Novo cut its cell therapy division, which has been trying to find a cure for type 1 diabetes, as the Ozempic maker continues to slash headcount to focus on lucrative areas of obesity and diabetes treatment https://t.co/T6F7l62GAA ...

Madison. We also had another study earlier this morning that maybe suggested it wasn't as good as Nova. Where exactly do we stand on the studies at this point.Yeah, I think there's been a lot of confusion about this drug. I mean, there was so much excitement and hype. We've been talking on the show for a while about how pill versions of popular weight loss shots are going to be the next big thing in this obesity market that has really captivated everyone for the past couple of years.But in some of the studi ...

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 ...