not have active or placebo eye drops administered in either arm. The comparator arm utilizes a non-drug eluting hydrogel-based intracanalicular insert.
-
The primary efficacy endpoint is statistically superior reduction
of intraocular pressure (IOP) from baseline with OTX-TP compared
to placebo at three diurnal time points (
8am ,10am ,4pm ) at 2, 6 and 12 weeks following insertion.
- The Company’s most recent results from ongoing NSR investigational device exemption (IDE) human clinical studies using the non-drug eluting version of the OTX-TP insert demonstrate significantly improved retention rates.
Sustained release intravitreal depots for the treatment of serious retinal diseases
-
The Company entered into a strategic collaboration, option and license
agreement with
Regeneron Pharmaceuticals for the development of a sustained release formulation of aflibercept, the vascular endothelial growth factor (VEGF) trap for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.-
Regeneron’s market share leading aflibercept is currently approved
by the
FDA for certain indications under the brand name EYLEA®. - Under the terms of the agreement, Regeneron has the option to obtain an exclusive license to use Ocular Therapeutix’s hydrogel-based technology for the development and commercialization of a sustained release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications.
-
Upon the exercise of the option,
Ocular Therapeutix would receive a payment of$10 million from Regeneron and would be eligible to receive up to a total of$305 million in milestone payments, including the option exercise payment, for a sustained release version of aflibercept as well as tiered high single-digit to low-to-mid teen-digit royalties on potential future net sales.
-
Regeneron’s market share leading aflibercept is currently approved
by the
- The Company has demonstrated up to 6 months of sustained release of a few different anti-VEGF drugs using its hydrogel-based drug delivery technology with a good safety profile in preclinical studies completed to date.
-
Ocular Therapeutix retains all rights to develop its sustained-release hydrogel-based drug delivery platform with all other non-VEGF targeting compounds as well as with small molecule pharmaceuticals, including tyrosine-kinase inhibitors (TKIs), for other retinal diseases. - The Company also demonstrated minimal inflammatory response in vivo through 26 weeks with both its anti-VEGF protein and TKI depots currently in development.
Third Quarter 2016 Financial Results
-
As of
September 30, 2016 , cash, cash equivalents and marketable securities totaled$75.7 million excluding$1.7 million in restricted cash. Cash used in operating activities was$7.3 million in the third quarter of 2016, compared to$9.7 million for the third quarter of 2015. The decrease in cash position in the third quarter of 2016 was$8.1 million . There was$15.6 million in outstanding debt as ofSeptember 30, 2016 and principal payments are due startingJanuary 2017 over a 36-month period. The Company expects that cash, cash equivalents and marketable securities will be sufficient to fund operating expenses, debt service obligations and capital expenditures into the fourth quarter of 2017. -
Ocular Therapeutix reported a net loss of approximately$9.6 million , or$(0.39) per share, for the quarter endedSeptember 30, 2016 , compared to a net loss of$11.5 million , or$(0.47) per share, for the quarter endedSeptember 30, 2015 . The third quarter 2016 results include$1.4 million in non-cash charges for stock-based compensation compared to$1.2 million in such non-cash charges in the third quarter of 2015. -
Total costs and operating expenses for the quarter ended
September 30, 2016 were$9.7 million , as compared to$11.6 million for the quarter endedSeptember 30, 2015 . Research and development (R&D) expenses for the quarter endedSeptember 30, 2016 were$5.7 million , compared to$8.3 million for the quarter endedSeptember 30, 2015 . The decrease in R&D expenses is primarily due to lower clinical trial costs. The patient enrollment phase of the third Phase 3 trial of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery was completed in the second quarter of 2016 and the first of two planned Phase 3 trials of OTX-TP for the treatment of glaucoma and ocular hypertension was initiated late in the third quarter of 2016 with the majority of costs expected to be incurred in future quarters. The decrease in R&D expenses was partially offset by an increase in sales and marketing expenses as we prepare for the potential launch of DEXTENZA for ocular pain indication subject toFDA approval of our NDA. -
As of
September 30, 2016 , there were approximately 24.9 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 8389302. An archive of the webcast will
be available until
About
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
Ocular Therapeutix, Inc. |
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Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share data) |
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(Unaudited) |
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Three Months Ended |
Nine Months Ended |
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September 30, |
September 30, |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||
Revenue: | ||||||||||||||||||
Product revenue | $ | 477 | $ | 388 | $ | 1,334 | $ | 960 | ||||||||||
Collaboration revenue | — | 41 | 42 | 354 | ||||||||||||||
Total revenue: | 477 | 429 | 1,376 | 1,314 | ||||||||||||||
Costs and operating expenses: | ||||||||||||||||||
Cost of product revenue | 112 | 91 | 316 | 227 | ||||||||||||||
Research and development | 5,686 | 8,263 | 19,737 | 19,725 | ||||||||||||||
Selling and marketing | 1,294 | 798 | 4,175 | 2,709 | ||||||||||||||
General and administrative | 2,623 | 2,451 | 8,002 | 6,575 | ||||||||||||||
Total costs and operating expenses |
9,715 | 11,603 | 32,230 | 29,236 | ||||||||||||||
Loss from operations | (9,238 | ) | (11,174 | ) | (30,854 | ) | (27,922 | ) | ||||||||||
Other income (expense): | ||||||||||||||||||
Interest income | 69 | 53 | 236 | 121 | ||||||||||||||
Interest expense | (426 | ) | (406 | ) | (1,262 | ) | (1,316 | ) | ||||||||||
Other income (expense), net | (1 | ) | 3 | (1 | ) | 6 | ||||||||||||
Total other expense, net |
(358 | ) | (350 | ) | (1,027 | ) | (1,189 | ) | ||||||||||
Net loss | (9,596 | ) | (11,524 | ) | (31,881 | ) | (29,111 | ) | ||||||||||
Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (0.47 | ) | $ | (1.29 | ) | $ | (1.28 | ) | ||||||
Weighted average common shares outstanding, basic and diluted | 24,853,880 | 24,713,597 | 24,792,087 | 22,757,646 | ||||||||||||||
Comprehensive loss: | ||||||||||||||||||
Net loss | $ | (9,596 | ) | $ | (11,524 | ) | $ | (31,881 | ) | $ | (29,111 | ) | ||||||
Other comprehensive income (loss): | ||||||||||||||||||
Unrealized gain (loss) on marketable securities | (5 | ) | (8 | ) | 73 | (16 | ) | |||||||||||
Total other comprehensive income (loss) | (5 | ) | (8 | ) | 73 | (16 | ) | |||||||||||
Total comprehensive loss | $ | (9,601 | ) | $ | (11,532 | ) | $ | (31,808 | ) | $ | (29,127 | ) | ||||||
Ocular Therapeutix, Inc. |
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Balance Sheets |
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(In thousands, except share and per share data) |
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(Unaudited) |
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September 30, |
December 31, |
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2016 |
2015 |
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Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ 52,234 | $ 30,784 | ||||||
Marketable securities | 23,513 | 74,280 | ||||||
Accounts receivable | 243 | 193 | ||||||
Inventory | 126 | 134 | ||||||
Prepaid expenses and other current assets | 708 | 1,592 | ||||||
Total current assets | 76,824 | 106,983 | ||||||
Property and equipment, net | 3,795 | 3,095 | ||||||
Restricted cash | 1,728 | 228 | ||||||
Total assets | $ 82,347 | $ 110,306 | ||||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ 1,680 | $ 1,957 | ||||||
Accrued expenses and deferred rent | 2,791 | 3,379 | ||||||
Deferred revenue | — | 42 | ||||||
Notes payable, net of discount, current | 3,772 | — | ||||||
Total current liabilities | 8,243 | 5,378 | ||||||
Deferred rent, long-term | 32 | 68 | ||||||
Notes payable, net of discount, long-term | 11,778 | 15,272 | ||||||
Total liabilities | 20,053 | 20,718 | ||||||
Commitments and contingencies (Note 11) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at September 30, 2016 and |
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December 31, 2015, no shares issued or outstanding at September 30, 2016 and December 31, 2015 |
— | — | ||||||
Common stock, $0.0001 par value; 100,000,000 shares authorized at September 30, 2016 and |
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December 31, 2015, 24,879,887 and 24,750,281 shares issued and outstanding at |
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September 30, 2016 and December 31, 2015, respectively |
2 | 2 | ||||||
Additional paid-in capital | 223,344 | 218,830 | ||||||
Accumulated deficit |
(161,057 |
) |
(129,176 |
) |
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Accumulated other comprehensive income (loss) | 5 |
(68 |
) |
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Total stockholders’ equity | 62,294 | 89,588 | ||||||
Total liabilities and stockholders’ equity | $ 82,347 | $ 110,306 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20161109005219/en/
Source:
Ocular Therapeutix, Inc.
Investors
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com