DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase inhaled insulin at the American Diabetes Association’s (ADA) 85th Scientific Sessions from June 20-23 in Chicago. Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, wi ...

MannKind Jefferies Global Healthcare Conference June 5, 2025 © Copyright 2025. All rights reserved. MannKind Corporation. Cautionary Statement Statements in this presentation that are not statements of historical fact are forward- looking statements that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward- looking statements are based upon ...

Summary of Conference Call Company Overview - **Company**: MannKind Corporation - **Core Product**: Afrezza, an inhaled insulin product - **Key Partnerships**: United Therapeutics Key Points and Arguments Financial Performance - MannKind has reduced its debt significantly, paying down over $250 million, leaving $35 million remaining on the balance sheet [3] - The company reported a 20% growth in new prescriptions (NRx) for diabetes in Q1 [4] - Cash equivalents stood at nearly $200 million [6] - Revenue growth year-over-year was 18%, with royalties up 32% [37] Product Development and Pipeline - **Afrezza**: - Expected label change in Q4, which is anticipated to drive growth [5] - Pediatric data submission to the FDA is planned for late June to early July, with hopes for approval next year [5][9] - The company is focusing on expanding Afrezza's use in gestational diabetes, with ongoing studies and published data [10][19] - The company aims to achieve a run rate of $203 million for Afrezza sales in the near term [20] - **Tyvaso DPI**: - Licensed to United Therapeutics, showing strong year-over-year growth [20] - Anticipated readout from the TETON-two study in the second half of the year [21] - **Clofazamine**: - Enrollment targets for the trial are ahead of schedule, with a focus on non-tuberculous mycobacterial (NTM) disease [6][24] - The inhaled formulation aims to mitigate risks associated with the oral version of the drug [25] - **02/2001 (IPF Asset)**: - Development is ongoing, with plans to initiate a Phase 2 study [33][34] Market Dynamics - The inhaled insulin market is becoming competitive with insulin pumps, but Afrezza offers unique advantages such as fixed dosing without the need for carb counting [8][9] - The pediatric market is seen as a pivotal opportunity for growth, with a focus on improving A1C levels in children with diabetes [44][45] Strategic Outlook - The company is optimistic about its growth trajectory, with multiple label changes and product approvals expected in the coming year [42] - MannKind is positioning itself to capture a significant share of the diabetes market, particularly among children and pregnant women [44][45] - The company anticipates that every 10% market share in pediatrics could yield approximately $150 million in net revenue [44] Risks and Considerations - The company acknowledges the challenges in scaling Afrezza's growth and the need for effective marketing strategies to overcome competition [4][39] - There are concerns regarding the variability in trial results and the need for proper dosing to achieve better control for patients [18] Additional Important Information - MannKind has a strong focus on improving patient outcomes and providing alternatives to traditional insulin delivery methods [12][19] - The company is actively engaging with the FDA and other stakeholders to ensure successful product development and market entry [5][42] - The potential market for NTM is estimated to be a billion-dollar market, with significant unmet needs [22][23]

Core Insights - MannKind Corporation is collaborating with NTT INDYCAR SERIES driver Conor Daly, who has Type 1 diabetes, to inspire local youth during the Chevrolet Detroit Grand Prix week [1][2] - Conor Daly, the only known U.S. professional racing driver competing full-time with Type 1 diabetes, will share his personal journey and provide karting tips [2][3] Company and Industry Summary - MannKind Corporation is sponsoring Conor Daly's participation in the Chevrolet Detroit Grand Prix, showcasing a bold magenta and teal livery with the tagline "Tired of Pricks?" [2] - The event will take place on May 29, 2025, at Full-Throttle Adrenaline Park, where Daly will engage with local youth and share his experiences with diabetes [3] - Conor Daly has a notable racing career, including achievements such as winning 19 races in 2005, competing in the Indianapolis 500, and earning Juncos-Hollinger Racing its first podium appearance in IndyCar [3]

Group 1 - The article discusses the analytical approach of Stephen, who combines clinical insight with valuation methods to analyze healthcare and tech stocks [1] - Stephen specializes in scenario-based DCF modeling, sensitivity analysis, and Monte Carlo simulations to identify asymmetric risk-reward opportunities [1] - The focus is on translating complex scientific and market dynamics into actionable investment theses [1] Group 2 - The article emphasizes the importance of independent verification of information and conducting thorough research before making investment decisions [3] - It highlights that past performance is not indicative of future results and that no specific investment recommendations are provided [4]

MannKind (MNKD) 2025 Conference Summary Company Overview - MannKind has a 34-year history, initially known for its inhaled insulin product, Afrezza, and has since pivoted to focus on orphan lung diseases and other pipeline assets [3][2] - The company has developed a proprietary dry powder inhalation technology that aims to improve drug delivery to the lungs, particularly for pulmonary diseases [6][7] Key Developments - MannKind has made significant progress with its Tyvaso DPI franchise, which includes trials for various inhaled drugs [4][2] - The company has monetized 10% of its royalty rights for $150 million to strengthen its balance sheet and reduce debt, which now stands at $35 million [12][14] - MannKind is focusing on developing treatments for non-tuberculous mycobacterial (NTM) lung disease, with an estimated 100,000 patients in both the US and Japan [17][18] Pipeline and Clinical Trials - MannKind is advancing a nebulized version of clofazimine and a dry powder version for NTM, targeting a large unmet need due to the side effects of existing treatments [20][21] - The ICON one study for NTM is progressing well, with expectations to complete patient enrollment by the end of the year [25][23] - The company is also developing an inhaled version of OFEV for idiopathic pulmonary fibrosis (IPF), aiming for better lung penetration and reduced side effects compared to existing treatments [31][32] Commercialization Strategy - MannKind is looking to expand its pipeline into other areas such as COPD and asthma, leveraging its successful technology [39][40] - The company has a strong balance sheet with approximately $200 million in cash, allowing for rapid pipeline progression [42] - Afrezza is expected to grow significantly, particularly with a focus on pediatric indications, which could potentially add $200 million in revenue [61][62] Market Opportunities - The company sees significant potential in international markets, particularly in India, where there is a large diabetic population [65][66] - MannKind is exploring partnerships and tenders in Europe and Asia to expand its market reach [67] Challenges and Considerations - The company acknowledges the competitive landscape and the need to differentiate its products from existing therapies [8][9] - There are ongoing concerns regarding the safety profile of inhaled insulin, which MannKind aims to address through data and education [60][55] Conclusion - MannKind is positioned for growth with a robust pipeline and a focus on addressing unmet medical needs in pulmonary diseases and diabetes management. The company is actively working to enhance its market presence and capitalize on new opportunities while managing its financial health effectively [70][69]

Financial Data and Key Metrics Changes - The company reported overall revenue growth of 18% in Q1 2025, driven by Tyvaso DPI revenues [18][19] - Non-GAAP net income for Q1 2025 was $22 million, representing a 43% increase compared to the same period in 2024 [21] - Net income for Q1 2025 was $13 million, a 24% increase from $11 million in Q1 2024 [20] Business Line Data and Key Metrics Changes - The endocrine business experienced a 20% growth in new prescriptions (NRxs) and a 14% growth in total prescriptions (TRxs) [4] - Tyvaso collaboration generated $30 million in royalty revenue and $29 million in manufacturing revenue for Q1 2025 [5][19] - Afrezza net revenues increased by 3% to $15 million, although impacted by one-time adjustments and shipment timing [19] Market Data and Key Metrics Changes - The orphan lung opportunity, particularly with Tyvaso DPI, is expected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [10] - The company anticipates significant revenue potential from pediatric patients, estimating that a 10% market share could yield $150 million in net revenue [24] Company Strategy and Development Direction - The company is focusing on expanding its pediatric market strategy for Afrezza, which will differ significantly from the adult market approach [66] - The strategy includes leveraging strong data from recent studies and enhancing the sales force's presence [63][64] - The company aims to build shareholder value through various catalysts, including the anticipated approval of pediatric indications and ongoing clinical trials [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Afrezza, particularly with new data and improved sales execution [63] - The company is optimistic about the upcoming pediatric indication approval and its potential impact on market uptake [66] - Management acknowledged the challenges posed by the macroeconomic environment but believes the company can navigate these headwinds effectively [87] Other Important Information - The company has activated 85% of sites for the MannKind 101 study across four countries, with 55 patients randomized and minimal dropouts [12][13] - The company is preparing for several upcoming scientific conferences to present new data and engage with the medical community [26] Q&A Session Summary Question: Can you provide initial thoughts on the Phase two-three trial design for MANKIND-201? - The company is considering a several dose arm trial compared to placebo, with ongoing discussions regarding patient selection [30][31] Question: Are you looking to measure FVC in the IPF study? - The company plans to look at multiple doses and aims to see a delta from placebo, focusing on patient enrollment for future phases [34][36] Question: What is the rationale behind the label update for adults? - The company is seeking to improve dosing conversion for better control and anticipates scaling faster in the adult market [45][46] Question: How are you thinking about the potential impact to supply chain for Afrezza? - The company does not anticipate significant supply chain impacts due to its US manufacturing base and is managing potential tariff issues [47][48] Question: Can you provide insights on the treatment landscape for NTM and the role of 201? - The company believes inhaled natendib could serve as a background therapy for new drugs, focusing on expanding treatment options for patients [52][54]

Financial Data and Key Metrics Changes - The company reported a 18% increase in overall revenues for Q1 2025, driven by strong performance in Tyvaso DPI royalties and collaboration services [17][18] - Non-GAAP net income for Q1 2025 was $22 million, representing a 43% increase compared to the same period in 2024 [20] - The company ended the quarter with cash and investments totaling $198 million, allowing for continued investment in its pipeline [20] Business Line Data and Key Metrics Changes - The endocrine business experienced a 20% growth in new prescriptions (NRxs) and a 14% growth in total prescriptions (TRxs) [4] - Tyvaso collaboration generated $30 million in royalty revenue and $29 million in manufacturing revenue for Q1 2025, marking a 32% and 18% increase respectively compared to the prior year [5][18] - Afrezza net revenues were $15 million, a 3% increase year-over-year, although impacted by one-time adjustments and shipment timing [18][19] Market Data and Key Metrics Changes - The orphan lung opportunity, particularly with Tyvaso DPI, is expected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [10] - The company anticipates significant market potential in the pediatric segment, estimating that a 10% market share could yield approximately $150 million in net revenue [22] Company Strategy and Development Direction - The company is focusing on expanding its pediatric offerings and anticipates filing for pediatric expansion in mid-2025 [4][22] - The strategy includes leveraging strong data from recent studies to enhance market penetration and address the pediatric diabetes market differently than the adult market [65][66] - The company aims to build shareholder value through a series of anticipated catalysts, including the approval of pediatric indications and ongoing clinical trials [21][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Afrezza, particularly with the positive reception of recent data and the potential for pediatric approval [6][61] - The company is optimistic about navigating economic headwinds, including tariffs, due to its predominantly US-based manufacturing [46][85] - Management highlighted the importance of ongoing clinical trials and the potential for new product launches to drive future growth [52][81] Other Important Information - The company is actively preparing for several upcoming scientific conferences to present new data and engage with the investment community [25] - Management noted that the current supply chain situation is manageable, with key products either exempt from tariffs or positioned to navigate potential impacts [46][47] Q&A Session Summary Question: Can you provide initial thoughts on the Phase two-three trial design for MANKIND-201? - Management indicated that they are still finalizing the trial design and have not provided extensive guidance on FDA feedback yet [29][30] Question: Are you looking to measure FVC in the IPF study? - Management confirmed that they will be looking at multiple doses and measuring delta from placebo, but specifics are still being finalized [34][35] Question: What is the rationale behind the label update for adults? - Management explained that the label change aims to improve dosing and control, with expectations for approval in Q4 [44] Question: How do you see the treatment landscape evolving for NTM and IPF? - Management noted the challenges in treating these diseases and emphasized the potential for their products to provide better tolerability and efficacy [52] Question: What are your thoughts on adherence in pediatric diabetes? - Management expressed optimism about adherence in pediatric patients, noting that caregivers are typically more diligent and that the product's profile may appeal to parents [72][74]

Financial Data and Key Metrics Changes - The company reported overall revenue growth of 18% in Q1 2025, driven primarily by Tyvaso DPI revenues [17][18] - Non-GAAP net income for Q1 2025 was $22 million, representing a 43% increase compared to the same period in 2024 [20] - Net income for Q1 2025 was $13 million, a 24% increase from $11 million in Q1 2024 [19] Business Line Data and Key Metrics Changes - The endocrine business experienced a 20% growth in new prescriptions (NRxs) and a 14% growth in total prescriptions (TRxs) [4] - Tyvaso collaboration generated $30 million in royalty revenue and $29 million in manufacturing revenue for Q1 2025 [5][18] - Afrezza net revenues increased by 3% year-over-year to $15 million, although impacted by one-time adjustments and shipment timing [18] Market Data and Key Metrics Changes - The orphan lung opportunity market is projected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [9] - The company anticipates significant revenue potential from pediatric patients, estimating that a 10% market share could yield $150 million in net revenue [22] Company Strategy and Development Direction - The company is focusing on expanding its pediatric market strategy for Afrezza, which will differ significantly from the adult market approach [65] - The strategy includes leveraging positive clinical data and enhancing educational outreach to healthcare providers [62][64] - The company aims to maintain a strong financial position with minimal debt while pursuing growth opportunities in its pipeline [3] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Afrezza, particularly with the anticipated pediatric indication approval [17][21] - The company is optimistic about the upcoming catalysts, including the completion of key trials and potential new product launches [21][24] - Management acknowledged the challenges posed by the macroeconomic environment but believes the company is well-positioned to navigate these headwinds [86] Other Important Information - The company has activated 85% of its sites for the MannKind 101 study across four countries, with 55 patients randomized and minimal dropouts [12] - The company is preparing for several upcoming scientific conferences to present new data and engage with the medical community [24] Q&A Session Summary Question: Can you provide initial thoughts on the Phase 2/3 trial design for MannKind 201? - Management indicated that discussions with the FDA are ongoing and that the trial design will likely involve several dose arms compared to placebo [28][30] Question: Are you looking to measure FVC in the IPF study? - Management confirmed that they are considering multiple doses and will analyze the data for a delta from placebo [34][35] Question: What is the rationale behind the label update for adults? - Management explained that the update aims to improve dosing efficiency and enhance adult uptake, with a focus on scaling faster [44][45] Question: How do you see the treatment landscape evolving for IPF? - Management noted the challenges in treating IPF and emphasized the potential for their inhaled therapies to provide better tolerability and efficacy [52][54] Question: How is the company managing supply chain impacts? - Management stated that the majority of manufacturing is US-based, minimizing tariff impacts, and they are confident in managing supply chain challenges [46][48]

Financial Position - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $198.2 million, with an accumulated deficit of $3.2 billion[214]. - As of March 31, 2025, the company had $198.2 million in capital resources and $36.3 million in outstanding borrowings[248]. - The company expects to meet its liquidity needs over the next 12 months based on current cash, sales of products, and potential financing sources[249]. Revenue Performance - For the three months ended March 31, 2025, total revenues increased by $12.1 million, or 18%, to $78.4 million compared to $66.3 million in the same period of 2024[218]. - Net revenue from commercial product sales was $18.973 million for Q1 2025, reflecting a slight increase of $0.209 million, or 1%, from $18.764 million in Q1 2024[218]. - Royalty revenue from United Therapeutics increased by $7.4 million, or 32%, for the three months ended March 31, 2025, driven by higher patient demand for Tyvaso DPI[221]. - Gross revenue from sales of Afrezza increased by $2.4 million, or 11%, for Q1 2025 compared to the same period in the prior year, primarily due to higher demand and price[218]. - Gross revenue from sales of V-Go decreased by $2.8 million, or 30%, for Q1 2025 compared to the same period in the prior year, attributed to lower demand[219]. Expenses - Research and development expenses increased by $1.0 million, or 10%, for Q1 2025, primarily due to increased expenditures for development activities and additional headcount[225]. - Selling, general and administrative expenses rose by $2.7 million, or 12%, for Q1 2025, mainly due to increases in headcount and promotional costs for Afrezza[226]. - Total expenses increased by $6.5 million, or 13%, for Q1 2025, totaling $56.1 million compared to $49.5 million in Q1 2024[223]. Profitability - The company’s gross margin for commercial products remained consistent at 80% for both Q1 2025 and Q1 2024[222]. - Non-GAAP adjusted net income for the three months ended March 31, 2025, was $21.629 million, up from $15.099 million in the prior year, with basic EPS increasing from $0.06 to $0.07[236]. Interest and Other Income - Interest income, net decreased by $1.5 million to $1.956 million for the three months ended March 31, 2025, a decline of 43% compared to the prior year[228]. - Interest expense increased by $2.1 million to $4.645 million, primarily due to $4.4 million related to an Afrezza net sales milestone[229]. - Total other expense rose by $2.848 million to $8.676 million, reflecting a 49% increase year-over-year[228]. Cash Flow - Cash used for operating activities was $6.4 million for the three months ended March 31, 2025, compared to cash generated of $6.7 million in the same period of 2024[244][245]. - A $2.5 million currency loss was realized for the three months ended March 31, 2025, due to fluctuations in the Euro exchange rate[252]. Commitments and Agreements - The company has $60.7 million in insulin purchase commitments and $90.0 million in milestone payments remaining under the Milestone Rights Agreement[239][240]. - The company filed a sales agreement prospectus for the sale of up to $200.0 million of common stock, with the full amount remaining available as of March 31, 2025[242].