MADRIGAL PHARMACEUTICALS, INC.
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
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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.
Jun 30, 2025 · Filed Aug 5, 2025
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 2025-03-31; filed 2025-05-01.
0001628280-25-021356
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001628280-25-037613
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 87 previous paragraphs and 107 current paragraphs.
52 unchanged; 26 reworded; 22 added; 9 removed; 0 previous and 7 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 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 (22)
Current report
We also expect to directly commercialize resmetirom in Europe, pending regulatory approval. In June 2025, we received a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency recommending approval of resmetirom for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. We expect to receive a decision regarding the grant of Conditional Marketing
Current report
In August 2025, we announced that Daniel Brennan was appointed to our Board of Directors. Mr. Brennan most recently served as Executive Vice President and Chief Financial Officer of Boston Scientific Corporation (“Boston Scientific”). At Boston Scientific, Mr. Brennan was responsible for several company functions, including global controllership, global internal audit, corporate finance, treasury, corporate tax, investor relations, and corporate business development. Prior to that, he was the company’s Senior Vice President and Corporate Controller and held other roles of increasing responsibility within finance. Mr. Brennan has served on the board of directors of Waters Corporation, a publicly listed company focused on the development of analytical instruments and software, since November 2022. Mr. Brennan previously served on the board of directors of Nuance Corporation, a publicly listed company, from 2018 until its acquisition by Microsoft in 2022. He holds a B.S. in Finance and Investments and an M.B.A from Babson College and is also a certified public accountant.
Current report
In July 2025, we entered into an exclusive global license agreement (the “CSPC License Agreement”) with CSPC Pharmaceutical Group Limited (“CSPC”) for SYH2086, a preclinical oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. Pursuant to the CSPC License Agreement, CSPC has granted us an exclusive global license to develop, manufacture, and commercialize SYH2086. The transaction is expected to close in the fourth quarter of 2025, subject to applicable regulatory clearance. Following closing, CSPC will receive an upfront payment of $120.0 million and is eligible to receive up to $2.0 billion in milestone payments if certain development, regulatory and commercial milestones are achieved, as well as royalties on net sales. We expect to initiate clinical development of SYH2086 in the first half of 2026.
Current report
In July 2025, we, as the borrower, and our wholly owned subsidiary Canticle Pharmaceuticals, Inc. (“Canticle”), as a guarantor, entered into a Financing Agreement (the “Financing Agreement”) with certain funds managed by Blue Owl Capital Corporation, as the lenders (the “Lenders”), and LSI Financing LLC as the administrative agent for the Lenders. Under the Financing Agreement, the Lenders have agreed to commit up to $500.0 million in senior secured credit facilities, consisting of (a) an initial term loan in an aggregate principal amount equal to $350.0 million (the “Initial Term Loan”) and (b) delayed draw term loans in an aggregate principal amount not to exceed $150.0 million (the “Delayed Draw Term Loans”). In addition, the Financing Agreement includes an uncommitted incremental facility in an aggregate principal amount not to exceed $250.0 million (the “Incremental Term Loans”), subject to the satisfaction of certain terms and conditions set forth in the Financing Agreement. The Initial Term Loan was funded on July 17, 2025. Delayed Draw Term Loans are available at our election from time to time until December 31, 2027. Incremental Term Loans are available at our and the Lenders’ mutual consent from time to time.
Current report
In July 2025, we announced that we received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering the FDA-approved use of Rezdiffra. The patent, which was issued on August 5, 2025, includes claims directed to Rezdiffra’s commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. The U.S. patent provides protection to February 2045 and will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
Current report
In June 2025, we announced that the CHMP adopted a positive opinion recommending approval of resmetirom for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The European Commission decision regarding marketing authorization is anticipated in August 2025.
Current report
In May 2025, we announced positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients (n=122) in the trial achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension (CSPH). The trial results were presented in a late-breaking oral abstract at the European Association for the Study of the Liver (EASL) Congress.
Current report
We recorded $212.8 million of product revenue, net for the three months ended June 30, 2025, compared to $14.6 million in the corresponding period in 2024. The increase is due to increased demand for Rezdiffra in 2025.
Current report
Our research and development expenses were $54.1 million for the three months ended June 30, 2025, compared to $71.1 million in the corresponding period in 2024. Research and development expenses decreased by $17.0 million in the 2025 period primarily due to a reduction in expenses related to clinical trials.
Current report
Six Months Ended June 30, 2025 and 2024
Current report
Revenue
Current report
Research and Development Expenses:
Current report
Our selling, general and administrative expenses were $364.7 million for the six months ended June 30, 2025, compared to $186.2 million in the corresponding period in 2024. Selling, general and administrative expenses increased by
Current report
Our net interest income was $17.6 million for the six months ended June 30, 2025, compared to $22.6 million in the corresponding period in 2024. The decrease in interest income was primarily due to lower cash balances in 2025 as compared to the same period in 2024.
Current report
Hercules Loan Facility
Current report
On July 17, 2025, we used the proceeds received from the Financing Agreement to repay all outstanding obligations under the Hercules Loan Facility, totaling $121.7 million, and upon such repayment, terminated the Hercules Loan Facility. The amount we repaid included $115.0 million of outstanding indebtedness plus accrued and unpaid interest as of the repayment date and exit fees. As a result of the termination, all credit commitments under the Hercules Loan Facility were terminated and all security interests and guarantees executed in connection with the Hercules Loan Facility were released.
Current report
Blue Owl Credit Facility
Current report
On July 17, 2025 (the “Closing Date”), we, as the borrower, and Canticle, as a guarantor (the “Guarantor”), entered the Financing Agreement with the Lenders and the Administrative Agent. Under the Financing Agreement, the Lenders have committed up to $500.0 million in senior secured credit facilities, consisting of (a) the Initial Term Loan in an aggregate principal amount equal to $350.0 million and (b) Delayed Draw Term Loans in an aggregate principal amount not to exceed $150.0 million. In addition, the Financing Agreement includes uncommitted Incremental Term Loans in an aggregate principal amount not to exceed $250.0 million (together with the Initial Term Loan and any Delayed Draw Term Loans, collectively the “Term Loans”), subject to the satisfaction of certain terms and conditions set forth in the Financing Agreement. The Initial Term Loan was funded on the Closing Date. Delayed Draw Term Loans are available at our election from time to time after the Closing Date until December 31, 2027. Incremental Term Loans are available at our and the Lenders’ mutual consent from time to time after the Closing Date.
Current report
Any outstanding principal on the Term Loans will bear interest at a rate per annum on the basis of a 360 day year equal to the sum of (i) the three-month forward-looking term secured overnight financing rate administered by the Federal Reserve Bank of New York (subject to 1.00% per annum floor) plus (ii) 4.75%. Accrued interest is payable quarterly following the funding of the Initial Term Loan on the Closing Date, on any date of prepayment or repayment of the Term Loans and at maturity. The outstanding balance of the Term Loans, if not repaid sooner, shall be due and payable in full on the maturity date thereof. The stated maturity date of the Term Loans is July 17, 2030.
Current report
We may prepay the Term Loans at any time (in whole or in part) and may be required to make mandatory prepayments upon the occurrence of certain customary prepayment events. In certain instances and during certain time periods, these prepayments will be subject to customary prepayment fees. The amount of any such prepayment fee may vary, but the maximum amount that may be due with any such prepayment would be an amount equal to 3.00% of the Term Loans being prepaid at such time, plus a customary make whole amount.
Current report
The Financing Agreement contains affirmative covenants and negative covenants applicable to us and our subsidiaries that are customary for financings of this type. We and the Guarantors are also required to maintain a minimum unrestricted cash balance of $100.0 million at all times. The Financing Agreement also includes representations, warranties, indemnities and events of default that are customary for financings of this type, including an event of default relating to us experiencing a change of control. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate our obligations under the Financing Agreement. Our obligations under the Financing Agreement are and will be guaranteed by certain of our existing and future direct and indirect subsidiaries, subject to certain exceptions (such subsidiaries, collectively, the “Guarantors”).
Current report
On July 17, 2025, concurrently with the entry into the Financing Agreement, we, the Guarantor and the Administrative Agent entered into a Pledge and Security Agreement. As security for our obligations under the Financing Agreement, we and the Guarantors are required to grant to the Administrative Agent, for the benefit of the Lenders and secured parties, a continuing first priority security interest in substantially all of our and the Guarantors’ assets (including all equity interests owned or hereafter acquired by us and the Guarantors), subject to certain customary exceptions.
Removed paragraphs (9)
Previous report
In February 2025, we announced positive two-year data from the open-label compensated MASH cirrhosis (consistent with stage F4c fibrosis) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients treated with Rezdiffra achieved significant reductions in liver stiffness measured by vibration-controlled transient elastography (VCTE), which is associated with a lower risk of progression to end-stage liver disease.
Previous report
In March 2025, Jacqualyn Fouse, Ph.D. was appointed to our Board of Directors. Dr. Fouse was previously Chief Executive Officer of Agios Pharmaceuticals, Inc. (“Agios”) from 2019 to 2022 and currently serves as the Chair of the Board of Directors of Agios. Prior to joining Agios, she served in executive leadership roles at Celgene Corporation, including President and Chief Operating Officer, President, Global Hematology & Oncology, and Chief Financial Officer.
Previous report
Cost of Sales
Previous report
Interest Income
Previous report
Interest Expense
Previous report
Cost of Sales
Previous report
Interest Income
Previous report
Interest Expense
Previous report
Loan Facility
Reworded paragraphs (26)
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 and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is expected to become the leading cause of liver transplantation in the United States and is already the leading cause of liver transplantation among women in the United States. 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 and only therapy approved by the FDA for patients with MASH and was commercially available in the United States beginning in April 2024. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO MASH 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 and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is the leading cause of liver transplantation in women and 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 and only therapy approved by the FDA for patients with MASH and was commercially available in the United States beginning in April 2024. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO MASH OUTCOMES trial, that, if successful, could expand the eligible patient population for Rezdiffra.
Previous wording
Our Patient Focus. Based on published epidemiology data and an analysis of medical claims using ICD-10 disease diagnosis codes, we estimate that approximately 1.5 million patients have been diagnosed with MASH in the United States, of which approximately 525,000 have MASH with moderate to advanced fibrosis. We estimate that approximately 315,000 diagnosed patients with MASH with moderate to advanced fibrosis are under the care of approximately 14,000 specialist prescribers which we are targeting during the commercial launch of Rezdiffra. Over time, 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.
Current wording
Our Patient Focus. Based on published epidemiology data and an analysis of medical claims using ICD-10 disease diagnosis codes, we estimate that approximately 1.5 million patients have been diagnosed with MASH in the United States, of which approximately 525,000 have MASH with moderate to advanced fibrosis. We estimate that approximately 315,000 diagnosed patients with MASH with moderate to advanced fibrosis are under the care of approximately 14,000 specialist prescribers which we are targeting during the commercial launch of Rezdiffra. Over time, 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. In addition, an estimated 245,000 patients with compensated MASH cirrhosis (consistent with F4c fibrosis) are currently under the care of liver specialists in the U.S.
Previous wording
We also expect to directly commercialize resmetirom in Europe if we receive a positive opinion from the Committee for Medicinal Products for Human Use and the subsequent grant of Conditional Marketing Authorization by the European Commission. A regulatory decision in the European Union is expected in mid-year 2025. The prevalence rate of MASH in Europe is similar to that of the United States. In the event of a positive decision, we expect to launch Rezdiffra in Europe on a country-by-country basis, commencing with Germany in the second half of 2025.
Current wording
Authorization by the European Commission in August 2025. In the event of a positive decision, we expect to launch Rezdiffra in Europe on a country-by-country basis, commencing with Germany in the second half of 2025.
Previous wording
In April 2025, we announced that David Soergel, M.D. was appointed as our Executive Vice President and Chief Medical Officer. Dr. Soergel previously served as Executive Vice President and Global Head of Cardiovascular, Renal and Metabolism Development at Novartis. Rebecca Taub, M.D., our Chief Medical Officer and President of Research & Development transitioned to the role of Senior Scientific and Medical Advisor.
Current wording
In April 2025, we announced that David Soergel, M.D. was appointed as our Executive Vice President and Chief Medical Officer. Dr. Soergel previously served as Executive Vice President and Global Head of Cardiovascular, Renal and
Previous wording
•expenses related to development and the production of non-clinical and clinical trial supplies, including fees paid to contract manufacturers;
Current wording
•expenses related to development and the production of clinical trial supplies, including fees paid to contract manufacturers;
Previous wording
Interest expense consists primarily of interest accrued on principal balances under our loan facility (the “Loan Facility”) with Hercules Capital, Inc. (“Hercules”).
Current wording
Interest expense consists primarily of interest accrued on principal balances that were outstanding under our loan facility (the “Hercules Loan Facility”) with Hercules Capital, Inc. (“Hercules”).
Previous wording
Cost of sales were incurred as a result of sales of Rezdiffra. For the three months ended March 31, 2025, we recorded $4.5 million of cost of sales.
Current wording
Cost of sales were incurred as a result of sales of Rezdiffra. For the three months ended June 30, 2025, we recorded $9.1 million of cost of sales compared to $0.6 million in the corresponding period in 2024.
Previous wording
Our selling, general and administrative expenses were $167.9 million for the three months ended March 31, 2025, compared to $80.8 million in the corresponding period in 2024. Selling, general and administrative expenses increased by $87.1 million in the 2025 period due primarily to increases for commercial launch activities for Rezdiffra, including a corresponding increase in headcount.
Current wording
Our selling, general and administrative expenses were $196.9 million for the three months ended June 30, 2025, compared to $105.4 million in the corresponding period in 2024. Selling, general and administrative expenses increased by $91.4 million in the 2025 period, primarily due to an increase in commercial activities for Rezdiffra, including a corresponding increase in headcount to support our commercialization efforts.
Previous wording
Our net interest income was $9.4 million for the three months ended March 31, 2025, compared to $8.3 million in the corresponding period in 2024. The increase in interest income was due primarily to higher principal balances.
Current wording
Our net interest income was $8.2 million for the three months ended June 30, 2025, compared to $14.2 million in the corresponding period in 2024. The decrease in interest income was primarily due to lower cash balances compared to the corresponding period in 2024.
Previous wording
Our interest expense was $3.3 million for the three months ended March 31, 2025, compared to $3.8 million in the corresponding period in 2024. The decrease of $0.5 million was primarily the result of lower interest rates in 2025.
Current wording
Our interest expense was $3.3 million for the three months ended June 30, 2025, compared to $3.7 million in the corresponding period in 2024. The decrease of $0.4 million was primarily the result of lower interest rates in 2025.
Previous wording
We began selling Rezdiffra in April 2024. For the three months ended March 31, 2025, we recorded $137.3 million of product revenue, net.
Current wording
For the six months ended June 30, 2025, we recorded $350.1 million of product revenue, net compared to $14.6 million in the corresponding period in 2024. The increase is due to a full six months of sales in 2025, as we began selling Rezdiffra in April 2024, as well as increased demand for Rezdiffra in 2025.
Previous wording
Our research and development expenses were $44.2 million for the three months ended March 31, 2025, compared to $71.2 million in the corresponding period in 2024. Research and development expenses decreased by $27.1 million in the 2025 period primarily due to the change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024 and a reduction in clinical trial expense.
Current wording
Our research and development expenses were $98.3 million for the six months ended June 30, 2025, compared to $142.3 million in the corresponding period in 2024. Research and development expenses decreased by $44.1 million in the 2025 period primarily due to the change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024 and a reduction in expenses related to clinical trials.
Previous wording
As of March 31, 2025, we had cash, cash equivalents, restricted cash, and marketable securities totaling $848.1 million compared to $931.3 million as of December 31, 2024, with this decrease attributable to funding of operations.
Current wording
As of June 30, 2025, we had cash, cash equivalents, restricted cash, and marketable securities totaling $802.0 million compared to $931.3 million as of December 31, 2024, with this decrease attributable to funding of operations. To date, we have funded our operations primarily through proceeds from sales of our capital stock and debt financings, and, since April 2024, sales of Rezdiffra. 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. In March 2024, the FDA approved Rezdiffra in the U.S. for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Rezdiffra became commercially available in the U.S. in April 2024.
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 significant 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 and our entry into any strategic transactions. To meet future long-term liquidity requirements, as well as maintain compliance with certain of our Loan Facility covenants, 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
Until we are able to generate sufficient revenue from Rezdiffra and any other future approved products, we anticipate that we will continue to incur significant 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 the CSPC License Agreement. 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 2024 Sales Agreement during the three months ended March 31, 2025. As of March 31, 2025, $300.0 million remained available for sale under the 2024 Sales Agreement and our related prospectus supplement.
Current wording
We did not make any sales under the 2024 Sales Agreement during the three and six months ended June 30, 2025. As of June 30, 2025, $300.0 million remained available for sale under the 2024 Sales Agreement and our related prospectus supplement.
Previous wording
In May 2022 we entered into a $250.0 million Loan Facility with Hercules. Under the terms of the Loan Facility, the first $50.0 million tranche (“Tranche 1”) was drawn at closing. On February 3, 2023, we entered into the First Amendment (the “First Amendment”) to the Loan Facility (as amended, the “Amended Loan Facility”). Under the Amended Loan Facility, $65.0 million was drawn in 2023 under the second tranche (“Tranche 2”). The third tranche (“Tranche 3”) of $75.0 million became available to us when we obtained FDA approval for Rezdiffra in March 2024. We did not draw on Tranche 3 prior to its expiration in June 2024. In August 2024, we entered into the Second Amendment (the “Second Amendment”) to the Loan Facility (as amended by the First Amendment and the Second Amendment, the “Second Amended Loan Facility”). Under the Second Amended Loan Facility, our borrowing capacity available in the fourth tranche under the Loan Facility (“Tranche 4”) is increased to include the $75.0 million available under Tranche 3 that was not utilized by us. After such increase, our current borrowing capacity is $135.0 million under Tranche 4, which is available subject to Hercules’ sole discretion.
Current wording
In May 2022 we entered into a $250.0 million Loan Facility with Hercules. Under the terms of the Hercules Loan Facility, the first $50.0 million tranche (“Tranche 1”) was drawn at closing. On February 3, 2023, we entered into the First Amendment (the “First Amendment”) to the Hercules Loan Facility (as amended, the “Amended Loan Facility”). Under the Amended Loan Facility, $65.0 million was drawn in 2023 under the second tranche (“Tranche 2”). The third tranche (“Tranche 3”) of $75.0 million became available to us when we obtained FDA approval for Rezdiffra in March 2024. We did not draw on Tranche 3 prior to its expiration in June 2024. In August 2024, we entered into the Second Amendment (the “Second Amendment”) to the Hercules Loan Facility (as amended by the First Amendment and the Second Amendment, the “Second Amended Loan Facility”). Under the Second Amended Loan Facility, our borrowing capacity available in the fourth tranche under the Hercules Loan Facility (“Tranche 4”) was increased to include the $75.0 million available under Tranche 3 that was not utilized by us. After such increase, our borrowing capacity was $135.0 million under Tranche 4, which was available subject to Hercules’ sole discretion.
Previous wording
The Loan Facility had a minimum interest rate of 7.45% and adjusted with changes in the prime rate. The First Amendment reduced the interest rate under the Amended Loan Facility to the greater of (i) the prime rate as reported in The Wall Street Journal plus 2.45% and (ii) 8.25%. We were originally scheduled to pay interest-only monthly payments of accrued interest under the Loan Facility through May 1, 2025, for a period of 36 months. In March 2024, the interest-only period was extended to May 1, 2026 when we achieved a milestone when Rezdiffra received FDA approval. The interest only period was further extended to May 3, 2027, upon the achievement of a revenue milestone, subject to compliance with applicable covenants, that were met as of December 31, 2024. The Loan Facility originally matured in May 2026, but the maturity date was extended to May 2027 when we achieved a milestone upon receipt of FDA approval for Rezdiffra in March 2024. The Loan Facility is secured by a security interest in substantially all of our assets, other than intellectual property. It includes an end of term charge of 5.35% of the aggregate principal amount, which is accounted for in the loan discount.
Current wording
The Hercules Loan Facility had a minimum interest rate of 7.45% and adjusted with changes in the prime rate. The First Amendment reduced the interest rate under the Amended Loan Facility to the greater of (i) the prime rate as reported in The Wall Street Journal plus 2.45% and (ii) 8.25%. We were originally scheduled to pay interest-only monthly payments of accrued interest under the Hercules Loan Facility through May 1, 2025, for a period of 36 months. In March 2024, the interest-only period was extended to May 1, 2026 when we achieved a milestone when Rezdiffra received FDA approval. The interest only period was further extended to May 3, 2027, upon the achievement of a revenue milestone, subject to compliance with applicable covenants, that were met as of December 31, 2024. The Hercules Loan Facility was originally set to mature in May 2026, but the maturity date was extended to May 2027 when we achieved a milestone upon receipt of FDA approval for Rezdiffra in March 2024. The Hercules Loan Facility was secured by a security interest in substantially all of our assets, other than intellectual property. It included an end of term charge of 5.35% of the aggregate principal amount, which was accounted for in the loan discount.
Previous wording
The Loan Facility includes affirmative and restrictive financial covenants which commenced on January 1, 2023, including maintenance of a minimum cash, cash equivalents and liquid funds covenant of $35.0 million, which may decrease in certain circumstances if we achieve certain clinical milestones and a revenue milestone. The Loan Facility also includes a revenue-based covenant that could apply commencing at or after the time that the financial reporting became due for the quarter ended September 30, 2024, however the covenant will be automatically waived pursuant to the terms of the Loan Facility at any time in which we maintain, as measured monthly, (i) a certain level of cash, cash equivalents and liquid funds relative to debt outstanding under the Loan Facility or (ii) a market capitalization of at least $1.2 billion. The Loan Facility contains event of default provisions for: our failure to make required payments or maintain compliance with covenants under the Loan Facility; our breach of certain representations or default under certain obligations outside the Loan Facility; insolvency, attachment or judgment events affecting us; and any circumstance which has occurred or could reasonably be expected to have a material adverse effect on us, provided that, any failure to achieve approval or certain other milestones under the Loan Facility shall not in and of itself constitute a material adverse effect. The Loan Facility also includes customary covenants associated with a secured loan facility, including covenants concerning financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts.
Current wording
The Hercules Loan Facility included affirmative and restrictive financial covenants which commenced on January 1, 2023, including maintenance of a minimum cash, cash equivalents and liquid funds covenant of $35.0 million, which could decrease in certain circumstances if we achieved certain clinical milestones and a revenue milestone. The Hercules Loan Facility also included a revenue-based covenant that could apply commencing at or after the time that the financial reporting became due for the quarter ended September 30, 2024, however the covenant would be automatically waived pursuant to the terms of the Hercules Loan Facility at any time in which we maintained, as measured monthly, (i) a certain level of cash, cash equivalents and liquid funds relative to debt outstanding under the Hercules Loan Facility or (ii) a market capitalization of at least $1.2 billion. The Hercules Loan Facility contained event of default provisions for: our failure to make required payments or maintain compliance with covenants under the Hercules Loan Facility; our breach of certain representations or default under certain obligations outside the Hercules Loan Facility; insolvency, attachment or judgment events affecting us; and any circumstance which could reasonably be expected to have a material adverse effect on us, provided that, any failure to achieve approval or certain other milestones under the Loan Facility did not in and of itself constitute a material adverse effect. The Hercules Loan Facility also included customary covenants associated with a secured loan facility, including covenants concerning financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts.
Previous wording
As of March 31, 2025, the outstanding principal under the Loan Facility was $115.0 million. The interest rate as of March 31, 2025 was 9.95%. As of March 31, 2025, we were in compliance with all loan covenants and provisions.
Current wording
As of June 30, 2025, the outstanding principal under the Hercules Loan Facility was $115.0 million. The interest rate as of June 30, 2025 was 9.95%. As of June 30, 2025, we were in compliance with all loan covenants and provisions of the Hercules Loan Facility.
Previous wording
Net cash used in operating activities was $88.9 million for the three months ended March 31, 2025, compared to $149.2 million for the corresponding period in 2024. The use of cash in these periods resulted primarily from our losses from operations, as adjusted for non-cash charges for stock-based compensation, and changes in our working capital accounts.
Current wording
Net cash used in operating activities was $135.9 million for the six months ended June 30, 2025, compared to $284.1 million for the corresponding period in 2024. The use of cash in these periods resulted primarily from our losses from operations, as adjusted for non-cash charges for stock-based compensation, and changes in our working capital accounts.
Previous wording
Net cash provided by investing activities was $163.9 million for the three months ended March 31, 2025, compared to $98.1 million for the corresponding period in 2024. Net cash provided by investing activities for the three months ended March 31, 2025 primarily consisted of $294.7 million from sales and maturities of marketable securities, partially offset by $130.8 million of purchases of marketable securities for our investment portfolio. Net cash provided by investing activities for the corresponding period in 2024 primarily consisted of $182.6 million from sales and maturities of marketable securities, partially offset by $84.2 million of purchases of marketable securities for our investment portfolio.
Current wording
Net cash provided by investing activities was $211.7 million for the six months ended June 30, 2025, compared to net cash used in investing activities of $24.0 million for the corresponding period in 2024. Net cash provided by investing activities for the six months ended June 30, 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 for our investment portfolio. Net cash used in investing activities for the corresponding period in 2024 primarily consisted of $365.0 million of purchases of marketable securities and a $5.0 million acquisition of an intangible asset, partially offset by $346.4 million from sales and maturities of marketable securities in our investment portfolio.
Previous wording
Net cash provided by financing activities was $8.6 million for the three months ended March 31, 2025, compared to $573.7 million for the corresponding period in 2024. Net cash provided by financing activities for the three months ended March 31, 2025 consisted of $8.6 million from exercises of stock options. Net cash provided by financing activities for the corresponding period in 2024 consisted primarily of$574.0 million of net proceeds from our 2024 Offering.
Current wording
Net cash provided by financing activities was $10.4 million for the six months ended June 30, 2025, compared to $707.8 million for the corresponding period in 2024. Net cash provided by financing activities for the six months ended June 30, 2025 consisted of $10.4 million from exercises of stock options. Net cash provided by financing activities for the corresponding period in 2024 consisted primarily of$659.9 million of net proceeds from our 2024 Offering and$49.7 million from exercises of stock options.
Previous wording
In 2019, we entered into an operating lease for office space in certain premises located in West Conshohocken, Pennsylvania (the “Office Lease”), which was further amended by three amendments entered into from 2019 to 2022. In May 2023, we entered into the Fourth Amendment to the Office Lease, which did not have a financial impact. In August 2023, we entered into the Fifth Amendment to the Office Lease (the “Fifth Lease Amendment”). The Fifth Lease Amendment extends the term of the Office Lease through November 2026. As a result of the Fifth Lease Amendment, an incremental $1.6 million right-of-use asset and lease liability were recorded during the year ended December 31, 2023. In April 2024 and May 2024, we entered into the Sixth Amendment and the Seventh Amendment to the Office Lease, respectively, leasing additional office space available in the same premises under the Office Lease. The lease for such additional office space commenced in September 2024 and resulted in an incremental $1.2 million right-of-use asset and lease liability recorded. In August 2024, we entered into the Eighth Amendment (the “Eighth Lease Amendment”) and in October 2024, we entered into the Ninth Amendment (the “Ninth Lease Amendment”) to the Office Lease, furthering expanding the amount of office space in the same premises. The leases for the additional office space under the Eighth Lease Amendment and the Ninth Lease Amendment commenced in December 2024 and resulted in an incremental $0.2 million right-of-use asset and lease liability recorded.
Current wording
Amendment extends the term of the Office Lease through November 2026. As a result of the Fifth Lease Amendment, an incremental $1.6 million right-of-use asset and lease liability were recorded during the year ended December 31, 2023. In April 2024 and May 2024, we entered into the Sixth Amendment and the Seventh Amendment to the Office Lease, respectively, leasing additional office space available in the same premises under the Office Lease. The lease for such additional office space commenced in September 2024 and resulted in an incremental $1.2 million right-of-use asset and lease liability recorded. In August 2024, we entered into the Eighth Amendment (the “Eighth Lease Amendment”) and in October 2024, we entered into the Ninth Amendment (the “Ninth Lease Amendment”) to the Office Lease, furthering expanding the amount of office space in the same premises. The leases for the additional office space under the Eighth Lease Amendment and the Ninth Lease Amendment commenced in December 2024 and resulted in an incremental $0.2 million right-of-use asset and lease liability recorded.
Previous wording
In May 2022, we entered into the $250.0 million Loan Facility. As of March 31, 2025, we had drawn $115.0 million under the Loan Facility. We are scheduled to pay interest-only monthly payments of accrued interest under the Loan Facility through May 1, 2026, which was extended to May 3, 2027 upon the achievement of a revenue milestone, and subject to compliance with applicable covenants.
Current wording
In May 2022, we entered into the $250.0 million Hercules Loan Facility. As of June 30, 2025, we had drawn $115.0 million under the Hercules Loan Facility. We were scheduled to pay interest-only monthly payments of accrued interest under the Loan Facility through May 1, 2026, which was extended to May 3, 2027 upon the achievement of a revenue milestone, and subject to compliance with applicable covenants. On July 17, 2025, we entered into the Financing Agreement and used a portion of the proceeds to repay the amounts outstanding under the Hercules Loan Facility. Accrued interest under the Financing Agreement is payable quarterly, on any date of prepayment or repayment of the term loans outstanding thereunder and at maturity. We are not required to repay any principal amounts outstanding under the Financing Agreement until maturity in July 2030, subject to certain prepayment events set forth in the Financing Agreement. See Note 8 “Long Term Debt” to the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information regarding the Financing Agreement.
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 March 31, 2025, the Company had approximately $89.1 million of obligations under these agreements related to active pharmaceutical ingredient, which is expected to be paid through December 2027.
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 June 30, 2025, the Company had approximately $71.2 million of obligations under these agreements related to active pharmaceutical ingredient, which is expected to be paid through December 2027.
Previous wording
Except as noted above and the future minimum payments due on the Loan Facility with Hercules set forth in “Note 8 – Long Term Debt” to the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, no significant changes to contractual obligations and commitments occurred during the three months ended March 31, 2025, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on February 26, 2025.
Current wording
Except as noted above, no significant changes to contractual obligations and commitments occurred during the six months ended June 30, 2025, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on February 26, 2025.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
Metabolism Development at Novartis. Rebecca Taub, M.D., our Chief Medical Officer and President of Research & Development transitioned to the role of Senior Scientific and Medical Advisor.
Current report — wording carried from elsewhere
Cost of sales were incurred as a result of sales of Rezdiffra. For the six months ended June 30, 2025, we recorded $13.6 million of cost of sales compared to $0.6 million in the corresponding period in 2024.
Current report — wording carried from elsewhere
The following table represents our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current report — wording carried from elsewhere
$178.5 million in the 2025 period primarily due to increases for commercial activities for Rezdiffra, including a corresponding increase in headcount to support our commercialization efforts.
Current report — wording carried from elsewhere
Our interest expense was $6.6 million for the six months ended June 30, 2025, compared to $7.5 million in the corresponding period in 2024. The decrease of $0.9 million was primarily the result of lower interest rates in 2025.
Current report — wording carried from elsewhere
In 2019, we entered into an operating lease for office space in certain premises located in West Conshohocken, Pennsylvania (the “Office Lease”), which was further amended by four amendments entered into from 2019 to May 2023. In August 2023, we entered into the Fifth Amendment to the Office Lease (the “Fifth Lease Amendment”). The Fifth Lease
Current report — wording carried from elsewhere
In April 2025, we entered into an operating lease for additional office space in West Conshohocken, Pennsylvania. The lease commenced in May 2025 and resulted in a $4.0 million right-of-use asset and lease liability.