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Ocular Therapeutix (OCUL) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2026-02-05 14:11
Ocular Therapeutix (OCUL) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to a loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +12.65%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.39 per share when it actually produced a loss of $0.37, delivering a surprise of +5.13%.Over the last four quarters, the ...
Ocular Therapeutix(OCUL) - 2025 Q4 - Annual Report
2026-02-05 12:58
Clinical Trials and Product Development - AXPAXLI is currently in Phase 3 trials for wet AMD and diabetic retinal disease, with plans to submit an NDA based on Week 52 data from the SOL-1 trial[706][711] - The SOL-1 trial has maintained an exceptional subject retention rate, with no safety signals identified to date[707] - The SOL-R trial achieved its randomization target of 631 subjects, with topline data expected in Q1 2027, ahead of previous guidance[709] - The company plans to initiate the SOL-X trial in Q2 2026 to evaluate long-term safety for subjects from the SOL-1 and SOL-R trials[710] - The company expects to continue incurring losses as it advances clinical trials for product candidates, including SOL-1, SOL-R, and HELIOS-3, and supports the commercialization of DEXTENZA[768] Financial Performance - DEXTENZA net product revenue for 2025 was $51.8 million, a decrease of $11.6 million or 18.3% compared to 2024, primarily due to Medicare reimbursement caps and rebates[716] - Product revenue decreased to $51.8 million in 2025 from $63.5 million in 2024, a decline of $11.6 million year-over-year[739] - Total revenue for 2025 was $51.9 million, down from $63.7 million in 2024, reflecting a decrease of $11.8 million[738] - Collaboration revenue was minimal at $0.1 million in 2025, down from $0.3 million in 2024, with no expected revenue for 2026[742] - The net loss for the year ended December 31, 2025, was $265.9 million, compared to $193.5 million in 2024 and $80.7 million in 2023, indicating a significant increase in losses[767] Expenses and Cost Management - Research and development expenses are expected to increase as the company continues to support the development of its product candidates[728] - Research and development expenses increased to $197.1 million in 2025 from $127.6 million in 2024, an increase of $69.5 million year-over-year[743] - Selling and marketing expenses rose to $53.9 million in 2025, up from $41.6 million in 2024, reflecting an increase of $12.3 million[748] - General and administrative expenses increased to $64.4 million in 2025 from $60.7 million in 2024, an increase of $3.7 million[751] - Operating expenses for 2025 totaled $322.0 million, primarily for research and development, selling and marketing, and general and administrative activities[778] Cash Flow and Financing - Cash and cash equivalents as of December 31, 2025, were $737.1 million, with outstanding notes payable of $82.5 million under the Barings Credit Facility[762] - The company raised approximately $561.7 million from financing activities in 2025, compared to $332.1 million in 2024 and $169.8 million in 2023[778] - In February 2024, the company raised approximately $316.4 million from the sale of 32,413,560 shares of common stock and pre-funded warrants[764] - Net cash used in operating activities was $70.2 million for the year ended December 31, 2023, primarily due to a net loss of $80.7 million and unfavorable changes in operating assets and liabilities of $7.4 million[782] - Net cash provided by financing activities for the year ended December 31, 2023 was $169.8 million, including proceeds from public offerings of $117.3 million and drawings under the Barings Credit Facility of $82.5 million[786] Debt and Obligations - The Barings Credit Facility has an outstanding principal of $82.5 million as of December 31, 2025[734] - Total contractual obligations and commitments amounted to $88.7 million as of December 31, 2025, with $82.5 million related to the Barings Credit Agreement[787] - The company has a secured term loan facility with a principal amount of $82.5 million under the Barings Credit Agreement[814] Revenue Recognition and Accounting Policies - Revenue from product sales is recognized when the customer obtains control of the product, which occurs upon delivery[800] - The company estimates variable consideration for product sales, including trade discounts and allowances, which are recorded as reductions of revenue[801] - The company has received minimal product returns to date and expects returns of DEXTENZA to remain minimal[804] - Chargebacks for government healthcare providers are established in the same period that related revenue is recognized, impacting product revenue and trade receivables[805] - The company estimates future claims for rebates and records a liability for these rebates, impacting product revenue[806] Intellectual Property and Royalties - The company has in-licensed a significant portion of its intellectual property from Incept, with obligations to pay royalties based on net sales of licensed products[792] - The Royalty Fee Derivative Liability was valued at $13.9 million as of December 31, 2025[815] - The Royalty Fee Derivative Liability is measured using a Monte Carlo simulation, considering expected future revenue and estimated volatility[810] - Changes in the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows[815] Future Outlook - The company anticipates continued increases in research and development expenses for 2026 and beyond as it progresses with multiple clinical trials[746] - The company anticipates additional funding will be required to support the commercialization of AXPAXLI if approved by the FDA[772] - The company plans to scale up manufacturing processes and capabilities to support sales and clinical trials of its product candidates[771]
Ocular Therapeutix(OCUL) - 2025 Q4 - Annual Results
2026-02-05 12:13
Exhibit 99.1 Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights SOL-1 Phase 3 superiority trial results remain masked to date SOL-1 data expected to be presented at the 49 Macula Society Annual Meeting Ocular plans to submit NDA for AXPAXLI™ in wet AMD based on SOL-1 52 Week data, pending positive results and planned FDA interactions Completed randomization of 631 subjects in SOL-R Phase 3 non-inferiority trial in December 2025; timing of topline results ...
Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
Globenewswire· 2026-02-05 12:00
SOL-1 Phase 3 superiority trial results remain masked to date SOL-1 data expected to be presented at the 49th Macula Society Annual Meeting Ocular plans to submit NDA for AXPAXLI™ in wet AMD based on SOL-1 52 Week data, pending positive results and planned FDA interactions Completed randomization of 631 subjects in SOL-R Phase 3 non-inferiority trial in December 2025; timing of topline results accelerated and now anticipated in 1Q 2027 HELIOS-3 Phase 3 trial in diabetic retinopathy underway Cash balance of ...
Ocular Therapeutix: Why SOL-1 Trial Outcome Is Likely Positive (NASDAQ:OCUL)
Seeking Alpha· 2026-02-04 12:30
Analyst’s Disclosure: I/we have a beneficial long position in the shares of OCUL either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any i ...
Ocular Therapeutix: Why SOL-1 Trial Outcome Is Likely Positive
Seeking Alpha· 2026-02-04 12:30
Core Insights - The article discusses the investment potential of OCUL, highlighting a beneficial long position in its shares by the analyst [1]. Group 1 - The analyst expresses a personal opinion on OCUL's stock performance and potential [1]. - There is no compensation received for the article other than from Seeking Alpha, indicating an independent analysis [1]. - The article does not provide specific investment recommendations or advice [2].
Ocular Therapeutix™ Appoints David W. Robinson as Global Chief Commercial Officer
Globenewswire· 2026-01-21 12:00
Accomplished global commercial leader with deep expertise in retina drug launches Primary architect for the industry-defining launch of EYLEA® while at Regeneron Most recently served as Chief Marketing Officer, Global Ophthalmology at Merck BEDFORD, Mass., Jan. 21, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that David W. Robinson has agreed to join the Company as Global Chi ...
Ocular Therapeutix, Inc. (OCUL): A Bull Case Theory
Yahoo Finance· 2026-01-15 18:03
Core Thesis - Ocular Therapeutix, Inc. is experiencing strong investor confidence due to its innovative ocular therapies, with shares trading at $13.24, reflecting a 62% gain over the past year and a 13% increase in the last three months [2] Company Overview - Ocular Therapeutix develops treatments for retinal diseases, glaucoma, ocular hypertension, and postsurgical inflammation using its proprietary Elotex bioabsorbable hydrogel technology [2][3] - The Elotex platform enables sustained-release drug delivery, improving patient compliance and treatment outcomes compared to traditional methods [3] Pipeline and Regulatory Strategy - The company is advancing its XPaxley treatment for wet age-related macular degeneration, targeting NDA submission in Q1 2026, contingent on positive initial data [3] - Regulatory strategy aligns closely with FDA requirements, potentially allowing a streamlined approval process through a single registrational trial [4] - If XPaxley demonstrates a 15% improvement over its comparator, it could secure FDA approval with a superiority claim [4] Financial Position - Recent quarterly report showed a loss per share of $0.38 on $14.5 million in revenue, but the company is well-capitalized with approximately $790 million in cash, providing a runway into 2028 [4] - Analysts are highly bullish, with all 10 current ratings as strong buys and an average price target of $24, implying an 82% upside [4] Investment Opportunity - Ocular Therapeutics presents a compelling investment opportunity due to its strong cash position, innovative technology, and favorable regulatory alignment, positioning it for significant upside as its pipeline advances [5]
Strength Seen in Ocular Therapeutix (OCUL): Can Its 6.1% Jump Turn into More Strength?
ZACKS· 2026-01-15 15:31
Core Viewpoint - Ocular Therapeutix's stock experienced a significant increase of 6.1% to $11.07, driven by rising investor confidence in its product pipeline, particularly for Axpaxli, aimed at treating wet age-related macular degeneration [1][2]. Group 1: Stock Performance - The stock's recent gain contrasts with a 27.5% decline over the previous four weeks, indicating a potential turnaround in investor sentiment [1]. - The trading session saw a higher-than-average volume of shares exchanged, suggesting increased market interest [1]. Group 2: Product Pipeline Developments - Ocular Therapeutix plans to submit a new drug application for Axpaxli in Q1 2026, contingent on positive results from the ongoing phase III SOL-1 study [2]. - Axpaxli is also being investigated for other conditions, including diabetic retinopathy and diabetic macular edema, expanding its potential market [2]. Group 3: Financial Expectations - The company is projected to report a quarterly loss of $0.33 per share, reflecting a year-over-year decrease of 13.8% [3]. - Expected revenues for the upcoming quarter are $15.1 million, down 11.6% from the same period last year [3]. Group 4: Earnings Estimate Trends - The consensus EPS estimate for Ocular Therapeutix has remained unchanged over the last 30 days, indicating stability in earnings expectations [4]. - A lack of movement in earnings estimate revisions typically correlates with stock price trends, suggesting that future performance should be monitored closely [4]. Group 5: Industry Context - Ocular Therapeutix holds a Zacks Rank of 3 (Hold), indicating a neutral outlook within the Zacks Medical - Drugs industry [5]. - In comparison, another company in the same industry, Profound Medical, has seen a 9.1% decline in its stock price, highlighting varying performance within the sector [5][6].
Biotech outperformance expected to continue in 2026, Baird analysts say
Proactiveinvestors NA· 2026-01-09 16:46
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...