Full Press Release Details
Ocular Therapeutix Reports Third
Quarter 2020 Financial Results and Business Update
Raised $75.2 Million in Proceeds Net of Fees
Net Product Revenue in Third Quarter of $5.4 Million, a 280% Increase from the Prior Quarter
Phase 1 Results and Recently Initiated Phase 2 Clinical Trial of OTX-CSI for the Chronic Treatment of Dry Eye Disease
Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries
BEDFORD, Mass. -(BUSINESS WIRE)-November 5,
2020-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 announced financial results for the
quarter ended September 30, 2020 and provided a business update.
"It has been a productive quarter
for Ocular Therapeutix with a number of key developments that we believe will drive significant long-term value," said Antony
Mattessich, President and CEO. "DEXTENZA 's momentum continues as a result of key initiatives implemented
earlier in the year and exemplified by a robust 280% increase over the prior quarter. This momentum has continued into the fourth
quarter with nearly 4,200 billable inserts sold to ASCs and HOPDs in the month of October. Within our pipeline, we have four clinical-stage
programs that are each highly differentiated ophthalmology specialty products in markets where current annual global sales are
estimated to exceed $20 billion. Each of these programs address the key unmet need in the indication it is targeting. With an
improved cash position following the completion of a successful financing in October and the recently concluded license agreement
with AffaMed Therapeutics, we believe we are now in a position to fund each of these four planned programs through its respective
read-out of Phase 2 clinical trial data to capture the full potential benefit of the Phase 2 value inflection."
Recent Business Updates
Reported the American Medical
Association (AMA) has established a permanent Category I Current Procedural Terminology (CPT) procedure code for 0356T for the
administration of drug-eluting intracanalicular inserts, including DEXTENZA (dexamethasone ophthalmic insert)
0.4 mg, effective January 1, 2022. The current professional fee for CPT code 0356T is expected to remain eligible
to be paid per the established local fee schedule, where available, until the newly issued CPT Category I code goes into effect
Completed common stock financing
in late October. The Company raised $75.2 million, net of fees, from a public offering of common stock in mid-October that
augments cash and cash equivalents of $70.6 million as of September 30, 2020. The Company believes it now has adequate resources
to fund its four planned Phase 2 programs.
License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries. The Company announced a
license agreement and a collaboration with AffaMed Therapeutics for the development and commercialization of DEXTENZA
and OTX-TIC in Greater China, South Korea, and the ASEAN markets. Under the terms of the agreement, Ocular Therapeutix is
entitled to receive an upfront payment of $12 million and is eligible to receive development, regulatory and commercial milestone
payments and clinical development support payments of up to $91 million in the aggregate, as well as royalties from future product
sales. Royalties are tiered and range from a low-teen to low-twenties percentage.
OTX-TKI (axitinib intravitreal
implant): OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor
with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal
OTX-TIC (travoprost intracameral
implant): OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle
glaucoma or ocular hypertension.
OTX-CSI (cyclosporine intracanalicular
insert): OTX-CSI is a long-acting, preservative-free cyclosporine intracanalicular insert for the chronic treatment of
OTX-DED (dexamethasone intracanalicular
insert): OTX-DED incorporates the FDA-approved corticosteroid dexamethasone as an active pharmaceutical ingredient into
a hydrogel, drug-eluting, preservative-free intracanalicular insert. OTX-DED is designed to release dexamethasone over a period
of two-to-three weeks for the short-term treatment of the signs and symptoms of dry eye disease.
DEXTENZA (dexamethasone ophthalmic
insert) 0.4 mg: DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain
following ophthalmic surgery.
Third Quarter Ended September 30,
2020 Financial Results
Gross product revenue net of discounts,
rebates, and returns, which the Company refers to as total net product revenue, was $5.9 million for the third quarter as compared
to $1.6 million in the second quarter. Net product revenue of DEXTENZA was $5.4 million in the third quarter versus $1.4 million
in the second quarter. The Company believes the significant increase of over 280% quarter-over-quarter was driven by the continued
re-opening of ACSs and HOPDs as well as the impact of the DEXTENZA rebate program and the more recent physician payment of the
procedure CPT code 0356T by some of the MACs. Net product revenue of ReSure Sealant in the third quarter was $0.5
million versus $0.2 million in the second quarter.
Research and development expenses for
the third quarter were $7.0 million versus $10.2 million for the comparable period in 2019 and primarily reflect a decrease in
personnel and other unallocated costs due the organizational restructuring announced in November 2019.
Selling and Marketing expenses for
the third quarter were $6.5 million versus $6.8 million for the comparable period in 2019, stemming primarily from a decrease in
travel, consulting, marketing and conference expenses as a result of the COVID-related slowdown offset somewhat by increased personnel
General and Administrative expenses
were $6.0 million in the third quarter versus $6.2 million in the comparable period in 2019, reflecting a decrease in personnel
expenses offset by an increase in professional costs.
The Company reported a net loss of
$(11.9) million, or a loss of $(0.19) per share on a basic basis and $(0.21) on a diluted basis for the third quarter. This compares
to a net loss of $(18.8) million, or a loss of $(0.40) per share on a basic basis and $(0.45) on a diluted basis, for the same
period in 2019. The net loss for the third quarter included $2.6 million in non-cash charges for stock-based compensation and depreciation
compared to $3.8 million for the same quarter in 2019. In addition, the net loss for the third quarter includes a non-cash gain
of $3.8 million related to the change in the fair value of the derivative liability associated with our convertible notes.
As of November 1, 2020, the Company
had approximately 71.4 million shares outstanding.
As of September 30, 2020, the
Company had $70.6 million in cash and cash equivalents versus $84.3 million at the end of the second quarter of 2020. The cash
at the end of the quarter does not include incremental cash of $75.2 million net of offering discounts, commissions and estimated
expenses that was raised in a follow-on public offering of common stock that was completed in October of 2020 and the anticipated
proceeds of $12 million in upfront payments from the recently announced licensing agreement with AffaMed.
Based on current plans and including
related estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses,
the Company believes that existing cash and cash equivalents, as of September 30, 2020 in combination with the net proceeds
from the recent equity offering, enables the Company to fund planned operating expenses, debt service obligations and capital expenditure
requirements into 2023. This cash guidance is subject to various assumptions including those related to the severity and duration
of the COVID-19 pandemic and other assumptions related to revenues and expenses associated with the commercialization of DEXTENZA,
and the pace and expense of our research and clinical development programs, as well as other aspects of the Company's business.
Conference Call & Webcast
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 8255125. An archive
of the webcast will be available until December 20, 2020 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