Executive Summary

Q4 2024 revenue of $76.8M (+31% y/y) with GAAP net income of $7.4M and non-GAAP net income of $23.0M; strength driven by Tyvaso DPI royalties (+28% y/y) and 55% growth in collaborations/services (manufacturing for UT) .
FY24 revenue reached $285.5M (+43% y/y); cash and investments were $203M at year end, and total debt principal was reduced by $236M to $36M remaining in 2.5% converts .
Strategic progress: Afrezza pediatric INHALE-1 achieved six‑month non-inferiority on mITT; sNDA meeting planned 1H25; Afrezza approved in India, with initial shipments targeted for 4Q25; MNKD‑101 (clofazimine) Phase 3 enrollment on track for interim target by YE25; MNKD‑201 (nintedanib DPI) successfully completed Phase 1 with FDA meeting planned in 1H25 .
No formal numerical guidance given; management highlighted an annualized revenue run-rate of ~$300M exiting 2024 and emphasized manufacturing readiness for potential Tyvaso DPI IPF expansion and disciplined investment ahead of a potential Afrezza pediatrics launch in 2026 .

What Went Well and What Went Wrong

What Went Well

Broad-based top-line expansion in Q4: total revenue +31% y/y to $76.8M, with Afrezza +18% y/y, royalties +28% y/y, and manufacturing/services +55% y/y .
Balance sheet transformation: $236M of debt principal eliminated in 2024; year-end cash/investments of $203M; only $36M of converts outstanding (2.5% due 2026) .
Pipeline and market access milestones: pediatric INHALE-1 six‑month data supported mITT non‑inferiority; Afrezza approved in India with shipments expected 4Q25; nintedanib DPI Phase 1 completed; MNKD-101 global Phase 3 progressing .

Selected quotes

“We…delivered robust revenues as we exited the year with an annual run rate of $300 million.” — CEO, Michael Castagna .
“TYVASO DPI-related revenues were over $200 million in 2024…We are very excited about the opportunity this provides us to fund our pipeline with nondilutive financing.” — CEO .
“We reported net income of $28 million…With this minimal debt balance and our robust cash position of $203 million, we have a strong balance sheet to execute on our objectives.” — CFO, Christopher Prentiss .

What Went Wrong

V-Go continues to be de‑emphasized: flat in Q4 (+1% y/y) and down 4% for FY24; sales force no longer actively promoting V‑Go, suggesting limited growth contribution ahead .
Higher operating costs in select areas: Q4 R&D +21% y/y and SG&A +17% y/y as development programs and personnel increased; full-year R&D +47% y/y .
Non-operating volatility: Q4 included a $13.4M loss on settlement of debt which reduced GAAP earnings; other interest and financing expense items remained meaningful .

Financial Results

Summary P&L Trends

Metric	Q2 2024	Q3 2024	Q4 2024
Total Revenues ($M)	$72.0	$70.0	$76.8
GAAP Net Income ($M)	$(2.0)	$12.0	$7.4
Non-GAAP Net Income ($M)	$14.0	$15.0	$23.0
Diluted EPS ($)	—	—	$0.03

Notes: Q4 diluted EPS from consolidated statements; non‑GAAP reconciled in press release. Q2/Q3 EPS not disclosed in documents cited above .

Revenue Mix by Quarter

Revenue ($M)	Q2 2024	Q3 2024	Q4 2024
Royalties (Tyvaso DPI)	$26.0	$27.0	$27.0
Collaborations & Services (manufacturing, etc.)	$26.0	$23.0	$26.7
Afrezza	$16.0	$15.0	$18.3
V‑Go	$4.0	~$5.0	$4.8
Total Revenues	$72.0	$70.0	$76.8

Profitability Ratios (calculated from cited figures)

Metric	Q2 2024	Q3 2024	Q4 2024
Net Income Margin (%)	-2.8% (−2.0/72.0)	17.1% (12.0/70.0)	9.7% (7.4/76.8)
EBIT (Income from Operations) ($M)	—	—	$26.5
EBIT Margin (%)	—	—	34.5% (26.5/76.8)

Notes: EBIT and EBIT margin disclosed/calculated only for Q4 from consolidated statements of operations .

Key KPIs and Balance Sheet

KPI	Q4 2024
Cash, Cash Equivalents & Investments ($M)	$203
Debt Principal Reduction in 2024 ($M)	$236
Convertible Notes Outstanding ($M)	$36 (2.5% due 2026)
Annualized Revenue Run‑Rate Exiting 2024	~$300M (management commentary)

FY24 Context

FY24 revenue $285.5M (+43% y/y); Afrezza $64.0M (+17%), Royalties $102.3M (+42%), Collaborations & Services $100.8M (+90%), V‑Go $18.3M (−4%) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial Guidance	2025	None disclosed	None disclosed; reiterated ~$300M annualized run-rate exiting 2024 (commentary, not formal guidance)	—
Afrezza (Pediatrics)	U.S. filing	—	sNDA meeting with FDA planned 1H25; potential approval early 2026 (management)	New timing detail
Afrezza (India)	Launch logistics	—	First shipment targeted for 4Q25, subject to local approvals/logistics	New timing detail
MNKD‑101 (Clofazimine)	Phase 3 enrollment	—	Interim enrollment target by YE25; interim analysis ~6–8 months after 100 evaluable patients	Timeline update
MNKD‑201 (Nintedanib DPI)	Next phase	—	FDA meeting in 1H25 to advance to next phase (Phase 2 design under discussion)	Next-step clarity
Tyvaso DPI (IPF)	Bridging study	—	Discussions with UT and FDA expected in 2Q; bridging aligned to TETON readouts	Process detail

Note: No formal quantitative revenue/EPS/margin guidance was provided in the Q4 materials; management emphasized operational milestones and run‑rate commentary .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
Afrezza pediatric program	INHALE‑1 top-line in 2H24; plan to file in 2025; foundational adult INHALE‑3 results	Six‑month INHALE‑1 mITT non‑inferiority; sNDA meeting planned 1H25; potential approval early 2026	Progressing toward filing/launch
Afrezza label/data (adults)	INHALE‑3 17‑week met primary; 30‑week data positive; publication path	Label change submitted for initial conversion dose; continued education plans	Building evidence/label optimization
Tyvaso DPI – IPF expansion	Await TETON 1/2; manufacturing scaling underway	UT gross‑to‑net headwinds now “new norm”; bridging study discussions in 2Q; manufacturing capacity ready for upside	Setup for potential expansion
Manufacturing capacity	High-speed fill/finish operational; spray drying PPQ then FDA filing	FDA sign-off on facility expansion; ready to supply higher UT volumes if IPF expands	Capacity strengthened
R&D execution: MNKD‑101	Phase 3 ICON‑1 sites activating; interim after 100; co-primary in US	~70% sites activated across 4 countries; YE25 interim enrollment target	On plan; global footprint expanding
R&D execution: MNKD‑201	Phase 1 readout/CTox in 4Q; FDA meeting for Phase 2/3 in 2025	Phase 1 completed; FDA meeting early Q2/1H25; Phase 2 design options discussed	Transitioning to next phase
International expansion	—	Afrezza approved in India; shipments planned 4Q25	New market access
Macro/rebate dynamics (UT)	UT demand strong; price/referrals robust	UT gross‑to‑net level in Q4 seen as steady state for 2025	New steady-state assumption

Management Commentary

“Our endocrine business unit had record revenues with Q4 revenue of $23 million and full year at $82 million…We expect our pediatric indication to be filed here in the first half with an approval in early 2026.” — CEO, Prepared remarks .
“We had $77 million in revenue [Q4] and $286 million for the full year…cash position ended at $203 million…reduced our debt principal by $236 million in 2024.” — CEO .
“TYVASO DPI-related revenues were over $200 million in 2024…[This] provides non-dilutive funding for our pipeline.” — CEO .
“Royalties…$27 million in the fourth quarter (+28% y/y)…collaboration and services…$27 million (+55% y/y)…Afrezza…$18 million (+18% y/y).” — CFO .
“Margins…probably getting to a fairly steady state that you can think about for going forward.” — CFO (Q&A) .

Q&A Highlights

Margins/outlook: CFO indicated manufacturing scale has improved margins and that the margin profile is nearing a steady state going forward .
UT gross-to-net: Management expects UT’s Q4 gross‑to‑net dynamic to be the “new norm” for 2025, informing internal assumptions for Tyvaso DPI royalties .
Capital allocation: Priority to invest in Afrezza pediatrics launch readiness and progress clofazimine/nintedanib, balanced against maintaining operational profitability .
Tyvaso DPI IPF manufacturing: Company received FDA facility expansion feedback and believes it can meet higher volume orders if TETON results support expansion; collaboration/services revenue would scale with volume .
MNKD‑201 Phase 2 design: Considering multi‑arm dose‑finding with naive/experienced patients (~26–30 weeks), targeting comparable efficacy with improved GI tolerability vs oral Ofev; final design pending FDA dialogue .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS could not be retrieved due to an SPGI daily request limit error at the time of analysis; as a result, we cannot formally score beat/miss versus consensus. Values retrieved from S&P Global.
Contextually, Q4 revenue grew 31% y/y to $76.8M with diluted EPS of $0.03; the principal drivers versus prior year were higher Tyvaso DPI royalties and increased manufacturing volumes, alongside Afrezza growth and stable V‑Go .

Key Takeaways for Investors

Durable top-line momentum underpinned by Tyvaso DPI economics and Afrezza growth, with Q4 mix balanced across royalties, manufacturing, and Afrezza; run-rate commentary (~$300M) provides a directional baseline entering 2025 .
Balance sheet materially strengthened (cash/investments $203M; converts $36M), enabling self-funding of Afrezza pediatrics, MNKD‑101, and MNKD‑201 without near-term dilution .
Pediatric Afrezza is a 2026 catalyst; management frames 10% pediatric share as ~$150M revenue potential and a path to >$200M Afrezza run-rate over time if uptake pillars (reimbursement hub, institutional selling, education/safety messaging) execute well .
Tyvaso DPI IPF optionality remains a significant medium‑term upside lever; UT gross‑to‑net now assumed steady state, while bridging study planning and MannKind’s manufacturing readiness set the stage for potential volume-driven upside .
MNKD‑101 (NTM) and MNKD‑201 (IPF) advance as differentiated inhaled therapies addressing tolerability and administration limitations of current standards; 2025 FDA interactions and 2026–27 readouts are key risk‑reduction milestones .
Near-term trading setup: absent formal guidance, shares will likely trade on clinical/regulatory catalysts (peds sNDA timeline clarity; UT TETON readouts; FDA meeting feedback on MNKD‑201) and on UT demand trends influencing royalties/manufacturing revenue pacing .

Appendix: Additional Detail

Q4 revenue drivers: “rise in royalties…due to higher patient demand for Tyvaso DPI; collaborations/services grew due to increased manufacturing…Net revenues for Afrezza and V‑Go increased primarily as a result of improved gross‑to‑net… and higher demand, and…pricing for Afrezza” .
Operating expense detail: R&D +21% y/y in Q4 and +47% for FY24; SG&A +17% y/y in Q4; FY24 SG&A roughly flat as restructuring savings offset increases .
Consolidated statements (Q4 and FY) confirm revenue, expense, and other income/expense composition; Q4 income from operations $26.5M; Q4 net income $7.4M; diluted EPS $0.03 .
Pediatric six‑month INHALE‑1: mITT met non‑inferiority margin (0.370% < 0.4%); lung function and safety comparable to MDI; Afrezza arm showed no concerning differences in hypoglycemia or lung parameters .
India approval: CDSCO approved Afrezza for adults; first shipment to Cipla expected by end of 2025, enabling scale benefits for manufacturing .

MANNKIND CORP (MNKD)·Q4 2024 Earnings Summary