Madrigal Pharmaceuticals, Inc. (MDGL): Business Model Canvas [Dec-2025 Updated]

You're looking at Madrigal Pharmaceuticals, Inc. (MDGL) right as they transition from a pipeline story to a commercial powerhouse, thanks to the successful launch of Rezdiffra, now the foundational oral treatment for MASH with moderate to advanced fibrosis. Honestly, seeing Q3 2025 net revenues hit $287.3 million from just that one product tells you the value proposition-the first-and-only approved oral therapy-is resonating with specialists and driving significant top-line growth. But the real analysis is in how they plan to defend this moat while aggressively pursuing combination therapies with partners like CSPC Pharmaceutical Group Limited; dig into the full Business Model Canvas below to see the key resources, the high SG&A costs for this launch, and the strategic activities driving this next phase of growth.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships Madrigal Pharmaceuticals, Inc. (MDGL) has locked in to support the launch and pipeline expansion of Rezdiffra (resmetirom). These partnerships are key to scaling production, extending intellectual property (IP) life, and ensuring patients can actually get the drug.

CSPC Pharmaceutical Group Limited for oral GLP-1 agonist SYH2086 licensing

Madrigal Pharmaceuticals, Inc. secured a major strategic move in mid-2025 to bolster its MASH pipeline by in-licensing an oral GLP-1 receptor agonist, SYH2086, from CSPC Pharmaceutical Group Limited. This move is clearly aimed at creating a potential best-in-class oral combination therapy with Rezdiffra.

The financial structure of this deal is significant, showing Madrigal Pharmaceuticals, Inc.'s commitment to the asset:

It's important to note that while Madrigal Pharmaceuticals, Inc. gets the exclusive global license to develop, manufacture, and commercialize SYH2086, CSPC retains the right to develop and commercialize other oral GLP-1 agonists within China, subject to certain conditions.

Contract Manufacturing Organizations (CMOs) for Rezdiffra production

Madrigal Pharmaceuticals, Inc. relies on Contract Manufacturing Organizations (CMOs) to scale the production of its foundational therapy, Rezdiffra. While specific CMO names and associated financial contracts aren't public, the scale of the commercial operation gives you a sense of the required manufacturing footprint.

The patient adoption numbers directly reflect the required output from this manufacturing network:

• As of September 30, 2025, more than 29,500 patients were on Rezdiffra therapy.
• Q3 2025 net sales reached $287.3 million.
• The company launched Rezdiffra in Germany in September 2025 following European Commission approval.

Clinical research organizations (CROs) for ongoing Phase 3 trials

Madrigal Pharmaceuticals, Inc. continues to utilize CROs to manage its complex, ongoing Phase 3 clinical program, which is essential for gathering the confirmatory data needed to support label expansion and maintain market leadership. The company is running four key Phase 3 trials.

The scope of these trials shows the level of external clinical management required:

• MAESTRO-NASH: Initiated in March 2019, this registrational trial involved more than 950 patients.
• MAESTRO-NAFLD-1: This trial generated two-year open-label data for the compensated MASH cirrhosis (F4c) arm, which included n=122 patients as of May 2025.
• MAESTRO-NASH OUTCOMES: This is the ongoing, fully enrolled, double-blind, placebo-controlled trial focused on clinical outcomes in patients with compensated MASH cirrhosis (F4c).

Galmed Pharmaceuticals for potential Rezdiffra/Aramchol combination IP

The partnership with Galmed Pharmaceuticals centers on securing and extending intellectual property protection for a potential combination therapy using Rezdiffra and Galmed's Aramchol. This is a defensive and offensive IP play in the MASH space.

The latest IP developments show progress in securing long-term exclusivity:

This patent strategy helps Madrigal Pharmaceuticals, Inc. build a moat around its core MASH franchise, so you can see why they are focused on this.

Payers and pharmacy benefit managers (PBMs) for market access

Market access, driven by negotiations with Payers and PBMs, dictates the commercial success of Rezdiffra post-launch. Madrigal Pharmaceuticals, Inc. set an initial benchmark price, and the focus has been on securing broad formulary placement.

Here are the key financial and access metrics as of late 2025:

• Rezdiffra's initial annual cost was set at $47,400 per year (announced March 2024).
• The company expected 80% commercial insurance coverage by the end of 2024, with Medicare access following in 2025.
• As of Q3 2025, quarterly net sales annualized above $1 billion.
• CEO stated in November 2025 that Rezdiffra is poised for continued broad, first-line access.
• Initial payer discussions anticipated requirements for prior authorization and testing for diagnosis.

Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Key Activities

You're focused on the operational engine driving Madrigal Pharmaceuticals, Inc. right now, and it's all about scaling Rezdiffra while securing the future pipeline. Here's a breakdown of the core activities as of late 2025, grounded in the latest numbers.

Commercial Scale-up and Global Launch of Rezdiffra (resmetirom)

The immediate focus is maximizing the commercial footprint of Rezdiffra following its initial launch. The momentum is significant, with sales rapidly annualizing above the $1 billion mark. This activity requires substantial Selling, General & Administrative (SG&A) investment to support the growing prescriber base and patient volume.

The third quarter of 2025 saw net sales hit $287.3 million, which was a 35% increase quarter-over-quarter from Q2 2025. By September 30, 2025, the company reported that more than 29,500 patients were on therapy, being managed by over 10,000 healthcare providers prescribing the drug. Looking ahead to 2026, management anticipates the gross-to-net impact will settle in the high 30% range, consistent with other specialty medicines as payer contracts take full effect starting January 1, 2026.

Executing the Confirmatory Phase 3 Outcomes Trial for Rezdiffra (MAESTRO-NASH)

Continued execution of the confirmatory trial is critical, as continued US approval for the initial indication may depend on verifying the clinical benefit in this ongoing study. The key activity here is managing the MAESTRO-NASH OUTCOMES trial, which specifically targets patients with compensated MASH cirrhosis (F4c), a population with no currently approved therapies. Data from this trial is essential for potentially expanding the indication.

New data analyses from the open-label F4c arm of the MAESTRO-NAFLD-1 trial were presented at The Liver Meeting 2025 in November. The pivotal MAESTRO-NASH biopsy trial previously showed that 91% of patients treated with Rezdiffra 100mg achieved improvement or stabilization of liver stiffness (VCTE) after one year.

Research and Development (R&D) for Combination Therapies like Rezdiffra + SYH2086

Madrigal Pharmaceuticals is actively building out its pipeline to extend leadership by developing complementary mechanisms, specifically pairing Rezdiffra with an oral GLP-1 receptor agonist. This involves executing the global licensing agreement with CSPC Pharma for MGL-2086 (formerly SYH2086). The plan is to advance this combination therapy to drive greater efficacy.

R&D expenses reflect this strategic investment. Third-quarter 2025 R&D expense totaled $174.0 million, which included a significant one-time upfront expense of $117 million associated with the MGL-2086 licensing deal. The company expects MGL-2086 to enter the clinic in the first half of 2026.

• Q3 2025 R&D Expense: $174.0 million
• Upfront Payment for MGL-2086: $117 million (included in Q3 R&D)
• Q2 2025 R&D Expense: $54.1 million
• Projected MGL-2086 Clinic Entry: First half of 2026

Securing and Defending Intellectual Property (IP) for Rezdiffra through 2045

Defending the asset is a major ongoing activity, evidenced by recent patent allowances. A new patent covering the FDA-approved weight-threshold dosing regimen was recently allowed and is expected to be listed in the FDA's Orange Book, providing protection into 2045. This is crucial because existing Orange Book patents are set to expire by 2033, with New Chemical Entity (NCE) exclusivity ending in 2029. The estimated generic launch date, based on current patents and exclusivities, is February 04, 2045.

Regulatory Filings and Approvals in New Geographies (e.g., Europe)

The company transitioned to a commercial-stage enterprise in Europe by securing conditional marketing authorization from the European Commission (EC) in August 2025. This made Rezdiffra the first and only approved MASH therapy in the EU. The key activity is the country-by-country rollout, which commenced with the launch in Germany in the fourth quarter of 2025.

The EC Decision is valid across the 27 Member States of the EU, plus Iceland, Liechtenstein and Norway. Madrigal estimates the initial European target population of diagnosed F2-F3 patients to be approximately 370,000.

Madrigal ended the third quarter of 2025 with $1.1 billion in cash, cash equivalents, restricted cash, and marketable securities, which helps fund these global commercial and R&D activities. Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Key Resources

The foundation of Madrigal Pharmaceuticals, Inc.'s business model rests on several distinct, high-value assets as of late 2025.

Rezdiffra (resmetirom) drug asset and its proprietary data represent the core value. This asset is supported by significant commercial traction and clinical understanding, evidenced by the latest sales figures and patient adoption rates.

• Net Product Revenue for Q3 2025: $287.3 million.
• Active Patients on Therapy (as of September 30, 2025): More than 29,500.
• U.S. Launch Performance (as of Q2 2025): Net sales were annualizing at well over $800 million.
• Total Employees (as of October 30, 2025): 528.

Intellectual property provides a long-term moat for this asset. Madrigal Pharmaceuticals, Inc. secured a new U.S. patent covering the commercial weight-threshold dosing regimen, which is critical for defending the asset against generic entry.

The strong cash position ensures the company can fund its commercial scale-up and pipeline diversification without immediate external pressure. This liquidity is a direct result of prior financing activities and strong product sales.

The financial strength as of the end of the third quarter of 2025 is substantial.

Building out the specialized commercial sales force and market access capabilities is another key resource. This team is focused on reaching the specific specialists who treat the target patient population.

• Healthcare Providers Prescribing Rezdiffra: More than 10,000.
• Prescriber Penetration (Top Targets as of Q2 2025): 80% of top 6,000 targets.
• Target U.S. Patient Population (F2/F3 MASH): Estimated at 7% on therapy as of Q2 2025.

Finally, the experienced R&D and executive leadership team guides the strategy, which includes pipeline expansion. This is evidenced by the recent strategic licensing deal.

• Pipeline Addition: Global licensing agreement for an oral GLP-1 development candidate (MGL-2086).
• Upcoming R&D Milestone: MGL-2086 expected to enter the clinic in the first half of 2026.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Value Propositions

You're looking at the core offering for Madrigal Pharmaceuticals, Inc. right now, and it centers entirely on Rezdiffra (resmetirom). This isn't just another drug; it's the first approved therapy in a major, underserved disease space.

First and only FDA/EC-approved oral treatment for MASH with moderate to advanced fibrosis (F2-F3)

The primary value proposition is market exclusivity as the first-in-class agent. Rezdiffra is the first approved medication for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in the U.S. and Europe, specifically indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis. The U.S. Food and Drug Administration (FDA) granted accelerated approval on March 14, 2024.

Liver-directed mechanism (THR-β agonist) targeting underlying disease drivers

The product works by being a thyroid hormone receptor (THR)-$\beta$ selective agonist, engineered to be liver-directed. This mechanism targets the core pathophysiology of MASH by modulating gene expression to improve lipid metabolism and reduce inflammation in the liver.

Demonstrated MASH resolution and liver fibrosis improvement in Phase 3 trials

The clinical data from the pivotal Phase 3 MAESTRO-NASH biopsy trial is what underpins this value. Madrigal Pharmaceuticals, Inc. achieved both the fibrosis improvement and MASH resolution primary endpoints. Here's a look at the hard numbers from the key trials:

Honestly, seeing a 51% rate of improvement in liver stiffness in the compensated cirrhosis (F4c) arm is a big deal for a population with no approved options.

Once-daily, oral administration for patient convenience

The formulation itself is a key feature. Rezdiffra is a once-daily, oral therapy. This is a significant convenience factor compared to potential future injectable or more complex regimens.

Potential for future combination therapy to optimize efficacy and tolerability

While not yet a formal indication, the latest data suggests strong compatibility with other agents. Secondary analyses show that the drug's benefits on MASH resolution and fibrosis improvement are not driven by weight loss, but enhanced by it. Furthermore, efficacy remained consistent regardless of whether patients were on background GLP-1 or SGLT2 inhibitor therapy. This strongly implies that Madrigal Pharmaceuticals, Inc. is positioning the drug as a foundational component in a multi-pronged treatment approach moving forward. The ongoing Phase 3 MAESTRO-NASH-OUTCOMES trial is evaluating use in compensated MASH cirrhosis (F4c) patients, an advanced population.

• Data presented in late 2025 reinforces confidence in Rezdiffra's potential across F2 to F4c MASH.
• The drug is designed to target key underlying causes of MASH.

Finance: draft Q4 2025 cash flow projection incorporating initial net sales estimates by next Tuesday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Customer Relationships

You're building a commercial presence for a first-in-class therapy, so your relationships with the medical community and investors are everything right now. Madrigal Pharmaceuticals, Inc. is clearly focused on high-touch engagement to drive adoption of Rezdiffra, especially given the high unmet need in metabolic dysfunction-associated steatohepatitis (MASH).

High-touch engagement with liver specialists and key opinion leaders (KOLs)

Madrigal Pharmaceuticals, Inc. is driving adoption by targeting the estimated 315,000 patients with moderate to advanced fibrosis (F2-F3) under the care of liver specialists in the U.S.. The initial US launch saw strong uptake; by Q1 2025, 70% of the top 6,000 target prescribers had already written a prescription for Rezdiffra. The penetration expanded to 50% of the broader 14,000 target prescriber base by that time. The company is also engaging the scientific community directly; for instance, Madrigal Pharmaceuticals had a significant presence at the American Association for the Study of Liver Disease (AASLD) Liver Meeting in November 2025, with 15 abstracts accepted, including two oral presentations.

Here's a quick look at the scale of patient onboarding as of late 2025:

Dedicated patient support and access programs for Rezdiffra

To ensure patients can start and stay on therapy, Madrigal Pharmaceuticals, Inc. established the Madrigal Patient Support program. This program helps patients find specialty pharmacies, verify insurance coverage, and identify financial assistance options. For patients with commercial insurance who have a valid prescription but whose insurance doesn't cover the full cost, the Copay Program is available, with enrollment valid for 12 months. For assistance with the Copay Program, patients can call 1-877-219-7770, Monday through Friday, 8 AM-8 PM ET. The Patient Assistance Program offers the drug at no cost for eligible patients with limited insurance, specifically mentioning support for Medicare/Medicaid, Underinsured, and Uninsured populations.

• Nurse Navigator support available throughout treatment.
• Online enrollment available at https://mpshcp.iassist.com/.
• Copay Program not valid for cash-paying patients or those on government-funded insurance like Medicare or Medicaid.

Direct communication with investors via conferences and financial reporting

Madrigal Pharmaceuticals, Inc. maintains a very active cadence of direct communication with the investment community, which is key for a company with its valuation profile. You can see this in their late 2025 schedule. The company hosted its Third-Quarter 2025 Financial Results Webcast on November 4, 2025. Following that, they were scheduled for several fireside chats in early December 2025:

• Jefferies Global Healthcare Conference in London: November 20, 2025.
• 8th Annual Evercore Healthcare Conference: December 2, 2025.
• Piper Sandler 37th Annual Healthcare Conference: December 3, 2025.

Earlier in the year, they presented at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. The company reported cash, cash equivalents, restricted cash, and marketable securities of $1.1 billion as of September 30, 2025.

Regulatory engagement with FDA and European Commission (EC)

Regulatory milestones are central to Madrigal Pharmaceuticals, Inc.'s customer base expansion. The European Commission (EC) granted conditional marketing authorization for Rezdiffra in August 2025. This made Rezdiffra the first and only approved therapy in the European Union (EU) for MASH. Following this, Madrigal launched Rezdiffra in Germany in September 2025. The initial US approval was granted under accelerated approval. Furthermore, a new US patent covering the FDA-approved use was listed in the Orange Book in August 2025, extending protection into 2045.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Channels

You're looking at how Madrigal Pharmaceuticals, Inc. gets Rezdiffra (resmetirom) into the hands of patients with metabolic dysfunction-associated steatohepatitis (MASH) as of late 2025. The channel strategy is clearly focused on a high-touch, specialty distribution model supported by targeted physician engagement and recent international expansion.

Specialty Pharmacy and Distributor Network for Drug Fulfillment

Madrigal Pharmaceuticals, Inc. uses a focused distribution method for Rezdiffra. The drug is available via a limited specialty pharmacy network. You can submit a prescription directly to one of the in-network specialty pharmacies if you are familiar with that process. Alternatively, prescriptions can be sent to Madrigal Patient Support, which then helps coordinate triaging to the payer-mandated or in-network specialty pharmacy after assessing insurance coverage and eligibility for financial assistance. Once enrolled, the specialty pharmacy contacts the patient to confirm delivery details. Depending on the patient's insurance coverage, the initial prescription delivery to the patient's home typically occurs within 30-45 days.

Direct Sales Force Detailing to Target U.S. Patients' Physicians

The commercial channel relies heavily on direct engagement with prescribing physicians. Madrigal Pharmaceuticals, Inc. is targeting a specific U.S. patient population of diagnosed MASH with moderate to advanced fibrosis (F2 to F3). This addressable market is estimated to be approximately 315,000 patients. The sales force details to these physicians to drive adoption. By the end of the first quarter of 2025, penetration reached 50% of the broader 14,000 target prescriber base. As of the third quarter of 2025, the company reported that more than 10,000 healthcare providers were prescribing Rezdiffra. The company noted that as of September 30, 2025, more than 29,500 patients were on therapy.

Here's a quick look at the commercial scale as of the end of Q3 2025:

Regulatory Submissions and International Launch

The channel expansion into Europe was enabled by key regulatory milestones. The European Commission (EC) granted conditional marketing authorization for Rezdiffra in August 2025. This followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP). The U.S. approval was granted under accelerated approval. The U.S. patent protection for Rezdiffra is listed in the Orange Book and provides protection into 2045.

Madrigal Pharmaceuticals, Inc. is executing a phased international rollout strategy. The initial European launch was planned for Germany in the fourth quarter of 2025. The company launched Rezdiffra in Germany in September 2025. Subsequent access across the remaining 27 EU member states, plus Iceland, Liechtenstein, and Norway, is dependent on negotiating reimbursement procedures in each country.

The channel strategy is also being bolstered by pipeline development to support future combination therapies:

• Closed global licensing agreement with CSPC Pharma for an oral GLP-1 receptor agonist.
• Upfront payment for the license was $120 million.
• Milestone payments for the license are up to $2 billion.
• Clinical trials for the new pipeline drug are expected by the first half of 2026.

The company is defintely moving quickly to secure and expand its commercial footprint.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Customer Segments

You're looking at the core patient base Madrigal Pharmaceuticals, Inc. (MDGL) is targeting right now with Rezdiffra, the first approved therapy for this condition. The initial focus is sharp and deep, which is smart for a specialty launch.

Adults with noncirrhotic MASH (NASH) with moderate to advanced fibrosis (F2-F3)

This is the currently approved indication for Rezdiffra, meaning these are the patients you can treat today. The medical rationale for targeting this group is clear: the risk of severe outcomes is already elevated significantly.

• Patients with MASH and moderate to advanced fibrosis (F2 to F3) have a 10 to 17 times higher risk of liver-related mortality compared to patients without fibrosis.
• MASH is also an independent driver of cardiovascular disease, which is the leading cause of mortality for these patients.
• Rezdiffra is indicated in conjunction with diet and exercise for these adults.

The commercial uptake has been quite strong since launch. As of the third quarter of 2025, more than 29,500 patients were actively on Rezdiffra therapy. This generated net sales of $287.3 million in the third quarter of 2025 alone. Still, management noted that greater than 90 percent of the target population was yet to be treated as of the Q3 2025 call.

Liver specialists (hepatologists, gastroenterologists) and endocrinologists

These are the key prescribers and the gatekeepers to the patient population. Madrigal Pharmaceuticals, Inc. is building out its commercial infrastructure to reach them directly. Honestly, getting the specialists on board is step one for any specialty drug.

As of September 30, 2025, more than 10,000 healthcare providers were prescribing Rezdiffra. These professionals are the ones diagnosing and managing the complex metabolic and liver aspects of MASH. The initial U.S. target market is defined by those under the care of liver specialists.

Here's a quick look at the initial target patient pools Madrigal is focused on reaching in the U.S. and Europe for the F2-F3 segment:

Future segment: Patients with compensated MASH cirrhosis (F4c)

This represents the next major expansion opportunity for Madrigal Pharmaceuticals, Inc., effectively doubling the potential market size if they secure approval. These patients are at an even higher risk level.

• Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality.
• Madrigal Pharmaceuticals, Inc. is studying Rezdiffra in an ongoing, fully enrolled Phase 3 outcomes trial for this group.
• In the U.S., an estimated 245,000 patients with compensated MASH cirrhosis (F4c) are currently under the care of liver specialists.

The company presented compelling two-year biomarker data from the open-label F4c arm of the Maestro-NAFLD-1 trial at the EASL Congress in 2025. This data showed significant improvements in liver stiffness and fibrosis biomarkers for patients treated with Rezdiffra in this advanced setting.

Global patient populations, starting with the U.S. and Europe

While the immediate focus is on the diagnosed, treatable F2-F3 population in developed markets, the overall prevalence is massive. Globally, prevalent MASH cases were estimated at 350.42 million in 2024, with a diagnosed population of 37.84 million. The overall diagnosed population in Europe was estimated at 5.49 million in 2024.

The U.S. patient burden is also projected to grow substantially; cases of MASH were forecast to increase from 14.9 million in 2020 to 23.2 million by 2050. The number of U.S. patients with MASH and clinically significant fibrosis (F≥2) was estimated to increase from 6.7 million in 2020 to 11.7 million by 2050. The company's strategy is definitely focused on capturing the most acute need first, which is the F2-F3 group, before expanding into the F4c group. Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Cost Structure

The Cost Structure for Madrigal Pharmaceuticals, Inc. (MDGL) is heavily weighted toward commercialization efforts for Rezdiffra (resmetirom) and significant investment in pipeline expansion, particularly following major licensing deals. This structure reflects a company transitioning from clinical-stage to a commercial-stage biopharma.

Selling, General, and Administrative (SG&A) Costs for Commercial Launch

The commercial launch of Rezdiffra drives substantial SG&A expenses. You saw SG&A costs reach $196.9 million in the second quarter of 2025, which was a significant step up from the prior year period's $105.4 million. This increase is directly tied to the annualization of higher commercial investment needed to support the Rezdiffra launch. By the third quarter of 2025, this expense continued to climb to $209.1 million.

Significant Research and Development (R&D) Expenses

Research and Development remains a major cost center, especially with the recent acquisition of new pipeline assets. For the third quarter of 2025, R&D expenses were reported at $174.0 million. This figure is notable because it includes a $117 million one-time expense related to the global licensing agreement for MGL-2086 (SYH2086). To give you context, Q2 2025 R&D was $54.1 million.

Cost of Goods Sold (COGS) for Rezdiffra Manufacturing

As Rezdiffra sales ramp up, so do the associated manufacturing costs. The Cost of Goods Sold (COGS) for Rezdiffra manufacturing in the third quarter of 2025 was reported as $18.1 million. This compares to the $9.1 million in COGS recorded for the three months ended June 30, 2025.

The quarterly operating expense profile clearly shows the shift in focus:

Upfront Licensing Fees

Madrigal Pharmaceuticals, Inc. is actively spending capital to secure future growth drivers. A key example is the global licensing agreement for SYH2086 (MGL-2086), an oral GLP-1 receptor agonist, from CSPC Pharmaceutical Group Limited. This deal required an upfront payment of $120 million. The total potential value of this agreement is substantial, reaching up to $2 billion in milestone payments, plus royalties on net sales.

Clinical Trial Costs for Ongoing Studies

The cost structure includes ongoing investment in clinical trials to expand Rezdiffra's label and advance the pipeline. You are funding the Phase III MAESTRO-NASH outcomes trial, which is evaluating Rezdiffra in patients with compensated MASH cirrhosis (F4c). This is a critical cost, as positive results could position Rezdiffra as the only therapy with outcomes data in MASH this decade. The results from an ongoing trial intended to prove whether treatment can improve health outcomes are expected in 2026 or 2027.

• The R&D expense in Q3 2025 included the $117 million one-time licensing charge.
• The company is advancing its pipeline with the MGL-2086 candidate, which is expected to enter the clinic in the first half of 2026.
• The cost for clinical trials can fluctuate; for instance, R&D expense decreased in Q2 2025 partly due to a reduction in clinical trial expenses compared to the prior year.

Finance: draft 13-week cash view by Friday.

Madrigal Pharmaceuticals, Inc. (MDGL) - Canvas Business Model: Revenue Streams

You're looking at the core engine of Madrigal Pharmaceuticals, Inc. (MDGL)'s value capture right now, which is almost entirely tied to the commercial success of its flagship product.

Net product sales of Rezdiffra (resmetirom)

The primary revenue stream for Madrigal Pharmaceuticals, Inc. (MDGL) is the direct sale of Rezdiffra (resmetirom), the first and only FDA and European Commission-approved treatment for MASH with moderate to advanced fibrosis. This is the company's current, realized revenue source.

The latest reported quarterly performance shows significant traction:

• Q3 2025 net revenues were $287.3 million.
• This Q3 performance means quarterly sales are now annualizing above $1 billion.
• As of September 30, 2025, more than 29,500 patients were on Rezdiffra therapy.
• The U.S. specialist-treated patient population targeted is approximately 315,000, suggesting early-stage penetration is only about 7% of that segment.

Here's a quick look at the recent revenue trajectory:

Potential future milestone payments from out-licensing agreements (not yet realized)

Madrigal Pharmaceuticals, Inc. (MDGL) has established agreements that create potential future, non-product revenue streams. These are contingent on specific future events, like development or regulatory achievements by partners.

• Closed a global licensing agreement with CSPC Pharma for an oral GLP-1 receptor agonist.
• The company secured up to $500 million in senior secured credit in July 2025, which is non-dilutive financing, not a milestone payment, but it strengthens the balance sheet to fund development.

Royalties from future international partnerships (as commercialization expands)

Revenue diversification is planned through geographic expansion, which will likely involve royalty or profit-sharing structures with local partners, though specific royalty rates aren't public.

• Rezdiffra launched in Germany in September 2025.
• The European Commission granted conditional marketing authorization in August 2025.
• The new U.S. patent for Rezdiffra provides exclusivity protection extending into 2045.

Analysts forecast annual revenue growth of 34.8% looking ahead.