Earnings summaries and quarterly performance for MANNKIND.
Executive leadership at MANNKIND.
MC
Michael Castagna
Detailed
Chief Executive Officer
CEO
CP
Christopher Prentiss
Detailed
Chief Financial Officer
DT
David Thomson
Detailed
Executive Vice President, General Counsel and Secretary
DM
Dominic Marasco
Detailed
President, Endocrine Business Unit
LS
Lauren Sabella
Detailed
Executive Vice President, Operations
SS
Sanjay Singh
Detailed
Executive Vice President, Technical Operations
ST
Stuart Tross
Detailed
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
Also covers: AQST, ARSP, CLSD +7 more
OB
Olivia Brayer
Cantor
4 questions for MNKD
Also covers: AMGN, AUPH, BMRN +8 more
AN
Anish Nikhanj
RBC Capital Markets
3 questions for MNKD
Also covers: APTO, CRMD, EXEL +6 more
BF
Brandon Folkes
Rodman & Renshaw
3 questions for MNKD
Also covers: ACHV, ANIP, AVDL +10 more
Faisal Khurshid
Leerink Partners
3 questions for MNKD
Also covers: ABCL, ANIP, GERN +4 more
Yun Zhong
Wedbush Securities
3 questions for MNKD
Also covers: ASND, MRKR, PASG +2 more
AP
Anthony Petrone
Mizuho Group
2 questions for MNKD
Also covers: ADMA, ALC, BSX +22 more
Recent press releases and 8-K filings for MNKD.
MannKind announces FUROSCIX pediatric approval and new patents for autoinjector
MNKD
Product Launch
New Projects/Investments
- MannKind Corporation received FDA approval for its FUROSCIX® On-body Infusor to treat edema in pediatric patients weighing 43 kg or more, expanding its existing adult indications for chronic heart failure and chronic kidney disease.
- The U.S. Patent and Trademark Office (USPTO) granted five new patents for the FUROSCIX ReadyFlow™ Autoinjector, extending intellectual property protection potentially through 2040.
- The FDA has set a PDUFA target action date of July 26, 2026, for the review of the FUROSCIX ReadyFlow™ Autoinjector's supplemental New Drug Application (sNDA).
Dec 23, 2025, 1:05 PM
MannKind Reports Strong Q3 Performance and Pipeline Advancements
MNKD
Revenue Acceleration/Inflection
New Projects/Investments
Product Launch
- 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.
Nov 19, 2025, 11:30 AM
MNKD Reports Strong Q3 2025 Revenue Growth and Pipeline Expansion
MNKD
Earnings
New Projects/Investments
Revenue Acceleration/Inflection
- 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.
Nov 19, 2025, 11:30 AM
MannKind Reports Strong Q3 Performance and Pipeline Progress
MNKD
Revenue Acceleration/Inflection
New Projects/Investments
M&A
- 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.
Nov 19, 2025, 11:30 AM
MannKind Discontinues ICON1 Phase 3 Clinical Trial for Nebulized Clofazimine
MNKD
New Projects/Investments
- MannKind Corporation has discontinued its ICON1 phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension (MannKind 101) for the treatment of refractory non-tuberculous mycobacteria (NTM) lung disease.
- The decision to discontinue the trial, made on November 8th, 2025, was due to futility, as none of the first 46 participants showed evidence of sputum culture conversion.
- The Independent Data Safety Monitoring Board (DSMB) agreed with the decision and did not identify any safety concerns during the study.
- MannKind believes the lack of efficacy is likely related to the nebulized formulation and potential issues with product preparation, rather than the clofazimine molecule itself.
- The company is continuing to advance MannKind 102, a dry powder formulation of clofazimine, from preclinical development towards phase 1, with updates anticipated around Q2 2026.
Nov 10, 2025, 2:00 PM
MannKind Discontinues ICoN-1 Phase III Clinical Trial for MNKD-101
MNKD
- MannKind Corporation has discontinued the ICoN-1 phase III clinical trial evaluating nebulized Clofazimine Inhalation Suspension (MNKD-101) for refractory nontuberculous mycobacteria (NTM) lung disease.
- The decision was made due to futility, as none of the first 46 participants completed the double-blinded treatment phase showed evidence of sputum culture conversion.
- The Independent Data Safety Monitoring Board (DSMB) agreed with the decision and did not identify any safety concerns during the study.
- The company believes the lack of efficacy is likely related to the nebulized formulation and its handling instructions, rather than the clofazimine molecule itself.
- MannKind is advancing MNKD-102, a dry powder formulation of clofazimine, from preclinical development towards phase I, with updates expected by Q2 2026.
Nov 10, 2025, 2:00 PM
MannKind Discontinues Phase 3 Clinical Trial for NTM Lung Disease Treatment
MNKD
Guidance Update
New Projects/Investments
- 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.
Nov 10, 2025, 2:00 PM
MannKind Discontinues Phase 3 Clinical Trial for MNKD-101
MNKD
New Projects/Investments
- 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.
Nov 10, 2025, 1:05 PM
MannKind Reports Record Q3 2025 Revenue and Completes SC Pharmaceuticals Acquisition
MNKD
Earnings
M&A
New Projects/Investments
- 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.
Nov 5, 2025, 2:00 PM
MannKind Corporation Announces Q3 2025 Financial Results and Key Product Milestones
MNKD
Earnings
M&A
Product Launch
- 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.
Nov 5, 2025, 2:00 PM
Quarterly earnings call transcripts for MANNKIND.
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