Oculis AG(OCS)

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Oculis Upsized Loan Facility to Access up to CHF 100 million
GlobeNewswire News Room· 2025-08-01 08:00
Core Viewpoint - Oculis Holding AG has amended its loan facility with BlackRock, increasing its borrowing capacity to CHF 75 million, potentially up to CHF 100 million, providing significant financial flexibility as the company advances its clinical pipeline and prepares for key regulatory milestones [1][2][3][4]. Financial Agreement - The Amended Loan Agreement replaces a previous loan agreement from May 29, 2024, and includes three tranches of CHF 25 million each, with an additional loan of up to CHF 25 million available under mutually agreed terms [2]. - No amounts were drawn at the signing of the agreement, indicating that the company is maintaining its current cash reserves while securing additional funding [2]. Clinical Development and Milestones - The additional capital will support Oculis in achieving key milestones, including regulatory discussions with the FDA for three indications of Privosegtor (OCS-05) in the second half of 2025, and the initiation of Phase 2/3 trials for Licaminlimab (OCS-02) and Privosegtor (OCS-05) in 2H 2025 and 1H 2026, respectively [3]. - The company anticipates topline results from the OCS-01 Phase 3 DIAMOND trials in Q2 2026, with a potential NDA filing in 2H 2026 if results are positive [3]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a late-stage clinical pipeline that includes three core product candidates: OCS-01, Privosegtor (OCS-05), and Licaminlimab (OCS-02) [5]. - The company is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team supported by international healthcare investors [5].
Oculis Publishes Results of 2025 Annual General Meeting
Globenewswire· 2025-06-05 08:00
Core Points - Oculis Holding AG held its 2025 Annual General Meeting on June 4, 2025, where all agenda items were approved by shareholders [1] - The company reported a standalone statutory financial loss of CHF 5,179,000 for the financial year ended December 31, 2024, with an accumulated balance sheet loss of CHF 46,577,000 to be carried forward [2] - The Board of Directors and Executive Committee received discharge for their activities in 2024 [2] Board and Compensation - Anthony Rosenberg was re-elected as chairperson of the Board of Directors, along with the re-election of other board members and the Compensation Committee [3] - PricewaterhouseCoopers SA was re-elected as Statutory Auditors, and PST Legal AG was re-elected as Independent Proxy [3] - Shareholders approved the compensation for non-executive members of the Board of Directors and the Executive Committee, along with a non-binding advisory vote on the 2024 Compensation Report [4][8] Capital and Share Issuance - A capital band of 27,266,837 registered shares was approved, resulting in a capital band between CHF 545,336.74 and CHF 818,005.11 [5] - Conditional share capital for employees and individuals in comparable positions was approved, allowing for the issuance of 12,480,000 registered shares with a maximum amount of CHF 124,800 [6] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a pipeline including OCS-01 for diabetic macular edema, OCS-05 for acute optic neuritis, and OCS-02 for dry eye disease [7]
Oculis to Participate in Upcoming June Investor Conferences
Globenewswire· 2025-06-03 08:00
Company Overview - Oculis Holding AG is a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs [4] - The company has a differentiated pipeline including OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease [4] - Oculis is headquartered in Switzerland and has operations in the U.S. and Iceland, led by an experienced management team [4] Upcoming Events - Oculis will participate in the Goldman Sachs Annual Healthcare Conference from June 9-11, 2025, in Miami, FL, with a fireside chat featuring CEO Riad Sherif on June 10 from 9:20 to 9:55 am ET [1] - The company will also attend the J.P. Morgan European Healthcare Conference on June 12, 2025, in London, U.K., with opportunities for one-on-one meetings [2] - Webcast links for these events will be available on the Oculis website under the Events & Presentation page [2]
Oculis Holding AG (OCS) 2025 Conference Transcript
2025-05-27 18:02
Summary of Oculus Fireside Chat Company Overview - **Company**: Oculus - **Industry**: Ophthalmology and Neuro-Ophthalmology - **Key Focus**: Development of a diversified and unique ophthalmology pipeline addressing unmet needs in ophthalmology and neuro-ophthalmology diseases with novel assets [1][2] Core Assets 1. **OCS O1**: - Based on OptiReach technology, designed for diabetic macular edema (DME) - Targets early intervention and non-responders among the 1.8 million diagnosed patients, with only 500,000 currently treated [4][34] - Aims to address the 1.3 million patients not receiving adequate treatment [4][36] 2. **OCS O2 (Lickamimab)**: - First precision medicine for dry eye disease, targeting patients with TNF R1 genotype - Approximately 10 million patients suffer from moderate to severe dry eye, with 20% having the TNF R1 gene, showing significantly better responses [5][44] 3. **OCS O5 (Privel Sector)**: - A novel neuroprotective treatment for acute optic neuritis, an orphan disease with no current neuroprotective treatments available - Positive data from Phase 2 ACUITY trial showing biological, anatomical, and functional efficacy [6][9][11] Market Dynamics - **DME Market**: - Current treatments are invasive (anti-VEGF and steroid implants), leading to low compliance; 60% of diagnosed patients are untreated [33] - OCS O1 aims to fill the treatment void for early-stage patients and provide a non-invasive option for those already treated [34][36] - **Acute Optic Neuritis**: - Estimated 65,000 patients in the US and Europe, with no approved products currently available [20] - OCS O5 is positioned to improve low contrast visual acuity (LCVA) and preserve neuronal health [20][24] Clinical Development and Regulatory Pathways - **OCS O5**: - Moving towards registrational studies based on positive Phase 2 results, with FDA interactions planned for the second half of the year [27][28] - **OCS O1**: - Phase 3 trial ongoing with over 800 patients, expecting results in Q2 of next year [39][41] - **Dry Eye Program**: - Phase 3 study design approved by the FDA, focusing on TNF R1 positive patients with a primary endpoint of global ocular discomfort score [42][44] Upcoming Catalysts - Regulatory interactions with the FDA for OCS O5 across three indications (acute optic neuritis, MS relapses, NAION) [47] - Top-line results from the DME trial expected in Q2 of next year [48] - Dry eye study results anticipated in the second half of next year [48] Additional Insights - The company emphasizes the importance of non-invasive treatments in improving patient compliance and outcomes in ophthalmology [35][41] - The potential for OCS O5 to expand into other indications beyond acute optic neuritis, such as glaucoma, is acknowledged [18][24]
Oculis AG(OCS) - 2025 FY - Earnings Call Transcript
2025-05-20 14:30
Financial Data and Key Metrics Changes - The company reported USD 206 million in cash on hand as of March, with no debt, providing a runway into early 2028 [4] - The company aims to file for NDA in the second half of next year if Phase III trial results are positive [15] Business Line Data and Key Metrics Changes - OCS-one, targeting diabetic macular edema (DME), showed a 7.2 letter gain in BCVA at week six, increasing to 7.6 at week twelve, with 25.3% of patients gaining 15 letters or more at week six, improving to 27.4% at week twelve [10] - Privel Sector for acute optic neuritis achieved a 43% reduction in retinal ganglion cell thickness at month three, maintained to month six, and an 18 letters improvement in low contrast visual acuity compared to placebo [21] - Lickminumab for dry eye disease demonstrated a negative 0.12 in inferior corneal staining, outperforming Xiidra, with six times better results for patients with TNFR1 genotype [32] Market Data and Key Metrics Changes - The addressable market for DME in the U.S. is estimated at 1.3 million patients, with only 0.5 million currently treated [14] - The market for acute optic neuritis has no approved neuroprotective therapies, indicating a significant opportunity for Privel Sector [18] - The potential market for multiple sclerosis is large, with 2.8 million affected worldwide and 170,000 estimated relapses per year in the U.S. [24] Company Strategy and Development Direction - The company is expanding its pipeline beyond ophthalmology into neuro ophthalmology, targeting large unmet needs with innovative products [33] - The strategy includes being the first-line treatment for early intervention in DME and addressing inadequacies in current treatments [13][15] - Plans to meet with the FDA to discuss registrational studies for acute optic neuritis and to advance investigational trials for new indications [28] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet needs in the ophthalmic and neuro-ophthalmic markets, emphasizing the potential for their innovative treatments to fill these gaps [33] - The company is well-positioned to generate multiple value catalysts in the coming quarters, with ongoing trials and expected results [33] Other Important Information - The company has completed patient enrollment for its Phase III trials for OCS-one, with results expected in Q2 of 2026 [12] - The management team is experienced and supported by leading international healthcare investors [4] Q&A Session All Questions and Answers Question: What are the next steps for the Privel Sector? - The company is moving full steam ahead on the investigational program for acute optic neuritis and adding two new indications: acute relapses in multiple sclerosis and NAION [23][28]
Oculis Holding AG (OCS) 2025 Conference Transcript
2025-05-14 23:00
Summary of Oculis Holding AG (OCS) Conference Call Company Overview - Oculis Holding AG is a global biopharmaceutical company focused on innovations in ophthalmology and neuro-ophthalmology [3][4] - The company is dual listed and has three core assets with multiple indications [3] Financial Position - Oculis reported $206 million in cash and cash equivalents as of March, with no debt and a runway extending into early 2028 [4] Core Assets and Indications 1. **OCS01 (OptiReach)** - A proprietary eye drop formulation of high concentration dexamethasone targeting diabetic macular edema (DME) [5][6] - Addresses a large unmet medical need with less than 60% of patients diagnosed and only 44% treated [9][10] - Estimated total US addressable patient population is 1.3 million [12] - Positive results from phase three studies, with a letter gain of 7.2 at week six and 7.6 at week twelve [13] - Safety profile is favorable with no unexpected adverse events [14] 2. **OCS05 (Preval Sector)** - A neuroprotective peptide small molecule targeting acute optic neuritis [6][18] - Demonstrated a 43% improvement in retinal ganglion cell thickness and 30% improvement in axon health at month six [25] - The indication has orphan drug designation and no approved therapies currently exist [20][33] 3. **OCS02 (Likaminomap)** - A topical anti-TNF eye drop for dry eye disease, utilizing a genotype-based precision medicine approach [34][35] - Only 13% of patients currently experience lasting relief from existing treatments [35] - Phase two study showed significant efficacy, particularly in patients with the TNF R1 genotype [38] Market Opportunity - The DME market is large and growing, with significant unmet needs due to low patient compliance with current invasive treatments [9][12] - The company aims to position OCS01 as a first-line treatment for early intervention and as a combination therapy for patients not responding adequately to existing treatments [12][17] - The total diagnosed population for DME is approximately 1.8 million, with a significant portion untreated [48] Commercial Strategy - Initial promotional efforts will focus on retinal specialists who treat patients with anti-VEGF therapies, followed by general ophthalmologists [50][51] - The company plans to leverage the existing patient base and the need for non-invasive treatment options [50][52] Future Milestones - Phase three results for OCS01 are expected in Q2 of the following year, with an NDA submission anticipated in the second half of 2026 [16][18] - Discussions with the FDA regarding registrational studies for OCS05 and OCS02 are planned for the second half of the year [33][34] Conclusion - Oculis is positioned to transform its product portfolio from ophthalmology to neuro-ophthalmology, with multiple late-stage assets and a strong clinical profile [42][43] - The company is focused on advancing its lead candidates and addressing significant unmet medical needs in the ophthalmology market [44]
Oculis Holding AG (OCS) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-08 23:10
Financial Performance - Oculis Holding AG reported a quarterly loss of $0.77 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.51, representing an earnings surprise of -50.98% [1] - The company posted revenues of $0.32 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 42.15%, compared to revenues of $0.22 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $0.23 million, and for the current fiscal year, it is -$2.14 on revenues of $0.89 million [7] Stock Performance - Oculis Holding AG shares have increased by approximately 8.4% since the beginning of the year, while the S&P 500 has declined by -4.3% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Oculis Holding AG belongs, is currently ranked in the top 33% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor decisions [5]
Oculis AG(OCS) - 2025 Q1 - Quarterly Report
2025-05-08 20:15
[Unaudited Condensed Consolidated Interim Financial Statements](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section presents the unaudited condensed consolidated interim financial statements, detailing the company's financial performance and position [Statements of Financial Position](index=3&type=section&id=Statements%20of%20Financial%20Position) Total assets significantly increased to **CHF 204.2 million** by March 31, 2025, driven by higher current assets, leading to a substantial rise in total equity due to share issuances Condensed Statement of Financial Position (in CHF thousands) | | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **204,171** | **120,353** | | Total non-current assets | 15,382 | 15,456 | | Total current assets | 188,789 | 104,897 | | *Cash and cash equivalents* | *59,873* | *27,708* | | *Short-term financial assets* | *122,055* | *70,955* | | **Total Equity and Liabilities** | **204,171** | **120,353** | | **Total Equity** | **162,626** | **73,383** | | Total Liabilities | 41,545 | 46,970 | [Statements of Loss](index=4&type=section&id=Statements%20of%20Loss) The company reported a net loss of **CHF 33.2 million** for Q1 2025, significantly wider than the prior year, primarily due to increased operating expenses and a substantial negative finance result Statement of Loss Highlights (in CHF thousands) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Operating income | 285 | 222 | | Research and development expenses | (14,771) | (10,856) | | General and administrative expenses | (5,488) | (4,694) | | **Operating loss** | **(19,974)** | **(15,328)** | | Fair value adjustment on warrant liabilities | (11,911) | (3,069) | | **Loss for the period** | **(33,213)** | **(16,093)** | | **Basic and diluted loss per share** | **(0.69)** | **(0.44)** | [Statements of Comprehensive Loss](index=5&type=section&id=Statements%20of%20Comprehensive%20Loss) Total comprehensive loss for Q1 2025 was **CHF 32.7 million**, significantly higher than the prior year, primarily driven by the net loss for the period Comprehensive Loss Reconciliation (in CHF thousands) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Loss for the period | (33,213) | (16,093) | | Other comprehensive (loss) income | 548 | 31 | | **Total comprehensive loss for the period** | **(32,665)** | **(16,062)** | [Statements of Changes in Equity](index=6&type=section&id=Statements%20of%20Changes%20in%20Equity) Total equity more than doubled to **CHF 162.6 million** in Q1 2025, primarily driven by significant inflows from share issuances and warrant exercises, partially offset by the net loss Key Changes in Equity - Q1 2025 (in CHF thousands) | Item | Amount | | :--- | :--- | | Balance as of January 1, 2025 | 73,383 | | Issuance of ordinary shares | 90,227 | | Warrants exercised | 35,719 | | Loss for the period | (33,213) | | Share-based compensation expense | 2,630 | | Transaction costs | (6,982) | | **Balance as of March 31, 2025** | **162,626** | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Despite increased operating and investing cash outflows, strong financing activities led to a net increase in cash and cash equivalents of **CHF 33.4 million** for Q1 2025 Summary of Cash Flows (in CHF thousands) | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash outflow for operating activities | (18,963) | (13,720) | | Net cash outflow for investing activities | (51,505) | (1,512) | | Net cash inflow from financing activities | 103,831 | 171 | | **(Decrease) increase in cash and cash equivalents** | **33,363** | **(15,061)** | - Effective January 1, 2025, the company reclassified **interest paid** from operating to financing activities and **interest received** from operating to investing activities, with prior periods recast for comparability[18](index=18&type=chunk)[22](index=22&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section provides detailed explanations supporting the financial statements, covering corporate information, accounting policies, financing activities, and specific breakdowns of assets, liabilities, and equity [1. Corporate Information](index=8&type=section&id=1.%20Corporate%20Information) Oculis Holding AG is a Swiss-based, global late clinical-stage biopharmaceutical company focused on developing innovative treatments for ophthalmic and neuro-ophthalmic diseases - Oculis is a global **late clinical-stage biopharmaceutical company** focused on therapeutics for ophthalmic and neuro-ophthalmic diseases[15](index=15&type=chunk) - The company's mission is to improve patient health by developing medicines that **save sight and improve eye care**[15](index=15&type=chunk) [2. Basis of Preparation and Changes to the Group's Accounting Policies](index=8&type=section&id=2.%20Basis%20of%20Preparation%20and%20Changes%20to%20the%20Group%27s%20Accounting%20Policies) The financial statements are prepared on a going concern basis, with a key accounting policy change reclassifying interest paid and received on the cash flow statement, applied retrospectively - The Board believes the Group has **sufficient funds for at least the next 12 months**, supported by current cash and February 2025 offering proceeds[16](index=16&type=chunk) - The company's long-term viability depends on its ability to **raise additional capital** to finance future operations[17](index=17&type=chunk) - Effective January 1, 2025, **interest paid and received were reclassified** on the cash flow statement from operating to financing and investing activities, respectively, applied retrospectively[18](index=18&type=chunk)[22](index=22&type=chunk) [3. Summary of Material Accounting Policies, Critical Judgments and Accounting Estimates](index=10&type=section&id=3.%20Summary%20of%20Material%20Accounting%20Policies%2C%20Critical%20Judgments%20and%20Accounting%20Estimates) Accounting policies and estimates remain consistent with 2024 annual statements, while the company evaluates the potential impact of **IFRS 18**, effective January 1, 2027 - Critical accounting estimates, assumptions, and judgments are **unchanged** from the 2024 annual financial statements[27](index=27&type=chunk) - The company is assessing the impact of **IFRS 18**, a new presentation and disclosure standard effective for periods beginning on or after January 1, 2027[29](index=29&type=chunk) [4. Financing Activities](index=12&type=section&id=4.%20Financing%20Activities) Key financing activities included a **CHF 90.2 million** share offering, establishment of a **CHF 50.0 million** loan facility, and a **$100.0 million** ATM offering program - In February 2025, the company raised **gross proceeds of CHF 90.2 million ($100.0 million)** from an underwritten offering of **5,000,000 ordinary shares**[30](index=30&type=chunk) - A loan facility agreement with Kreos Capital provides up to **CHF 50.0 million** in borrowing capacity, with no amounts drawn as of March 31, 2025[31](index=31&type=chunk) - An **ATM offering program** was established to sell up to **$100.0 million** of ordinary shares, with no sales through March 31, 2025[34](index=34&type=chunk) [5. Segment Information](index=14&type=section&id=5.%20Segment%20Information) Oculis operates as a **single business segment**, with the majority of non-current assets, including all intangible assets, located in Switzerland - The company is managed and operated as **one reportable business segment**[37](index=37&type=chunk) Non-Current Assets by Geography (in CHF thousands) | Asset Type | Switzerland | Iceland | Others | Total | | :--- | :--- | :--- | :--- | :--- | | Intangible assets | 13,292 | - | - | 13,292 | | Property and equipment | 188 | 160 | 16 | 364 | | Right-of-use assets | 660 | 558 | - | 1,218 | | **Total** | **14,140** | **718** | **16** | **14,874** | [6. Intangible Assets](index=14&type=section&id=6.%20Intangible%20Assets) Intangible assets totaled **CHF 13.3 million** as of March 31, 2025, primarily comprising licenses for drug candidates Licaminlimab and Privosegtor, with recent milestone payments for the latter - Intangible assets of **CHF 13.3 million** comprise licenses for **Licaminlimab (OCS-02)** from Novartis and **Privosegtor (OCS-05)** from Accure[39](index=39&type=chunk) - Milestone payments of **CHF 1.1 million** to Accure for Privosegtor (OCS-05) were triggered by Phase 2 trial completion and FDA IND clearance, paid in Q1 2025[39](index=39&type=chunk) [7. Income and Expenses](index=14&type=section&id=7.%20Income%20and%20Expenses) Operating expenses increased to **CHF 20.3 million** in Q1 2025, mainly due to higher R&D costs, while the finance result worsened to a **CHF 13.2 million loss** from fair value adjustments and foreign exchange losses Operating Expenses Breakdown (in CHF thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | 14,771 | 10,856 | | General and administrative | 5,488 | 4,694 | | **Total operating expenses** | **20,259** | **15,550** | - The increase in R&D spending primarily supported clinical trial expenses for the **Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01** in diabetic macular edema (DME)[41](index=41&type=chunk) Finance Result Breakdown (in CHF thousands) | Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Finance income | 493 | 581 | | Finance expense | (247) | (41) | | Fair value adjustment on warrant liabilities | (11,911) | (3,069) | | Foreign currency exchange gain (loss) | (1,567) | 1,794 | | **Finance result** | **(13,232)** | **(735)** | [8. Other Current Assets and Accrued Income](index=16&type=section&id=8.%20Other%20Current%20Assets%20and%20Accrued%20Income) Other current assets remained stable at **CHF 5.9 million**, with a decrease in prepaid clinical expenses offset by an increase in prepaid G&A expenses and accrued R&D income - The decrease in prepaid clinical expenses resulted from the **advancement of the OCS-01 DIAMOND trials** in DME[44](index=44&type=chunk) - Accrued income is derived from **R&D tax credits** provided by the Icelandic government[45](index=45&type=chunk) [9. Share-based Compensation](index=16&type=section&id=9.%20Share-based%20Compensation) Share-based compensation expense more than doubled to **CHF 2.6 million** in Q1 2025 due to new grants and the vesting of earnout options and shares upon achieving stock price targets - Total share-based compensation expense was **CHF 2.6 million** for Q1 2025, a significant increase from **CHF 1.1 million** in Q1 2024[54](index=54&type=chunk) Share-Based Award Activity - Q1 2025 | Award Type | Granted | Outstanding as of Mar 31, 2025 | | :--- | :--- | :--- | | Options & SARs | 973,931 | 5,217,801 | | Restricted Stock Units (RSUs) | 594,524 | 1,057,287 | - VWAP price targets of **$15.00 and $20.00** were met, resulting in **168,571 earnout options** becoming exercisable[55](index=55&type=chunk) [10. Cash and Cash Equivalents, and Short-term Financial Assets](index=20&type=section&id=10.%20Cash%20and%20Cash%20Equivalents%2C%20and%20Short-term%20Financial%20Assets) The company's liquidity significantly strengthened, with combined cash and short-term financial assets increasing to **CHF 181.9 million**, primarily held in Swiss Francs and US Dollars Cash and Short-Term Financial Assets by Currency (in CHF thousands) | Currency | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Swiss Franc | 116,831 | 63,810 | | US Dollar | 56,732 | 25,189 | | Euro | 8,213 | 8,960 | | Other | 152 | 704 | | **Total** | **181,928** | **98,663** | [11. Warrant Liabilities](index=20&type=section&id=11.%20Warrant%20Liabilities) Warrant liabilities decreased to **CHF 14.9 million** in Q1 2025, driven by warrant exercises generating **CHF 18.9 million** in cash, partially offset by a **CHF 11.9 million** fair value loss Warrant Liability Movement - Q1 2025 (in CHF thousands) | Item | Amount | | :--- | :--- | | Balance as of January 1, 2025 | 19,851 | | Fair value loss on warrant liabilities | 11,911 | | Exercise of public and private warrants | (16,825) | | **Balance as of March 31, 2025** | **14,937** | - The exercise of **1,806,297 warrants** in Q1 2025 generated **cash proceeds of CHF 18.9 million**[62](index=62&type=chunk) - The **CHF 11.9 million fair value loss** was primarily due to an increase in the trading price of public warrants[61](index=61&type=chunk) [12. Accrued Expenses and Other Payables](index=22&type=section&id=12.%20Accrued%20Expenses%20and%20Other%20Payables) Accrued expenses and other payables increased to **CHF 19.9 million**, primarily due to higher product development and G&A expenses, partially offset by lower personnel-related costs Accrued Expenses Breakdown (in CHF thousands) | Category | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Product development related expenses | 15,354 | 13,702 | | Personnel related expenses | 2,199 | 3,696 | | General and administration related expenses | 2,249 | 749 | | **Total** | **19,860** | **18,198** | [13. Shareholders' Equity](index=22&type=section&id=13.%20Shareholders%27%20Equity) This section details the company's equity structure, including conditional capital, a capital band authorizing up to **22.7 million** new shares, and the vesting of **2.8 million** earnout shares upon achieving stock price targets - The company has a capital band authorizing the Board to issue up to **22,721,850 ordinary shares** until May 29, 2029[71](index=71&type=chunk) - As of March 31, 2025, **3,500,000 treasury shares** were held, reserved for the ATM Offering Program[72](index=72&type=chunk)[9](index=9&type=chunk) - Achieving **$15.00 and $20.00 VWAP targets** resulted in the vesting of **1,422,723 earnout shares** on each occasion[74](index=74&type=chunk) [14. Loss per Share](index=24&type=section&id=14.%20Loss%20per%20Share) Basic and diluted loss per share increased to **CHF 0.69** for Q1 2025, calculated on a net loss of **CHF 33.2 million** and a weighted-average of **48.3 million shares** Loss Per Share Calculation | | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Net loss (in CHF thousands) | (33,213) | (16,093) | | Weighted-average shares | 48,263,134 | 36,621,162 | | **Basic and diluted net loss per share** | **(0.69)** | **(0.44)** | - **9,435,724 potentially dilutive securities** were excluded from diluted loss per share calculation as their effect was anti-dilutive due to the net loss[78](index=78&type=chunk) [15. Related Party Disclosures](index=26&type=section&id=15.%20Related%20Party%20Disclosures) Key management personnel compensation totaled **CHF 3.4 million** for Q1 2025, a significant increase from the prior year, driven by higher salaries, cash, and share-based compensation Key Management Compensation (in CHF thousands) | Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Salaries, cash compensation & other benefits | 1,755 | 966 | | Pension | 105 | 92 | | Share-based compensation expense | 1,522 | 915 | | **Total** | **3,382** | **1,973** | [16. Subsequent Events](index=26&type=section&id=16.%20Subsequent%20Events) No material events occurred after March 31, 2025, that would require disclosure or adjustment in the financial statements - There are **no material subsequent events** to report[81](index=81&type=chunk)
Oculis Reports Q1 Financial Results and Provides Company Update
Globenewswire· 2025-05-08 20:05
Core Insights - Oculis Holding AG reported significant advancements in its clinical portfolio, including the completion of patient randomization in Phase 3 trials and the initiation of a genotype-based development program in ophthalmology [2][5][6] - The company is well-positioned for future growth with a strengthened financial position and several upcoming value inflection points [2][5] Clinical Developments - OCS-01: Enrollment in Phase 3 DIAMOND trials for diabetic macular edema (DME) has been completed with over 800 patients, with topline results expected in Q2 2026 [5][10] - Licaminlimab (OCS-02): A genotype-based development plan for dry eye disease (DED) is aligned with FDA, with the first registrational trial anticipated in 2H 2025 [5][10] - Privosegtor (OCS-05): Positive results from the ACUITY trial indicate neuroprotective effects, leading to plans for a global registration program in acute optic neuritis and potential expansion into other neuro-ophthalmology indications [5][6][10] Financial Overview - As of March 31, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $206.3 million, reflecting a significant increase from $109.0 million as of December 31, 2024, due to a $100.0 million financing [5][10] - Research and development expenses for Q1 2025 were $16.4 million, up from $12.4 million in Q1 2024, primarily due to costs associated with active clinical trials [10][14] - The net loss for Q1 2025 was $36.9 million, compared to $18.4 million in the same period in 2024, driven by advancements in clinical development and increased general and administrative expenses [10][14]
Oculis Reports Q1 2025 Financial Results and Provides Company Update
Globenewswire· 2025-05-08 20:05
Core Insights - Oculis Holding AG reported significant advancements in its clinical portfolio, including the completion of patient randomization in Phase 3 trials and the initiation of a genotype-based development program in ophthalmology [2][5][6] - The company is well-positioned for future growth with a strengthened financial position and several upcoming value inflection points [2][5] Clinical Developments - Oculis completed randomization of over 800 patients in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01, with topline results expected in Q2 2026 [5][7] - Licaminlimab (OCS-02) is set to initiate its first registrational trial in the second half of 2025, focusing on a personalized medicine approach for dry eye disease [5][12] - Privosegtor (OCS-05) demonstrated promising neuroprotective effects in the ACUITY trial for acute optic neuritis, with plans for a global registration program [5][6][12] Financial Overview - As of March 31, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $206.3 million, bolstered by a $100 million financing in February 2025 [5][12] - Research and development expenses for Q1 2025 were $16.4 million, an increase from $12.4 million in Q1 2024, primarily due to active clinical trials [12][16] - The net loss for Q1 2025 was $36.9 million, compared to $18.4 million in the same period in 2024, driven by clinical development advancements and increased general and administrative expenses [12][16] Market Opportunity - Diabetic macular edema (DME) currently affects approximately 37 million people globally, representing a market opportunity of around $5 billion [6]