Executive Summary

Q3 2025 delivered a record revenue quarter at $82.1M (+17% y/y), with non-GAAP EPS of $0.07; revenue modestly beat S&P Global consensus ($80.25M*) and normalized EPS materially beat ($0.0188*) on stronger Tyvaso DPI royalties and manufacturing revenue . Values retrieved from S&P Global.*
Segment mix remained robust: Royalties $33.3M (+23% y/y), Collaborations & Services $26.5M (+14%), Afrezza $18.5M (+23%), while V-Go declined (-19% y/y). Tyvaso DPI contributed ~$59.8M in combined royalties and manufacturing revenue in Q3 .
Strategic catalysts: closed SC Pharmaceuticals (FUROSCIX) on Oct 7; sNDA for FUROSCIX ReadyFlow auto-injector submitted (acceptance decision expected by YE25); Afrezza pediatric sBLA accepted (PDUFA May 29, 2026). Cash, equivalents and investments were $286.3M at 9/30/25; management drew additional term loans for the acquisition .
Key “why”: revenue strength was driven by Tyvaso DPI demand and higher UT product sales; non-GAAP EPS outperformance reflects add-backs (e.g., royalty sale accounting, FX, stock comp, impairment) while GAAP EPS was pressured by a $6.4M investment impairment and higher SG&A tied to growth and acquisition activity .

What Went Well and What Went Wrong

What Went Well

Tyvaso DPI momentum: “record revenue quarter” with $33M royalties and $26M manufacturing in Q3; UT developed an 80 mcg cartridge to improve patient convenience .
Afrezza growth: Q3 Afrezza revenue +23% y/y to $18.5M; NRx +31% and TRx +27% y/y as focus shifts to type 1 ahead of pediatrics .
Pipeline/regulatory progress: Afrezza pediatric sBLA accepted (PDUFA 5/29/26); FUROSCIX ReadyFlow sNDA submitted; ICON-1 NTM Phase 3 hit interim enrollment target ahead of schedule; IPF Phase 2 (INFLO/MNKD-201) initiated (first patient expected Q1 2026) .

What Went Wrong

GAAP profitability optics: GAAP net income fell to $8.0M vs $11.6M a year ago, largely on a $6.4M impairment and higher SG&A (+22% y/y); non-GAAP net income still rose to $22.4M (+45% y/y) .
V-Go contraction: net revenue fell to $3.8M (-19% y/y) tied to lower demand as product is no longer actively promoted .
Elevated operating spend: SG&A up $5.2M (+22% y/y) to support Afrezza pediatric preparation and acquisition-related costs; R&D up 9% y/y given ICON-1 enrollment and MNKD-201 scale-up .

Financial Results

Revenue and EPS (GAAP/non-GAAP) vs prior quarters and estimates

Metric	Q1 2025	Q2 2025	Q3 2025
Total Revenue ($USD)	$78.354M	$76.527M	$82.130M
GAAP Diluted EPS ($)	$0.04	$0.00	$0.03
Non-GAAP EPS – Basic ($)	$0.07	$0.05	$0.07
S&P Global Revenue Consensus ($USD)	—	—	$80.2476M*
S&P Global Primary EPS Consensus Mean ($)	—	—	$0.01875*
Actual vs Consensus (Revenue)	—	—	Beat (by ~$1.9M)*
Actual vs Consensus (Normalized EPS)	—	—	Beat (by ~$0.051)*

Values retrieved from S&P Global.*

Segment Revenue Mix

Segment ($USD)	Q1 2025	Q2 2025	Q3 2025
Royalties	$30.005M	$31.228M	$33.319M
Collaborations & Services	$29.376M	$22.845M	$26.506M
Afrezza	$14.887M	$18.329M	$18.493M
V-Go	$4.086M	$4.125M	$3.812M
Total	$78.354M	$76.527M	$82.130M

Margins

Margin	Q1 2025	Q2 2025	Q3 2025
EBIT Margin %	31.65%*	13.93%*	22.86%*
Net Income Margin %	16.79%*	0.87%*	9.72%*

Values retrieved from S&P Global.*

KPIs and Cash

KPI	Q1 2025	Q2 2025	Q3 2025
Tyvaso DPI – Royalties + Manufacturing ($USD)	$59.381M (30.005 + 29.376)	$54.073M (31.228 + 22.845)	~$59.825M (33.319 + 26.506)
Afrezza Rx Growth (NRx/TRx y/y)	+20% / +14% (narrative)	Adult performance detail; strategic expansion underway	+31% NRx / +27% TRx
Cash, Equivalents & Investments (period-end)	$198M (3/31)	$201.2M (6/30)	$286.3M (9/30)

Guidance Changes

No formal quantitative financial guidance was provided. Management offered operational/regulatory timing guidance summarized below.

Metric	Period	Previous Guidance	Current Guidance	Change
Afrezza Pediatric sBLA (FDA)	PDUFA	—	May 29, 2026 assigned	New timing
Afrezza Adult Label – Initial Conversion Dose	Decision timing	4Q 2025 expected	Decision expected Q1 2026	Timing slip
FUROSCIX ReadyFlow Auto-Injector sNDA	Acceptance decision	Submitted Q3 2025	Review acceptance decision expected by YE 2025	New milestone
UT Collaboration New Program Upfront	Revenue recognition	—	$5M upfront received; revenue recognition to begin Q4 as activities progress	New item
Collaborations & Services (manufacturing)	FY 2025	—	Expect full-year ~in line with $51M recorded in 1H25	Commentary (maintained trajectory)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025)	Previous Mentions (Q2 2025)	Current Period (Q3 2025)	Trend
Tyvaso DPI performance & IPF bridging	Strong royalties; awaiting TETON; bridge likely BREEZE-like	Continued growth; manufacturing timing variability	Record quarter; UT 80mcg cartridge; anticipate IPF DPI bridging discussion post TETON-2	Positive momentum
Afrezza growth & pediatric strategy	NRx +20%, TRx +14%; strong KOL engagement; peds filing mid-2025	Adult campaign “Insulin in the Moment”; salesforce expansion; peds launch planning	+31% NRx/+27% TRx; dedicated peds focus at top centers; label conversion dose update timing	Building to peds launch
Supply chain/tariffs	Predominantly U.S. manufacturing; minimal tariff impact expected	Reinforced U.S. facility coverage; V-Go inventory flexibility	—	Stable risk
R&D execution (NTM, IPF)	ICON-1 enrollment on track; MNKD-201 progressed post FDA feedback	ICON-1 ahead of schedule; INFLO Phase 2 details (BID/TID)	ICON-1 interim enrollment target achieved early; INFLO initiated; first patient Q1 2026	Advancing
FUROSCIX commercialization	—	—	Acquisition closed; 27k Q3 doses (+153% y/y); Q3 unaudited revenue $19.3M; ReadyFlow sNDA submitted	Expansion catalyst
Digital health (BluHale)	—	—	BluHale dosing tracker highlighted for peds launch integration	Emerging initiative

Management Commentary

“We delivered a record revenue quarter of $82 million… We recorded our highest revenue quarter for TYVASO DPI, earning $33 million in royalties and $26 million in manufacturing related revenue.” (Michael Castagna) .
“Afrezza grew 31% in new prescriptions and 27% in total prescriptions year over year… Afrezza grew 23% in Q3 2025 compared to Q3 2024.” (Michael Castagna) .
“In the third quarter, total revenues grew 17% over the prior year to $82 million, driven primarily by royalties earned on TYVASO DPI… Non-GAAP Net Income was $22.4 million… non-GAAP EPS of $0.07.” (Chris Prentiss) .
“FDA accepted for review the sBLA for Afrezza in the pediatric population… assigned a PDUFA date of May 29, 2026.” (Press release) .
“FUROSCIX ReadyFlow Auto-Injector sNDA filing submitted… review acceptance decision expected by YE 2025.” (Press release) .

Q&A Highlights

FUROSCIX competitive landscape and pricing: Management expects market expansion with multiple entrants; focus on smoothing, reimbursement support, and readiness to compete; ReadyFlow auto-injector expected to simplify admissions and reduce COGS, improving margins .
Tyvaso DPI IPF bridging: UT likely to discuss a BREEZE-like bridging study with FDA following TETON-2; timing dependent on UT’s regulatory interactions .
Afrezza label conversion dose: Update timing shifted; strategy is to improve initial dosing and titration to reduce “lack of effect” adverse events, supporting persistence and prescriber confidence .
Balance sheet and deleveraging: $36M convert due March 1, 2026; near-term priority is investing in growth while addressing the convert “in the near term” .
ICON-1 (NTM) interim: Trial ~90% powered; interim may drive sample-size adjustments or futility; FDA loosened ECG entry screening criteria; early OE safety signals supportive .

Estimates Context

Q3 2025 results vs S&P Global consensus: Revenue $82.13M vs $80.25M* (beat); Primary EPS (normalized) $0.07 vs $0.0188* (beat); 8 estimates for both EPS and revenue. GAAP diluted EPS was $0.03; note that S&P “Primary EPS” reflects normalized metrics, not GAAP . Values retrieved from S&P Global.*

Key Takeaways for Investors

Revenue quality remains high with Tyvaso DPI driving consistent double-digit growth; combined royalties and manufacturing approached ~$60M in Q3, supporting durable cash generation ahead of potential IPF label expansion via bridging .
Afrezza trajectory is improving with double-digit Rx growth and pediatric filing accepted; label conversion dose update should aid dosing accuracy and persistence, while a dedicated peds institutional strategy is being built for 2026 launch .
Q3 non-GAAP EPS strength vs consensus was aided by recurring add-backs and operational execution; monitor GAAP-to-non-GAAP adjustments (impairment, FX, royalty sale accounting, stock comp) to assess earnings quality .
SC Pharmaceuticals acquisition adds a new commercial pillar (FUROSCIX) with clear operational levers (ReadyFlow auto-injector, CAM build-out, hospital discharge protocols) to accelerate growth into 2026 .
Expense growth reflects strategic investments (Afrezza peds launch prep, expanded field force, acquisition costs); expect SG&A elevated near-term with medium-term operating leverage contingent on commercial uptake .
Balance sheet can support execution (9/30 cash/investments $286.3M; access to term loans); watch convert maturity (Mar 2026) and integration synergies to balance growth and deleveraging .
Near-term stock catalysts: UT’s IPF DPI pathway clarity post TETON-2, FUROSCIX ReadyFlow sNDA acceptance decision by YE25, and ongoing ICON-1 enrollment progress; narrative skews positive on multiple fronts .

Appendix: Detailed Financial Tables

Consolidated Statements Highlights (GAAP)

Metric ($USD)	Q3 2025	Q3 2024
Total Revenues	$82.130M	$70.079M
Income from Operations	$18.896M	$12.760M
Net Income	$7.985M	$11.550M
Net Income per Share – Basic	$0.03	$0.04
Net Income per Share – Diluted	$0.03	$0.04

Non-GAAP Reconciliation (EPS – Basic)

Period	GAAP EPS	Adjustments (key items)	Non-GAAP EPS
Q3 2025	$0.03	Royalty sale accounting, interest on royalty liability, acquisition expenses, impairment, stock comp, FX	$0.07
Q3 2024	$0.04	Royalty sale accounting, interest on royalty liability, stock comp, FX, bargain purchase gain	$0.06

Notes: See press release for full reconciliation and definitions .

Prior Quarters (for trend)

Q2 2025: Revenue $76.5M (+6% y/y); GAAP basic/diluted EPS $0.00; non-GAAP EPS $0.05 .
Q1 2025: Revenue $78.4M (+18% y/y); GAAP diluted EPS $0.04; non-GAAP EPS $0.07 .

Sources

Q3 2025 8-K and press release: revenue, segment mix, GAAP/non-GAAP, pipeline and acquisition updates .
Q3 2025 earnings call transcript: operational color on Tyvaso DPI, Afrezza, FUROSCIX, pipeline, Q&A .
Q2 2025 press release and call: quarterly comps, guidance commentary .
Q1 2025 press release and call: quarterly comps and strategic framing .

S&P Global disclaimer: All items marked with an asterisk were retrieved from S&P Global (analyst consensus and fundamentals).

MANNKIND CORP (MNKD)·Q3 2025 Earnings Summary