Press Release
Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2015 Financial Results
PDUFA target action date of
Initiation of Phase 3 clinical program for OTX-TP for the treatment of glaucoma and ocular hypertension expected in 3Q 2016
Conference Call Today at
“With a
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
-
In
December 2015 , a New Drug Application (NDA) was accepted for filing by theU.S. Food and Drug Administration (FDA ) for DEXTENZA (sustained release dexamethasone), Intracanalicular Depot for the treatment of post-surgical ocular pain.-
The
FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) ofJuly 24, 2016 for the NDA. - The data included in the NDA are from one Phase 2 clinical trial and two Phase 3 clinical trials conducted with DEXTENZA for the treatment of post-surgical ocular inflammation and pain.
-
If the
FDA grants marketing approval for DEXTENZA for the treatment of post-surgical ocular pain on the PDUFA action date, the Company expects to launch this product in early 2017.
-
The
-
A third Phase 3 clinical trial for DEXTENZA for post-surgical ocular
inflammation and pain is currently enrolling with 285 patients out of
a planned total of 436 patients enrolled as of
March 7, 2016 .-
If the Company achieves favorable results in the 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 in the first half of 2017 aiming to broaden its label to include the post-surgical inflammation indication.
-
If the Company achieves favorable results in the third Phase 3
trial and subject to approval of the NDA for post-surgical ocular
pain by the
DEXTENZA for the treatment of allergic conjunctivitis
-
In
November 2015 ,Ocular Therapeutix commenced enrollment in a second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA for the treatment of allergic conjunctivitis.-
The Company reported topline results of its first Phase 3 allergic
conjunctivitis clinical trial in
October 2015 . The primary endpoint of treatment of ocular itching associated with allergic conjunctivitis was successfully achieved in this trial. -
If the primary efficacy endpoint for ocular itching 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 in the fourth quarter of 2016.
-
The Company reported topline results of its first Phase 3 allergic
conjunctivitis clinical trial in
DEXTENZA for the treatment of inflammatory dry eye disease
-
In
December 2015 ,Ocular Therapeutix reported encouraging topline results from an exploratory Phase 2 clinical trial designed to evaluate a range of objective and subjective measures (signs and symptoms, respectively) for DEXTENZA for the treatment of inflammatory dry eye disease.- The trial showed a statistically significant difference between the DEXTENZA treatment arm and the placebo arm in the efficacy measure of total corneal staining change from baseline at day 30.
- Supportive efficacy measures of conjunctival staining showed clinically meaningful benefit; improvement in the frequency and severity of symptoms of eye dryness, itchiness, and scratchiness were also seen.
- This trial was designed to optimize the enrollment of patients based on signs.
-
The Company plans to meet with the
FDA to discuss the Phase 2 results 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 announced its Phase 3 clinical development strategy for OTX-TP for the treatment of glaucoma and ocular hypertension following a meeting with theFDA in the first quarter of 2016.-
Ocular Therapeutix intends to commence the first of two planned Phase 3 clinical trials in the third quarter of 2016 after holding an End of Phase 2 meeting with theFDA in the second quarter of 2016. - The Company does not expect a timolol comparator or validation arm will be required in the study design and does not anticipate that eye drops, placebo or active, will be administered in either arm.
-
The Company expects that the
FDA will require that OTX-TP show a statistically superior reduction of intraocular pressure (IOP), compared to placebo, as a primary efficacy endpoint, as well as clinically meaningful reduction of IOP.
-
Fourth Quarter and Full Year 2015 Financial Results
-
As of
December 31, 2015 , cash, cash equivalents and marketable securities totaled$105.1 million . Cash used in operating activities was$8.6 million in the fourth quarter of 2015 and$33.7 million for the year endedDecember 31, 2015 . There was$15.6 million in outstanding debt as ofDecember 31, 2015 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$10.6 million , or$(0.43) per share, for the quarter endedDecember 31, 2015 , compared to a net loss of$8.0 million , or$(0.37) per share, for the quarter endedDecember 31, 2014 . The fourth quarter 2015 results include$1.3 million in non-cash charges for stock-based compensation compared to$1.0 million in such non-cash charges in the fourth quarter of 2014. The Company reported a net loss of approximately$39.7 million , or$(1.71) per share, for the year endedDecember 31, 2015 , compared to a net loss of$28.7 million , or$(2.69) per share, for the year endedDecember 31, 2014 . The 2015 results include$4.6 million in non-cash charges for stock-based compensation compared to$5.0 million in such non-cash charges in 2014 including a stock grant made in connection with the expansion of the Company’s intellectual property rights. -
Total operating expenses for the three and twelve month periods ended
December 31, 2015 were$10.7 million and$39.9 million , respectively, as compared to$8.1 million and$27.9 million for the comparable periods in 2014. Research and development (R&D) expenses for the three and twelve month periods endedDecember 31, 2015 were$6.9 million and$26.6 million , respectively, compared to$5.1 million and$18.9 million for the comparable periods in 2014. The increases are primarily related to personnel costs and clinical trials of DEXTENZA and OTX-TP product candidates 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$0.4 million and$1.8 million in revenue during the three month and twelve month periods endedDecember 31, 2015 from product sales of ReSure® Sealant and from collaborations with corporate partners. -
As of
December 31, 2015 , 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 60154048. 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 inflammation and pain, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and
OTX-TP for the treatment of glaucoma and ocular hypertension, the
ongoing development of the Company’s sustained release hydrogel depot
technology and the advancement of the Company's other product
candidates, the potential utility of any of the Company’s product
candidates, the sufficiency of the Company’s cash resources 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. |
|||||||||||||||||||
|
Three Months Ended |
Year Ended |
||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||||||
| Revenue: | |||||||||||||||||||
| Product revenue | $ | 394 |
$ |
193 |
|
$ |
1,354 |
$
|
460 |
||||||||||
| Collaboration revenue | 42 | 312 | 396 |
|
312 |
||||||||||||||
| Total revenue: | 436 | 505 | 1,750 |
|
772 |
||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Cost of product revenue | 92 | 30 | 319 | 91 | |||||||||||||||
| Research and development | 6,886 | 5,148 | 26,611 | 18,880 | |||||||||||||||
| Selling and marketing | 1,143 | 658 | 3,852 | 1,982 | |||||||||||||||
| General and administrative | 2,590 | 2,216 | 9,165 | 6,913 | |||||||||||||||
| Total operating expenses | 10,711 | 8,052 | 39,947 | 27,866 | |||||||||||||||
| Loss from operations |
(10,275 |
) |
(7,547 | ) | (38,197 | ) | (27,094 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Interest income | 45 | — | 166 | 7 | |||||||||||||||
| Interest expense |
(408 |
) | (407 | ) | (1,724 | ) | (1,119 | ) | |||||||||||
| Other income (expense), net | 1 | — | 7 | (442 | ) | ||||||||||||||
| Total other expense, net |
(362 |
) | (407 | ) | (1,551 | ) | (1,554 | ) | |||||||||||
| Net loss |
(10,637 |
) | (7,954 | ) |
(39,748 |
) |
(28,648 |
) | |||||||||||
| Accretion of redeemable convertible preferred stock to redemption value | — | — | — |
(11 |
) |
||||||||||||||
| Net loss attributable to common stockholders | $ |
(10,637 |
) | $ | (7,954 | ) | $ | (39,748 | ) | $ | (28,659 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ |
(0.43 |
) | $ | (0.37 | ) | $ | (1.71 | ) | $ | (2.69 | ) | |||||||
| Weighted average common shares outstanding, basic and diluted | 24,732,847 | 21,289,378 | 23,244,162 | 10,652,865 | |||||||||||||||
| Comprehensive loss: | |||||||||||||||||||
| Net loss | $ |
(10,637 |
) |
$ | (7,954 | ) | $ |
(39,748 |
) |
$ |
(28,648 |
) |
|||||||
| Other comprehensive loss: | |||||||||||||||||||
| Unrealized loss on marketable securities |
(52 |
) |
— |
(68 |
) |
— | |||||||||||||
| Total other comprehensive loss |
(52 |
) |
— |
(68 |
) |
— | |||||||||||||
| Total comprehensive loss | $ |
(10,689 |
) | $ | (7,954 | ) | $ | (39,816 | ) | $ | (28,648 | ) | |||||||
|
OCULAR THERAPEUTIX, INC. |
||||||||
|
BALANCE SHEETS |
||||||||
|
|
||||||||
| December 31, | ||||||||
| 2015 | 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,784 | $ | 37,393 | ||||
| Marketable securities | 74,280 | 37,435 | ||||||
| Accounts receivable | 193 | 329 | ||||||
| Inventory | 134 | 133 | ||||||
| Prepaid expenses and other current assets | 1,592 | 893 | ||||||
| Total current assets | 106,983 | 76,183 | ||||||
| Property and equipment, net | 3,095 | 1,782 | ||||||
| Restricted cash | 228 | 228 | ||||||
| Total assets | $ | 110,306 | $ | 78,193 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,957 | $ | 1,316 | ||||
| Accrued expenses and deferred rent | 3,379 | 3,016 | ||||||
| Deferred revenue | 42 | 188 | ||||||
| Notes payable, net of discount, current | — | 1,354 | ||||||
| Total current liabilities | 5378 | 5,874 | ||||||
| Deferred rent, long-term | 68 | 112 | ||||||
| Notes payable, net of discount, long-term | 15,272 | 13,511 | ||||||
| Total liabilities | 20,718 | 19,497 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at December 31, 2015 and 2014; no shares issued or outstanding at December 31, 2015 and 2014 | — | — | ||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at December 31, 2015 and December 31, 2014; 24,750,281 and 21,333,507 shares issued and outstanding at December 31, 2015 and 2014, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 218,830 | 148,122 | ||||||
| Accumulated deficit | (129,176 ) | (89,428 ) | ||||||
| Accumulated other comprehensive loss | (68) | — | ||||||
| Total stockholders’ equity | 89,588 | 58,696 | ||||||
| Total liabilities and stockholders’ equity | $ | 110,306 | $ | 78,193 | ||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160310005366/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
