Oculis AG(OCS)
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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]
Earnings Preview: Oculis Holding AG (OCS) Q1 Earnings Expected to Decline
ZACKS· 2025-05-07 15:06
Company Overview - Oculis Holding AG (OCS) is expected to report a year-over-year decline in earnings with a projected loss of $0.51 per share, reflecting a change of -15.9% compared to the previous year [3] - Revenues are anticipated to remain flat at $0.22 million, unchanged from the year-ago quarter [3] Earnings Expectations - The consensus EPS estimate has been revised 5.01% higher in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Oculis is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -7.32%, suggesting a bearish outlook on earnings prospects [10][11] Historical Performance - Oculis has not been able to beat consensus EPS estimates in any of the last four quarters, with the last reported quarter showing a surprise of -58.33% [12][13] Market Reaction - The stock may experience upward movement if the actual results exceed expectations, while a miss could lead to a decline [2] - The combination of a negative Earnings ESP and a Zacks Rank of 3 makes it challenging to predict an earnings beat for Oculis [11][16]