MADRIGAL PHARMACEUTICALS, INC.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
MDGL$399.63-0.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-07-30.
0001628280-26-050845
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-03.
0001628280-26-069145
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 104 previous paragraphs and 100 current paragraphs.
65 unchanged; 30 reworded; 5 added; 8 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO-NASH OUTCOMES trial, that, if successful, is expected to support the full FDA approval of Rezdiffra for noncirrhotic MASH, and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis. In this event-driven trial, we are assessing progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra versus placebo. We expect data from the MAESTRO-NASH OUTCOMES trial in late 2027. In addition, we plan to initiate an additional Phase 3 trial in compensated MASH cirrhosis. MAESTRO-CSPH is a new Phase 3 event-driven trial that is expected to enroll more than 2,000 F4c patients, with a population enriched for clinically significant portal hypertension (“CSPH”). Together, we expect data from MAESTRO-NASH OUTCOMES and MAESTRO-CSPH to provide us with the most comprehensive dataset in F4c. Pending regulatory discussions, we expect to initiate MAESTRO-CSPH in the first half of 2027 and anticipate results in the early 2030s.
Current report
In August 2026, we announced the appointment of John C. Reed, M.D., Ph.D. to our Board of Directors. Dr. Reed currently serves as Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson (“J&J”) and is a member of J&J’s Executive Committee, where he leads research and development across oncology, immunology, neuroscience and other areas of significant unmet medical need. Prior to joining J&J in April 2023, Dr. Reed held executive leadership positions at Sanofi and Roche, serving on their respective executive committees. Earlier in his career, he served as President and Chief Executive Officer of Sanford-Burnham Medical Research Institute (now Sanford Burnham Prebys), where he established multiple disease-focused research centers and platform technology organizations.
Current report
Nine Months Ended September 30, 2026 and 2025
Current report
$34.6 million increase in facility-related and other internal expenses, primarily due to higher information technology costs to support the expansion of our operations.
Current report
In September 2025, we entered into an operating lease for office space in Waltham, Massachusetts. The lease commenced in July 2026 and resulted in the recognition of an $8.1 million right-of-use asset and a $6.8 million lease liability. The right-of-use asset includes approximately $1.3 million of prepaid lease payments.
Removed paragraphs (8)
Previous report
In May 2026, we announced an exclusive global license agreement (the “Arrowhead License Agreement”) with Arrowhead Pharmaceuticals Inc. (“Arrowhead”) for ARO-PNPLA3 (now referred to as MGL-0795), a clinical-stage siRNA asset targeting a mutation in the PNPLA3 gene, a genetically validated driver of MASH. MGL-0795 is a GalNac-conjugated siRNA designed to reduce expression of PNPLA3. Mutations in the PNPLA3 gene have been shown to disrupt the liver’s ability to properly process fat. This leads to increased fat accumulation in hepatocytes, and is strongly associated with MASH progression and a high risk of developing hepatocellular carcinoma. The results of two Phase 1 trials suggested that a single dose of MGL-0795 reduced liver fat content in homozygous carriers of the PNPLA3 I148M variant, providing proof-of-concept as a precision-medicine approach in this patient population. We will consult with the FDA on design of a Phase 2 combination trial with resmetirom.
Previous report
In May 2026, we presented several posters at the European Association for the Study of the Liver (EASL) Congress. Over a mean follow-up period of approximately nine months, real world data demonstrated that nearly 50% of patients treated with Rezdiffra achieved at least a 25% improvement in liver stiffness, a key measure of treatment response. We also presented a secondary analysis from our Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 trials demonstrating that Rezdiffra improved key histologic MASH endpoints and significantly reduced multiple atherogenic lipoproteins associated with cardiovascular risk, including LDL and Lp(a), regardless of baseline statin use. In addition, we presented data showing that a MASH-specific risk stratification model (ANTICIPATE-NASH) that estimates clinically significant portal hypertension (CSPH) risk and likelihood of liver-related events was applied to MAESTRO-NAFLD-1 OLE F4c results. The proportion of patients classified as higher risk for CSPH decreased from 75% at baseline to 54.5% at Year 2.
Previous report
In June 2026, the United Kingdom’s Medicines and Healthcare Regulatory Agency authorized Rezdiffra to treat adult patients with MASH with moderate to advanced liver fibrosis.
Previous report
In June 2026, we initiated a Phase 1 single ascending dose trial of MGL-2086 in healthy volunteers to assess safety and a dose response. In addition, in July 2026, we nominated the first siRNA candidate for clinical development pursuant to the Ribocure License Agreement.
Previous report
In June 2026, the United States Patent and Trademark Office (USPTO) issued us three new patents directed toward resmetirom. U.S. Patent No. 12,667,575 is directed to administering a weight-threshold step-down 60mg or 80mg resmetirom dose for patients with F2/F3 MASH also using a moderate CYP2C8 inhibitor. This patent issued on June 30, 2026, and expires in February 2045. U.S. Patent No. 12,661,359 is directed to the administration of rosuvastatin and resmetirom and limits the daily dose of rosuvastatin to a maximum of 20mg per day to reduce or eliminate dose-related side effects. This patent issued on June 23, 2026, and expires in January 2042. These two patents have been listed in the
Previous report
FDA’s Orange Book. In addition, U.S. Patent No. 12,661,361 is directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c). This patent issued on June 23, 2026, and expires in September 2042.
Previous report
Six Months Ended June 30, 2026 and 2025
Previous report
In September 2025, we entered into an operating lease for office space in Waltham, Massachusetts. The commencement date had not occurred as of June 30, 2026. Upon lease commencement, we expect to make total lease payments of $9.9 million over an 84-month lease term. As of June 30, 2026, we recorded a $1.3 million prepaid lease payment related to approved change orders, which will be included in the measurement of the right-of-use asset upon commencement.
Reworded paragraphs (30)
Previous wording
We are a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is the leading cause of liver transplantation in women, the second leading cause of all liver transplantation in the United States and the fastest-growing indication for liver transplantation in Europe. Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. In March 2024, Rezdiffra became the first therapy approved by the U.S. Food and Drug Administration (“FDA”) for patients with MASH and was commercially available in the United States beginning in April 2024. Following receipt of conditional marketing authorization (“CMA”) from the European Commission (“EC”), we launched Rezdiffra in Germany in September 2025. Rezdiffra was the first medication approved by both the FDA and EC for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3 fibrosis). We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO-NASH OUTCOMES trial, that, if successful, could expand the eligible patient population for Rezdiffra.
Current wording
We are a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is the leading cause of liver transplantation in women, the second leading cause of all liver transplantation in the United States and the fastest-growing indication for liver transplantation in Europe. Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. In March 2024, Rezdiffra became the first therapy approved by the U.S. Food and Drug Administration (“FDA”) for patients with MASH and was commercially available in the United States beginning in April 2024. Following receipt of conditional marketing authorization (“CMA”) from the European Commission (“EC”), we launched Rezdiffra in Germany in September 2025. Rezdiffra was the first medication approved by both the FDA and EC for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3 fibrosis).
Previous wording
The FDA’s accelerated approval and the EC’s conditional marketing authorization, as well as Rezdiffra’s approved prescribing information, were supported by 52-week data from our Phase 3 MAESTRO-NASH trial in which both 100 mg and 80 mg doses of Rezdiffra demonstrated statistically significant improvement compared to placebo on (i) MASH resolution with no worsening of fibrosis and (ii) an improvement in fibrosis by at least one stage with no worsening of the nonalcoholic fatty liver disease (“NAFLD”) activity score. MAESTRO-NASH remains ongoing as an outcomes trial where we are generating confirmatory outcomes data to 54-months that, if positive, is expected to verify a clinical benefit and support the full FDA approval of Rezdiffra to treat noncirrhotic MASH. We expect outcomes data from this trial in 2028. In addition, full FDA approval of Rezdiffra to treat noncirrhotic MASH could also be based on results from our Phase 3 MAESTRO-NASH OUTCOMES trial. In this event-driven trial, we are assessing progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra versus placebo. A positive outcome in this trial is also expected to support the full FDA approval of Rezdiffra for noncirrhotic MASH, and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis. We expect results from the MAESTRO-NASH OUTCOMES trial in 2027. We have agreed to submit results from these trials to the European Medicines Agency (“EMA”) in support of full approval of Rezdiffra in the European Union.
Current wording
The FDA’s accelerated approval and the EC’s conditional marketing authorization, as well as Rezdiffra’s approved prescribing information, were supported by 52-week data from our Phase 3 MAESTRO-NASH trial in which both 100 mg and 80 mg doses of Rezdiffra demonstrated statistically significant improvement compared to placebo on (i) MASH resolution with no worsening of fibrosis and (ii) an improvement in fibrosis by at least one stage with no worsening of the nonalcoholic fatty liver disease (“NAFLD”) activity score. MAESTRO-NASH remains ongoing as an outcomes trial where we are generating confirmatory outcomes data to 54-months that, if positive, is expected to verify a clinical benefit and support the full FDA approval of Rezdiffra to treat noncirrhotic MASH. We expect outcomes data from MAESTRO-NASH in 2028. In addition, as discussed above, full FDA approval of Rezdiffra to treat noncirrhotic MASH could also be based on results from our Phase 3 MAESTRO-NASH OUTCOMES trial. A positive outcome in this trial is also expected to support the full FDA approval of Rezdiffra for noncirrhotic MASH, and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis. We have agreed to submit results from these trials to the European Medicines Agency (“EMA”) in support of full approval of Rezdiffra in the European Union.
Previous wording
MASH is a more advanced form of metabolic dysfunction-associated steatotic liver disease (“MASLD”). MASLD has become the most common liver disease in the United States and other developed countries and is characterized by an accumulation of fat in the liver with no other apparent causes. MASH can progress to cirrhosis or liver failure, can require liver transplantation and can also result in liver cancer. Patients with MASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. In addition, MASH patients with moderate to advanced fibrosis (consistent with fibrosis stages F2 and F3) have a 10-to-17 times higher risk of liver-related mortality. MASH is also an independent driver of cardiovascular disease, which is the leading cause of mortality for patients.
Current wording
MASH is a more advanced form of metabolic dysfunction-associated steatotic liver disease (“MASLD”). MASLD has become the most common liver disease in the United States and other developed countries and is characterized by an accumulation of fat in the liver with no other apparent causes. MASH can progress to cirrhosis or liver failure, can require liver transplantation and can also result in liver cancer. Patients with MASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. In addition, MASH patients with moderate to advanced fibrosis (consistent with fibrosis stages F2 and F3) have a 10-to-17 times higher risk of liver-related mortality. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, which is the leading cause of mortality for patients.
Previous wording
Based on published epidemiology data and an analysis of medical claims using ICD-10 disease diagnosis codes as of 2023, we estimate that 315,000 patients diagnosed with MASH with moderate to advanced fibrosis (stages F2 to F3) were under the care of specialist prescribers which we are targeting during the launch of Rezdiffra in the U.S. Through 2025, we estimate that the number of patients under specialist care in the U.S. has grown nearly 50% to approximately 460,000 patients with moderate to advanced fibrosis, and as disease awareness improves and disease prevalence increases, we expect the number of identified MASH patients with moderate to advanced fibrosis eligible for treatment to grow significantly going forward. In addition, we estimate that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of specialists across Europe.
Current wording
Based on published epidemiology data and an analysis of medical claims using ICD-10 disease diagnosis codes as of year-end 2023, we estimated that 315,000 patients diagnosed with MASH with moderate to advanced fibrosis (stages F2 to F3) were under the care of specialist prescribers which we are targeting during the launch of Rezdiffra in the U.S. Through the first half of 2026, we estimate that the number of patients under the care of our target prescribers in the U.S. has grown to more than 530,000 patients with moderate to advanced fibrosis, and as disease awareness improves and disease prevalence increases, we expect the number of identified MASH patients with moderate to advanced fibrosis eligible for treatment to grow significantly going forward. We also estimate that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of specialists across Europe. In addition, we estimate that the number of patients with compensated MASH cirrhosis under the care of our target prescribers in the U.S. has grown from approximately 245,000 as of the end of 2024 to approximately 360,000 as of June 30, 2026.
Previous wording
We recorded $364.3 million of product revenue, net for the three months ended June 30, 2026, compared to $212.8 million in the corresponding period in 2025. The increase was driven by increased demand for Rezdiffra in the United States in 2026.
Current wording
We recorded $431.3 million of product revenue, net for the three months ended September 30, 2026, compared to $287.3 million in the corresponding period in 2025. The increase was driven by increased demand for Rezdiffra in the United States in 2026.
Previous wording
Cost of sales were incurred as a result of sales of Rezdiffra and includes non-cash stock-based compensation expense for employees dedicated to the production of Rezdiffra. For the six months ended June 30, 2026, we recorded $66.9 million of cost of sales compared to $13.6 million in the corresponding period in 2025. The increase in cost of sales was primarily driven by (i) an increase in royalties payable to Roche as a result of an increase in net sales of Rezdiffra in 2026 and (ii) a write-down of $10.4 million for certain work-in-process inventory that may not meet quality specifications.
Current wording
Cost of sales was incurred as a result of sales of Rezdiffra and includes non-cash stock-based compensation expense for employees dedicated to the production of Rezdiffra. For the three months ended September 30, 2026, we recorded $37.8 million of cost of sales compared to $18.1 million in the corresponding period in 2025. The increase in cost of sales was primarily driven by an increase in royalties payable to Roche as a result of an increase in net sales of Rezdiffra in 2026.
Previous wording
Our research and development expenses were $91.2 million for the three months ended June 30, 2026, compared to $54.1 million in the corresponding period in 2025. Research and development expenses include non-cash stock-based compensation expense associated with employees engaged in research and development activities. Research and development expenses increased by $37.1 million in the 2026 period, primarily due to one-time upfront business development expenses of $25.0 million and an $8.0 million increase in compensation and benefit-related expenses and stock-based compensation expense as a result of increased headcount in connection with pipeline expansion activities.
Current wording
Our research and development expenses were $71.8 million for the three months ended September 30, 2026, compared to $174.0 million in the corresponding period in 2025. Research and development expenses include non-cash stock-based compensation expense associated with employees engaged in research and development activities. Research and development expenses decreased by $102.2 million in the 2026 period. The decrease was primarily attributable to one-time upfront business development expenses of $117.3 million recognized in the corresponding period in 2025. This decrease was partially offset by higher clinical development costs resulting from additional studies related to our expanded pipeline in 2026 and a $7.3 million increase in compensation and benefit-related expenses, including stock-based compensation, reflecting increased headcount to support pipeline expansion activities in 2026.
Previous wording
Our selling, general and administrative expenses were $289.4 million for the three months ended June 30, 2026, compared to $196.9 million in the corresponding period in 2025. Selling, general and administrative expenses includes non-cash stock-based compensation expense. Selling, general and administrative expenses increased by $92.5 million in the 2026 period, primarily due to a $39.2 million increase in professional fees and other external expenses as a result of continued investment in commercial activities for Rezdiffra, including direct-to-consumer (DTC) marketing efforts and a $36.4 million increase in compensation and benefit-related expenses and stock-based compensation expense primarily due to headcount for the endocrinology field force expansion that began in the fourth quarter of 2025.
Current wording
Our selling, general and administrative expenses were $265.7 million for the three months ended September 30, 2026, compared to $209.1 million in the corresponding period in 2025. Selling, general and administrative expenses includes non-cash stock-based compensation expense. Selling, general and administrative expenses increased by $56.6 million in the 2026 period, primarily due to a $21.1 million increase in professional fees and other external expenses as a result of continued investment in commercial activities for Rezdiffra, including direct-to-consumer (DTC) marketing efforts and a $29.7 million increase in compensation and benefit-related expenses and stock-based compensation expense primarily due to headcount for the endocrinology field force expansion that began in the fourth quarter of 2025.
Previous wording
Our net interest income was $7.1 million for the three months ended June 30, 2026, compared to $8.2 million in the corresponding period in 2025. The decrease in interest income was primarily due to lower interest rates and lower average balances of interest-bearing cash equivalents and marketable securities compared to the corresponding period in 2025.
Current wording
Our net interest income was $8.2 million for the three months ended September 30, 2026, compared to $10.3 million in the corresponding period in 2025. The decrease in interest income was primarily due to lower interest rates and lower average balances of interest-bearing cash equivalents and marketable securities compared to the corresponding period in 2025.
Previous wording
Our interest expense was $7.9 million for the three months ended June 30, 2026, compared to $3.3 million in the corresponding period in 2025. The increase of $4.7 million was primarily the result of a higher average outstanding principal balance after entering into the Financing Agreement.
Current wording
Our interest expense was $8.1 million for the three months ended September 30, 2026, compared to $7.5 million in the corresponding period in 2025. The increase was primarily attributable to a higher average outstanding principal balance, reflecting the full quarter impact of borrowings under the Financing Agreement.
Previous wording
The following table provides comparative unaudited results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table provides comparative unaudited results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
We recorded $675.6 million of product revenue, net for the six months ended June 30, 2026, compared to $350.1 million in the corresponding period in 2025. The increase was driven by increased demand for Rezdiffra in the United States in 2026.
Current wording
We recorded $1,106.9 million of product revenue, net for the nine months ended September 30, 2026, compared to $637.3 million in the corresponding period in 2025. The increase was driven by increased demand for Rezdiffra in the United States in 2026.
Previous wording
Cost of sales were incurred as a result of sales of Rezdiffra and includes non-cash stock-based compensation expense for employees dedicated to the production of Rezdiffra. For the three months ended June 30, 2026, we recorded $40.0 million of cost of sales compared to $9.1 million in the corresponding period in 2025. The increase in cost of sales was primarily driven by (i) an increase in royalties payable to Roche as a result of an increase in net sales of Rezdiffra in 2026 and (ii) a write-down of $10.4 million for certain work-in-process inventory that may not meet quality specifications.
Current wording
Cost of sales were incurred as a result of sales of Rezdiffra and includes non-cash stock-based compensation expense for employees dedicated to the production of Rezdiffra. For the nine months ended September 30, 2026, we recorded $104.7 million of cost of sales compared to $31.7 million in the corresponding period in 2025. The increase in cost of sales was primarily driven by (i) an increase in royalties payable to Roche as a result of an increase in net sales of Rezdiffra in 2026 and (ii) a write-down of $10.4 million for certain work-in-process inventory that did not meet quality specifications.
Previous wording
The following table represents our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table represents our research and development expenses for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Our research and development expenses were $199.9 million for the six months ended June 30, 2026, compared to $98.3 million in the corresponding period in 2025. Research and development expenses include non-cash stock-based compensation expense associated with employees engaged in research and development activities. Research and development expenses increased by $101.6 million in the 2026 period, primarily due to one-time upfront business development expenses of $79.3 million related to business development transactions during the six months ended June 30, 2026 and a $16.7 million increase in compensation and benefit-related expenses and stock-based compensation expense as a result of increased headcount in connection with pipeline expansion activities.
Current wording
Our research and development expenses were $271.6 million for the nine months ended September 30, 2026, compared to $272.3 million in the corresponding period in 2025. Research and development expenses include non-cash stock-based compensation expense associated with employees engaged in research and development activities. Research and development expenses decreased by $0.6 million in the 2026 period. The change included a $24.0 million decrease in professional fees and other external expenses, primarily attributable to lower upfront business development expenses in 2026, partially offset by higher clinical development costs resulting from additional studies related to our expanded pipeline in 2026. The decrease in professional fees and other external expenses was offset by a $24.1 million increase in compensation and benefit-related expenses, including stock-based compensation, reflecting increased headcount to support pipeline expansion activities.
Previous wording
The following table represents our selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table represents our selling, general and administrative expenses for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Our selling, general and administrative expenses were $557.9 million for the six months ended June 30, 2026, compared to $364.7 million in the corresponding period in 2025. Selling, general and administrative expenses includes non-cash stock-based compensation expense. Selling, general and administrative expenses increased by $193.2 million in the 2026 period, primarily due to a $82.4 million increase in professional fees and other external expenses as a result of continued investment in commercial activities for Rezdiffra, including direct-to-consumer (DTC) marketing efforts and a $82.0 million increase in compensation and benefit-related expenses and stock-based compensation expense primarily due to headcount for the endocrinology field force expansion that began in the fourth quarter of 2025.
Current wording
Our selling, general and administrative expenses were $823.6 million for the nine months ended September 30, 2026, compared to $573.9 million in the corresponding period in 2025. Selling, general and administrative expenses includes non-cash stock-based compensation expense. Selling, general and administrative expenses increased by $249.8 million in the 2026 period, primarily due to (i) a $103.5 million increase in professional fees and other external expenses as a result of continued investment in commercial activities for Rezdiffra, including direct-to-consumer (DTC) marketing efforts, (ii) a $111.7 million increase in compensation and benefit-related expenses and stock-based compensation expense primarily due to headcount for the endocrinology field force expansion that began in the fourth quarter of 2025 and (iii) a
Previous wording
Our net interest income was $15.3 million for the six months ended June 30, 2026, compared to $17.6 million in the corresponding period in 2025. The decrease in interest income was primarily due to lower interest rates and lower average balances of interest-bearing cash equivalents and marketable securities compared to the corresponding period in 2025.
Current wording
Our net interest income was $23.6 million for the nine months ended September 30, 2026, compared to $27.9 million in the corresponding period in 2025. The decrease in interest income was primarily due to lower interest rates and lower average balances of interest-bearing cash equivalents and marketable securities compared to the corresponding period in 2025.
Previous wording
Our interest expense was $15.8 million for the six months ended June 30, 2026, compared to $6.6 million in the corresponding period in 2025. The increase in interest expense was primarily the result of a higher average outstanding principal balance after entering into the Financing Agreement.
Current wording
Our interest expense was $23.8 million for the nine months ended September 30, 2026, compared to $14.0 million in the corresponding period in 2025. The increase in interest expense was primarily the result of a higher average outstanding principal balance after entering into the Financing Agreement.
Previous wording
As of June 30, 2026, we had cash, cash equivalents, restricted cash, and marketable securities totaling $838.9 million compared to $988.6 million as of December 31, 2025. We have historically funded our operations primarily through proceeds from sales of our capital stock and debt financings. In July 2025, we entered into a senior secured credit facility that provides up to $500.0 million. See Note 8 “Long Term Debt” for additional details. We began receiving revenue from sales of Rezdiffra following the receipt of accelerated FDA approval in March 2024 and CMA from the EC in August 2025.
Current wording
As of September 30, 2026, we had cash, cash equivalents, restricted cash, and marketable securities totaling $961.8 million compared to $988.6 million as of December 31, 2025. We have historically funded our operations primarily through proceeds from sales of our capital stock and debt financings. In July 2025, we entered into a senior secured credit facility that provides up to $500.0 million. See Note 8 “Long Term Debt” for additional details. We began receiving revenue from sales of Rezdiffra following the receipt of accelerated FDA approval in March 2024 and CMA from the EC in August 2025. Although we generated net income of $55.4 million for the three months ended September 30, 2026, we have incurred losses since inception, including approximately $96.9 million for the nine months ended September 30, 2026, resulting in an accumulated deficit of approximately $2,187.4 million as of September 30, 2026. We may experience significant fluctuations in our operating results on a quarterly basis, including incurring net losses in future periods, and our ability to achieve and maintain consistent profitability will depend, in part, on our ability to generate sufficient revenue from Rezdiffra and any other products, if approved, to offset our costs and expenses.
Previous wording
Until we are able to generate sufficient revenue from Rezdiffra and any other future approved products, we anticipate that we will continue to incur losses. While our rate of cash usage will likely increase in the future, in particular to support our product development and clinical trial efforts, our commercialization efforts and geographic expansion activities and our business development goals, we believe our available cash resources are sufficient to fund our operations past one year from the issuance of the financial statements contained herein. Our future long-term liquidity requirements will be substantial and will depend on many factors, including our ability to effectively commercialize Rezdiffra, our decisions regarding future geographic expansion, the conduct of any future preclinical studies and clinical trials, our entry into any strategic transactions, our ability to maintain compliance with the liquidity covenant in the Financing Agreement and potential milestone payments payable pursuant to our license agreements. To meet future long-term liquidity requirements, we may need to raise additional capital to fund our operations through equity or debt financings, collaborations, partnerships or other strategic transactions. Additional capital, if needed, may not be available on terms acceptable to us, or at all. If adequate funds are not available, or if the terms of potential funding sources are unfavorable, this could have a material adverse effect on our business, results of operations and financial condition. We have the ability to delay certain commercial activities, geographic expansion activities and certain research activities and related clinical expenses, if necessary, due to liquidity concerns until a date when those concerns are relieved.
Current wording
While our rate of cash usage will likely increase in the future, in particular to support our product development and clinical trial efforts, our commercialization efforts and geographic expansion activities and our business development goals, we believe our available cash resources are sufficient to fund our operations past one year from the issuance of the financial statements contained herein. Our future long-term liquidity requirements will be substantial and will depend on many factors, including our ability to effectively commercialize Rezdiffra, our decisions regarding future geographic expansion, the conduct of any future preclinical studies and clinical trials, our entry into any strategic transactions, our ability to maintain compliance with the liquidity covenant in the Financing Agreement and potential milestone payments payable pursuant to our license agreements. To meet future long-term liquidity requirements, we may need to raise additional capital to fund our operations through equity or debt financings, collaborations, partnerships or other strategic transactions. Additional capital, if needed, may not be available on terms acceptable to us, or at all. If adequate funds are not available, or if the terms of potential funding sources are unfavorable, this could have a material adverse effect on our business, results of operations and financial condition. We have the ability to delay certain commercial activities, geographic expansion activities and certain research activities and related clinical expenses, if necessary, due to liquidity concerns until a date when those concerns are relieved.
Previous wording
We did not make any sales under the Sales Agreement during the three and six months ended June 30, 2026 or 2025. As of June 30, 2026, $300.0 million remained available for sale under the Sales Agreement and our related prospectus supplement.
Current wording
We did not make any sales under the Sales Agreement during the three and nine months ended September 30, 2026 or 2025. As of September 30, 2026, $300.0 million remained available for sale under the Sales Agreement and our related prospectus supplement.
Previous wording
As of June 30, 2026, the outstanding principal amount under the Financing Agreement was $350.0 million. The interest rate as of June 30, 2026 was 8.45%. Interest expense was $7.9 million and $15.8 million for the three and six months ended June 30, 2026, respectively. Interest expense was $3.3 million and $6.6 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2026, we were in compliance with all loan covenants and provisions.
Current wording
As of September 30, 2026, the outstanding principal amount under the Financing Agreement was $350.0 million. The interest rate as of September 30, 2026 was 8.48%. Interest expense was $8.1 million and $23.8 million for the three and nine months ended September 30, 2026, respectively. Interest expense was $7.5 million and $14.0 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2026, we were in compliance with all loan covenants and provisions.
Previous wording
Net cash used in operating activities was $144.1 million for the six months ended June 30, 2026, compared to $135.9 million for the corresponding period in 2025. The use of cash in these periods resulted primarily from our losses from operations, driven by commercialization efforts, including purchases of API, one-time upfront payments related to business development transactions and higher annual incentive bonus payouts, partially offset by cash receipts from sales of Rezdiffra, as adjusted for non-cash charges, and changes in our working capital accounts.
Current wording
Net cash used in operating activities was $23.6 million for the nine months ended September 30, 2026, compared to $56.1 million for the corresponding period in 2025. The use of cash in these periods resulted primarily from our losses from operations, driven by commercialization efforts, including purchases of API, one-time upfront payments related to business development transactions and higher annual incentive bonus payouts, partially offset by cash receipts from sales of Rezdiffra, as adjusted for non-cash charges, and changes in our working capital accounts.
Previous wording
Net cash provided by investing activities was $226.4 million for the six months ended June 30, 2026, compared to net cash provided by investing activities of $211.7 million for the corresponding period in 2025. Net cash provided by investing activities for the six months ended June 30, 2026 primarily consisted of $541.2 million from sales and maturities of marketable securities, partially offset by $306.7 million of purchases of marketable securities for our investment portfolio and $8.1 million of purchases of property and equipment. Net cash provided by investing activities for the corresponding period in 2025 primarily consisted of $568.1 million from sales and maturities of marketable securities, partially offset by $356.3 million of purchases of marketable securities in our investment portfolio.
Current wording
Net cash provided by investing activities was $320.2 million for the nine months ended September 30, 2026, compared to net cash provided by investing activities of $4.7 million for the corresponding period in 2025. Net cash provided by investing activities for the nine months ended September 30, 2026 primarily consisted of $773.8 million from sales and maturities of marketable securities, partially offset by $441.6 million of purchases of marketable securities for our investment portfolio and $12.0 million of purchases of property and equipment. Net cash provided by investing activities for the corresponding period in 2025 primarily consisted of $843.2 million from sales and maturities of marketable securities, partially offset by $834.6 million of purchases of marketable securities in our investment portfolio.
Previous wording
Net cash provided by financing activities was $5.4 million for the six months ended June 30, 2026, compared to $10.4 million for the corresponding period in 2025. Net cash provided by financing activities for the six months ended June 30, 2026 consisted of $5.4 million from the exercise of stock options. Net cash provided by financing activities for the corresponding period in 2025 consisted of$10.4 million from the exercise of stock options.
Current wording
Net cash provided by financing activities was $15.4 million for the nine months ended September 30, 2026, compared to $247.0 million for the corresponding period in 2025. Net cash provided by financing activities for the nine months ended September 30, 2026 consisted of $15.4 million from the exercise of stock options. Net cash provided by financing activities for the corresponding period in 2025 consisted of $350.0 million of proceeds from the Financing Agreement and$28.1 million from the exercise of stock options, partially offset by a repayment of $121.7 million under the Hercules Loan Facility and $9.4 million of debt issuance costs.
Previous wording
In July 2025, we entered into the CSPC License Agreement with CSPC for MGL-2086 (formerly known as SYH2086), a preclinical oral small molecule GLP-1 receptor agonist. Pursuant to the CSPC License Agreement, CSPC has granted us an exclusive global license to develop, manufacture, and commercialize MGL-2086. The transaction closed in September 2025. We paid CSPC an upfront payment of $120.0 million in October 2025. CSPC is eligible to receive up to $2.0 billion in development, regulatory and commercial milestone payments, as well as royalties on net sales ranging from mid-single digits to low-double digits.
Current wording
In July 2025, we entered into the CSPC License Agreement with CSPC for MGL-2086 (formerly known as SYH2086), an oral small molecule GLP-1 receptor agonist. Pursuant to the CSPC License Agreement, CSPC has granted us an exclusive global license to develop, manufacture, and commercialize MGL-2086. The transaction closed in September 2025. We paid CSPC an upfront payment of $120.0 million in October 2025. CSPC is eligible to receive up to $2.0 billion in development, regulatory and commercial milestone payments, as well as royalties on net sales ranging from mid-single digits to low-double digits.
Previous wording
In May 2026, we entered into the Arrowhead License Agreement with Arrowhead granting us an exclusive global license to ARO-PNPLA3 (now referred to as MGL-0795). Pursuant to the Arrowhead License Agreement, we made an upfront payment of $25.0 million, which was recognized as research and development expense in June 2026. In addition,
Current wording
In May 2026, we entered into the Arrowhead License Agreement with Arrowhead granting us an exclusive global license to ARO-PNPLA3 (now referred to as MGL-0795). Pursuant to the Arrowhead License Agreement, we made an upfront payment of $25.0 million, which was recognized as research and development expense in June 2026. In addition, Arrowhead is eligible to receive up to $975.0 million in development, regulatory and commercial milestone payments, as well as royalties on net sales ranging from high-single digits to the mid-teens.
Previous wording
We have entered into customary contractual agreements in support of the Phase 3 clinical trials and in connection with manufacturing Rezdiffra. As of June 30, 2026, we had approximately $239.4 million of obligations under these agreements related to active pharmaceutical ingredient, which is expected to be paid through December 2029.
Current wording
We have entered into customary contractual agreements in support of the Phase 3 clinical trials and in connection with manufacturing Rezdiffra. As of September 30, 2026, we had approximately $305.9 million of obligations under these agreements related to active pharmaceutical ingredient, which is expected to be paid through December 2029.
Previous wording
Except as noted above, no significant changes to contractual obligations and commitments occurred during the six months ended June 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the SEC on February 19, 2026.
Current wording
Except as noted above, no significant changes to contractual obligations and commitments occurred during the nine months ended September 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the SEC on February 19, 2026.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Arrowhead is eligible to receive up to $975.0 million in development, regulatory and commercial milestone payments, as well as royalties on net sales ranging from high-single digits to the mid-teens.