Earnings summaries and quarterly performance for MANNKIND.
Executive leadership at MANNKIND.
Michael Castagna
Chief Executive Officer
Christopher Prentiss
Chief Financial Officer
David Thomson
Executive Vice President, General Counsel and Secretary
Dominic Marasco
President, Endocrine Business Unit
Lauren Sabella
Executive Vice President, Operations
Sanjay Singh
Executive Vice President, Technical Operations
Stuart Tross
Executive Vice President, Chief People and Workplace Officer
Board of directors at MANNKIND.
Research analysts who have asked questions during MANNKIND earnings calls.
Andreas Argyrides
Oppenheimer & Co. Inc.
4 questions for MNKD
Olivia Brayer
Cantor
4 questions for MNKD
Anish Nikhanj
RBC Capital Markets
3 questions for MNKD
Brandon Folkes
Rodman & Renshaw
3 questions for MNKD
Faisal Khurshid
Leerink Partners
3 questions for MNKD
Yun Zhong
Wedbush Securities
3 questions for MNKD
Anthony Petrone
Mizuho Group
2 questions for MNKD
Recent press releases and 8-K filings for MNKD.
- MannKind reported pro forma revenues exceeding $100 million in Q3 2025, driven by strong performance from FUROSCIX, which generated $19.3 million in Q3 revenue (up 93% year-over-year), and Tyvaso DPI, contributing $59 million in Q3 related revenue (up 15% year-over-year).
- The company is strategically focusing on the pediatric market for AFREZZA, which is projected to achieve $70 million-$75 million this year, with a 10% market share in kids potentially adding $150 million in net revenue. New trials are underway for newly diagnosed pediatric patients and gestational diabetes.
- Pipeline advancements include the initiation of a Phase IB trial for nintedanib DPI in the U.S. and a Phase II trial (INFLOW 2) ex-U.S. for Idiopathic Pulmonary Fibrosis (IPF).
- MannKind is expanding the market for FUROSCIX with an increased sales force of 80 representatives and the upcoming introduction of an autoinjector, targeting a $10 billion+ market opportunity in heart failure.
- MNKD's pro forma revenues exceeded $100 million in Q3 2025, driven by strong performance from Furoscix and Tyvaso DPI.
- Furoscix generated $19.3 million in Q3 2025 revenue, representing a 93% year-over-year increase, supported by a sales force expansion to 80 reps and a new nephrology indication contributing 15% of Q3 sales.
- Tyvaso DPI related revenue reached $59 million in Q3 2025, marking a 15% year-over-year growth.
- The company is strategically expanding Afrezza into the pediatric market with new trials, projecting $150 million in net revenue for every 10% market share in kids, and is also exploring its use for gestational diabetes mellitus (GDM).
- MNKD is advancing its pipeline with a Phase 1B trial for tetanib and a Phase 2 study for inflow two (ex U.S.), alongside development of a bumetanide product and nintedanib DPI.
- MannKind's Furoscix generated $19.3 million in Q3, marking a 93% year-over-year increase, supported by a sales force expanded to 80 representatives and a new nephrology indication.
- Tyvaso DPI contributed $59 million in Q3 related revenue, demonstrating a 15% year-over-year growth.
- The company's pro forma revenues, following the scPharmaceuticals acquisition, surpassed $100 million in Q3.
- MannKind is advancing its pipeline with a Phase 1B trial for tetanib in the U.S. and a Phase 2 study for inflow two ex-U.S. for IPF, alongside a pediatric trial for Afrezza targeting newly diagnosed children.
- A new two-unit cartridge for Afrezza is being introduced in the pediatric trial, and a gestational diabetes (GDM) trial for Afrezza is nearing completion with positive safety data.
- MannKind Corporation has discontinued the ICON one Phase 3 clinical trial evaluating nebulized clofazamine inhalation suspension (MannKIND-101) for the treatment of refractory non-tuberculosis mycobacterium (NTM) lung disease.
- The decision was made on November 8, 2025, due to futility, as none of the first 46 participants showed evidence of sputum culture conversion, although no safety concerns were identified by the independent Data Safety Monitoring Board.
- The company believes the lack of efficacy is likely related to the nebulized formulation and potential issues with patient preparation and delivery, rather than the clofazamine molecule itself, which has established activity against NTM.
- MannKind is now focusing on advancing its MannKIND-102 dry powder formulation of clofazamine, which is currently moving from preclinical development towards Phase 1, with updates expected around Q2.
- Despite this setback, MannKind highlighted its position as a diversified company with multiple revenue streams and pipeline opportunities.
- MannKind Corporation announced on November 10, 2025, the discontinuation of its Phase 3 clinical trial (ICoN-1 Study) for nebulized inhalation suspension of clofazimine (MNKD-101).
- The decision was based on an analysis of sputum culture conversion data from the first 46 participants, none of whom showed evidence of sputum culture conversion, leading to concerns about achieving the study's primary endpoint.
- The data safety monitoring board (DSMB) agreed with the decision to discontinue the trial due to futility on November 8, 2025, and confirmed that no safety issues were found.
- The company plans to investigate the reasons for this outcome to guide the ongoing development of MNKD-102, a dry powder formulation of clofazimine, which is advancing towards Phase 1.
- MannKind reported record total revenues of $82 million in Q3 2025, a 17% increase over the prior year, driven by strong performance from Tyvaso DPI and Afrezza.
- The company completed the acquisition of SC Pharmaceuticals, with Furoscix generating $19.3 million in unaudited revenue in Q3 2025 and $47.1 million year-to-date, reflecting 153% and 95% growth respectively over the prior year periods. Furoscix revenues will be included in MannKind's financial results starting Q4.
- Key pipeline advancements include the Afrezza supplemental BLA for pediatric patients accepted for review with a PDUFA date of Q2 2026, and the SNDA for the 306 auto injector submitted in Q3 2025 with an expected PDUFA date of Q3 2026.
- MannKind utilized $133 million of its cash and investments and borrowed $325 million on a five-year term loan facility to fund the SC Pharmaceuticals acquisition, while achieving non-GAAP net income of $22.4 million and non-GAAP EPS of $0.07 for Q3 2025.
- MannKind Corporation reported a record revenue quarter of $82 million for Q3 2025.
- The company completed the acquisition of scPharmaceuticals, adding FUROSCIX, and generated $59 million in Tyvaso DPI royalty and manufacturing-related revenue.
- For Q3 2025, GAAP Net Income was $8.0 million and Non-GAAP Adjusted Net Income was $22.4 million.
- Key pipeline advancements include the Afrezza SBLA acceptance for FDA review for pediatric use, with a PDUFA date of May 29, 2026, and the submission of the sNDA for the FUROSCIX ReadyFlow Autoinjector in Q3 2025.
- MannKind Corporation reported Q3 2025 revenues of $82.1 million, a 17% increase compared to Q3 2024, and year-to-date 2025 revenues of $237.0 million, up 14% from YTD 2024. For Q3 2025, GAAP net income was $8.0 million ($0.03 basic EPS) and non-GAAP net income was $22.4 million ($0.07 basic EPS).
- The company completed the acquisition of scPharmaceuticals on October 7, 2025, which is anticipated to diversify and accelerate revenue growth with FUROSCIX®.
- Key pipeline advancements include the FDA's acceptance for review of the Afrezza pediatric sBLA with a PDUFA date of May 29, 2026, and the submission of the FUROSCIX ReadyFlow Autoinjector sNDA.
- As of September 30, 2025, MannKind held $286.3 million in cash, cash equivalents, and investments.
- MannKind Corporation completed the acquisition of scPharmaceuticals Inc. on October 7, 2025, making scPharma a direct wholly owned subsidiary.
- The aggregate cash paid for the acquisition and the extinguishment of scPharma's debt amounted to approximately $296.5 million and $82.6 million, respectively, partially funded by $250.0 million in delayed draw term loans borrowed on October 7, 2025.
- As part of the acquisition, scPharma shareholders received one non-tradable contingent value right (CVR) per share, entitling them to potential future cash payments of up to an aggregate amount of $1.00 per CVR.
- CVR payments are contingent upon two milestones: FDA approval of an Injection Product (Milestone 1), with payments ranging from $0.25 to $0.75 per CVR based on the achievement date by June 30, 2027; and achieving at least $110.0 million in worldwide net sales of Products by December 31, 2026 (Milestone 2), with payments ranging from $0.10 to $0.25 per CVR based on sales volume.
- MannKind is undergoing a significant transformation, diversifying its focus beyond diabetes to inhalation therapeutics, marked by its recent acquisition of scPharmaceuticals and strategic partnerships.
- The company anticipates several key catalysts over the next 18 months, including an October 2025 label change for Afrezza and its pediatric approval in May 2026, the closing of scPharmaceuticals in Q4 2025 with autoinjector approval expected in July 2026, and a mid-2026 interim readout for clofazimine (MNKD-101).
- MannKind's pipeline also includes nintedanib (MNKD-201), which is moving into Phase II with top-line data expected in H1 2027, and continued collaboration with United Therapeutics on Tyvaso DPI for IPF following positive TETON-2 data.
- Following the scPharmaceuticals closing in Q4 2025, MannKind expects to have approximately $325 million in debt and $150 million in cash on its balance sheet, and is prepared to fund all ongoing investments.
Quarterly earnings call transcripts for MANNKIND.
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