Part I Financial Information [Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position, results of operations, and cash flows for the periods ended June 30, 2025 [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $7.91 billion from $7.36 billion at year-end 2024, driven by growth in marketable investments and property, plant, and equipment Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$7,908.0** | **$7,364.0** | | Cash and cash equivalents | $1,593.1 | $1,697.2 | | Total marketable investments | $3,373.3 | $3,045.1 | | Property, plant, and equipment, net | $1,362.4 | $1,222.4 | | **Total Liabilities** | **$734.4** | **$920.0** | | Line of credit | $— | $300.0 | | **Total Stockholders' Equity** | **$7,173.6** | **$6,444.0** | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2025, revenues grew 14.4% to $1.59 billion, with net income reaching $631.7 million and diluted EPS of $13.02 Statement of Operations Summary (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | YoY Change | H1 2025 | H1 2024 | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total revenues | $798.6 | $714.9 | +11.7% | $1,593.0 | $1,392.6 | +14.4% | | Operating income | $364.5 | $319.9 | +13.9% | $747.3 | $676.2 | +10.5% | | Net income | $309.5 | $278.1 | +11.3% | $631.7 | $584.7 | +8.0% | | Diluted EPS | $6.41 | $5.85 | +9.6% | $13.02 | $12.03 | +8.2% | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities increased 7% to $652.9 million for the six months ended June 30, 2025, while investing activities shifted to a net use of $464.6 million Six Months Ended June 30, Cash Flow Summary (in millions) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $652.9 | $608.7 | | Net cash (used in) provided by investing activities | $(464.6) | $655.3 | | Net cash used in financing activities | $(292.4) | $(1,116.0) | | **Net (decrease) increase in cash** | **$(104.1)** | **$148.0** | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on revenues, share-based compensation, a new $2.5 billion credit facility, and ongoing litigation - In April 2025, the company entered into a new **$2.5 billion unsecured revolving credit facility**, maturing in 2030, with a zero outstanding balance as of June 30, 2025[37](index=37&type=chunk)[39](index=39&type=chunk)[43](index=43&type=chunk) - Total share-based compensation expense for the six months ended June 30, 2025 was **$69.6 million**, a decrease from $75.3 million in 2024 due to the exercise of remaining STAP awards[47](index=47&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - The effective tax rate for the first six months of 2025 was **24%**, up from 22% in 2024, primarily due to decreased excess tax benefits from share-based compensation[66](index=66&type=chunk) Revenues by Product - Six Months Ended June 30 (in millions) | Product | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Tyvaso DPI | $617.7 | $485.8 | +27.2% | | Nebulized Tyvaso | $318.2 | $284.9 | +11.7% | | Remodulin | $272.9 | $275.3 | -0.9% | | Orenitram | $244.6 | $213.3 | +14.7% | | Unituxin | $116.6 | $110.1 | +5.9% | | **Total Revenues** | **$1,593.0** | **$1,392.6** | **+14.4%** | - The company is involved in multiple legal proceedings, including patent and trade secret litigation with Liquidia, and accrued a **$72.6 million liability** from Sandoz litigation as of June 30, 2025[81](index=81&type=chunk)[82](index=82&type=chunk)[84](index=84&type=chunk) [Management's Discussion and Analysis (MD&A)](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance driven by Tyvaso DPI and Orenitram sales, competitive pressures, R&D pipeline progress, and capital expenditure plans [Results of Operations](index=35&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, revenues increased 14% to $1.59 billion, with R&D and SG&A expenses rising due to milestone payments, organ manufacturing, and a PP&E impairment charge Six Months Ended June 30, 2025 vs 2024 (in millions) | Line Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $1,593.0 | $1,392.6 | $200.4 | 14% | | Cost of Sales | $180.1 | $150.7 | $29.4 | 20% | | Research & Development | $283.0 | $243.7 | $39.3 | 16% | | Selling, General, & Administrative | $382.6 | $322.0 | $60.6 | 19% | | Operating Income | $747.3 | $676.2 | $71.1 | 11% | - Tyvaso DPI net product sales increased by **$131.9 million (27%)** for the first six months of 2025, driven by patient growth and increased utilization following Medicare Part D redesign[167](index=167&type=chunk)[169](index=169&type=chunk) - R&D expense growth was driven by a **$35.0 million increase** in milestone payments for drug delivery technologies and increased spending on manufactured organ projects[182](index=182&type=chunk) - SG&A expenses included a **$21.7 million impairment charge** for certain property, plant, and equipment during the second quarter of 2025[183](index=183&type=chunk)[185](index=185&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) R&D focuses on expanding existing product indications and advancing manufactured organs, with key milestones including TETON 2 data expected in September 2025 and FDA IND clearance for UKidney - Enrollment is complete for the TETON 1 and TETON 2 Phase 3 studies of Nebulized Tyvaso for Idiopathic Pulmonary Fibrosis (IPF), with topline data from TETON 2 expected in **September 2025**[130](index=130&type=chunk)[134](index=134&type=chunk) - The FDA cleared an Investigational New Drug (IND) application for the **UKidney xenotransplant product** in January 2025, allowing a clinical trial to commence[142](index=142&type=chunk)[143](index=143&type=chunk)[146](index=146&type=chunk) - Recent acquisitions of Miromatrix and IVIVA have expanded capabilities in regenerative medicine, with a Phase 1 study of miroliverELAP® initiated in **June 2025**[159](index=159&type=chunk) [Financial Condition, Liquidity, and Capital Resources](index=40&type=section&id=Financial%20Condition%2C%20Liquidity%2C%20and%20Capital%20Resources) The company maintains a strong liquidity position with $4.97 billion in cash and marketable investments, secured a new $2.5 billion credit facility, and authorized a $1.0 billion share repurchase program - Total cash, cash equivalents, and marketable investments stood at **$4.97 billion** as of June 30, 2025[193](index=193&type=chunk) - In April 2025, the company entered into a new five-year, **$2.5 billion unsecured revolving credit facility**, with a zero balance as of June 30, 2025[192](index=192&type=chunk)[199](index=199&type=chunk) - In July 2025, the board authorized a new share repurchase program for up to **$1.0 billion** of common stock, expiring March 31, 2026[191](index=191&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its exposure to market risk has not materially changed since December 31, 2024 - There have been no material changes in the company's exposure to market risk since the end of the previous fiscal year[202](index=202&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2025, disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures are effective[203](index=203&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, such controls[203](index=203&type=chunk) Part II Other Information [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed discussion of litigation from Note 12 of the financial statements, including disputes with Sandoz and Liquidia - The company refers to Note 12 of the consolidated financial statements for details on legal proceedings[205](index=205&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including reliance on treprostinil therapies, intense competition, IRA impact, manufacturing challenges, and unique litigation risks as a Public Benefit Corporation - The company relies heavily on sales of its **treprostinil-based therapies**, which comprise the vast majority of its revenues[206](index=206&type=chunk) - Competition is a major risk, with over fifteen competing PAH drugs and new entrants like Merck's Winrevair and Liquidia's Yutrepia, approved in **May 2025**[210](index=210&type=chunk) - The Inflation Reduction Act (IRA) is expected to significantly impact revenues, particularly the Medicare Part D manufacturer discounting program affecting Tyvaso DPI and Orenitram starting in **2025**[244](index=244&type=chunk)[246](index=246&type=chunk) - Significant manufacturing risks exist, including reliance on third-party manufacturers like MannKind for Tyvaso DPI and complex processes for manufactured organ programs[214](index=214&type=chunk)[215](index=215&type=chunk)[225](index=225&type=chunk) - The company's status as a Public Benefit Corporation (PBC) requires balancing shareholder interests with its public benefit purpose, exposing it to unique litigation risks[293](index=293&type=chunk)[294](index=294&type=chunk)[296](index=296&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or repurchases of its outstanding equity securities during the six months ended June 30, 2025 - During the six months ended June 30, 2025, the company did not repurchase any of its equity securities or sell any unregistered equity securities[297](index=297&type=chunk) [Other Information](index=57&type=section&id=Item%205.%20Other%20Information) In Q2 2025, Chairperson and CEO Dr. Martine Rothblatt and officer Michael Benkowitz adopted Rule 10b5-1(c) trading plans to exercise stock options and sell shares - On May 2, 2025, Chairperson and CEO Dr. Martine Rothblatt adopted a Rule 10b5-1(c) trading plan to exercise up to **294,000 stock options**[298](index=298&type=chunk) - On June 3, 2025, trusts beneficially owned by officer Michael Benkowitz adopted a Rule 10b5-1(c) trading plan to exercise up to **576,940 stock options**[299](index=299&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the new Credit Agreement from April 2025 and amended Stock Incentive Plan - Key exhibits filed include the Credit Agreement dated **April 25, 2025**, and the Amended and Restated 2015 Stock Incentive Plan[301](index=301&type=chunk)

Technical Analysis - United Therapeutics (UTHR) has recently reached a key level of support and has overtaken the 50-day moving average, indicating a short-term bullish trend [1] - The 50-day simple moving average is considered important as it helps establish support and resistance levels, and UTHR shares have increased by 6.9% over the past four weeks [2] Earnings Estimates - Positive earnings estimate revisions for UTHR strengthen the bullish case, with no estimates decreasing in the past two months and two estimates increasing, leading to a rise in the consensus estimate [3] - The current Zacks Rank for UTHR is 3 (Hold), suggesting potential for continued gains [2][3]

Company Overview - United Therapeutics (UTHR) shares increased by 3.5% to close at $286.14, following a period of decline where the stock lost 7.7% over the past four weeks [1] - The rise in share price is linked to a recovery after a decline due to positive results from a pulmonary arterial hypertension (PAH) study conducted by Insmed, which evaluated a prodrug formulation of UTHR's treprostinil [2] Financial Performance - United Therapeutics is expected to report quarterly earnings of $6.87 per share, reflecting a year-over-year increase of 17.4% [3] - Revenue projections for the upcoming quarter stand at $796.42 million, which is an 11.4% increase compared to the same quarter last year [3] Earnings Estimates and Market Sentiment - The consensus EPS estimate for United Therapeutics has been revised 0.7% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - The company currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook in the market [4] Industry Context - United Therapeutics operates within the Zacks Medical - Drugs industry, where BioCryst Pharmaceuticals (BCRX) is another player, having closed 2% lower at $10.40 [4] - BioCryst's consensus EPS estimate remains unchanged at $0.02, representing a significant year-over-year change of 133.3% [5]

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]

Summary of Liquidia Corp (LQDA) 2025 Conference Call Company Overview - **Company**: Liquidia Corp (LQDA) - **Product**: Eutrebia, an inhaled treprostinil formulation approved for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [4][12] Key Points and Arguments Product Approval and Launch - Eutrebia received approval on May 23, 2025, for both PAH and PHILD, allowing simultaneous launch into both indications [4][12] - The product is based on PRINT technology, enabling the creation of dry particles in the respirable range, which enhances efficacy, safety, and convenience [4][5] Differentiation Factors - **Safety**: Eutrebia avoids upper airway deposition, reducing cough and throat irritation, which are common with incumbent products [5] - **Efficacy**: The formulation allows for higher therapeutic doses, potentially 3 to 4 times the current standard [5] - **Convenience**: The low resistance device does not require energy for de-aggregation, making it easier for patients to use [5][6] Market Potential - Historical precedents in the PAH market suggest that addressing safety, efficacy, and convenience can lead to significant market share conversion within 12 to 18 months [6][10] - The oral prostacyclin market is valued at $2 billion in North America, with Tyvaso generating similar revenue, indicating a substantial opportunity for Eutrebia [32] Pricing and Patient Access - Eutrebia is priced at parity with Tyvaso DPI, ensuring competitive positioning [12][13] - A 28-day voucher program allows patients to start therapy immediately while awaiting reimbursement, enhancing access [13][14] Launch Metrics and Supply Chain - Shipments began five business days post-approval, with patient prescriptions filled shortly thereafter [15] - The company has built a robust supply chain, ensuring sufficient inhaler availability for a successful launch [16][17] Sales Strategy - Liquidia has a sales force of approximately 60, targeting 6,500 key prescribers across 150 centers of excellence and 750 community centers [21][22] - The company aims to match or exceed the share of voice of competitors, focusing primarily on Eutrebia [23] Clinical Data and Reception - Initial data from the ASCENT study shows promising tolerability and efficacy, with only one dropout due to a respiratory infection among the first 20 patients [25][26] - There is significant enthusiasm among doctors for transitioning patients from nebulized Tyvaso to Eutrebia, indicating a potential shift in treatment paradigms [29] Future Studies and Development - A prospective study will be initiated to demonstrate the efficacy of transitioning patients from nebulized therapies to Eutrebia [31] - Liquidia is also developing L606, a next-generation liposomal formulation aimed at providing a twice-daily dosing option [46][49] Legal Landscape - Liquidia has faced multiple lawsuits from United Therapeutics but has been successful in defending its position, with ongoing litigation expected to resolve favorably [59][60] Financial Outlook - The company anticipates reaching profitability within three to four quarters post-launch, supported by efficient processes and existing cash reserves [37][38] Additional Important Points - Liquidia is focused on changing the standard of care for PAH and PHILD patients, aiming to establish Eutrebia as the first-choice treatment option [32][36] - The company is preparing to provide detailed launch metrics and patient access information in future earnings calls [18][19] This summary encapsulates the critical insights from the Liquidia Corp conference call, highlighting the company's strategic positioning, product differentiation, market potential, and future growth plans.

Core Viewpoint - United Therapeutics has seen a 9% increase in share price over the past month, outperforming the S&P 500, but estimates have trended downward recently, raising questions about future performance leading up to the next earnings report [1][2]. Group 1: Earnings Performance - The last earnings report for United Therapeutics was about a month ago, and the stock has performed positively since then [1]. - The stock has a Zacks Rank of 3 (Hold), indicating an expectation of in-line returns in the coming months [4]. Group 2: Estimates and Scores - Estimates for United Therapeutics have been revised downward over the past month, suggesting a cautious outlook [2][4]. - The company has a Growth Score of B, a Momentum Score of F, and a Value Score of B, resulting in an aggregate VGM Score of B, placing it in the second quintile for investment strategy [3].

Summary of Liquidia's Conference Call Company Overview - **Company**: Liquidia - **Industry**: Biotech, specifically in the cardiopulmonary space - **Lead Product**: Eutrebia, a treatment for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PHILD) [3][12] Key Points and Arguments Product Development and Approval - Liquidia is approaching its PDUFA date for Eutrebia, which is set for May 24, indicating a potential approval for the treatment of PAH and PHILD [3][15] - Eutrebia utilizes proprietary print technology to create a dry powdered formulation of treprostinil, allowing for better lung deposition and tolerability [3][5] - The company has developed five launch strategies, including product profile development, a best-in-class sales force, patient support services, product availability, and payer access [4][5] Market Dynamics - The reference brand, United Therapeutics' Tyvaso, has a sales run rate of approximately $2 billion, with a market characterized by less than 20% penetration in PHILD [19][21] - Liquidia estimates the PHILD market to have around 60,000 patients, presenting significant growth opportunities [21][30] - The PAH market is described as crowded, with Liquidia aiming to position Eutrebia as the first choice among prostacyclins due to its ability to titrate to higher doses [22][23] Competitive Landscape - Liquidia is aware of ongoing litigation from United Therapeutics, which has filed multiple patents against them to delay Eutrebia's market entry [8][11] - The company is confident in its legal position and is committed to providing alternative treatments for patients [12][69] Sales and Marketing Strategy - Liquidia has a 50-person sales force with extensive experience in PAH, focusing on building relationships with healthcare providers [36][38] - The sales force has engaged in unbranded promotional efforts to educate physicians about the product and its technology [38][39] - The company plans to ensure broad access to Eutrebia through relationships with payers, targeting a market mix of approximately 50% Medicare Part D and 35-40% commercial [48][49] Product Differentiation - Eutrebia is designed to be easy to use, requiring no refrigeration and allowing for quick inhalation [51][55] - The device is familiar to pulmonologists, which may facilitate adoption among patients [55][56] - Liquidia emphasizes the importance of patient-reported outcomes and quality of life improvements as key measures of success [58][61] Future Outlook - Liquidia is preparing for a Phase 3 study of L606, a liposomal sustained release formulation, which could provide a once-daily treatment option [64][66] - The company is focused on maximizing the benefits of inhaled treprostinil and is optimistic about its long-term positioning in the market [66] Additional Important Information - Liquidia has been proactive in manufacturing commercial supply in anticipation of approval, ensuring sufficient product availability at launch [44][45] - The company is committed to addressing the needs of patients with PAH and PHILD, aiming to provide effective treatment options [12][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]