Full Press Release Details
Ocular Therapeutix Provides Fourth Quarter
and Year-End 2022 Results and Corporate Update
Presented Positive 10-month Interim Data from
the U.S.-based Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) for the Treatment of Wet AMD at the Angiogenesis, Exudation,
and Degeneration Annual 2023 Meeting
Initiated Phase 1 Clinical Trial of OTX-TKI
(axitinib intravitreal implant) for the Treatment of Diabetic Retinopathy in December 2022
Top-Line Data from Phase 2 Clinical Trial of
OTX-TIC (travoprost intracameral implant) for the Treatment of Patients with Primary Open-Angle Glaucoma or Ocular Hypertension Expected
Total Net Revenue for Full Year 2022 was $51.5
million, Representing Growth of 18% Over the Prior Year
DEXTENZA Net Product Revenue
in the Fourth Quarter of 2022 was $13.9 million, Representing Growth of approximately 17% Over Previous Quarter and 14% Over Comparable
DEXTENZA Net Product Revenue for the Year Ending
2023 is Estimated to be between $55 and $60 million, Representing Growth of Approximately 10% to 20% Over Prior Year
Mass.-(BUSINESS WIRE)- March 6, 2023 - 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, 2022, and provided updates
on its ophthalmology pipeline.
was a productive year for Ocular and we are off to a great start in 2023," said Antony Mattessich, President and CEO. "Most
notably, we are really excited to see the potential value of our pipeline continue to emerge following the recent interim data we shared
on OTX-TKI, our axitinib-containing hydrogel insert for the treatment of wet AMD, diabetic retinopathy and other VEGF mediated retinal
diseases. We believe the results we shared in February at the Angiogenesis Annual Meeting demonstrated the potential for best-in-class
durability in a $15B global market for wet AMD and diabetic retinopathy that is increasingly driven by durability. As we enter 2023, we
expect our pipeline to achieve key milestones as we look to advance OTX-TKI into pivotal trials and also present much anticipated
top-line data from our Phase 2 clinical trial of OTX-TIC for the treatment of glaucoma. On the commercial side, DEXTENZA has established
itself as a material and important product and I am encouraged that we have begun to regain sales momentum with volumes up more than 20%
in in-market sales over the first two months of 2023 versus 2022. Overall, I am pleased with our progress and believe the realization
of anticipated milestones in 2023 will further our corporate mission of becoming a mid-tier strategic within ophthalmology."
OTX-TKI (axitinib intravitreal
implant) for the potential treatment of wet AMD and other retinal vascular diseases.
OTX-TKI (axitinib intravitreal implant) for the potential
treatment of diabetic retinopathy
OTX-TIC (travoprost intracameral implant) for the
treatment of patients with primary open-angle glaucoma or ocular hypertension.
OTX-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of dry eye disease and OTX-CSI (cyclosporine intracanalicular insert) for
the chronic treatment of dry eye disease
DEXTENZA (dexamethasone ophthalmic
insert) 0.4mg approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with
allergic conjunctivitis.
Fourth Quarter and Year End December 31,
2022 Financial Results
Total net revenue, which includes both gross
DEXTENZA product revenue net of discounts, rebates, and returns, which the Company refers to as net product revenue, and collaboration
revenue was $14.1 million for the fourth quarter of 2022 and represented 18% growth over the prior quarter and 15% growth over the comparable
Total net revenue for the full year 2022 was
$51.5 million versus $43.5 million in 2021, an increase of 18%.
Research and development expenses for the
fourth quarter of 2022 were $13.5 million versus $12.6 million for the comparable period in 2021 driven primarily by an increase in personnel
offset by both a reduction in overall clinical trial expenses and a delay in timing of clinical trials. Overall R&D expenses for the
full year increased $3.4 million to $53.5 million from $50.1 million in 2021, reflecting the trends identified above.
Selling and marketing expenses in the fourth
quarter of 2022 were $10.5 million as compared to $9.1 million for the comparable quarter of 2021, reflecting primarily an increase in
field force personnel. Overall, selling and marketing expenses for the full year increased to $39.9 million from $35.2 million in 2021,
driven primarily by increased personnel costs and increased spending on consulting, trade shows and conferences.
General and administrative expenses were $8.3
million for the fourth quarter of 2022 versus $7.5 million in the comparable quarter of 2021, primarily due to an increase in personnel
related costs, including stock-based compensation. Overall, G&A expenses for the full year increased $0.3 million to $32.2 million
from $31.9 million in 2021, again reflecting the trends identified above.
The Company reported a net loss for the fourth
quarter of 2022 of $(15.5) million, or a loss of $(0.20) per share on a basic basis and a loss of $(0.24) on a diluted basis, compared
to a net loss of $(3.9) million, or net loss of $(0.05) per share on a basic basis and a loss of $(0.23) per share on a diluted basis
for the comparable period in 2021. Net loss in the fourth quarter of 2022 included a $5.2 million non-cash item attributable to a decrease
in the fair value of the derivative liability associated with the Company's convertible notes, as the price of its common stock
decreased during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.7 million in the
fourth quarter of 2022 versus $4.4 million for the comparable quarter in 2021. Overall, the Company reported a net loss of $(71.0) million
or a loss of $(0.92) per share on a basic basis and a loss of $(0.97) on a diluted basis for the full year ended December 31, 2022
versus a net loss of $(6.6) million or a loss of $(0.09) per share on a basic basis and a loss of $(0.98) on a diluted basis in 2021.
As of March 1, 2023, the Company had
77.5 million shares outstanding.
2023 Financial Guidance
Conference Call & Webcast Information
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. A live audio webcast will be available at www.ocutx.com. Interested parties
may also register for the webcast via this link. Analysts wishing to participate in the question and answer session should
use this link. A replay of the webcast will be available via the company's investor website approximately two hours after
the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary
bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA ,
is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated
with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets include: OTX-TKI (axitinib intravitreal implant),
currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC (travoprost intracameral implant),
currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-DED (dexamethasone
intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and OTX-CSI (cyclosporine intracanalicular
insert) for the chronic treatment of dry eye disease, both of which have completed Phase 2 clinical trials.
DEXTENZA is FDA approved for the treatment
of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the
canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and
exits the nasolacrimal system without the need for removal.
Please see full Prescribing and Safety Information at www.DEXTENZA.com.
Forward Looking Statements
Any statements in this press release about
future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA or any of the
Company's products or product candidates; the development and regulatory status of the Company's product candidates, such
as the Company's development of and prospects for approvability of OTX-TKI for the treatment of retinal diseases including wet
AMD and diabetic retinopathy including the timing of planned pivotal clinical trials, OTX-TIC for the treatment of primary open-angle