Summary of Biomea Fusion Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS:BMEA) - **Industry**: Biotechnology, focusing on metabolic diseases, specifically diabetes and obesity [14][15] Core Points and Arguments Metabolic Disease Focus - Biomea is positioned in the metabolic space, targeting diabetes and obesity, which are identified as significant health challenges [14][15] - The company aims to address the root causes of diabetes by focusing on insulin deficiency rather than just symptom management [19][20] Product Development - **Icovamenib**: A menin inhibitor designed to regenerate beta cells in the pancreas, targeting insulin-deficient patients [21][22] - The drug aims to provide a more effective treatment for diabetes by addressing the underlying issue of insufficient insulin production [20][21] - **Next-Generation GLP-1 Receptor Agonist**: Biomea is developing an oral GLP-1 receptor agonist based on the orforglipron scaffold, which aims to improve patient compliance and efficacy [23][41] Clinical Trials and Data - The company is preparing for Phase 2 trials, focusing on insulin-deficient patients and those failing GLP-1 therapy [40][41] - Initial data from trials show promising results, with a significant reduction in HbA1c levels and weight loss in patients [27][50] - The company plans to release data in Q1 of the following year, with expectations of enrolling patients quickly [31][41] Safety and Efficacy - Biomea emphasizes a favorable safety profile for icovamenib, with minimal side effects compared to placebo [26][27] - The company has a safety database covering over 400 patients, which is considered sufficient for regulatory discussions with the FDA [44][45] Future Directions - Biomea is exploring additional applications for icovamenib in obesity and Type 1 diabetes, indicating a broader potential for the drug beyond its initial indications [51][57] - The company is focused on refining dosing instructions to minimize variability in trial results [30][36] Important but Overlooked Content - The discussion highlights the innovative approach of icovamenib in directly targeting menin, contrasting with other menin inhibitors that focus on preventing protein interactions, which may lead to side effects [25][26] - The potential for icovamenib to enhance the effects of existing GLP-1 therapies, leading to greater weight loss and improved metabolic outcomes, is a significant point of interest [50][51] - Biomea's strategic focus on a defined patient population (insulin-deficient and GLP-1 failing patients) is crucial for its clinical development and regulatory strategy [39][40]

Business Strategy - Novo Nordisk cut its cell therapy division focused on type 1 diabetes cure [1] - The company is slashing headcount to focus on lucrative areas of obesity and diabetes treatment [1] Industry Focus - The company is prioritizing obesity and diabetes treatment areas [1]

Core Insights - There is confusion surrounding the performance of a new obesity drug, with initial excitement not matching the results seen in studies [1][2] - The drug has shown better performance in diabetes patients compared to those with obesity, leading to mixed investor sentiment [2] Group 1: Drug Performance - The weight loss efficacy of the drug is around 11%, which is lower than the anticipated 15% [3] - Despite the lower efficacy in weight loss, doctors are still likely to prescribe the drug widely if approved, as it represents a significant new option in the obesity treatment market [3] Group 2: Market Implications - The introduction of pill versions of popular weight loss injections is expected to be a major development in the obesity market [1] - The mixed results from the studies may impact investor expectations and market dynamics for obesity treatments [2]

MannKind FY Conference Summary Company Overview - MannKind Corporation (NasdaqGM:MNKD) has been in operation for 34 years, primarily known for inhalation therapeutics and diabetes treatments [4][5] - The company is diversifying away from diabetes, focusing on applying inhalation technology in various therapeutic areas [4] Recent Developments - MannKind has entered late-stage development programs, including cofazamine in Phase 3 and nintedanib in Phase 2 [4] - The company has partnered with United Therapeutics, which has positively impacted the performance of Tyvaso DPI [4][5] - A significant acquisition of SC Pharmaceuticals was announced, marking a transformative decision for the company [5][14] Key Growth Drivers - Upcoming label change for Afrezza in October 2025, aimed at resolving dosing issues [9] - Anticipated acceptance of the pediatric file for Afrezza within the next few weeks [9] - Enrollment of the 100th evaluable patient for cofazamine expected in the next 60 to 90 days [9] - SC Pharmaceuticals acquisition expected to close in Q4 2025 [9][10] - Multiple catalysts anticipated over the next 18 months, including pediatric approval and autoinjector developments [11] SC Pharmaceuticals Acquisition - The acquisition was driven by the need for a complementary asset and the potential for faster growth [14] - The overlap between diabetes and heart failure markets was highlighted, with a significant percentage of heart failure patients also having diabetes [15] - The integration plan focuses on maximizing the sales force's effectiveness across both companies [15][20] Tyvaso DPI and IPF Developments - Positive results from the TEPTEN-2 study are expected to enhance the royalty stream from United Therapeutics [21] - United Therapeutics is heavily investing in idiopathic pulmonary fibrosis (IPF), with a billion-dollar commitment to manufacturing and development [22] - MannKind is confident in the FDA's expedited review process for Tyvaso DPI and its potential impact on patients [22][23] Nintedanib Phase 2 Trial - The trial is expected to start soon, with top-line data anticipated in the first half of 2027 [30] - The study will involve 228 patients, testing different dosing regimens [30][34] - Confidence in the inhaled approach is based on previous studies showing no significant gastrointestinal side effects [41] Afrezza Relaunch Strategy - The label change for Afrezza is seen as a critical step for its relaunch, particularly in pediatric populations [62][64] - A new marketing campaign and sales materials are set to be implemented in Q4 2025 [62] - The company aims to target a broader market, including pediatric patients and those with gestational diabetes [72][75] Financial Outlook - MannKind is positioned for a challenging financial year ahead but has sufficient capital to support its initiatives [78] - The company anticipates significant revenue growth from multiple product launches and clinical trial results in 2026 [78] - The management emphasizes the importance of successful integration of SC Pharmaceuticals to build confidence for future M&A opportunities [81] Conclusion - MannKind is at a pivotal moment with multiple upcoming catalysts and a strong focus on expanding its product offerings and market presence [84] - The company believes it remains undervalued compared to peers, with a solid revenue growth outlook and cash reserves to fund innovation [84]

Financial Performance & Strategic Aspirations - Novo Nordisk achieved sales growth of 18% (CER) in the first six months of 2025, with operating profit growth of 29% (CER)[11] - Obesity care sales reached DKK 38.8 billion, a 58% increase at CER, highlighting the strong performance in this therapeutic area[11] - Rare disease sales increased by 15% at CER, reaching DKK 9.5 billion[11] - The company returned DKK 36.5 billion to shareholders, demonstrating a commitment to attractive capital allocation[11] Market Dynamics & Key Products - In the US, the branded anti-obesity medication market experienced growth exceeding 160%[28] - International Operations saw sales growth of 19%, driven by GLP-1 Diabetes and Obesity care[33] - Total GLP-1 class market share in International Operations reached 71%[36] - Global diabetes and obesity unmet need is significant, with less than 1% of people with obesity globally treated with branded AOMs[44] Research & Development Highlights - Amycretin is advancing to phase 3 development based on successful phase 1b/2a trial results, showing significant body weight loss[49, 53] - Semaglutide 2.4 mg demonstrated a 20% reduction in MACE in the SELECT trial for people with overweight or obesity and established CVD[249]

Core Insights - Eli Lilly and Co. released topline results from the SURPASS-CVOT trial, showing that Mounjaro (tirzepatide) demonstrated a non-inferior rate of major adverse cardiovascular events (MACE-3) compared to Trulicity (dulaglutide) [1][3] Group 1: Trial Results - Mounjaro achieved the primary objective of non-inferiority in MACE-3, which includes cardiovascular death, heart attack, or stroke, with an 8% lower risk compared to Trulicity [3] - The trial enrolled over 13,000 participants and lasted more than four and a half years, making it the largest and longest study of tirzepatide to date [3] - Mounjaro showed a 16% lower all-cause mortality rate compared to Trulicity [4] Group 2: Additional Findings - Mounjaro demonstrated improvements in key measures such as A1C, weight, renal function, and all-cause mortality, although these results were not controlled for multiplicity-adjusted type-1 error [2][6] - An indirect comparison analysis indicated that Mounjaro reduced the risk of MACE-3 by 28% and all-cause mortality by 39% compared to a hypothetical placebo [4] Group 3: Safety and Tolerability - The safety and tolerability profiles of Mounjaro and Trulicity were generally consistent with established data, with 13.3% of Mounjaro participants discontinuing treatment due to adverse events, compared to 10.2% for Trulicity [6] - Mounjaro improved cardiovascular biomarkers, including lipids and systolic blood pressure, compared to Trulicity [6] Group 4: Regulatory Plans - Eli Lilly plans to submit the trial data to global regulatory authorities by the end of the year [6]

Core Insights - Eli Lilly's diabetes drug Mounjaro demonstrated heart health benefits in a late-stage trial compared to Trulicity, meeting the study's primary goal of non-inferiority in treating Type 2 diabetes with cardiovascular disease [2][4] - Despite the positive results, Eli Lilly's shares fell 4% in premarket trading as the outcomes did not exceed some analysts' expectations for superiority over Trulicity [2][3] - The trial showed Mounjaro reduced the risk of cardiovascular death, heart attack, or stroke by 8% compared to Trulicity, with additional benefits including a 16% lower rate of all-cause mortality [4][5] Company Positioning - Eli Lilly believes the new data strengthens Mounjaro's position as the preferred choice for Type 2 diabetes patients, especially as Trulicity faces patent expiration in 2027 [3][10] - The company plans to submit heart health data to global regulators by the end of the year, potentially leading to approvals for Mounjaro's use in cardiovascular health by 2026 [11] Market Dynamics - Mounjaro's current approval already covers many patients with Type 2 diabetes who also have cardiovascular disease, as approximately 30% of these patients are affected [13] - Analysts suggest that even if Mounjaro shows similar heart health benefits as Trulicity, it may not significantly change prescribing behaviors among doctors [14][15] Clinical Insights - The trial was the longest and largest to date on tirzepatide, enrolling over 13,000 participants, and showed Mounjaro's advantages in cardiovascular measures and weight loss [4][16] - Some clinicians noted that the difference in all-cause mortality rates between Mounjaro and Trulicity is clinically significant, aiding in treatment decision-making [6][7] Competitive Landscape - Eli Lilly is solidifying its lead over Novo Nordisk in the growing market for diabetes and weight loss drugs, with both companies demonstrating additional health benefits of their products [10]

Financial Performance & Pipeline Funding - MannKind reported total revenue of $78 million for Q1 2025, an 18% increase compared to $66 million in Q1 2024[86] - Tyvaso DPI collaboration generated $30 million in royalty revenue in Q1 2025, a 32% increase compared to Q1 2024[11, 86] - Manufacturing-related revenue from Tyvaso DPI was $29 million in Q1 2025, a 16% year-over-year increase[11, 50] - The company's cash, cash equivalents, and investments stand at $198 million[13] - Tyvaso DPI revenue for the last four quarters reached $1.1 billion[50] Afrezza Development & Market Expansion - Afrezza demonstrated a 20% growth in new prescriptions (NRx) in Q1 2025 compared to Q1 2024[11] - The company anticipates a label update for Afrezza in Q4 2025[11] - MannKind expects to submit a supplemental Biologics License Application (sBLA) for pediatric indication expansion in mid-2025[11] - Projected sales of Afrezza are estimated to be over $200 million, with every 10% of pediatric market share potentially adding ~$150 million in annual revenue[41] MNKD-101 & MNKD-201 Clinical Trials - MannKind expects to meet the interim enrollment target for the Clofazimine Inhalation Suspension (MNKD-101) Phase 3 global enrollment by the end of 2025, with approximately 70 patients randomized to date[11] - The company plans to advance Nintedanib DPI (MNKD-201) into the next phase of global development in the second half of 2025[11]

Analyst & Investor Day May 22, 2025 New York, New York 1 Welcome to Analyst & Investor Day Pravesh Khandelwal Vice President, Investor Relations 2 2 Forward-looking statements Safe Harbor Statement Regarding Forward-Looking Statements This presentation contains express or implied "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements concern our current expectations regarding our future results ...