Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2023 Results
- Ocular Therapeutix, Inc. is making significant strides in retinal care with a focus on wet AMD, diabetic retinopathy, and glaucoma treatments.
- The company appointed key strategic and clinical experts, enhancing its position in the field.
- Successful financings raised over $440 million, supporting the development of AXPAXLI and other clinical programs.
- Total net revenue increased by 13.4% in 2023, driven by DEXTENZA sales.
- The company's cash balance of $195.8 million as of December 31, 2023, along with $325 million in gross proceeds from a recent private placement, is expected to support operations into at least 2028.
- Upcoming milestones include top-line clinical data for AXPAXLI in diabetic retinopathy and PAXTRAVA in glaucoma, expected in Q2 2024.
- Ocular Therapeutix plans to host an Investor Day in Q2 2024 to outline its updated corporate strategy.
- Rising research and development expenses, particularly in clinical and regulatory areas, are a concern.
- Net losses increased significantly, with a net loss of $(80.7) million for the year ended December 31, 2023.
- Non-cash charges for stock-based compensation and depreciation and amortization have also increased, impacting the company's financial performance.
Insights
The recent financial report from Ocular Therapeutix, Inc. highlights a modest revenue growth in the fourth quarter of 2023, with an increase of 5.0% compared to the same period in 2022. This growth is primarily attributed to sales of DEXTENZA, indicating a positive market reception for the product. However, the company's net loss widened significantly in the fourth quarter, from $(15.5) million in 2022 to $(29.2) million in 2023, which could be concerning to investors. The reported net loss includes non-cash expenses related to derivative liabilities, which are important to consider when evaluating the company's financial health.
Ocular's cash position appears strong, with a year-end cash balance of $196 million and an additional $325 million from a recent private placement. This financial backing is expected to support operations into at least 2028, suggesting a solid runway for the company's research and development activities. The company's ability to raise capital through financings is indicative of investor confidence in its pipeline and strategic direction.
Ocular Therapeutix's commitment to retinal disease treatments is evident with the initiation of the Phase 3 SOL-1 study for AXPAXLI in wet AMD, a leading cause of blindness among older adults. The strategic focus on this area, coupled with the anticipation of topline clinical data in Q2 2024, suggests significant potential for market expansion and revenue diversification if the trials prove successful. The company's strategic hires, including top experts in the field, demonstrate a strengthened effort to accelerate its clinical programs and potentially enhance its competitive position in the ophthalmology market.
The upcoming investor day in Q2 2024 will be crucial for stakeholders to gain insights into the company's updated corporate strategy and long-term vision. This event may serve as a pivotal moment for Ocular, potentially affecting investor sentiment and stock valuation based on the strategic objectives and milestones presented.
In the context of the ophthalmic pharmaceutical market, Ocular Therapeutix's focus on innovative therapies for eye diseases such as wet AMD and diabetic retinopathy positions the company in a high-growth potential sector. The prevalence of these conditions is increasing with the aging population and effective treatments are in high demand. The company's strategic appointments and clinical trial advancements indicate an aggressive pursuit of market leadership in this niche.
However, the competitive landscape is robust, with other biopharmaceutical companies also vying for market share. The success of Ocular's clinical trials and subsequent FDA approvals will be critical to gaining a foothold. Investors will likely monitor the company's research and development efficiency and time-to-market capabilities closely, as these are key factors in the fast-paced pharmaceutical industry.
Leadership Appointments Move Ocular Towards Being a Leader in Retinal Care
Screening Underway in AXPAXLI™ Phase 3 SOL-1 Trial for Wet AMD
Topline Clinical Data for AXPAXLI in Diabetic Retinopathy and PAXTRAVA™ in Glaucoma Expected in Q2 2024
Cash Expected to Support Operations Into At Least 2028 Based on
Planning to Host an Investor Day in Q2 2024 to Outline Updated Corporate Strategy
BEDFORD, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today reported financial results for the fourth quarter 2023 and full year ended December 31, 2023.
“I joined Ocular because I see the opportunity to unlock significant value for patients and stockholders through the development of safe, effective and durable treatments for retinal diseases, starting with our lead candidate, AXPAXLI for wet AMD,” said Pravin Dugel, MD, Executive Chairman of Ocular Therapeutix. “Bringing together our dedicated, world-class team of acknowledged strategic and clinical experts has enabled us to position Ocular as a leader in retinal care. Our goal is to bring AXPAXLI to the market as soon as possible. Our strengthened team provides us with an opportunity to enrich and accelerate the AXPAXLI clinical programs.”
Dr. Dugel concluded, “I believe the Company has made outstanding progress over the last several months, with the initiation of the Phase 3 SOL-1 study with AXPAXLI in wet AMD and successful financings that raised more than
Recent Achievements:
- Named Pravin Dugel, MD as Executive Chairman and appointed key strategic and clinical experts, including Jeff Heier, MD, as Chief Scientific Officer, Peter Kaiser, MD, as Medical Director, and Sanjay Nayak, MBBS, PhD, as Chief Strategy Officer, to create a world renowned and respected team and move the Company to the forefront of retinal care
- Announced first subjects screened and received their first aflibercept injection in the Phase 3 SOL-1 study with AXPAXLI in wet AMD, being conducted according to a Special Protocol Assessment Agreement with FDA
- Completed two recent financings raising more than
$440 million in total gross proceeds to fund the Phase 3 clinical development of AXPAXLI for the treatment of wet AMD as well as to fund continued clinical development of AXPAXLI for the treatment of diabetic retinopathy
Anticipated Upcoming Milestones:
- April 5-8, PAXTRAVA™ ASCRS: Topline results from the Phase 2 trial (NCT05335122) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT)
- Q2 2024: Ocular Therapeutix Investor Day (exact date to be announced)
- Q2 2024: Topline Phase 1 results from the HELIOS trial evaluating AXPAXLI in subjects with non-proliferative diabetic retinopathy (NCT05695417)
Fourth Quarter and Year End December 31, 2023 Financial Results
Total cash and cash equivalents (Cash) were
Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue; and collaboration revenue. Total net revenue was
Research and development expenses for the fourth quarter of 2023 were
Selling and marketing expenses were
General and administrative expenses were
Net loss for the fourth quarter of 2023 was
Overall, the Company reported a net loss of
Outstanding shares as of March 6, 2024 were approximately 148.6 million.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, including glaucoma. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in the first of two planned pivotal Phase 3 trials for wet AMD, the SOL-1 trial, and a Phase 1 clinical trial for the treatment of non-proliferative diabetic retinopathy. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension.
Ocular’s expertise in the formulation, development and commercialization of innovative therapies and the ELUTYX™ platform supported the development and launch of its first commercial drug product, DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. ELUTYX is also the foundation for two other clinical-stage assets, OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, as well as several preclinical programs.
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DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, and ELUTYX™ are trademarks of Ocular Therapeutix, Inc.
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 the DEXTENZA website.
Forward-Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI and its other product candidates; the Company’s cash runway and 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; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial, the planned SOL-2 trial and the Company’s other ongoing clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the SPA for the SOL-1 trial; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the risks that the leadership appointments referenced in this release are not successful in achieving the anticipated results; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; 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
dnotman@ocutx.com
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
| Ocular Therapeutix, Inc. | |||||||||
| Consolidated Balance Sheets | |||||||||
| (in thousands, except share and per share data) | |||||||||
| December 31, | December 31, | ||||||||
| 2023 | 2022 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 195,807 | $ | 102,300 | |||||
| Accounts receivable, net | 26,179 | 21,325 | |||||||
| Inventory | 2,305 | 1,974 | |||||||
| Restricted cash | 150 | — | |||||||
| Prepaid expenses and other current assets | 7,794 | 4,028 | |||||||
| Total current assets | 232,235 | 129,627 | |||||||
| Property and equipment, net | 11,739 | 9,856 | |||||||
| Restricted cash | 1,614 | 1,764 | |||||||
| Operating lease assets | 6,472 | 8,042 | |||||||
| Total assets | $ | 252,060 | $ | 149,289 | |||||
| Liabilities and Stockholders’ Equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 4,389 | $ | 5,123 | |||||
| Accrued expenses and other current liabilities | 28,666 | 24,097 | |||||||
| Deferred revenue | 255 | 576 | |||||||
| Operating lease liabilities | 1,586 | 1,599 | |||||||
| Total current liabilities | 34,896 | 31,395 | |||||||
| Other liabilities: | |||||||||
| Operating lease liabilities, net of current portion | 6,878 | 8,678 | |||||||
| Derivative liabilities | 29,987 | 6,351 | |||||||
| Deferred revenue, net of current portion | 14,135 | 13,387 | |||||||
| Notes payable, net | 65,787 | 25,257 | |||||||
| Other non-current liabilities | 108 | 93 | |||||||
| Convertible Notes, net | 9,138 | 28,749 | |||||||
| Total liabilities | 160,929 | 113,910 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders’ equity: | |||||||||
| Preferred stock, | — | — | |||||||
| Common stock, | 12 | 8 | |||||||
| Additional paid-in capital | 788,697 | 652,213 | |||||||
| Accumulated deficit | (697,578 | ) | (616,842 | ) | |||||
| Total stockholders’ equity | 91,131 | 35,379 | |||||||
| Total liabilities and stockholders’ equity | $ | 252,060 | $ | 149,289 | |||||
| Ocular Therapeutix, Inc. | |||||||||||||||||
| Consolidated Satements of Operations and Comprehensive Loss | |||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Revenue: | |||||||||||||||||
| Product revenue, net | $ | 14,677 | $ | 13,902 | $ | 57,870 | $ | 50,457 | |||||||||
| Collaboration revenue | 125 | 174 | 573 | 1,037 | |||||||||||||
| Total revenue, net | 14,802 | 14,076 | 58,443 | 51,494 | |||||||||||||
| Costs and operating expenses: | |||||||||||||||||
| Cost of product revenue | 1,386 | 1,013 | 5,281 | 4,540 | |||||||||||||
| Research and development | 16,195 | 13,543 | 61,055 | 53,462 | |||||||||||||
| Selling and marketing | 9,246 | 10,533 | 40,549 | 39,922 | |||||||||||||
| General and administrative | 8,024 | 8,348 | 33,940 | 32,224 | |||||||||||||
| Total costs and operating expenses | 34,851 | 33,437 | 140,825 | 130,148 | |||||||||||||
| Loss from operations | (20,049 | ) | (19,361 | ) | (82,382 | ) | (78,654 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 1,460 | 423 | 3,983 | 798 | |||||||||||||
| Interest expense | (4,153 | ) | (1,847 | ) | (11,338 | ) | (7,022 | ) | |||||||||
| Change in fair value of derivative liabilities | (6,478 | ) | 5,243 | (5,188 | ) | 13,841 | |||||||||||
| Gains and losses on extinguishment of debt, net | — | — | 14,190 | — | |||||||||||||
| Other income (expense), net | — | — | (1 | ) | (1 | ) | |||||||||||
| Total other income (expense), net | (9,171 | ) | 3,819 | 1,646 | 7,616 | ||||||||||||
| Net loss | $ | (29,220 | ) | $ | (15,542 | ) | $ | (80,736 | ) | $ | (71,038 | ) | |||||
| Net loss per share, basic | $ | (0.35 | ) | $ | (0.20 | ) | $ | (1.01 | ) | $ | (0.92 | ) | |||||
| Weighted average common shares outstanding, basic | 84,429,883 | 77,010,385 | 79,827,362 | 76,875,036 | |||||||||||||
| Net loss per share, diluted | $ | (0.35 | ) | $ | (0.24 | ) | $ | (1.02 | ) | $ | (0.97 | ) | |||||
| Weighted average common shares outstanding, diluted | 90,199,115 | 82,779,617 | 85,596,594 | 82,644,267 | |||||||||||||
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