BEDFORD, Mass., March 06, 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 fourth quarter and year ended December 31, 2022, and provided updates on its ophthalmology pipeline.
“2022 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.”
Business Updates
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 period in 2021.
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
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 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 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.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 13,902 | $ | 12,308 | $ | 50,457 | $ | 43,522 | ||||||||
| Collaboration revenue | 174 | — | 1,037 | — | ||||||||||||
| 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): | ||||||||||||||||
| Interest income | 423 | 6 | 798 | 33 | ||||||||||||
| Interest expense | (1,847 | ) | (1,681 | ) | (7,022 | ) | (6,761 | ) | ||||||||
| 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 | $ | (15,542 | ) | $ | (3,850 | ) | $ | (71,038 | ) | $ | (6,553 | ) | ||||
| 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 | ||||||||||||
OCULAR THERAPEUTIX, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 102,300 | $ | 164,164 | ||||
| Accounts receivable, net | 21,325 | 21,135 | ||||||
| Inventory | 1,974 | 1,250 | ||||||
| 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 | ||||||
| Restricted cash | 1,764 | 1,764 | ||||||
| Operating lease assets | 8,042 | 4,867 | ||||||
| Total assets | $ | 149,289 | $ | 204,887 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,123 | $ | 4,592 | ||||
| Accrued expenses and other current liabilities | 24,097 | 20,121 | ||||||
| Deferred revenue | 576 | — | ||||||
| Operating lease liabilities | 1,599 | 1,624 | ||||||
| Total current liabilities | 31,395 | 26,337 | ||||||
| Other liabilities: | ||||||||
| Operating lease liabilities, net of current portion | 8,678 | 5,924 | ||||||
| Derivative liability | 6,351 | 20,192 | ||||||
| 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 | ||||||
| Total liabilities | 113,910 | 116,888 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at December 31, 2022 and December 31, 2021, respectively | — | — | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized and 77,201,819 and 76,731,940 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 8 | 8 | ||||||
| Additional paid-in capital | 652,213 | 633,795 | ||||||
| Accumulated deficit | (616,842 | ) | (545,804 | ) | ||||
| Total stockholders’ equity | 35,379 | 87,999 | ||||||
| Total liabilities and stockholders’ equity | $ | 149,289 | $ | 204,887 | ||||
| Last Trade: | US$8.52 |
| Daily Change: | -0.26 -2.96 |
| Daily Volume: | 1,064,584 |
| Market Cap: | US$1.330B |
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