DEXTENZA® NDA Resubmission Submitted and
Accepted by the U.S. Food and Drug Administration
DEXTENZA Given December 28, 2018 Target PDUFA
Date
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical
company focused on the formulation, development, and
commercialization of innovative therapies for diseases and
conditions of the eye, today announced financial results for the
second quarter ended June 30, 2018 and provided a business
update.
“We are encouraged with our progress through the first half of
2018,” said Antony Mattessich, President and Chief Executive
Officer. “The on-time resubmission and establishment of a December
28th PDUFA date for DEXTENZA® were critical achievements and we are
pleased to have accomplished them. Clearly, we need to demonstrate
that the transformation we have experienced internally translates
to externally-validated results. While the team understands the
approval of DEXTENZA is our top priority, we will continue to drive
our pipeline forward which should be increasingly appreciated as we
demonstrate our ability to execute.”
Key Highlights and Upcoming Events
- DEXTENZA® New Drug Application (NDA)
resubmission completed and accepted by the U.S. Food and Drug
Administration (FDA). Ocular resubmitted the NDA to the FDA on
June 28th and announced the acceptance of the filing on July 19th.
As expected the resubmission will be treated as a Class 2 response
with a six-month review period. The target action date under the
Prescription Drug User Fee Act, or PDUFA, is December 28,
2018.
- Initiated commercialization planning
for DEXTENZA. If DEXTENZA is approved, Ocular intends to launch
it with a specialty sales team and has begun executing on the
commercial build-out.
- OTX-TP (travoprost insert) Phase 3
topline efficacy data for the treatment of glaucoma expected in the
first half of 2019. Enrollment in the 550 patient Phase 3 trial
remains steady and the Company continues to anticipate topline data
in the first half of 2019. The Company has also dosed the first
patient in the third quarter in an open-label, one-year safety
extension study that will be included as part of the current
pivotal program. This study will provide additional long-term
safety data with repeat administration of OTX-TP.
- Dosed first patient in Phase 1
clinical trial of OTX-TIC (travoprost implant). OTX-TIC, Ocular
Therapeutix’s second glaucoma product candidate, is a
bioresorbable, travoprost-containing hydrogel intracameral implant.
The U.S. Phase 1 trial is a multi-center, open-label, prospective,
dose escalation clinical trial to evaluate the safety, efficacy,
durability, and tolerability of OTX-TIC in patients with primary
open-angle glaucoma and ocular hypertension.
- Initiated OTX-TKI (tyrosine kinase
inhibitor implant) ex-U.S. Phase 1 clinical trial; the first
patient is expected to be dosed in the third quarter. OTX-TKI
is a bioresorbable, hydrogel fiber implant with anti-angiogenic
properties delivered by intravitreal injection being developed to
treat patients with wet Age-related Macular Degeneration (AMD) and
other retinal diseases. Preclinical data have demonstrated the
ability to deliver an efficacious dose of OTX-TKI to the posterior
segment of the eye for the treatment of VEGF-induced retinal
leakage for an extended duration of up to twelve months. The Phase
1 trial is a multi-center, open-label, dose escalation study
testing the safety, durability, and tolerability of OTX-TKI.
- Regeneron collaboration continues
for the development of OTX-IVT (aflibercept implant). The
Company, along with Regeneron, continues the pre-clinical
development of an extended-delivery formulation of the VEGF trap
aflibercept (EYLEA®), delivered by intravitreal injection, for the
treatment of retinal diseases such as wet AMD. The Company remains
pleased with the state of the collaboration and the teams have been
working well together.
Second Quarter 2018 Financial Results
- As of the quarter-ended June 30, 2018,
the Company had $56.8 million in cash and cash equivalents versus
$62.9 million at the end of the first quarter of 2018. The cash
balance benefited from $8.4 million in net proceeds generated from
the sale of common stock under the Company’s 2016 Sales Agreement,
or ATM, during the second quarter of 2018. Offsetting the ATM
inflows during the quarter were a net loss of $13.8 million,
principal debt payments of $1.6 million, and capital expenditures
of $0.6 million. At the end of Q2 2018, $24.1 million remained
available to be sold under the 2016 Sales Agreement and the Company
will continue to monitor the opportunity to sell additional common
stock as appropriate under the facility.
- Based on the Company’s current plans
and forecasted expenses, Ocular Therapeutix believes that existing
cash and cash equivalents will fund operating expenses, debt
service obligations, and capital expenditures into the second
quarter of 2019, exclusive of the potential $10 million option
payment from our Regeneron partnership.
- Research and development expenses for
the second quarter were $8.7 million versus $8.1 million for the
second quarter of 2017 and reflect an increase in compensation
costs associated with additional hiring primarily in the technical
operations and quality departments, as well as an increase in
facilities expenses associated with additional lab space at
corporate headquarters.
- Selling and marketing expenses for the
second quarter were $0.9 million as compared to $6.8 million for
the same quarter in 2017. This decrease relates to a significant
reduction in pre-commercial activities as a result of the delay in
the launch of DEXTENZA.
- General and Administrative expenses
were $4.4 million for the second quarter versus $3.7 million in the
comparable quarter of 2017. The increase in expenses stemmed
primarily from increases in legal costs related to the defense of
ongoing legal proceedings.
- Revenues for the second quarter of 2018
were driven exclusively by ReSure Sealant and totaled approximately
$0.6 million compared with $0.4 million in the same period for
2017, reflecting principally an increased number of units
sold.
- The Company reported a net loss of
$(13.8) million, or a loss of $(0.37) per share for the second
quarter of 2018. This compares to a net loss of $(18.7) million, or
a loss of $(0.64) per share, for the same period in 2017. The net
loss for the second quarter of 2018 included $2.4 million in
non-cash charges for stock-based compensation and depreciation
compared to $2.1 million for the same quarter in 2017.
- The Company had approximately 38.5
million shares issued and outstanding as of June 30, 2018 compared
to 37.3 million shares issued and outstanding as of March 31,
2018.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host
a live conference call and webcast today at 4:30 pm Eastern
Time to review the Company's financial results and provide a
general business update. The live webcast can be accessed by
visiting the Investors 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 live conference call. The conference ID number for
the live call will be 7875199. An archive of the webcast will be
available until November 7, 2018 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the formulation, development, and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary bioresorbable hydrogel-based formulation
technology. Ocular Therapeutix’s lead product candidate, DEXTENZA®
(dexamethasone insert), has completed Phase 3 clinical development
for the treatment of ocular pain and inflammation following
ophthalmic surgery. OTX-TP (travoprost insert) is an
intracanalicular insert in Phase 3 clinical development for the
reduction of intraocular pressure in patients with primary
open-angle glaucoma and ocular hypertension. The Company’s earlier
stage assets include OTX-TIC, an extended-delivery travoprost
intracameral implant for the reduction of intraocular pressure in
patients with glaucoma and ocular hypertension, as well as
sustained release intravitreal implants for the treatment of
retinal diseases. These intravitreal implants include the
development of OTX-TKI, a tyrosine kinase inhibitor (TKI), and, in
collaboration with Regeneron, OTX-IVT, an extended-delivery
protein-based anti-vascular endothelial growth factor (VEGF) trap.
Ocular Therapeutix's first product, ReSure® Sealant, is
FDA-approved to seal corneal incisions following cataract
surgery.
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 regulatory submissions for and the timing and conduct of,
or implications of results from, clinical trials of DEXTENZA® for
the treatment of post-surgical ocular pain and inflammation,
including with respect to manufacturing deficiencies identified by
the FDA, the Company’s expectations regarding the NDA filed with
the FDA, the FDA’s response to the resubmitted NDA and the
prospects for approvability of DEXTENZA for these indications,
OTX-TP for the treatment of primary open-angle glaucoma and ocular
hypertension, OTX-TIC for the treatment of primary open-angle
glaucoma and ocular hypertension, OTX-TKI for the treatment of
retinal diseases including wet AMD, and OTX-IVT as an
extended-delivery formulation of the VEGF trap aflibercept for the
treatment of retinal diseases including wet AMD; the ongoing
development of the Company’s extended-delivery hydrogel depot
technology; the potential utility of any of the Company’s product
candidates; potential commercialization of the Company’s product
candidates; the potential benefits and future operation of the
collaboration with Regeneron Pharmaceuticals, including any
potential future payments thereunder; 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 or any product candidate that
receives regulatory approval, the initiation, timing 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, the outcome of the
Company’s ongoing legal proceedings 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 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.
Statements of Operations and
Comprehensive Loss
(In thousands, except share and per
share data)
(Unaudited)
Three Months Ended Six Months
Ended June 30, June 30, 2018 2017
2018 2017 Revenue: Product revenue $ 648 $ 438
$ 988 $ 913 Total revenue 648
438 988 913 Costs and
operating expenses: Cost of product revenue 153 104 233 219
Research and development 8,745 8,117 16,972 14,846 Selling and
marketing 867 6,832 1,584 12,859 General and administrative
4,447 3,724 9,218 7,000
Total costs and operating expenses 14,212
18,777 28,007 34,924 Loss
from operations (13,564 ) (18,339 ) (27,019 )
(34,011 ) Other income (expense): Interest income 215 113
391 205 Interest expense (455 ) (468 ) (941 )
(911 ) Total other expense, net (240 ) (355 )
(550 ) (706 ) Net loss
$
(13,804 )
$
(18,694 )
$
(27,569 ) $ (34,717 ) Net loss per share, basic and diluted $ (0.37
) $ (0.64 ) $ (0.76 ) $ (1.22 ) Weighted average common shares
outstanding, basic and diluted 37,524,512
29,026,259 36,160,251 28,352,348
Comprehensive loss: Net loss $ (13,804 ) $ (18,694 ) $ (27,569 ) $
(34,717 ) Other comprehensive loss: Unrealized gain on marketable
securities — 9 — 5
Total other comprehensive income — 9
— 5 Total comprehensive loss $
(13,804 ) $ (18,685 ) $ (27,569 ) $ (34,712 )
Ocular Therapeutix, Inc.
Balance Sheets
(In thousands, except share and per
share data)
(Unaudited)
June 30, December 31, 2018
2017 Assets Current assets: Cash and cash equivalents
$ 56,834 $ 41,538 Accounts receivable 285 226 Inventory 131 122
Prepaid expenses and other current assets 1,222
1,453 Total current assets 58,472 43,339 Property and
equipment, net 10,373 10,478 Restricted cash 1,614
1,614 Total assets $ 70,459 $ 55,431
Liabilities and Stockholders’ Equity Current liabilities:
Accounts payable $ 2,137 $ 3,571 Accrued expenses and deferred rent
3,680 4,310 Notes payable, net of discount, current 6,082
5,545 Total current liabilities 11,899 13,426
Deferred rent, long-term 3,283 3,387 Notes payable, net of
discount, long-term 9,548 12,471 Total
liabilities 24,730 29,284 Commitments
and contingencies Stockholders’ equity: Preferred stock, $0.0001
par value; 5,000,000 shares authorized and no shares issued or
outstanding at June 30, 2018 and December 31, 2017, respectively —
— Common stock, $0.0001 par value; 100,000,000 shares authorized
and 38,476,937 and 29,658,202 shares issued and outstanding at June
30, 2018 and December 31, 2017 4 3 Additional paid-in capital
310,559 263,409 Accumulated deficit (264,834 )
(237,265 ) Total stockholders’ equity 45,729
26,147 Total liabilities and stockholders’ equity $ 70,459
$ 55,431
.
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version on businesswire.com: https://www.businesswire.com/news/home/20180807005740/en/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke PartnersChris BrinzeyManaging
Directorchris.brinzey@westwicke.comorMediaOcular
TherapeutixScott CorningSenior Vice President,
Commercialscorning@ocutx.com
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