Full Press Release Details
Ocular Therapeutix Reports Second Quarter
2022 Financial Results and Business Update
Interim Data from the U.S.-based Clinical Trial
for OTX-TKI for the Treatment of Wet AMD to be Presented at American Academy of Ophthalmology (AAO) in the Third Quarter of 2022
(dexamethasone ophthalmic insert) 0.4 mg Recorded Quarterly Net Product Revenue of $12.1 Million, Representing Year-Over-Year
Reiterated DEXTENZA Annual Net Product Revenue
Guidance for 2022 between $55 to $60 million, Representing Annual Growth of Approximately 26% to 38%
Conference Call to Discuss Second Quarter Results
to be Held at 4:30 p.m. ET
Mass.--(BUSINESS WIRE)- August 8, 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 June 30, 2022, and provided updates on its ophthalmology
"Through the first half of the year
we are making good progress executing on our commercial strategy and developing our strong ophthalmology pipeline," said Antony
Mattessich, President and Chief Executive Officer. "Looking ahead, we plan to announce interim data from the U.S.-based Phase 1
clinical trial of OTX-TKI for the treatment of wet AMD in the third quarter. Wet AMD represents a large market opportunity for a highly
differentiated product, and we believe that OTX-TKI has the potential to become a new standard of care in the management of serious retinal
diseases. On the commercial front, DEXTENZA achieved net revenue of $12.1 million for the quarter despite staffing challenges 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
drivers such as the recent recommendation of continued separate payment through 2023 by CMS, bringing new territories online, and the
ramp-up of our new office-based salesforce should have a positive impact on DEXTENZA sales over the remainder of 2022 and beyond."
Recent Business Updates
OTX-TKI Data Expected to be Presented
at American Academy of Ophthalmology (AAO) Meeting at the End of September
Implemented Organizational Changes to
Strengthen the Company's Alignment Around Its Retina Programs and the Overall Development of its Ophthalmology Pipeline
The U.S. Commercial Uptake of DEXTENZA
Key Pipeline Program Updates
Second Quarter Ended June 30, 2022
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 $12.3 million for the second quarter and represented an approximately 5% increase over the same
period in 2021. Net product revenue of DEXTENZA in the second quarter of 2022 was $12.1 million versus $11.1 million in the comparable
quarter of 2021, reflecting a 9% increase. Total net revenue for the second quarter of 2022 also included collaboration revenue of $0.1
million from the Company's licensing agreement with AffaMed.
and development expenses for the second quarter were $13.1 million versus $13.9 million for the comparable period in 2021 driven primarily
by a reduction in clinical and pre-clinical spending offset by an increase in unallocated personnel costs and other expenses.
and marketing expenses in the quarter were $10.1 million as compared to $8.4 million for the comparable quarter of 2021, due primarily
to an increase in professional fees related to trade shows, conferences and advertising.
and administrative expenses were $7.8 million for the second quarter versus $8.6 million in the comparable quarter of 2021, primarily
reflecting a decrease in professional fees.
Company reported a net loss of $ (18.8) million, or a loss of $ (0.24) and $ (0.25) per share on a basic and diluted basis, respectively,
for the second quarter ended June 30, 2022. This compares to a net loss of $(8.5) million, or a loss of $(0.11) per share on a basic
basis and $(0.25) per share on a diluted basis. for the comparable period in 2021. Net loss in the second quarter of 2022 was reduced
by a $2.8 million non-cash item attributable to a decrease in the fair value of the derivative liability associated with the Company's
convertible notes, as the price of its common stock declined during the quarter. Non-cash charges for stock-based compensation and depreciation
and amortization were $4.8 million in the second quarter of 2022 versus $4.9 million for the comparable quarter of 2021.
As of August 5, 2022, the
Company had 77.0 million shares outstanding.
2022 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. The live webcast can be accessed by visiting the Investors section of the Company's website at
investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that
may be needed to access the webcast. Alternatively, please call (800) 715-9871 (U.S.) or (646) 307-1963 (International) to listen to the
live conference call. The conference ID number for the live call will be 9296568. A replay of the webcast will be available on the Company's
website for 90 days following the live call.
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, 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 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, ReSure Sealant or any product candidate that receives regulatory approval,
including the conduct of post-approval studies, the ability to successfully develop and commercialize products for the ophthalmology
office setting, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any 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, whether clinical trial data such as the data reported in this release will be indicative
of the results of subsequent clinical trials, availability of data from clinical trials and expectations for regulatory submissions and