BEDFORD, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2023, and provided updates on its ophthalmology pipeline.
“The strong start to the year has continued through the end of the first quarter,” said Antony Mattessich, President and CEO. “We have been in productive conversations with the FDA and believe we have a pivotal design for OTX-TKI in diabetic retinopathy and two potential designs in wet AMD. While we are eager to advance both of these programs, we look forward to sharing top-line 12-month data from our U.S.-based Phase 1 trial for OTX-TKI in wet AMD at the Clinic Trials at the Summit meeting being held in June. We are also making excellent progress advancing our next late-stage program, the Phase 2 trial of OTX-TIC for the treatment of glaucoma. This trial continues to enroll well, and we continue to anticipate providing top-line data from this trial in the fourth quarter of 2023. Glaucoma represents another large potential ophthalmology market where we believe our hydrogel technology, which we have branded as Elutyx™, has the potential to redefine the current standard of care. On the commercial side, DEXTENZA finished with a strong quarter. In-market billable unit volumes were approximately 8% ahead of fourth quarter volumes, and we continue to guide towards a full year 2023 net product revenue of $55 to $60 million. Overall, I am pleased with our continued progress in building a mid-tier strategic within ophthalmology.”
Business Updates
Presented Pre-Clinical and Clinical Data at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held April 23rd to 27th
OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal vascular diseases.
OTX-TKI (axitinib intravitreal implant) for the treatment of diabetic retinopathy
OTX-TIC (travoprost intracameral implant) for the treatment of 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.
First Quarter Ended March 31, 2023 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 $13.4 million for the first quarter of 2023, slightly ahead of first quarter 2022 net revenues of $13.2 million and slightly behind fourth quarter net revenue of $14.1 million. DEXTENZA net product revenue grew from $12.5 million to $13.2 million over the comparable period in 2022 while collaboration revenue declined from $0.7 million to $0.2 million.
Research and development expenses for the first quarter of 2023 were $14.7 million versus $13.1 million for the comparable period in 2022, driven primarily by an increase in expenses associated with clinical and preclinical programs.
Selling and marketing expenses in the first quarter of 2023 were $10.8 million as compared to $9.1 million for the comparable quarter of 2022, reflecting primarily an increase field force personnel.
General and administrative expenses were $9.1 million for the first quarter of 2023 versus $7.6 million in the comparable quarter of 2022, primarily due to an increase in personnel-related costs, including stock-based compensation, and professional fees.
The Company reported a net loss for the first quarter of 2023 of $(30.3) million, or a loss of $(0.39) per share on both a basic basis and diluted basis, compared to a net loss of $(12.5) million, or a net loss of $(0.16) per share on a basic basis and a loss of $(0.22) per share on a diluted basis for the comparable period in 2022. Net loss in the first quarter of 2023 included a $6.6 million non-cash item attributable to a change in the fair value of the derivative liability associated with the Company’s convertible notes, increasing total other expenses as the price of the Company’s common stock increased during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $5.1 million in the first quarter of 2023 versus $4.8 million for the comparable quarter in 2022.
As of May 4, 2023, the Company had approximately 77.5 million shares outstanding.
2023 Financial Guidance
Conference Call & Webcast Information
Members of 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.
About DEXTENZA
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 Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
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or
ICR Westwicke
Chris Brinzey, 339-970-2843
Managing Director
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended | |||||||
March 31, | |||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue, net | $ | 13,214 | $ | 12,498 | |||
Collaboration revenue | 160 | 689 | |||||
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): | |||||||
Interest income | 563 | 18 | |||||
Interest expense | (1,768 | ) | (1,683 | ) | |||
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 | $ | (30,318 | ) | $ | (12,542 | ) | |
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)
(Unaudited)
March 31, | December 31, | ||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 79,026 | $ | 102,300 | |||
Accounts receivable, net | 21,124 | 21,325 | |||||
Inventory | 2,266 | 1,974 | |||||
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 | |||||
Restricted cash | 1,764 | 1,764 | |||||
Operating lease assets | 7,625 | 8,042 | |||||
Total assets | $ | 128,573 | $ | 149,289 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,441 | $ | 5,123 | |||
Accrued expenses and other current liabilities | 21,993 | 24,097 | |||||
Deferred revenue | 463 | 576 | |||||
Operating lease liabilities | 1,818 | 1,599 | |||||
Total current liabilities | 29,715 | 31,395 | |||||
Other liabilities: | |||||||
Operating lease liabilities, net of current portion | 8,114 | 8,678 | |||||
Derivative liability | 12,914 | 6,351 | |||||
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 | |||||
Total liabilities | 118,862 | 113,910 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2023 and December 31, 2022, respectively | — | — | |||||
Common stock, $0.0001 par value; 200,000,000 shares authorized and 77,516,638 and 77,201,819 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 8 | 8 | |||||
Additional paid-in capital | 656,863 | 652,213 | |||||
Accumulated deficit | (647,160 | ) | (616,842 | ) | |||
Total stockholders’ equity | 9,711 | 35,379 | |||||
Total liabilities and stockholders’ equity | $ | 128,573 | $ | 149,289 |
Last Trade: | US$8.50 |
Daily Change: | 0.05 0.59 |
Daily Volume: | 1,270,350 |
Market Cap: | US$1.340B |
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