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Ocular Therapeutix Reports Fourth Quarter and Year End 2020 Financial Results and Business Update BEDFORD, Mass.--(BUSINESS WIRE)- March 11 , 2021 -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company fo

Key Takeaway: Ocular Therapeutix Reports Fourth Quarter and Year End 2020 Financial Results and Business Update BEDFORD, Mass.--(BUSINESS WIRE)- March 11, 2021 -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercializat

Full Press Release Details

Ocular Therapeutix Reports Fourth
Quarter and Year End 2020 Financial Results and Business Update
BEDFORD, Mass.--(BUSINESS WIRE)- March 11,
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
fourth quarter and year ended December 31, 2020 and provided updates on its leading ophthalmology pipeline.
"The fourth quarter marked considerable commercial, clinical
and regulatory progress for the Company," said Antony Mattessich, President and Chief Executive Officer. "Physician
interest in DEXTENZA remains high, and despite the challenging backdrop of COVID, adoption by ASCs and HOPDs continues to
drive strong growth in reported sales. In the fourth quarter of 2020, in-market purchases were in excess of 14,000 billable units,
representing sequential quarterly growth of greater than 40%. Beyond DEXTENZA, we have a unique pipeline of ophthalmology product
candidates that each target indications within multi-billion dollar segments of the ophthalmology market. In 2021 we look forward
to initiating multiple Phase 2 programs."
Recent Business Updates
Presented Interim Data from the
Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) in Patients with Wet Age-Related Macular Degeneration (wet AMD)
at Angiogenesis, Exudation, and Degeneration 2021. Interim data from the Phase 1 clinical trial continued to support that
the product candidate has been generally well tolerated and observed to have a favorable safety profile, shows preliminary biological
activity with a decrease in retinal fluid observed by two months in some subjects in cohorts 2 and 3 and initial durability in
several subjects in cohort 2 over six months and in one subject over 13 months. The presentation can be accessed by visiting the
Investors section of the Company's website at investors.ocutx.com.
Presented Interim Data from the
Phase 1 Clinical Trial of OTX-TIC (travoprost intracameral implant) in Patients with Primary Open Angle Glaucoma or Ocular Hypertension
at the 10th Annual Glaucoma 360 New Horizons Forum. Interim data from the Phase 1 clinical trial from the four fully enrolled
cohorts generally showed a mean reduction in intraocular pressure from baseline of 7-11 mm Hg with onset of action as early as
two days after insertion and sustained durability of activity of six months or longer with a single implant in many subjects. Overall,
no serious ocular adverse events were noted. The presentation can be accessed by visiting the Investors section of the Company's
website at investors.ocutx.com.
Dosed First Patient in Phase
2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical trial is a U.S.-based,
randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations of a new dexamethasone
drug product candidate OTX-DED (dexamethasone intracanalicular insert) in approximately 150 subjects with dry eye disease. In accordance
with the clinical trial protocol, the 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, eye dryness score/frequency of eye dryness using visual analog scale, and total corneal
fluorescein staining.
Commercial Uptake of DEXTENZA. Net product revenue of DEXTENZA (dexamethasone ophthalmic insert) 0.4mg
for the quarter was $6.9 million, a 28% sequential increase over the third quarter of 2020. The Company believes the record
quarter of DEXTENZA sales was driven by continued increases in surgical volumes, new account growth, the positive impact of
the DEXTENZA rebate program and greater awareness by physicians of procedure reimbursement. Further building on the
reimbursement, in November the American Medical Association announced its intention to establish a permanent Category 1
Current Procedure Terminology (CPT) Code, effective January 1, 2022, for the administration of drug-eluting
intracanalicular inserts, including DEXTENZA.
Notified of target PDUFA date for DEXTENZA allergic conjunctivitis
sNDA. On March 4th, the Company announced the supplemental New Drug Application (sNDA) for DEXTENZA
(dexamethasone ophthalmic insert) 0.4 mg has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has
set an action date under the Prescription Drug User Fee Act (PDUFA) of October 18, 2021.
Promoted Michael Goldstein, MD,
MBA, to President, Ophthalmology and Appointed Rabia Gurses-Ozden, MD as Senior Vice President, Clinical Development. Following
his promotion, Dr. Goldstein is maintaining his role as Chief Medical Officer while adding responsibilities for commercial
operations in alignment with the overall Company strategy. Dr. Ozden has become responsible for leading the clinical development
of Ocular Therapeutix's current and growing pipeline of indications focusing on the front and back of the eye. The strategic
appointments reflect Ocular's commitment to developing innovative therapies for diseases and conditions of the eye and are
expected to play a key role in supporting Ocular's potential growth.
Received $12 Million Initial
Upfront Payment from Recently Signed AffaMed Collaboration. In October, the Company entered into a licensing agreement
with AffaMed Therapeutics for rights to develop and commercialize DEXTENZA and OTX-TIC in greater China, South Korea and the ASEAN
markets. Beyond the $12 million in upfront payments, the Company has the potential to receive up to an additional $91 million in
future aggregate milestones and payments and to receive tiered double-digit royalties on future sales.
Raised an Additional $86.3 Million
in Net Proceeds from Equity Offering. In December, the Company raised $86.3 million net in a follow-on equity offering
at a public offering price of $21.50 per share. The Company had $228.1 million in cash and cash equivalents as of December 31,
Fourth Quarter and Year Ended December 31,
2020 Financial Results
Gross product revenue
net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was approximately $7.4 million
for the three months ended December 31, 2020, reflecting a 25% sequential increase over the third quarter and a 226% increase
over the fourth quarter 2019. Net product revenue of DEXTENZA in the fourth quarter 2020 was $6.9 million versus $5.4 million
in the third quarter 2020 and reflects an approximate 28% sequential increase. Total net product revenue for the fourth quarter
of 2020 also includes net product revenue of $0.5 million from ReSure Sealant. Overall, net product revenue for the year was
$17.4 million versus $4.2 million for 2019 and primarily reflects a strong uptake in DEXTENZA sales during the second half of 2020.
Research and development
expenses for the fourth quarter were $7.6 million versus $10.1 million for the comparable period in 2019 primarily driven by the
reduction in force executed in the fourth quarter of 2019 and reduced clinical trial costs associated with the completion of the
Phase 3 DEXTENZA allergic conjunctivitis trial and the Phase 3 OTX-TP trial, offset by increases in the costs associated with the
Phase 1 clinical trials of OTX-TKI, OTX-TIC and OTX-CSI as well as the commencement of the Phase 2 clinical trial of OTX-CSI. Overall
R&D expenses for the full year decreased $12.4 million to $28.7 million from $41.1 million in 2019, reflecting the trends identified
Selling and marketing expenses for the fourth quarter were $6.8
million as compared to $7.1 million for the same quarter in 2019. The modest decrease relates to reduced consulting fees and travel-related
costs offset by increased personnel costs. Overall, selling and marketing expenses for the full year increased to $26.6 million
from $24.5 million in 2019, driven primarily by increased personnel costs offset by reduced spending on consulting, conferences
Finally, general and administrative
expenses were $6.6 million for the fourth quarter versus $5.6 million in the comparable quarter of 2019. The increase in expenses
stemmed primarily from increased personnel expenses and consulting fees. Overall, G&A expenses for the full year increased
$0.8 million to $22.9 million from $22.1 million in 2019, again reflecting primarily increased personnel and consulting fees.
With respect to financial
results for the fourth quarter, the Company reported a net loss of $(85.6) million, or a loss of $(1.21) per share on a basic and
diluted basis. This compares to a net loss of $(26.0) million, or a loss of $(0.54) per share on a basic and diluted basis for
the same period in 2019. As operating expenses were modestly down quarter over quarter, the significant increase in loss was driven
almost exclusively by a non-cash charge of $69.5 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 172% increase in the Company's
common stock price during the fourth quarter of 2020 as compared to the third quarter of 2020. We expect the change in fair value
of the derivative liability to continue to fluctuate until it is settled based on the extent changes occur in the underlying assumptions
in calculating fair value including the price of the Company's common stock. The net loss for the fourth quarter also included
$2.8 million in non-cash charges for stock-based compensation and depreciation compared to $2.6 million for the same quarter in
2019. Overall, the Company reported a net loss of $(155.6) million or a loss of $(2.56) per share on a basic and diluted basis
for the full year ended December 31, 2020 versus a net loss of $(86.4) million or a loss of $(1.91) per share on a basic and
diluted basis in 2019.
As of March 2, 2021,
the Company had 76.1 million shares outstanding.
Last updated: Mar 11, 2021