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MANNKIND (MNKD)

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Earnings summaries and quarterly performance for MANNKIND.

Recent press releases and 8-K filings for MNKD.

MannKind Discusses 2025 Performance, 2026 Outlook, and Pipeline Progress
MNKD
Guidance Update
Product Launch
New Projects/Investments
  • MannKind reported Q4 and full year 2025 total revenues of nearly $350 million, representing a 46% annual growth rate, and projects 2026 revenue to exceed $450 million.
  • The Phase 1 study for MNKD-201 (Nintedanib DPI) for IPF is progressing with 4 patients enrolled and 10 in screening for the 24-person study, with the first part expected to conclude within 30-45 days. Phase 2 enrollment is anticipated to begin in Q2 , with the program viewed as a blockbuster opportunity.
  • The PDUFA date for Afrezza's pediatric approval is May 29th, with a planned launch in January 2027.
  • FUROSCIX sales are expected to be driven by the hospital segment for heart failure and nephrology for chronic kidney disease, with significant potential from the upcoming auto-injector.
  • Despite recent stock volatility related to United Therapeutics' Tyvaso soft mist inhaler, MannKind emphasizes the significant cash flow from Tyvaso DPI royalties ($700 million to $1 billion over several years) and its focus on internal pipeline growth.
1 day ago
MannKind Reports Strong 2025 Revenue, Provides 2026 Guidance, and Updates on Key Pipeline Programs
MNKD
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • MannKind reported Q4 and full year 2025 total revenues of nearly $350 million, representing a 46% annual growth rate, and projects 2026 revenue to climb above $450 million.
  • Key drivers for 2026 revenue include Afrezza's pediatric expansion, FUROSCIX autoinjector approval, and royalties from Tyvaso DPI.
  • The MNKD-201 (nintedanib DPI) program for IPF is progressing, with 4 patients enrolled and 10 in screening in the Phase 1 study, and Phase 2 enrollment expected to begin in Q2. This program is considered a blockbuster opportunity.
  • The PDUFA target date for Afrezza pediatric approval is May 29th , and the ReadyFlow Autoinjector for FUROSCIX is anticipated to significantly expand its market.
  • The company addressed the recent stock reaction to United Therapeutics' (UT) soft mist inhaler for Tyvaso, emphasizing that MannKind has strong near-term growth drivers from its own pipeline and expects continued revenue from Tyvaso DPI.
1 day ago
MannKind Reports Strong 2025 Revenue, Provides 2026 Guidance, and Updates on Pipeline Progress
MNKD
Earnings
Guidance Update
New Projects/Investments
  • MannKind reported Q4 and full-year 2025 total revenues of nearly $350 million, representing a 46% annual growth rate.
  • The company projects 2026 revenue to climb above $450 million, driven by Afrezza's pediatric expansion, O6 auto injector approval, and royalties from Tyvaso DPI.
  • The MNKD-201 program for IPF has initiated its Phase 1 study in December, with 4 patients enrolled and 10 in screening, and Phase 2 is expected to begin enrolling patients early in Q2.
  • The PDUFA date for Afrezza pediatric approval is May 29 , and the INHALE-first trial for naive pediatric patients is underway with 3-4 patients enrolled.
  • Management addressed the recent stock reaction concerning United Therapeutics' potential soft mist inhaler for Tyvaso, stating that Tyvaso DPI is still expected to generate $700 million to $1 billion in cash flow over the next several years.
1 day ago
MannKind Discusses 2025 Financials, 2026 Outlook, and Pipeline Progress
MNKD
Guidance Update
Product Launch
New Projects/Investments
  • MannKind reported Q4 and full year 2025 total revenues of nearly $350 million, representing a 46% annual growth rate, and projects 2026 revenue to climb above $450 million.
  • The Phase 1 study for MNKD-201 (Nintedanib DPI) for IPF, a potential blockbuster opportunity, initiated in December 2025, is progressing with 4 patients enrolled and 10 in screening for a 24-person study; Phase 2 enrollment is expected in Q2 2026.
  • The PDUFA date for Afrezza's pediatric approval is May 29th, with a planned launch in January 2027.
  • Key drivers for FUROSCIX sales in 2026 include expansion into the hospital segment and targeting nephrologists for chronic kidney disease, with future potential from an auto-injector.
  • The recent stock reaction to UT's soft mist inhaler announcement was attributed to investors unwinding hedge positions, but MannKind's CEO highlighted strong near-term prospects for 2026, 2027, and 2028 from other growth drivers.
1 day ago
MannKind Reports Record Q4 2025 Revenue and Outlines 2026 Growth Drivers
MNKD
Earnings
M&A
Product Launch
  • MannKind reported record quarterly revenue of $112 million in Q4 2025, representing a 46% increase year-over-year, with full-year 2025 total revenue reaching $349 million, up 22%.
  • The company completed the acquisition of scPharmaceuticals in Q4 2025, integrating FUROSCIX, which contributed $23.3 million in net sales for the quarter, an increase of 91% year-over-year.
  • Key upcoming catalysts include PDUFA dates for the Afrezza pediatric indication on May 29 and the FUROSCIX ReadyFlow Autoinjector on July 26, positioning the company for potential growth.
  • MannKind projects a clear path to over $450 million revenue run rate in 2026 and expects to receive over $350 million in Tyvaso DPI royalties over the next 36 months.
1 day ago
MannKind Reports Record Q4 2025 Revenue and Outlines Key Growth Catalysts
MNKD
Earnings
Product Launch
Guidance Update
  • MannKind reported record quarterly revenue of $112 million in Q4 2025 and nearly $350 million in total revenue for the full year 2025, reflecting a 46% compound annual growth rate over the past five years.
  • Key upcoming catalysts include PDUFA dates for the Afrezza pediatric indication on May 29 and the FUROSCIX ReadyFlow Autoinjector on July 26.
  • FUROSCIX net sales reached $23.3 million in Q4 2025 (up 91% year-over-year) and $70.4 million for the full year 2025, with a projected 2026 sales range of $100 million to $120 million.
  • The company anticipates a revenue run rate exceeding $450 million in 2026 and plans to invest up to an additional $40 million to support upcoming product launches.
  • The long-term supply agreement with United Therapeutics is expected to generate over $400 million in revenue from minimum orders over the next six years and over $350 million in royalties over the next 36 months.
1 day ago
Mannkind Reports Record Q4 2025 Revenue and Provides Key Product Updates
MNKD
Earnings
M&A
Product Launch
  • Mannkind reported record quarterly revenue of $112 million for Q4 2025 and total revenue of $349 million for the full year 2025.
  • The company completed the scPharmaceuticals acquisition, strengthening its cardiometabolic franchise with FUROSCIX®.
  • Key upcoming catalysts include PDUFA dates for Afrezza® Pediatric Indication on May 29, 2026, and FUROSCIX ReadyFlow™ Autoinjector on July 26, 2026.
  • For Q4 2025, GAAP Net Loss was $(15.9) million, while Non-GAAP Adjusted Net Income was $1.5 million.
1 day ago
MannKind Reports Record Q4 and Full Year 2025 Revenue, Highlights Product Growth and Upcoming Catalysts
MNKD
Earnings
Revenue Acceleration/Inflection
Product Launch
  • MannKind reported record quarterly revenue of $112 million in Q4 2025, a 46% increase from the prior year quarter, contributing to a full year 2025 total revenue of $349 million, up 22%.
  • Key product performance in Q4 2025 included FUROSCIX net sales of $23.3 million (up 91% year-over-year) and Afrezza net US sales of $22.3 million (up 22% year-over-year). For the full year 2025, FUROSCIX generated $70.4 million and Afrezza $74.6 million.
  • The company anticipates significant catalysts with PDUFA dates for the Afrezza pediatric indication on May 29 and the FUROSCIX ReadyFlow Autoinjector on July 26, and projects a clear path to over $450 million revenue run rate in 2026.
  • The long-term supply agreement with United Therapeutics for Tyvaso DPI has 6 years remaining, with minimum orders expected to deliver over $400 million in revenue and a revenue floor of approximately $50 million per year through 2031.
1 day ago
MannKind Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
MNKD
Earnings
M&A
Product Launch
  • MannKind Corporation reported total revenues of $112 million for Q4 2025, a 46% increase compared to Q4 2024, and $349 million for the full year 2025, up 22% from 2024.
  • Key product net sales for Q4 2025 included Furoscix® at $23 million, a 91% increase from Q4 2024, and Afrezza® at $23 million, a 25% increase from Q4 2024.
  • The company reported a net loss of $(15.9) million and basic EPS of $(0.05) for Q4 2025, and net income of $5.9 million and basic EPS of $0.02 for the full year 2025.
  • MannKind successfully completed the acquisition of scPharmaceuticals Inc. on October 7, 2025, and held $176 million in cash, cash equivalents, and investments as of December 31, 2025.
  • Significant upcoming milestones include PDUFA dates for Afrezza pediatric indication on May 29, 2026, and Furoscix ReadyFlow™ Autoinjector on July 26, 2026.
1 day ago
MannKind Announces FDA Approval for Updated Afrezza Label
MNKD
  • MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder.
  • This update revises recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens, providing clearer guidance for healthcare providers.
  • The revised dosing recommendations, supported by clinical trials, are intended to facilitate a clinically appropriate and safe transition for adult patients initiating Afrezza.
Jan 26, 2026, 11:05 AM