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MADRIGAL PHARMACEUTICALS, INC. (MDGL)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net revenue was $103.3M, up 66% quarter-over-quarter from $62.2M in Q3 2024, driven by strong Rezdiffra adoption, expanding prescriber penetration, and broad payer coverage .
  • More than 11,800 patients were actively on Rezdiffra by year-end; management highlighted momentum into 2025 and expects robust year-over-year net sales growth with gross-to-net discounts increasing as the launch matures .
  • New two-year MAESTRO-NAFLD-1 open-label F4c data showed a mean 6.7 kPa reduction in liver stiffness and 51% of patients achieving ≥25% reduction, reinforcing confidence in the fully enrolled MAESTRO-NASH OUTCOMES trial (data anticipated in 2027) .
  • No formal 2025 financial guidance was provided; management indicated consensus could tighten and move higher based on early Q1 2025 trends and reiterated plans for a targeted Europe launch beginning with Germany in H2 2025, pending approval .

What Went Well and What Went Wrong

What Went Well

  • “We generated $103 million in net sales in the fourth quarter of 2024, reflecting 66% quarter-over-quarter growth… Our launch trajectory continues to track in line with some of the most successful specialty medicine launches in the past decade.” — CEO Bill Sibold .
  • Prescriber penetration improved: ~60% of top 6,000 targets wrote Rezdiffra in Q4 (up from ~40% in Q3), and ~40% of the broader 14,000 target base wrote prescriptions; >75% of scripts came from top targets .
  • Two-year F4c VCTE results showed a mean 6.7 kPa reduction and 51% achieving ≥25% reduction, supporting confidence in outcomes data and potential indication expansion to F4c MASH .

What Went Wrong

  • Operating expenses scaled materially with commercialization: Q4 SG&A rose to $141.2M (from $107.6M in Q3), reflecting launch activities and headcount expansion; net loss remained high at $(59.4)M for Q4 .
  • Gross-to-net discount expected to increase in 2025 due to normal early-launch dynamics and Medicare Part D redesign, potentially tempering net revenue conversion despite strong demand .
  • No formal 2025 guidance; while management tone was positive, the lack of explicit targets may limit near-term visibility for investors tracking the trajectory versus consensus .

Financial Results

Quarterly P&L and Key Line Items

MetricQ2 2024Q3 2024Q4 2024
Net Revenue ($USD Millions)$14.6 $62.2 $103.3
Cost of Sales ($USD Millions)$0.6 $2.2 $3.4
R&D Expense ($USD Millions)$71.1 $68.7 $25.6
SG&A Expense ($USD Millions)$105.4 $107.6 $141.2
Loss from Operations ($USD Millions)$(162.5) $(116.3) $(67.0)
Interest Income ($USD Millions)$14.2 $13.0 $11.1
Interest Expense ($USD Millions)$3.7 $3.7 $3.5
Net Loss ($USD Millions)$(152.0) $(107.0) $(59.4)
Diluted EPS ($)$(7.10) $(4.92) $(2.71)

Year-over-Year Q4 Comparison

MetricQ4 2023Q4 2024YoY Change
Net Revenue ($USD Millions)$0.0 $103.3 +$103.3M
Net Loss ($USD Millions)$(112.2) $(59.4) +$52.8M
Diluted EPS ($)$(5.68) $(2.71) +$2.97
SG&A ($USD Millions)$46.5 $141.2 +$94.7M
R&D ($USD Millions)$70.6 $25.6 $(45.0)M

Margins (Document-derived calculations)

MetricQ2 2024Q3 2024Q4 2024
Net Income Margin %(1,037.7%) (171.9%) (57.5%)
EBIT Margin % (Loss from Ops / Revenue)(1,111.4%) (187.1%) (64.9%)

Note: Margins are calculated from cited revenue and loss from operations/net loss figures in the company’s press releases/8-K exhibits.

KPIs

KPIValueSource
Patients on Rezdiffra at YE 2024>11,800
Commercial coverage achieved>80% of commercial lives by Q3 2024
Biopsy requirement among covered lives<5% (NITs accepted)
Prescriber penetration (top 6,000)~60% wrote in Q4 (up from ~40% in Q3)
Prescriber breadth (14,000 target base)~40% wrote by YE 2024
Share of scripts from top prescribers>75%
Inventory levels2–4 weeks, within expectations
Cash, cash equivalents, restricted cash & marketable securities (Dec 31, 2024)$931.3M

Segment Breakdown

  • Single-product commercial stage; no reported segment revenue allocations .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance/CommentaryChange
Net Sales (trajectory)FY 2025NoneExpect robust YoY net sales growth; momentum into 2025 Maintained (no formal)
Gross-to-Net DiscountFY 2025NoneAnticipated to increase vs 2024; Q1 seasonal dynamics and Medicare Part D redesign noted Maintained (no formal)
R&D ExpenseFY 2025NoneExpected somewhat higher vs 2024 Maintained (no formal)
SG&A ExpenseFY 2025NoneExpected to increase with U.S. launch investment and Europe preparation Maintained (no formal)
Europe Launch TimelineH2 2025NoneTargeted country-by-country launch starting with Germany, pending EMA approval New disclosure
MAESTRO-NASH OUTCOMES Data Timing2027NoneExpect 2027 readout; confidence reinforced by F4c VCTE data Maintained (timeline reiterated)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 & Q-1)Current Period (Q4 2024)Trend
Payer Coverage & AccessCoverage >50% by Q2; goal of 80% by YE >80% coverage achieved by Q3; NITs accepted by most plans Improving; structural access in place
Prescriber AdoptionBuilding care pathways; early enthusiasm 60% of top 6,000 prescribers active; 40% of 14,000 targets active; >75% scripts from top targets Broadening & deepening
Net Sales Ramp$14.6M in Q2; $62.2M in Q3 $103.3M in Q4; 66% QoQ growth Accelerating
F4c Outcomes & VCTE DataEnrollment completed (Oct 2024) 6.7 kPa mean reduction; 51% ≥25% reduction; 2027 outcomes timeline Confidence reinforced
Gross-to-Net DynamicsNormalizing launch economics GTN expected to rise in 2025; Part D redesign impact incremental Headwind manageable
Europe CommercializationPlans for direct commercialization post-EMA decision mid-2025 Country-by-country approach; positive pricing/value dialogue expectations Execution planning

Management Commentary

  • “We generated $103 million in net sales in the fourth quarter of 2024, reflecting 66% quarter-over-quarter growth… Our launch trajectory continues to track in line with some of the most successful specialty medicine launches in the past decade.” — CEO Bill Sibold .
  • “We ended 2024 with $931.3 million in cash… well resourced to support the ongoing launch of Rezdiffra in both the U.S. and our planned launch in Europe.” — CFO Mardi Dier .
  • “Patients achieved a mean 6.7 kPa reduction… the largest mean reduction reported in an F4c MASH patient population to date… 51% achieved ≥25% reduction.” — Management summary of F4c cohort .
  • “We are expanding geographically… plan to take a targeted country-by-country approach… beginning with Germany in the second half of the year [2025].” — CEO Bill Sibold .

Q&A Highlights

  • Launch cadence and 2025 momentum: Management sees steady patient adds in Q1, typical Q1 dynamics, and believes Q1 2025 consensus will narrow upward based on early trends .
  • Clinical meaningfulness of 6.7 kPa reduction: Baseline ~25 kPa; reductions ≥5 kPa or ≥25% are predictive of fewer liver-related events and potential one-stage fibrosis improvement; supports optimism for outcomes trial .
  • Guidance stance: No formal guidance; commentary points to robust YoY growth and consensus narrowing upward for 2025 .
  • Payer/Gross-to-net and Part D: GTN expected higher in 2025; Medicare Part D redesign impact is incremental given 2024 rebates; ~1/3 of patients are Medicare .
  • Competitive landscape & GLP-1s: ~25% of Rezdiffra patients already on GLP-1s; combination seen as market-expanding with Rezdiffra’s liver-directed profile supporting continued leadership .

Estimates Context

  • S&P Global consensus estimates were unavailable at time of query due to system limits. Therefore, comparisons to Wall Street consensus could not be provided and should be treated as unavailable via S&P Global at this time.
  • Management indicated expectations for Q1 2025 and FY 2025 consensus to narrow and move higher based on observed momentum, but provided no numeric guidance .

Key Takeaways for Investors

  • Demand ramp is strong and broad-based: Q4 net sales of $103.3M with prescriber penetration increasing and access infrastructure largely in place; expect continued growth despite GTN headwinds typical of early launches .
  • Clinical expansion potential: Two-year F4c VCTE data meaningfully de-risk outcomes; 2027 MAESTRO-NASH OUTCOMES readout is a major medium-term catalyst .
  • Europe strategy: Country-by-country launch beginning H2 2025 (pending approval) with disciplined pricing/value positioning, offering additional geographic upside .
  • Operating leverage path: SG&A elevated as expected for commercialization; R&D to trend modestly higher in 2025; watch for improving operating loss as revenues scale .
  • Near-term trading implications: Limited formal guidance may cap visibility; monitor monthly prescription trends, payer policy stability post-Part D redesign, and competitor entries (GLP-1) as potential sentiment drivers .
  • Narrative drivers: First-in-disease positioning, outcomes confidence, and international expansion remain the core bull points; GTN normalization and expense scaling are the main watch items .
  • Cash runway: ~$931M cash supports commercialization and European launch prep without near-term financing needs, reducing execution risk .