Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | MADRIGAL PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001157601 | |
Entity File Number | 001-33277 | |
Current Fiscal Year End Date | --12-31 | |
Entity Tax Identification Number | 04-3508648 | |
Entity Incorporation, State or Country Code | DE | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 18,471,233 | |
City Area Code | 267 | |
Local Phone Number | 824-2827 | |
Trading Symbol | MDGL | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, $0.0001 Par Value Per Share | |
Entity Address, Address Line One | Four Tower Bridge | |
Entity Address, Address Line Two | 200 Barr Harbor Drive, Suite 200 | |
Entity Address, City or Town | West Conshohocken | |
Entity Address, Postal Zip Code | 19428 | |
Entity Address, State or Province | PA |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 77,196 | $ 331,549 |
Marketable securities | 221,222 | 27,225 |
Prepaid expenses and other current assets | 3,177 | 2,595 |
Total current assets | 301,595 | 361,369 |
Property and equipment, net | 455 | 601 |
Right-of-use asset | 411 | 602 |
Total assets | 302,461 | 362,572 |
Current liabilities: | ||
Accounts payable | 17,534 | 23,831 |
Accrued expenses | 81,761 | 91,461 |
Lease liability | 411 | 602 |
Total current liabilities | 99,706 | 115,894 |
Long term liabilities: | ||
Loan payable, net of discount | 99,249 | 49,289 |
Total long term liabilities | 99,249 | 49,289 |
Total liabilities | 198,955 | 165,183 |
Stockholders' equity: | ||
Preferred stock, par value $0.0001 per share authorized: 5,000,000 shares at June 30, 2023 and December 31, 2022; 2,369,797 and 2,369,797 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | ||
Common stock, par value $0.0001 per share authorized: 200,000,000 at June 30, 2023 and December 31, 2022; 18,459,033 and 18,102,523 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 2 | 2 |
Additional paid-in-capital | 1,228,949 | 1,160,079 |
Accumulated other comprehensive loss | (89) | (32) |
Accumulated deficit | (1,125,356) | (962,660) |
Total stockholders' equity | 103,506 | 197,389 |
Total liabilities and stockholders' equity | $ 302,461 | $ 362,572 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 2,369,797 | 2,369,797 |
Preferred stock, shares outstanding | 2,369,797 | 2,369,797 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 18,459,033 | 18,102,523 |
Common stock, shares outstanding | 18,459,033 | 18,102,523 |
Condensed Consolidated Statemen
Condensed Consolidated Statements Of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenues: | ||||
Total revenues | ||||
Operating expenses: | ||||
Research and development | 68,605 | 58,499 | 130,759 | 106,428 |
General and administrative | 17,845 | 11,774 | 34,027 | 21,432 |
Total operating expenses | 86,450 | 70,273 | 164,786 | 127,860 |
Loss from operations | (86,450) | (70,273) | (164,786) | (127,860) |
Interest income | 3,551 | 323 | 7,327 | 392 |
Interest expense | (2,901) | (780) | (5,237) | (780) |
Net loss | $ (85,800) | $ (70,730) | $ (162,696) | $ (128,248) |
Net loss per common share: | ||||
Basic net loss per common share | $ (4.69) | $ (4.14) | $ (8.91) | $ (7.5) |
Diluted net loss per common share | $ (4.69) | $ (4.14) | $ (8.91) | $ (7.5) |
Basic weighted average number of common shares outstanding | 18,310,952 | 17,103,395 | 18,249,778 | 17,103,395 |
Diluted weighted average number of common shares outstanding | 18,310,952 | 17,103,395 | 18,249,778 | 17,103,395 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net Loss | $ (85,800) | $ (70,730) | $ (162,696) | $ (128,248) |
Other comprehensive income (loss): | ||||
Unrealized loss on available-for-sale securities | (3) | (45) | (57) | (367) |
Comprehensive loss | $ (85,803) | $ (70,775) | $ (162,753) | $ (128,615) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common stock | Additional paid-in Capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Balance at Dec. 31, 2021 | $ 196,107 | $ 2 | $ 863,495 | $ (80) | $ (667,310) | |
Balance (in shares) at Dec. 31, 2021 | 1,969,797 | 17,103,395 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense related to stock options for services | 7,477 | 7,477 | ||||
Unrealized loss on marketable securities | (322) | (322) | ||||
Net loss | (57,518) | (57,518) | ||||
Balance at Mar. 31, 2022 | 145,744 | $ 2 | 870,972 | (402) | (724,828) | |
Balance (in shares) at Mar. 31, 2022 | 1,969,797 | 17,103,395 | ||||
Balance at Dec. 31, 2021 | 196,107 | $ 2 | 863,495 | (80) | (667,310) | |
Balance (in shares) at Dec. 31, 2021 | 1,969,797 | 17,103,395 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Unrealized loss on marketable securities | (367) | |||||
Net loss | (128,248) | |||||
Balance at Jun. 30, 2022 | 83,535 | $ 2 | 879,538 | (447) | (795,558) | |
Balance (in shares) at Jun. 30, 2022 | 1,969,797 | 17,103,395 | ||||
Balance at Mar. 31, 2022 | 145,744 | $ 2 | 870,972 | (402) | (724,828) | |
Balance (in shares) at Mar. 31, 2022 | 1,969,797 | 17,103,395 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense related to stock options for services | 7,944 | 7,944 | ||||
Unrealized loss on marketable securities | (45) | (45) | ||||
Hercules warrant | 622 | 622 | ||||
Net loss | (70,730) | (70,730) | ||||
Balance at Jun. 30, 2022 | 83,535 | $ 2 | 879,538 | (447) | (795,558) | |
Balance (in shares) at Jun. 30, 2022 | 1,969,797 | 17,103,395 | ||||
Balance at Dec. 31, 2022 | $ 197,389 | $ 2 | 1,160,079 | (32) | (962,660) | |
Balance (in shares) at Dec. 31, 2022 | 18,102,523 | 2,369,797 | 18,102,523 | |||
Increase (Decrease) in Stockholders' Equity | ||||||
Sale of common shares to related parties and exercise of common stock options, net of transaction cost | $ 17,903 | 17,903 | ||||
Sale of common shares to related parties and exercise of common stock options, net of transaction cost ( in shares) | 180,551 | |||||
Compensation expense related to stock options for services | 11,250 | 11,250 | ||||
Unrealized loss on marketable securities | (54) | (54) | ||||
Hercules warrant | 544 | 544 | ||||
Net loss | (76,896) | (76,896) | ||||
Balance at Mar. 31, 2023 | 150,136 | $ 2 | 1,189,776 | (86) | (1,039,556) | |
Balance (in shares) at Mar. 31, 2023 | 2,369,797 | 18,283,074 | ||||
Balance at Dec. 31, 2022 | $ 197,389 | $ 2 | 1,160,079 | (32) | (962,660) | |
Balance (in shares) at Dec. 31, 2022 | 18,102,523 | 2,369,797 | 18,102,523 | |||
Increase (Decrease) in Stockholders' Equity | ||||||
Unrealized loss on marketable securities | $ (57) | |||||
Net loss | (162,696) | |||||
Balance at Jun. 30, 2023 | $ 103,506 | $ 2 | 1,228,949 | (89) | (1,125,356) | |
Balance (in shares) at Jun. 30, 2023 | 18,459,033 | 2,369,797 | 18,459,033 | |||
Balance at Mar. 31, 2023 | $ 150,136 | $ 2 | 1,189,776 | (86) | (1,039,556) | |
Balance (in shares) at Mar. 31, 2023 | 2,369,797 | 18,283,074 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of common and preferred shares in equity offerings, excluding to related parties, net of transaction costs | 21,754 | 21,754 | ||||
Issuance of common and preferred shares in equity offerings, excluding to related parties, net of transaction costs (in shares) | 85,901 | |||||
Sale of common shares to related parties and exercise of common stock options, net of transaction cost | 6,251 | 6,251 | ||||
Sale of common shares to related parties and exercise of common stock options, net of transaction cost ( in shares) | 90,058 | |||||
Compensation expense related to stock options for services | 10,973 | 10,973 | ||||
Unrealized loss on marketable securities | (3) | (3) | ||||
Hercules warrant | 195 | 195 | ||||
Net loss | (85,800) | (85,800) | ||||
Balance at Jun. 30, 2023 | $ 103,506 | $ 2 | $ 1,228,949 | $ (89) | $ (1,125,356) | |
Balance (in shares) at Jun. 30, 2023 | 18,459,033 | 2,369,797 | 18,459,033 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements Of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (162,696) | $ (128,248) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 22,223 | 15,421 |
Depreciation and amortization expense | 250 | 217 |
Amortization of debt issuance costs and discount | 987 | 178 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (582) | (1,442) |
Accounts payable | (6,297) | (10,086) |
Accrued expense | (9,700) | 16,788 |
Accrued interest, net of interest received on maturity of investments | (3,562) | (101) |
Net cash used in operating activities | (159,377) | (107,273) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (290,696) | (116,496) |
Sales and maturities of marketable securities | 100,204 | 191,813 |
Purchases of property and equipment, net of disposals | (104) | (155) |
Net cash provided by (used in) investing activities | (190,596) | 75,162 |
Cash flows from financing activities: | ||
Proceeds from issuances of stock, excluding related parties, net of transaction costs | 21,754 | 0 |
Proceeds from the sale of related party stock and exercise of common stock options, net of transaction costs | 24,154 | 0 |
Proceeds from issuance of loan payable | 50,000 | 50,000 |
Payment of debt issuance costs | (288) | (886) |
Net cash provided by financing activities | 95,620 | 49,114 |
Net increase (decrease) in cash and cash equivalents | (254,353) | 17,003 |
Cash and cash equivalents at beginning of period | 331,549 | 36,269 |
Cash and cash equivalents at end of period | 77,196 | 53,272 |
Supplemental disclosure of cash flow information: | ||
Obtaining a right-of-use asset in exchange for a lease liability | $ 0 | $ 583 |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Business and Basis of Presentation | 1. Organization, Business, and Basis of Presentation Organization and Business Madrigal Pharmaceuticals, Inc. (the “Company” or “Madrigal”) is a clinical-stage pharmaceutical company developing novel, high-quality, small-molecule drugs addressing major unmet needs in cardiovascular, metabolic, and liver diseases. The Company’s lead compound, resmetirom, is being advanced for non-alcoholic non-alcoholic MAESTRO-NAFLD-1 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, we believe 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 we will have for the full year ending December 31, 2023 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 statements for the year ended December 31, 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principle of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany balances 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. 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 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. The Company adjusts the cost of available-for-sale available-for-sale 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 six months ended June 30, 2023 and 2022, the Company did not have any realized gains or losses on marketable securitie 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 June 30, 2023, 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 six months ended June 30, 2023 and 2022, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2023 and December 31, 2022, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet. 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 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 our 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. Patents Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company’s consolidated statements of operations. Stock-Based Compensation The Company recognizes stock-based compensation expense based on the grant date fair value of stock options and restricted stock units granted to employees, officers, and directors. 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 Income Taxes The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based on the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company currently maintains a 100% valuation allowance on its deferred tax assets. Comprehensive Loss Comprehensive 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 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 six months ended June 30, 2023 and 2022, 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: Six Months Ended June 30, 2023 2022 Common stock options 2,583,540 2,976,545 Restricted stock units 222,300 — Preferred stock 2,369,797 1,969,797 Warrants 18,403 14,899 Recent Accounting Pronouncements None |
Liquidity and Uncertainties
Liquidity and Uncertainties | 6 Months Ended |
Jun. 30, 2023 | |
Liquidity and Uncertainties | |
Liquidity and Uncertainties | 3. Liquidity and Uncertainties The Company is subject to risks common to development stage 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 U.S. Food and Drug Administration (FDA) and other government regulations. The Company has incurred losses since inception, including approximately $162.7 million for the six months ended June 30, 2023, resulting in an accumulated deficit of approximately $1,125 million as of June 30, 2023. Management expects to incur losses for the foreseeable future. To date, the Company has funded its operations primarily through proceeds from sales of the Company’s capital stock and debt financings. The Company believes that its cash, cash equivalents and marketable securities at June 30, 2023 will be sufficient to fund operations past one year from the issuance of these financial statements. To meet its future capital needs, the Company intends 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 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 research activities and related clinical expenses if necessary due to liquidity concerns until a date when those concerns are relieved |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 6 Months Ended |
Jun. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 4. Cash, Cash Equivalents and Marketable Securities A summary of cash, cash equivalents and available-for-sale June 30, 2023 Cost Unrealized gains Unrealized losses Fair value Cash and cash equivalents: Cash (Level 1) $ 8,185 $ — $ — $ 8,185 Money market funds (Level 1) 69,011 — — 69,011 Total cash and cash equivalents 77,196 — — 77,196 Marketable securities: Corporate debt securities due within 1 144,036 13 (105 ) 143,944 U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2) 77,275 6 (3 ) 77,278 Total cash, cash equivalents and marketable securities $ 298,507 $ 19 $ (108 ) $ 298,418 December 31, 2022 Cost Unrealized gains Unrealized losses Fair value Cash and cash equivalents: Cash (Level 1) $ 15,100 $ — $ — $ 15,100 Money market funds (Level 1) 316,449 — — 316,449 Total cash and cash equivalents 331,549 — — 331,549 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 27,257 7 (39 ) 27,225 Total cash, cash equivalents and marketable securities $ 358,806 $ 7 $ (39 ) $ 358,774 |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | 5. Accrued Liabilities Accrued liabilities as of June 30, 2023 and December 31, 2022 consisted of the following (in thousands): June 30, December 31, Contract research organization costs $ 58,050 $ 53,119 Other clinical study related costs 3,605 6,582 Manufacturing and drug supply 3,556 11,262 Compensation and benefits 5,453 14,864 Professional fees 9,494 4,867 Other 1,603 767 Total accrued liabilities $ 81,761 $ 91,461 |
Long Term Debt
Long Term Debt | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Long Term Debt | 6. Long Term Debt In May 2022 the Company and its wholly-owned subsidiary, Canticle Pharmaceuticals, Inc., entered into the $250.0 million Loan Facility with the several banks and other financial institutions or entities party thereto (each, a “Lender” and collectively referred to as 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 be drawn by the Company, subject to the approval of Hercules. The Loan Facility had a minimum interest rate of 7.45% and adjusts with changes in the prime rate. The Company will pay interest-only monthly payments of accrued interest under the Loan Facility for a period of 30 months, which period may be extended to 36, 48, and 60 months upon the successive achievement of certain clinical and regulatory milestones and if the Company maintains compliance with applicable covenants. The Loan Facility matures in May 2026 and may be extended an additional year upon the achievement of certain clinical and regulatory milestones. 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 “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 Company has the ability to draw the remaining $15.0 million available under Tranche 2 by September 30, 2023 in accordance with the Amended Loan Facility. Tranche 2 8-K The Loan Facility includes affirmative and restrictive financial covenants commencing 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, and a revenue-based covenant that could apply commencing at or after the time that financial reporting is due for the quarter ending September 30, 2024. 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 June 30, 2023, the outstanding principal under the Loan Facility was $100.0 million. The interest rate as of June 30, 2023 was 10.70%. As of June 30, 2023, 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 June 30, 2023 are as follows (in thousands): Period Ending June 30, 2023: Amount 2023 (remaining six months) $ 5,372 2024 10,878 2025 69,044 Thereafter 46,363 $ 131,657 Less amount representing interest (26,307 ) Less unamortized discount (6,101 ) Loans payable, net of discount $ 99,249 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 7. 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 Company has never declared cash dividends on its common stock and does not expect to do so in the foreseeable future. Preferred Stock The Series A and B Preferred Stock have a par value of $0.0001 per share and are convertible into shares of the common stock at a one-to-one winding-up as-if-converted-to-Common-Stock as-converted December 2022 Registered Direct Offering In December 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a group of institutional accredited investors, who were existing, non-controlling At-The-Market In June 2021, the Company entered into an at-the-market initially “at-the-market” In December 2022, the Company sold 738,900 shares of common stock through December 31, 2022. on Form S-3 (the “Registration Statement”) and In May 2023, the Company amended the 2021 Agreement (the “Sales Agreement Amendment in additional $200 million in Registration Statement S-3 sales of “at-the-market” Amendment, Registration Statement Amendment |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | 8. Stock-based Compensation The Company’s 2015 Stock Plan, as amended, is our primary equity incentive compensation plan through which equity based grants are awarded. The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory an aggregate of Stock Options The following table summarizes stock option activity during the six months ended June 30, 2023: Shares Weighted Outstanding at January 1, 2023 2,857,054 $ 81.78 Options granted 5,205 283.08 Options exercised (270,609 ) 89.26 Options cancelled (8,110 ) 84.12 Outstanding at June 30, 2023 2,583,540 $ 81.40 Exercisable at June 30, 2023 1,719,944 $ 76.62 The total cash received by the Company as a result of stock option exercises was $21.8 million and $0 million, respectively, for the six months ended June 30, 2023 and 2022. The total intrinsic value of options exercised was $48.9 million and $0 million, respectively, for the six months ended June 30, 2023 and 2022. The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the six months ended June 30, 2023 and 2022 were $219.02 and $55.84, respectively. Restricted Stock Units The Company’s share-based compensation plan provides for awards of restricted stock units to employees, officers, directors and consultants to the Company. Restricted stock units vest over the service period, and are subject to forfeiture if employment or service terminates before vesting. As of June 30, 2023, the Company had 222,300 restricted stock units outstanding, with a weighted average grant date fair value of $294.19 per unit. Stock-Based Compensation Expense Stock-based compensation expense during the six months ended June 30, 2023 and 2022 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Stock-based compensation expense by type of award: Stock options $ 7,431 $ 7,944 $ 16,029 $ 15,421 Restricted stock units 3,542 — 6,194 — Total stock-based compensation expense $ 10,973 $ 7,944 $ 22,223 $ 15,421 Effect of stock-based compensation expense by line item: Research and development $ 5,184 $ 3,301 $ 10,570 $ 6,488 General and administrative 5,789 4,643 11,653 8,933 Total stock-based compensation expense included in net loss $ 10,973 $ 7,944 $ 22,223 $ 15,421 Unrecognized stock-based compensation expense as of June 30, 2023 was $98.2 million with a weighted average remaining period of 2.90 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies The Company has a Research, Development and Commercialization Agreement with Hoffmann-La The agreement requires future milestone payments to Roche. Remaining milestones under the agreement total $8 million and are payable upon Madrigal achieving specified objectives related to future regulatory approval in the United States and 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 has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the six months ended June 30, 2023 and 2022. The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the clinical trials. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Principle of Consolidation | Principle of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany balances 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. |
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 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. The Company adjusts the cost of available-for-sale available-for-sale 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 six months ended June 30, 2023 and 2022, the Company did not have any realized gains or losses on marketable securitie |
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. As of June 30, 2023, 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 six months ended June 30, 2023 and 2022, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2023 and December 31, 2022, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet. |
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 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 our 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. |
Patents | Patents Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company’s consolidated statements of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes stock-based compensation expense based on the grant date fair value of stock options and restricted stock units granted to employees, officers, and directors. 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 |
Income Taxes | Income Taxes The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based on the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company currently maintains a 100% valuation allowance on its deferred tax assets. |
Comprehensive Loss | Comprehensive Loss Comprehensive 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 |
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 six months ended June 30, 2023 and 2022, 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: Six Months Ended June 30, 2023 2022 Common stock options 2,583,540 2,976,545 Restricted stock units 222,300 — Preferred stock 2,369,797 1,969,797 Warrants 18,403 14,899 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements None |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of the outstanding securities not included in the computation of diluted net loss per common share as their inclusion 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: Six Months Ended June 30, 2023 2022 Common stock options 2,583,540 2,976,545 Restricted stock units 222,300 — Preferred stock 2,369,797 1,969,797 Warrants 18,403 14,899 |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Summary of cash, cash equivalents and available-for-sale marketable securities | A summary of cash, cash equivalents and available-for-sale June 30, 2023 Cost Unrealized gains Unrealized losses Fair value Cash and cash equivalents: Cash (Level 1) $ 8,185 $ — $ — $ 8,185 Money market funds (Level 1) 69,011 — — 69,011 Total cash and cash equivalents 77,196 — — 77,196 Marketable securities: Corporate debt securities due within 1 144,036 13 (105 ) 143,944 U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2) 77,275 6 (3 ) 77,278 Total cash, cash equivalents and marketable securities $ 298,507 $ 19 $ (108 ) $ 298,418 December 31, 2022 Cost Unrealized gains Unrealized losses Fair value Cash and cash equivalents: Cash (Level 1) $ 15,100 $ — $ — $ 15,100 Money market funds (Level 1) 316,449 — — 316,449 Total cash and cash equivalents 331,549 — — 331,549 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 27,257 7 (39 ) 27,225 Total cash, cash equivalents and marketable securities $ 358,806 $ 7 $ (39 ) $ 358,774 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of June 30, 2023 and December 31, 2022 consisted of the following (in thousands): June 30, December 31, Contract research organization costs $ 58,050 $ 53,119 Other clinical study related costs 3,605 6,582 Manufacturing and drug supply 3,556 11,262 Compensation and benefits 5,453 14,864 Professional fees 9,494 4,867 Other 1,603 767 Total accrued liabilities $ 81,761 $ 91,461 |
Long Term Debt (Tables)
Long Term Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Long-Term Debt [Table Text Block] | Future minimum payments, including interest and principal, under the loans payable outstanding as of June 30, 2023 are as follows (in thousands): Period Ending June 30, 2023: Amount 2023 (remaining six months) $ 5,372 2024 10,878 2025 69,044 Thereafter 46,363 $ 131,657 Less amount representing interest (26,307 ) Less unamortized discount (6,101 ) Loans payable, net of discount $ 99,249 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Summary of stock option activity | The following table summarizes stock option activity during the six months ended June 30, 2023: Shares Weighted Outstanding at January 1, 2023 2,857,054 $ 81.78 Options granted 5,205 283.08 Options exercised (270,609 ) 89.26 Options cancelled (8,110 ) 84.12 Outstanding at June 30, 2023 2,583,540 $ 81.40 Exercisable at June 30, 2023 1,719,944 $ 76.62 |
Schedule of stock-based compensation expense | Stock-based compensation expense during the six months ended June 30, 2023 and 2022 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Stock-based compensation expense by type of award: Stock options $ 7,431 $ 7,944 $ 16,029 $ 15,421 Restricted stock units 3,542 — 6,194 — Total stock-based compensation expense $ 10,973 $ 7,944 $ 22,223 $ 15,421 Effect of stock-based compensation expense by line item: Research and development $ 5,184 $ 3,301 $ 10,570 $ 6,488 General and administrative 5,789 4,643 11,653 8,933 Total stock-based compensation expense included in net loss $ 10,973 $ 7,944 $ 22,223 $ 15,421 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Income Taxes (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes | |
Valuation allowance on deferred tax assets (as a percent) | 100% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Basic and Diluted Loss Per Common Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Stock options | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 2,583,540 | 2,976,545 |
Restricted stock units | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 222,300 | 0 |
Preferred Stock | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 2,369,797 | 1,969,797 |
Warrants | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 18,403 | 14,899 |
Liquidity and Uncertainties (De
Liquidity and Uncertainties (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Liquidity and Uncertainties | |||||||
Net loss | $ (85,800) | $ (76,896) | $ (70,730) | $ (57,518) | $ (162,696) | $ (128,248) | |
Accumulated deficit | $ (1,125,356) | $ (1,125,356) | $ (962,660) |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Cash, Cash Equivalents and Marketable Securities | ||
Total cash, cash equivalents and marketable securities, Unrealized gains | $ 19 | $ 7 |
Total cash, cash equivalents and marketable securities, Unrealized losses | (108) | (39) |
Carrying value | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 77,196 | 331,549 |
Total cash, cash equivalents and marketable securities, Cost | 298,507 | 358,806 |
Fair value | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 77,196 | 331,549 |
Total cash, cash equivalents and marketable securities, Fair value | $ 298,418 | $ 358,774 |
Corporate debt securities due within 1 year of date of purchase | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 1 year | 1 year |
Corporate debt securities due within 1 year of date of purchase | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, unrealized gains | $ 13 | $ 7 |
Marketable securities, unrealized losses | (105) | (39) |
Corporate debt securities due within 1 year of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, cost | 144,036 | 27,257 |
Corporate debt securities due within 1 year of date of purchase | Fair value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, fair value | $ 143,944 | 27,225 |
U.S. government and government sponsored entities due within 1 year of date of purchase | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 1 year | |
U.S. government and government sponsored entities due within 1 year of date of purchase | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, unrealized gains | $ 6 | |
Marketable securities, unrealized losses | (3) | |
U.S. government and government sponsored entities due within 1 year of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, cost | 77,275 | |
U.S. government and government sponsored entities due within 1 year of date of purchase | Fair value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, fair value | 77,278 | |
Cash | Carrying value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 8,185 | 15,100 |
Cash | Fair value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 8,185 | 15,100 |
Money market funds | Carrying value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 69,011 | 316,449 |
Money market funds | Fair value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | $ 69,011 | $ 316,449 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Contract research organization costs | $ 58,050 | $ 53,119 |
Other clinical study related costs | 3,605 | 6,582 |
Manufacturing and drug supply | 3,556 | 11,262 |
Compensation and benefits | 5,453 | 14,864 |
Professional fees | 9,494 | 4,867 |
Other | 1,603 | 767 |
Total accrued liabilities | $ 81,761 | $ 91,461 |
Long Term Debt - Schedule of M
Long Term Debt - Schedule of Maturities of Long-Term Debt (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Long-Term Debt, Fiscal Year Maturity [Abstract] | |
2023 (remaining six months) | $ 5,372 |
2024 | 10,878 |
2025 | 69,044 |
Thereafter | 46,363 |
Long-Term Debt | 131,657 |
Less amount representing interest | (26,307) |
Less unamortized discount | (6,101) |
Loans payable, net of discount | $ 99,249 |
Long Term Debt (Details)
Long Term Debt (Details) - USD ($) $ in Millions | 1 Months Ended | ||||||||
Feb. 03, 2023 | Jan. 02, 2023 | May 09, 2022 | May 01, 2022 | May 31, 2022 | Sep. 30, 2023 | Jun. 30, 2023 | Jun. 19, 2023 | Jan. 01, 2023 | |
Debt instrument, Face amount | $ 100 | ||||||||
Interest rate | 10.70% | ||||||||
Percenatge of Term charges on aggregate principal amount | 5.35% | ||||||||
Debt conversion, converted instrument, warrants or options issued | 14,899 | ||||||||
Debt conversion, converted instrument, amount | $ 0.6 | ||||||||
Loan Facility [Member] | |||||||||
Line of credit facility, maximum borrowing capacity | $ 35 | ||||||||
Line of credit facility, expiration date | Sep. 30, 2024 | ||||||||
Loan Facility And Amended Loan Facility [Member] | |||||||||
Long term debt floor interest rate percentage | 8.25% | ||||||||
Loan Facility And Amended Loan Facility [Member] | Prime Rate [Member] | |||||||||
Long term debt floor interest rate percentage | 2.45% | ||||||||
Loan Facility And Amended Loan Facility [Member] | Tranche Two [Member] | |||||||||
Proceeds from issuance of debt | $ 35 | ||||||||
Line of credit facility, maximum borrowing capacity | $ 65 | $ 15 | $ 15 | ||||||
Debt conversion, converted instrument, warrants or options issued | 3,504 | ||||||||
Debt conversion, converted instrument, amount | $ 0.7 | ||||||||
Line of Credit Facility, Current Borrowing Capacity | 15 | ||||||||
Loan Facility And Amended Loan Facility [Member] | Tranche three [Member] | |||||||||
Line of Credit Facility, Remaining Borrowing Capacity | 75 | ||||||||
Loan Facility And Amended Loan Facility [Member] | Tranche fouth [Member] | |||||||||
Line of Credit Facility, Remaining Borrowing Capacity | 15 | ||||||||
Loan Facility And Amended Loan Facility [Member] | Subsequent Event [Member] | Tranche Two [Member] | |||||||||
Line of credit facility, maximum borrowing capacity | $ 15 | ||||||||
Loan Facility And Amended Loan Facility One [Member] | Tranche fouth [Member] | |||||||||
Line of Credit Facility, Remaining Borrowing Capacity | 60 | ||||||||
Drawn In Two Separate Tranches Upon Achievement of Resmetirom Clinical And Regulatory Milestone | |||||||||
Unused borrowing capacity that can be drawn | $ 125 | ||||||||
Term Loan [Member] | |||||||||
Debt instrument, Face amount | 250 | ||||||||
Proceeds from issuance of debt | $ 50 | ||||||||
Long term debt floor interest rate percentage | 7.45% | ||||||||
Debt Instrument Interest Payments Terms | The Company will pay interest-only monthly payments of accrued interest under the Loan Facility for a period of 30 months, which period may be extended to 36, 48, and 60 months upon the successive achievement of certain clinical and regulatory milestones | ||||||||
Term Loan [Member] | Loan Facility And Amended Loan Facility [Member] | |||||||||
Proceeds from issuance of debt | $ 35 | ||||||||
Term Loan [Member] | Drawn In Two Separate Tranches Upon Achievement of Resmetirom Clinical And Regulatory Milestone | |||||||||
Unused borrowing capacity that can be drawn | $ 75 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Common Stock (Details) | 6 Months Ended |
Jun. 30, 2023 Vote | |
Stockholders' Equity Note [Abstract] | |
Number of votes per share that common stockholders are entitled to receive | 1 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Preferred Stock (Details) | 1 Months Ended | ||
Jun. 30, 2017 Vote $ / shares shares | Jun. 30, 2023 $ / shares | Dec. 31, 2022 $ / 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 | shares | 1 | ||
Preferred shares number voting rights | Vote | 0 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Registered Offering (Details) - 2022 Registered Direct Offering - Purchase Agreement $ / shares in Units, $ in Millions | 1 Months Ended |
Dec. 23, 2022 USD ($) $ / shares shares | |
Stockholders' Equity (Deficit) | |
Proceeds from issuance or sale of equity, Gross | $ | $ 100 |
Proceeds from issuance or sale of equity | $ | $ 99.5 |
Common stock | |
Stockholders' Equity (Deficit) | |
Stock Issued During Period, Shares, New Issues | shares | 44,444 |
Shares issued, Price per share | $ / shares | $ 225 |
Series B Preferred Stock | |
Stockholders' Equity (Deficit) | |
Stock Issued During Period, Shares, New Issues | shares | 400,000 |
Shares issued, Price per share | $ / shares | $ 225 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - At The Market Issuances (Details) - At-The-Market Issuance Sales Agreement - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | 12 Months Ended | 24 Months Ended | ||
May 31, 2023 | Jun. 30, 2021 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
2021 Sales Agreement | ||||||
Stockholders' Equity (Deficit) | ||||||
Number of shares sold by the entity | 738,900 | 497,043 | 1,235,943 | |||
Value of shares sold by the entity | $ 159.1 | $ 199.9 | ||||
Net proceeds after deducting commissions and other transactions costs | $ 155.9 | $ 195.8 | ||||
Remaining reserved amount under shelf registration | $ 0 | |||||
2023 Sales Agreement | ||||||
Stockholders' Equity (Deficit) | ||||||
Number of shares sold by the entity | 85,901 | |||||
Value of shares sold by the entity | $ 22.4 | |||||
Net proceeds after deducting commissions and other transactions costs | 21.8 | |||||
Remaining reserved amount under shelf registration | $ 177.6 | |||||
Cowen & Co. LLC | Maximum | ||||||
Stockholders' Equity (Deficit) | ||||||
Maximum aggregate offering price | $ 200 | $ 200 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based compensation expense | ||
Options outstanding to purchase of common stock | 2,805,840 | |
Maximum | ||
Stock-based compensation expense | ||
Expiration period | 10 years | |
Stock options | ||
Stock-based compensation expense | ||
Shares available for future issuance | 670,634 | |
Shares | ||
Outstanding at the beginning of the year (in shares) | 2,857,054 | |
Options granted (in shares) | 5,205 | |
Options exercised (in shares) | (270,609) | |
Options cancelled (in shares) | (8,110) | |
Outstanding at the end of the year (in shares) | 2,583,540 | |
Exercisable at the end of the year (in shares) | 1,719,944 | |
Weighted average exercise price | ||
Outstanding at the beginning of the year (in dollars per share) | $ 81.78 | |
Options granted (in dollars per share) | 283.08 | |
Options exercised (in dollars per share) | 89.26 | |
Options cancelled (in dollars per share) | 84.12 | |
Outstanding at the end of the year (in dollars per share) | 81.4 | |
Exercisable at the end of the year (in dollars per share) | $ 76.62 | |
Additional disclosures | ||
Total intrinsic value of options exercised | $ 48.9 | $ 0 |
Proceeds resulting from exercise of stock options | $ 21.8 | $ 0 |
Weighted-average grant date fair value of options (in dollars per share) | $ 219.02 | $ 55.84 |
Stock-based Compensation - Expe
Stock-based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 10,973 | $ 7,944 | $ 22,223 | $ 15,421 |
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 5,184 | 3,301 | 10,570 | 6,488 |
General and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 5,789 | 4,643 | 11,653 | 8,933 |
Stock options | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 7,431 | 7,944 | 16,029 | 15,421 |
Restricted Stock Units (RSUs) | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 3,542 | $ 0 | $ 6,194 | $ 0 |
Stock-based Compensation - Unre
Stock-based Compensation - Unrecognized Expense (Details) - Stock options $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Unrecognized stock-based compensation expense | |
Unrecognized stock compensation expense | $ 98.2 |
Weighted average remaining period (in years) | 2 years 10 months 24 days |
Stock-based Compensation - Rest
Stock-based Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) | Jun. 30, 2023 $ / shares shares |
Stock-based compensation expense | |
Outstanding restricted units | shares | 222,300 |
Weighted average grant date fair value | $ / shares | $ 294.19 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies | ||
Licensed product sales | $ 0 | $ 0 |
Research, Development and Commercialization Agreement | Hoffmann-La Roche ("Roche") | ||
Commitments and Contingencies | ||
Remainder of future milestone payments | $ 8 |