Ocular Therapeutix™ Reports Third Quarter 2024 Results and Business Highlights
Ocular Therapeutix (NASDAQ: OCUL) reported Q3 2024 financial results and business updates. The company achieved total net revenue of $15.4 million, a 2.3% increase from Q3 2023. Cash position stands at $427.2 million, expected to fund operations into 2028. The Phase 3 SOL-1 trial for AXPAXLI in wet AMD is expected to complete randomization by year-end 2024, with topline data anticipated in Q4 2025. The company reported a net loss of $36.5 million or $(0.22) per share. Full-year 2024 DEXTENZA revenue guidance is projected between $62.0-67.0 million.
Ocular Therapeutix (NASDAQ: OCUL) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha raggiunto un fatturato netto totale di 15,4 milioni di dollari, con un aumento del 2,3% rispetto al terzo trimestre del 2023. La posizione di liquidità è di 427,2 milioni di dollari, prevista per sostenere le operazioni fino al 2028. Si prevede che lo studio di Fase 3 SOL-1 per AXPAXLI nell'AMD umida completerà la randomizzazione entro la fine del 2024, con i dati preliminari attesi nel quarto trimestre del 2025. L'azienda ha riportato una perdita netta di 36,5 milioni di dollari ovvero $(0,22) per azione. Le previsioni di fatturato per DEXTENZA per l'intero anno 2024 sono stimate tra i 62,0 e 67,0 milioni di dollari.
Ocular Therapeutix (NASDAQ: OCUL) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre el negocio. La compañía logró ingresos netos totales de 15,4 millones de dólares, un aumento del 2,3% en comparación con el tercer trimestre de 2023. La posición de efectivo asciende a 427,2 millones de dólares, lo que se espera que financie las operaciones hasta 2028. Se espera que el ensayo de Fase 3 SOL-1 para AXPAXLI en la DMAE húmeda complete la aleatorización para finales de 2024, con datos preliminares anticipados para el cuarto trimestre de 2025. La compañía reportó una pérdida neta de 36,5 millones de dólares o $(0,22) por acción. La guía de ingresos para DEXTENZA para todo el año 2024 se proyecta entre 62,0 y 67,0 millones de dólares.
Ocular Therapeutix (NASDAQ: OCUL)는 2024년 3분기 재무 결과 및 비즈니스 업데이트를 발표했습니다. 이 회사는 총 순수익 1540만 달러를 달성했으며, 이는 2023년 3분기 대비 2.3% 증가한 수치입니다. 현금 보유량은 4억 2720만 달러로, 2028년까지 운영 자금을 지원할 것으로 예상됩니다. 습성 AMD에 대한 AXPAXLI의 3상 SOL-1 시험은 2024년 연말까지 무작위 배정을 완료할 예정이며, 상위 데이터는 2025년 4분기에 예상됩니다. 이 회사는 3650만 달러의 순손실을 보고했으며, 주당 $(0.22)입니다. 2024년 전체 연도의 DEXTENZA 수익 안내는 6200만에서 6700만 달러 사이로 예상됩니다.
Ocular Therapeutix (NASDAQ: OCUL) a publié ses résultats financiers pour le troisième trimestre 2024 ainsi que des mises à jour sur son activité. L'entreprise a réalisé un chiffre d'affaires net total de 15,4 millions de dollars, soit une augmentation de 2,3 % par rapport au troisième trimestre 2023. La position de liquidités s'élève à 427,2 millions de dollars, ce qui devrait financer les opérations jusqu'en 2028. L'essai de Phase 3 SOL-1 pour AXPAXLI dans l'AMD humide devrait achever la randomisation d'ici la fin de l'année 2024, avec des données préliminaires attendues au quatrième trimestre 2025. L'entreprise a signalé une perte nette de 36,5 millions de dollars ou $(0,22) par action. Les prévisions de revenus pour DEXTENZA pour l'année complète 2024 se situent entre 62,0 et 67,0 millions de dollars.
Ocular Therapeutix (NASDAQ: OCUL) hat die finanziellen Ergebnisse für das dritte Quartal 2024 sowie Unternehmensupdates veröffentlicht. Das Unternehmen erzielte einen Gesamtumsatz von 15,4 Millionen Dollar, was einem Anstieg von 2,3% gegenüber dem dritten Quartal 2023 entspricht. Die Liquiditätslage liegt bei 427,2 Millionen Dollar, was voraussichtlich die Betriebskosten bis 2028 decken wird. Die Phase-3-Studie SOL-1 für AXPAXLI bei feuchter AMD soll bis Ende 2024 die Randomisierung abschließen, wobei die wichtigsten Daten für das vierte Quartal 2025 erwartet werden. Das Unternehmen meldete einen Nettoverlust von 36,5 Millionen Dollar oder $(0,22) pro Aktie. Die Prognose für die Einnahmen von DEXTENZA für das Gesamtjahr 2024 wird auf zwischen 62,0 und 67,0 Millionen Dollar geschätzt.
- Cash position of $427.2M sufficient to fund operations into 2028
- 2.3% increase in total net revenue to $15.4M in Q3 2024
- DEXTENZA revenue guidance raised to $62.0-67.0M for 2024
- Accelerated enrollment timeline for SOL-1 Phase 3 trial
- Net loss increased to $36.5M in Q3 2024 vs $0.5M in Q3 2023
- R&D expenses increased to $37.1M from $15.0M YoY
- Selling and marketing expenses increased to $10.6M from $9.3M YoY
- G&A expenses rose to $12.2M from $8.6M YoY
Insights
Q3 2024 shows mixed financial performance with some concerning trends.
The robust cash position of
The accelerated enrollment in SOL-1 trial for AXPAXLI in wet AMD represents significant operational progress. The trial's completion ahead of schedule, with topline data expected in Q4 2025, could potentially expedite the path to market. The FDA's confirmation of SOL-R as an adequate second study for NDA submission strengthens the regulatory strategy.
The dual-trial approach with SOL-1 and SOL-R demonstrates strategic planning, addressing both efficacy and practical clinical considerations like durability and flexible dosing. This comprehensive data package could provide competitive advantages in the wet AMD market, where treatment burden remains a key challenge.
SOL-1 expected to be fully randomized by YE 2024 with topline data expected in Q4 2025
Active clinical trial sites now enrolling patients directly into SOL-R
Cash balance of
Ocular to host a Q3 2024 conference call and webcast today, November 14th, at 8:00 AM ET
BEDFORD, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including an update on the Phase 3 registrational program for AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) in development for wet age-related macular degeneration (wet AMD).
“2024 has been a year of significant change and tremendous execution at Ocular, but this is all in anticipation of what’s ahead. We are making outstanding progress on enrollment in the two complementary studies in our registrational program for AXPAXLI in wet AMD, SOL-1 and SOL-R. I’m thrilled to share that SOL-1 has reached a key enrollment milestone, as we have now ‘flipped the switch’ to allow direct enrollment of subjects into SOL-R. We expect to complete SOL-1 randomization by year-end, with topline data to follow in the fourth quarter of 2025. As SOL-1 quickly approaches complete randomization, eligible subjects who are not ultimately randomized can seamlessly enroll in SOL-R, creating a streamlined and efficient pathway that capitalizes on recruitment momentum at our clinical sites,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix.
Dr. Dugel continued, “SOL-1 and SOL-R were strategically designed with the goals of de-risking clinical outcomes, aligning with regulatory standards, enhancing each other’s enrollment, and providing a broad evaluation of AXPAXLI’s durability, repeatability, and flexibility. Thanks to the team’s strong execution, attention to patient care, and long-standing relationships in the retina community, we have enrolled SOL-1 faster than we expected and continue to build enthusiasm for SOL-R. Supported by our dedicated team and strong financial resources, Ocular is on solid footing as we head towards what we expect will be an important milestone year in 2025.”
Recent Achievements and Upcoming Milestones:
- Accelerated timelines for SOL-1 AXPAXLI registrational trial (Phase 3, wet AMD). The exceptional pace of recruitment in the SOL-1 superiority trial is expected to result in full randomization by the end of 2024. This is meaningfully ahead of prior guidance. Topline data from the SOL-1 trial are now expected during the fourth quarter of 2025. The study is being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA).
- Direct enrollment open for SOL-R AXPAXLI repeat dosing registrational trial (Phase 3, wet AMD). Initial subjects enrolling in SOL-R were previously required to be loading or randomization failures in SOL-1. As SOL-1 nears the completion of randomization, physicians can now directly enroll eligible subjects into SOL-R. This trial was designed to complement SOL-1 with repeat and flexible dosing while providing commercially meaningful data. In a written Type C response, the FDA confirmed in August of this year that the SOL-R trial should be appropriate for use as Ocular’s second adequate and well-controlled study to support a potential New Drug Application (NDA) and product label for wet AMD.
Third Quarter Ended September 30, 2024, Financial Results:
Total cash and cash equivalents were
Total net revenue was
Research and development expenses for the third quarter of 2024 were
Selling and marketing expenses were
General and administrative expenses were
Net loss for the third quarter of 2024 was
Outstanding shares as of November 11, 2024, were approximately 157.2 million.
Conference Call and Webcast Information:
Ocular Therapeutix will host a conference call and webcast today at 8:00 AM ET to discuss recent business progress and third quarter 2024 financial results. To access the call, please dial: 1 (877) 407-9039 (United States) or 1 (201) 689-8470 (International). The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days.
About AXPAXLI
AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) is an investigational, bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases.
About the SOL-1 Study
The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina. The trial is intended to randomize approximately 300 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye.
The superiority study has an eight-week loading segment prior to randomization, a 9-month treatment segment, and a safety follow-up. During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 or gain at least 10 early treatment diabetic retinopathy (ETDRS) letters at Day 1 are then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg) and assessed monthly for the duration of the study. The clinical trial protocol requires that, during the study, subjects in any arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg).
The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. The study is being conducted under a Special Protocol Agreement (SPA) with the FDA.
About the SOL-R Study
The registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm study that will involve sites located in the U.S. and the rest of the world. The trial is intended to randomize approximately 825 subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within three months prior to enrollment.
The non-inferiority study reflects a patient enrichment strategy that includes multiple loading doses of aflibercept (2 mg) and monitoring to exclude subjects with significant retinal fluid fluctuations. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 24. Subjects in the second arm receive aflibercept (2 mg) on-label every 8 weeks. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Week 24, aligned with the AXPAXLI treatment arm for adequate masking. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg).
The primary endpoint of SOL-R is non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year. In a written Type C response received in August 2024, the FDA agreed that the SOL-R repeat dosing wet AMD study should be appropriate as an adequate and well-controlled study in support of a potential New Drug Application and product label.
About Wet AMD
Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally and 1.65 million in the United States alone (2023 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions. 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 Phase 3 clinical trials for wet age-related macular degeneration (wet AMD).
Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA™ (travoprost intracameral implant or OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.
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The Ocular Therapeutix logo and DEXTENZA® are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.
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; the timing, design, and enrollment of the Company’s SOL-1 and SOL-R Phase 3 clinical 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 potential utility of any of the Company’s product candidates; the Company’s objective to become a leader in retinal care; the Company’s guidance regarding its projected total net product revenues for DEXTENZA; the Company’s cash runway and 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 any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials; the ability to grow DEXTENZA revenues in accordance with the Company’s forecasts; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the Special Protocol Assessment for the SOL-1 trial; the risk that the FDA may not agree that the protocol and statistical analysis plan of SOL-R or the data generated by the SOL-1 and SOL-R trials support marketing approval, even if the trials are successful; 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, whether preliminary or interim data from a clinical trial will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; availability of data from clinical trials and expectations for regulatory submissions and approvals; 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 may 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 & Media
Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
bslattery@ocutx.com
| Ocular Therapeutix, Inc. Consolidated Balance Sheets (in thousands, except share and per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 427,220 | $ | 195,807 | ||||
| Accounts receivable, net | 30,235 | 26,179 | ||||||
| Inventory | 2,405 | 2,305 | ||||||
| Restricted cash | — | 150 | ||||||
| Prepaid expenses and other current assets | 13,151 | 7,794 | ||||||
| Total current assets | 473,011 | 232,235 | ||||||
| Property and equipment, net | 10,050 | 11,739 | ||||||
| Restricted cash | 1,614 | 1,614 | ||||||
| Operating lease assets | 5,694 | 6,472 | ||||||
| Total assets | $ | 490,369 | $ | 252,060 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,001 | $ | 4,389 | ||||
| Accrued expenses and other current liabilities | 30,451 | 28,666 | ||||||
| Deferred revenue | 190 | 255 | ||||||
| Operating lease liabilities | 1,717 | 1,586 | ||||||
| Total current liabilities | 36,359 | 34,896 | ||||||
| Other liabilities: | ||||||||
| Operating lease liabilities, net of current portion | 5,592 | 6,878 | ||||||
| Derivative liabilities | 14,465 | 29,987 | ||||||
| Deferred revenue, net of current portion | 14,000 | 14,135 | ||||||
| Notes payable, net | 67,815 | 65,787 | ||||||
| Other non-current liabilities | 117 | 108 | ||||||
| Convertible Notes, net | — | 9,138 | ||||||
| Total liabilities | 138,348 | 160,929 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 16 | 12 | ||||||
| Additional paid-in capital | 1,194,701 | 788,697 | ||||||
| Accumulated deficit | (842,696 | ) | (697,578 | ) | ||||
| Total stockholders’ equity | 352,021 | 91,131 | ||||||
| Total liabilities and stockholders’ equity | $ | 490,369 | $ | 252,060 | ||||
| Ocular Therapeutix, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue: | |||||||||||||||
| Product revenue, net | $ | 15,347 | 14,950 | $ | 46,441 | $ | 43,193 | ||||||||
| Collaboration revenue | 78 | 131 | 200 | 449 | |||||||||||
| Total revenue, net | 15,425 | 15,081 | 46,641 | 43,642 | |||||||||||
| Costs and operating expenses: | |||||||||||||||
| Cost of product revenue | 1,561 | 1,377 | 4,396 | 3,895 | |||||||||||
| Research and development | 37,054 | 15,019 | 86,646 | 44,860 | |||||||||||
| Selling and marketing | 10,573 | 9,315 | 30,750 | 31,304 | |||||||||||
| General and administrative | 12,235 | 8,584 | 46,054 | 25,915 | |||||||||||
| Total costs and operating expenses | 61,423 | 34,295 | 167,846 | 105,974 | |||||||||||
| Loss from operations | (45,998 | ) | (19,214 | ) | (121,205 | ) | (62,332 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 5,653 | 1,212 | 15,611 | 2,524 | |||||||||||
| Interest expense | (3,224 | ) | (3,426 | ) | (10,471 | ) | (7,187 | ) | |||||||
| Change in fair value of derivative liabilities | 7,076 | 6,722 | (1,103 | ) | 1,290 | ||||||||||
| Gains and losses on extinguishment of debt, net | — | 14,190 | (27,950 | ) | 14,190 | ||||||||||
| Other expense | — | — | — | (1 | ) | ||||||||||
| Total other income (expense), net | 9,505 | 18,698 | (23,913 | ) | 10,816 | ||||||||||
| Net loss | $ | (36,493 | ) | $ | (516 | ) | $ | (145,118 | ) | $ | (51,516 | ) | |||
| Net loss per share, basic | $ | (0.22 | ) | $ | (0.01 | ) | $ | (0.94 | ) | $ | (0.66 | ) | |||
| Weighted average common shares outstanding, basic | 166,992,735 | 79,373,272 | 154,990,112 | 78,276,341 | |||||||||||
| Net loss per share, diluted | $ | (0.22 | ) | $ | (0.25 | ) | $ | (0.94 | ) | $ | (0.77 | ) | |||
| Weighted average common shares outstanding, diluted | 166,992,735 | 85,142,504 | 154,990,112 | 84,045,573 | |||||||||||
FAQ
What was Ocular Therapeutix (OCUL) revenue in Q3 2024?
When will OCUL's SOL-1 trial for AXPAXLI complete enrollment?
What is OCUL's cash runway as of Q3 2024?
What is OCUL's revenue guidance for DEXTENZA in 2024?
