Summary of LENS Therapeutics Corporate Update Conference Call Company Overview - **Company**: LENS Therapeutics - **Product**: LNZ100, now known as VIS, an FDA-approved eye drop for presbyopia treatment Key Industry Insights - **Market Size**: Presbyopia affects approximately 128 million adults in the U.S., significantly larger than other eye conditions like dry eye and glaucoma combined [22][23] - **Unmet Need**: Current treatments (reading glasses, progressive lenses) are seen as inconvenient, highlighting the demand for effective alternatives [6][22] Core Product Insights - **FDA Approval**: LNZ100 is the first and only ecyclin-based eye drop for presbyopia, with clinically proven near vision improvement lasting up to 10 hours [4][15] - **Mechanism of Action**: The product is a predominantly pupil-selective meiotic that interacts with the iris with minimal ciliary muscle stimulation, providing a unique solution for presbyopia [7][16] - **Clinical Trials**: Approval based on three phase three trials demonstrating significant near vision improvement within 30 minutes of dosing [14][15] Commercial Strategy - **Sales Force**: An 88-member sales team has been fully trained and deployed, targeting 15,000 eye care professionals [8][10] - **Marketing Campaigns**: Direct-to-eye care professional marketing campaign initiated, with a consumer campaign expected to launch in 2026 [11][28] - **Product Availability**: Samples expected in October, with full commercial availability by mid-Q4 [12][29] - **Pricing**: $79 for a box of 25 vials, with a three-month supply available for $198 [12][29] Financial Position - **Cash Reserves**: Over $205 million in cash available to support commercial operations, significantly higher than previous guidance [31][32] - **Commercial Spend**: Estimated annual commercial spend of $80 to $100 million starting in 2026 [33][88] Launch Metrics and Expectations - **Initial Focus**: Early metrics will include unique eye care professionals prescribing the product and total new patient starts [34] - **Sampling Strategy**: Emphasis on ensuring samples are well-stocked and utilized in doctors' offices to drive early adoption [78] Additional Considerations - **Consumer Education**: The brand "VIS" is designed to resonate with consumers, being one of only nine single-syllable brand names approved by the FDA in the past 15 years [11][27] - **Safety Profile**: The product has shown no serious treatment-related adverse events across over 30,000 treatment days, with mild and transient reactions [16][46] Potential Risks and Challenges - **Market Competition**: While LENS acknowledges competition, the focus remains on the unique benefits of VIS compared to existing treatments [72][73] - **Consumer Adoption**: The timing of the direct-to-consumer campaign is strategically planned to ensure eye care professionals are prepared before consumer outreach begins [95] Conclusion LENS Therapeutics is poised for a significant market entry with VIS, addressing a substantial unmet need in presbyopia treatment. The company's robust commercial strategy, strong financial position, and innovative product profile position it well for future growth and success in the ophthalmic market.

Group 1 - LENZ Therapeutics, Inc. has a market capitalization of $825 million and holds $190 million in cash [1] - The company has a PDUFA date set for August 8, 2025, for its drug aceclidine (1.75%), which is aimed at treating presbyopia [1] - Presbyopia currently affects 128 million individuals in the U.S. [1]

Core Insights - Viatris Inc. announced positive top-line results from the VEGA-3 Phase 3 trial for MR-141, demonstrating significant improvement in near visual acuity for patients with presbyopia without compromising distance vision [1][2] - The trial involved 545 patients and showed that MR-141 significantly outperformed placebo in achieving primary and secondary endpoints [5][6] - The company plans to submit an application to the U.S. FDA in the second half of 2025 [1][8] Company Overview - Viatris is a global healthcare company that combines generics and brand medications to address healthcare needs, supplying high-quality medicines to approximately 1 billion patients annually [7] - The company is headquartered in the U.S. with global centers in Pittsburgh, Shanghai, and Hyderabad [7] Industry Context - Presbyopia affects nearly 128 million people in the U.S., approximately 90% of adults over 45, and is projected to impact 2.1 billion people globally by 2030 [6] - The condition leads to significant economic losses, estimated between $11 billion and $25 billion due to uncorrected cases, highlighting the need for effective near-vision correction solutions [6]

Summary of the Conference Call Company Overview - The conference focused on LENS Therapeutics, discussing their upcoming regulatory update and product launch plans for LENS100, a treatment for presbyopia [1][2]. Regulatory Updates - The PDUFA date for LENS100 is set for August 8, with positive feedback from the FDA during a recent late cycle review [2][4]. - No major or minor observations were noted by the FDA, indicating a smooth regulatory path towards approval [3][4]. Product Differentiation - LENS100 is the only presbyopia treatment utilizing aceclidine, which effectively creates a small pinhole pupil below two millimeters, enhancing near vision without significant side effects [5][6][8]. - In clinical trials, 71% of participants experienced at least three lines of near vision improvement, significantly outperforming competitors like Vuity [10][12]. - The product's efficacy profile shows a sustained effect, with 40% of participants maintaining improvement at ten hours post-application, compared to only 10% for Vuity [10][12]. Market Potential - The presbyopia market is estimated to exceed $3 billion, with 128 million presbyopes in the U.S. and 4 million new cases annually [13][14]. - The company anticipates a 6% penetration rate among presbyopes, leading to approximately 8 million long-term users [16][20]. - The pricing strategy is expected to be around $79 per prescription, similar to Vuity, which had a successful launch with 150,000 scripts sold [19][20]. Commercial Strategy - A sales force of 88 representatives has been established, primarily targeting optometrists, as they account for 80% of script sales in the presbyopia market [22][24]. - The marketing strategy will focus on digital channels, with a budget of $75 to $80 million for direct-to-consumer (DTC) advertising in the first year [39][67]. - The company plans to sample the product heavily to ensure consumer experience and retention, aiming for a higher refill rate than competitors [49][51]. Financial Outlook - LENS Therapeutics is well-funded, with expectations of reaching cash flow positivity by the PDUFA date, bolstered by a strong balance sheet and non-dilutive cash from licensing deals [65][66]. - The projected commercial spend post-launch is approximately $100 million, with a focus on maintaining a lean operational structure [67][68]. Intellectual Property and Supply Chain - The product is protected by a robust IP portfolio, including five years of data exclusivity upon approval and multiple granted patents [61][62]. - The supply chain is designed to be efficient, with API production in the U.S. and fill-finish operations in Germany, ensuring a duty-free status [55][56]. Future Growth and Licensing - The company is exploring opportunities for expansion through mergers and acquisitions, aiming to build a broader portfolio around LENS100 [70][71]. - Licensing agreements are already in place for markets in China and Southeast Asia, with plans to expand into Europe and other regions through partnerships [73][74]. Conclusion - LENS Therapeutics is positioned for a successful product launch with a strong regulatory outlook, differentiated product offering, and a comprehensive commercial strategy aimed at capturing a significant share of the presbyopia market [1][20][70].

LNZ100 Product & Clinical Trial Highlights - LNZ100, an aceclidine eye drop, aims to provide seamless vision for the majority of 128 million US presbyopes, with a potential launch in Q4 2025[3],[5],[48] - Clinical trials showed 71% of participants achieved ≥3-line improvement at 0.5 hours and 40% at 10 hours[3] - 84% of participants achieved a 4-line gain at some point during the efficacy studies, and 52% achieved a 5-line gain[36] - 41% of participants achieved at least 1 line of distance vision improvement[44] Market Opportunity & Commercial Readiness - The presbyopia market is estimated to be a $3B+ market[3],[5],[59] - Phase 3 patient surveys indicated 75% interest for continued use of LNZ100[3],[49] - ECPs survey indicated that 61% (~215) of their ~350 monthly patients are presbyopic[51],[52] - At a conservative 6% adoption rate or ~8 million users and a 42% refill rate, LNZ100 has blockbuster potential[59] Financial Position & Exclusivity - The company ended Q1 2025 with $194.1M in cash and anticipates >$190M at PDUFA, with cash to positive cash flow[3] - The product has market exclusivity based on a broad IP portfolio and potential new chemical entity (NCE) status[3] - The company has 8 granted patents (Exp 2034-2044) and 7 patents under review (Exp 2034-2044) in the US[64]

Company Overview - LENZ Therapeutics, Inc. is a pre-commercial biopharmaceutical company focused on developing and commercializing the first and only aceclidine-based eye drop aimed at improving near vision in individuals with presbyopia [3] - The product candidate, LNZ100, is a preservative-free, single-use, once-daily eye drop containing aceclidine [3] - Presbyopia affects an estimated 1.8 billion people globally and 128 million people in the United States [3] Upcoming Events - Company management will participate in several investor conferences, including: - William Blair 45 Annual Growth Stock Conference on June 3, 2025, in Chicago, IL, with a management presentation at 1:40pm EDT [1] - Jefferies Global Healthcare Conference on June 4-5, 2025, in New York City, NY, with a management presentation at 9:55am EDT [2] - Goldman Sachs 46 Annual Global Healthcare Conference on June 9, 2025, in Miami Beach, FL, featuring a fireside chat at 4:00pm EDT [2] - Live audio webcasts of the presentations will be available on the LENZ Therapeutics website, with replays accessible for 12 months following the events [2] Regulatory Milestones - The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100 [3] - The company is committed to commercializing an effective pharmaceutical solution for presbyopia that enhances vision for "all eyes, all day" [3]

Core Points - LENZ Therapeutics and Lotus Pharmaceutical have entered into an exclusive licensing and commercialization agreement for LNZ100, aimed at treating presbyopia in South Korea and select Southeast Asian countries [1][2] - The agreement includes up to $125 million in upfront and milestone payments to LENZ, along with tiered, double-digit royalties on future net sales [2] - Lotus will have exclusive rights for the development, manufacturing, registration, and commercialization of LNZ100 in the specified regions [2] Company Overview - LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first aceclidine-based eye drop for presbyopia, a condition affecting approximately 1.8 billion people globally [4] - LNZ100 is a preservative-free, single-use, once-daily eye drop that has undergone a Phase 3 study for registration [4] - The FDA has set a target action date of August 8, 2025, for LNZ100's New Drug Application (NDA) [4] Lotus Pharmaceutical - Founded in 1966, Lotus is an international pharmaceutical company with a strong focus on both novel and generic pharmaceuticals [5] - The company has a robust R&D and manufacturing platform in Asia, certified by major regulatory authorities including the US FDA and EU EMA [5] - Lotus is actively developing over 100 pharmaceutical projects and has a diverse portfolio that includes oncology, complex generics, and biosimilars [6]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with approximately $194.1 million in cash, cash equivalents, and marketable securities, which has been upwardly revised from over $170 million to over $185 million projected cash at PDUFA [27][28] - Total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4, with a net cash burn of $15 million [28][29] - Net loss per share was $0.53 in Q1 2025, compared to $3.53 in Q1 2024, reflecting a significant improvement in financial performance [30][31] Business Line Data and Key Metrics Changes - The company is focused on the launch of LNZ100, a treatment for presbyopia, with a strong emphasis on commercial readiness and engagement with eye care professionals [5][6] - The unbranded campaign has reached over 12,000 eye care professionals (ECPs) and delivered more than 2 million online impressions [9][10] - The sales force has expanded, with over 40% of the field sales team already hired, and 97% of new team members have prior eye care or pharmaceutical experience [19][20] Market Data and Key Metrics Changes - Presbyopia affects an estimated 128 million people in the U.S., presenting a substantial market opportunity [14][15] - The company aims to capture a significant share of the $3 billion market for presbyopia treatments, with a focus on a once-daily eye drop solution [16][67] Company Strategy and Development Direction - The company is preparing for the launch of LNZ100 with a three-pillar commercial strategy: enabling doctors to recommend the product, empowering patients to request it, and ensuring seamless access [10][25] - The company has established a strong intellectual property position with seven granted patents and additional patents under review, ensuring long-term protection for LNZ100 [82][83] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver effective treatments for presbyopia, emphasizing the importance of sampling and patient experience in driving adoption [32][44] - The company is monitoring economic conditions, noting that historical data suggests medical aesthetics products may be less impacted by recessions compared to elective procedures [88][90] Other Important Information - The company has received positive feedback from eye care professionals regarding the clinical potential of LNZ100, which is expected to enhance patient care [7][8] - The FDA has shown a high level of engagement, with the late cycle review meeting scheduled for later this month, keeping the company on track for the August 8 PDUFA date [11][12] Q&A Session Summary Question: Infrastructure for sample distribution post-launch - The company has contracted a sampling distributor and is coordinating systems to ensure seamless delivery of samples to ECPs immediately after approval [35][36] Question: Preparation for continued use and refills of LNZ100 - The sales team is undergoing training to ensure they can effectively communicate product benefits and drive patient adherence post-sampling [38][43] Question: Metrics to disclose for patient demand - The company plans to provide metrics on new script rates and refill rates, focusing on IQVIA data for tracking [41][42] Question: Management of sample distribution and expected conversion rates - Samples will be managed through a monthly shipment to reps, with tracking to ensure they reach high-potential prescribers [48][51] Question: E-pharmacy partnership mechanics - The e-pharmacy partner is integrated within the eye care professional ecosystem, ensuring a seamless prescription process and strong patient follow-up [55][84] Question: Impact of potential recession on call points - The company believes its product will be less affected by economic downturns due to its focus on quality of life improvements [88][91] Question: Additional patent protection for LNZ100 - The company has a strong patent estate with seven granted patents and additional patents under review, ensuring robust protection for the product [82][83] Question: Potential competition from other approved eye drops - Management believes that the effectiveness of LNZ100 will differentiate it from competitors, emphasizing the importance of initial patient experience [96][97]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with approximately $194.1 million in cash, cash equivalents, and marketable securities, which has been upwardly revised from over $170 million to over $185 million projected cash at PDUFA [26][27] - Total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4 2024, with a net cash burn of $15 million [27][28] - The net loss per share was $0.53 in Q1 2025, compared to $3.53 in Q1 2024, reflecting a significant improvement in financial performance [29] Business Line Data and Key Metrics Changes - The company is focused on the launch of LNZ100, a treatment for presbyopia, with a strong emphasis on commercial readiness and engagement with eye care professionals [5][6] - The unbranded campaign has reached over 12,000 eye care professionals (ECPs) and delivered more than 2 million online impressions [9][10] - The sales force is being expanded, with over 40% of the field sales team already hired, and 97% of new team members having prior eye care or pharmaceutical experience [18][19] Market Data and Key Metrics Changes - Presbyopia affects approximately 128 million Americans, presenting a substantial market opportunity for LNZ100 [8][14] - The initial launch of LNZ100 is expected to tap into a market that is significantly larger than those affected by other eye conditions [14] Company Strategy and Development Direction - The company aims to establish LNZ100 as a category-defining treatment for presbyopia, with a commercial strategy structured around enabling doctors to recommend the product, empowering patients to request it, and ensuring seamless access [10][22] - The company is preparing for a potential August 8 PDUFA date, with a focus on building brand awareness and a strong product access strategy [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver effective treatments for presbyopia, highlighting the strong engagement with the FDA and the positive feedback from eye care professionals [11][30] - The company is aware of potential economic challenges but believes that its product will be viewed as essential, potentially insulating it from significant downside risks during a recession [85][86] Other Important Information - The company has received definitive rulings confirming that LNZ100 will be duty-free, enhancing its competitive position [12] - The company has a strong patent estate, with seven granted patents and additional patents under review, ensuring robust protection for LNZ100 [79][80] Q&A Session Summary Question: Infrastructure for sample distribution post-launch - The company has contracted a sampling distributor and is coordinating systems to ensure seamless distribution of samples to ECPs immediately after approval [35] Question: Preparation for continued use and refills of LNZ100 - The sales team is undergoing training to ensure they can effectively communicate product benefits and drive patient adherence post-sampling [37][42] Question: Metrics to disclose for patient demand - The company plans to provide metrics on new script rates and refill rates, focusing on IQVIA data for tracking [39][40] Question: Sample distribution management - Samples will be managed through a vendor, with reps tracking distribution and ensuring accountability [47][50] Question: E-pharmacy partnership mechanics - The e-pharmacy will streamline the prescription process, allowing for easy patient access and auto-refill options [53][54] Question: Marketing plans and influencer engagement - The influencer campaign will begin in early 2026, after ensuring ECPs are well-informed about the product [60][62] Question: Additional patent protection for LNZ100 - The company has a strong patent estate with several patents under review, ensuring long-term protection for the product [79][80] Question: Impact of potential recession on consumer sentiment - Historical data suggests that the medical aesthetics category is somewhat insulated from recession risks, and the company is focused on major metropolitan markets [85][88] Question: Competition from alternative products - The company believes that the effectiveness of LNZ100 will differentiate it from competitors, emphasizing the importance of sampling [92][93]

Core Viewpoint - LENZ Therapeutics is progressing towards the potential launch of LNZ100, an aceclidine-based eye drop for presbyopia, with a PDUFA target action date set for August 8, 2025, and has reported a strong financial position to support its operations leading up to and post-launch [1][3][11]. Financial Highlights - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $194.1 million, with an anticipated cash balance exceeding $185.0 million by the PDUFA date [1][6][7]. - Research and Development (R&D) expenses decreased to $5.8 million for Q1 2025, down from $10.5 million in Q1 2024, primarily due to the completion of the Phase 3 CLARITY study [7][17]. - Selling, General and Administrative (SG&A) expenses increased to $11.1 million in Q1 2025 from $5.6 million in Q1 2024, driven by personnel-related costs and pre-commercial marketing expenses [8][17]. - The net loss for Q1 2025 was $14.6 million, or $0.53 per share, compared to a net loss of $16.6 million, or $3.53 per share, in the same period of 2024 [9][17]. Regulatory and Development Updates - The NDA for LNZ100 has been accepted by the FDA, with no significant review issues reported, and the review process remains on track [2][3]. - The FDA has confirmed that it will not hold an Advisory Committee Meeting regarding the NDA for LNZ100, indicating a smooth review process [3][4]. - The company received definitive rulings from the U.S. Department of Customs and Border Protection, confirming LNZ100 as duty-free and of U.S. origin [4]. Commercialization Efforts - The company is actively preparing for the U.S. commercial launch of LNZ100, with a full commercial and sales force infrastructure in place and plans to hire 88 sales representatives by July 1, 2025 [5][11]. - A successful Commercial Day event was held on April 15, 2025, where management shared updates on commercialization strategy and insights from key opinion leaders [5].