Company Overview - Oculis is a global biopharma company listed on NASDAQ, focusing on ophthalmology and neuro-ophthalmology with late-stage registrational candidates [2] - The company has three candidates in Phase III trials and two main franchises [2] Product Pipeline - The first franchise includes OCS-01, which is the first noninvasive self-administered eye drop for diabetic macular edema (DME), with a readout planned for Q2 of this year [3] - The second candidate in this franchise is Licaminlimab, aimed at treating dry eye disease, with a readout expected in Q4 2026 [3] Neuro-Ophthalmology Franchise - The second franchise focuses on neuro-ophthalmology, featuring privosegtor, which is the first product to demonstrate effectiveness in neuroprotection [4] - Privosegtor has shown consistent results in preserving neurons across all endpoints, including functional, anatomical, and biological measures [4]

Summary of Oculis Conference Call Company Overview - **Company**: Oculis - **Industry**: Biopharmaceuticals, specifically in ophthalmology and neuro-ophthalmology - **Stock Exchange**: Nasdaq-listed - **Financial Position**: Strong balance sheet with no debt, cash runway until 2029 excluding a facility loan of CHF 100 million ($125 million) [2][3] Key Products and Pipeline Ocular Franchise - **OCS-01**: - First non-invasive self-administered eye drop for diabetic macular edema (DME) - Phase 3 readout planned for Q2 2023 - Targets a market of 1.8 million diagnosed patients in the US, with only half currently treated [2][5][6] - Demonstrated a 7.6 letters gain in best-corrected visual acuity (BCVA) at week 12 in trials, with 27% of patients gaining more than 15 letters [10] - Expected submission for approval in Q4 2023, with potential approval in 2027 [12] - **Licaminlimab**: - First precision medicine in ophthalmology for dry eye disease - Utilizes a biomarker to identify high responders, allowing for smaller and more efficient Phase 3 trials [12][13] - Expected top-line results in Q4 2026 [41] Neuro-Ophthalmology Franchise - **Privosegtor**: - First product in neuroprotection, targeting optic neuritis and NAION - Received Breakthrough Therapy Designation - Demonstrated preservation of retinal and ganglion cells in trials, with significant functional improvements [16][21] - Market potential of $7 billion for optic neuritis and NAION, with no current solutions available [18] - Phase 3 trials (Pioneer 1 and Pioneer 2) expected to start in 2026, with readouts planned for 2027 [23][35] Market Opportunity - **DME Market**: - Significant unmet medical need with a large patient pool, as DME is the leading cause of blindness in the working-age population in the US [34] - OCS-01 aims to address both early intervention and patients not responding to current treatments [7][9] - **Neuro-Ophthalmology Market**: - High potential due to the lack of existing treatments for conditions like optic neuritis and NAION, which are closely linked to multiple sclerosis (MS) [19][20] - Plans to expand treatment to all types of MS relapses, significantly increasing the addressable market [40] Strategic Focus - **Commercial Strategy**: - Focus on the US market for launch, with potential partnerships for ex-US markets [26] - Emphasis on innovative and differentiated product profiles to ensure successful commercial launches [26] - **Execution and Risk Management**: - Acknowledgment of execution risk as a primary concern, with a commitment to high-quality trial execution [31][32] - Confidence in the biological efficacy of products based on consistent preclinical and clinical data [39] Manufacturing and Partnerships - **Manufacturing Strategy**: - Oculis does not have in-house manufacturing capabilities; instead, it partners with established global manufacturers to maintain flexibility and quality [44] Conclusion - Oculis is positioned to make significant advancements in the ophthalmology and neuro-ophthalmology sectors with its innovative product pipeline, addressing critical unmet medical needs and leveraging a strong financial position for future growth [25]

Visionary Innovation Riad Sherif, M.D. Chief Executive Officer J.P. Morgan Healthcare Conference January 14, 2026 Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identi ...

Company Overview - Oculis is a Swiss-based biopharma company focused on improving eye care and saving patients' vision, with operations in the US and Iceland [2] - The company has developed a differentiated pipeline of drug candidates for conditions such as diabetic macular edema (DME) and acute optic neuritis (AON) [2] Pipeline and Drug Candidates - Oculis has several late-stage clinical studies, including OCS-01, a potential treatment for DME, which affects over 37 million people globally, projected to rise to 53 million by 2040 [1][2] - OCS-01 is the first topical eye drop for DME, with two fully enrolled Phase 3 trials (DIAMOND) involving over 800 patients, and topline data expected in 2Q26 [7][10] - The company plans to submit a New Drug Application (NDA) to the FDA in 2H26, with the DME market estimated at $5 billion globally [7][10] - Oculis is also developing privosegtor (OCS-05) for AON and NAION, with several clinical trials underway, including positive results from Phase 2 trials [8][11] Financial Position - As of the end of Q3, Oculis had $182.2 million in cash and liquid assets, which increased to $300 million following a capital raise campaign in October [9] Analyst Insights - Analysts view Oculis as offering a diversified ophthalmology pipeline with high unmet needs, particularly for DME with OCS-01 showing promising efficacy and safety [10] - The stock has received a Strong Buy consensus rating, with a price target of $38 indicating an 81% upside potential, while the current stock price is $20.97 [11]

Core Insights - Oculis Holding AG is advancing its late-stage pipeline, particularly focusing on Privosegtor and OCS-01, which address significant unmet medical needs in ophthalmology and neuro-ophthalmology [1][6] Group 1: Privosegtor - Privosegtor has received breakthrough therapy designation from the U.S. FDA for treating optic neuritis, based on positive results from the ACUITY Phase 2 trial [2][10] - In the ACUITY trial, patients receiving Privosegtor showed an average gain of 18 letters in vision improvement compared to placebo, indicating a clinically meaningful two-fold improvement in visual resolution [3] - The PIONEER program has been launched to support registration for Privosegtor in optic neuritis and non-arteritic anterior optic neuropathy (NAION), with a potential market opportunity exceeding $7 billion in the U.S. [4][7] Group 2: OCS-01 - OCS-01 is in Phase 3 development as the first eye drop treatment for diabetic macular edema (DME), targeting a market opportunity of approximately $3 billion in the U.S. [5][15] - The diagnosed DME population in the U.S. is estimated to be around 1.8 million, highlighting the significant unmet medical need for effective treatments [5] - Topline results from the DIAMOND Phase 3 trials for OCS-01 are expected in Q2 2026, with an NDA submission planned for Q4 2026 [5][6] Group 3: Market Potential - The combined market potential for Oculis' neuroprotective therapies and DME treatments could exceed $30 billion, reflecting the substantial unmet needs in these areas [6][10] - The company is positioned to transform treatment landscapes in neuro-axonal diseases and diabetic eye conditions, which currently lack effective therapies [6][15]

Group 1: Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 100 points on Tuesday [1] - Microchip Technology Inc's shares rose significantly after the company revised its fiscal third-quarter revenue expectations upward [1] Group 2: Microchip Technology Inc - Microchip now anticipates third-quarter fiscal 2026 net sales of approximately $1.185 billion, surpassing its previous guidance range of $1.109 billion to $1.149 billion [2] - The stock price of Microchip Technology increased by 8.1%, reaching $72.47 on Tuesday following the announcement [2] Group 3: Other Notable Stock Movements - Alumis Inc saw a remarkable 129% increase in its stock price to $19.04 after positive trial results for envudeucitinib [3] - Aeva Technologies Inc's stock rose by 31.5% to $17.21 due to its technology being selected for NVIDIA's autonomous vehicle platform [3] - Terrestrial Energy Inc's shares increased by 26.9% to $8.87 after securing an agreement with the U.S. Department of Energy [3] - Bright Minds Biosciences Inc gained 25% to $100.00 following successful Phase 2 trial results [3] - OneStream Inc's stock rose by 25.1% to $23.00 amid reports of a potential buyout [3] - Other companies such as SanDisk Corp, Beam Therapeutics Inc, and Albemarle Corp also recorded significant stock price increases [3]

Core Insights - Oculis Holding AG announced that its neuroprotective drug, Privosegtor, has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, addressing significant unmet medical needs in this area [1][7]. Company Overview - Oculis is a global biotechnology company focused on innovation for treating eye diseases, with a pipeline that includes three key development drugs: Privosegtor, OCS-01, and Licaminlimab [15]. - The company is headquartered in Switzerland and has operations in the United States and Iceland, backed by leading global healthcare investment funds [15]. Drug Development and Market Opportunity - Privosegtor is a small molecule peptide mimic that can cross the blood-brain and retinal barriers, potentially becoming the first neuroprotective treatment for optic nerve disorders, with a combined market opportunity of over $7 billion in the U.S. alone [2][5]. - The ACUITY Phase 2 study demonstrated significant improvements in visual acuity with Privosegtor, showing an average increase of 18 letters on the ETDRS visual acuity scale compared to placebo after three months [4][7]. Clinical Trial Insights - The ACUITY study involved 36 eligible patients aged 18 to 60 with recent onset optic neuritis, comparing Privosegtor with placebo alongside intravenous steroids [12][13]. - Results indicated that Privosegtor not only improved visual acuity but also maintained the structural integrity of the retina and optic nerve, which typically suffer damage during acute optic neuritis [4][9]. Regulatory Status - The Breakthrough Therapy Designation is intended to expedite FDA review for drugs that show substantial improvement over existing treatments for serious conditions [14]. - Following a successful meeting with the FDA in 2025, Oculis initiated the PIONEER program, which includes three registration studies to support the approval of Privosegtor for optic neuritis and NAION [5][6].

Core Insights - Oculis Holding AG's neuroprotective candidate Privosegtor has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, highlighting its potential as a first-of-its-kind therapy in this area [1][7]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmology and ophthalmology, with a late-stage clinical pipeline that includes Privosegtor, OCS-01, and Licaminlimab [15]. Product Details - Privosegtor is a novel peptoid small molecule designed to penetrate both the blood-brain and retinal barriers, potentially addressing significant unmet medical needs in optic neuropathies, with a market opportunity estimated at $7 billion in the U.S. alone [2][5]. - The drug has shown substantial improvements in visual function, with an average gain of 18 letters in Low Contrast Visual Acuity (LCVA) compared to placebo in the Phase 2 ACUITY trial [4][7]. Clinical Trial Insights - The ACUITY trial demonstrated that Privosegtor not only improved visual function but also preserved anatomical structures of the retina and optic nerve, indicating its neuroprotective potential [3][4]. - The trial involved 36 patients with acute optic neuritis, showing that those treated with Privosegtor alongside IV methylprednisolone experienced significant visual improvements [12]. Regulatory and Market Implications - Following a successful meeting with the FDA, Oculis initiated the PIONEER program, which includes three pivotal trials aimed at supporting registration plans for Privosegtor in optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) [5][6]. - The unmet medical needs in these conditions are significant, as there are currently no approved neuroprotective therapies available [10][11].

Core Viewpoint - Oculis Holding AG (OCS) shows significant potential for upside, with a mean price target of $44.67 indicating a 106% increase from its current price of $21.68, reflecting strong analyst optimism about the company's earnings prospects [1][11]. Price Targets and Analyst Consensus - The average price target for OCS is based on nine short-term estimates, ranging from a low of $29.00 to a high of $55.07, with a standard deviation of $9.51, indicating variability in analyst predictions [2]. - The lowest estimate suggests a 33.8% increase, while the highest points to a 154% upside, highlighting the potential for significant price movement [2]. - A low standard deviation among price targets indicates a high degree of agreement among analysts regarding the stock's price direction, which can serve as a starting point for further research [9]. Earnings Estimates and Analyst Revisions - Analysts have shown strong agreement in revising OCS's earnings estimates higher, which correlates with potential stock price increases [11]. - Over the past 30 days, five earnings estimates have been revised upward, resulting in a 10.4% increase in the Zacks Consensus Estimate for the current year [12]. - OCS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13]. Caution on Price Targets - While price targets are a common tool for investors, they can often mislead, as empirical research shows that they rarely indicate actual stock price movements [7][10]. - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8].

Core Viewpoint - Oculis Holding AG has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - For the fiscal year ending December 2025, Oculis is expected to earn -$2.22 per share, unchanged from the previous year, but analysts have raised their estimates by 7.2% over the past three months [8]. Institutional Investor Influence - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Oculis Holding AG's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].