Ocular Therapeutix™ Provides First Quarter 2023 Financial Results and Corporate Update
12-month Top-Line Data from the
Presented Pre-Clinical and Clinical Data on Three Pipeline Programs at the 2023
DEXTENZA® Net Product Revenue in the First Quarter of 2023 was
Reiterated DEXTENZA Net Product Revenue for the Year Ending 2023 is Estimated to be between
“The strong start to the year has continued through the end of the first quarter,” said
Presented Pre-Clinical and Clinical Data at the 2023
- Data presented included clinical and preclinical updates on OTX-TKI, OTX-TIC, and gene delivery programs that demonstrate the depth of the ELUTYX technology and its potential to provide solutions to improve efficacy and reduce the complexity and burden of the current standard of care for a number of diseases in both the front and back of the eye.
- Access to the presentations made at ARVO are available on the Company’s investor website.
OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal vascular diseases.
- The Company plans to present top-line 12-month data from its
U.S.-based Phase 1 clinical trial of OTX-TKI for the treatment of wet AMD at the Clinical Trials at the Summit 2023 meeting being held June 10th 2023 in Park City, Utah.
- The Company has been in discussions with the FDA for the clinical development of OTX-TKI in the treatment of wet AMD and has two potential pivotal designs. Subject to obtaining the necessary financing, the Company plans to be prepared to initiate the first pivotal trial for OTX-TKI for the treatment of wet AMD as early as Q3 2023.
OTX-TKI (axitinib intravitreal implant) for the treatment of diabetic retinopathy
- The Company is currently enrolling patients in a
U.S.-based, randomized, masked Phase 1 clinical trial in approximately 21 patients randomized 2:1 to either a 600 µg OTX-TKI single implant containing axitinib or a sham control.
- The Company has been in discussions with the FDA for the clinical development of OTX-TKI in the treatment of diabetic retinopathy and has a potential pivotal design. Subject to receiving favorable top-line data from the ongoing Phase 1 trial and obtaining the necessary financing to fund the trial, the Company plans to be prepared to initiate a Phase 3 clinical trial as early as Q1 2024.
OTX-TIC (travoprost intracameral implant) for the treatment of primary open-angle glaucoma or ocular hypertension.
- The Company continues to enroll its
U.S.-based Phase 2 prospective, multi-center, randomized, controlled clinical trial evaluating the safety, tolerability, and efficacy of OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension compared to DURYSTA®. The trial is designed to evaluate whether OTX-TIC can demonstrate a clinically meaningful decrease in intraocular pressure while preserving endothelial cell health.
- The Company continues to enroll patients in the Phase 2 trial and plans to provide top-line data in Q4 2023.
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
- The Company has initiated a small study in the second quarter of 2023 to evaluate the performance of OTX-DED versus fast-dissolving collagen plugs and no inserts at all in order to identify a proper placebo control for any future trials of these product candidates.
- The Company plans to use the results of this study to inform the next steps for both the OTX-DED and OTX-CSI programs.
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.
- Net product revenue of DEXTENZA for the first quarter of 2023 was
$13.2 million, slightly ahead of first quarter 2022 net product revenue of $12.5 millionand slightly behind fourth quarter net product revenue of $13.9 million.
- In-market unit volume—units sold to ambulatory surgery centers (ASCs) and hospital outpatient departments (HOPDs)—was 34,491 for the first quarter of 2023, an approximate 8% increase in unit volume over the fourth quarter of 2022.
- The Company is reiterating its guidance of DEXTENZA net product revenue for the full year 2023 to be between
$55and $60 million, which would represent potential growth of approximately 10% to 20% over 2022. The Company believes that DEXTENZA is currently used in less than 5% of cataract procedures and that growth in 2023 will be driven by: continued separate reimbursement now available under the non-opioid pain management drug as a surgical supply provision in ASCs; a renewed focus on sales to ASCs and specifically strategic accounts that own and control multiple ASCs; the continuing success of the revised pricing and discounting strategy that was implemented in the third quarter of 2022; and the introduction of a Commercial Assurance Program. The Company believes the momentum with ASCs will more than offset the impact of the loss of separate drug reimbursement in the HOPD setting in 2023.
First Quarter Ended
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
Research and development expenses for the first quarter of 2023 were
Selling and marketing expenses in the first quarter of 2023 were
General and administrative expenses were
The Company reported a net loss for the first quarter of 2023 of
2023 Financial Guidance
- Net product revenue in 2023 is expected to be in the range of
$55to $60 million, representing anticipated growth of approximately 10% to 20% over 2022. The growth is anticipated to be driven by sales of DEXTENZA for the treatment of post-surgical inflammation and pain in the ASC setting.
- As of
March 31, 2023, the Company had $79.0 millionin cash and cash equivalents versus $102.3 millionas of December 31, 2022. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA and anticipated cash outflows from operating expenses, the Company believes that its existing cash and cash equivalents are sufficient to enable the Company to fund planned operating expenses, debt service obligations and capital expenditure requirements to the middle of 2024. This cash guidance is subject to a number of assumptions including the revenues, expenses and reimbursement associated with DEXTENZA, and the pace of research and clinical development programs, among other aspects of the business, and excludes expenses related to the Company’s planned clinical trials for OTX-TKI for the treatment of wet AMD and for the treatment of diabetic retinopathy.
Conference Call & Webcast Information
Members of the
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, timing 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 glaucoma or ocular hypertension, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of dry eye disease; the Company’s plans to advance the development of its product candidates or preclinical programs; the Company’s ability to fund the planned and future development of its product candidates, whether through strategic alliances or other fundraising; the potential utility of any of the Company’s product candidates; the size of potential markets for the Company’s product candidates; 2023 financial guidance, including estimated net product revenue; the sufficiency of the Company’s cash resources; and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval, the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, whether clinical trial data will be indicative of the results of subsequent clinical trials in the same or other indications or that interim data will be indicative of the full data from a clinical trial, uncertainties as to the timing and availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to meet supply demands, the Company’s ability to generate its projected net product revenue and in-market sales on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, any additional financing needs, the Company’s ability to recruit and retain key personnel, and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
Chief Financial Officer
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended|
|Product revenue, net||$||13,214||$||12,498|
|Total revenue, net||13,374||13,187|
|Costs and operating expenses:|
|Cost of product revenue||1,214||1,300|
|Research and development||14,747||13,100|
|Selling and marketing||10,835||9,063|
|General and administrative||9,127||7,557|
|Total costs and operating expenses||35,923||31,020|
|Loss from operations||(22,549||)||(17,833||)|
|Other income (expense):|
|Change in fair value of derivative liability||(6,563||)||6,958|
|Other expense, net||(1||)||(2||)|
|Total other (expense) income, net||(7,769||)||5,291|
|Net loss per share, basic||$||(0.39||)||$||(0.16||)|
|Weighted average common shares outstanding, basic||77,386,287||76,745,663|
|Net loss per share, diluted||$||(0.39||)||$||(0.22||)|
|Weighted average common shares outstanding, diluted||77,386,287||82,514,895|
Ocular Therapeutix, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|Cash and cash equivalents||$||79,026||$||102,300|
|Accounts receivable, net||21,124||21,325|
|Prepaid expenses and other current assets||4,746||4,028|
|Total current assets||107,162||129,627|
|Property and equipment, net||12,022||9,856|
|Operating lease assets||7,625||8,042|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||21,993||24,097|
|Operating lease liabilities||1,818||1,599|
|Total current liabilities||29,715||31,395|
|Operating lease liabilities, net of current portion||8,114||8,678|
|Deferred revenue, net of current portion||13,340||13,387|
|Notes payable, net of discount||25,321||25,257|
|Other non-current liabilities||100||93|
|2026 convertible notes, net||29,358||28,749|
|Commitments and contingencies|
|Additional paid-in capital||656,863||652,213|
|Total stockholders’ equity||9,711||35,379|
|Total liabilities and stockholders’ equity||$||128,573||$||149,289|
Source: Ocular Therapeutix, Inc.