MADRIGAL PHARMACEUTICALS INC
For the period ended Dec 31, 2023. Filed Feb 28, 2024.
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FY2023 · Filed Feb 28, 2024
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Notes to Consolidated Financial Statements
- Organization, Business and Basis of Presentation
Organization and Business
Madrigal Pharmaceuticals, Inc. (the “Company” or “Madrigal”) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (“NASH”), a liver disease with high unmet medical need. The Company's lead candidate, resmetirom, a once-daily, oral, liver-directed thyroid hormone receptor-β (“THR-β”) agonist designed to target key underlying causes of NASH, is in registration status following review acceptance by the U.S. Food and Drug Administration (the “FDA”) for its New Drug Application (“NDA”) in September 2023.
Basis of Presentation
Certain prior period amounts have been reclassified to align with current period presentation.
- 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 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.
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. 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 years ended December 31, 2023, 2022 and 2021, 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 years ended December 31, 2023, 2022 and 2021, the Company didnot have any realized gains or losses on marketable securities.
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 December 31, 2023 and 2022, 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 years ended December 31, 2023, 2022 and 2021, the Company did not have any transfers of financials assets between Levels 1 and 2. As of December 31, 2023 and 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 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 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 milestones 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 statements of operations. Patent expenses were approximately $0.9 million, $0.5 million and $0.5 million for the years ended December 31, 2023, 2022 and 2021, respectively.
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 share-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 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 sources. Changes in unrealized gains and losses on marketable securities represent the only difference between the Company’s net loss and comprehensive loss.
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 years ended December 31, 2023, 2022 and 2021, 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:
| As of December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Common stock options | 2,355,779 | 2,857,054 | 2,301,574 |
| Restricted stock units | 376,117 | — | — |
| Performance-based restricted stock units | 150,000 | — | — |
| Preferred stock | 2,369,797 | 2,369,797 | 1,969,797 |
| Warrants | 2,067,552 | 14,899 | — |
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, 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. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2023-07 on its financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, 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 is currently evaluating the impact of ASU 2023-09 on its financial statements.
- 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 and other government regulations.
The Company has incurred losses since inception, including approximately $373.6 million for the year ended December 31, 2023, resulting in an accumulated deficit of approximately $1,336.3 million and $962.7 million as of December 31, 2023 and 2022, respectively. 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. In October 2023, the Company completed a public offering and received approximately $472.0 million net cash proceeds. The Company believes that its cash, cash equivalents and marketable securities at December 31, 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 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 planned commercialization costs, product manufacturing, research activities and related clinical expenses if necessary due to liquidity concerns until a date when those concerns are relieved.
- Cash, Cash Equivalents and Marketable Securities
A summary of cash, cash equivalents and available-for-sale marketable securities held by the Company as of December 31, 2023 and 2022 is as follows (in thousands):
| December 31, 2023 | ||||
|---|---|---|---|---|
| Cost | Unrealizedgains | Unrealized losses | Fair value | |
| Cash and cash equivalents: | ||||
| Cash (Level 1) | $2,729 | $— | $— | $2,729 |
| Money market funds (Level 1) | 78,555 | — | — | 78,555 |
| US government and government sponsored entities (Level 1) | 14,967 | — | — | 14,967 |
| Corporate debt securities due within 3 months of date of purchase (Level 2) | 3,664 | — | — | 3,664 |
| Total cash and cash equivalents | 99,915 | — | — | 99,915 |
| Marketable securities: | ||||
| Corporate debt securities due within 1 year of date of purchase (Level 2) | 382,028 | 195 | (7) | 382,216 |
| US government and government sponsored entities due within 1 year of date of purchase (Level 2) | 150,743 | 280 | (1) | 151,022 |
| Corporate debt securities due within 1 to 2 years of date of purchase (Level 2) | $977 | $1 | $— | $978 |
| Total cash, cash equivalents and marketable securities | $633,663 | $476 | $(8) | $634,131 |
| 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 as of December 31, 2023 and 2022 consisted of the following (in thousands):
| December 31,2023 | December 31,2022 | |
|---|---|---|
| Contract research organization costs | $50,737 | $53,119 |
| Other clinical study related costs | 3,724 | 6,582 |
| Manufacturing and drug supply | 9,705 | 11,262 |
| Compensation and benefits | 17,030 | 14,864 |
| Professional fees | 6,814 | 4,867 |
| Other | 1,970 | 767 |
| Total accrued liabilities | $89,980 | $91,461 |
- 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 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 may also draw up to an additional $125.0 million intwo separate tranches upon achievement of certain resmetirom clinical and regulatory milestones. A fourth tranche of $75.0 million may be 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 will pay interest-only monthly payments of accrued interest under the Loan Facility through May 1, 2025, for a period of 36 months, which period may be extended to May 1, 2026 and May 3, 2027, upon the achievement of regulatory approval milestones and future revenue covenants, subject to compliance with applicable covenants. The Loan Facility matures in May 2026 and may be extended an additional year upon the achievement of certain 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 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 remains unchanged by the Amendment, and such borrowings are available subject to the Company obtaining a certain FDA approval for resmetirom. Coincident with the expansion of Tranche 2 borrowing capacity by $15.0 million, the Amendment reduced the fourth tranche under the Loan Facility (“Tranche 4”) by $15.0 million to $60.0 million, which amount is available subject to Hercules’ sole discretion. In connection with the $35.0 million drawn under Tranche 2 at the closing of the Amendment, $15.0 million drawn in June of 2023, and $15.0 million drawn in September of 2023, the Company issued to Hercules and affiliates Tranche 2 Warrants to purchase an aggregate of 4,555 shares of common stock, which had a Black-Scholes value of $0.9 million. The 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 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.
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, 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 approval or certain other milestones under the Loan Facility shall not in and of itself constitute a material adverse effect. The Loan Facility also includes customary covenants associated with a secured loan facility, including covenants concerning financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts.
As of December 31, 2023, the outstanding principal under the Loan Facility was $115.0 million. The interest rate as of December 31, 2023 was 10.95%. As of December 31, 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 December 31, 2023 are as follows (in thousands):
| Period Ending December 31, 2023: | Amount |
|---|---|
| 2024 | $12,802 |
| 2025 | 79,604 |
| 2026 | 53,387 |
| $145,793 | |
| Less amount representing interest | (24,641) |
| Less unamortized discount | (5,672) |
| Loans payable, net of discount | $115,480 |
- Stockholders’ Equity
Common Stock
Each common stockholder is entitled toone 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 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 aone-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 haveno 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.
2023 Public Offering
On September 28, 2023, the Company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC, as representative of the several underwriters named therein, pursuant to which the Company sold to the underwriters in an underwritten public offering (the “2023 Offering”): (i)1,248,098 shares of common stock at a public offering price of $151.69 per share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 2,048,098 shares of common stock at a public offering price of $151.6899 per 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. The 2023 Offering closed on October 3, 2023.
The gross proceeds of the 2023 Offering was $500.0 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 $472.0 million. The Company intends to use the net proceeds from the Offering for its clinical and commercial activities in preparation for a potential launch of resmetirom in the U.S. and for general corporate purposes, including, without limitation, research and development expenditures, clinical trial expenditures, manufacture and supply of drug substance and drug products, potential acquisitions or licensing of new technologies, capital expenditures and working capital.
The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of 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 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.
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 stockholders of the Company, pursuant to which the Company sold securities to the Investors in an offering that was registered under the Company’s existing shelf registration statement (the “2022 Registered Direct Offering”). Under the terms of the Purchase Agreement, the Company sold 44,444 shares of its common stock at a price of $225 per share, and 400,000 shares of its Series B Convertible Preferred Stock at a price of $225 per share. The 2022 Registered Direct Offering resulted in gross proceeds to the Company of approximately $100.0 million, and net proceeds to the Company of approximately $99.5 million. The 2022 Registered Direct Offering closed on December 23, 2022.
At-The-Market Issuance Sales Agreement
In November 2020, the Company entered into an at-the-market sales agreement (the “2020 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 2020 Sales Agreement authorized an aggregate offering of up to $200.0 million in shares of our 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. The 2020 Sales Agreement was terminated in June 2021 when the Company filed a new shelf registration statement.
Under the 2020 Sales Agreement the Company sold 1,126,733 shares for an aggregate of approximately $137.4 million in gross proceeds, with net proceeds to the Company of approximately $134.8 million after deducting commissions and other transaction costs. Of those shares sold,1,087,126 were sold in 2021, and 39,607 were sold in 2020.
In June 2021, the Company entered into an at-the-market sales agreement (the “Original 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 Original 2021 Sales Agreement authorized an aggregate offering of up to $200.0 million in shares of our 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 Original 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 December 2022, the Company sold 738,900 shares under the Original 2021 Sales Agreement for an aggregate of $159.1 million in gross proceeds, with net proceeds to the Company of $155.9 million after deducting commissions and other transaction costs. In total, under the Original 2021 Sales Agreement the Company sold 1,235,943 shares for an aggregate of $199.9 million in gross proceeds, with net proceeds to the Company of approximately $195.8 million after deducting commissions and other transaction costs. Of those shares sold,738,900 were sold in 2022, and 497,043 were sold in 2021. All shares were sold pursuant to the Company’s effective shelf registration statement on Form S-3 ( the
"Registration Statement") and the prospectus supplement relating thereto. As of December 31, 2023, no amounts remained reserved and available for sale under the Original 2021 Sales Agreement and the related prospectus supplement.
In May 2023, the Company amended the 2021 Agreement (the “Sales Agreement Amendment”), with Cowen, pursuant to which the Company may, from time to time, issue and sell an additional $200.0 million in shares of its common stock. The Company is not obligated to make any sales of its common stock under this arrangement. Any shares sold will be sold pursuant to the Registration Statement and prospectus supplement filed pursuant to the Registration Statement. The Sales Agreement Amendment authorizes 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.
During the three months ended December 31, 2023, under the Sales Agreement Amendment, the Company soldno shares. During the year ended December 31, 2023, and in total under the Sales Agreement Amendment, the Company sold 98,101 shares 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. As of December 31, 2023, $174.8 million remained reserved and available for sale under the 2023 Sales Agreement Amendment and the Company’s related prospectus supplement.
- Stock-based Compensation
2015 Stock Plan
The 2015 Stock Plan, as amended (the “2015 Stock Plan”), is our shareholder-approved incentive plan 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 of Directors. 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 thanten years from the date the option is granted. As of December 31, 2023,711,054 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 thanten 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 December 31, 2023,193,392 shares were available for future issuance under the 2023 Inducement Plan.
Stock Options
The following table summarizes stock option activity during the year ended December 31, 2023:
| Shares | Weighted average exercise price | Weighted average remaining contractual life (years) | Aggregate intrinsic value (in thousands) | |
|---|---|---|---|---|
| Outstanding at January 1, 2023 | 2,857,054 | $81.78 | ||
| Options granted | 31,111 | 190.91 | ||
| Options exercised | (460,385) | 88.83 | ||
| Options cancelled | (72,001) | 144.24 | ||
| Outstanding at December 31, 2023 | 2,355,779 | $79.94 | 5.51 | $359,861 |
| Exercisable at December 31, 2023 | 1,774,976 | $74.49 | 4.71 | $281,400 |
The total cash received by the Company as a result of stock option exercises was $34.0 million, $9.0 million and $1.0 million for the years ended December 31, 2023, 2022, and 2021. The total intrinsic value of options exercised was $70.4 million $47.3 million and $0.1 million for the years ended December 31, 2023, 2022, and 2021. The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the year ended December 31, 2023, 2022 and 2021 was $149.15, $54.68, and $73.29, 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.
The following table summarizes RSU activity, excluding performance-based RSUs, during the year ended December 31, 2023:
| Shares | Weighted average grant date fair value | |
|---|---|---|
| Unvested at January 1, 2023 | — | $— |
| RSUs granted | 398,600 | 243.81 |
| RSUs vested | (356) | 299.98 |
| RSUs forfeited | (22,127) | 283.05 |
| Unvested at December 31, 2023 | 376,117 | $241.45 |
Performance-Based Restricted Stock Units
The Company has granted various performance-based restricted stock units (“PSUs”) to certain senior leadership. 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.
As of December 31, 2023, the Company granted 50,000 PSUs. The maximum number of PSUs eligible to be earned of 150,000 are outstanding under the Inducement Plan as of December 31, 2023, with a weighted average grant date fair value of $146.37 per unit.
Outstanding Awards
As of December 31, 2023, the Company had restricted stock units, performance stock units, and options outstanding pursuant to which an aggregate of 2,881,896 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 years ended December 31, 2023, 2022 and 2021 was as follows (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Stock-based compensation expense by type of award: | |||
| Stock options | $30,613 | $31,625 | $26,873 |
| Restricted stock units | 14,974 | — | — |
| Performance-based restricted stock units | 4,148 | — | — |
| Total stock-based compensation expense | $49,735 | $31,625 | $26,873 |
| Effect of stock-based compensation expense by line item: | |||
| Research and development | $20,864 | $13,876 | $10,698 |
| General and administrative | 28,871 | 17,749 | 16,175 |
| Total stock-based compensation expense included in net loss | $49,735 | $31,625 | $26,873 |
Unrecognized stock-based compensation expense as of December 31, 2023 was $118.2 million with a weighted average remaining period of 2.66 years.
- Leases
In 2019, the Company entered into an operating lease for office space, which was renewed and extended in 2020. The Company adopted ASU 2016-02, “Leases,” on January 1, 2019 requiring, among other changes, operating and finance leases with terms exceeding twelve months to be recognized as a right-of-use asset (or “ROU”) and lease liabilities on the balance sheet. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The lease term is determined to be the non-cancelable period including any lessee renewal options that are considered reasonably certain of exercise. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company used judgment to determine an appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term in a similar economic environment.
In August 2023, The Company entered into the Fifth Amendment to its Office Lease (the “Lease Amendment”). The Lease Amendment extends the term of the lease through November 2026. As a result of the Lease Amendment, an incremental $1.6 million ROU asset and lease liabilities were recorded during the year ended December 31, 2023.
Future minimum payments under the Company’s operating leases related to the ROU asset and lease liability as of December 31, 2023 was as follows (in thousand):
| Operating Leases | |
|---|---|
| 2024 | 937 |
| 2025 | 478 |
| 2026 | 446 |
| Total minimum payments | $1,861 |
| Less: imputed interest | (148) |
| Present value of lease liabilities | $1,713 |
As of December 31, 2023, the weighted average remaining operating lease term was 2.9 years and the weighted average discount rate used to determine the operating lease liabilities was 10.95%. Cash paid related to the lease liability was $1.1 million and $0.7 million for years ended December 31, 2023 and 2022 respectively. Operating lease costs were $1.1 million and $0.8 million for years ended December 31, 2023 and 2022 respectively. Rent, short term and variable leases costs were immaterial during the years ended December 31, 2023, 2022 and 2021.
- Commitments and Contingencies
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. Remaining milestones under the agreement total $8.0 million and are earned by 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 hadno Licensed Product sales for the years ended December 31, 2023, 2022 and 2021.
In August 2023, The Company entered into the Fifth Amendment to the Office Lease (the "Lease Amendment"). The Lease Amendment extends the term of the lease through November 2026. As a result of the Lease Amendment, an incremental $1.6 million ROU asset and lease liabilities were recorded during the year ended December 31, 2023.
The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the clinical trials.
- Income Taxes
At December 31, 2023, the Company had federal net operating loss (“NOL”) carryforwards of approximately $489.0 million available to reduce future taxable income, of which $40.4 million will expire between 2031 and 2037. The Company also has state operating loss carryforwards of approximately $477.6 million, available to reduce future taxable income, which expire between 2031 and 2042. The Company has unused federal research and development carryforwards of approximately $46.1 million which will begin to expire in 2031.
The Internal Revenue Code (“IRC”) limits the amounts of NOL carryforwards that a Company may use in any one year in the event of certain cumulative changes in ownership over a three-year period as described in Section 382 of the IRC. Such change in ownership could limit the Company’s utilization of the NOL, and could be triggered by subsequent sales of securities by the Company or stockholders. The deferred tax asset related to the NOL reflected on the financial statements could be affected by this limitation. Although a formal analysis has not been completed, the Company has determined that an ownership change likely occurred for Madrigal during the year ended December 31, 2017. The net operating losses are estimated to be subject to an annual limitation, of which none are expected to expire before becoming available to reduce future taxable income.
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. As there is no assurance of future taxable income, a full valuation allowance has been established to offset the deferred tax assets. The valuation allowance increased $112.0 million for the year ended December 31, 2023. Changes in the deferred tax asset will be recorded as an income tax benefit or expense on the accompanying consolidated statements of operations.
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2023 there wereno uncertain positions. The 2019 through 2023 tax returns are open to review by the IRS and state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. There wasno income tax related interest and penalties included in the income tax provision for 2023.
Temporary differences that give rise to deferred tax assets and liabilities are as follows (in thousands):
| For the years ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Deferred Tax Liabilities | |||
| Unrealized gains on investments | $117 | $— | $— |
| Total Deferred Tax Liabilities | $117 | $— | $— |
| Deferred Tax Assets | |||
| Charitable contributions | $37 | $45 | $53 |
| Accrued expenses | 3,857 | 2,398 | 1,857 |
| Intangibles | 503 | 589 | 783 |
| Stock compensation | 33,976 | 27,226 | 24,335 |
| Property, plant & equipment | 95 | 106 | 80 |
| Unrealized loss on investment | — | 8 | 23 |
| Net operating losses | 121,552 | 68,305 | 47,864 |
| Capitalized R&D | 175,145 | 137,328 | 112,848 |
| R&D credit | 48,074 | 35,103 | 23,799 |
| Total deferred tax assets before valuation allowance | 383,239 | 271,108 | 211,642 |
| Valuation allowance | (383,122) | (271,108) | (211,642) |
| Total deferred tax assets | 117 | — | — |
| Net deferred tax assets | $— | $— | $— |
Differences between the effective income tax rate and the US statutory rate were as follows (in thousands):
| For the years ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Tax benefit at U.S. federal statutory rate | $(78,462) | $(62,023) | $(50,788) |
| Stock based compensation | (8,287) | (7,844) | — |
| 162M limitation | 3,183 | 7,996 | 22 |
| Other nondeductible expenses | 53 | 16 | 5 |
| State income taxes benefit before valuation allowance, net of federal benefit | (16,246) | 13,090 | (19,622) |
| Increase in domestic valuation allowance | 112,606 | 59,466 | 79,258 |
| Research and development credit | (12,971) | (10,712) | (9,002) |
| Other adjustments | 124 | 11 | 127 |
| Income tax expense (benefit) | $— | $— | $— |
- Quarterly Financial Data (unaudited)
The following tables present a summary of quarterly results of operations for 2023 and 2022 (in thousands, except shares and per share data):
| Three months ended | ||||
|---|---|---|---|---|
| March 31, 2023 | June 30, 2023 | September 30, 2023 | December 31,2023 | |
| Revenues: | ||||
| Total revenues | $— | $— | $— | $— |
| Operating expenses: | ||||
| Research and development | 62,154 | 68,605 | 70,951 | 70,640 |
| General and administrative | 16,182 | 17,845 | 27,583 | 46,536 |
| Total operating expenses | 78,336 | 86,450 | 98,534 | 117,176 |
| Loss from operations | (78,336) | (86,450) | (98,534) | (117,176) |
| Interest income | 3,776 | 3,551 | 3,298 | 8,953 |
| Interest expense | (2,336) | (2,901) | (3,504) | (3,971) |
| Other income | — | — | — | — |
| Net loss | $(76,896) | $(85,800) | $(98,740) | $(112,194) |
| Net loss per common share: | ||||
| Basic and diluted net loss per common share | $(4.23) | $(4.69) | $(5.34) | $(5.68) |
| Basic and diluted weighted average number of common shares outstanding | 18,187,924 | 18,310,952 | 18,476,414 | 19,760,842 |
| Three months ended | ||||
|---|---|---|---|---|
| March 31, 2022 | June 30, 2022 | September 30, 2022 | December 31,2022 | |
| Revenues: | ||||
| Total revenues | $— | $— | $— | $— |
| Operating expenses: | ||||
| Research and development | 47,929 | 58,499 | 68,271 | 70,742 |
| General and administrative | 9,658 | 11,774 | 12,141 | 14,557 |
| Total operating expenses | 57,587 | 70,273 | 80,412 | 85,299 |
| Loss from operations | (57,587) | (70,273) | (80,412) | (85,299) |
| Interest income | 69 | 323 | 717 | 1,076 |
| Interest expense | — | (780) | (1,502) | (1,682) |
| Other income | — | — | — | — |
| Net loss | $(57,518) | $(70,730) | $(81,197) | $(85,905) |
| Net loss per common share: | ||||
| Basic and diluted net loss per common share | $(3.36) | $(4.14) | $(4.75) | $(4.98) |
| Basic and diluted weighted average number of common shares outstanding | 17,103,395 | 17,103,395 | 17,103,395 | 17,237,517 |
- Subsequent Event
None.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.