Ocular Therapeutix™ Reports Fourth Quarter and Year End 2020 Financial Results and Business Update

Rhea-AI Summary

Ocular Therapeutix (NASDAQ:OCUL) reported its financial results for Q4 2020, highlighting significant commercial and clinical advancements. DEXTENZA® sales exceeded 14,000 units, marking over 40% sequential growth. The company showcased promising interim data from Phase 1 trials of OTX-TKI and OTX-TIC, indicating favorable safety and preliminary effectiveness. Additionally, a Phase 2 trial for OTX-DED was initiated. DEXTENZA's Q4 net revenue reached $6.9 million, a 28% increase from Q3, bolstered by rising surgical volumes and new account growth. The FDA set a PDUFA date of October 18, 2021, for DEXTENZA's sNDA review.

Positive

• Q4 net revenue of DEXTENZA was $6.9 million, a 28% increase from Q3 2020.
• Over 14,000 units of DEXTENZA sold in Q4, representing over 40% sequential growth.
• Promising interim Phase 1 data for OTX-TKI and OTX-TIC, indicating good safety and preliminary efficacy.
• Initiation of Phase 2 trial for OTX-DED, targeting dry eye disease.

Negative

• No significant negative aspects reported.

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.

U.S. 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 4^th, 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 ma

FAQ

What were Ocular Therapeutix's Q4 2020 financial results?

Ocular Therapeutix reported Q4 2020 net revenue of $6.9 million for DEXTENZA, a 28% sequential increase from Q3.

What updates were provided for DEXTENZA in the latest press release?

The press release noted over 14,000 DEXTENZA units sold in Q4 2020, representing a growth of over 40%. The FDA has set a PDUFA date of October 18, 2021, for DEXTENZA's sNDA.

What clinical trials did Ocular Therapeutix announce in the press release?

Ocular Therapeutix announced interim data from Phase 1 trials for OTX-TKI and OTX-TIC, as well as the initiation of a Phase 2 trial for OTX-DED.

How did the COVID-19 pandemic affect Ocular Therapeutix's sales?

Despite challenges due to COVID-19, Ocular Therapeutix reported high physician interest and continued growth in DEXTENZA sales driven by ASCs and HOPDs.

What major developments occurred in Ocular Therapeutix's pipeline?

Ocular Therapeutix highlighted advancements in its pipeline, focusing on multi-billion dollar ophthalmology markets, with plans to initiate multiple Phase 2 programs in 2021.