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Ocular Therapeutix Reports Third Quarter 2022 Financial Results and Business Update Announced Positive Interim Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD at the American Acade

Key Takeaway: Ocular Therapeutix Reports Third Quarter 2022 Financial Results and Business Update Announced Positive Interim Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting Initiation

Full Press Release Details

Ocular Therapeutix Reports Third Quarter
2022 Financial Results and Business Update
Announced Positive Interim Data from the U.S.-based
Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting
Initiation of OTX-TKI Phase 1 Clinical Trial
for the treatment of Diabetic Retinopathy Planned for Q1 of 2023 and Phase 2/3 Clinical Trial for the treatment of Wet AMD Planned for
(dexamethasone ophthalmic insert) 0.4 mg Recorded Quarterly Net Product Revenue of $11.9 Million
Revised DEXTENZA Annual Net Product Revenue
Guidance for 2022 to be between $48 to $52 million, Representing Annual Growth of Approximately 10% to 20%
Conference Call to Discuss Third Quarter Results
to be Held at 4:30 p.m. ET
Mass.--(BUSINESS WIRE)- November 7, 2022 -- 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 reported financial results for the quarter ended September 30, 2022, and provided updates on its ophthalmology
presented arguably the most important clinical data in the Company's history at this year's AAO meeting" commented Antony
Mattessich, President and CEO. "In the 7-month data from our U.S.-based Phase 1 clinical trial of a 600 g, single implant
OTX-TKI for the treatment of controlled wet AMD, 80% and 73% of subjects were rescue-free up to 6 and 7 months, respectively.
In addition to our goal of moving OTX-TKI into a Phase 2/3 trial for the treatment of wet AMD in
Q3 of 2023, we also plan to initiate a Phase 1 trial for the treatment of diabetic retinopathy (DR) in Q1 of 2023. Pending good results,
and subject to a follow-up meeting with the FDA, we believe we could be in position to initiate our first Phase 3 trial of OTX-TKI for
the treatment of DR in Q1 of 2024. On the commercial front, DEXTENZA achieved net revenue of $11.9 million for the quarter despite
the continued staffing challenges that we have observed at our ASC and HOPD customers that hindered their ability to operate at full capacity.
We believe these challenges are transient in nature and that recent staffing of our sales force at targeted levels and bringing new sales
territories online should have a near and long term positive impact on DEXTENZA sales."
OTX-TKI (axitinib intravitreal
implant) for the potential treatment of wet AMD, diabetic retinopathy and other retinal diseases.
OTX-TIC (travoprost intracameral implant)
for the treatment of patients with primary open-angle glaucoma or ocular hypertension.
Dry Eye Programs moving forward in a
measured manner with a collaborative study of OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs
and symptoms of dry eye disease.
DEXTENZA (dexamethasone ophthalmic insert)
0.4mg is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with
allergic conjunctivitis.
Third Quarter Ended September 30,
2022 Financial Results
revenue, which includes both gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product
revenue, and collaboration revenue was $12.0 million for the third quarter of 2022 and represented an approximately 2% decrease over the
same period in 2021. DEXTENZA net product revenue was $11.9 million for the third quarter of 2022, flat to the comparable quarter of 2021
and down approximately 2% on a sequential quarterly basis. Net revenue in the third quarter of 2022 also included $0.1 million in collaboration
revenue associated with the Company's work with AffaMed. Net product revenue in the third quarter of 2021, included $0.3 million
attributable to sales of ReSure Sealant.
and development expenses for the third quarter of 2022 were $13.7 million versus $12.7 million for the comparable period in 2021 driven
primarily by an increase in personnel and a higher level of preclinical development activity.
and marketing expenses in the third quarter of 2022 were $10.2 million as compared to $9.6 million for the comparable quarter of 2021,
reflecting primarily an increase in field force personnel.
and administrative expenses were $8.5 million for the third quarter of 2022 versus $8.1 million in the comparable quarter of 2021, primarily
due to an increase in personnel related costs, including stock-based compensation.
Company reported a net loss for the third quarter of 2022 of $(24.2) million, or a loss of $(0.31) per share on a basic and diluted basis,
compared to net income of $2.7 million, or net income of $0.03 per share on a basic basis and a loss of $(0.23) per share on a diluted
basis for the same period in 2021. Net loss in the third quarter of 2022 included a $1.1 million non-cash item attributable to an increase
in the fair value of the derivative liability associated with the Company's convertible notes, as the price of its common stock
increased during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.7 million in the
third quarter of 2022 versus $4.4 million for the same quarter in 2021.
As of November 4, 2022,
the Company had 77.0 million shares outstanding.
2022 Financial Guidance
Conference Call & Webcast Information
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. A live audio webcast will be available at www.ocutx.com. Interested parties
may also register for the webcast via this link.
Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available
via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are
advised to join 15 minutes prior to the start time.
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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated
with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets include: OTX-TKI (axitinib intravitreal implant),
currently in Phase 1 clinical trials for the treatment of wet AMD and other retinal diseases; OTX-TIC (travoprost intracameral implant),
currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI (cyclosporine
intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term
treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials. Ocular Therapeutix's first
product, ReSure Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.
DEXTENZA is FDA approved for the treatment
of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the
canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and
exits the nasolacrimal system without the need for removal.
Please see full Prescribing and Safety Information at www.DEXTENZA.com.
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 development and regulatory status of the Company's product candidates, such as the
Company's development of and prospects for approvability of OTX-TIC for the treatment of primary open-angle glaucoma or ocular
hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD and diabetic retinopathy, OTX-DED for the short-term treatment
of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of dry eye disease; the Company's plans to
advance the development of its product candidates or preclinical programs; the ongoing development of the Company's extended-delivery
hydrogel depot technology; the potential utility of any of the Company's product candidates; the size of potential markets for
the Company's product candidates; the potential benefits and future operations of Company collaborations, including any potential
future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA
and ReSure Sealant; the expected impact of the COVID-19 pandemic on the Company and its operations; 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 preclinical and clinical
development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking
Last updated: Nov 7, 2022