MannKind CMO MannKind appoints Dr. Ajay Ahuja as EVP, Chief Medical Officer WESTLAKE VILLAGE, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced the appointment of Ajay Ahuja, MD, MBA, as Chief Medical Officer, effective today. Dr. Ahuja will report directly to Michael Castagna, PharmD, Chief E ...

Presentation Ross Cohen Great. Thank you all for joining us today, and welcome to the Morgan Stanley Healthcare Conference. Just a quick note on disclosures. For important disclosures, please see the Morgan Stanley research disclosure website. Or if you have any questions, please reach out to your Morgan Stanley sales representative. So welcome to the group here, and thank you for attending the fireside for MannKind. My name is Ross Cohen. I'm an Executive Director from the Morgan Stanley Healthcare Inves ...

Company Overview - MannKind has been in operation for 34 years, originally focusing on inhalation therapeutics and diabetes [5] - The company has undergone significant changes in the past month, indicating a shift in its strategic direction [5] Strategic Focus - Over the last 7 to 8 years, MannKind has diversified away from its primary focus on diabetes [5] - The company is now concentrating on applying its inhalation technology in areas that can create the most impact for shareholders, patients, and employees [5]

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]

MannKind FY Conference Summary Company Overview - **Company**: MannKind Corporation (NasdaqGM: MNKD) - **Event**: HC Wainwright Annual Global Investment Conference - **Date**: September 09, 2025 Key Points Development Pipeline - **ICON-1 Phase 3 Trial**: Enrollment is progressing well with 90 patients randomized, on track for interim analysis by year-end [8] - **Primary Endpoints**: U.S. requires a co-primary endpoint of quality of life questionnaire alongside sputum culture conversion, while outside the U.S. only sputum culture conversion is required [9][10] - **Safety Insights**: Low dropout rates suggest good tolerability; two-thirds of patients on active drug, one-third on placebo, with low discontinuation rates observed [11] Differentiation of Products - **Inhaled Clofazimine**: Aims to reduce systemic exposure and side effects compared to oral formulations, bypassing the GI tract to avoid GI-related adverse events [14][15] - **Market Positioning Against Arikayce**: Inhaled clofazimine is positioned as a first-line treatment for refractory NTM, targeting patients who are intolerant to or do not respond to Arikayce [18][19] Geographic Treatment Paradigms - **U.S. vs. Japan**: Similar treatment guidelines, but more historical use of Arikayce in the U.S. than in Japan; many patients in both regions have discontinued Arikayce due to tolerability issues [20] Regulatory and Commercial Strategy - **Filing Strategy**: Plans to file for approval in both U.S. and Japan post-phase 3 trial completion [21] - **Tier One Development**: Phase 2 trial for idiopathic pulmonary fibrosis (IPF) to start by year-end, focusing on safety and efficacy with a double-blind, placebo-controlled design [27][28] - **Combination Therapy Potential**: Future therapies for IPF may involve combination treatments, allowing for background treatments with existing therapies [34][35] Financial Position and Capital Deployment - **Revenue Streams**: Growing royalties and manufacturing revenue from United Therapeutics provide non-dilutive financing for the pipeline [40] - **Investment Plans**: Anticipated investments in product launches, including pediatric approval for Afrezza expected next summer [41] Future Opportunities - **Expansion Beyond Current Indications**: Potential to explore additional indications for nintedanib beyond IPF, progressive pulmonary fibrosis, and scleroderma interstitial lung disease [36] Additional Insights - **Market Dynamics**: The company is optimistic about capturing different patient subpopulations and addressing high recurrence rates in NTM treatment [19] - **Cash Flow Position**: MannKind has been cash flow positive for the last couple of years, providing a strong foundation for future investments [41]

Core Insights - The company has transitioned from being primarily a diabetes-focused entity to diversifying its portfolio, particularly in the area of rare diseases and orphan lung conditions [1] - The partnership with UT has been fruitful and continues to develop positively, indicating a strong collaborative effort in research and development [1] - The company aims to create more catalysts for growth and positive developments to attract momentum and catalyst-driven investors [1]

Core Insights - The company is focused on the acquisition and integration process, emphasizing its importance for future success [1] - A label change for Afrezza is anticipated, which is considered a significant upcoming event [1] - The company is preparing to scale up manufacturing and ensure emergency supplies as new data from the TETON study becomes available [1] - There is ongoing collaboration related to a new formulation opportunity, indicating continued innovation efforts [1]

Summary of MannKind's Conference Call Company Overview - **Company**: MannKind Corporation - **Industry**: Biotechnology, specifically focusing on inhaled insulin and treatments for pulmonary diseases Key Points and Arguments Strategic Priorities - **Acquisition Integration**: The primary focus is on the integration of a recent acquisition, emphasizing that successful integration is crucial for future growth [3][4] - **Label Change for Afrezza**: A significant label change for Afrezza is anticipated, which is considered important for the company's future [3][4] - **Teton Data**: The company is preparing for the influx of data from the Teton studies, which will influence manufacturing and supply strategies [4][5] Financial Insights - **Royalty Deal**: A royalty deal valued at $1.5 billion for a 10% royalty on Tyvaso was initiated, with a milestone payment of $50 million contingent on achieving certain sales targets [10][11] - **Valuation Concerns**: Despite the positive developments, the company's current trading value is below the estimated $2 billion valuation based on the royalty sale [11][12] Market Opportunities - **IPF Market**: The idiopathic pulmonary fibrosis (IPF) market is highlighted as having significant potential, with current treatments showing high dropout rates. The company believes that their product could become a backbone treatment [16][18] - **Patient Needs**: There is a strong emphasis on the unmet needs of IPF patients, with current options being inadequate [14][16] Product Development - **Internal Candidate (MNKD 201)**: The company is developing an inhaled version of Nintentinib, believing it will complement existing treatments rather than compete directly [27][30] - **Phase Two Trials**: Plans for a Phase Two trial are underway, focusing on different dosing regimens and the potential for combination therapies [30][36] Commercial Strategy - **Acquisition of SC Pharma**: The acquisition aims to diversify revenue streams and reduce reliance on Tyvaso, which currently accounts for 65% of revenue [45][48] - **Sales Force Expansion**: The company plans to increase the number of sales representatives to enhance market presence and support for new products [55][56] Regulatory and Market Access - **Label Expansion for Afrezza**: A label change is expected in October, which will allow for new dosing information and potentially improve market access [63][64] - **Pediatric Opportunity**: The company is preparing for a pediatric launch, with dedicated resources to ensure focus on this segment [65][66] Challenges and Considerations - **Part D Redesign**: The redesign of Medicare Part D poses challenges for patient access, but the company is optimistic about improving access as the year progresses [59][71] - **Physician Acceptance**: There is a noted shift in physician attitudes towards inhaled insulin, particularly regarding lung safety, which has historically been a barrier to prescription [68][70] Additional Important Insights - **Patient-Centric Approach**: The company emphasizes the importance of patient access and the need for effective treatments for those with limited options [14][25] - **Market Dynamics**: The competitive landscape is evolving, and the company is focused on ensuring that their products can meet the needs of patients effectively [40][42] This summary encapsulates the key discussions and insights from MannKind's conference call, highlighting the company's strategic direction, market opportunities, and challenges ahead.

Financial Data and Key Metrics Changes - The company is profitable and growing, with a focus on diversifying its revenue streams and increasing operational leverage [6][10][88] - The goal is to achieve a roughly 50-50 ratio between royalties/manufacturing and in-line commercialization products [10] Business Line Data and Key Metrics Changes - The acquisition of SC Pharmaceuticals is aimed at diversifying the business, with a focus on drug-device combinations and leveraging existing expertise in injectable platforms [4][6] - The company is targeting a $5 billion market for insulin pumps, indicating significant revenue potential from this segment [8] Market Data and Key Metrics Changes - There are approximately 100,000 patients in the U.S. and over 100,000 in Japan for the targeted market, indicating a large unmet need despite existing competition [38] - The company anticipates that the pediatric segment could significantly influence overall insulin prescriptions, as it represents a critical entry point for new treatments [69][72] Company Strategy and Development Direction - The company is focusing on the cardiometabolic space, with a strategy to integrate new acquisitions and enhance its product pipeline [9][60] - There is a strong emphasis on clinical development in rare diseases, particularly in orphan lung diseases, to differentiate from competitors [2][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the competitive landscape and highlighted the importance of timely clinical trial enrollments to avoid delays [24][25] - The management team is optimistic about the upcoming pediatric launch of Afrezza, viewing it as a potential inflection point for revenue growth [65][68] Other Important Information - The company has invested significantly in scaling up manufacturing capabilities to meet future demand, with plans for a new facility in North Carolina [60] - The management is focused on ensuring that the integration of SC Pharmaceuticals is successful while also preparing for the pediatric launch of Afrezza [65][86] Q&A Session Summary Question: How does the acquisition of SC Pharmaceuticals fit into the company's strategy? - The acquisition is seen as a way to diversify the business and leverage existing expertise in drug-device combinations, with a focus on scaling revenue [4][6] Question: What is the expected market opportunity for the new products? - The company estimates a large market potential, particularly in the cardiometabolic space, with significant overlap in patient populations [9][38] Question: How does the company plan to address competition in the market? - Management believes there is enough unmet need to support multiple products in the market, and they are focusing on differentiating their offerings [37][40] Question: What are the key priorities for the company moving forward? - Key priorities include the integration of SC Pharmaceuticals, the pediatric launch of Afrezza, and advancing clinical development programs [65][86] Question: How does the company view the potential for Afrezza in the pediatric market? - The management sees a significant opportunity in the pediatric segment, with plans to hire a dedicated team to support the launch [68][69]

Core Insights - MannKind Corporation has announced that United Therapeutics Corporation has exercised its option to develop a second dry powder inhalation therapy under their 2018 collaboration agreement [1][2] Group 1: Collaboration and Agreement Details - The original agreement led to the FDA approval of Tyvaso DPI in May 2022 and included an option for United Therapeutics to expand the license to additional active ingredients [2] - Under the expanded agreement, MannKind will formulate a second investigational molecule using its proprietary Technosphere platform, while United Therapeutics will handle preclinical and clinical development [2] - MannKind will receive an upfront payment of $5 million, with potential development milestone payments of up to $35 million and 10% royalties on net sales of any resulting product [3] Group 2: Development Activities - Formulation and development activities for the new investigational molecule will commence immediately [4] Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices to address serious unmet medical needs, particularly in endocrine and orphan lung diseases [5] - The company aims to utilize its formulation capabilities and device engineering to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension [6]