MetaVia (NasdaqCM:MTVA) Conference February 25, 2026 10:15 AM ET Company ParticipantsHyung Heon Kim - President and CEOModeratorWelcome back, everyone. We have MetaVia Inc., trades on the Nasdaq under the symbol MTVA. It's a clinical stage biotech company focused on transforming cardiometabolic diseases. It's developing the treatment for obesity and vanogliprl for the treatment of MASH. Happy to welcome the president, H.H. Kim. Welcome back to the conference today. We're very much looking forward to hearing ...

Lanifibranor's Potential - Lanifibranor is presented as a potential best-in-disease oral therapy for MASH (Metabolic dysfunction-Associated SteatoHepatitis), targeting progressive fibrosis in F2/F3 MASH patients[1,5] - The company anticipates regulatory filings in 2027 and a potential commercial launch in 2028, pending approval[8] - Phase 2b trial data showed a 24% effect size on the dual endpoint of fibrosis improvement and MASH resolution in just 24 weeks[70] - The Phase 3 NATiV3 clinical trial is fully recruited with 1,009 patients in the main cohort and 410 in the exploratory cohort[56] - Topline data from the Phase 3 trial is expected in the second half of 2026[8,64] MASH Market and Medical Understanding - The MASH market is expected to exceed $15 billion by 2035[15] - Approximately 19 million were diagnosed with MASH in the U S in 2025, representing ~10% of the patients with MASH[13] - Approximately 910,000 patients have clinically actionable F2/F3 disease, with about 374,000 (~40%) under treated care[14] Financial Position - The company raised $172 million from investors in November 2025[8] - The company's cash runway extends until the middle of Q3 2027, assuming full exercise of the 3rd tranche[8,67]

Summary of Madrigal Pharmaceuticals FY Conference Call Company Overview - **Company**: Madrigal Pharmaceuticals (NasdaqGS:MDGL) - **Industry**: Metabolic and liver disease - **Key Product**: Rezdiffra, the first-ever approved product for MASH (Metabolic Associated Steatotic Hepatitis) Core Points and Arguments 1. **Market Leadership**: Madrigal is positioned as a leader in the MASH space with a successful product launch, achieving over $1 billion in annualized sales after six quarters [3][4][29]. 2. **Future Growth**: The company anticipates significant growth opportunities with the upcoming F4C indication data expected in 2027, which could potentially double the market opportunity for Rezdiffra [4][30]. 3. **Patient Base**: As of Q3 2025, over 29,500 patients are on Rezdiffra therapy, with 10,000 prescribers, indicating a strong foundation for continued growth [9][10]. 4. **Market Dynamics**: The MASH market is currently under-penetrated, with only 10% of diagnosed patients being treated. The company sees potential for expansion similar to other large specialty markets [11][12]. 5. **Pipeline Development**: Madrigal is focused on building a robust pipeline in MASH, including new mechanisms of action and combination therapies to enhance treatment efficacy [17][18][20]. Important Developments 1. **Combination Therapies**: The company is exploring combination therapies with new assets like a DGAT2 inhibitor and an oral GLP-1 molecule, which are expected to enhance the efficacy of Rezdiffra [20][25]. 2. **Clinical Trials**: Ongoing and upcoming trials include the Maestro Outcomes trial for F4C and the Maestro NASH study for F2, F3, with data expected in 2027 and 2028 respectively [17][18]. 3. **Market Access**: Madrigal has secured first-line access with no step-edit requirements, which is crucial for maintaining strong market presence against competitors [10][49]. Financial Outlook 1. **Sales Growth**: The company expects robust net revenue growth in 2026 despite anticipated changes in gross-to-net dynamics due to commercial contracting [49][50]. 2. **Profitability Timeline**: While profitability is not the immediate focus, the company is confident in achieving it as top-line growth outpaces spending [45][46]. Additional Insights 1. **Global Expansion**: Madrigal has launched in Germany and is exploring opportunities in other countries, particularly in the Middle East, but does not expect significant contributions from international sales in 2026 [55][56]. 2. **Competitive Landscape**: The company acknowledges the presence of competitors but believes that the unique profile of Rezdiffra and its established market access will allow it to thrive [10][53]. Conclusion Madrigal Pharmaceuticals is strategically positioned to lead the MASH market with its innovative product Rezdiffra and a growing pipeline. The company is focused on maximizing its market potential through combination therapies and expanding its patient base while maintaining a strong financial outlook for the coming years [28][30].

Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Development of novel therapeutics targeting fatty acid synthesis for diseases such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) and acne [1][2] Key Points on MASH Program - **Lead Molecule**: Denifenstat, a potent FASN (fatty acid synthase) inhibitor, is being developed for MASH and acne [2][3] - **Mechanism of Action**: Denifenstat targets fat, inflammation, and fibrosis, differentiating it from other treatments that primarily focus on fat oxidation or mobilization [3][10] - **Clinical Data**: - Phase IIB study showed a 30% placebo-adjusted improvement in fibrosis [10] - In F4 patients, 11 out of 13 showed a one or two-stage improvement in fibrosis [6][4] - **Combination Therapy**: A combination program with resmetirom is underway, showing enhanced effects on inflammation and fibrosis [6][18] - **Funding Needs**: Approximately $400 million is required to complete the Phase III study for the F2 and F3 populations, with current cash reserves at $125 million [16][30] Key Points on Acne Program - **Partnership**: Collaboration with Ascletis in China for acne studies, showing 20% placebo-adjusted improvements in lesion reduction [8][23] - **Regulatory Pathway**: Plans to seek FDA guidance in early 2026 regarding the use of Ascletis' Phase III data for U.S. regulatory approval [24][25] - **Next-Gen Molecule**: Development of TVB-3567, a more potent follow-on oral FASN product, is in Phase I [25][26] - **Market Potential**: The acne market is significant, with an estimated 50 million Americans affected, and the introduction of effective treatments is expected to increase patient demand [23][24] Financial Considerations - **Royalty Stream**: Expected inflow of approximately $120 million from milestones and royalties related to the acne program in China [29] - **Capitalization Requirements**: The company acknowledges the need for substantial funding to support ongoing and future clinical programs [30] Additional Insights - **Unique Positioning**: Denifenstat is the only FASN inhibitor in development, which is a significant differentiator in the market [11][12] - **Long-Term Strategy**: The company recognizes the necessity for combination therapies in treating patients effectively, indicating a strategic approach to drug development [20][21] - **Intellectual Property**: New IP filed for the combination therapy is expected to provide protection until 2044 [22] This summary encapsulates the critical insights from the Sagimet Biosciences FY conference call, highlighting the company's strategic direction, clinical advancements, and financial outlook.

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its financial performance [5][21] - The guidance for top-line growth for 2025 has been narrowed to a range of 8%-11%, with corresponding adjustments to operating profit growth [21] Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from international operations (IO) and 24% from the U.S. [11] - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the U.S. [11] Market Data and Key Metrics Changes - The U.S. market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [12] - The company is currently addressing only 3-4 million patients in the obesity market, compared to an estimated 100 million potential patients [12] Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap of these conditions with other comorbidities [8][10] - The acquisition of Akero is part of the strategy to deepen its focus on metabolic diseases, particularly MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's commitment to expanding its product portfolio [9][14] - The company is preparing for the launch of oral semaglutide, which is expected to capture a significant portion of the market due to its unique profile [96][97] Other Important Information - The company is facing regulatory challenges regarding the Metsera acquisition, but remains confident in the quality of the portfolio and its potential [59][68] - There are ongoing discussions about the competitive landscape in the U.S. for GLP-1 products, with management noting a slight decline in Ozempic scripts but a belief in continued growth potential outside the U.S. [82][84] Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management indicated that they will not progress to phase III trials without clear differentiation in efficacy, safety, or scalability [25] Question: Can you explain the recent pricing trends for GLP-1 products? - Management confirmed that pricing for Ozempic is expected to decline by 10%-15% year-on-year, while Wegovy's pricing has also seen a decrease [27][28] Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of direct purchasing channels and expanding product offerings [31][36] Question: What is the outlook for revenue growth in 2026? - Management refrained from providing specific guidance for 2026 but highlighted the potential of the Wegovy pill launch and ongoing pipeline developments as future growth drivers [49][51] Question: What if the FTC blocks the Metsera acquisition? - Management expressed confidence in the acquisition's merits and readiness to discuss its benefits with the FTC [56][59] Question: Are there any supply limitations for the oral semaglutide? - Management reassured that there are no anticipated supply limitations for the oral semaglutide launch [101]

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its R&D pipeline and business development activities [4][20]. - The guidance for top-line growth for 2025 has been narrowed to a range of 8-11%, with corresponding adjustments to operating profit growth [20]. Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from International Operations (IO) and 24% from the US [10]. - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the US [10]. Market Data and Key Metrics Changes - The US market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [11]. - The company is addressing a market of approximately 100 million patients in the US for obesity treatment, with only 3-4 million currently being treated [11]. Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap with comorbidities such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [6][7]. - Recent acquisitions, including that of Akero, are aimed at deepening the company's focus on core therapy areas and addressing unmet needs in comorbidities associated with obesity and diabetes [7][15]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's strategic focus on expanding its product portfolio [11][13]. - The company acknowledged challenges in the US market, including pricing pressures and competition, but remains committed to leveraging its pipeline and product offerings to drive future growth [20][49]. Other Important Information - The company is preparing for the regulatory submission of new products, including the oral semaglutide and MyMADE for rare diseases, which are expected to contribute to future revenue growth [19][50]. - Management emphasized the importance of understanding patient behaviors and needs in the consumer market, particularly in relation to comorbidities and treatment formats [35][100]. Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management stated that they will not progress to phase three without clear differentiation in efficacy, safety, or scalability, and they are awaiting confirmation from phase two data [23]. Question: What are the pricing trends for GLP-1 medications? - Management indicated that pricing for Ozempic is expected to remain stable, with a year-on-year decrease of about 10-15%, while Wegovy's pricing has seen a decline in Q3 [26][27]. Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of product formats and direct purchasing channels [30][35]. Question: What is the outlook for the UK market? - Management noted that the UK market is competitive and price-sensitive, but they are seeing strong performance from their products despite pricing pressures [43]. Question: Can you discuss the Metsera acquisition and potential FTC challenges? - Management expressed confidence in the acquisition's merits and their readiness to discuss it with the FTC, emphasizing the quality of the portfolio [52][56]. Question: What is the expected impact of the oral semaglutide launch? - Management believes that the oral market represents a significant opportunity, with expectations of capturing a substantial share due to its unique profile [95][100].

Financial Data and Key Metrics Changes - Third quarter 2025 net sales totaled $287.3 million, up 35% from the second quarter of 2025 [23][24] - R&D expenses for the third quarter of 2025 were $174 million, compared to $68.7 million in the third quarter of 2024, primarily due to a one-time $117 million expense associated with the global licensing agreement for MGL-2086 [24][25] - SG&A expenses for the third quarter of 2025 were $209.1 million, compared to $107.6 million in the third quarter of 2024, reflecting higher commercial investment to support the Rezdiffra launch [25] Business Line Data and Key Metrics Changes - Rezdiffra's sales are annualizing at greater than $1 billion in only its sixth quarter of launch, with over 29,500 patients currently on therapy, up from more than 23,000 at the end of the second quarter [4][6][7] - The number of prescribers for Rezdiffra exceeded 10,000, indicating strong adoption and penetration in the market [8][27] Market Data and Key Metrics Changes - The MASH market is still in its early stages, with Rezdiffra positioned as a first-line therapy, benefiting from a unique profile that surpasses other first-to-market products [9][10] - The company anticipates that the market will expand, driven by increased awareness and diagnosis, particularly with the entry of competitors like Wegovy [10][11] Company Strategy and Development Direction - The company is focused on maximizing the value of Rezdiffra and building its pipeline, with a strong emphasis on payer contracting strategies for first-line access [4][12] - The strategy includes expanding globally, with a recent launch in Germany following European approval, and enhancing targeting efforts towards endocrinologists [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Rezdiffra's growth potential, citing a strong adherence rate and the drug's well-tolerated profile as key factors for long-term chronic use [11][72] - The company is optimistic about the outcomes of ongoing trials, particularly the Maestro NASH outcomes trial, which is expected to read out in 2027 [16][47] Other Important Information - The company ended the third quarter of 2025 with $1.1 billion in cash and equivalents, providing strong resources to support the ongoing launch of Rezdiffra and advance multiple pipeline programs [25][26] - The gross-to-net impact is expected to be in the high 30% range starting January 1, 2026, consistent with other innovative specialty medicines [24][14] Q&A Session Summary Question: How could AASLD data further de-risk Maestro NASH outcomes? - Management highlighted the positive feedback from gastroenterologists and the foundational therapy status of Rezdiffra, expressing excitement about the upcoming AASLD meeting [31][32] Question: Pros and cons of combining Rezdiffra with MGL-2086 versus other GLP-1s? - Management clarified that MGL-2086 is an orforglipron derivative, emphasizing the rationale for combining it with Rezdiffra to enhance efficacy [37][38] Question: Thoughts on competitive positioning amid recent M&A in the space? - Management views recent M&A as validation of the MASH market and believes it will lead to greater diagnosis and treatment opportunities, favoring Rezdiffra's profile [45][46] Question: Feedback on Rezdiffra's adherence rate and net pricing expectations? - Management confirmed strong adherence rates and indicated that gross-to-net dynamics would likely lead to some future decline in pricing, but they remain optimistic about market access [51][53] Question: Comments on Aetna's formulary coverage decision? - Management stated that Rezdiffra will be available through prior authorization or medical exception, with no expected meaningful impact on patient access [59] Question: Observations on Novo's marketing campaign and its impact on the addressable patient pool? - Management noted that while it is early to quantify the impact, there are signs of increased referrals and diagnosis, which could benefit Rezdiffra [63][64] Question: Path to profitability and focus areas moving forward? - Management emphasized the focus on driving top-line growth and building out the pipeline, indicating that profitability will be considered in the future [68]

Financial Data and Key Metrics Changes - In Q3 2025, net sales totaled $287.3 million, representing a 35% increase quarter over quarter [22][24] - R&D expenses increased to $174 million from $68.7 million in Q3 2024, primarily due to a one-time $117 million expense for a global licensing agreement [23][24] - SG&A expenses rose to $209.1 million compared to $107.6 million in Q3 2024, reflecting higher commercial investment for the Rezdiffra launch [24] Business Line Data and Key Metrics Changes - Rezdiffra's sales are annualizing at over $1 billion within six quarters of launch, with over 29,500 patients currently on therapy, up from over 23,000 at the end of Q2 2025 [3][5][25] - The number of prescribers for Rezdiffra exceeded 10,000, indicating strong adoption and penetration in the market [6][25] Market Data and Key Metrics Changes - The MASH market is still in its early stages, with Rezdiffra positioned as a first-line therapy, benefiting from a unique profile that surpasses other first-to-market products [8][10] - The company anticipates that the market will expand, driven by increased awareness and diagnosis, particularly with the entry of competitors like Novo [61] Company Strategy and Development Direction - The company is focused on maximizing the value of Rezdiffra and expanding its pipeline, with a strong emphasis on payer contracting for first-line access in 2026 [3][11] - The strategy includes a thoughtful approach to pipeline development, aiming to combine Rezdiffra with other mechanisms like GLP-1s to enhance treatment efficacy [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Rezdiffra's growth potential, citing a strong adherence rate and a favorable market position [10][68] - The company is optimistic about the upcoming data presentations at AASLD, which are expected to bolster confidence in the Maestro NASH outcomes trial [32][19] Other Important Information - The company ended Q3 2025 with $1.1 billion in cash and equivalents, providing a strong financial position to support ongoing operations and pipeline advancements [25] - The gross-to-net impact is expected to rise to the high 30% range in 2026, consistent with other innovative specialty medicines [23][12] Q&A Session Summary Question: How could AASLD data further de-risk Maestro NASH outcomes? - Management highlighted the positive feedback from gastroenterologists and the foundational role of Rezdiffra in treatment, expressing excitement for the upcoming AASLD data [29][31] Question: Pros and cons of combining Rezdiffra with MGL-2086 versus other GLP-1s? - The company clarified that MGL-2086 is an orforglipron derivative, emphasizing the rationale for combining it with Rezdiffra to enhance efficacy [35][36] Question: Thoughts on competitive positioning amid recent M&A in the space? - Management views recent M&A as validation of the MASH market, believing it will lead to increased diagnosis and treatment opportunities for Rezdiffra [41][43] Question: Feedback on Rezdiffra's adherence rates and net pricing expectations? - Management confirmed strong adherence rates and indicated that while some gross-to-net decline is expected, they are well-positioned for stable pricing [49][51] Question: Insights on Aetna's formulary coverage decision? - Management stated that Aetna's non-coverage will not significantly impact access, as Rezdiffra will still be available through prior authorization [55][56] Question: Observations on Novo's marketing campaign and its impact on patient numbers? - Management noted that while it is early to quantify, there are signs of increased referrals and diagnosis, which could benefit Rezdiffra [60][62] Question: Path to profitability and future growth strategies? - The focus remains on driving top-line growth and expanding the pipeline, with profitability being a longer-term goal [63][68]

Summary of Aligos Therapeutics Conference Call Company Overview - **Company**: Aligos Therapeutics (NasdaqCM:ALGS) - **Focus**: Development of therapies for liver and viral diseases, specifically targeting chronic hepatitis B virus (HBV) and metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Key Points on Chronic Hepatitis B Virus (HBV) - **Prevalence**: HBV is the largest chronic viral infection globally, affecting approximately three times more people than HIV [3] - **Current Treatments**: Standard care involves nucleoside and nucleotide analogs, which block virus replication but do not eliminate the long-lived cccDNA form of the virus [3][4] - **Clinical Outcomes**: A study in Taiwan showed that after five years of treatment with nucleoside analogs, 4% of patients developed liver cancer, and 5% experienced liver decompensation [4] - **Need for Better Therapies**: Deep and rapid suppression of HBV is essential to prevent liver disease and cancer, highlighting the limitations of current therapies [5] PEVI/PHOSCOVIR Development - **Lead Program**: PEVI is a next-generation capsid assembly modulator designed to treat chronic HBV [2] - **Mechanism of Action**: PEVI blocks the encapsulation of pre-genomic RNA and reduces cccDNA levels, which is a significant advancement over first-generation capsid assembly modulators [10][11] - **Clinical Data**: In a 96-week study, 100% of E antigen negative patients achieved HBV DNA levels below 10 international units, compared to only 20% in traditional treatments [16][22] - **Resistance**: PEVI has shown effectiveness against resistant variants of HBV, which is a significant advantage over previous treatments that led to drug resistance [17][18] B Supreme Phase II Study - **Study Design**: The B Supreme study will compare PEVI with nucleoside analogs in both E positive and E negative patient populations, focusing on achieving HBV DNA levels below 10 [21][22] - **Endpoints**: The study will measure antigen reductions and cccDNA levels, with paired biopsies to assess integration events related to HBV lifecycle [24][26] - **Regulatory Approval**: The study has received approval from regulatory agencies in 14 countries, indicating broad acceptance of its design [19][24] Future Milestones and Commercial Opportunity - **Upcoming Data**: Key data from the B Supreme study will be presented at the AASLD meeting, including post-treatment effects and interim analyses [46][47] - **Market Opportunity**: With 94% of HBV patients needing better chronic suppressive therapy, PEVI is positioned to become the standard of care, potentially increasing the rate of functional cures in combination therapies [39][42][44] MASH and ALG-055009 Development - **Overview**: ALG-055009 is a thyroid hormone receptor beta agonist aimed at treating MASH, showing improved potency and reduced side effects compared to existing therapies [50][52] - **Clinical Results**: In Phase IIa studies, ALG-055009 demonstrated a 46% reduction in liver fat, outperforming similar drugs [54] - **Partnership Discussions**: Aligos is in discussions with potential partners for ALG-055009, aiming to leverage its capabilities in cardiometabolic diseases [56] Conclusion - Aligos Therapeutics is advancing innovative therapies for HBV and MASH, with promising clinical data and a clear regulatory pathway for its lead programs. The company is well-positioned to address significant unmet needs in these areas, with a focus on improving patient outcomes and reducing healthcare costs associated with liver diseases [57][58]

Core Insights - Pharmaceutical companies are heavily investing in drugs for MASH, a liver disease associated with obesity and metabolic issues, with significant acquisitions occurring this year [1] - Magical Pharmaceuticals has launched Resifa, the first FDA-approved drug for MASH, which is expected to drive market growth and awareness [1][2] Industry Overview - The MASH market has approximately 315,000 diagnosed patients in the U.S., with only 7% currently treated, indicating substantial room for growth [4][5] - The diagnosis rate for MASH is estimated at 10%, suggesting many patients remain undiagnosed and untreated [5] - The market is anticipated to evolve into a significant specialty market, similar to established markets like rheumatoid arthritis and psoriasis, which have multiple products and substantial revenue [6][7] Company Positioning - Magical Pharmaceuticals has reported an $800 million run rate, indicating strong initial market performance with only 7% penetration [7] - The company believes that increased competition will enhance awareness and treatment options, benefiting all players in the market [6][10] - The company is confident in its ability to compete against larger firms due to its strong product profile and experienced team [9][10]