Full Press Release Details
Ocular Therapeutix Reports Third Quarter
2021 Financial Results and Business Update
DEXTENZA (dexamethasone ophthalmic
insert) 0.4 mg Recorded Net Quarterly Sales of $11.9 Million, Representing Year-Over-Year Growth of 120%
FDA Approved Supplemental New Drug Application
(sNDA) for DEXTENZA for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
DEXTENZA Will Be Paid Through the End of 2022
and is Eligible for Separate Payment in the Ambulatory Surgery Center Beyond 2022
Conference Call to Discuss Third Quarter Results
to be Held at 4:30 p.m. ET
BEDFORD, Mass.--(BUSINESS WIRE)- November
8, 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 third quarter
of 2021, and provided updates on its ophthalmology pipeline.
"The previous four months have been
an exceptionally busy time at Ocular," said Antony Mattessich, President and Chief Executive Officer. "We had a couple of
positive outcomes that we believe will set the course for the future of DEXTENZA . The first was the approval of the sNDA
for itching associated with allergic conjunctivitis that opens a large, new and discrete opportunity for DEXTENZA in the office setting.
The second was Medicare's final rule that determined that DEXTENZA will be paid separately in the hospital outpatient and ASC settings
in 2022 and is eligible under the current criteria for separate payment in the ASC as a non-opioid pain management drug beyond 2022,
positioning our vibrant business in the surgical setting to grow into the foreseeable future. We also continued to advance our pipeline.
While we were disappointed with the outcome of our Phase 2 dry eye clinical trial with OTX-CSI, we expect to announce the Phase 2 clinical
trial topline results for OTX-DED, our clinical trial in episodic dry eye disease in the first quarter of 2022. Further, our U.S.-based
clinical trial of OTX-TKI in wet-AMD is enrolling well, and we expect to initiate a Phase 2 clinical trial for OTX-TIC in glaucoma by
the end of the year. Overall, we are pleased with our continued progress as we enter a period of significant data and news flow that
will shape our leadership position within ophthalmology."
Recent Business Updates
FDA Approved Supplemental New Drug
Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the Treatment of Ocular Itching Associated
with Allergic Conjunctivitis. The approval represents the second label expansion for DEXTENZA and makes it the first FDA-approved,
physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated
with allergic conjunctivitis with a single administration for up to 30 days. Allergic conjunctivitis represents the Company's first
indication that will primarily be prescribed by physicians within the office setting and begins to lay the commercial foundation for
additional potential pipeline product candidates to be used to treat patients in that setting.
Final Rules for the Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) from the Centers for Medicare
The U.S. Commercial Uptake of DEXTENZA.
Net product revenue of DEXTENZA for the quarter was $11.9 million, a 120% increase over the third quarter of
2020 and a 7% sequential improvement over the second quarter of 2021. The Company believes that DEXTENZA recorded a solid third quarter
performance in light of lower than anticipated elective surgery volumes due to COVID-19. While it is early in the fourth quarter, monthly
growth in ASC volumes appears to be coming back on track as the Company estimates sales of in-market sales of over 9,600 billable units
in October, its second-largest month ever. In-market sales of billable units were 6,924, 9,321 and 8,737 for the months of July, August
and September respectively.
Announced Results from Phase 2 Clinical
Trial Evaluating OTX-CSI (cyclosporine intracanalicular insert) for the Treatment of Dry Eye Disease. The Phase 2 clinical trial
of OTX-CSI was designed to evaluate the safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI by measuring
signs and symptoms of dry eye disease in 140 subjects treated in both eyes over approximately 16 weeks (a 12-week study period, with an
additional 4-week safety follow-up). The Phase 2 study did not show separation between the OTX-CSI treated subjects (both formulations)
and the vehicle-treated subjects (both formulations) for the primary endpoint of increased tear production at 12 weeks as measured by
the Schirmer's Test. All formulations of OTX-CSI were observed to have a generally favorable safety profile and were well tolerated.
The Company is continuing to analyze the data, including retention data showing lower than anticipated insert retention rates in the active
Expanded Board of Directors and Leadership
Team. In September 2021, the Company added Merilee Raines to its board of directors and Karen-Leigh Edwards as Senior Vice President
of Technical Operations, and in October 2021, promoted Chris White to the new role of Chief Business Officer. The organizational moves
add expertise in finance, experience building high-performance global enterprise-wide manufacturing operations, and a focus on building
Ocular's position as a leading ophthalmology company.
Presenting Data on Commercial Products
and Pipeline at Major Medical Meetings: Six Abstracts Accepted for Presentation at the 2021 American Academy of Ophthalmology Annual Meeting
and Four Presentations at American Academy of Optometry Annual Meeting 2021.
Third Quarter Ended September 30, 2021
product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $12.2 million and
represented a 107% increase over the same period in 2020 and a 4% increase over the second quarter in 2021. Net product revenue
of DEXTENZA in the third quarter was $11.9 million versus $5.4 million in the comparable quarter of 2020, reflecting an approximate 120%
increase. Total net product revenue for the third quarter in 2021 also includes net product revenue of $0.3 million from ReSure
and development expenses for the third quarter were $12.7 million versus $7.0 million for the comparable period in 2020 driven primarily
by increased headcount, increased unallocated expenses and increased clinical trial costs associated with the initiation of the US-based
Phase 1 trial of OTX-TKI as well as the ongoing Phase 2 clinical trials for OTX-CSI and OTX-DED, the ongoing Phase 1 clinical trial of
OTX-TKI in Australia and the ongoing clinical trial for DEXTENZA for post-surgical inflammation and pain in pediatric subjects.
and marketing expenses in the quarter were $9.6 million as compared to $6.5 million for the same quarter in 2020, reflecting increased
personnel costs associated with an expansion of the field force and an increase in facility-related and other costs.
and administrative expenses were $8.1 million for the third quarter versus $6.0 million in the comparable quarter of 2020. The increase
in expenses stemmed primarily from increased personnel expenses and professional fees.
Company reported net income of $2.7 million, or income of $0.03 per share on a basic basis and a loss of $(0.23) per share on a diluted
basis for the three months ended September 30, 2021. This compares to a net loss of $11.9 million, or a loss of $(0.19) per share on a
basic and a loss of $(0.21) per share on a diluted basis for the same period in 2020. Net income in the 2021 period was due primarily
to a $23.8 million non-cash, net change in the fair value of the derivative liability associated with our convertible note, driven by
a decrease in the price of our common stock during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization
were $4.4 million in the third quarter versus $2.6 million for the same quarter in 2020.
November 3, 2021, the Company had 76.6 million shares outstanding.
September 30, 2021, the Company had $179.3 million in cash and cash equivalents versus $191.9 million at June 30, 2021. Based on current
plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure product sales and anticipated cash outflows from operating
expenses, the Company believes that existing cash and cash equivalents, as of September 30, 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, expenses and reimbursement
associated with DEXTENZA, and the pace of research and clinical development programs, among 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 3683601. An archive of the
webcast will be available until February 8, 2022 on the Company's website.
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 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