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MADRIGAL PHARMACEUTICALS, INC. (MDGL)·Q2 2025 Earnings Summary

Executive Summary

  • Strong quarter driven by Rezdiffra launch momentum: Q2 2025 net sales reached $212.8M, up 55% QoQ and massively higher YoY as adoption broadened; >23,000 patients were on therapy as of June 30, and ~60% of targeted prescribers have written prescriptions .
  • Strategic durability and pipeline optionality improved: new U.S. patent extends Rezdiffra protection to Feb. 4, 2045; a global license for an oral GLP‑1 (SYH2086) adds a combination path; and a $500M Blue Owl credit facility strengthens non‑dilutive funding .
  • EU expansion nearing: CHMP issued a positive opinion in June; EC decision expected in August with an initial Germany launch approach in 2H25, positioning incremental 2026+ revenue contribution .
  • No formal revenue guidance: management reiterated they are not providing revenue guidance near‑term; focus remains on steady patient adds through 2025, with EU monetization more a 2026 story, per call Q&A .

What Went Well and What Went Wrong

What Went Well

  • Commercial execution: Net sales grew to $212.8M with 55% QoQ growth; >23,000 active patients; ~80% of top ~6,000 prescribers have written Rezdiffra; ~60% penetration across ~14,000 total targets .
  • Strategic moat: New U.S. patent covering weight‑threshold dosing extends protection to 2045, reinforcing exclusivity and label‑aligned dosing regimen .
  • Global and lifecycle expansion: Positive CHMP opinion (EU approval anticipated), F4c two‑year data showing broad, sustained efficacy, and a GLP‑1 oral license enabling a once‑daily combo path .
  • CEO tone: “We’ve delivered another exceptional quarter driven by continued strong Rezdiffra demand… building a company with the potential to lead in this space for decades” .

What Went Wrong

  • Losses persist amid scale‑up: Q2 operating expenses rose to $260.0M (vs. $177.2M YoY) with SG&A at $196.9M to support commercialization; net loss per share was $(1.90) despite strong sales .
  • Interest income down on lower cash balances; cash declined to $802.0M from $931.3M at year‑end as operations scale (partially offset by Blue Owl facility) .
  • Limited visibility on near‑term guidance: Management declined to provide revenue guidance, leaving the buy‑side to extrapolate trajectory from patient adds and prescriber penetration; EU revenue likely more a 2026 story .

Financial Results

Income Statement and Key Line Items (USD)

MetricQ2 2024Q1 2025Q2 2025
Net Revenue ($M)$14.64 $137.25 $212.80
Cost of Sales ($M)$0.64 $4.51 $9.07
R&D Expense ($M)$71.09 $44.17 $54.08
SG&A Expense ($M)$105.45 $167.88 $196.86
Total OpEx ($M)$177.18 $216.56 $260.00
Loss from Operations ($M)$(162.54) $(79.31) $(47.20)
Interest Income ($M)$14.22 $9.37 $8.23
Interest Expense ($M)$(3.66) $(3.30) $(3.26)
Net Loss ($M)$(151.97) $(73.24) $(42.28)
Diluted EPS ($)$(7.10) $(3.32) $(1.90)

Notes: QoQ net sales growth was 55% from Q1→Q2 2025 per company slides .

Balance Sheet Highlights (Period End)

MetricQ2 2024Q1 2025Q2 2025
Cash, Cash Equivalents, Restricted Cash & Marketable Securities ($M)$931.25 $848.07 $802.02
Total Assets ($M)$1,042.25 $996.63 $1,015.38
Total Liabilities ($M)$287.86 $285.99 $319.40
Stockholders’ Equity ($M)$754.38 $710.64 $695.98

Commercial KPIs

KPIQ2 2024Q3 2024Q4 2024Q1 2025Q2 2025
Rezdiffra Net Sales ($M)$14.6 $62.2 $103.3 $137.3 $212.8
Active Patients on Therapy>2,000 >6,800 >11,800 >17,000 >23,000
Top ~6,000 Target Prescribers Adopted (%)————~80%
Penetration of ~14,000 Total Targets (%)——~40% ~50% ~60%

Segment reporting: Not applicable (single commercial therapy); no segment table disclosed .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY25None providedNo plans to provide near‑term revenue guidanceMaintained no guidance
EU Launch Timing2H25/2026Expect EU decision mid‑2025; plan Germany first in 2H25, subject to approvalPositive CHMP; EC decision expected Aug 2025; Germany launch approach in 2H25; revenue more a 2026 storyMaintained timelines; clarified revenue timing
OpEx / Margins / OI&E / TaxFY25Not providedNot providedNo change

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Patent/ExclusivityMentioned new IP steps as 2024 highlight; building long‑term runway New U.S. patent extends protection to Feb. 4, 2045, aligned with FDA‑label dosing Strengthening moat
EU ExpansionEU MAA under CHMP review; plan to launch in Germany 2H25 pending approval Positive CHMP; EC decision Aug 2025; Germany first, leveraging U.S. blueprint Moving to launch
F4c (Cirrhosis) PathCompletion of MAESTRO‑NASH OUTCOMES enrollment; two‑year OLE signals improvement in stiffness and CSPH risk EASL: broad, sustained 2‑year efficacy; potential to double opportunity if outcomes positive (data in 2027) De‑risking via data
GLP‑1 Combination—Oral GLP‑1 (SYH2086) licensed globally; aim for best‑in‑disease once‑daily combo Pipeline expansion
Commercial TrajectoryRezdiffra launch with strong early uptake; 11,800 patients YE’24 $212.8M sales; >23,000 patients; strong prescriber breadth/depth; 55% QoQ growth Accelerating
Capital/Balance SheetYE24 cash $931.3M; strong capital post‑offering $500M Blue Owl facility; cash $802.0M at 6/30/25 Added flexibility

Management Commentary

  • CEO Bill Sibold: “We’ve delivered another exceptional quarter driven by continued strong Rezdiffra demand… securing a new U.S. patent… advancing our pipeline… preparing to enter Europe… and strengthening our balance sheet… We’re building a company with the potential to lead in this space for decades” .
  • Strategic intent: “Scale Rezdiffra across fibrosis stages and geographies, advance a pipeline of complementary therapies, and deliver sustained value” .
  • CFO on guidance (Q&A): “We haven’t discussed [revenue guidance] publicly and we have no plans in the near term to give guidance… we believe that we’ll be steadily adding patients through the rest of the year” .

Q&A Highlights

  • Revenue guidance: Management reiterated no near‑term revenue guidance; focus on sustained patient growth in 2H25 .
  • EU monetization cadence: Expect EU commercialization to start with Germany 2H25; revenue recognition characterized as more of a 2026 story .
  • GLP‑1 strategy: Positioned to uniquely combine Rezdiffra with SYH2086 to create a once‑daily, well‑tolerated oral combo; differentiation emphasized vs other GLP‑1 efforts .
  • Commercial drivers: Strengthening prescriber base and real‑world experience support sustained growth through 2025 .

Estimates Context

  • S&P Global consensus: Not available via tool for Q2 2025; therefore we cannot quantify beat/miss vs S&P Global for revenue or EPS. Values retrieved from S&P Global were unavailable at query time.
  • Actuals (for reference) were: Revenue $212.8M; Diluted EPS $(1.90) .
MetricS&P Global ConsensusActualSurprise
Revenue ($M)N/A$212.8 N/A
Diluted EPS ($)N/A$(1.90) N/A

Key Takeaways for Investors

  • The launch is tracking well-above early expectations with 55% QoQ sales growth and broad prescriber uptake; commercial momentum appears sustainable into 2H25 on continued patient adds .
  • Strategic durability improved: a new U.S. patent extends exclusivity to 2045, reducing long‑term erosion risk and supporting premium positioning .
  • EU approval is a near‑term catalyst (EC decision Aug 2025), with initial Germany launch in 2H25; financial impact likely builds through 2026 .
  • The GLP‑1 combination pathway (SYH2086) broadens efficacy potential and competitive differentiation; clinical start targeted for 1H26 .
  • F4c remains a meaningful upside lever; two‑year OLE data de‑risk prospects ahead of MAESTRO‑NASH OUTCOMES readout in 2027, which could roughly double the addressable opportunity if positive .
  • Operating leverage should improve as scale builds, but elevated SG&A will persist near term to support ramp and EU launch; balance sheet strength (plus Blue Owl facility) provides growth capital without equity dilution .
  • Lack of formal revenue guidance keeps near‑term modeling anchored to observed patient/prescriber trends and GTN assumptions; watch for continued breadth/depth gains and EU launch execution as stock drivers .

Appendix: Additional Context and Data Points

  • Q2 2025 net revenues were $212.8M vs $14.6M in Q2 2024; operating expenses were $260.0M (COGS $9.1M; R&D $54.1M; SG&A $196.9M) .
  • As of June 30, 2025, cash, cash equivalents, restricted cash and marketable securities were $802.0M; plus access to up to $500M in senior secured credit (initial $350M funded; $150M DDTL available; and potential $250M incremental) .
  • Patients with compensated MASH cirrhosis (F4c) in the two‑year OLE showed significant improvements in CSPH risk categories and liver stiffness; 35% met criteria suggesting regression from F4 to potential F3 at two years .