Full Press Release Details
Reports Second Quarter 2024 Results
AXPAXLI Repeat Dosing Study in Wet AMD Acceptable to FDA as Registrational Trial
in SOL-1 Continues to Accelerate and SOL-R Actively Enrolling Patients
of $459.7M as of June 30, 2024, Expected to Fund Operations into 2028
a Q2 2024 Conference Call and Webcast Today, August 7th, at 8:00 AM ET
BEDFORD, MA, August 7, 2024 (GLOBE
NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company
committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases
and other eye conditions, today reported financial results for the second quarter ended June 30, 2024 and provided recent business
highlights, including an update on the Phase 3 AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) wet age-related
macular degeneration (wet AMD) program.
"I am pleased to report that Ocular
is making outstanding progress in 2024. Over the last six months, we have clarified our mission of becoming a leader in the treatment
of retinal disease and thoughtfully assembled the team to deliver this mission. The exemplary work of our clinical team has allowed Ocular
to accelerate enrollment in the SOL-1 superiority study of AXPAXLI in wet AMD and to swiftly design and initiate the SOL-R non-inferiority
repeat dosing study. We are also pleased to report that the FDA has now confirmed that SOL-R is appropriate for use as our second registrational
study," said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. "In
June, we held a successful Investor Day that allowed us to put SOL-1 and SOL-R into context as complementary studies, addressing questions
on durability and repeat dosing. We believe this could put us in a strong position to target a favorable label for AXPAXLI in wet AMD,
potentially providing desired flexibility for physicians. The Investor Day also provided us with an opportunity to review the durable
and consistent data from the HELIOS study in non-proliferative diabetic retinopathy (NPDR). With these HELIOS data, plus data from our
two prior clinical trials in wet AMD, we remain extremely enthusiastic about our SOL-1 and SOL-R registrational studies."
concluded, "We believe this is just the beginning of a new age in retinal disease care,
and we look forward to updating the investment community and our stakeholders on our progress."
Recent Achievements and Upcoming
Second Quarter Ended June 30,
2024, Financial Results
cash and cash equivalents were $459.7 million as of June 30, 2024. Based on current plans
and related estimates of anticipated cash inflows from DEXTENZA , the Company believes that its current cash balance is
sufficient to support its planned expenses, obligations, and capital expenditure requirements into 2028.
net revenue was $16.4 million for the second quarter of 2024, an 8.3% increase over
total net revenue of $15.2 million in the comparable period in 2023, driven by increased revenues from DEXTENZA sales. The Company expects
full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, compared to $57.9 million reported in 2023.
Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as
net product revenue, and collaboration revenue.
and development expenses for the second quarter of 2024 were $28.9 million versus $15.1 million
for the comparable period in 2023, reflecting an increase in overall clinical expenses associated with product development programs,
specifically the ongoing enrollment in the SOL-1 Phase 3 clinical trial, and the design and initiation of start-up activities in the
SOL-R Phase 3 clinical trial, as well as additional personnel and professional services to support these clinical trials.
and marketing expenses were $10.0 million in the second quarter of 2024, as compared to $11.2
million for the comparable quarter of 2023, primarily reflecting a decrease in professional fees and stock compensation and other personnel
and administrative expenses were $19.7 million for the second quarter of 2024 versus $8.2 million
in the comparable quarter of 2023, primarily due to an increase in one-time personnel-related costs, including stock-based compensation
expense for certain employees who departed the Company, restructuring costs, and professional services, including legal expense.
loss for the second quarter of 2024 was $(43.8) million, or a net loss of $(0.26) per
share on both a basic and diluted basis, compared to a net loss of $(20.7) million, or a net loss of $(0.26) per share
on both a basic and diluted basis, for the comparable period in 2023. The net loss in the second quarter of 2024 included a $(3.0) million
non-cash loss attributable to the changes in the fair value of the derivative liability associated with the Barings credit facility,
as compared to a $1.1 million non-cash gain attributable solely to the change in the fair value of the derivative liability associated
with the Company's convertible notes for the comparable quarter in 2023.
shares as of August 2, 2024, were approximately 155.9 million.
Conference Call and Webcast Information
Therapeutix will host a conference call and webcast today at 8:00 AM ET to discuss recent business progress and second quarter financial
results. To access the call, please dial: 1 (800) 343-4136 (United States) or 1 (203) 518-9843 (International) and reference
the conference ID "OCULAR". To access the webcast, please click here.
The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section
of the Investor Relations page. A replay of the webcast will be archived for 90 days.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
is a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative
therapies for retinal diseases and other eye conditions. AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI), Ocular's
product candidate for retinal disease, is based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology.
AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD).
Ocular's pipeline also leverages
the ELUTYX technology in its commercial product DEXTENZA , an FDA-approved corticosteroid for the treatment of ocular
inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate
PAXTRAVA (travoprost intracameral implant or OTX-TIC), which has completed a Phase 2 clinical trial for the treatment of
open-angle glaucoma or ocular hypertension.
Follow the Company on its website, LinkedIn
The Ocular Therapeutix logo and DEXTENZA
are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI , PAXTRAVA , ELUTYX , and Ocular Therapeutix
are trademarks of Ocular Therapeutix, Inc.
Any statements in this press release about future expectations, plans, and prospects
for the Company, including the development and regulatory status of the Company's product candidates; the timing, design, and enrollment
of the Company's SOL-1 and SOL-R Phase 3 clinical trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company's
plans to advance the development of AXPAXLI and its other product candidates; the potential utility of any of the Company's product
candidates; the Company's objective to become a leader in retinal care; the Company's guidance regarding its projected total
net product revenues for DEXTENZA; the Company's cash runway and 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
statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing any product or product
candidate that receives regulatory approval; the ability to retain regulatory approval of any product or product candidate that receives
regulatory approval; the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials; the risk that the FDA
will not agree with the Company's interpretation of the written agreement under the Special Protocol Assessment for the SOL-1 trial;
the risk that the FDA may not agree that the protocol and statistical analysis plan of SOL-R or the data generated by the SOL-1 and SOL-R
trials support marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of
later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier
trials, whether preliminary or interim data from a clinical trial will be predictive of final data from such trial, or whether data from
a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; availability of
data from clinical trials and expectations for regulatory submissions and approvals; the Company's scientific approach and general
development progress; 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; the 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