Full Press Release Details
Ocular Therapeutix Reports Fourth Quarter
and Year-End 2021 Financial Results and Business Update
(dexamethasone ophthalmic insert) 0.4 mg Recorded Net Quarterly Sales of $12.2 Million, Representing Year-Over-Year
Creating New Business Unit Focused on Optimizing
the Commercial Opportunity for DEXTENZA in the Office Setting
Completed Enrollment in U.S.-based Clinical
Trial for OTX-TKI for the Treatment of Wet AMD; Data Anticipated in the Second Half of 2022
Conference Call to Discuss Fourth Quarter Results
to be Held at 4:30 p.m. ET
Mass.--(BUSINESS WIRE)- February 28, 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 and year ended December 31, 2021, and provided updates on its
ophthalmology pipeline.
"Ocular has had another strong quarter
and a productive year," said Antony Mattessich, President and Chief Executive Officer. "Our commercialization of DEXTENZA
continues to ramp. We successfully expanded the DEXTENZA label and achieved durable reimbursement that will sustain DEXTENZA's
growth well into the future. The creation of a specialized business unit focusing solely on DEXTENZA in the office setting will allow
us to build the DEXTENZA franchise beyond the surgical setting and also establish the necessary commercial infrastructure to support
our innovative product pipeline. Our pipeline has progressed well. Recent data from our Australia-based OTX-TKI Phase 1 trial continues
to support a product profile that we believe could become standard of care in the treatment of wet AMD. We plan to provide data from
our U.S.-based Phase 1 clinical trial for OTX-TKI, which recently completed enrollment, later in the year. In the treatment of glaucoma,
we are excited to have initiated our Phase 2 trial for OTX-TIC and we are actively screening subjects. In the treatment of dry eye disease,
we continue to analyze the full data set from our Phase 2 studies in OTX-CSI and OTX-DED, and look forward to presenting the clinical-regulatory
and manufacturing strategies for these programs. Overall, we made great progress and look forward to a busy 2022 that will further advance
our strong position within ophthalmology."
Recent Business Updates
Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA for the quarter was $12.2 million, a 77%
increase over the fourth quarter of 2020 despite lower than anticipated elective surgeries due to the surge of the Omicron variant of
COVID-19. In the fourth quarter of 2021, in-market purchases were in excess of 29,000 billable units, representing sequential quarterly
growth of approximately 17%. While the reduced level of elective surgeries continued into January, the Company is seeing encouraging
signs that levels are rebounding in February.
of a New Business Unit Focused on Optimizing the Commercial Opportunity in the Office Setting. In October 2021, the Company
received supplemental FDA approval expanding DEXTENZA's label to include the treatment of ocular itching associated with allergic
conjunctivitis. To optimize that opportunity, the Company is establishing a separate commercial business unit consisting of Key Account
Managers (KAMs) and Field Reimbursement Managers (FRMs) focused on the office setting. This group could also serve to support the Company's
broader pipeline of product candidates, if approved, and their potential future use in the office setting.
Presented Updated Interim Data on OTX-TKI
and OTX-TIC at recent medical meetings.
Key Pipeline Program Updates
Fourth Quarter Ended December 31,
2021 Financial Results
product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $12.3 million for
the fourth quarter and represented a 66% increase over the same period in 2020. Net product revenue of DEXTENZA in the fourth quarter
was $12.2 million versus $6.9 million in the comparable quarter of 2020, reflecting an approximate 77% increase. Total net product revenue
for the fourth quarter in 2021 also includes net product revenue of $58 thousand from ReSure Sealant. Overall, net product
revenue for the year was $43.5 million versus $17.4 million for 2020, reflecting a strong uptake in DEXTENZA sales.
and development expenses for the fourth quarter were $12.6 million versus $7.6 million for the comparable period in 2020 driven primarily
by an increase in unallocated expenses, predominantly unallocated personnel costs and increased clinical trial costs associated with:
the initiation of the US-based Phase 1 trial of OTX-TKI and the initiation of the US-based Phase 2 trial for OTX-TIC; the 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. Overall R&D expenses for the full year increased $21.4 million to $50.1
million from $28.7 million in 2020, reflecting the trends identified above.
and marketing expenses in the quarter were $9.1 million as compared to $6.8 million for the same quarter in 2020, reflecting increased
personnel costs associated primarily with an expansion of the field force. Overall, selling and marketing expenses for the full year increased
to $35.2 million from $26.6 million in 2020, driven primarily by increased personnel costs and increased spending on consulting, trade
shows and conferences.
and administrative expenses were $7.5 million for the fourth quarter versus $6.6 million in the comparable quarter of 2020. The increase
in expenses stemmed primarily from increased personnel expenses and professional fees. Overall, G&A expenses for the full year increased
$9.0 million to $31.9 million from $22.9 million in 2020, again reflecting primarily increased personnel and professional fees.
Company reported a net loss of $(3.9) million, or a loss of $(0.05) per share on a basic basis and a loss of $(0.23) per share on a diluted
basis for the three months ended December 31, 2021. This compares to a net loss of $(85.6) million, or a loss of $(1.21) per share
on a basic and diluted basis for the same period in 2020. Net loss in the fourth quarter of 2021 included a $15.9 million non-cash gain
in the fair value of the derivative liability associated with the Company's convertible notes, driven by a decrease in the price
of its common stock during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.4 million
in the fourth quarter versus $2.8 million for the same quarter in 2020. Overall, the Company reported a net loss of $(6.6) million or
a loss of $(0.09) per share on a basic basis and a loss of $(0.98) on a diluted basis for the full year ended December 31, 2021 versus
a net loss of $(155.6) million or a loss of $(2.56) per share on both a basic and diluted basis in 2020.
February 24, 2022, the Company had 76.8 million shares outstanding.
December 31, 2021, the Company had $164.2 million in cash and cash equivalents versus $179.3 million at September 30, 2021.
Based on current plans and related estimates of anticipated cash inflows from DEXTENZA and anticipated cash outflows from operating expenses,
the Company believes that existing cash and cash equivalents, as of December 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, 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 1909039. An archive of the webcast will be available until April 30,
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 includes 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)
recently began a Phase 2 clinical trial to evaluate the reduction of intraocular pressure in patients with primary open-angle glaucoma
or ocular hypertension. Ocular Therapeutix has also completed Phase 2 clinical trials for 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. 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.