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MANNKIND CORP (MNKD)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue rose 18% year over year to $78.35M, driven by Tyvaso DPI royalties ($30.01M) and collaborations/services manufacturing revenue ($29.38M). GAAP net income was $13.16M; diluted EPS was $0.04; non-GAAP net income was $21.63M and $0.07 basic EPS .
  • Versus S&P Global consensus, revenue was a modest beat (+3.3%), while EPS was a slight miss (-5.9%); estimates breadth was 6 (revenue) and 4 (EPS)*. The mix shift toward royalties and manufacturing supported results .
  • Management reiterated near-term directional guidance: Tyvaso DPI royalties expected to continue growing; collaborations/services to be “relatively flat” on an annual basis near-term, and Afrezza pediatric sBLA filing targeted for mid-2025 .
  • Key stock catalysts: pediatric Afrezza sBLA submission (mid-2025), adult label conversion update expected Q4 2025, Tyvaso DPI IPF pathway progress (bridging study planning post-TETON readouts), and MNKD-101 Phase 3 ICON-1 interim enrollment target by YE 2025 .

What Went Well and What Went Wrong

What Went Well

  • Tyvaso DPI-related revenues remained substantial: Q1 royalties $30.01M (+32% YoY) and collaborations/services $29.38M (+18% YoY), supporting non-dilutive funding for the pipeline .
  • Afrezza momentum improved: NRx +20% and TRx +14% YoY, with management highlighting stronger prescriber engagement and reduced historical objections; CEO: “Our endocrine business grew 20% on NRxs and 14% on TRxs” .
  • Balance sheet resilience: cash, cash equivalents and investments totaled $198M at Q1-end, enabling continued investment in MNKD-101 and MNKD-201 without heavy leverage .

What Went Wrong

  • Afrezza net sales grew only 3% YoY to $14.89M, impacted by timing of shipments at year-end 2024 and prior year one-time favorable gross-to-net adjustment .
  • V-Go net revenue declined 6% YoY to $4.09M as the company ceased active promotion (since Q4 2024), reflecting lower demand .
  • SG&A and R&D both increased (SG&A +12% YoY to $25.01M; R&D +10% YoY to $11.02M) due to headcount, Afrezza promotional spend, and pipeline scale-up (MNKD-101 Phase 3; MNKD-201 manufacturing scale-up) .

Financial Results

Core Financials vs Prior Periods and Estimates

MetricQ1 2024Q4 2024Q1 2025
Revenue ($USD)$66.263M $76.776M $78.354M
Diluted EPS ($)$0.04 $0.03 $0.04
Net Income ($USD)$10.630M $7.422M $13.158M
Net Income Margin %16.0% (10.630/66.263) 9.7% (7.422/76.776) 16.8% (13.158/78.354)
Operating Income ($USD)$16.722M $26.495M $22.293M
Operating Margin %25.2% (16.722/66.263) 34.5% (26.495/76.776) 28.5% (22.293/78.354)

Consensus vs Actual (Q1 2025)

MetricConsensusActualSurprise
Revenue ($USD)$75.859M*$78.354M +3.3%
EPS ($)$0.0425*$0.04 -5.9%

Values marked with * retrieved from S&P Global.

Segment/Category Revenue Breakdown

Category ($USD)Q1 2024Q1 2025
Royalties$22.651M $30.005M
Collaborations & Services$24.848M $29.376M
Afrezza$14.438M $14.887M
V-Go$4.326M $4.086M
Total Revenue$66.263M $78.354M

KPIs

KPIQ1 2025
Afrezza NRx YoY Growth (%)+20%
Afrezza TRx YoY Growth (%)+14%
Cash, Cash Equivalents & Investments ($USD)$198M
Tyvaso DPI Royalties ($USD)$30.005M
Collaborations & Services ($USD)$29.376M

Prior Two Quarters Snapshot (for Trend)

MetricQ3 2024Q4 2024
Revenue ($USD)$82.130M*$76.776M
Diluted EPS ($)$0.04*$0.03
Net Income ($USD)$7.985M*$7.422M

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Tyvaso DPI RoyaltiesFY 2025 (directional)N/A“Expect…to continue to grow” New qualitative
Collaborations & ServicesFY 2025 (directional)N/A“Remain relatively flat on an annual basis in the near term” New qualitative
Afrezza Pediatric sBLA FilingMid-2025“Anticipate filing in 1H 2025 pending FDA feedback” “Expected to be filed mid-2025” Clarified timing
Afrezza Adult Label Conversion Dose2H/Q4 2025“Label application submitted” “Hopeful approval in Q4 2025” Timeline update

No formal quantitative guidance was issued for revenue, margins, OpEx, OI&E, or tax rate .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Afrezza pediatric sBLAFDA expects 12-month data; filing targeted 1H 2025 Filing mid-2025; strong pediatric safety profile; distinct launch strategy for academic centers Advancing; timing clarified
Afrezza adult label updateLabel change submitted (conversion dosing) Expect approval Q4 2025; aim to improve early control Progressing
Tyvaso DPI IPF bridgingAnticipated post-TETON readouts; planning with UT Likely BREEZE-like bridging study; details pending UT/FDA Planning phase
Supply chain / tariffsU.S.-based manufacturing mitigates exposure Minimal impact anticipated; key products exempt/managed Stable, low risk
MNKD-101 (NTM)Phase 3 ICON-1 sites activating; interim at ~100 patients in 2026 85% sites activated; 55 patients randomized; interim enrollment target YE 2025 On track; enrollment building
MNKD-201 (IPF)Phase 1 completed; Phase II/III design in planning Global Phase II/III design: multi-dose arms vs placebo; endpoints and design under FDA discussion Moving to next phase
Manufacturing capacityExpanding Danbury capacity; ready for UT orders No major CapEx needed; ample device and fill-line capacity Adequate capacity

Management Commentary

  • CEO on growth profile: “Our Tyvaso collaboration remains strong…Q1 royalty revenue of $30 million and manufacturing revenue of $29 million” .
  • CFO on revenue trajectory: “We expect our royalty revenue to continue to grow…collaboration and services revenue to remain relatively flat on an annual basis” .
  • CEO on Afrezza pediatrics: “We expect to file for approval of Afrezza in the pediatric population this summer” .
  • CEO on capacity and CapEx: “We don’t need to build another plant in the next 5 years…plenty of capacity to support the growth” .

Q&A Highlights

  • MNKD-201 Phase II/III design: multi-dose arms vs placebo; seeking delta vs placebo without powering for specific thresholds; endpoint considerations include FVC and dose-response structure .
  • Tyvaso DPI bridging to IPF: likely a BREEZE-like study; timing contingent on TETON readouts and FDA alignment .
  • Afrezza adult label update: conversion dosing change aimed at improved early glycemic control; potential commercial benefit if approved in Q4 2025 .
  • Supply chain/tariffs: U.S. manufacturing mitigates tariff risks; key materials managed; minimal expected impact .
  • Pediatric adherence and uptake: caregivers’ diligence and teen compliance dynamics suggest potential for faster pediatric uptake; lung safety data viewed favorably .

Estimates Context

  • Q1 2025 revenue beat consensus by ~3.3% ($78.35M vs $75.86M*), led by stronger Tyvaso DPI royalties and manufacturing revenues; EPS was modestly below consensus (-5.9%; $0.04 vs $0.0425*) .
  • With directional commentary for royalties (growth) and collaborations/services (flat near-term), estimates may adjust to reflect sustained Tyvaso DPI demand and timing effects in Afrezza net sales* .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Mix quality strong: royalty and manufacturing streams from Tyvaso DPI drove an 18% YoY revenue increase and supported non-GAAP profitability .
  • Print shows a revenue beat but EPS miss vs consensus; narrative likely emphasizes durable royalties and manufacturing while Afrezza grows selectively .
  • Near-term catalysts: pediatric sBLA (mid-2025), adult label update Q4 2025, and UT’s IPF/TETON path for DPI bridging—watch for updates that could shift revenue trajectories .
  • Pipeline execution: MNKD-101 Phase 3 enrollment trending toward YE 2025 interim target; MNKD-201 advancing to Phase II/III with a global design—risk-reduction milestones into 2026 .
  • Capacity and tariff risk low: ample Danbury manufacturing capacity; minimal anticipated tariff impact—supports scalability without heavy CapEx .
  • Afrezza commercial focus: stronger prescriber engagement and pediatric launch planning (academic centers, reimbursement hub); adult label conversion could enhance outcomes .
  • Balance sheet flexibility: $198M in cash/investments post-Q1 enables continued pipeline funding and commercial execution without near-term leverage concerns .