Full Press Release Details
Provides Second Quarter 2023 Financial Results and Corporate Update
Net Product Revenue in Q2 2023 was $15.0 million, Representing Growth of Approximately 24% Over Q2 2022
$82.5 million Credit Facility; Cash Runway Now Forecasted into 2025
Planned Pivotal Clinical Trials for OTX-TKI in Wet AMD Expected to Initiate in Q3 2023
Completed Enrollment
of HELIOS U.S.-based OTX-TKI Phase 1 Clinical Trial for Treatment of Non-Proliferative Diabetic Retinopathy; 6-Month Interim Data Anticipated
Completed Enrollment
of OTX-TIC Phase 2 Clinical Trial and Began Pilot Repeat-Dose Sub-Study
Mass.-(BUSINESS WIRE)- August 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 second quarter ended June 30, 2023, and
provided updates on its ophthalmology pipeline.
"The progress at Ocular Therapeutix
over this last quarter has been significant," said Antony Mattessich, President and CEO. "We reached the milestone of $15.0
million in DEXTENZA net product revenues for the quarter and achieved revenue growth of 24% over the same quarter prior year and 14%
over the previous quarter. This represents the third straight quarter of sequential growth of in-market unit sales and gives us great
confidence in DEXTENZA's ability to augment funding of our fast-developing pipeline. As importantly, we now have a path forward
with OTX-TKI in wet AMD and expect to initiate our first pivotal trial in the United States for wet AMD before the end of this quarter.
We were also able to secure a credit facility of $82.5M that puts the funding in place to be able to initiate the trial and extends our
runway into 2025. We believe that our successes in R&D and improved commercial performance have positioned us well for the future."
(axitinib intravitreal implant) for the potential treatment of wet AMD and other retinal vascular diseases
(axitinib intravitreal implant) for the treatment of non-proliferative diabetic retinopathy (NPDR).
(travoprost intracameral implant) for the treatment of primary open-angle glaucoma or ocular hypertension.
(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
(dexamethasone ophthalmic insert) 0.4mg approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular
itching associated with allergic conjunctivitis.
$82.5 million Credit Facility
Ended June 30, 2023 Financial Results
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 $15.2 million for the second quarter of 2023, an increase of approximately 24% over
second quarter 2022 net revenues of $12.3 million and an increase of approximately 13% over first quarter net revenue of $13.4 million.
For the second quarter of 2023, DEXTENZA net product revenue grew to $15.0 million from $12.1 million over the comparable period in 2022
while collaboration revenue grew to $0.2 million from $0.1 million.
and development expenses for the second quarter of 2023 were $15.1 million versus $13.1 million for the comparable period in 2022, driven
primarily by an increase in expenses associated with clinical trial programs.
and marketing expenses in the second quarter of 2023 were $11.2 million as compared to $10.1 million for the comparable quarter of 2022,
reflecting primarily an increase in field force personnel.
and administrative expenses were $8.2 million for the second quarter of 2023 versus $7.8 million in the comparable quarter of 2022, primarily
due to an increase in personnel-related costs, including stock-based compensation and professional fees.
Company reported a net loss for the second quarter of 2023 of $(20.7) million, or a loss of $(0.26) per share on both a basic and diluted
basis, compared to a net loss of $(18.8) million, or a net loss of $(0.24) per share on a basic basis and a net loss of $(0.25) per share
on a diluted basis for the comparable period in 2022. The net loss in the second quarter of 2023 included a $1.1 million non-cash item
attributable to a change in the fair value of the derivative liability associated with the Company's convertible notes, decreasing
total other expenses as the price of the Company's common stock decreased during the quarter. Non-cash charges for stock-based
compensation and depreciation and amortization were $5.1 million in the second quarter of 2023 versus $4.8 million for the comparable
of August 3, 2023, the Company had approximately 79.4 million shares outstanding.
Call & Webcast Information
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.
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-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.
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.
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,
including the timing and design of the Company's planned pivotal trials of OTX-TKI for the treatment of wet AMD; the Company's
cash runway and sufficiency of the Company's cash resources; 2023 financial guidance, including estimated net product revenue;
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, including the conduct of post-approval studies; 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, timing, conduct and outcomes of clinical trials;
availability of data from clinical trials and expectations for regulatory submissions and approvals; uncertainties inherent in estimating
the Company's cash runway, future expenses and other financial results, including its ability to fund future operations, including
clinical trials; Company's existing indebtedness and the ability of the Company's creditors to accelerate the maturity of
such indebtedness upon the occurrence of certain events of default; the Company's ability to enter into strategic alliances or
generate additional funding on a timely basis, on favorable terms, or at all; 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 press 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, whether as a result of new information, future events or otherwise, except as required by law. 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 press release.
Chief Financial Officer
Chris Brinzey, 339-970-2843
Ben Shannon, 443-213-0495
Ocular Therapeutix, Inc.