Ocular Therapeutix™ Provides Fourth Quarter and Year-End 2022 Results and Corporate Update
Presented Positive 10-month Interim Data from the
Initiated Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) for the Treatment of Diabetic Retinopathy in
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 in Q4 2023
Total Net Revenue for Full Year 2022 was
DEXTENZA® Net Product Revenue in the Fourth Quarter of 2022 was
DEXTENZA Net Product Revenue for the Year Ending 2023 is Estimated to be between
“2022 was a productive year for Ocular and we are off to a great start in 2023,” said
OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet AMD and other retinal vascular diseases.
- The Company presented positive interim 10-month data from its
U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD at the Angiogenesis, Exudation, and Degeneration 2023 Annual Meeting held virtually in February.
- All OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10. Overall, a 92% reduction in treatment burden was observed in OTX-TKI treated subjects for up to 10 months.
- Subjects treated with a single OTX-TKI implant demonstrated stable and sustained BCVA (mean change from baseline of -0.3 letters) and CSFT (mean change from baseline of -1.3 µm) in the OTX-TKI arm at 10 months, which was comparable with the aflibercept arm (mean change from BCVA baseline of -0.8 letters; mean change from CSFT baseline of -4.5 µm).
- Interim data showed a single OTX-TKI implant was generally well tolerated with no drug-related ocular or systemic serious adverse events (SAEs) observed.
- The Company will follow subjects at least until their respective one-year anniversaries of initial dosing, in accordance with the clinical trial protocol.
- The Company is in active discussions with the FDA for potential clinical trial requirements. Subject to those discussions and obtaining the necessary financing, which could be provided through a strategic alliance, the Company aims to be prepared to initiate a pivotal trial in wet AMD in Q3 2023.
OTX-TKI (axitinib intravitreal implant) for the potential treatment of diabetic retinopathy
- The Company believes that the interim 10-month data from the
U.S.-based Phase 1 clinical trial evaluating OTX-TKI for the treatment of wet AMD, as well as the product candidate’s mechanism of action, support the use of OTX-TKI as a potential treatment of other VEGF-mediated retinal vascular diseases, including diabetic retinopathy.
- The Company initiated a Phase 1 clinical trial for the treatment of diabetic retinopathy in
December 2022. This masked trial includes approximately 10 sites and is designed to include approximately 21 patients randomized 2:1 to either a 600 µg OTX-TKI single implant containing axitinib or sham control.
- Subject to the initial results of this trial, discussions with the FDA, and obtaining additional financing, the Company believes it will be positioned to initiate a pivotal trial for the treatment of diabetic retinopathy in Q1 2024.
OTX-TIC (travoprost intracameral implant) for the treatment of patients with 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. 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 plans to provide top-line data from the trial 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 continues to advance both dry eye programs and plans to launch a small study in the first half 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 fourth quarter of 2022 was
$13.9 million, representing growth of approximately 17% over the previous quarter and approximately 14% over the fourth quarter of 2021. Overall, DEXTENZA net product revenue for the year was $50.5 millionversus $42.0 millionfor 2021, representing growth of 20%.
- The Company is guiding 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. DEXTENZA market share is believed to be less than 5% of the overall potential market and growth in 2023 is anticipated to be driven by: continued separate reimbursement now available under the non-opioid pain management drug as a surgical supply provision in the ambulatory surgery center (ASC); a renewed focus on sales to ASCs; and ASCs operating at higher capacity as staffing issues continue to resolve from challenges caused by the COVID-19 pandemic, leading to continued modest annual growth in cataract procedure volume. We believe the momentum with ASCs will more than offset the impact of the loss of separate drug reimbursement in the hospital outpatient department setting in 2023.
Fourth Quarter and Year End
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
Total net revenue for the full year 2022 was
Research and development expenses for the fourth quarter of 2022 were
Selling and marketing expenses in the fourth quarter of 2022 were
General and administrative expenses were
The Company reported a net loss for the fourth quarter of 2022 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
December 31, 2022, the Company had $102.3 millionin cash and cash equivalents versus $121.0 millionat September 30, 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.
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 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, the severity and duration of the COVID-19 pandemic including its effect on the Company’s revenues and relevant regulatory authorities’ operations, 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.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended||Year Ended|
|Product revenue, net||$||13,902||$||12,308||$||50,457||$||43,522|
|Total revenue, net||14,076||12,308||51,494||43,522|
|Costs and operating expenses:|
|Cost of product revenue||1,013||1,107||4,540||4,406|
|Research and development||13,543||12,578||53,462||50,083|
|Selling and marketing||10,533||9,136||39,922||35,190|
|General and administrative||8,348||7,534||32,224||31,880|
|Total costs and operating expenses||33,437||30,355||130,148||121,559|
|Loss from operations||(19,361||)||(18,047||)||(78,654||)||(78,037||)|
|Other income (expense):|
|Change in fair value of derivative liability||5,243||15,872||13,841||78,121|
|Other income (expense), net||—||—||(1||)||1|
|Total other income , net||3,819||14,197||7,616||71,484|
|Net loss per share, basic||$||(0.20||)||$||(0.05||)||$||(0.92||)||$||(0.09||)|
|Weighted average common shares outstanding, basic||77,010,385||76,616,389||76,875,035||76,392,870|
|Net loss per share, diluted||$||(0.24||)||$||(0.23||)||$||(0.97||)||$||(0.98||)|
|Weighted average common shares outstanding, diluted||82,779,617||82,385,621||82,644,267||82,162,102|
Consolidated Balance Sheets
(In thousands, except share and per share data)
|Cash and cash equivalents||$||102,300||$||164,164|
|Accounts receivable, net||21,325||21,135|
|Prepaid expenses and other current assets||4,028||4,751|
|Total current assets||129,627||191,300|
|Property and equipment, net||9,856||6,956|
|Operating lease assets||8,042||4,867|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||24,097||20,121|
|Operating lease liabilities||1,599||1,624|
|Total current liabilities||31,395||26,337|
|Operating lease liabilities, net of current portion||8,678||5,924|
|Deferred revenue, net of current portion||13,387||13,000|
|Notes payable, net of discount||25,257||25,000|
|Other Non-Current Liabilities||93||—|
|2026 convertible notes, net||28,749||26,435|
|Commitments and contingencies|
|Additional paid-in capital||652,213||633,795|
|Total stockholders’ equity||35,379||87,999|
|Total liabilities and stockholders’ equity||$||149,289||$||204,887|
Source: Ocular Therapeutix, Inc.