MannKind (NasdaqGM:MNKD) 2025 Conference November 19, 2025 06:30 AM ET Company ParticipantsMichael Castagna - CEOMichael CastagnaWhich insulin and IU patient will get? Insulin and IU patient will get. I'll talk about in a second. We've initiated a IB trial here for nintedanib. That'll be mainly in the U.S. to satisfy the FDA to go into phase III. We have INFLOW 2, which will be going out ex-U.S., and that will be the bridge to the phase III dosing. I'll start off with the newest acquisitions, and that's whe ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) announced today that Michael Castagna, Chief Executive Officer, and Chris Prentiss, Chief Financial Officer, are scheduled to present and share updates during the Jefferies London Healthcare Conference on Wednesday, November 19, at 6:30 am ET/11:30 am GMT. The link to the live audio webcast of the session is available on MannKind Corporation’s website at: https://investors.mannkindcorp.com/even ...

PresentationOperator Good morning, and welcome to MannKind Corporation's investor call to discuss a clinical trial update. As a reminder, this call is being recorded on November 10, 2025, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and will be available for approximately 90 days. During the course of this call, management may make certain forward-looking statements, including regarding MannKind's product candidates that are not historical ...

MannKind Corporation Investor Call Summary Company Overview - **Company**: MannKind Corporation (NasdaqGM: MNKD) - **Date of Call**: November 10, 2025 - **Focus**: Clinical trial update regarding MannKind's product candidates, specifically the discontinuation of the ICON one Phase three clinical trial for nebulized clofazamine inhalation suspension (MannKind-one hundred one) for treating refractory non-tuberculosis mycobacterium (NTM) lung disease [1][2][4] Key Points and Arguments 1. **Discontinuation of Clinical Trial**: The ICON one Phase three clinical trial was discontinued due to futility, as none of the first 46 participants showed evidence of sputum culture conversion [4][5][6] 2. **Acquisition Background**: MannKind acquired Q Rum Pharma in 2020, which had developed the nebulized formulation of clofazamine, with plans to transition to a dry powder formulation [4] 3. **Safety Profile**: The Data Safety Monitoring Board (DSMB) did not identify any safety concerns during the study, indicating that the lack of efficacy is likely related to the nebulized formulation rather than the molecule itself [6][9] 4. **Next Steps**: MannKind is investigating the reasons for the unexpected trial outcome, focusing on the suspension formulation and its handling instructions [7][8] 5. **Future Development**: The company is advancing the MannKind-one hundred two dry powder formulation of clofazamine towards Phase one trials, with hopes for its efficacy in treating NTM lung disease [8][9] 6. **DPI Candidate Confidence**: There is increased confidence in the dry powder inhaler (DPI) formulation due to better predictability of delivered doses compared to the nebulized formulation, which requires more patient intervention [13][21] 7. **Partial Conversions Observed**: While there were no complete sputum culture conversions, some partial conversions were noted, and the team is analyzing patient-reported outcomes for further insights [14][15][34] 8. **Regulatory Engagement**: MannKind plans to meet with the FDA to discuss findings and next steps for the DPI formulation, with updates expected in Q2 2026 [29][30] Additional Important Information 1. **Human Capital Investment**: The company has invested significant resources in developing both nebulized and DPI formulations, reflecting its commitment to innovative patient-centric solutions [5] 2. **Training and Preparation Issues**: The trial's failure may be linked to improper handling and preparation of the nebulized formulation, highlighting the importance of adherence to protocols [20][22] 3. **Ongoing Research**: MannKind is conducting a 1b trial for another product (02/2001) in idiopathic pulmonary fibrosis (IPF) patients, which is expected to provide insights into the tolerability of the dry powder formulation [35][36] 4. **Market Position**: Despite the setback, MannKind remains committed to developing therapies for serious lung diseases and is monitoring the competitive landscape for potential impacts on its pipeline [40]

MannKind Corporation (MNKD) saw a stock decline after the announcement that it would discontinue its trial testing MNKD-101, a nebulized form of clofazimine intended for treating refractory nontuberculous mycobacterial lung disease. The stock fell by 10% in premarket trading. During ...

MannKind has made the decision to discontinue the ICoN-1 Phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease, following a futility determination based on medical monitoring dataThis outcome does not impact the development of MNKD-102, MannKind’s dry powder inhalation (DPI) formulation of clofazimine, which remains under consideration for future clinical advancementMannKind extends its sincere gratitude to the study participants, i ...

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Core Points - MannKind Corporation, in partnership with Alfred E. Mann Charities and The Diabetes Link, launched the Centennial Al Mann Scholarship to honor the legacy of its founder Alfred E. Mann, distributing $100,000 in scholarship funds to support young adults living with diabetes pursuing higher education in life sciences [1][2][8] - The scholarship program aims to empower students aged 18-22 with type 1 or type 2 diabetes, providing up to $10,000 per recipient, distributed in annual installments of $2,500 [3][4] - The initiative reflects Alfred E. Mann's commitment to improving human life through medical advancement and philanthropy, continuing his vision of giving back to the community [2][5] Company Overview - MannKind Corporation is a biopharmaceutical company focused on transforming chronic disease care through innovative, patient-centric solutions, particularly in cardiometabolic and orphan lung diseases [6][7] - The company has a history of developing breakthrough medical devices and treatments, including the inhaled insulin product Afrezza, which was brought to market with a significant investment of nearly $1 billion by Alfred E. Mann [5][6] Partnership and Community Impact - The partnership with The Diabetes Link aims to expand access to higher education for young adults with diabetes, addressing the rising costs of college and easing financial burdens [5][12] - The Diabetes Link is a national nonprofit organization dedicated to empowering young adults living with diabetes through peer support and resources, envisioning a future where they thrive in their personal and professional lives [12]

Core Insights - MannKind (MNKD) reported quarterly earnings of $0.03 per share, exceeding the Zacks Consensus Estimate of $0.01 per share, but down from $0.04 per share a year ago, resulting in an earnings surprise of +200.00% [1] - The company generated revenues of $82.13 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 1.43% and up from $70.08 million year-over-year [2] - MannKind has outperformed consensus revenue estimates three times in the last four quarters [2] Earnings Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [2] - The earnings report indicates a mixed trend in estimate revisions ahead of the release, leading to a Zacks Rank 3 (Hold) for the stock, suggesting it will perform in line with the market [6] Future Outlook - Current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $88.91 million, and for the current fiscal year, it is $0.09 on revenues of $324.74 million [7] - The sustainability of the stock's price movement will depend on management's commentary during the earnings call [3][4] Industry Context - MannKind operates within the Zacks Medical - Biomedical and Genetics industry, which is currently ranked in the top 40% of over 250 Zacks industries [8] - The industry’s performance can significantly impact MannKind's stock performance, with research indicating that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - The company reported record revenue of $82 million for Q3 2025, representing a 17% increase year-over-year [14] - Total revenues for the year-to-date period reached $237 million, indicating a 14% growth compared to the same period last year [17] - GAAP net income for Q3 was $8 million, down from $11.6 million in the prior year, while non-GAAP net income increased to $22.4 million from $15.4 million [18] Business Line Data and Key Metrics Changes - Tyvaso DPI generated $33 million in royalties, a 23% increase, and $26 million in manufacturing-related revenue [4] - Afrezza's net revenue rose 23% to $18.5 million, with a 31% increase in new prescriptions and a 27% increase in total prescriptions year-over-year [5][14] - V-Go contributed $3.8 million, down 19% year-over-year, consistent with the company's expectations as it no longer actively promotes the product [15] Market Data and Key Metrics Changes - Furoscix revenue reached $19.3 million in Q3 2025, with year-to-date revenue of $47.1 million, a 95% increase over the same period in 2024 [9] - The company anticipates significant market opportunities in heart failure and chronic kidney disease, with 2.1 million addressable heart failure episodes in the U.S. [10] Company Strategy and Development Direction - The acquisition of SC Pharmaceuticals is aimed at unlocking the potential of Furoscix and advancing inhaled bumetanide for fluid overload and heart failure [2][7] - The company is focused on expanding its footprint in cardiometabolic care and enhancing its commercial scale through the integration of SC Pharmaceuticals [6][7] - The strategy includes increasing the share of voice in cardiology and nephrology to raise awareness and drive adoption of Furoscix [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in clinical development programs and the potential for growth through various catalysts [3] - The company is preparing for the pediatric launch of Afrezza, with a focus on driving prescribing among top prescribers [6] - Management highlighted the importance of early intervention in heart failure care, aligning with upcoming changes in Medicare payment models [11] Other Important Information - The company has submitted a supplemental BLA for Afrezza, with a PDUFA date set for Q2 2026 [2] - The company utilized $133 million of its cash and investments to fund the acquisition of SC Pharmaceuticals and borrowed $325 million on a term loan facility [16] Q&A Session Summary Question: Thoughts on recent approvals from Furoscix competitors and pricing context - Management acknowledged awareness of competitors and emphasized product differentiation and lifecycle management as key focuses [28] Question: Timing for the Tyvaso bridging study in IPF - Management indicated that the bridging study could be similar to the BREEZE study, with communication to the FDA expected soon [34] Question: Integration process with SC Pharmaceuticals - Integration is progressing smoothly, with cultural similarities easing the process and key personnel already placed in leadership roles [36] Question: Peak sales opportunity for Furoscix - Management referenced analyst reports suggesting peak sales could exceed $500 million, with further guidance pending [45] Question: Impact of the Ready Flow Auto-Injector on unique prescribers - Management highlighted the potential for market expansion and increased awareness among cardiologists as key growth drivers [79]