Executive Summary

Strong quarter: revenue $133.0M (+47% YoY) and first GAAP profit ($2.9M; $0.05 diluted EPS), with performance led by LIVMARLI and steady bile-acid portfolio; both revenue and EPS exceeded Street consensus (rev $130.5M*, EPS -$0.14*) .
Guidance: FY25 revenue updated to $500–$510M (raised low end from prior $490–$510M), implying flat-to-down Q4 sequentially due to distributor lumpiness and no further Takeda sell-in in Q4; management expects to finish near the upper end of the range .
Commercial drivers: LIVMARLI tablet adoption in eligible patients, ongoing PFIC launch momentum in the U.S. and ex-U.S., and contributions from CHOLBAM/CHENODAL underpin growth; ~$5M Takeda Japan sales in Q3 will not repeat in Q4 .
Pipeline catalysts intact: VISTAS (PSC) topline in Q2’26; VANTAGE (PBC) and EXPAND (LIVMARLI label expansion) enrollment completing in 2026; new Phase 2 MRM-3379 in Fragile X initiated .

What Went Well and What Went Wrong

What Went Well

Scale and profitability: Revenue grew to $133.0M with GAAP net income of $2.9M, reflecting operating leverage as cost growth lagged revenue; CFO: “we delivered GAAP profitability… generating approximately $3 million in net income” .
Commercial execution: LIVMARLI net sales $92.2M (+56% YoY) with strong U.S. and international demand; CHOLBAM/CHENODAL $40.8M (+31% YoY) .
Guidance confidence and tone: COO: “we now expect to land in the upper end of our prior full year 2025 guidance range, with $500–$510 million in revenues” . CEO: “well positioned heading into 2026 with strong commercial momentum and multiple upcoming catalysts” .

What Went Wrong

Q4 set-up softer sequentially: Management highlighted international distributor timing and ~$5M Takeda Q3 sell-in that will not recur in Q4, implying flat sequential revenue at the guidance midpoint .
Expense intensity: Total operating expenses rose to $130.4M (vs. $103.1M YoY), including $18.1M SBC in Q3, reinforcing that consistent GAAP profitability is not yet the baseline despite the milestone .
International variability: Partner/distributor ordering cycles continue to create quarter-to-quarter lumpiness, a dynamic that affected Q3 (benefit) and weighs on the Q4 outlook .

Financial Results

Actuals vs Consensus (Q3 2025)

Metric	Q3 2025 Actual	Consensus*	Surprise
Revenue ($USD Millions)	$133.0	$130.5*	—
Diluted EPS ($)	$0.05	-$0.14*	—

Notes: “Surprise” qualitatively: both revenue and EPS were beats. Street values marked with “*” are from S&P Global; see disclaimer below.

P&L Trends (oldest → newest)

Metric	Q3 2024	Q2 2025	Q3 2025
Revenue ($USD Millions)	$90.4	$127.8	$133.0
Total Operating Expenses ($USD Millions)	$103.1	$132.8	$130.4
EBIT ($USD Millions)	-$12.7	-$5.0	$2.6
Net Income - (IS) ($USD Millions)	-$14.2	-$5.9	$2.9
Diluted EPS ($)	-$0.30	-$0.12	$0.05
EBIT Margin %	-14.03%*	-3.90%*	1.96%*

Street/financials note: Values marked with “*” retrieved from S&P Global.

Segment and Product Sales (oldest → newest)

Metric	Q1 2025	Q2 2025	Q3 2025
LIVMARLI Net Product Sales ($USD Millions)	$73.2	$88.2	$92.2
Bile Acid Medicines (CHOLBAM + CHENODAL) ($USD Millions)	$38.4	$39.6	$40.8
Total Net Product Sales ($USD Millions)	$111.6	$127.8	$133.0

Key Operating and Balance Sheet KPIs (oldest → newest)

KPI	Q1 2025	Q2 2025	Q3 2025
Cost of Sales ($USD Millions)	$23.0	$23.4	$25.5
Non-cash in OpEx (SBC + amort. + other) ($USD Millions)	$21.9	$24.5	$24.0
Cash, Cash Equivalents & Investments ($USD Millions)	$298.6	$321.7	$378.0

S&P Global disclaimer: Any values marked with “*” are retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY 2025 (as of Q4’24)	$420–$435M	—	—
Revenue	FY 2025 (as of Q1’25)	$435–$450M	—	Raised
Revenue	FY 2025 (as of Q2’25)	$490–$510M	—	Raised
Revenue	FY 2025 (as of Q3’25)	$490–$510M	$500–$510M	Raised (low end)

Management commentary indicates Q4 sequential revenue at the midpoint is roughly flat given international order timing and no further Takeda sell-in in Q4 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
International variability and partner ordering	Q2: Outperformance in International drove guidance raise . Q1: New partner markets introduced inventory stocking; lumpiness noted .	Q3 benefited from distributor orders and ~$5M Takeda Japan; no Takeda expected in Q4, creating flat sequential setup .	Stable but lumpy
PFIC launch trajectory	Q1: Early PFIC adds healthy; better-than-expected launch pace .	PFIC continues to contribute meaningfully in U.S. and abroad .	Improving
LIVMARLI tablet adoption	Q1: FDA approval; expected to aid convenience and switching .	“Substantial proportion” of eligible patients switching in first full quarter .	Improving
PBC competitive landscape (linerixibat)	Q1: Volixibat interim showed strong placebo-adjusted itch reduction; BTD granted .	Confident on volixibat dose/activity; positioning spans 1L/2L pruritus regardless of ALP .	Favorable
PSC program (VISTAS)	Q1: Enrollment nearing completion; PSC unmet need emphasized .	Enrollment completed; topline Q2’26; safety profile consistent; pruritus remains primary endpoint focus .	On track
IP/Paragraph IV risk	—	Aware of potential filers; “quite confident” in method-of-use IP; prepared to defend .	Watch
BD strategy	Q1: Active but disciplined; no urgency .	High bar maintained; focus on underappreciated assets .	Steady

Management Commentary

CEO: “Mirum is well positioned heading into 2026 with strong commercial momentum and multiple upcoming catalysts.”
COO: “We now expect to land in the upper end of our prior full year 2025 guidance range, with $500–$510 million in revenues.”
CFO: “We… delivered GAAP profitability in the third quarter, generating approximately $3 million in net income… a milestone, not yet a consistent expectation.”
CMO: “PSC represents a significant area of unmet need… interim analysis recommended keeping the sample size… supporting a strong signal for final analysis.”

Q&A Highlights

Q4 cadence: Flat sequential revenue implied at the guidance midpoint given distributor order timing and no additional Takeda sales in Q4; LIVMARLI U.S. and bile acids to grow, with variability concentrated internationally .
LIVMARLI tablet: First full quarter showed “substantial” switching among eligible patients (≥25 kg), supporting persistence/adherence improvements over time .
IP outlook: Company “quite confident” in method-of-use IP around dosing; prepared to defend if Paragraph IV filings occur; none to date .
PBC competition/pricing: Volixibat dose/activity viewed favorably vs analogs; pricing still under analysis with PBC therapeutics as potential benchmarks .
PSC safety/endpoint: DMC has not raised issues; pruritus remains the regulatory pathway; secondary measures (fatigue, bile acids) expected to move but are not primary .

Estimates Context

Q3 2025: Revenue beat ($133.0M vs $130.5M*); EPS beat ($0.05 vs -$0.14*). Upside came from strong LIVMARLI and bile acids, plus partner orders and initial Japan dynamics .
FY 2025: Guidance $500–$510M vs Street $507.9M* (near inline at the midpoint). Given Q4 flat sequential set-up, consensus may modestly adjust quarterly mix but full-year appears aligned with the upper end of guidance .

S&P Global disclaimer: Consensus values marked with “*” are retrieved from S&P Global.

Key Takeaways for Investors

Clear beat-and-raise quarter: solid top-line beat and a swing to GAAP profitability, with FY guidance nudged higher at the low end; stock narrative likely focuses on durable growth and cash generation .
Q4 optics matter: Expectation management around international/distributor lumpiness and no further Takeda sales in Q4 reduces risk of sequential disappointment; underlying U.S. trajectories remain positive .
Durable commercial engine: LIVMARLI tablet adoption and PFIC launch momentum are incremental tailwinds; bile acids remain steady contributors .
Pipeline optionality into 2026–27: VISTAS (PSC) topline in Q2’26; VANTAGE (PBC) and EXPAND label expansion completing enrollment next year—multiple catalyst paths ahead .
Competitive positioning: Volixibat’s activity and broad pruritus positioning in PBC are strengths, with management confident versus emerging competitors .
IP watch but confident: Management expects potential Paragraph IV activity but is prepared to defend; near-term risk manageable per comments .
Cash runway: $378M in cash/investments and improving cash margins support independent execution and selective BD .

Additional Context: AASLD (Q4 events)

New data readouts at AASLD include VANTAGE analyses (fatigue/sleep, IL-31), real-world maralixibat in PSC, and adult cholestasis genetic testing insights—supporting scientific leadership ahead of 2026 catalysts .

Mirum Pharmaceuticals, Inc. (MIRM)·Q3 2025 Earnings Summary