89Bio (ETNB) 2025 Conference Transcript

Summary of 89Bio (ETNB) Conference Call Company Overview - Company: 89Bio - Focus: Development of picocefermin, an FGF21 analog for treating NASH (Non-Alcoholic Steatohepatitis) and severe hypertriglyceridemia (SHTG) [3][52] Key Points on FGF21 and NASH - Mechanism of Action: FGF21 is a unique FGF21 analog that addresses metabolic dysregulation, liver fat reduction, and fibrosis directly [3][4][6] - Clinical Efficacy: FGF21 shows benefits in fibrosis improvement as early as 24 weeks, compared to other drugs that may take longer [6][10] - Market Dynamics: Recent successful drug approvals in the NASH space have increased confidence in the market, with a shift towards more potent second-generation products [7][10] Competitive Landscape - Recent Deals: GSK's acquisition of Boston Pharmaceuticals' efemulsipherman for $800 million validates interest in the NASH market and the FGF21 mechanism [11][12] - Market Potential: The F4 cirrhotic population represents the highest unmet need and pricing power in the NASH market [13][14] Differentiating Characteristics of Pegosafirman - Dosing and Administration: Pegosafirman can be dosed once a week or every two weeks, with a favorable tolerability profile compared to competitors [18][21][23] - Efficacy Data: In phase 2 studies, pegosafirman showed a 20% placebo-adjusted delta in fibrosis improvement, with a relative risk benefit of 3.5 [18][19][20] - Tolerability: Lower rates of gastrointestinal adverse events compared to other FGF21 agents, which is crucial for patient compliance [21][22] Physician and Patient Perspectives - Physician Preferences: Key criteria include fibrosis benefit, tolerability, and the ability to address steatohepatitis [27][28][30] - Patient Preferences: Patients prioritize dosing convenience, adverse event profiles, and affordability [32][33] Market Strategy and Future Outlook - Targeting Endocrinologists: As the market evolves, endocrinologists are expected to play a significant role in treating NASH, especially with the approval of GLP-1s [34][35] - Market Size: The F4 space alone could exceed $5 billion, indicating significant potential for multiple successful players [38] Combination Therapies - Potential Combinations: The combination of FGF21 with GLP-1s could yield synergistic benefits, but safety and tolerability will be critical factors [49][50] Severe Hypertriglyceridemia (SHTG) Strategy - Target Population: Patients with triglycerides above 500 mg/dL, often with metabolic dysfunction, represent a significant market opportunity [52][53] - Efficacy in SHTG: Phase 2 studies showed a 57% to 63% reduction in triglycerides, positioning pegosafirman as a second-line therapy for refractory patients [54][55] Conclusion - Overall Outlook: 89Bio is well-positioned in the NASH and SHTG markets with a differentiated product profile and a strong focus on patient and physician needs, supported by promising clinical data and market validation through recent industry deals [56]