Full Press Release Details
Ocular Therapeutix Reports Second Quarter
2021 Financial Results and Business Update
DEXTENZA Recorded Net Quarterly
Sales of $11.1 Million, Representing Quarterly Sequential Growth of Approximately 65%
Initiated First Clinical Trial in the U.S.
to Assess a Single OTX-TKI Implant Containing a 600 g Dose of Axitinib for the Treatment of Wet Age-Related Macular Degeneration
Conference Call to Discuss Second Quarter
Results to be Held at 4:30 p.m. ET
BEDFORD, Mass.--(BUSINESS WIRE)- August
9, 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 second
quarter of 2021, and provided updates on its ophthalmology pipeline.
"It has been a productive quarter for Ocular
as we work to build a leading ophthalmology company," said Antony Mattessich, President and Chief Executive Officer. "Net
product revenue for DEXTENZA was up nearly 700% against the prior year period and we achieved record quarterly in-market
sales of nearly 25,000 billable units, representing a 50% sequential increase over the first quarter. Beyond DEXTENZA, we made significant
progress in advancing our pipeline of product candidates, dosing the first patient in our U.S.-based trial of OTX-TKI, and completing
a research agreement with Mosaic Biosciences targeting dry-AMD that further builds our product pipeline. In the second half of 2021,
we look forward to continued momentum with DEXTENZA, including a PDUFA date in allergic conjunctivitis in October, and further development
of our pipeline which includes the expected completion of our Phase 2 clinical trial with OTX-CSI, our cyclosporine-containing intracanalicular
insert for the chronic treatment of dry eye disease."
Recent Business Updates
First Patient Dosed in U.S.-based Clinical
Trial Evaluating OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet AMD. The Phase 1 clinical trial in the U.S.
is a prospective, randomized, controlled, multi-center trial evaluating a single OTX-TKI implant containing a 600 g dose of axitinib
with an anti-VEGF induction injection, compared with a 2 mg dose of aflibercept administered every 8 weeks in subjects previously treated
with anti-VEGF therapy. This is the first clinical trial utilizing the Company's single dose, 600 g implant. This trial is
designed to assess the safety, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD and is being conducted under
an exploratory IND, at five sites with a total of 20 randomized subjects: 15 subjects being treated with a single OTX-TKI implant with
an anti-VEGF induction injection, and 5 subjects being treated at eight-week intervals with a dose of aflibercept. OTX-TKI has the potential
to be a novel sustained release administration of axitinib, with six months or longer durability, which includes a potential new mechanism
of action for the treatment for patients with wet AMD and other retinal diseases.
U.S. Commercial Uptake of DEXTENZA. Net product revenue
of DEXTENZA for the quarter was $11.1 million, a nearly 700% increase over the second quarter 2020, and an approximately
65% sequential increase over the first quarter of 2021. DEXTENZA in-market unit volume to surgery centers was a record of nearly 25,000
billable inserts, an approximately 50% sequential increase over the previous quarter. The Company believes this growth reflects strong
end-user demand for DEXTENZA driven by an increase in cataract procedure volumes and market share gains. June 2021 in-market unit sales
set a monthly record of 9,779 billable inserts as cataract volumes continued to increase through the second quarter of 2021 after a slowing
of procedures earlier in the year as result of regional COVID surges. As previously reported, April and May in-market unit sales were
8,025 billable inserts and 7,186 billable inserts, respectively.
DEXTENZA Pass-Through Payment Status Recommended for Extension
Through the End of 2022. CMS, in its CY 2022 Outpatient Prospective Payment System (OPPS) proposed rule on July 19, 2021, recommended
that pass-through status of DEXTENZA be extended six months through the end of 2022. The Company expects that, if finalized, this
decision would move any negotiation between the Company and CMS on DEXTENZA's post-pass-through payment status into the next rulemaking
cycle, a year from now. The Company continues to believe there are a number of pathways whereby it can continue to provide patient access
to DEXTENZA in ASCs and HOPDs beyond the pass-through period and expects to be working actively in advance of the 2023 rulemaking cycle.
New Medicare Physician
Fee Schedule Proposed for Insertion of DEXTENZA. The Medicare Physician Fee Schedule proposed rule was also issued in July. The
proposed rule indicated that the Company's CPT procedural code, 0356T for the Insertion of a drug-eluting implant into the lacrimal
canaliculus, continues to be on track to convert to a Category 1 code in January of 2022 with a proposed procedure payment of $31.91 in
the facility and $37.61 in the physician's office for unilateral insertion. The Company is pleased with the prospect of the Category
1 code conversion for the procedure since Category 1 CPT codes typically benefit from broader coverage and payment among all types of
payers. However, the Company intends to use the formal comment period to actively pursue higher potential payment rates that it believes
Data at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Meeting. Eight company presentations and five presentations
from investigator-initiated trials were presented at the 2021 ASCRS Meeting on July 23-27th. Data was presented on multiple programs
advancing in clinic as well as DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use and ReSure
Sealant. The data being presented continue to support the use of DEXTENZA to treat post-operative ocular inflammation and pain
and the ability to research the use of our proprietary hydrogel technology to potentially address the unmet needs in the ophthalmic space,
specifically in glaucoma, dry eye disease and allergic conjunctivitis. Posters for the Company-sponsored presentations can be accessed
on the corporate website.
Regeneron Collaboration to Develop a
Sustained-Release Formulation of Aflibercept for the Treatment of Wet AMD and other Serious Retinal Diseases Terminated. Regeneron
has terminated its collaboration with the Company. The collaboration with Regeneron was initially formed in 2016, and later amended in
2020 to focus on the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal
space for the treatment of retinal diseases. Ocular is now free to potentially pursue discovery work in this area on its own or with a
Second Quarter Ended June 30, 2021 Financial
revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was $11.7 million and represented
a 631% increase over the same period in 2020. Net product revenue of DEXTENZA in the second quarter was $11.1 million
versus $1.4 million in the comparable quarter 2020, reflecting a nearly seven times increase. Total net product revenue for the second
quarter also includes net product revenue of $0.6 million from ReSure Sealant, compared with $0.2 million from ReSure
Sealant in the comparable quarter 2020.
Research and development expenses
for the second quarter were $13.9 million versus $8.0 million for the comparable period in 2020 primarily driven by increased headcount
as well as 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 Phase 3 pediatric
clinical trial of DEXTENZA in accordance with the FDA's post-approval requirements.
Selling and marketing expenses
in the quarter were $8.4 million as compared to $6.2 million for the same quarter in 2020, reflecting increased personnel costs associated
with expansion of our field force.
Finally, general and administrative
expenses were $8.6 million for the second quarter versus $5.1 million in the comparable quarter of 2020. The increase in expenses stemmed
primarily from increased personnel expenses and professional fees.
financial results for the second quarter, the Company reported a net loss of $8.5 million, or $(0.11) per share on a basic and
$(0.25) per share on a diluted basis. This compares to a net loss of $36.6 million, or $(0.64) per share on a basic and diluted
basis for the same period in 2020. The decreased loss was due primarily from a $30.4 million 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 was $4.9 million in the second quarter
versus $2.5 million for the same quarter in 2020.
As of August 4, 2021, the Company
had 76.6 million shares outstanding.
As of June 30, 2021, the Company
had $191.9 million in cash and cash equivalents versus $209.4 million at March 31, 2021. Based on our 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 June 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