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Mirum Pharmaceuticals, Inc. (MIRM)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 total revenue was $111.6M, up 61% year over year; GAAP net loss per share improved to $0.30 vs $0.54 in Q1 2024 .
  • Mirum raised FY 2025 revenue guidance to $435–$450M from $420–$435M previously; sequential revenue also increased vs Q4 2024 ($99.4M) on broad-based product strength; this is a clear positive surprise and potential stock catalyst .
  • LIVMARLI net sales were $73.2M (+71% YoY) and bile acid medicines were $38.4M (+47% YoY); FDA approved LIVMARLI tablet formulation and Japan approved LIVMARLI for ALGS & PFIC, expanding global reach and convenience .
  • VISTAS (PSC) enrollment expected to complete in Q3 2025 with topline data in Q2 2026; 28-week VANTAGE (PBC) interim data at EASL showed statistically significant pruritus benefit and sBA reductions, reinforcing pipeline momentum .
  • Q1 revenue and EPS beat Wall Street consensus: revenue $111.6M vs $98.4M*, EPS ($0.30) vs ($0.33)*; Mirum reiterated expectation for positive cash flow in 2025, underscoring operational discipline .

What Went Well and What Went Wrong

What Went Well

  • Strong commercial execution: net product sales reached $111.6M; LIVMARLI grew 71% YoY to $73.2M; bile acid portfolio grew 47% YoY to $38.4M .
  • Strategic approvals expanding addressable market and adoption: LIVMARLI tablets approved by FDA (one-tablet dosing for older patients); LIVMARLI approved in Japan for ALGS & PFIC via Takeda partnership .
  • Management raised FY revenue guidance to $435–$450M, citing robust demand across medicines; CEO emphasized “strong start to the year with commercial growth and multiple milestones” .

Selected quotes:

  • “We’re excited to continue our strong execution across our commercial medicines and pipeline throughout the year.” — CEO Chris Peetz .
  • “The approval of LIVMARLI in tablet form provides a meaningful additional treatment option…a convenient one-tablet per dose option for older patients.” — President/COO Peter Radovich .
  • “We are thrilled to see LIVMARLI approved…in Japan…Under Takeda’s leadership, we are confident that LIVMARLI could have a meaningful impact.” — CEO Chris Peetz .

What Went Wrong

  • Higher operating expenses: total OpEx rose to $126.8M from $95.7M YoY, including $21.9M in non-cash items; loss from operations remained negative at ($15.2M) (improved YoY but still a loss) .
  • Inventory dynamic temporarily boosted international revenue: ~$6M partner inventory build included in international LIVMARLI sales, which may not repeat in subsequent quarters (one-time Q1 event) .
  • GAAP profitability remains negative; management guided to positive cash flow but noted they are not expecting GAAP profitability “anytime soon” due to non-cash charges .

Financial Results

Core P&L vs Prior Year and Prior Quarter

MetricQ1 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$69.2 $99.4 $111.6
Net Product Sales ($USD Millions)$68.9 $99.4 $111.6
Cost of Sales ($USD Millions)$17.8 $22.8 $23.0
R&D ($USD Millions)$32.2 $44.0 $46.0
SG&A ($USD Millions)$45.6 $56.8 $57.7
Loss from Operations ($USD Millions)($26.5) ($24.2) ($15.2)
GAAP EPS ($)($0.54) —($0.30)

Notes: Q4 2024 quarterly GAAP EPS not disclosed in press release table; full-year EPS shown (not comparable) .

Margin Metrics

MetricQ1 2024Q4 2024Q1 2025
Gross Margin %74.3% (computed from $69.2 − $17.8) 77.1% (computed from $99.4 − $22.8) 79.4% (computed from $111.6 − $23.0)
Operating Margin %(38.2%) (computed: ($26.5)/$69.2) (24.3%) (computed: ($24.2)/$99.4) (13.6%) (computed: ($15.2)/$111.6)

Segment/Product Breakdown (Q1 2025)

SegmentQ1 2025 Sales ($USD Millions)YoY Growth
LIVMARLI$73.2 +71%
Bile Acid Medicines (CHOLBAM, CTEXLI)$38.4 +47%
Total Net Product Sales$111.6 +61% (vs $69.2 total revenue)

KPIs and Balance Sheet

KPIQ1 2025
Unrestricted Cash, Cash Equivalents & Investments$298.6M
Accounts Receivable$95.9M
Intangible Amortization (Quarter)$5.9M
Stock-based Compensation (Quarter)$15.8M
Total Operating Expenses$126.8M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Global Net Product Sales (Revenue)FY 2025$420M–$435M $435M–$450M Raised
Cash FlowFY 2025Positive cash flow Positive cash flow reiterated Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Commercial performanceQ3 net sales $90.3M; LIVMARLI $59.1M; bile acids $31.2M Q4 net product sales $99.4M; FY $336.4M Q1 net product sales $111.6M; LIVMARLI $73.2M; bile acids $38.4M Accelerating
Guidance2024 guidance increased to $330–$335M 2025 guidance $420–$435M Raised to $435–$450M Positive
Regulatory milestonesPDUFA for chenodiol in CTX (Dec 28, 2024) CTEXLI FDA approval; LIVMARLI PFIC label expansion LIVMARLI tablet FDA approval; Japan approval via Takeda Expanding
Pipeline: volixibat PSC (VISTAS)Interim positive signals; study progressing Enrollment completion 2H 2025; topline 2026 Enrollment completion Q3 2025; topline Q2 2026 On track, timeline refined
Pipeline: volixibat PBC (VANTAGE)Interim data; Breakthrough Therapy Enrollment completion 2026 28-week interim at EASL: statistically significant pruritus improvements; sBA reductions; IL-31 reductions Sustained efficacy
Profitability & cash flowCash flow positive business in 2024 Guide to positive cash flow in 2025 Cash flow positive in Q1; expect full year positive; GAAP profitability not near-term Improving cash generation

Management Commentary

  • “We’re pleased with the FDA’s approval of LIVMARLI’s tablet formulation…a convenient single tablet dose.” — CEO Chris Peetz .
  • “We are updating our full year revenue guidance to be $435 million to $450 million…driven by robust growth from all 3 of our commercial medicines.” — CEO Chris Peetz .
  • “The cash contribution margin…improved from ~47% in Q1 last year to ~53% in Q1 this year.” — CFO Eric Bjerkholt .
  • “We saw strong demand growth in our direct European markets…our international distributor and partner revenue this quarter included about $6 million of inventory…a new dynamic.” — President/COO Peter Radovich .
  • “We have an allowed patent…cover[s] the [LIVMARLI] tablet formulation…extend coverage out to 2043.” — CEO Chris Peetz .

Q&A Highlights

  • VANTAGE (PBC) at 28 weeks: pruritus benefit deepened; safety profile consistent; each volixibat dose significant; combined placebo-adjusted −2.51 ItchRO (p=0.0004). 70% achieved ≥50% sBA reduction; IL-31 reductions observed .
  • LIVMARLI tablet adoption: attractive option for patients ≥25kg (older children/adolescents/adults); expected to drive switch and new demand; IP extension to ~2043 under allowed patent .
  • Access dynamics: U.S. access “very strong”; step-through policies in ALGS often preferential to LIVMARLI; differentiation driven by clinical value and support .
  • PSC expectations (VISTAS): pruritus reduction anticipated in range seen in VANTAGE; competitive landscape unsatisfied with no approved therapies; volixibat expected to be preferred if approved .
  • International inventory: Q1 included ~$6M of partner inventory stock; characterized as a Q1 event as partners build warehouse stock; expect pull-through in 2025 .
  • Profitability: cash flow positive Q1 and expected FY; GAAP profitability not expected near-term due to non-cash charges .

Estimates Context

  • Q1 2025 actual vs consensus: Revenue $111.585M vs $98.397M*; EPS ($0.30) vs ($0.329); both represent beats. Coverage: 8 revenue and 8 EPS estimates .
  • Near-term estimate trend (forward view): consensus revenue Q3 2025 $130.5M*, Q4 2025 $135.7M*, Q1 2026 $141.6M*; consensus EPS Q3 2025 ($0.14), Q4 2025 ($0.06), Q1 2026 $0.00*; indicates expectations for improving EPS trajectory*.
MetricQ1 2025 ActualQ1 2025 ConsensusBeat/Miss
Revenue ($USD Millions)$111.585 $98.397*Beat
GAAP EPS ($)($0.30) ($0.329)*Beat
Revenue - # of Estimates—8*—
EPS - # of Estimates—8*—

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Clear top-line momentum with broad-based product strength and a raised FY revenue guide; sequential growth and YoY acceleration support estimate upgrades .
  • Multiple regulatory wins (tablet formulation; Japan approval) expand adoption and geographic reach; IP on tablet formulation extends protection to ~2043, supporting durability .
  • Pipeline de-risking with sustained VANTAGE efficacy and refined PSC timelines; upcoming PSC topline (Q2 2026) and continued PBC progress are key medium-term catalysts .
  • Cash generation improves: cash flow positive in Q1 and expected for FY despite non-cash charges; supports strategic flexibility without immediate need for external capital .
  • Watch for normalization of international inventory effects in Q2–Q3; underlying demand trend remains strong but Q1 partner stock build was one-time .
  • Near-term trading: guidance raise and consensus beats are positive; tablet launch in June could add incremental demand; EASL data further validates volixibat .
  • Medium-term thesis: durable commercial growth in rare diseases plus IBAT pipeline optionality (PSC/PBC) and Fragile X program initiation create multi-year catalysts with operational discipline .