MannKind Corporation MNKD on Monday agreed to acquire scPharmaceuticals Inc. SCPH for a deal value of up to approximately $360 million, or $5.35 per share.The deal marks MannKind’s strategic expansion into cardiorenal medicine, establishing its cardiometabolic business alongside its orphan lung division. It is also made possible on the heels of MannKind’s $500 million strategic financing agreement with Blackstone. ScPharmaceuticals currently markets Furoscix, an FDA-approved on-body infuser delivering furos ...

Acquisition expected to diversify and accelerate double-digit revenue growth with FUROSCIX®, an innovative treatment for edema due to chronic heart failure and chronic kidney disease, addressing significant unmet needUpfront cash payment of $5.35 per share plus one non-tradable contingent value right (CVR) per share payable upon achieving specific regulatory and net sales milestones worth up to $1.00 per CVR in cash Upfront cash payment represents a 36% premium to scPharmaceuticals’ 90 trading day VWAP, and ...

Financial Data and Key Metrics Changes - The company reported Q2 revenues of $77 million, a 6% increase over 2024, and year-to-date revenues of $155 million, reflecting a 12% increase over 2024 [6][18] - The balance sheet remains strong with $201 million in cash and access to $500 million in non-dilutive capital from Blackstone [7][22] - Total revenues over the trailing four quarters exceeded $300 million, with expectations for continued growth [18] Business Line Data and Key Metrics Changes - The endocrine business unit generated $18.3 million in revenue, representing a 13% growth over 2024 [6] - Afrezza net revenues for Q2 were $18 million, a 13% increase year-over-year, while V Go net revenue was approximately $4 million, an 8% decrease [19][20] - Tyvaso DPI royalties contributed $31 million in Q2, marking a 22% increase from the same quarter last year [18] Market Data and Key Metrics Changes - The company targets about 25% of all rapid-acting scripts, with 1% of the rapid-acting market estimated at a $300 million run rate for Afrezza [4] - The NTM market is expected to exceed $1 billion by the end of the decade, with a focus on the US and Japan [7] Company Strategy and Development Direction - The company is focused on creating shareholder value, minimizing dilution, and enhancing flexibility for future growth [3] - Upcoming trials include the launch of the inflow trial for NTM by the end of 2025 and the pediatric indications for Afrezza [6][14] - The company aims to enhance its commercial infrastructure and expand its sales force in preparation for the pediatric launch of Afrezza [16][73] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming TETON-two results and their potential impact on business plans [3][14] - The company anticipates continued growth in royalty revenue driven by Tyvaso DPI sales and expects Afrezza to maintain its growth trajectory [20][21] - Management highlighted the importance of the Blackstone deal in providing the necessary capital for growth and innovation [25][22] Other Important Information - The company has entered into a strategic financing arrangement with Blackstone, providing access to up to $500 million in non-dilutive funding [22] - The company is preparing for a new marketing campaign called "insulin in the moment" to enhance awareness and adoption of Afrezza [15] Q&A Session Summary Question: Can you walk us through the timeline for a potential bridging study in IPF? - Management indicated that the timeline could be faster than previous studies, depending on the results of TETON-two and TETON-one [30][31] Question: How is the intended DPI program positioned in the current treatment landscape? - Management noted that the program is designed to be used in combination with existing therapies and is focused on patients intolerant to current treatments [34][40] Question: What is the typical Afrezza patient profile today? - The breakdown of patients is approximately 45% Type 1 and 55% Type 2, with a growing focus on Type 1 patients [66][67] Question: What are the conditions for drawing additional capital from the Blackstone agreement? - The company can draw funds at its discretion without specific sales or development milestones [98]

Core Viewpoint - MannKind Corporation has entered into a strategic financing agreement with Blackstone, providing up to $500 million in non-dilutive capital to support its growth strategies and commercial initiatives [1][2]. Group 1: Financing Details - MannKind will receive an initial $75 million in cash at closing, with a total financing facility of up to $500 million [1]. - The financing includes a $125 million delayed draw term loan (DDTL) available over the next 24 months, and an additional $300 million uncommitted DDTL subject to mutual consent [2]. - The facility bears interest at a SOFR variable rate plus 4.75%, with potential increases based on leverage ratios, and matures in August 2030 without scheduled amortization payments [2]. Group 2: Strategic Implications - The funding will enhance MannKind's operational flexibility and support the expansion of its commercial team in anticipation of the pediatric indication for Afrezza, pending approval [2]. - The capital will also facilitate continued pipeline advancement and potential business development opportunities [2]. - Blackstone's involvement is expected to provide MannKind with access to a value creation platform and life sciences expertise, aiding in commercialization efforts [2]. Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing inhaled therapeutic products for endocrine and orphan lung diseases [3]. - The company aims to address serious unmet medical needs through innovative dry-powder formulations and inhalation devices [4].

Core Insights - MannKind Corporation reported a 6% increase in revenues for Q2 2025, totaling $76.5 million compared to $72.4 million in Q2 2024, driven by higher sales of Afrezza and royalties from Tyvaso DPI [6][9] - The company submitted a supplemental Biologics License Application (sBLA) for Afrezza in pediatric patients, marking a significant milestone [2][7] - MannKind is advancing its orphan lung pipeline, with the ICoN-1 trial for inhaled clofazimine ahead of schedule and plans to initiate a Phase 2 trial for nintedanib DPI by the end of 2025 [4][5] Financial Performance - Year-to-date revenues for 2025 reached $154.9 million, a 12% increase from $138.6 million in the same period of 2024 [11][13] - Afrezza sales in Q2 2025 were $18.3 million, up 13% from $16.3 million in Q2 2024 [8][9] - The company reported a net income of $0.7 million for Q2 2025, compared to a net loss of $2.0 million in Q2 2024, reflecting a $2.7 million improvement [12][24] Research and Development - Research and development expenses increased by 16% in Q2 2025, primarily due to ongoing patient enrollment in the ICoN-1 study and increased personnel costs [12][20] - The company plans to initiate a Phase 2 clinical trial for nintedanib DPI for idiopathic pulmonary fibrosis (IPF) by the end of 2025 [5][20] Market Position and Strategy - MannKind's majority of revenue and future pipeline programs are derived from its U.S.-based manufacturing facility in Danbury, CT, which mitigates potential tariff exposure [8] - The company is focused on developing innovative inhaled therapeutic products to address unmet medical needs in diabetes and orphan lung diseases [16][17]

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]

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 - Fourth quarter revenues were $77 million, a 31% increase over the previous year's fourth quarter. For the full year 2024, revenues reached $286 million, a 43% increase compared to the prior year [35] - Net income for 2024 was $28 million, or $0.10 per share, compared to a net loss of $12 million, or $0.04 per share for 2023. On a non-GAAP basis, net income was $68 million, or $0.25 per share for 2024, compared to $6 million, or $0.02 per share for the prior year [41] - The year-end cash position was $203 million, with a reduction in debt principal by $236 million in 2024, resulting in a remaining debt balance of $36 million [42] Business Line Data and Key Metrics Changes - The endocrine business unit achieved record revenues with Q4 revenue of $23 million and full-year revenue of $82 million [6] - Afrezza net revenue for Q4 was $18 million, an 18% increase due to higher demand and improved growth-to-net adjustments. For the full year 2024, Afrezza revenue was $64 million, a 17% increase over 2023 [37] - V-Go net revenue was approximately $5 million for Q4, a 1% increase over the same quarter in the prior year, but full-year revenues were $18 million, a decrease of 4% due to lower product demand [38] Market Data and Key Metrics Changes - Tyvaso DPI royalties contributed $27 million in Q4, a 28% increase over the same quarter last year. Royalties for the year were $102 million, a 42% increase due to United Therapeutics' increase in net revenue from sales of Tyvaso DPI [36] - DPI-related revenues exceeded $200 million in 2024, marking a significant milestone for the Technosphere platform [18] Company Strategy and Development Direction - The company has five key pillars for future growth, including two FDA-approved products, a strong balance sheet, and funding for novel pipeline opportunities [5] - The strategy includes expanding the pediatric market for Afrezza, with a filing expected in the first half of 2025 and potential approval in the second quarter of 2026 [13][15] - The company is also focusing on the development of clofazamine inhalation suspension and TETON DPI, with ongoing clinical trials and FDA meetings planned [8][9][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting record revenues and a strong pipeline. They emphasized the importance of pediatric opportunities and the potential for significant revenue growth from Afrezza [44][49] - The management team acknowledged the competitive landscape but believes that their products can meet unmet needs in the market, particularly in the IPF space [30][32] Other Important Information - The company transformed its balance sheet in 2024, paying down significant debt and maintaining a robust cash position to support growth initiatives [42] - The company is preparing for a busy travel schedule to engage with stakeholders and promote its growth story [48] Q&A Session Summary Question: Can you talk about margins over the next few quarters? - Management indicated that margins are improving due to better utilization of manufacturing plants and expect steady state margins going forward [52] Question: Can you provide more details on gross to net discounting and rebates? - Management noted that the current discounting trends are expected to continue and that discussions regarding bridging studies are ongoing [54][56] Question: How do you balance operational profitability versus investment in pediatric launch for Afrezza? - Management stated that capital deployment will focus on driving the best return for shareholders while preparing for the pediatric launch [60][62] Question: What are the critical success factors for Afrezza in the pediatric market? - Management identified reimbursement processes, institutional selling capabilities, and education as key factors for success in the pediatric market [71][75] Question: What are the potential contributions from the agreement with CIPLA in India? - Management expects that the agreement could have significant volume implications, improving overall efficiency and cost of goods sold [78] Question: Can you elaborate on the contracting dynamics and potential catch-up in Q1? - Management expects steady state revenue dynamics and does not anticipate major shifts in gross margins or net revenue [81][84] Question: What are the safety and efficacy endpoints for the upcoming FDA meeting regarding 201? - Management outlined plans for a Phase 2 trial with multiple arms to assess different dosing regimens and their efficacy [88][89]