Full Press Release Details
Ocular Therapeutix Provides
Business Update and Response to COVID-19 Global Pandemic
BEDFORD, Mass. -(BUSINESS WIRE)-April 13, 2020-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 its response to the COVID-19 pandemic and related
impact on Ocular Therapeutix's business operations.
the global COVID-19 pandemic, our first priority is for the safety and well-being of our employees, patients, clinical collaborators
and customers," said Antony Mattessich, President and Chief Executive Officer. "While we are doing everything in our
power to respond appropriately to the current crisis, we are also preparing Ocular Therapeutix and our community of stakeholders
to thrive in the future. The Company is well positioned despite the challenging economic conditions.
Clinical and Pipeline Update
(axitinib intravitreal implant): OTX-TKI is a bioresorbable, hydrogel implant
incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties delivered by intravitreal injection
to the posterior segment of the eye for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal
diseases. Two cohorts of six subjects each, a lower dose cohort of 200 g and a higher dose cohort of 400 g have been
enrolled in a Phase 1 clinical trial.
(travoprost intracameral implant): OTX-TIC is a long-acting travoprost intracameral implant in development for the
treatment of patients with primary open angle glaucoma or ocular hypertension. The Company presented interim Phase 1 data on OTX-TIC
at the Glaucoma 360 Conference held in San Francisco, CA in February 2020 from the first two cohorts enrolled.
(cyclosporine intracanalicular insert): The Company recently filed an IND and intends to begin a Phase 1 clinical
trial for the treatment of dry eye disease in the middle of 2020.
DEXTENZA (dexamethasone ophthalmic insert) for use in
other ocular surface indications:
First Quarter Financial Update and 2020 Outlook
to the economic slowdown, preliminary first quarter 2020 total net product revenue is expected to be approximately $2.6
million, approximately 13% ahead of fourth quarter 2019 total net product revenue (although less than the Company's
prior guidance of $3.0 million to $3.2 million). First quarter 2020 revenue was negatively impacted by a rapid
deceleration of DEXTENZA orders in the second half of March due to COVID-19 and restrictions placed on elective surgical
procedures at ambulatory surgery centers and hospitals. Preliminary DEXTENZA net product revenue is estimated to have grown
approximately 31% to $2.1 million for the first quarter 2020 over fourth quarter 2019 net product revenue of $1.6 million
(although less than the Company's prior guidance of $2.4 million to $2.6 million). Preliminary ReSure
Sealant net product revenue for the first quarter 2020 is estimated to be approximately $0.5 million. While it is difficult
to predict the extent or duration of the impact of the global COVID-19 pandemic on future financial results, March trends
have intensified into April and the Company anticipates current guidelines and recommendations from the global health
authorities, including the delay of elective surgeries, will significantly impact revenue in the second quarter. The Company
is not providing revenue guidance for the remainder of 2020. Although some of the postponed cataract surgeries are expected
to be recaptured in the second half of the year, overall volume is expected to be down since ambulatory surgery centers will
be re-hiring staff and some patients may be hesitant to return immediately after surgery centers resume business.
The Company will continue
to adhere to the guidelines and safety measures that are applicable including stay at home policies and the reporting of only essential
personnel for business continuity in order to ensure the safety of its employees, customers and investigators and their staff.
The Company is also contributing to the fight against COVID-19 through donations of personal protective equipment to local health
focused on managing expenses and evaluating ways to maximize operating efficiencies while preserving short and long-term
growth opportunities. Subject to the completion of its financial closing procedures, the Company currently estimates that as
of March 31, 2020, it had approximately $48.2 million in cash and cash equivalents. Based on current plans and related
estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating
expenses, the Company believes that existing cash and cash equivalents, together with second quarter net proceeds from sales
of common stock pursuant to its 2019 Sales Agreement with Jefferies LLC, will enable the Company to fund planned operating
expenses, debt service obligations and capital expenditure requirements into the first quarter of 2021, consistent with prior
guidance. This cash guidance is subject to various assumptions including an expected rebound in cataract surgeries beginning
in the third quarter, and other assumptions related to revenues and expenses associated with the commercialization of
DEXTENZA, variable expense reductions and the pace of research and clinical development programs as well as other aspects of
the Company's business.
addition, the Company has applied for a low interest loan through the Paycheck Protection Program under the Coronavirus Aid, Relief
and Economic Security (CARES) Act. Subject to certain conditions, some or all of such loans may qualify for forgiveness.
The Company is currently in the process of finalizing its financial
results for first quarter 2020. The above
estimates of net product revenue and cash balance are based
on preliminary information and
management estimates, subject to the completion of the Company's
financial closing procedures.
About DEXTENZA (dexamethasone ophthalmic
DEXTENZA is an FDA-approved corticosteroid indicated for the
treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lower lacrimal punctum and
into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for
up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.
DEXTENZA is contraindicated in patients with active corneal,
conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve,
defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure
should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard
for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound
healing and increase the incidence of bleb formation.
The most commonly reported ocular adverse reactions that occurred
in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in
intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).
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 first commercial drug product, DEXTENZA ,
is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is conducting
a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP
(intracanalicular travoprost insert) is an intracanalicular insert in clinical development for the reduction of intraocular pressure
in patients with primary open-angle glaucoma and ocular hypertension. The Company's earlier stage development assets include
OTX-TIC, an extended-delivery intracameral travoprost 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 OTX-TKI, containing the tyrosine kinase inhibitor (TKI) axitinib, 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 commercialization of DEXTENZA , ReSure
Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes
for, DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's
development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis,
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; the potential benefits and future operation of the collaboration with Regeneron
Pharmaceuticals, including any potential future payments thereunder; projected or estimated net product revenue; the expected