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Ocular Therapeutix Provides First Quarter 2023 Financial Results and Corporate Update 12-month Top-Line Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet

Key Takeaway: Ocular Therapeutix Provides First Quarter 2023 Financial Results and Corporate Update 12-month Top-Line Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet AMD to be Presented in June at the Clinical Trials at th

Full Press Release Details

Ocular Therapeutix Provides First Quarter
2023 Financial Results and Corporate Update
12-month Top-Line Data from the U.S.-based Phase
1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet AMD to be Presented in June at the Clinical Trials
at the Summit 2023 Meeting
Presented Pre-Clinical and Clinical Data on
Three Pipeline Programs at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held April 23rd to 27th
DEXTENZA Net Product Revenue
in the First Quarter of 2023 was $13.2 million, Representing Growth of Approximately 6% Over the First Quarter of 2022
Reiterated DEXTENZA Net Product Revenue for
the Year Ending 2023 is Estimated to be between $55 and $60 million, Representing Anticipated Growth of Approximately 10% to 20% Over
BEDFORD, Mass.-(BUSINESS WIRE)- May
8, 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 first quarter
ended March 31, 2023, and provided updates on its ophthalmology pipeline.
"The strong start to the year has continued through the end of
the first quarter," said Antony Mattessich, President and CEO. "We have been in productive conversations with the FDA and
believe we have a pivotal design for OTX-TKI in diabetic retinopathy and two potential designs in wet AMD. While we are eager to advance
both of these programs, we look forward to sharing top-line 12-month data from our U.S.-based Phase 1 trial for OTX-TKI in wet AMD at
the Clinic Trials at the Summit meeting being held in June. We are also making excellent progress advancing our next late-stage program,
the Phase 2 trial of OTX-TIC for the treatment of glaucoma. This trial continues to enroll well, and we continue to anticipate providing
top-line data from this trial in the fourth quarter of 2023. Glaucoma represents another large potential ophthalmology market where we
believe our hydrogel technology, which we have branded as Elutyx , has the potential to redefine the current standard
of care. On the commercial side, DEXTENZA finished with a strong quarter. In-market billable unit volumes were approximately 8% ahead
of fourth quarter volumes, and we continue to guide towards a full year 2023 net product revenue of $55 to $60 million. Overall, I am
pleased with our continued progress in building a mid-tier strategic within ophthalmology."
Presented Pre-Clinical and
Clinical Data at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held April 23rd to 27th
OTX-TKI (axitinib intravitreal
implant) for the treatment of wet AMD and other retinal vascular diseases.
OTX-TKI (axitinib intravitreal implant) for the treatment
of diabetic retinopathy
OTX-TIC (travoprost intracameral implant) for the
treatment of primary open-angle glaucoma or ocular hypertension.
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.
First Quarter Ended March 31, 2023 Financial
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 $13.4 million for the first quarter of 2023, slightly ahead of first quarter 2022 net
revenues of $13.2 million and slightly behind fourth quarter net revenue of $14.1 million. DEXTENZA net product revenue grew from
$12.5 million to $13.2 million over the comparable period in 2022 while collaboration revenue declined
from $0.7 million to $0.2 million.
Research and development expenses
for the first quarter of 2023 were $14.7 million versus $13.1 million for the comparable period in 2022, driven primarily by an increase
in expenses associated with clinical and preclinical programs.
Selling and marketing expenses in the first
quarter of 2023 were $10.8 million as compared to $9.1 million for the comparable quarter of 2022, reflecting primarily an increase field
General and administrative expenses were $9.1
million for the first quarter of 2023 versus $7.6 million in the comparable quarter of 2022, primarily due to an increase in personnel-related
costs, including stock-based compensation, and professional fees.
The Company reported a net loss for the first
quarter of 2023 of $(30.3) million, or a loss of $(0.39) per share on both a basic basis and diluted basis, compared to a net loss of
$(12.5) million, or a net loss of $(0.16) per share on a basic basis and a loss of $(0.22) per share on a diluted basis for the comparable
period in 2022. Net loss in the first quarter of 2023 included a $6.6 million non-cash item attributable to a change in the fair value
of the derivative liability associated with the Company's convertible notes, increasing total other expenses as the price of the
Company's common stock increased during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization
were $5.1 million in the first quarter of 2023 versus $4.8 million for the comparable quarter in 2022.
As of May 4, 2023, the Company had approximately
77.5 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. 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 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-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, 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.
Forward Looking Statements
Any statements in this press release about
future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA or any of the
Company's products or product candidates; the development and regulatory status of the Company's product candidates, such
as the Company's development of, timing of, and prospects for approvability of OTX-TKI for the treatment of retinal diseases including
wet AMD and diabetic retinopathy including the timing of planned pivotal clinical trials, OTX-TIC for the treatment of primary open-angle
glaucoma or ocular hypertension, 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 Company's ability to fund the planned and future development of its product candidates, whether through strategic alliances
or other fundraising; the potential utility of any of the Company's product candidates; the size of potential markets for the Company's
product candidates; 2023 financial guidance, including estimated net product revenue; 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,"
Last updated: May 8, 2023