Press Release
Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2016 Financial Results
PDUFA Target Action Date of
Enrollment Continues in the First Phase 3 Clinical Trial with OTX-TP (travoprost insert) for the Treatment of Glaucoma and Ocular Hypertension
Completed
Conference Call Today at 8:30 am Eastern Time
“We continue to execute our diversification strategy as we seek to
improve the standard of care across many ophthalmic indications using
our proprietary hydrogel platform technology,” said
Dr. Sawhney continued, “We also continue to make substantial progress
across our additional drug product development programs targeting common
causes of blindness such as glaucoma and wet AMD. Together, our programs
comprise a potential market opportunity of more than
Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA™
-
In
February 2017 , theU.S. Food and Drug Administration (FDA ) accepted the Company’s New Drug Application (NDA) resubmission for DEXTENZA (dexamethasone insert) 0.4 mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery and established a target action date under the Prescription Drug User Fee Act (PDUFA) ofJuly 19, 2017 . -
In
November 2016 ,Ocular Therapeutix announced positive topline results from its most recent Phase 3 clinical trial of DEXTENZA for the treatment of post-surgical ocular inflammation and pain.- The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14, and the absence of pain on day 8, respectively.
- Secondary efficacy endpoints for the trial included differences in the absence of anterior chamber (AC) flare, absence of AC cells, and ocular pain. As previously reported, all of these secondary endpoints were met with statistical significance at all time points, with the exception of the endpoint for the absence of AC cells at day 2.
- Approximately 46% of patients in the DEXTENZA treatment group were shown to have an absence of AC flare at day 4 after insertion, which the Company believes provides further support of the early onset anti-inflammatory effect of DEXTENZA.
- The Company has completed the full safety assessment for this Phase 3 clinical trial. DEXTENZA has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.
-
Subject to the approval of the NDA for post-surgical ocular pain
by the
FDA ,Ocular Therapeutix intends to submit an NDA supplement for DEXTENZA to broaden its label to include an indication for post-surgical inflammation.
-
DEXTENZA is also in Phase 3 clinical development for the treatment of
allergic conjunctivitis. The Company is planning to initiate a
non-significant risk device study in the middle of 2017 to confirm the
effect on efficacy of the placebo insert used in previous studies
compared with a rapidly resorbing placebo insert.
- Subject to 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 (travoprost insert)
-
Ocular Therapeutix continues to enroll patients in the first of two
planned Phase 3 clinical trials for OTX-TP (travoprost insert) for the
treatment of glaucoma and ocular hypertension.
- The Phase 3 trial design includes a treatment group receiving OTX-TP and a placebo group receiving a non-drug eluting version of the Company’s hydrogel platform technology based intracanalicular insert.
- Importantly, there is no timolol comparator or validation arm and no active or placebo eye drops being administered in either arm.
-
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 intervals of 2, 6 and 12 weeks following insertion.
-
The Company plans to commence its second Phase 3 clinical trial with
OTX-TP for the treatment of glaucoma and ocular hypertension in the
second half of 2017.
- If approved, OTX-TP may potentially become the first non-invasive, sustained release therapy for the treatment of glaucoma.
Sustained release intravitreal depots for the treatment of serious retinal diseases
-
In partnership with
Regeneron Pharmaceuticals ,Ocular Therapeutix continues to advance the development of an extended release hydrogel-based formulation of Regeneron’s protein-based anti-vascular endothelial growth factor (VEGF) trap, aflibercept, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.-
Regeneron’s aflibercept is currently approved by the
FDA for certain indications under the brand name EYLEA®. -
Ocular Therapeutix has demonstrated up to 6 months of sustained release of several anti-VEGF drugs using its hydrogel platform technology, with a good safety profile, in preclinical studies completed to date.
-
Regeneron’s aflibercept is currently approved by the
-
In parallel,
Ocular Therapeutix continues to advance its proprietary hydrogel platform technology for intravitreal drug delivery with tyrosine-kinase inhibitors (TKIs).- The Company expects to enter Phase 1 clinical testing with its TKI depots in the second half of 2017.
Fourth Quarter and Full Year 2016 Financial Results
-
In
January 2017 ,Ocular Therapeutix completed a registered underwritten public offering of$25 million of shares of its common stock pursuant to a shelf registration statement that was previously filed with and declared effective by theSecurities and Exchange Commission . - As of December 31, 2016, cash, cash equivalents and marketable securities totaled $68.1 million. Cash used in operating activities was $7.6 million in the fourth quarter of 2016 and $34.0 million for the year ended December 31, 2016.
-
There was $15.6 million in outstanding debt as of December 31, 2016.
In
March 2017 , the Company amended the terms of its existing credit facility to increase the total commitment to$38.0 million , including$18.0 million at closing, which was used primarily to pay-off outstanding balances as of the closing date, and options on two additional tranches of$10.0 million , the availability of each of which is based on the achievement of regulatory and commercial milestones. The interest-only payment period was extended throughFebruary 1, 2018 , with provisions to further extend the interest-only period based on the achievement of certain regulatory and commercial milestones. 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 second quarter of 2018. The Company will need to obtain additional capital to support the planned commercial launch of DEXTENZA, subject toFDA approval. - Ocular Therapeutix reported a net loss of approximately $(12.8) million, or $(0.52) per share, for the quarter ended December 31, 2016, compared to a net loss of $(10.6) million, or $(0.43) per share, for the quarter ended December 31, 2015. The fourth quarter 2016 results include $1.7 million in non-cash charges for stock-based compensation compared to $1.3 million in such non-cash charges in the fourth quarter of 2015. The Company reported a net loss of approximately $(44.7) million, or $(1.80) per share, for the year ended December 31, 2016, compared to a net loss of $(39.7) million, or $(1.71) per share, for the year ended December 31, 2015. The 2016 results include $6.0 million in non-cash charges for stock-based compensation compared to $4.6 million in such non-cash charges in 2015.
- Total costs and operating expenses for the three and twelve month periods ended December 31, 2016 were $13.0 million and $45.2 million, respectively, as compared to $10.7 million and $39.9 million for the comparable periods in 2015. Research and development (R&D) expenses for the three and twelve month periods ended December 31, 2016 were $7.3 million and $27.1 million, respectively, compared to $6.9 million and $26.6 million for the comparable periods in 2015. The Company continues to advance the clinical and preclinical development of its hydrogel platform technology and its portfolio of drug product candidates.
- Ocular Therapeutix generated $0.5 million and $1.9 million in revenue during the three month and twelve month periods ended December 31, 2016 from product sales of ReSure® Sealant and from collaborations with corporate partners.
- As of December 31, 2016, there were approximately 25.0 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:30 am 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 77324558. An archive of the webcast will be available until March 24, 2017 on the Company’s website.
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 resubmission of the NDA filed with the FDA and potential
|
OCULAR THERAPEUTIX, INC. STATEMENTS OF OPERATIONS and COMPREHENSIVE LOSS (In thousands, except share and per share data) |
||||||||||||||||||||||||||||||||||||||||||||||||||
|
Three Months Ended
December 31, |
|
Year Ended December 31, |
||||||||||||||||||||||||||||||||||||||||||||||||
| 2016 |
|
2015 |
2016 | 2015 | ||||||||||||||||||||||||||||||||||||||||||||||
| Revenue: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Product revenue | $ | 511 |
|
$ |
394 |
|
$ |
1,845 |
|
$ |
1,354 |
|||||||||||||||||||||||||||||||||||||||
| Collaboration revenue | — | 42 | 42 |
|
396 |
|||||||||||||||||||||||||||||||||||||||||||||
| Total revenue: | 511 | 436 | 1,887 |
|
1,750 |
|||||||||||||||||||||||||||||||||||||||||||||
| Costs and operating expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Cost of product revenue | 127 | 92 | 443 | 319 | ||||||||||||||||||||||||||||||||||||||||||||||
| Research and development | 7,328 | 6,886 | 27,065 | 26,611 | ||||||||||||||||||||||||||||||||||||||||||||||
| Selling and marketing | 2,526 | 1,143 | 6,701 | 3,852 | ||||||||||||||||||||||||||||||||||||||||||||||
| General and administrative | 3,002 | 2,590 | 11,004 | 9,165 | ||||||||||||||||||||||||||||||||||||||||||||||
| Total costs and operating expenses | 12,983 | 10,711 | 45,213 | 39,947 | ||||||||||||||||||||||||||||||||||||||||||||||
| Loss from operations |
(12,472 |
) | (10,275 | ) | (43,326 | ) | (38,197 | ) | ||||||||||||||||||||||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Interest income | 68 | 45 | 304 | 166 | ||||||||||||||||||||||||||||||||||||||||||||||
| Interest expense |
(418 |
) |
(408 |
) | (1,680 | ) | (1,724 | ) | ||||||||||||||||||||||||||||||||||||||||||
| Other income (expense), net | — | 1 | (1 | ) | 7 | |||||||||||||||||||||||||||||||||||||||||||||
| Total other expense, net |
(350 |
) | (362 | ) | (1,377 | ) | (1,551 | ) | ||||||||||||||||||||||||||||||||||||||||||
| Net loss attributable to common stockholders | $ |
(12,822 |
) | $ | (10,637 | ) | $ | (44,703 | ) | $ | (39,748 | ) | ||||||||||||||||||||||||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ |
(0.52 |
) | $ | (0.43 | ) | $ | (1.80 | ) | $ | (1.71 | ) | ||||||||||||||||||||||||||||||||||||||
| Weighted average common shares outstanding, basic and diluted | 24,888,602 | 24,732,847 |
|
24,816,348 |
23,244,162 | |||||||||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | $ |
(12,822 |
) |
$ |
(10,637 |
) | $ |
(44,703 |
) |
$ |
(39,748 |
) |
||||||||||||||||||||||||||||||||||||||
| Other comprehensive (loss) gain: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Unrealized (loss) gain on marketable securities |
(10 |
) |
(52 |
) |
63 |
(68 |
) |
|||||||||||||||||||||||||||||||||||||||||||
| Total other comprehensive (loss) gain |
(10 |
) |
(52 |
) |
63 |
(68 |
) |
|||||||||||||||||||||||||||||||||||||||||||
| Total comprehensive loss | $ |
(12,832 |
) | $ |
(10,689 |
) | $ | (44,640 | ) | $ | (39,816 | ) | ||||||||||||||||||||||||||||||||||||||
|
BALANCE SHEETS
(In thousands, except share and per share data) |
||||||||||
| December 31, | ||||||||||
| 2016 | 2015 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 32,936 | $ | 30,784 | ||||||
| Marketable securities | 35,209 | 74,280 | ||||||||
| Accounts receivable | 250 | 193 | ||||||||
| Inventory | 113 | 134 | ||||||||
| Prepaid expenses and other current assets | 1,390 | 1,592 | ||||||||
| Total current assets | 69,898 | 106,983 | ||||||||
| Property and equipment, net | 3,313 | 3,095 | ||||||||
| Restricted cash | 1,728 | 228 | ||||||||
| Total assets | $ | 74,939 | $ | 110,306 | ||||||
| Liabilities and Stockholders’ Equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 2,116 | $ | 1,957 | ||||||
| Accrued expenses and deferred rent | 4,635 | 3,379 | ||||||||
| Deferred revenue | — | 42 | ||||||||
| Notes payable, net of discount, current | 1,549 | — | ||||||||
| Total current liabilities | 8,300 | 5,378 | ||||||||
| Deferred rent, long-term | 537 | 68 | ||||||||
| Notes payable, net of discount, long-term | 14,094 | 15,272 | ||||||||
| Total liabilities | 22,931 | 20,718 | ||||||||
|
Commitments and contingencies |
||||||||||
| Stockholders’ equity: | ||||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at December 31, 2016 and 2015; no shares issued or outstanding at December 31, 2016 and 2015 | — | — | ||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at December 31, 2016 and 2015; 25,024,100 and 24,750,281 shares issued and outstanding at December 31, 2016 and 2015, respectively | 3 | 2 | ||||||||
| Additional paid-in capital | 225,889 | 218,830 | ||||||||
| Accumulated deficit | (173,879) | (129,176) | ||||||||
| Accumulated other comprehensive loss | (5) | (68) | ||||||||
| Total stockholders’ equity | 52,008 | 89,588 | ||||||||
| Total liabilities and stockholders’ equity | $ | 74,939 | $ | 110,306 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170310005297/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
Medical
Dynamics
Sandra Correa, 646-599-8637
Media Group Director
scorrea@rxmedyn.com
or
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Marketing &
Commercial Operations
scorning@ocutx.com
