0001628280-25-021356 | 10-Q | XBRL Viewer | Madrigal Pharmaceuticals INC

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Long Term Debt - Narrative (Details)		1 Months Ended
Long Term Debt - Narrative (Details)	Feb. 03, 2023 USD ($)	Sep. 30, 2023 USD ($) shares	Jun. 30, 2023 USD ($)	Feb. 28, 2023 USD ($)	May 31, 2022 USD ($) tranche shares	Mar. 31, 2025 USD ($)	Aug. 22, 2024 USD ($)	Mar. 31, 2024 USD ($)	Jan. 01, 2023 USD ($)
Debt Instrument [Line Items]
Number of warrants issued for purchase of common shares (in shares) \| shares					14,899
Warrants and rights outstanding		$ 900,000			$ 600,000
Loans payable, net of discount						$ 118,005,000
Hercules Warrants
Debt Instrument [Line Items]
Number of warrants issued for purchase of common shares (in shares) \| shares		4,555
Secured Debt \| Line of Credit
Debt Instrument [Line Items]
Term charges on aggregate principal amount, (as a percent)					5.35%
Secured Debt \| Loan Facility \| Line of Credit
Debt Instrument [Line Items]
Debt instrument, face amount					$ 250,000,000.0
Line of credit facility, number of withdrawals upon milestone achievements \| tranche					2
Long term debt floor interest rate (as a percent)					7.45%
Accrued interest payments, term (in months)					36 months
Minimum liquidity covenant									$ 35,000,000.0
Debt instrument, covenant, market capitalization minimum									$ 1,200,000,000
Loans payable, net of discount						$ 115,000,000.0
Line of credit facility, interest rate (as a percent)						9.95%
Secured Debt \| Loan Facility \| Line of Credit \| Variable Rate Component One
Debt Instrument [Line Items]
Basis spread on variable rate (as a percent)		2.45%
Secured Debt \| Loan Facility \| Line of Credit \| Variable Rate Component Two
Debt Instrument [Line Items]
Basis spread on variable rate (as a percent)		8.25%
Secured Debt \| Loan Facility, Tranche 1 \| Line of Credit
Debt Instrument [Line Items]
Proceeds from issuance of debt					$ 50,000,000.0
Secured Debt \| Loan Facility, Tranches 2 and 3 \| Line of Credit
Debt Instrument [Line Items]
Additional drawn					125,000,000.0
Secured Debt \| Loan Facility, Tranche 2 \| Line of Credit
Debt Instrument [Line Items]
Proceeds from issuance of debt	$ 35,000,000.0	$ 15,000,000.0	$ 35,000,000.0
Additional drawn	$ 65,000,000.0
Line of credit facility, increase (decrease)			15,000,000.0
Line of credit facility, increase In maximum borrowing capacity				$ 15,000,000.0
Secured Debt \| Loan Facility, Tranche 3 \| Line of Credit
Debt Instrument [Line Items]
Line of credit facility, current borrowing capacity							$ 75,000,000	$ 75,000,000
Secured Debt \| Loan Facility, Tranche 4 \| Line of Credit
Debt Instrument [Line Items]
Additional drawn					$ 75,000,000.0			$ 60,000,000
Line of credit facility, current borrowing capacity							$ 135,000,000
Line of credit facility, decrease In maximum borrowing capacity			$ 15,000,000

Segment Information

3 Months Ended

Mar. 31, 2025

Segment Reporting [Abstract]

Segment Information

The Company operates as one reportable segment focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”). The Company's Chief Executive Officer, as the chief operating decision maker ("CODM"), leads the Company in support of four core values—focus on the patient, having an owner mindset, the relentless pursuit of innovation and commitment to collaboration. To best align the Company with these values, the CODM reviews consolidated financials, along with qualitative information, to evaluate performance, manage and allocate resources, make operating decisions, and assess planning and forecasting on a total company basis. Assets, liabilities, and equity are reviewed and presented on the same level as the Company's consolidated balance sheet.

Management does not segment business operations for internal reporting or decision making purposes. As the Company has a single reporting segment, the segment accounting policies are the same as those at the Company level, as described in Note 2 "Summary of Significant Accounting Policies". As of March 31, 2025, the Company did not have revenue or material assets outside of the U.S.

The following table presents net income reported at the segment measure of profit and loss:


	Three Months Ended March 31,
	2025		2024
Product revenue, net	$	137,250	$	—
Cost of sales	(4,513)		—
Research and development - personnel and internal expense	(15,023)		(16,716)
Research and development - external expense	(29,149)		(54,521)
Selling, general and administrative	(167,876)		(80,800)
Other segment income (expense)(1)	6,073		4,496
Net loss	$	(73,238)	$	(147,541)

(1) Other segment expense includes interest income and interest expense.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

Long Term Debt

3 Months Ended

Mar. 31, 2025

Debt Disclosure [Abstract]

Long Term Debt

In May 2022, the Company and its wholly-owned subsidiary, Canticle Pharmaceuticals, Inc., entered into the $250.0 million loan facility (the “Loan Facility”) with the several banks and other financial institutions or entities party thereto (collectively, the “Lenders”), and Hercules Capital, Inc. (“Hercules”), in its capacity as administrative agent and collateral agent for itself and the Lenders. Under the terms of the Loan Facility, the first $50.0 million tranche was drawn at closing. The Company also could draw up to an additional $125.0 million in two separate tranches upon achievement of certain resmetirom clinical and regulatory milestones. A fourth tranche of $75.0 million could have been drawn by the Company, subject to the approval of Hercules. The Loan Facility had a minimum interest rate of 7.45% and adjusted with changes in the prime rate. The Company was 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 the Company 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 the Company 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 the Company’s 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. In connection with the first tranche drawn at closing, the Company issued Hercules a warrant to purchase 14,899 shares of Company common stock, which had a Black-Scholes value of $0.6 million.

On February 3, 2023, the Company entered into the First Amendment (the “First Amendment”) to the Loan Facility (as amended, the “Amended Loan Facility”). Under the Amended Loan Facility, an additional $35.0 million was drawn under a second, expanded, $65.0 million tranche (“Tranche 2”) in February of 2023 following the Company’s achievement of the Phase 3 clinical development milestone. An additional $15.0 million was drawn under Tranche 2 in June of 2023. The remaining $15.0 million available under Tranche 2 was drawn in September of 2023 in accordance with the Amended Loan Facility.

The third tranche (“Tranche 3”) of $75.0 million was unchanged by the First Amendment, and such borrowings became available when the Company achieved a milestone with FDA approval for Rezdiffra in March 2024. The Company did not elect to draw Tranche 3 before it expired in June 2024, but subsequently entered into an amendment to extend the availability of these funds in August 2024. Coincident with the expansion of Tranche 2 borrowing capacity by $15.0 million, the First Amendment reduced the fourth tranche under the Loan Facility (“Tranche 4”) by $15.0 million to $60.0 million.

In connection with the $35.0 million drawn under Tranche 2 at the closing of the First Amendment, $15.0 million drawn in June of 2023, and $15.0 million drawn in September 2023, the Company issued to Hercules and affiliates warrants to purchase an aggregate of 4,555 shares of common stock, which had a Black-Scholes value of $0.9 million. 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%. The First Amendment and the Amended Loan Facility summary terms were disclosed in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023.

On August 22, 2024, the Company 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, the Company’s borrowing capacity available under Tranche 4 is increased to include the $75.0 million available under Tranche 3 that was not utilized by the Company. After such increase, the Company’s current borrowing capacity is $135.0 million under Tranche 4, which is available subject to Hercules’ sole discretion.

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 the Company achieves 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 financial reporting became due for the quarter ended September 30, 2024, however, the revenue-based covenant will be automatically waived pursuant to the terms of the Loan Facility at any time in which the Company maintains, as measured monthly, (i) a certain level of cash, cash equivalents and liquid funds relative outstanding debt under the Loan Facility or (ii) a market capitalization of at least $1.2 billion. The Loan Facility contains event of default provisions for: the Company’s failure to make required payments or maintain compliance with covenants under the Loan Facility; the Company’s breach of certain representations or default under certain obligations outside the Loan Facility; insolvency, attachment or judgment events affecting the Company; and any circumstance which has occurred or could reasonably be expected to have a material adverse effect on the Company, provided that, any failure to achieve a clinical milestone or approval milestone 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.

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, the Company was in compliance with all loan covenants and provisions.

Future minimum payments, including interest and principal, under the loans payable outstanding as of March 31, 2025 are as follows (in thousands):


Period Ending March 31, 2025:	Amount
2025	$	8,741
2026	11,601
2027	126,016
Thereafter	—
	$	146,358
Less amount representing interest	(25,206)
Less unamortized discount	(3,147)
Loans payable, net of discount	$	118,005

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024
Pay vs Performance Disclosure
Net loss	$ (73,238)	$ (147,541)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Commitments and Contingencies (Details) $ in Millions	1 Months Ended		3 Months Ended	12 Months Ended	48 Months Ended
Commitments and Contingencies (Details) $ in Millions	Dec. 31, 2024 USD ($)	Mar. 31, 2024 USD ($)	Mar. 31, 2025 USD ($)	Dec. 31, 2024 USD ($)	Dec. 31, 2022 amendment
Commitments and Contingencies
Purchase obligation			$ 89.1
Number of office lease amendment \| amendment					3
Obtaining a right-of-use asset in exchange for a lease liability	$ 0.2		1.2	$ 1.6
Hoffmann-La Roche ("Roche") \| Research, Development and Commercialization Agreement
Commitments and Contingencies
Milestone payment due		$ 5.0
Remainder of future milestone payments			$ 3.0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Summary of Significant Accounting Policies - Basic and Diluted Loss Per Common Share (Details) - shares	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Common stock options
Anti-dilutive securities
Antidilutive securities excluded from computation of earnings per share (in shares)	1,526,018	2,458,227
Restricted stock units
Anti-dilutive securities
Antidilutive securities excluded from computation of earnings per share (in shares)	694,995	530,671
Performance-based restricted stock units
Anti-dilutive securities
Antidilutive securities excluded from computation of earnings per share (in shares)	292,970	252,404
Preferred stock
Anti-dilutive securities
Antidilutive securities excluded from computation of earnings per share (in shares)	2,369,797	2,369,797
Warrants
Anti-dilutive securities
Antidilutive securities excluded from computation of earnings per share (in shares)	3,625,244	3,625,244

Long Term Debt - Maturities of Long-Term Debt (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2025 USD ($)
Debt Disclosure [Abstract]
2025	$ 8,741
2026	11,601
2027	126,016
Thereafter	0
Long-term debt	146,358
Less amount representing interest	(25,206)
Less unamortized discount	(3,147)
Loans payable, net of discount	$ 118,005

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Inventory (Tables)

3 Months Ended

Mar. 31, 2025

Inventory Disclosure [Abstract]

Schedule of Inventory

The following table summarizes the Company's inventory balances as of March 31, 2025 and December 31, 2024 (in thousands):


	March 31, 2025		December 31, 2024
Raw materials	$	—	$	—
Work in process	50,969		29,533
Finished goods	4,272		4,535
Total	$	55,241	$	34,068

Product Revenue, Net

3 Months Ended

Mar. 31, 2025

Revenue from Contract with Customer [Abstract]

Product Revenue, Net

The following table summarizes balances and activity for gross to net reserves (in thousands):


	Chargebacks, Discounts for Prompt Pay and Other Allowances		Rebates, Customer Fees/Credits, Co-Pay Assistance, and Other		Totals
Balance at December 31, 2024	$	4,188	$	21,703	$	25,891
Provision related to sales in the current year	5,239		29,380		34,619
Adjustments related to prior year sales	(1,066)		(329)		(1,395)
Payments and customer credits issued	(3,866)		(17,385)		(21,251)
Balance at March 31, 2025	$	4,495	$	33,369	$	37,864

Concentrations of Credit Risk and Significant Customers

The Company generates revenue from a small number of large, reputable customers. The following customers accounted for over 10% of total gross product revenue during the three months ended March 31, 2025. As Rezdiffra was made commercially available in April 2024, there were no sales and no corresponding customer concentrations for the comparable period in 2024.


	Three Months Ended March 31,
	2025		2024

Customer A	34	%	—	%
Customer B	23	%	—	%
Customer C	15	%	—	%
Customer D	10	%	—	%

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

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-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-13

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org/606/tableOfContent

+ Details

Stockholders' Equity- Common Stock (Details)	3 Months Ended
Stockholders' Equity- Common Stock (Details)	Mar. 31, 2025 vote
Equity [Abstract]
Number of votes per share that common stockholders are entitled to receive	1

Liquidity and Uncertainties (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024
Liquidity and Uncertainties
Net loss	$ (73,238)	$ (147,541)
Accumulated deficit	$ (1,875,420)		$ (1,802,182)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Summary of Significant Accounting Policies - Marketable Securities (Details) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Accounting Policies [Abstract]
Realized gains or losses on marketable securities	$ 0	$ 0

Cover Page - shares	3 Months Ended
Cover Page - shares	Mar. 31, 2025	Apr. 28, 2025
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2025
Document Transition Report	false
Entity File Number	001-33277
Entity Registrant Name	MADRIGAL PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	04-3508648
Entity Address, Address Line One	Four Tower Bridge
Entity Address, Address Line Two	200 Barr Harbor Drive, Suite 200
Entity Address, City or Town	West Conshohocken
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19428
City Area Code	267
Local Phone Number	824-2827
Title of 12(b) Security	Common Stock, $0.0001 Par Value Per Share
Trading Symbol	MDGL
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		22,203,282
Amendment Flag	false
Document Fiscal Year Focus	2025
Entity Central Index Key	0001157601
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q1

Product Revenue, Net - Schedules of Concentrations of Credit Risk and Significant Customers (Details) - Revenue Benchmark - Customer Concentration Risk	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Customer A
Concentration Risk [Line Items]
Concentration risk, percentage (as a percent)	34.00%	0.00%
Customer B
Concentration Risk [Line Items]
Concentration risk, percentage (as a percent)	23.00%	0.00%
Customer C
Concentration Risk [Line Items]
Concentration risk, percentage (as a percent)	15.00%	0.00%
Customer D
Concentration Risk [Line Items]
Concentration risk, percentage (as a percent)	10.00%	0.00%

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2025

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Principle of Consolidation

The accompanying unaudited consolidated financial statements have been prepared in conformity with GAAP and include accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, and the reported amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.

Revenue Recognition

The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“ASC 606”). Revenue is recognized at a point in time when the customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in

the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s).

Product Revenue, Net

On March 14, 2024, the Company announced that the FDA granted accelerated approval of Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The Company enters into agreements with specialty pharmacies and specialty distributors (each a “Customer” and collectively the “Customers”) to sell Rezdiffra in the U.S. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer.

Revenue is recorded net of variable consideration, which includes prompt pay discounts, returns, chargebacks, rebates, and co-payment assistance. The variable consideration is estimated based on contractual terms as well as management assumptions. The amount of variable consideration is calculated by using the expected value method, which is the sum of probability-weighted amounts in a range of possible outcomes, or the most likely amount method, which is the single most likely amount in a range of possible outcomes. Estimates are reviewed quarterly and adjusted as necessary.

Accruals are established for gross to net deductions and actual amounts incurred are offset against applicable accruals. The Company reflects these accruals as either a reduction in the related account receivable from the customer or as an accrued liability, depending on the means by which the deduction is settled. Sales deductions are based on management’s estimates that involve a substantial degree of judgment.

Prompt Pay: Customers receive a prompt pay discount for payments made within a contractually agreed number of days before the due date. The discounts are accounted for as a reduction of the transaction price and recorded as a contra receivable.

Returns: The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Product returns are estimated based on forecasted sales and historical and industry data. Returns are permitted in accordance with the return of goods policy defined within each customer agreement. A returns reserve is recorded as an accrued liability.

Chargebacks: The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to the customer who directly purchases from the Company. The customer charges the Company for the difference between what it pays to the Company for the product and the selling price to the qualified healthcare providers, with the difference recorded as a contra receivable.

Co-Payment Assistance: Co-payment assistance programs are offered to eligible end-users as price concessions and are recorded as accrued liabilities and a reduction of the transaction price. The Company uses a third-party to administer the co-payment program for pharmacy benefit claims.

Rebates: The Company is subject to discount obligations under government programs, including Medicaid and Medicare. Reserves for rebates are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenues and a current liability that is included in accrued expenses on the consolidated balance sheet. The Company’s estimate for rebates is based on statutory discount rates, expected utilization or an estimated number of patients on treatment, as applicable.

Trade Receivables, Net

The Company's trade receivables relate to amounts due from Customers related to product sales and are recorded net of prompt pay discounts and chargebacks. The Company assesses collectability of overdue receivables and those determined to be uncollectible are written-off. As of March 31, 2025, there were no receivables written off.

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. The Company maintains its cash in bank accounts, the balance of which, at times, exceeds Federal Deposit Insurance Corporation insured limits.

The primary objective of the Company’s investment activities is to preserve its capital for the purpose of funding operations and the Company does not enter into investments for trading or speculative purposes. The Company’s cash is deposited in highly rated financial institutions predominantly in the United States. The Company invests in money market funds and high-grade, commercial paper and corporate bonds, which management believes are subject to minimal credit and market risk.

Marketable Securities

Marketable securities consist of investments in high-grade corporate obligations and government and government agency obligations that are classified as available-for-sale. Since these securities are available to fund current operations, they are classified as current assets on the consolidated balance sheets.

The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion as a component of interest income, net. Realized gains and losses and declines in value, if any, that the Company judges to be the result of impairment or as a result of recognizing an allowance for credit losses on available-for-sale securities are reported as a component of interest income. To determine whether an impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis. During the three months ended March 31, 2025 and 2024, the Company determined it did not have any securities that were other-than-temporarily impaired.

Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. Realized gains and losses are determined on the specific identification method. During the three months ended March 31, 2025 and 2024, realized gains and losses on marketable securities were not material.

Fair Value of Financial Instruments

The carrying amounts of the Company’s financial instruments, which include cash equivalents and marketable securities, approximate their fair values. The fair value of the Company’s financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels:

Level 1—quoted prices in active markets for identical assets and liabilities.

Level 2—observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.

Level 3—unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs.

As of March 31, 2025, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs. During the three months ended March 31, 2025 and 2024, the Company did not have any transfers of financial assets between Levels 1 and 2. As of March 31, 2025 and December 31, 2024, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.

Inventory

Inventory, which consists of work in process and finished goods, is stated at the lower of cost or estimated net realizable value, using actual cost, based on a first-in, first-out method. The balance sheet classification of inventory as

current or non-current is determined by whether the inventory will be consumed within the Company’s normal operating cycle. The Company analyzes its inventory levels quarterly and writes down inventory subject to expiry or in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. These write downs are charged to cost of sales in the accompanying Consolidated Statements of Income. The Company capitalizes inventory costs when future commercial sale in the ordinary course of business is probable.

The Company considered regulatory approval of its product candidate to be uncertain and product manufactured prior to regulatory approval could not have been sold unless regulatory approval was obtained. As such, the manufacturing costs incurred prior to regulatory approval were not capitalized as inventory, but rather were expensed as incurred as research and development expenses. The Company began capitalizing inventory in March 2024 after FDA approval was granted for Rezdiffra.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including cash compensation and stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs. In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of its drug, and conducted clinical trials, all of which are considered research and development expenditures. Management uses significant judgment in estimating the amount of research and development costs recognized in each reporting period. Management analyzes and estimates the progress of its clinical trials, completion of milestone events per underlying agreements, invoices received and contracted costs when estimating the research and development costs to accrue in each reporting period. Actual results could differ from the Company’s estimates.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries, benefits and stock-based compensation expenses for employees, management costs, costs associated with obtaining and maintaining our patent portfolio, commercial and marketing activities, advertising, corporate insurance, professional fees for accounting, auditing, consulting and legal services and allocated overhead expenses.

Leases

The Company determines if an arrangement is a lease at contract inception. All leases are classified as operating leases. Lease assets represent the right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the leasing arrangement. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. When an implicit rate is not readily determinable, an incremental borrowing rate is estimated based on information available at commencement. Lease expense is recognized on a straight-line basis over the lease term. Short-term leases of twelve months or less at commencement date are expensed on a straight-line basis over the lease term.

Patents

Costs to secure and defend patents are expensed as incurred and are classified as selling, general and administrative expense in the Company’s consolidated statements of operations.

Intangible Assets

Intangible assets with finite lives are amortized to cost of sales over their estimated useful lives using the straight-line method. Intangible assets are tested for recoverability whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.

Stock-Based Compensation

The Company recognizes stock-based compensation expense based on the grant date fair value of stock options, restricted stock units, and other stock-based compensation awards granted to employees, officers, directors, and consultants. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period.

The Company uses the Black-Scholes option pricing model to determine the grant date fair value of stock options as management believes it is the most appropriate valuation method for its option grants. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options. The expected lives for options granted represent the period of time that options granted are expected to be outstanding. The Company uses the simplified method for determining the expected lives of options. Expected volatility is based upon an industry estimate or blended rate including the Company’s historical trading activity. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant. The Company estimates the forfeiture rate based on historical data. This analysis is re-evaluated at least annually and the forfeiture rate is adjusted as necessary.

For other stock-based compensation awards granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s common stock achieving or exceeding certain price targets, the Company uses a Monte Carlo simulation model to estimate the grant date fair value and recognize stock compensation expense over the derived service period. The Monte Carlo simulation model requires key inputs for risk-free interest rate, dividend yield, volatility, and expected life.

The assumptions used in computing the fair value of equity awards reflect the Company’s best estimates but involve uncertainties related to market and other conditions. Changes in any of these assumptions may materially affect the fair value of awards granted and the amount of stock-based compensation recognized.

Certain of the employee stock options granted by the Company are structured to qualify as incentive stock options (“ISOs”). Under current tax regulations, the Company does not receive a tax deduction for the issuance, exercise or disposition of ISOs if the employee meets certain holding requirements. If the employee does not meet the holding requirements, a disqualifying disposition occurs, at which time the Company may receive a tax deduction. The Company does not record tax benefits related to ISOs unless and until a disqualifying disposition is reported. In the event of a disqualifying disposition, the entire tax benefit is recorded as a reduction of income tax expense. The Company has not recognized any income tax benefit for its stock-based compensation arrangements due to the fact that the Company does not believe it is more likely than not it will realize the related deferred tax assets.

Income Taxes

The Company accounts for income taxes in accordance with FASB ASC 740, “Income Taxes”, which prescribes the use of the liability method where deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all of the deferred tax assets will not be realized based on the weight of available positive and negative evidence. The Company currently maintains a 100% valuation allowance on its deferred tax assets.

Comprehensive Income (Loss)

Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The difference between the Company’s net income (loss) and comprehensive income (loss) includes changes in unrealized gains and losses on marketable securities and unrealized foreign currency translation adjustments.

Basic and Diluted Loss Per Common Share

Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the three months ended March 31, 2025 and 2024, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of common stock issuable upon the exercise of stock options and warrants or vesting of restricted stock units, and common stock issuable upon the conversion of preferred stock would be anti-dilutive. The

following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive:


	Outstanding at March 31,
	2025	2024
Common stock options	1,526,018	2,458,227
Restricted stock units	694,995	530,671
Performance-based restricted stock units	292,970	252,404
Preferred stock	2,369,797	2,369,797
Warrants	3,625,244	3,625,244

Recent Accounting Pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which enhances the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company adopted ASU 2023-07 for its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission on February 26, 2025.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the disclosures required for income taxes in the Company's annual consolidated financial statements. The amendments are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the adoption of ASU 2023-09 to have a significant impact on its financial statements.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”), which applies to all public entities and requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt the new standard prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. The Company is currently evaluating the impact of ASU 2024-03 on its financial statements.

Stockholders' Equity - Preferred Stock (Details)	Mar. 31, 2025 vote $ / shares	Dec. 31, 2024 $ / shares
Stockholders' Equity (Deficit)
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Convertible Series A and B Preferred Stock
Stockholders' Equity (Deficit)
Preferred stock, par value (in dollars per share)	$ 0.0001
Preferred stock conversion ratio (in shares)	1
Preferred shares number voting rights \| vote	0

Stock-based Compensation (Tables)

3 Months Ended

Mar. 31, 2025

Share-Based Payment Arrangement [Abstract]

Schedule of Stock Option Activity

The following table summarizes stock option activity during the three months ended March 31, 2025:


	Shares	Weighted average exercise price
Outstanding at December 31, 2024	1,528,143	$	93.57
Options granted	99,202	342.11
Options exercised	(100,277)	88.83
Options cancelled	(1,050)	87.09
Outstanding at March 31, 2025	1,526,018	$	110.04
Exercisable at March 31, 2025	1,150,985	$	78.44

Stock-based compensation expense during the three months ended March 31, 2025 and 2024 was as follows (in thousands):


	Three Months Ended March 31,
	2025		2024
Stock-based compensation expense by type of award:
Stock options	$	5,439	$	6,886
Restricted stock units	11,788		8,625
Performance-based restricted stock units	3,704		4,391
Total stock-based compensation expense	$	20,931	$	19,902
Effect of stock-based compensation expense by line item:
Research and development	$	5,215	$	5,907
Selling, general and administrative	15,716		13,995
Total stock-based compensation expense included in net loss	$	20,931	$	19,902

Schedule of RSU Activity

The following table summarizes RSU activity, excluding performance-based RSUs, during the three months ended March 31, 2025:


	Shares	Weighted average grant date fair value
Outstanding at December 31, 2024	499,559	$	237.07
RSUs granted	285,451	345.21
RSUs vested	(81,564)	257.46
RSUs forfeited	(8,451)	262.40
Outstanding at March 31, 2025	694,995	$	278.75

Schedule of PSU Activity

The following table summarizes PSU activity during the three months ended March 31, 2025:


	PSUs	Eligible to Earn PSUs	Weighted average grant date fair value
Outstanding PSUs at December 31, 2024	92,760	235,520	$	257.77
PSUs granted	53,725	107,450	593.49
PSUs attained	(50,000)	(50,000)	146.37
PSUs forfeited	—	—	—
Outstanding at March 31, 2025	96,485	292,970	$	502.43

Product Revenue, Net - Schedule Of Gross To Net Adjustments Reserve (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2025 USD ($)
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward]
Balance, beginning	$ 25,891
Provision related to sales in the current year	34,619
Adjustments related to prior year sales	(1,395)
Payments and customer credits issued	(21,251)
Balance, ending	37,864
Chargebacks, Discounts for Prompt Pay and Other Allowances
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward]
Balance, beginning	4,188
Provision related to sales in the current year	5,239
Adjustments related to prior year sales	(1,066)
Payments and customer credits issued	(3,866)
Balance, ending	4,495
Rebates, Customer Fees/Credits, Co-Pay Assistance, and Other
Contract with Customer, Asset, Allowance for Credit Loss [Roll Forward]
Balance, beginning	21,703
Provision related to sales in the current year	29,380
Adjustments related to prior year sales	(329)
Payments and customer credits issued	(17,385)
Balance, ending	$ 33,369

Cash, Cash Equivalents, Restricted Cash, and Marketable Securities - Cash, Cash Equivalents and Available-for-Sale Marketable Securities (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Schedule of Investments [Line Items]
Total cash and cash equivalents	$ 188,646	$ 105,019
Marketable securities:
Unrealized gains	435	625
Unrealized losses	(78)	(157)
Cost	847,711	930,783
Fair value	848,068	931,251
Corporate Debt Securities
Schedule of Investments [Line Items]
Total cash and cash equivalents	88,201	2,511
Marketable securities:
Cost	340,305	367,950
Unrealized gains	51	190
Unrealized losses	(35)	(64)
Fair value	340,321	368,076
Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)
Marketable securities:
Cost	5,209	3,282
Unrealized gains	8	0
Unrealized losses	0	(6)
Fair value	5,217	3,276
US government and government sponsored entities (Level 1)
Schedule of Investments [Line Items]
Total cash and cash equivalents		12,711
U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2)
Marketable securities:
Cost	273,004	382,793
Unrealized gains	244	279
Unrealized losses	(43)	(62)
Fair value	273,205	383,010
US government and government sponsored entities due within 1 to 2 years of date of purchase (Level 2)
Marketable securities:
Cost	40,547	71,739
Unrealized gains	132	156
Unrealized losses	0	(25)
Fair value	40,679	71,870
Cash
Schedule of Investments [Line Items]
Total cash and cash equivalents	34,902	24,495
Money Market Funds
Schedule of Investments [Line Items]
Total cash and cash equivalents	$ 65,543	$ 65,302

Segment Information (Tables)

3 Months Ended

Mar. 31, 2025

Segment Reporting [Abstract]

Schedule of Segment Information

The following table presents net income reported at the segment measure of profit and loss:


	Three Months Ended March 31,
	2025		2024
Product revenue, net	$	137,250	$	—
Cost of sales	(4,513)		—
Research and development - personnel and internal expense	(15,023)		(16,716)
Research and development - external expense	(29,149)		(54,521)
Selling, general and administrative	(167,876)		(80,800)
Other segment income (expense)(1)	6,073		4,496
Net loss	$	(73,238)	$	(147,541)

(1) Other segment expense includes interest income and interest expense.

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2025	Dec. 31, 2024
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	2,369,797	2,369,797
Preferred stock, shares outstanding (in shares)	2,369,797	2,369,797
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	22,187,716	22,004,679
Common stock, shares outstanding (in shares)	22,187,716	22,004,679

Segment Information - Narrative (Details)	3 Months Ended
Segment Information - Narrative (Details)	Mar. 31, 2025 segment value
Segment Reporting [Abstract]
Number of reportable segments \| segment	1
Number of core values supporting \| value	4

Cash, Cash Equivalents, Restricted Cash, and Marketable Securities

3 Months Ended

Mar. 31, 2025

Cash and Cash Equivalents [Abstract]

Cash, Cash Equivalents, Restricted Cash, and Marketable Securities

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

The Company held restricted cash of $5.0 million as of March 31, 2025 and December 31, 2024 as collateral to its corporate credit card program.

A summary of cash, cash equivalents and available-for-sale marketable securities held by the Company as of March 31, 2025 and December 31, 2024 is as follows (in thousands):


	March 31, 2025
	Cost		Unrealized gains		Unrealized losses		Fair value
Cash (Level 1)	$	34,902	$	—	$	—	$	34,902
Money market funds (Level 1)	65,543		—		—		65,543

Corporate debt securities due within 3 months of date of purchase (Level 2)	88,201		—		—		88,201
Total cash and cash equivalents	188,646		—		—		188,646
Marketable securities:
Corporate debt securities due within 1 year of date of purchase (Level 2)	340,305		51		(35)		340,321
U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2)	273,004		244		(43)		273,205
U.S. government and government sponsored entities due within 1 to 2 years of date of purchase (Level 2)	40,547		132		—		40,679
Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)	5,209		8		—		5,217
Total cash, cash equivalents, restricted cash and marketable securities	$	847,711	$	435	$	(78)	$	848,068


	December 31, 2024
	Cost		Unrealized gains		Unrealized losses		Fair value
Cash and cash equivalents:
Cash (Level 1)	$	24,495	$	—	$	—	$	24,495
Money market funds (Level 1)	65,302		—		—		65,302
US government and government sponsored entities (Level 1)	12,711		—		—		12,711
Corporate debt securities due within 3 months of date of purchase (Level 2)	2,511		—		—		2,511
Total cash and cash equivalents	105,019		—		—		105,019
Marketable securities:
Corporate debt securities due within 1 year of date of purchase (Level 2)	367,950		190		(64)		368,076
US government and government sponsored entities due within 1 year of date of purchase (Level 2)	382,793		279		(62)		383,010
US government and government sponsored entities due within 1 to 2 years of date of purchase (Level 2)	71,739		156		(25)		71,870
Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)	3,282		—		(6)		3,276
Total cash, cash equivalents, restricted cash and marketable securities	$	930,783	$	625	$	(157)	$	931,251

Stockholders' Equity - Public Offering (Details) $ / shares in Units, $ in Millions	Apr. 02, 2024 USD ($)	Mar. 21, 2024 USD ($) $ / shares shares	May 31, 2022 shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of warrants issued for purchase of common shares (in shares)			14,899
Pre-funded warrants
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Beneficial ownership threshold percentage		0.0999
Beneficial ownership maximum percentage		0.1999
Beneficial ownership notice period (in days)		61 days
2024 Public Stock Offering
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares issued in transaction (in shares)		750,000
Shares issued (in dollars per share) \| $ / shares		$ 260.00
Sale of stock received on transaction, gross \| $		$ 600.0
Cash received on stock transaction after deduction of issuance costs \| $		$ 574.0
2024 Public Stock Offering \| Pre-funded warrants
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of warrants issued for purchase of common shares (in shares)		1,557,692
Class of warrant or right, exercise price of warrants or rights (in dollars per share) \| $ / shares		$ 259.9999
Stock price discount per share (in dollars per share) \| $ / shares		$ 0.0001
Over-Allotment Option
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares issued in transaction (in shares)		346,153
Purchasing period		30 days
Cash received on stock transaction after deduction of issuance costs \| $	$ 85.9

Stock-based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Stock-based compensation expense
Stock-based compensation expense	$ 20,931	$ 19,902
Research and development
Stock-based compensation expense
Stock-based compensation expense	5,215	5,907
Selling, general and administrative
Stock-based compensation expense
Stock-based compensation expense	15,716	13,995
Stock options
Stock-based compensation expense
Stock-based compensation expense	5,439	6,886
Restricted stock units
Stock-based compensation expense
Stock-based compensation expense	11,788	8,625
Performance-based restricted stock units
Stock-based compensation expense
Stock-based compensation expense	$ 3,704	$ 4,391

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Name Accounting Standards Codification
-Section 35
-Paragraph 1D
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+ Details

Summary of Significant Accounting Policies (Policies)	3 Months Ended
Summary of Significant Accounting Policies (Policies)	Mar. 31, 2025
Accounting Policies [Abstract]
Principle of Consolidation	Principle of Consolidation The accompanying unaudited consolidated financial statements have been prepared in conformity with GAAP and include accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, and the reported amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Revenue Recognition	Revenue Recognition The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“ASC 606”). Revenue is recognized at a point in time when the customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). Product Revenue, Net On March 14, 2024, the Company announced that the FDA granted accelerated approval of Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The Company enters into agreements with specialty pharmacies and specialty distributors (each a “Customer” and collectively the “Customers”) to sell Rezdiffra in the U.S. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer. Revenue is recorded net of variable consideration, which includes prompt pay discounts, returns, chargebacks, rebates, and co-payment assistance. The variable consideration is estimated based on contractual terms as well as management assumptions. The amount of variable consideration is calculated by using the expected value method, which is the sum of probability-weighted amounts in a range of possible outcomes, or the most likely amount method, which is the single most likely amount in a range of possible outcomes. Estimates are reviewed quarterly and adjusted as necessary. Accruals are established for gross to net deductions and actual amounts incurred are offset against applicable accruals. The Company reflects these accruals as either a reduction in the related account receivable from the customer or as an accrued liability, depending on the means by which the deduction is settled. Sales deductions are based on management’s estimates that involve a substantial degree of judgment. Prompt Pay: Customers receive a prompt pay discount for payments made within a contractually agreed number of days before the due date. The discounts are accounted for as a reduction of the transaction price and recorded as a contra receivable. Returns: The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Product returns are estimated based on forecasted sales and historical and industry data. Returns are permitted in accordance with the return of goods policy defined within each customer agreement. A returns reserve is recorded as an accrued liability. Chargebacks: The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to the customer who directly purchases from the Company. The customer charges the Company for the difference between what it pays to the Company for the product and the selling price to the qualified healthcare providers, with the difference recorded as a contra receivable. Co-Payment Assistance: Co-payment assistance programs are offered to eligible end-users as price concessions and are recorded as accrued liabilities and a reduction of the transaction price. The Company uses a third-party to administer the co-payment program for pharmacy benefit claims. Rebates: The Company is subject to discount obligations under government programs, including Medicaid and Medicare. Reserves for rebates are recorded in the same period the related product revenue is recognized, resulting in a reduction of product revenues and a current liability that is included in accrued expenses on the consolidated balance sheet. The Company’s estimate for rebates is based on statutory discount rates, expected utilization or an estimated number of patients on treatment, as applicable. Trade Receivables, Net The Company's trade receivables relate to amounts due from Customers related to product sales and are recorded net of prompt pay discounts and chargebacks. The Company assesses collectability of overdue receivables and those determined to be uncollectible are written-off. As of March 31, 2025, there were no receivables written off.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. The Company maintains its cash in bank accounts, the balance of which, at times, exceeds Federal Deposit Insurance Corporation insured limits. The primary objective of the Company’s investment activities is to preserve its capital for the purpose of funding operations and the Company does not enter into investments for trading or speculative purposes. The Company’s cash is deposited in highly rated financial institutions predominantly in the United States. The Company invests in money market funds and high-grade, commercial paper and corporate bonds, which management believes are subject to minimal credit and market risk.
Marketable Securities	Marketable Securities Marketable securities consist of investments in high-grade corporate obligations and government and government agency obligations that are classified as available-for-sale. Since these securities are available to fund current operations, they are classified as current assets on the consolidated balance sheets. The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion as a component of interest income, net. Realized gains and losses and declines in value, if any, that the Company judges to be the result of impairment or as a result of recognizing an allowance for credit losses on available-for-sale securities are reported as a component of interest income. To determine whether an impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis.
Fair Value of Financial Instruments	Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash equivalents and marketable securities, approximate their fair values. The fair value of the Company’s financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels: Level 1—quoted prices in active markets for identical assets and liabilities. Level 2—observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3—unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs.
Inventory	Inventory Inventory, which consists of work in process and finished goods, is stated at the lower of cost or estimated net realizable value, using actual cost, based on a first-in, first-out method. The balance sheet classification of inventory as current or non-current is determined by whether the inventory will be consumed within the Company’s normal operating cycle. The Company analyzes its inventory levels quarterly and writes down inventory subject to expiry or in excess of expected requirements, or that has a cost basis in excess of its expected net realizable value. These write downs are charged to cost of sales in the accompanying Consolidated Statements of Income. The Company capitalizes inventory costs when future commercial sale in the ordinary course of business is probable. The Company considered regulatory approval of its product candidate to be uncertain and product manufactured prior to regulatory approval could not have been sold unless regulatory approval was obtained. As such, the manufacturing costs incurred prior to regulatory approval were not capitalized as inventory, but rather were expensed as incurred as research and development expenses. The Company began capitalizing inventory in March 2024 after FDA approval was granted for Rezdiffra.
Research and Development Costs	Research and Development Costs Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including cash compensation and stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs. In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of its drug, and conducted clinical trials, all of which are considered research and development expenditures. Management uses significant judgment in estimating the amount of research and development costs recognized in each reporting period. Management analyzes and estimates the progress of its clinical trials, completion of milestone events per underlying agreements, invoices received and contracted costs when estimating the research and development costs to accrue in each reporting period. Actual results could differ from the Company’s estimates.
Selling, General and Administrative Expenses	Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries, benefits and stock-based compensation expenses for employees, management costs, costs associated with obtaining and maintaining our patent portfolio, commercial and marketing activities, advertising, corporate insurance, professional fees for accounting, auditing, consulting and legal services and allocated overhead expenses.
Leases	Leases The Company determines if an arrangement is a lease at contract inception. All leases are classified as operating leases. Lease assets represent the right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the leasing arrangement. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. When an implicit rate is not readily determinable, an incremental borrowing rate is estimated based on information available at commencement. Lease expense is recognized on a straight-line basis over the lease term. Short-term leases of twelve months or less at commencement date are expensed on a straight-line basis over the lease term.
Patents	Patents Costs to secure and defend patents are expensed as incurred and are classified as selling, general and administrative expense in the Company’s consolidated statements of operations.
Intangible Assets	Intangible Assets Intangible assets with finite lives are amortized to cost of sales over their estimated useful lives using the straight-line method. Intangible assets are tested for recoverability whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.
Stock-Based Compensation	Stock-Based Compensation The Company recognizes stock-based compensation expense based on the grant date fair value of stock options, restricted stock units, and other stock-based compensation awards granted to employees, officers, directors, and consultants. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. The Company uses the Black-Scholes option pricing model to determine the grant date fair value of stock options as management believes it is the most appropriate valuation method for its option grants. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options. The expected lives for options granted represent the period of time that options granted are expected to be outstanding. The Company uses the simplified method for determining the expected lives of options. Expected volatility is based upon an industry estimate or blended rate including the Company’s historical trading activity. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant. The Company estimates the forfeiture rate based on historical data. This analysis is re-evaluated at least annually and the forfeiture rate is adjusted as necessary. For other stock-based compensation awards granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s common stock achieving or exceeding certain price targets, the Company uses a Monte Carlo simulation model to estimate the grant date fair value and recognize stock compensation expense over the derived service period. The Monte Carlo simulation model requires key inputs for risk-free interest rate, dividend yield, volatility, and expected life. The assumptions used in computing the fair value of equity awards reflect the Company’s best estimates but involve uncertainties related to market and other conditions. Changes in any of these assumptions may materially affect the fair value of awards granted and the amount of stock-based compensation recognized. Certain of the employee stock options granted by the Company are structured to qualify as incentive stock options (“ISOs”). Under current tax regulations, the Company does not receive a tax deduction for the issuance, exercise or disposition of ISOs if the employee meets certain holding requirements. If the employee does not meet the holding requirements, a disqualifying disposition occurs, at which time the Company may receive a tax deduction. The Company does not record tax benefits related to ISOs unless and until a disqualifying disposition is reported. In the event of a disqualifying disposition, the entire tax benefit is recorded as a reduction of income tax expense. The Company has not recognized any income tax benefit for its stock-based compensation arrangements due to the fact that the Company does not believe it is more likely than not it will realize the related deferred tax assets.
Income Taxes	Income Taxes The Company accounts for income taxes in accordance with FASB ASC 740, “Income Taxes”, which prescribes the use of the liability method where deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all of the deferred tax assets will not be realized based on the weight of available positive and negative evidence. The Company currently maintains a 100% valuation allowance on its deferred tax assets.
Comprehensive Income (Loss)	Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The difference between the Company’s net income (loss) and comprehensive income (loss) includes changes in unrealized gains and losses on marketable securities and unrealized foreign currency translation adjustments.
Basic and Diluted Loss Per Common Share	Basic and Diluted Loss Per Common Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the three months ended March 31, 2025 and 2024, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of common stock issuable upon the exercise of stock options and warrants or vesting of restricted stock units, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which enhances the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company adopted ASU 2023-07 for its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission on February 26, 2025. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the disclosures required for income taxes in the Company's annual consolidated financial statements. The amendments are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the adoption of ASU 2023-09 to have a significant impact on its financial statements. In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”), which applies to all public entities and requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt the new standard prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. The Company is currently evaluating the impact of ASU 2024-03 on its financial statements.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Statement of Comprehensive Income [Abstract]
Net Loss	$ (73,238)	$ (147,541)
Other comprehensive income (loss):
Unrealized loss on available-for-sale securities	(111)	(640)
Unrealized foreign currency gain	32	0
Comprehensive loss	$ (73,317)	$ (148,181)

- Definition

Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.

+ References + Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Accrued Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Accrued Liabilities, Current [Abstract]
Contract research organization costs	$ 24,375	$ 30,250
Other clinical study related costs	2,026	2,161
Manufacturing and drug supply	5,278	9,941
Compensation and benefits	18,272	34,957
Professional fees	27,733	17,512
Gross to net accrued liabilities	33,369	21,703
Other	13,112	8,171
Total accrued liabilities	$ 124,165	$ 124,695

Product Revenue, Net (Tables)

3 Months Ended

Mar. 31, 2025

Revenue from Contract with Customer [Abstract]

Schedule Of Gross To Net Adjustments Reserve

The following table summarizes balances and activity for gross to net reserves (in thousands):


	Chargebacks, Discounts for Prompt Pay and Other Allowances		Rebates, Customer Fees/Credits, Co-Pay Assistance, and Other		Totals
Balance at December 31, 2024	$	4,188	$	21,703	$	25,891
Provision related to sales in the current year	5,239		29,380		34,619
Adjustments related to prior year sales	(1,066)		(329)		(1,395)
Payments and customer credits issued	(3,866)		(17,385)		(21,251)
Balance at March 31, 2025	$	4,495	$	33,369	$	37,864

Schedule of Concentrations of Credit Risk and Significant Customers

The following customers accounted for over 10% of total gross product revenue during the three months ended March 31, 2025. As Rezdiffra was made commercially available in April 2024, there were no sales and no corresponding customer concentrations for the comparable period in 2024.


	Three Months Ended March 31,
	2025		2024

Customer A	34	%	—	%
Customer B	23	%	—	%
Customer C	15	%	—	%
Customer D	10	%	—	%

Segment Information - Schedule of Segment Information (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Segment Reporting [Abstract]
Product revenue, net	$ 137,250	$ 0
Cost of sales	(4,513)	0
Research and development - personnel and internal expense	(15,023)	(16,716)
Research and development - external expense	(29,149)	(54,521)
Selling, general and administrative	(167,876)	(80,800)
Other segment income (expense)	6,073	4,496
Net loss	$ (73,238)	$ (147,541)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
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+ Details

Liquidity and Uncertainties	3 Months Ended
Liquidity and Uncertainties	Mar. 31, 2025
Liquidity and Uncertainties
Liquidity and Uncertainties	Liquidity and Uncertainties The Company is subject to risks common to development stage companies and early commercial companies in the biopharmaceutical industry including, but not limited to, uncertainty of product development and commercialization, dependence on key personnel, uncertainty of market acceptance of products and product reimbursement, product liability, uncertain protection of proprietary technology, potential inability to raise additional financing necessary for development and commercialization, and compliance with the FDA and other government regulations. The Company has incurred losses since inception, including approximately $73.2 million for the three months ended March 31, 2025, resulting in an accumulated deficit of approximately $1,875.4 million as of March 31, 2025. To date, the Company has funded its operations primarily through proceeds from sales of the Company’s capital stock and debt financings. 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. Management expects to incur losses until the Company is able to generate sufficient revenue from Rezdiffra and any other approved products. The Company believes that its cash, cash equivalents and marketable securities at March 31, 2025 will be sufficient to fund operations past one year from the issuance of these financial statements. The Company’s future long-term liquidity requirements will be substantial and will depend on many factors, including the Company’s ability to effectively commercialize Rezdiffra, the Company’s decisions regarding future geographic expansion, the conduct of any future preclinical studies and clinical trials and the Company entering into any strategic transactions. To meet its future capital needs, the Company may need to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transactions on acceptable terms or otherwise. The inability of the Company to obtain sufficient funds on acceptable terms when needed, if at all, could have a material adverse effect on the Company’s business, results of operations and financial condition. The Company has 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.

Accrued Liabilities (Tables)

3 Months Ended

Mar. 31, 2025

Accrued Liabilities, Current [Abstract]

Schedule of Accrued Liabilities

Accrued liabilities as of March 31, 2025 and December 31, 2024 consisted of the following (in thousands):


	March 31, 2025		December 31, 2024
Contract research organization costs	$	24,375	$	30,250
Other clinical study related costs	2,026		2,161
Manufacturing and drug supply	5,278		9,941
Compensation and benefits	18,272		34,957
Professional fees	27,733		17,512
Gross to net accrued liabilities	33,369		21,703
Other	13,112		8,171
Total accrued liabilities	$	124,165	$	124,695

Cash, Cash Equivalents, Restricted Cash, and Marketable Securities (Tables)

3 Months Ended

Mar. 31, 2025

Cash and Cash Equivalents [Abstract]

Summary of Cash, Cash Equivalents and Investments

A summary of cash, cash equivalents and available-for-sale marketable securities held by the Company as of March 31, 2025 and December 31, 2024 is as follows (in thousands):


	March 31, 2025
	Cost		Unrealized gains		Unrealized losses		Fair value
Cash (Level 1)	$	34,902	$	—	$	—	$	34,902
Money market funds (Level 1)	65,543		—		—		65,543

Corporate debt securities due within 3 months of date of purchase (Level 2)	88,201		—		—		88,201
Total cash and cash equivalents	188,646		—		—		188,646
Marketable securities:
Corporate debt securities due within 1 year of date of purchase (Level 2)	340,305		51		(35)		340,321
U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2)	273,004		244		(43)		273,205
U.S. government and government sponsored entities due within 1 to 2 years of date of purchase (Level 2)	40,547		132		—		40,679
Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)	5,209		8		—		5,217
Total cash, cash equivalents, restricted cash and marketable securities	$	847,711	$	435	$	(78)	$	848,068


	December 31, 2024
	Cost		Unrealized gains		Unrealized losses		Fair value
Cash and cash equivalents:
Cash (Level 1)	$	24,495	$	—	$	—	$	24,495
Money market funds (Level 1)	65,302		—		—		65,302
US government and government sponsored entities (Level 1)	12,711		—		—		12,711
Corporate debt securities due within 3 months of date of purchase (Level 2)	2,511		—		—		2,511
Total cash and cash equivalents	105,019		—		—		105,019
Marketable securities:
Corporate debt securities due within 1 year of date of purchase (Level 2)	367,950		190		(64)		368,076
US government and government sponsored entities due within 1 year of date of purchase (Level 2)	382,793		279		(62)		383,010
US government and government sponsored entities due within 1 to 2 years of date of purchase (Level 2)	71,739		156		(25)		71,870
Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)	3,282		—		(6)		3,276
Total cash, cash equivalents, restricted cash and marketable securities	$	930,783	$	625	$	(157)	$	931,251

Inventory

3 Months Ended

Mar. 31, 2025

Inventory Disclosure [Abstract]

Inventory

The following table summarizes the Company's inventory balances as of March 31, 2025 and December 31, 2024 (in thousands):


	March 31, 2025		December 31, 2024
Raw materials	$	—	$	—
Work in process	50,969		29,533
Finished goods	4,272		4,535
Total	$	55,241	$	34,068

There was no provision for excess inventory recorded as of March 31, 2025 or December 31, 2024.

Inventory (Details) - USD ($)	Mar. 31, 2025	Dec. 31, 2024
Inventory Disclosure [Abstract]
Raw materials	$ 0	$ 0
Work in process	50,969,000	29,533,000
Finished goods	4,272,000	4,535,000
Total	55,241,000	34,068,000
Provision for excess inventory	$ 0	$ 0

Stock-based Compensation - Performance-Based Restricted Stock Units (Details)	3 Months Ended
	Mar. 31, 2025 $ / shares shares
Performance-Based Restricted Stock Units (PSUs)
Shares
Outstanding, beginning balance (in shares)	92,760
PSUs granted (in shares)	53,725
PSUs attained (in shares)	(50,000)
PSUs forfeited (in shares)	0
Outstanding, ending balance (in shares)	96,485
Weighted average grant date fair value
Unvested, beginning balance (in dollars per share) \| $ / shares	$ 257.77
PSUs granted (in dollars per share) \| $ / shares	593.49
PSUs attained (in dollars per share) \| $ / shares	146.37
PSUs forfeited (in dollars per share) \| $ / shares	0
Unvested, ending balance (in dollars per share) \| $ / shares	$ 502.43
Eligible to Earn PSUs
Shares
Outstanding, beginning balance (in shares)	235,520
PSUs granted (in shares)	107,450
PSUs attained (in shares)	(50,000)
PSUs forfeited (in shares)	0
Outstanding, ending balance (in shares)	292,970

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands	Total	Nonrelated Party	Related Party	Preferred stock	Common stock	Common stock Nonrelated Party	Common stock Related Party	Additional paid-in Capital	Additional paid-in Capital Nonrelated Party	Additional paid-in Capital Related Party	Accumulated other comprehensive income (loss)	Accumulated deficit
Balance (in shares) at Dec. 31, 2023				2,369,797	19,875,427
Balance at Dec. 31, 2023	$ 405,333			$ 0	$ 2			$ 1,741,153			$ 468	$ (1,336,290)
Increase (Decrease) in Stockholders' Equity
Issuance of common shares and sale of warrants in equity offerings, excluding to related parties, net of transaction costs (in shares)						750,000
Issuance of common shares and sale of warrants in equity offerings, excluding to related parties, net of transaction costs		$ 311,560							$ 311,560
Sale of warrants to related parties in equity offerings, exercise of common stock options, and restricted stock vesting, net of transaction costs (in shares)							59,236
Sale of warrants to related parties in equity offerings, exercise of common stock options, and restricted stock vesting, net of transaction costs			$ 262,145							$ 262,145
Stock-based compensation expense related to equity-classified awards	19,902							19,902
Unrealized loss on marketable securities and foreign currency	(640)										(640)
Unrealized loss on marketable securities	(640)
Net loss	(147,541)											(147,541)
Balance (in shares) at Mar. 31, 2024				2,369,797	20,684,663
Balance at Mar. 31, 2024	$ 850,759			$ 0	$ 2			2,334,760			(172)	(1,483,831)
Balance (in shares) at Dec. 31, 2024	22,004,679			2,369,797	22,004,679
Balance at Dec. 31, 2024	$ 754,383			$ 0	$ 2			2,556,095			468	(1,802,182)
Increase (Decrease) in Stockholders' Equity
Issuance of common shares and sale of warrants in equity offerings, excluding to related parties, net of transaction costs (in shares)						183,037
Issuance of common shares and sale of warrants in equity offerings, excluding to related parties, net of transaction costs		$ 8,640							$ 8,640
Sale of warrants to related parties in equity offerings, exercise of common stock options, and restricted stock vesting, net of transaction costs (in shares)	100,277
Stock-based compensation expense related to equity-classified awards	$ 20,931							20,931
Unrealized loss on marketable securities and foreign currency	(79)										(79)
Unrealized loss on marketable securities	(111)
Net loss	$ (73,238)											(73,238)
Balance (in shares) at Mar. 31, 2025	22,187,716			2,369,797	22,187,716
Balance at Mar. 31, 2025	$ 710,637			$ 0	$ 2			$ 2,585,666			$ 389	$ (1,875,420)

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Mar. 31, 2025
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of operations in the normal course of business. 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 March 2027. The Company has a Research, Development and Commercialization Agreement with Hoffmann-La Roche (“Roche”) which grants the Company a sole and exclusive license to develop, use, sell, offer for sale and import any Licensed Product as defined by the agreement. The agreement requires future milestone payments to Roche. In March 2024, upon receiving FDA approval of Rezdiffra, a milestone was achieved and $5.0 million became due to Roche. Remaining milestones under the agreement total $3.0 million and are payable upon the Company achieving specified objectives related to future regulatory approval in Europe of resmetirom or a product developed from resmetirom. Furthermore, a tiered single-digit royalty is payable on net sales of resmetirom or a product developed from resmetirom, subject to certain reductions. The Company began accruing for royalty payments following its commercial launch of Rezdiffra in April 2024. In 2019, the Company entered into an operating lease for office space located in West Conshohocken, Pennsylvania (the “Office Lease”), which was later updated by three amendments entered into from 2019 to 2022. In May 2023, the Company entered into the Fourth Amendment to the Office Lease, which did not have a financial impact. In August 2023, the Company entered into the Fifth Amendment to the Office Lease (the “Fifth Lease Amendment”). The Fifth Lease Amendment extended 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 liabilities were recorded during the year ended December 31, 2023. In April 2024 and May 2024, the Company entered into the Sixth Amendment and the Seventh Amendment to the Office Lease, respectively, leasing additional office space in the same premises under the Office Lease. The lease for the additional office space commenced in September 2024 and resulted in an incremental $1.2 million right-of-use asset and lease liability being recorded for the quarter ended March 31, 2025. In August 2024, the Company entered into the Eighth (the “Eighth Lease Amendment”) and in October 2024, the Company entered into the Ninth Amendment (the “Ninth Lease Amendment”) to the Office Lease further expanding the amount of office space in the same premises. The lease 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.

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Current assets:
Cash and cash equivalents	$ 183,646	$ 100,019
Restricted cash	5,000	5,000
Marketable securities	659,422	826,232
Trade receivables, net	61,428	53,822
Inventory	55,241	34,068
Prepaid expenses and other current assets	23,242	13,786
Total current assets	987,979	1,032,927
Property and equipment, net	1,901	2,190
Intangible assets, net	4,639	4,729
Right-of-use asset	2,110	2,401
Total assets	996,629	1,042,247
Current liabilities:
Accounts payable	42,056	43,599
Accrued liabilities	124,165	124,695
Lease liability	1,016	983
Total current liabilities	167,237	169,277
Long term liabilities:
Loan payable, net of discount	118,005	117,569
Lease liability	750	1,018
Total long term liabilities	118,755	118,587
Total liabilities	285,992	287,864
Stockholders’ equity:
Preferred stock, par value $0.0001 per share authorized: 5,000,000 shares at March 31, 2025 and December 31, 2024; 2,369,797 and 2,369,797 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively	0	0
Common stock, par value $0.0001 per share authorized: 200,000,000 at March 31, 2025 and December 31, 2024; 22,187,716 and 22,004,679 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively	2	2
Additional paid-in-capital	2,585,666	2,556,095
Accumulated other comprehensive income	389	468
Accumulated deficit	(1,875,420)	(1,802,182)
Total stockholders’ equity	710,637	754,383
Total liabilities and stockholders’ equity	$ 996,629	$ 1,042,247

Summary of Significant Accounting Policies - Income Taxes (Details)	3 Months Ended
	Mar. 31, 2025
Income Taxes
Valuation allowance on deferred tax assets (as a percent)	100.00%

Stock-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	3 Months Ended
	Sep. 30, 2023	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024
Unrecognized stock-based compensation expense
Unrecognized stock compensation expense		$ 242.7
Weighted average remaining period (in years)		3 years 1 month 13 days
2015 Stock Plan
Unrecognized stock-based compensation expense
Shares available for future issuance (in shares)		722,608
2023 Inducement Plan
Unrecognized stock-based compensation expense
Expiration period (in years)	10 years
Shares available for future issuance (in shares)		25,956
Common stock, capital shares reserved for future issuance (in shares)		500,000
2015 Stock Plan And Inducement Plan
Unrecognized stock-based compensation expense
Common stock granted and issuable (in shares)		2,513,983
Stock Options
Unrecognized stock-based compensation expense
Proceeds resulting from exercise of stock options		$ 8.6	$ 1.4
Total intrinsic value of options exercised		$ 25.7	$ 3.8
Weighted-average grant date fair value of options (in dollars per share)		$ 203.05	$ 152.05
Stock Options \| 2015 Stock Plan
Unrecognized stock-based compensation expense
Expiration period (in years)		10 years
Restricted Stock Units (RSUs)
Unrecognized stock-based compensation expense
Equity award other than options, nonvested (in shares)		694,995		499,559
Weighted average grant date fair value (in dollars per share)		$ 278.75		$ 237.07
Restricted Stock Units (RSUs) \| 2015 Stock Plan
Unrecognized stock-based compensation expense
Equity award other than options, nonvested (in shares)		694,995
Weighted average grant date fair value (in dollars per share)		$ 278.75

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Cash flows from operating activities:
Net loss	$ (73,238)	$ (147,541)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	20,931	19,902
Depreciation and amortization expense	379	168
Amortization of debt issuance costs and discount	436	655
Amortization and interest accretion related to operating leases	56	0
Changes in operating assets and liabilities:
Trade receivables, net	(7,606)	0
Prepaid expenses and other current assets	(9,456)	(10,885)
Inventory	(21,173)	(854)
Accounts payable	(1,543)	(11,513)
Accrued liabilities	(530)	2,291
Accrued interest, net of interest received on maturity of investments	2,853	(1,380)
Net cash used in operating activities	(88,891)	(149,157)
Cash flows from investing activities:
Purchases of marketable securities	(130,812)	(84,197)
Sales and maturities of marketable securities	294,690	182,607
Acquisition of intangible asset	0	0
Purchases of property and equipment, net of disposals	0	(357)
Net cash provided by investing activities	163,878	98,053
Cash flows from financing activities:
Net cash provided by financing activities	8,640	573,706
Net increase in cash, cash equivalents, and restricted cash	83,627	522,602
Cash, cash equivalents, and restricted cash at beginning of period	105,019	99,915
Cash, cash equivalents, and restricted cash at end of period	188,646	622,517
Supplemental disclosure of cash flow information:
Intangible assets in accounts payable at the end of the period	0	5,000
Nonrelated Party
Cash flows from financing activities:
Proceeds from issuance or sale of equity	8,640	311,561
Related Party
Cash flows from financing activities:
Proceeds from issuance or sale of equity	$ 0	$ 262,145

Stock-based Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs)	3 Months Ended
	Mar. 31, 2025 $ / shares shares
Shares
Outstanding, beginning balance (in shares) \| shares	499,559
Granted (in shares) \| shares	285,451
Vested (in shares) \| shares	(81,564)
Forfeited (in shares) \| shares	(8,451)
Outstanding, ending balance (in shares) \| shares	694,995
Weighted average grant date fair value
Unvested, beginning balance (in dollars per share) \| $ / shares	$ 237.07
Granted (in dollars per share) \| $ / shares	345.21
Vested (in dollars per share) \| $ / shares	257.46
Forfeited (in dollars per share) \| $ / shares	262.40
Unvested, ending balance (in dollars per share) \| $ / shares	$ 278.75

Cash, Cash Equivalents, Restricted Cash, and Marketable Securities - Narrative (Details) - USD ($) $ in Millions	Mar. 31, 2025	Dec. 31, 2024
Cash and Cash Equivalents [Abstract]
Restricted cash	$ 5.0	$ 5.0

Long Term Debt (Tables)

3 Months Ended

Mar. 31, 2025

Debt Disclosure [Abstract]

Schedule of Maturities of Long-Term Debt

Future minimum payments, including interest and principal, under the loans payable outstanding as of March 31, 2025 are as follows (in thousands):


Period Ending March 31, 2025:	Amount
2025	$	8,741
2026	11,601
2027	126,016
Thereafter	—
	$	146,358
Less amount representing interest	(25,206)
Less unamortized discount	(3,147)
Loans payable, net of discount	$	118,005

Stock-based Compensation

3 Months Ended

Mar. 31, 2025

Share-Based Payment Arrangement [Abstract]

Stock-based Compensation

2015 Stock Plan

The Company’s 2015 Stock Plan, as amended (the “2015 Stock Plan”), is one of the Company’s equity incentive compensation plans through which equity based grants are awarded. The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock, restricted stock units and other stock-based compensation awards to employees, officers, directors, and consultants of the Company. The administration of the 2015 Stock Plan is under the general supervision of the Compensation Committee of the Board. The terms of stock options awarded under the 2015 Stock Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years from the date the option is granted. As of March 31, 2025, 722,608 shares were available for future issuance under the 2015 Stock Plan.

2023 Inducement Plan

In September 2023, the Company adopted the 2023 Inducement Plan (the “Inducement Plan”), pursuant to which the Company may from time to time make equity grants to new employees as a material inducement to their employment. The Inducement Plan was adopted without stockholder approval, pursuant to Nasdaq Listing Rule 5635(c)(4), and is administered by the Compensation Committee of the Board. The Inducement Plan provides for the granting of non-statutory stock options, restricted stock, restricted stock units, performance stock units and other stock-based compensation awards to new employees, but does not allow for the granting of incentive stock options. The terms of the stock options under the Inducement Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years from the date the option or award is granted. A total of 500,000 shares of the Company’s common stock were reserved for issuance under the Inducement Plan. As of March 31, 2025, 25,956 shares were available for future issuance under the 2023 Inducement Plan.

Stock Options

The following table summarizes stock option activity during the three months ended March 31, 2025:


	Shares	Weighted average exercise price
Outstanding at December 31, 2024	1,528,143	$	93.57
Options granted	99,202	342.11
Options exercised	(100,277)	88.83
Options cancelled	(1,050)	87.09
Outstanding at March 31, 2025	1,526,018	$	110.04
Exercisable at March 31, 2025	1,150,985	$	78.44

The total cash received by the Company as a result of stock option exercises was $8.6 million and $1.4 million, respectively, for the three months ended March 31, 2025 and 2024. The total intrinsic value of options exercised was $25.7 million and $3.8 million, respectively, for the three months ended March 31, 2025 and 2024. The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the three months ended March 31, 2025 and 2024 were $203.05 and $152.05, respectively.

Restricted Stock Units

The Company’s 2015 Stock Plan provides for awards of restricted stock units (“RSUs”) to employees, officers, directors and consultants to the Company. The Company’s Inducement Plan provides for awards of RSUs to new employees. RSUs vest over a period of months or years, or upon the occurrence of certain performance criteria or the attainment of stated goals or events, and are subject to forfeiture if employment or service terminates before vesting. As of March 31, 2025, the Company had 694,995 restricted stock units outstanding, with a weighted average grant date fair value of $278.75 per unit.

The following table summarizes RSU activity, excluding performance-based RSUs, during the three months ended March 31, 2025:


	Shares	Weighted average grant date fair value
Outstanding at December 31, 2024	499,559	$	237.07
RSUs granted	285,451	345.21
RSUs vested	(81,564)	257.46
RSUs forfeited	(8,451)	262.40
Outstanding at March 31, 2025	694,995	$	278.75

Performance-Based Restricted Stock Units

The Company has granted various performance-based restricted stock units (“PSUs”) to certain senior personnel. Depending on the terms of the PSUs and the outcome of the pre-established performance criteria, which may include a market and/or performance condition, a recipient may ultimately earn the target number of PSUs granted or a specified multiple thereof at the end of the vesting period.

The following table summarizes PSU activity during the three months ended March 31, 2025:


	PSUs	Eligible to Earn PSUs	Weighted average grant date fair value
Outstanding PSUs at December 31, 2024	92,760	235,520	$	257.77
PSUs granted	53,725	107,450	593.49
PSUs attained	(50,000)	(50,000)	146.37
PSUs forfeited	—	—	—
Outstanding at March 31, 2025	96,485	292,970	$	502.43

Outstanding Awards

As of March 31, 2025, the Company had restricted stock units, performance stock units, and options outstanding pursuant to which an aggregate of 2,513,983 shares of its common stock may be issued pursuant to the terms of all awards granted under the 2015 Stock Plan and Inducement Plan.

Stock-Based Compensation Expense

Stock-based compensation expense during the three months ended March 31, 2025 and 2024 was as follows (in thousands):


	Three Months Ended March 31,
	2025		2024
Stock-based compensation expense by type of award:
Stock options	$	5,439	$	6,886
Restricted stock units	11,788		8,625
Performance-based restricted stock units	3,704		4,391
Total stock-based compensation expense	$	20,931	$	19,902
Effect of stock-based compensation expense by line item:
Research and development	$	5,215	$	5,907
Selling, general and administrative	15,716		13,995
Total stock-based compensation expense included in net loss	$	20,931	$	19,902

Unrecognized stock-based compensation expense as of March 31, 2025 was $242.7 million with a weighted average remaining period of 3.12 years.

Stockholders' Equity	3 Months Ended
Stockholders' Equity	Mar. 31, 2025
Equity [Abstract]
Stockholders' Equity	Stockholders’ Equity Common Stock Each common stockholder is entitled to one vote for each share of common stock held. The common stock will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the Company’s stockholders. Each share of common stock is entitled to receive dividends, as and when declared by the Company’s Board of Directors (the “Board”). The Company has never declared cash dividends on its common stock and does not expect to do so in the foreseeable future. Preferred Stock The Company’s Series A Preferred Stock and Series B Preferred Stock (together, the “Series A and B Preferred Stock”) have a par value of $0.0001 per share and are convertible into shares of the Company’s common stock at a one-to-one ratio, subject to adjustment as provided in the Certificates of Designation of Preferences, Rights and Limitations of Series A Preferred Stock and Series B Preferred Stock that the Company filed with the Secretary of State of the State of Delaware on June 21, 2017 and December 22, 2022, respectively. The terms of the Series A and B Preferred Stock are set forth in such Certificates of Designation. Each share of the Series A and B Preferred Stock is convertible into shares of common stock following notice that may be given at the holder’s option. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, after the satisfaction in full of the debts of the Company and the payment of any liquidation preference owed to the holders of shares of capital stock of the Company ranking prior to the Series A and B Preferred Stock upon liquidation, the holders of the Series A and B Preferred Stock shall participate pari passu with the holders of the common stock (on an as-if-converted-to-common-stock basis) in the net assets of the Company. Shares of the Series A and B Preferred Stock will generally have no voting rights, except as required by law. Shares of the Series A and B Preferred Stock will be entitled to receive dividends before shares of any other class or series of capital stock of the Company (other than dividends in the form of the common stock) equal to the dividend payable on each share of the common stock, on an as-converted basis. 2024 Public Offering On March 18, 2024, the Company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC, Jefferies LLC, Cowen and Company, LLC, Evercore Group L.L.C. and Piper Sandler & Co, as representatives of the several underwriters named therein (the “2024 Underwriters”), pursuant to which the Company sold to the 2024 Underwriters in an underwritten public offering (the “2024 Offering”): (i) 750,000 shares of common stock at a public offering price of $260.00 per share, (ii) pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 1,557,692 shares of common stock at a public offering price of $259.9999 per 2024 Pre-Funded Warrant, which represents the per share public offering price for the common stock less a $0.0001 per share exercise price for each such Pre-Funded Warrant, and (iii) a 30-day option for the 2024 Underwriters to purchase up to 346,153 additional shares of common stock at the public offering price of $260.00 per share (the “Underwriters’ Option”). The 2024 Offering closed on March 21, 2024. The gross proceeds of the 2024 Offering was $600.0 million, and the Company received net proceeds, after deducting the underwriting discount and commissions and other estimated offering expenses payable by the Company, of approximately $574.0 million. The Underwriters’ Option was later exercised in full, and closed on April 2, 2024. The net proceeds to the Company for the exercise of the Underwriters’ Option, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, was approximately $85.9 million. The Company intends to use the net proceeds from the 2024 Offering for its commercial activities in connection with the launch of Rezdiffra in the United States and for general corporate purposes, including, without limitation, research and development expenditures, ongoing clinical trial expenditures, manufacture and supply of drug substance and drug products, potential ex-U.S. commercialization or partnering opportunities, potential acquisitions or licensing of new technologies, capital expenditures and working capital. The 2024 Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of 2024 Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of 2024 Pre-Funded Warrants may increase or decrease this percentage, but not in excess of 19.99%, by providing at least 61 days prior notice to the Company. At-The-Market Issuance Sales Agreement In June 2021, the Company entered into an at-the-market sales agreement (the “2021 Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company could, from time to time, issue and sell shares of its common stock. The 2021 Sales Agreement initially authorized an aggregate offering of up to $200.0 million in shares of the Company’s common stock, at the Company’s option, through Cowen as its sales agent. Sales of common stock through Cowen could be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by the Company and Cowen. Subject to the terms and conditions of the 2021 Sales Agreement, Cowen would use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company imposed). In May 2023, the Company entered into an amendment to the 2021 Sales Agreement (the “Sales Agreement Amendment”), with Cowen, pursuant to which the Company could, from time to time, issue and sell an additional $200.0 million in shares of its common stock, until it was terminated in May 2024. The Company was not obligated to make any sales of its common stock under this arrangement. Any shares sold would be sold pursuant to the Registration Statement and prospectus supplement filed pursuant to the Registration Statement. The 2021 Sales Agreement, as amended by the Sales Agreement Amendment, authorized sales of shares of the Company’s common stock, from time to time, at the Company’s option, through Cowen as its sales agent. Sales of common stock through Cowen may be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, and as described in the prospectus supplement. Since the entry into the Sales Agreement Amendment in May 2023, the Company sold 98,101 shares in total under the 2021 Sales Agreement, as amended by the Sales Agreement Amendment, for an aggregate of $25.2 million in gross proceeds, with net proceeds to the Company of approximately $24.5 million after deducting commissions and other transaction costs. All shares were sold pursuant to the Company’s effective Registration Statement and the prospectus supplement relating thereto. In total, the Company sold 1,334,044 shares of common stock having an aggregate offering price of $225.1 million pursuant to the 2021 Sales Agreement, as amended by the Sales Agreement Amendment. In May 2024, the Company entered into a Sales Agreement (the “2024 Sales Agreement”) with Cowen, replacing and superseding the 2021 Sales Agreement. The Company is authorized to issue and sell up to $300.0 million in shares of the Company’s common stock under the 2024 Sales Agreement. The Company sold no shares in the three months ended March 31, 2025 under the 2024 Sales Agreement.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
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-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Paragraph 13
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478448/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.3-04)
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-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Revenues:
Product revenue, net	$ 137,250	$ 0
Operating expenses:
Cost of sales	4,513	0
Research and development	44,172	71,237
Selling, general and administrative	167,876	80,800
Total operating expenses	216,561	152,037
Loss from operations	(79,311)	(152,037)
Interest income	9,370	8,334
Interest expense	(3,297)	(3,838)
Net loss	$ (73,238)	$ (147,541)
Net loss per common share:
Basic net loss per common share (in dollars per share)	$ (3.32)	$ (7.38)
Diluted net loss per common share (in dollars per share)	$ (3.32)	$ (7.38)
Basic weighted average number of common shares outstanding (in shares)	22,091,314	20,001,569
Diluted weighted average number of common shares outstanding (in shares)	22,091,314	20,001,569

Stockholders' Equity - At The Market Issuances (Details) - USD ($) $ in Millions	1 Months Ended		3 Months Ended	23 Months Ended	36 Months Ended	46 Months Ended
	May 31, 2023	Jun. 30, 2021	Mar. 31, 2025	Mar. 31, 2025	May 07, 2024	Mar. 31, 2025	May 31, 2024
Two Thousand and Twenty Two Registered Direct Offering
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Cash received on stock transaction after deduction of issuance costs		$ 200.0
2021 Sales Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum aggregate offering price					$ 225.1
Sale of stock received on transaction, gross				$ 25.2
Cash received on stock transaction after deduction of issuance costs				$ 24.5
2021 Sales Agreement \| Common stock
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares issued in transaction (in shares)						1,334,044
Public Stock Offering
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares issued in transaction (in shares)				98,101
2024 Sales Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares issued in transaction (in shares)			0
Authorized capital							$ 300.0
Cowen & Co. LLC \| Maximum \| 2021 Sales Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum aggregate offering price	$ 200.0

Organization, Business and Basis of Presentation	3 Months Ended
Organization, Business and Basis of Presentation	Mar. 31, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization, Business and Basis of Presentation	Organization, Business, and Basis of Presentation Organization and Business Madrigal Pharmaceuticals, Inc. (the “Company” or “Madrigal”) is 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”). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. The U.S. Food and Drug Administration (the “FDA”) considers the term NASH interchangeable with MASH. 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. The Company’s 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 FDA-approved therapy 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). Basis of Presentation Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. However, the Company believes that the disclosures included in these financial statements are adequate to make the information presented not misleading. The unaudited condensed consolidated financial statements, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of such interim results. The interim results are not necessarily indicative of the results that the Company will have for the full year ending December 31, 2025 or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes to those financial statements for the year ended December 31, 2024.

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2025

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

The

following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive:


	Outstanding at March 31,
	2025	2024
Common stock options	1,526,018	2,458,227
Restricted stock units	694,995	530,671
Performance-based restricted stock units	292,970	252,404
Preferred stock	2,369,797	2,369,797
Warrants	3,625,244	3,625,244

Accrued Liabilities

3 Months Ended

Mar. 31, 2025

Accrued Liabilities, Current [Abstract]

Accrued Liabilities

Accrued liabilities as of March 31, 2025 and December 31, 2024 consisted of the following (in thousands):


	March 31, 2025		December 31, 2024
Contract research organization costs	$	24,375	$	30,250
Other clinical study related costs	2,026		2,161
Manufacturing and drug supply	5,278		9,941
Compensation and benefits	18,272		34,957
Professional fees	27,733		17,512
Gross to net accrued liabilities	33,369		21,703
Other	13,112		8,171
Total accrued liabilities	$	124,165	$	124,695

Insider Trading Arrangements

3 Months Ended

Mar. 31, 2025

Trading Arrangements, by Individual

Material Terms of Trading Arrangement

Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities that were adopted by our executive officers and directors during the quarter ended March 31, 2025. Each of the plans was entered into during an open trading window and is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (each a “Trading Plan”).

Name and Title

Action Taken (Date)

Scheduled Start Date of Trading Plan

Scheduled Expiration Date of Trading Plan

Maximum Number of Shares Subject to Trading Plan

Paul Friedman, M.D., Director

Adoption (March 14, 2025)

June 13, 2025

July 22, 2026

206,256

Rebecca Taub, M.D., Senior Scientific and Medical Advisor and Director

Adoption (March 14, 2025)

June 13, 2025

July 22, 2026

76,564

Non-Rule 10b5-1 Arrangement Adopted

false

Rule 10b5-1 Arrangement Terminated

false

Non-Rule 10b5-1 Arrangement Terminated

false

Paul Friedman [Member]

Trading Arrangements, by Individual

Name

Paul Friedman, M.D.,

Title

Director

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

Adoption (March 14, 2025)

Expiration Date

July 22, 2026

Arrangement Duration

404 days

Aggregate Available

206,256

Rebecca Taub [Member]

Trading Arrangements, by Individual

Name

Rebecca Taub, M.D.,

Title

Senior Scientific and Medical Advisor and Director

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

Adoption (March 14, 2025)

Expiration Date

July 22, 2026

Arrangement Duration

404 days

Aggregate Available

76,564

Stock-based Compensation - Stock Option (Details)	3 Months Ended
Stock-based Compensation - Stock Option (Details)	Mar. 31, 2025 $ / shares shares
Shares
Outstanding at the beginning of the year (in shares) \| shares	1,528,143
Options granted (in shares) \| shares	99,202
Options exercised (in shares) \| shares	(100,277)
Options cancelled (in shares) \| shares	(1,050)
Outstanding at the ending of the year (in shares) \| shares	1,526,018
Exercisable at the ending of the year (in shares) \| shares	1,150,985
Weighted average exercise price
Outstanding at the beginning of the year (in dollars per share) \| $ / shares	$ 93.57
Options granted (in dollars per share) \| $ / shares	342.11
Options exercised (in dollars per share) \| $ / shares	88.83
Options cancelled (in dollars per share) \| $ / shares	87.09
Outstanding at the ending of the year (in dollars per share) \| $ / shares	110.04
Exercisable at the ending of the year (in dollars per share) \| $ / shares	$ 78.44