Full Press Release Details
Ocular Therapeutix Reports
Second Quarter 2020 Financial Results and Business Update
Newly Published Physician Fee Schedules
for 0356T for the Administration of Intracanalicular Inserts to Support Ongoing DEXTENZA Launch
May Financing Yields $48.3 Million in
DEXTENZA Net Product Revenue in Second
Quarter of $1.4 million; Billable In-Market Sales Record Achieved in June
BEDFORD, Mass. -(BUSINESS WIRE)-August 7, 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 second quarter ended
June 30, 2020 and provided a business update.
"Despite the challenges caused by the global pandemic,
it has been a very productive quarter for Ocular Therapeutix," said Antony Mattessich, President and CEO. "Our clinical
programs continue to support potential product profiles that, if approved, we believe could become the standards-of-care in the
treatment of Wet AMD, glaucoma and ocular surface diseases including dry-eye disease and allergic conjunctivitis. We also added
a new program for the treatment of episodic dry eye. We have positioned ourselves to potentially enter Phase 2 trials on four
major programs within the next 12 months that could, if approved, compete in some of the largest global ophthalmology markets.
On the sales side, despite the global COVID-19 pandemic, we saw a welcome bounce back in DEXTENZA sales
with nearly 2,300 in-market units sold in June, exceeding our previous monthly record by 40% and eclipsing $1 million of in-market
sales in a calendar month for the first time. With a new rebate program and the establishment of physician reimbursement fee schedules
for the insertion of DEXTENZA at two Medicare Administrative Contractors that cover approximately 30% of the Medicare population,
we expect, subject to the potential impact of the pandemic, adoption trends to accelerate in the second half of the year."
Announced published physician fee schedules for the administration
of intracanalicular inserts. In July, the Company announced that Novitas Solutions and First Coast, two of seven Medicare
Administrative Contractors (MACs) representing approximately 30% of all Medicare beneficiaries, established physician fee schedules
for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA (dexamethasone ophthalmic
insert) 0.4mg, effective July 1, 2020. Physicians in these geographies seeking reimbursement for the administration of DEXTENZA
are now eligible to be paid per the established local fee schedule. In addition, four of the remaining five MACs have retired their
non-coverage policies for 0356T, and the Company believes that these MACs may publish fee schedules in the near future.
Announced new product candidate (OTX-DED) to treat
episodic dry eye disease. There are approximately 8.6 million patients diagnosed with episodic dry eye disease in the
United States, according to Market Scope (2019 report). Many of these dry eye patients experience episodic flares of their
signs and symptoms which the Company believes are likely related to inflammation. Currently available topical steroids may
lead to adverse events such as elevated intraocular pressure (IOP) or cataracts if used chronically and all contain
preservatives which can cause ocular surface toxicity, resulting in itching and burning. OTX-DED, a new product candidate
with a lower dose of dexamethasone and a smaller insert size than DEXTENZA, is designed to offer these patients the
opportunity, if approved, to be treated with a non-abusable, physician-administered, preservative-free and hands-free steroid
therapy. Since OTX-DED has a lower concentration of dexamethasone compared with DEXTENZA, the Company is able to leverage the
DEXTENZA safety package generated to date and plans to file a Phase 2-enabling Investigative New Drug (IND) Application with
the U.S. Food and Drug Administration (FDA) by the end of 2020.
Amended collaboration with Regeneron for the development
of a suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. In May, the Company amended its existing
collaboration with Regeneron to develop an extended-delivery, suprachoroidal injection formulation of the FDA-approved VEGF trap
aflibercept. Under the new amendment, Regeneron has agreed to compensate Ocular Therapeutix on a cost-plus basis for all work performed
under the pre-clinical portion of the collaboration. The back-end economics of the original agreement remain the same with the
potential for option exercise fees and milestone payments of $305 million and tiered, escalating royalties from the high single
digits into the low-to-mid teens.
Completed common stock financing. In May, the
Company raised $48.3 million, net of fees, from a public offering of stock. Cash and cash equivalents as of June 30, 2020 was $84.3
million and is expected to provide funding for at least the next twelve months.
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 diseases. The Company is conducting a Phase 1, prospective, multi-center, open-label,
dose-escalation clinical trial in Australia intended to evaluate the safety, durability, tolerability, and biological activity
of OTX-TKI for the treatment of wet AMD. Two cohorts of six subjects each have been enrolled, a lower-dose cohort of 200 g
and a higher-dose cohort of 400 g.
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. The Company is conducting a Phase 1, prospective,
multi-center, open-label, dose-escalation clinical trial which is intended to evaluate the safety, biological activity, durability
and tolerability of OTX-TIC for the reduction of elevated IOP in patients with primary open angle glaucoma or ocular hypertension.
OTX-CSI (cyclosporine intracanalicular insert)
OTX-CSI is a long-acting
cyclosporine intracanalicular insert for the treatment of chronic dry eye disease. The Company has recently initiated a Phase 1,
open-label, single-center clinical trial in the United States to evaluate the safety, biological activity, durability, and tolerability
of OTX-CSI for the treatment of dry eye disease.
| The five patient cohort for the Phase 1 trial has been enrolled. | |
| The safety committee has met and is supportive of moving forward with a double masked, randomized, placebo-controlled, multi-center Phase 2 trial. | |
| The Company anticipates initiating a 105 patient Phase 2 clinical trial by year end. |
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.
Second Quarter Ended June 30, 2020 Financial Results
believes that its existing cash and cash equivalents of $84.3 million as of June 30, 2020 will enable the Company to fund its planned
operating expenses, debt service obligations and capital expenditure requirements for at least the next twelve months. This estimate
is based on the Company's currently forecasted operating plan which includes estimates of anticipated cash inflows from DEXTENZA
and ReSure Sealant product sales and cash outflows from operating expenses. These
estimates are subject to various assumptions including those related to the severity and duration of the COVID-19 pandemic, a continuing
expected rebound in cataract surgeries in the third quarter of 2020 and beyond, the revenues and expenses associated with the commercialization
of DEXTENZA, variable expense reductions, the pace of the Company's research and clinical development programs, and other
aspects of the Company's business. We have based our estimate on assumptions that may prove to be wrong, and we could
use our capital resources sooner than we currently expect and would therefore need to raise additional capital to support our ongoing
operations or adjust our plans accordingly.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will
host a live conference call and webcast today at 8:30 am 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 6937647. An archive of the webcast will
be available until September 21, 2020 on the Company's website.
About DEXTENZA (dexamethasone ophthalmic
DEXTENZA is an FDA-approved corticosteroid indicated for the
treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lacrimal punctum and into the
canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to
30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.
DEXTENZA is contraindicated in patients with active corneal,
conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve,
defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure
should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard
for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound