Sign in
MC

MANNKIND CORP (MNKD)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was mixed: revenue grew 6% YoY to $76.5M but declined QoQ and came in below consensus, while EPS met S&P Global “Primary EPS” consensus; GAAP EPS was flat due to FX losses and higher SG&A tied to Afrezza expansion .
  • Results vs estimates: Revenue missed ($76.5M vs $78.8M consensus*) on lower collaborations/services (timing, one-time items), while “Primary EPS” was in line at $0.05*; GAAP diluted EPS was $0.00 .
  • Strategic financing: New up to $500M Blackstone senior secured facility (non-dilutive) enhances flexibility for pediatric Afrezza launch prep, pipeline acceleration, and BD optionality; $75M funded at close .
  • Near-term catalysts: Afrezza pediatric sBLA review acceptance decision expected early Q4’25; ICoN‑1 (MNKD‑101) interim enrollment target of 100 patients aimed for early Q4’25; MNKD‑201 Phase 2 (IPF) initiation by YE’25; continued Tyvaso DPI royalty growth .

What Went Well and What Went Wrong

  • What Went Well

    • Tyvaso DPI royalties continued strong: $31.2M in Q2, +22% YoY, driving total revenue growth; management highlighted record referrals setting up Q3 .
    • Afrezza momentum: Q2 Afrezza revenue rose 13% YoY to $18.3M; sBLA for pediatric use submitted with review acceptance decision expected early Q4’25 .
    • Balance sheet optionality secured: Up to $500M Blackstone facility (SOFR + 4.75%, August 2030 maturity) supports Afrezza pediatric launch build-out, pipeline, and BD; $75M drawn at close .

  • What Went Wrong

    • Revenue mix headwinds: Collaborations/services fell 12% YoY due to net impact of one-time items; V-Go declined 8% on lower demand; overall revenue missed consensus .
    • Profitability pressure: SG&A rose 31% YoY on headcount and Afrezza promotion; FX swung to a $5.4M loss vs a gain last year; GAAP diluted EPS $0.00 despite non‑GAAP EPS of $0.05 .
    • QoQ softness: Revenue declined vs Q1 due to manufacturing timing in collaborations/services as MNKD balanced Tyvaso DPI, Afrezza, and development programs; operating income compressed .

Management quotes:

  • “Q2 highlights are highlighted by record revenue of Tyvaso DPI sales, also record referrals for patients in Q2, which should set us up for Q3.” — CEO .
  • “This strategic financing significantly increases our operating flexibility and provides us substantial access to non-dilutive capital on favorable terms…” — CEO (Blackstone) .

Financial Results

Overall performance (oldest → newest):

MetricQ4 2024Q1 2025Q2 2025
Revenue ($M)$76.776 $78.354 $76.527
Net Income ($M)$7.422 $13.158 $0.668
GAAP Diluted EPS ($)$0.03 $0.04 $0.00
Non-GAAP EPS ($)$0.08 $0.07 $0.05

Margins and operating leverage (company filings; operating margin computed from income from operations/revenue):

MetricQ4 2024Q1 2025Q2 2025
Income from Operations ($M)$26.495 $22.293 $5.299
Operating Margin % (computed)34.5% 28.5% 6.9%

Segment/revenue mix (YoY, Q2):

Revenue Component ($M)Q2 2024Q2 2025YoY %
Royalties$25.592 $31.228 +22%
Collaborations & Services$26.014 $22.845 -12%
Afrezza$16.289 $18.329 +13%
V-Go$4.491 $4.125 -8%
Total Revenue$72.386 $76.527 +6%

KPIs and balance sheet:

KPIQ2 2025Prior Context
Tyvaso DPI Royalties ($M)$31.228 Record referrals in Q2; expect royalty growth to continue
Afrezza Revenue ($M)$18.329 Stronger adult/peds positioning; new “Insulin in the Moment” campaign, sales force expansion underway
Cash & Investments ($M)$201.2 (as of 6/30/25) +$75M initial draw from Blackstone facility at close

Results vs S&P Global consensus (oldest → newest):

MetricQ4 2024Q1 2025Q2 2025
Revenue Consensus Mean ($M)75.0*75.9*78.8*
Revenue Actual ($M)76.776 78.354 76.527
Beat/(Miss) ($M)+1.8+2.5-2.3
Primary EPS Consensus Mean ($)0.035*0.0425*0.05*
EPS Actual (Primary/Non‑GAAP) ($)n/a0.07 0.05
GAAP Diluted EPS ($)0.03 0.04 0.00

Values marked with * retrieved from S&P Global.

Guidance Changes

Note: Company did not provide formal numeric FY guidance; management gave qualitative/segment-level outlook and pipeline timing.

Metric/TopicPeriodPrevious GuidanceCurrent Guidance/CommentaryChange
Royalties (Tyvaso DPI)2H 2025—Anticipate continued growth driven by UT net sales; record referrals in Q2 set up Q3 New qualitative
Collaborations & ServicesFY 2025—Expect FY to be “in line with” $51M recorded in 1H (implies 2H roughly similar to 1H) New qualitative
Afrezza (Commercial)2H 2025—Expect continued growth with expanded promotional efforts; label conversion dose decision expected 4Q’25 New qualitative
Afrezza Pediatric sBLARegulatoryExpected mid‑2025 filing sBLA submitted; review acceptance decision expected early 4Q’25 Progressed
MNKD‑101 (ICoN‑1)ClinicalInterim target by YE’25 Enrollment ahead of schedule; expect 100 evaluable patients early 4Q’25 Accelerated
MNKD‑201 (IPF DPI)ClinicalNext phase in 2H’25 Plan to initiate Phase 2 by YE’25; trial design shared on call Maintained
FinancingCapital—Up to $500M Blackstone facility; $75M initial draw; SOFR+4.75%; matures Aug 2030 New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24, Q1’25)Current Period (Q2’25)Trend
Tyvaso DPI trajectoryStrong royalty growth; manufacturing volumes increasing $31.2M royalties (+22% YoY); record referrals; continued growth expected Improving
Afrezza strategyPediatric data readouts approaching; label update under FDA review sBLA submitted; new HCP/consumer campaign; sales force/MSL build; target 50% market coverage in 2026 Accelerating
MNKD‑101 (NTM)Global Phase 3 ramp; interim target by YE’25 Enrollment ahead of schedule; interim enrollment target now early Q4’25 Improving
MNKD‑201 (IPF)Completed Phase 1; planning next phase Phase 2 design/details; plan to initiate by YE’25; ex‑US placebo‑controlled design to enable faster execution Advancing
Capital strategyDeleveraging in 2024; strong YE cash $500M Blackstone non‑dilutive facility; $75M drawn to support growth/BD Strengthened
FX/cost headwindsNoted FX tailwinds in 4Q’24 $5.4M FX loss; SG&A +31% on headcount/promo investments Worsened in Q2
Supply chain/tariffs—Majority of revenue/pipeline from U.S. Danbury facility; mitigates tariff exposure Stable/Low risk

Management Commentary

  • Strategic direction: “The next six to eight quarters are going to showcase our cumulative work over the past seven years… we now have access to additional capital to provide us flexibility” — CEO .
  • Afrezza pediatrics: “The submission of our sBLA for Afrezza in pediatric patients is a meaningful milestone” — CEO .
  • MNKD‑201 (IPF): “We plan to launch our [Phase 2] trial called INFLOW by year end 2025… primary objective [is] safety and tolerability… secondary around FVC and efficacy signals” — CEO .
  • Tyvaso DPI: “Our Q2 highlights are highlighted by record revenue of Tyvaso DPI sales, also record referrals for patients in Q2” — CEO .
  • Financing: “This strategic financing significantly increases our operating flexibility… to support the expansion of our commercial team… pipeline advancement, and BD” — CEO .

Q&A Highlights

  • IPF/Tyvaso DPI bridging: Management deferred to UT on regulatory timelines; optimistic that positive TETON‑2 readout (Sept) could accelerate path pending FDA interactions .
  • MNKD‑201 trial design: Pivoted to ex‑US, placebo‑controlled on top of background therapy (pirfenidone and future agents allowed) to meet ethical/practical constraints; targeting BID vs TID dosing exploration; Phase 2 primary focus on tolerability/safety with early FVC signal, to power Phase 3 appropriately .
  • MNKD‑101 (NTM): If interim sputum conversion is favorable at ~180, options include database lock vs waiting for remaining patients to reach six months; QIDP/fast track enable potential rolling submission and expedited review .
  • Afrezza focus and footprint: Adult prescriber breadth/depth expanding; peds likely requires institutional KAMs; parents/caregivers signal high interest; co‑promotion of Baqsimi with Amphastar helps pediatric reach .
  • Blackstone facility rationale: Flexibility for catalysts over 18–24 months (peds launch prep, late‑stage programs, BD); $125M DDTL largely at MNKD’s discretion and an additional $300M uncommitted tranche by mutual consent .

Estimates Context

  • Q2 2025: Revenue missed consensus ($76.5M vs $78.8M*), primarily due to lower collaborations/services (timing, one-time items) offsetting royalty strength; “Primary EPS” met at $0.05* while GAAP diluted EPS was $0.00, reflecting higher SG&A and a $5.4M FX loss .
  • Q1 2025 and Q4 2024 set a high bar: Both quarters beat revenue consensus; Q1 also delivered stronger non‑GAAP EPS, helped by royalty and manufacturing strength .
  • Revisions risk: Street models may increase Tyvaso DPI royalty trajectories and Afrezza commercial spend assumptions, flatten collaborations/services seasonality (manufacturing timing), and update FX sensitivity; pipeline timelines (peds sBLA, ICoN‑1 interim, MNKD‑201 start) likely reflected after milestones land .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Royalty engine remains robust (Tyvaso DPI +22% YoY), but manufacturing timing can swing collaborations/services intra‑year; anticipate continued royalty growth into 2H .
  • Near-term regulatory and clinical catalysts (pediatric Afrezza review acceptance in early Q4, ICoN‑1 interim enrollment in early Q4, MNKD‑201 Phase 2 start by YE’25) could reset trajectory and narrative .
  • Q2 revenue miss and margin compression stemmed from mix (lower collaborations/services), investment in Afrezza expansion, and FX losses—not core demand weakness; management expects underlying trends to improve .
  • Blackstone facility provides non‑dilutive, flexible capital through 2030 to scale Afrezza pediatrics and advance late‑stage lung programs; supports optionality for BD .
  • Watch UT’s TETON‑2 IPF readout in September and subsequent regulatory dialogue; outcomes may influence Tyvaso DPI trajectory and MNKD narrative .
  • Afrezza growth strategy (HCP/consumer campaign, expanded field force, institutional KAMs) aims to broaden prescriber base and accelerate pediatric adoption on approval .
  • Model considerations: lift royalties, moderate collaborations/services quarter‑to‑quarter volatility, raise SG&A for commercial build, and incorporate FX sensitivity; EPS cadence likely back‑half weighted to pipeline/newsflow .

Appendix: Additional Data Tables

YoY revenue detail (Q2 2025 vs Q2 2024):

  • Total revenue: $76.527M vs $72.386M (+6%) .
  • Afrezza: $18.329M vs $16.289M (+13%); V‑Go: $4.125M vs $4.491M (-8%); Collaborations/services: $22.845M vs $26.014M (-12%); Royalties: $31.228M vs $25.592M (+22%) .

Operating expense drivers (Q2 2025 YoY):

  • R&D +16% on ICoN‑1 enrollment, MNKD‑201 scale‑up (offset by completion of prior studies) .
  • SG&A +31% tied to headcount/MSLs and Afrezza promotional costs .
  • FX loss $5.4M vs $0.5M gain prior year, driven by USD/EUR exposures in Amphastar insulin supply commitments .

Balance sheet snapshot (6/30/25):

  • Cash, cash equivalents and investments: $201.2M .
  • Senior secured facility: $75M initial term funded; $125M DDTL available 24 months (customary conditions); additional $300M uncommitted DDTL by mutual consent; SOFR + 4.75%; matures Aug 2030 .

Citations:

  • Q2 2025 8-K/press release and financials .
  • Q2 2025 earnings call transcript .
  • Q1 2025 press release and financials .
  • Q4 2024 press release and financials .
  • Blackstone financing press release .

Values marked with * retrieved from S&P Global.