Press Release
Ocular Therapeutix™ Reports First Quarter 2016 Financial Results and Provides Corporate Update
PDUFA target action date of
Second Phase 3 clinical trial for DEXTENZA for the treatment of
allergic conjunctivitis fully enrolled; topline results expected
First Phase 3 clinical trial for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension with placebo control arm expected to commence in the third quarter of 2016
Conference call today at
“This is an exciting time for
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
-
Based on a New Drug Application (NDA) filed in December with the
U.S. Food and Drug Administration (FDA ) for DEXTENZA (sustained release dexamethasone), Intracanalicular Depot for the treatment of post-surgical ocular pain, theFDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) ofJuly 24, 2016 for the NDA.-
Should the
FDA grant marketing approval for DEXTENZA for the treatment of post-surgical ocular pain on the PDUFA action date, 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 early 2017.
-
Should the
-
A third Phase 3 clinical trial for DEXTENZA for post-surgical ocular
inflammation and pain is over 90% enrolled, with 395 patients out of a
planned total of 436 patients enrolled as of
May 3, 2016 .- 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
-
Ocular Therapeutix has completed enrollment in a second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA for the treatment of allergic conjunctivitis.-
The Company expects topline results from this trial to be
available in
June 2016 . -
If the primary efficacy endpoint for ocular itching associated
with allergic conjunctivitis is met in the second Phase 3 trial
and subject to the approval of the NDA submitted for DEXTENZA for
the treatment of post-surgical ocular pain, the Company expects to
submit an NDA supplement to the
FDA for ocular itching associated with allergic conjunctivitis.
-
The Company expects topline results from this trial to be
available in
DEXTENZA for the treatment of dry eye disease
-
Ocular Therapeutix plans to meet with theFDA in mid-2016 to discuss the results from a recently conducted exploratory Phase 2 clinical trial designed to evaluate a range of objective and subjective measures (signs and symptoms, respectively) and potential Phase 3 clinical trial designs for dry eye-related indications.
OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension
-
Ocular Therapeutix recently completed an End-of-Phase 2 Review with theFDA for OTX-TP (sustained release travoprost) for the treatment of Glaucoma and Ocular Hypertension.- Based on this review, the Company intends to initiate the first of two planned Phase 3 clinical trials during the third quarter of 2016.
- The primary efficacy endpoint will be superiority in the reduction of intraocular pressure (IOP) from baseline in the OTX-TP treatment arm compared to the 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.
First Quarter 2016 Financial Results
-
As of
March 31, 2016 , cash, cash equivalents and marketable securities totaled$95.5 million . Cash used in operating activities was$9.3 million in the first quarter of 2016, compared to$6.9 million for the first quarter of 2015. There was$15.6 million in outstanding debt as ofMarch 31, 2016 and no principal payments are due untilJanuary 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 Therapeutix reported a net loss of approximately$10.8 million , or$(0.44) per share, for the quarter endedMarch 31, 2016 , compared to a net loss of$7.6 million , or$(0.35) per share, for the quarter endedMarch 31, 2015 . The first quarter 2016 results include$1.3 million in non-cash charges for stock-based compensation compared to$0.9 million in such non-cash charges in the first quarter of 2015. -
Total operating expenses for the quarter ended
March 31, 2016 were$11.0 million , as compared to$7.5 million for the quarter endedMarch 31, 2015 . Research and development (R&D) expenses for the quarter endedMarch 31, 2016 were$7.1 million , compared to$4.7 million for the quarter endedMarch 31, 2015 . The increases are primarily related to personnel costs and clinical trials of DEXTENZA for the treatment of post-surgical inflammation and pain, DEXTENZA for the treatment of allergic conjunctivitis and OTX-TP for the treatment of glaucoma and ocular hypertension 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 Therapeutix generated$458,000 in revenue during the three months endedMarch 31, 2016 from product sales of ReSure® Sealant and from collaborations with corporate partners. -
As of
March 31, 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 3038508. 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 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 pending PDUFA date for the NDA filed with the
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OCULAR THERAPEUTIX, INC. |
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STATEMENTS OF OPERATIONS and COMPREHENSIVE LOSS |
||||||||
|
(In thousands, except share and per share data) |
||||||||
|
Three Months Ended |
||||||||
| 2016 | 2015 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 416 | $ | 238 | ||||
| Collaboration revenue | 42 | 188 | ||||||
| Total revenue: | 458 | 426 | ||||||
|
Costs and operating expenses: |
||||||||
| Cost of product revenue | 99 | 56 | ||||||
| Research and development | 7,073 | 4,719 | ||||||
| Selling and marketing | 1,389 | 870 | ||||||
| General and administrative | 2,406 | 1,894 | ||||||
|
Total costs and operating expenses |
10,967 | 7,539 | ||||||
| Loss from operations |
(10,509 |
) |
(7,113 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 87 | 40 | ||||||
| Interest expense |
(418 |
) |
(505 | ) | ||||
| Total other expense, net |
(331 |
) |
(465 | ) | ||||
| Net loss |
$ |
(10,840 |
) |
$ | (7,578 | ) | ||
| Net loss per share, basic and diluted |
$ |
(0.44 |
) |
$ | (0.35 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 24,751,682 | 21,362,731 | ||||||
|
Comprehensive loss: |
||||||||
| Net loss | $ | (10,840 | ) | $ | (7,578 | ) | ||
|
Other comprehensive income: |
||||||||
|
Unrealized gains on marketable securities |
68 | — | ||||||
|
Total other comprehensive income |
68 | — | ||||||
| Total comprehensive loss |
$ |
(10,772 |
) |
$ | (7,578 | ) | ||
|
OCULAR THERAPEUTIX, INC. |
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|
BALANCE SHEETS |
||||||||
|
(In thousands, except share and per share data) |
||||||||
|
March 31, |
December 31, |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,212 | $ | 30,784 | ||||
| Marketable securities | 49,244 | 74,280 | ||||||
| Accounts receivable | 227 | 193 | ||||||
| Inventory | 127 | 134 | ||||||
| Prepaid expenses and other current assets | 1,287 | 1,592 | ||||||
| Total current assets | 97,097 | 106,983 | ||||||
| Property and equipment, net | 3,107 | 3,095 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 100,432 | $ | 110,306 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,063 | $ | 1,957 | ||||
| Accrued expenses and deferred rent | 2,779 | 3,379 | ||||||
| Deferred revenue | — | 42 | ||||||
| Notes payable, net of discount, current | 1,161 | — | ||||||
| Total current liabilities | 6,003 | 5,378 | ||||||
| Deferred rent, long-term | 55 | 68 | ||||||
| Notes payable, net of discount, long-term | 14,204 | 15,272 | ||||||
| Total liabilities | 20,262 | 20,718 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at March 31, 2016 and December 31, 2015; no shares issued or outstanding at March 31, 2016 and December 31, 2015 | — | — | ||||||
|
Common stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2016 and December 31, 2015, respectively; 24,758,786 and 24,750,281 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively |
2 | 2 | ||||||
| Additional paid-in capital | 220,184 | 218,830 | ||||||
| Accumulated deficit | (140,016 | ) | (129,176 | ) | ||||
| Accumulated other comprehensive loss | — | (68 | ) | |||||
| Total stockholders’ equity | 80,170 | 89,588 | ||||||
| Total liabilities and stockholders’ equity | $ | 100,432 | $ | 110,306 | ||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160510005503/en/
Source:
Investors
Ocular Therapeutix, Inc.
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
