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MADRIGAL PHARMACEUTICALS, INC. (MDGL)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 net sales of Rezdiffra reached $137.3M, up 33% QoQ from $103.3M in Q4 2024, driven by strong demand and deeper prescriber adoption despite typical Q1 headwinds .
  • More than 17,000 patients were actively on Rezdiffra as of March 31, 2025, versus 11,800 at year-end 2024; prescriber penetration rose to 70% of the top-6,000 targets and ~50% across the 14,000 total targets .
  • SG&A stepped up with commercial investments; management reiterated gross-to-net discounts will increase through 2025, while R&D is expected to be similar to 2024, and cash ended at $848.1M supporting U.S. and planned EU launch in 2H 2025 .
  • Near-term catalysts: late-breaking F4c data at EASL (two-year cohort showing 6.7 kPa mean liver stiffness reduction and CSPH risk downshifts) and a mid-year EMA decision, positioning Rezdiffra for expanded outcomes and European commercialization potential .

What Went Well and What Went Wrong

What Went Well

  • Demand and breadth/depth of prescribers drove sequential net sales growth (+33% QoQ) with inventory levels within the 2–4 week target range; management highlighted “an exceptional launch” and a “world class team” execution .
  • Patient adoption accelerated: 17,000+ active patients by quarter-end vs 11,800 in Q4, and penetration of 70% of top 6,000 prescribers and ~50% of total targets; CEO: “we’re adding patients at a rate that's consistent with…top-tier specialty launches” .
  • Clinical momentum: EASL late-breaking F4c results demonstrated broad improvements and a mean 6.7 kPa liver stiffness reduction; CEO: “we believe Rezdiffra is on track to become the foundational therapy across F2 to F4c MASH” .

What Went Wrong

  • Operating loss and net loss remained substantial as SG&A ramped for commercialization; Q1 total operating expenses were $216.6M (vs $170.3M in Q4), net loss was $(73.2)M and EPS was $(3.32) .
  • Gross-to-net discount expected to “increase and step up” through 2025 as payer contracting advances; CFO flagged ongoing choppiness, implying near-term net sales sensitivity to reimbursement dynamics .
  • Competitive overhang from GLP-1 label expansion in MASH; management expects market expansion but acknowledged payer reauthorization processes and potential step-through dynamics, while asserting confidence in Rezdiffra’s liver-directed profile .

Financial Results

Consolidated Quarterly Performance

MetricQ3 2024Q4 2024Q1 2025
Product Revenue, net ($USD Millions)$62.2 $103.3 $137.3
Total Operating Expenses ($USD Millions)$178.5 $170.3 $216.6
Cost of Sales ($USD Millions)$2.2 $3.4 $4.5
R&D Expense ($USD Millions)$68.7 $25.6 $44.2
SG&A Expense ($USD Millions)$107.6 $141.2 $167.9
Loss from Operations ($USD Millions)$(116.3) $(67.0) $(79.3)
Interest Income ($USD Millions)$13.0 $11.1 $9.4
Interest Expense ($USD Millions)$3.7 $3.5 $3.3
Net Loss ($USD Millions)$(107.0) $(59.4) $(73.2)
EPS (Basic & Diluted, $USD)$(4.92) $(2.71) $(3.32)
Cash, Cash Equivalents, Restricted Cash & Marketable Securities ($USD Millions)$1,003.6 $931.3 $848.1

Margins

MetricQ3 2024Q4 2024Q1 2025
Net Income Margin %-171.9% (calc from revenue & net loss) -57.5% (calc) -53.4% (calc)
Operating Margin %-187.1% (calc from revenue & op loss) -64.8% (calc) -57.8% (calc)

Notes: Margins are calculated from reported revenue, loss from operations, and net loss in the cited tables .

Segment Breakdown

SegmentQ3 2024Q4 2024Q1 2025
Product Revenue, net ($USD Millions)$62.2 $103.3 $137.3

Madrigal reports a single commercial product revenue line (Rezdiffra) in the quarter .

KPIs

KPIQ3 2024Q4 2024Q1 2025
Commercial Payer Coverage>80% (achieved one quarter early) >80% maintained >80% maintained
Patients on Therapyn/a>11,800 >17,000
Prescriber Penetration (Top 6,000)~40% ~60% ~70%
Prescriber Penetration (Total 14,000)~40% ~40% ~50%
Inventory Rangen/a2–4 weeks 2–4 weeks

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Sales OutlookFY 2025Robust YoY growth expected; no formal guidance Robust YoY growth expected; no formal guidance Maintained
Gross-to-Net DiscountFY 2025Increase vs 2024; choppy early in launch Increase/step-up through 2025 with payer contracting Maintained/clarified step-up
R&D ExpenseFY 2025Somewhat higher vs 2024 Similar level vs 2024 Lowered vs prior commentary
SG&A ExpenseFY 2025 / Q2 2025Increase in 2025 Increase in 2025 with step-up into Q2 Raised (near-term step-up)
EU Launch2H 2025 (pending EMA)Mid-year EMA opinion; launch Germany 2H 2025 Mid-year EMA decision on track; Germany launch 2H 2025 Maintained
Formal Financial GuidanceFY 2025Not providing formal guidance Not providing formal guidance; expect consensus to narrow/move up Maintained/added consensus color

Earnings Call Themes & Trends

TopicQ3 2024 Mentions (Q-2)Q4 2024 Mentions (Q-1)Q1 2025 Mentions (Current)Trend
Payer Coverage & Access>80% commercial coverage; <5% require biopsy Maintained access; launch trajectory strong GTN step-up with contracting; access sustained Stable access; rising GTN headwind
Prescriber Adoption & DepthEarly penetration; wiring practices Top 6,000 at 60%; total 14,000 at 40% Top 6,000 at 70%; total 14,000 at ~50% Expanding breadth/depth
Patient Adoptionn/a>11,800 active patients >17,000 active patients Accelerating
EU ExpansionEMA mid-2025, plan Germany 2H 2025 On track for mid-year EMA; country-by-country pricing Mid-year action; NIT readiness; pricing discipline Executing plan
Outcomes (F4c) ProgramCompleted enrollment MAESTRO-NASH OUTCOMES Two-year open-label F4c VCTE data (6.7 kPa) EASL late-breaker: CSPH downshifts; mean 6.7 kPa Strengthening data set
Competition (GLP-1)Anticipated market evolution Expect market expansion; combo/exposure 25–50% Reiterate coexistence; confident profile; payer dynamics Manageable competitive tailwind
DTC & Awarenessn/aEmphasis on education and action Positive DTC feedback; new campaign (defusemash.com) Building demand
Macro/Supply Chainn/aInventory 2–4 weeks; U.S. manufacturing Inventory on plan; U.S.-based supply chain Operationally stable

Management Commentary

  • CEO, launch execution: “By any measure, this is an exceptional launch…we’re performing at or near the top…we're just getting started.”
  • Patient growth: “We ended the first quarter of 2025 with more than 17,000 patients on Rezdiffra…adding patients at a rate that’s consistent with…top-tier specialty launches.”
  • F4c data significance: “Patients saw a mean reduction of 6.7 kilopascals in liver stiffness at 2 years…suggests that many patients are moving into a lower risk category.”
  • EU readiness: “We remain on track for a midyear regulatory decision in Europe…plan to launch in Germany in the second half of the year.”
  • CFO, GTN & OpEx: “In 2025, we expect gross to net discount to increase and step up as we move through the year…SG&A expenses to increase in 2025, including a step-up into the second quarter.”

Q&A Highlights

  • Growth trajectory with semaglutide entry: Management expects years of growth ahead; GLP-1 entry should expand diagnosis and market size, with consensus narrowing/moving up .
  • Payer reauthorization: Typically 12-month reauth; persistency supported by real-world efficacy and tolerability, with early adherence signs comparable to other well-tolerated orals .
  • EU label/NITs: On track for mid-year action; Europe is “ahead” on NIT readiness per guidelines; pricing to recognize innovation on a country-by-country basis .
  • Gross-to-net dynamics: A disciplined multi-year approach; began contracting in Q2; GTN likely steps up through 2025 though Q1 was slightly favorable .
  • Outcomes confidence: Mechanistic rationale plus 6.7 kPa reduction and CSPH risk shifts bolster confidence in MAESTRO-NASH OUTCOMES (data expected 2027) .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2025 EPS and revenue was unavailable at the time of this analysis; management guided qualitatively that consensus should narrow and move up based on observed momentum .
  • Without published S&P Global consensus figures, beats/misses versus estimates cannot be determined; investors should track near-term revisions post-EASL and pre-EMA decision.

Key Takeaways for Investors

  • Rezdiffra’s Q1 2025 net sales rose 33% QoQ to $137.3M on expanding prescriber and patient adoption; breadth and depth indicators point to durable growth into Q2 and FY 2025 .
  • SG&A and GTN step-ups are prudent investments and normalization for a first-in-disease launch; expect near-term operating losses but improving net margin trajectory as revenue scales .
  • F4c late-breaking data (6.7 kPa mean reduction, CSPH downgrades) enhances the outcomes narrative and supports confidence ahead of MAESTRO-NASH OUTCOMES (2027) .
  • EU is a strategically important expansion; mid-year EMA decision and a targeted Germany launch in 2H 2025 can be stock catalysts; pricing discipline will be key for contribution-positive markets .
  • GLP-1 label expansion likely grows the MASH market; Rezdiffra’s liver-directed profile and real-world tolerability support combination or sequential use without undermining core demand .
  • Liquidity remains strong ($848.1M cash) to fund U.S. launch, EU entry, and outcomes program; BD optionality exists without “bet-the-company” risk .
  • Watch drivers: Q2 sequential net sales growth; GTN progression with payer contracts; EASL follow-up webcast; EMA decision; prescriber penetration and patient retention metrics .

Appendix: Additional Relevant Press Releases and Updates

  • April 16, 2025: Founder/CMO transition; David Soergel appointed CMO, reinforcing clinical leadership for pipeline expansion .
  • March 11, 2025: Jacqualyn Fouse appointed to Board; governance depth added ahead of EU expansion and pipeline initiatives .
  • May 10, 2025 (post-quarter): EASL late-breaker—two-year F4c cohort shows significant CSPH risk improvements and 6.7 kPa mean liver stiffness reduction; safety consistent, low discontinuations .