Full Press Release Details
Ocular Therapeutix Provides Third Quarter
2023 Financial Results and Corporate Update
FDA Agrees to Overall Design of the First Pivotal
Trial for AXPAXLI in Wet AMD under a Special Protocol Assessment; Expect First Subject Dosed by Year-End
Top-line Data from U.S.-based HELIOS Trial
Evaluating AXPAXLI for Treatment of Non-Proliferative Diabetic Retinopathy Anticipated to be Presented in in Q2 2024
Top-line Data from U.S.-based Phase 2 Clinical
Trial of OTX-TIC for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Anticipated to be Presented at ASCRS Meeting in
DEXTENZA Net Product Revenue
in Q3 2023 was $15.0 million, Representing Growth of Approximately 26% Over Q3 2022
BEDFORD, Mass.-(BUSINESS WIRE)- November
7, 2023 - 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 third
quarter ended September 30, 2023, and provided updates on its ophthalmology pipeline.
"We made significant progress at Ocular Therapeutix in the third
quarter," said Antony Mattessich, President and CEO. "In a critical step forward for our clinical program, we initiated the
first pivotal trial evaluating AXPAXLI for the treatment of wet AMD and subsequently have received FDA agreement with our overall clinical
plan under a Special Protocol Assessment. We are thrilled to have agreement with the FDA regarding our trial design and are very excited
to continue moving forward toward our goal of bringing a potentially transformative new treatment to wet AMD patients coping with vision
AXPAXLI (axitinib intravitreal
implant) for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal vascular diseases.
AXPAXLI (axitinib intravitreal
implant) for the treatment of non-proliferative diabetic retinopathy (NPDR).
OTX-TIC (travoprost intracameral
implant) for the treatment of primary open-angle glaucoma (OAG) or ocular hypertension (OHT).
OTX-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of dry eye disease and OTX-CSI (cyclosporine intracanalicular insert)
for the chronic treatment of dry eye disease.
DEXTENZA (dexamethasone
ophthalmic insert) 0.4mg approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated
with allergic conjunctivitis.
Third Quarter Ended September 30, 2023
net revenue, which includes both gross DEXTENZA product revenue net of discounts, rebates, and returns, which the Company refers to as
net product revenue, and collaboration revenue was $15.1 million for the third quarter of 2023, an increase of approximately 26% over
third quarter 2022 net revenues of $12.0 million and in line with second quarter net revenue of $15.2 million. For the third quarter
of 2023, DEXTENZA net product revenue grew to $15.0 million from $11.9 million over the comparable period in 2022 while collaboration
revenue was approximately $0.1 million for each period.
and development expenses for the third quarter of 2023 were $15.0 million versus $13.7 million for the comparable period in 2022, driven
primarily by an increase in expenses associated with clinical trial programs and personnel-related costs, including stock-based compensation
to support those programs.
and marketing expenses in the third quarter of 2023 were $9.3 million as compared to $10.2 million for the comparable quarter of 2022,
reflecting primarily a decrease in professional fees and services.
and administrative expenses were $8.6 million for the third quarter of 2023 versus $8.5 million in the comparable quarter of 2022, primarily
due to an increase in personnel-related costs, including stock-based compensation offset by lower professional related fees and services.
Company reported a net loss for the third quarter of 2023 of $(0.5) million, or a net loss of $(0.01) per share on a basic basis and
($0.25) per share on a diluted basis, compared to a net loss of $(24.2) million, or a net loss of $(0.31) per share on both a basic and
diluted basis per share for the comparable period in 2022. Net loss in the third quarter of 2023 included a $ 6.7 million non-cash gain
attributable to a change in the fair value of the derivative liabilities associated with the Company's convertible notes and the
Barings credit facility. The Company also recorded gains and losses from debt extinguishment, net, of $14.2 million in the third quarter
of 2023. Non-cash charges for stock-based compensation and depreciation and amortization were $5.4 million in the third quarter of 2023
versus $4.7 million for the comparable quarter in 2022. As of November 3, 2023, the Company had approximately 79.4 million shares outstanding.
2023 Financial Guidance
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. 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 ELUTYX . 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: AXPAXLI (axitinib intravitreal implant), currently in a pivotal Phase 3 trial for wet AMD and a Phase 1 clinical trial for the
treatment of diabetic retinopathy; 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.
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.
AXPAXLI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule,
multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal
diseases. AXPAXLI is also referred to by its laboratory code, OTX-TKI.
Forward Looking Statements
Any statements in this press release about
future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA; the development, regulatory status
and prospects of the Company's product candidates, including the timing and design of the Company's pivotal trials of AXPAXLI
(also called OTX-TKI) for the treatment of wet AMD including the SOL trial, of the Company's ongoing HELIOS trial evaluating AXPAXLI
for the treatment of non-proliferative diabetic retinopathy, and of the Company's ongoing Phase 2 clinical trial evaluating OTX-TIC
for the treatment of primary open-angle glaucoma or ocular hypertension; the Company's plans to advance the development of its
product candidates or preclinical programs; the potential utility of any of the Company's product candidates; projected net product
revenue, in-market sales and other financial and operational metrics of DEXTENZA; the Company's cash runway and 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 statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing
DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA
or any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure
and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of clinical trials; the risk that
the FDA will not agree with the Company's interpretation of the written agreement under the SPA; the risk that even though the