Full Press Release Details
Ocular Therapeutix Reports First Quarter
2021 Financial Results and Business Update
Achieved Quarterly Record of 16,634 Billable Units Sold to End Customers, Representing Quarterly Sequential
Mass.--(BUSINESS WIRE)- May 5, 2021 -- 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 of 2021, and provided updates on its strong ophthalmology pipeline.
"Our progress in the first quarter of 2021 was significant,"
said Antony Mattessich, President and Chief Executive Officer. "Revenue for DEXTENZA was up over 200% against the
prior year period and we achieved record quarterly, in-market sales in excess of 16,000 billable units, representing 15% sequential quarterly
growth. Encouragingly, the momentum we saw in the first quarter has continued into the second quarter with estimated sales in excess
of 8,000 billable units in April alone. Beyond DEXTENZA, we have made progress in advancing our pipeline of product candidates that
continue to show potential to set the standard of care in their respective disease areas. We have had a large presence at this year's
ongoing ARVO meeting with seven total presentations highlighting both pre-clinical and clinical updates in our key programs. In 2021
we look forward to continued momentum with DEXTENZA and further development of our pipeline which includes the planned initiation of
two Phase 2 programs in wet-AMD and glaucoma and the expected completion of a Phase 2 clinical trial in dry eye disease."
Recent Business Updates
Pre-Clinical and Clinical Data at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Six
company presentations and one presentation from an investigator-initiated trial are being held at the 2021 Association for Research in
Vision and Ophthalmology (ARVO) Virtual Meeting this week. Updated interim analyses of Phase 1 data for both OTX-TKI for the treatment
of wet age-related macular degeneration (wet AMD) and other retinal diseases and OTX-TIC for the reduction of intraocular pressure in
patients with primary open-angle glaucoma or ocular hypertension were presented. Both presentations provided additional data that continue
to support the development of products that could become the standard of care in these large markets.
are also being presented on the Company's products targeting ocular surface disease including pre-clinical pharmacokinetic data
on OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
Additionally, we are presenting a post-hoc analysis of data on DEXTENZA
(dexamethasone ophthalmic insert) for the treatment of allergic
conjunctivitis. The use of DEXTENZA in allergic conjunctivitis is currently under U.S. Food and Drug Administration (FDA) review with
a target action Prescription Drug User Fee Act (PDUFA) date of October 18, 2021. This presentation evaluates the safety of the product
candidate across the four clinical trials conducted.
Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA for the quarter was $6.7 million, an approximately
220% increase over the first quarter of 2020. Net sales for the quarter were flat relative to the previous quarter primarily due to variations
in distributor inventory levels. DEXTENZA in-market unit volume to surgery centers, which is the best determinant of true underlying
demand, achieved a record in the first quarter of 16,634 billable inserts and grew at approximately 15% sequentially over the previous
quarter. As previously reported, January and February in-market billable inserts were 4,582 and 4,901, respectively. In-market
demand then rebounded strongly in March with sales of billable inserts achieving a record month of 7,151 units.
The Company is also reporting that April in-market, billable units
are estimated to have exceeded 8,000 units, setting a new monthly record.
First Patient in Phase 2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical
trial is a U.S.-based, prospective, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations
of a new dexamethasone drug product candidate OTX-DED in approximately 150 subjects with dry eye disease. Subjects are to be followed
for approximately two months after randomization. This trial is designed to assess the safety and efficacy of OTX-DED for the short-term
treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, the visual analog score of eye dryness
and severity, and total corneal fluorescein staining.
First Quarter Ended March 31, 2021
Gross product revenue net of
discounts, rebates, and returns, which the Company refers to as total net product revenue, was $7.3 million for the three months ended
March 31, 2021, representing a greater than 175% increase over the first quarter of 2020. Net product revenue of DEXTENZA
in the first quarter was $6.7 million versus $2.1 million in the comparable quarter 2020 and reflects an approximate 220% increase.
Total net product revenue for the first quarter of 2021 also includes net product revenue of $0.6 million from ReSure
Research and development expenses
for the first quarter of 2021 were $10.9 million versus $6.1 million for the comparable period in 2020 primarily driven by increased headcount
as well as increased clinical trial costs associated with the ongoing Phase 2 clinical trial for OTX-CSI, the commencement of the Phase
2 clinical trial of OTX-DED and the ongoing Phase 1 clinical trials of OTX-TKI and OTX-TIC.
Selling and marketing expenses in the first quarter of 2021 were $8.1
million as compared to $7.1 million for the same quarter in 2020, primarily reflecting increased personnel costs associated with expansion
General and administrative expenses
were $7.7 million for the first quarter of 2021 versus $5.2 million in the comparable quarter of 2020. The increase in expenses stemmed
primarily from increased personnel expenses and professional fees.
The Company reported net income
of $3.1 million, or a profit of $0.04 per share on a basic basis and a net loss of $(20.8) million, or a loss of $(0.24) per share on
a diluted basis in the first quarter of 2021. This compares to a net loss of $(21.5) million, or a loss of $(0.41) per share on a basic
and diluted basis for the same period in 2020. As operating expenses increased quarter over quarter, the modest profit was driven by a
non-cash gain of $25.0 million related to the change in the fair value of the derivative liability associated with the Company's
convertible notes. This change in fair value was due primarily to a decline in the Company's common stock price during the first
quarter of 2021. Non-cash charges for stock-based compensation and depreciation and amortization were $3.7 million in the first quarter
of 2021 versus $2.4 million for the same quarter in 2020.
As of May 1, 2021, the Company
had 76.3 million shares outstanding.
of March 31, 2021, the Company had $209.4 million in cash and cash equivalents versus $228.1 million at December 31, 2020. Based
on current plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure product sales and cash outflows from operating
expenses, the Company believes that existing cash and cash equivalents, as of March 31, 2021, will enable the Company to fund planned
operating expenses, debt service obligations and capital expenditure requirements through 2023. This
cash guidance is subject to a number of assumptions including those related to the severity and duration of the COVID-19 pandemic, the
revenues and expenses associated with the commercialization of DEXTENZA, and the pace of research and clinical development programs, and
other aspects of the business.
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 (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the live conference call.
The conference ID number for the live call will be 3944056. An archive of the webcast will be available until August 5, 2021 on the
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 FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix
has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a
supplemental new drug application to include the treatment of ocular itching associated with allergic conjunctivitis as an additional
approved indication of DEXTENZA. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include
OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral
implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix
is currently evaluating each of 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 in Phase 2 clinical
trials. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery
formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure Sealant,
is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.
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