ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
(Address of Principal Executive Offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
☒ |
Accelerated filer |
☐ | ||||
Non-accelerated filer |
☐ |
Smaller reporting company |
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Emerging growth company |
Auditor Firm Id: |
Auditor Name: |
Auditor Location: |
PART IV
Item 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | |
Item 15(a) | The following documents are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K: | |
Item 15(a)(1) and (2) | The Consolidated Financial Statements beginning on page F-1 are filed as part of this Annual Report on Form 10-K. Other financial statement schedules have been omitted because the information required to be presented in them is not applicable or is shown in the financial statements or related notes. | |
Item 15(a)(3) | We have filed, or incorporated into this Annual Report on Form 10-K by reference, the exhibits listed on the accompanying Exhibit Index. | |
Item 15(b) | See Item 15(a)(3) above. | |
Item 15(c) | See Item 15(a)(2) above. |
2
3
4
Exhibit Number |
Exhibit Description |
Filed |
Incorporated by |
Filing Date | SEC File / Registration Number |
|||||||||
101.INS | Inline XBRL Instance Document. | X | ||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document. | X | ||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | X | ||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | X | ||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | X | ||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | X | ||||||||||||
104 | Inline XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101 Inline XBRL Document Set. | X |
* | Indicates a management contract, compensatory plan or arrangement. |
** | The certifications attached as Exhibit 32.1 that accompany this Annual Report on Form 10-K are not deemed filed with the SEC and are not to be incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, regardless of any general incorporation language contained in any filing. |
† | Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. |
5
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
MADRIGAL PHARMACEUTICALS INC. | ||||||
Date: March 3, 2023 | By: | /s/ PAUL A. FRIEDMAN, M.D. | ||||
Paul A. Friedman, M.D. | ||||||
Chief Executive Officer | ||||||
(Principal Executive Officer) |
Pursuant to the requirements of the Exchange Act, as amended, this Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signatures |
Title |
Date | ||
/s/ PAUL A. FRIEDMAN, M.D. Paul A. Friedman, M.D. |
Chairman of the Board of Directors and Chief Executive Officer (Principal Executive Officer) | March 3, 2023 | ||
/s/ ALEX G. HOWARTH Alex G. Howarth |
Chief Financial Officer (Principal Accounting and Financial Officer) | March 3, 2023 |
Page |
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F-2 |
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Consolidated Financial Statements: |
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F-5 |
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F-6 |
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F-7 |
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F-8 |
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F-9 |
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F-10 |
December 31, |
December 31, |
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2022 |
2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Marketable securities |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Right-of-use |
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
Accrued expenses |
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Lease liability |
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Total current liabilities |
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Long term liabilities: |
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Loan payable, net of discount |
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Lease liability |
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Total long term liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, par value $ |
— | |||||||
Common stock, par value $ |
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Additional paid-in-capital |
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Accumulated other comprehensive loss |
( |
) | ( |
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Accumulated deficit |
( |
) | ( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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Year Ended December 31, |
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2022 |
2021 |
2020 |
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Revenues: |
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Total revenues |
$ | $ | $ | |||||||||
Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
( |
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Interest income |
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Interest expense |
( |
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Other income |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
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Net loss per common share: |
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Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Basic and diluted weighted average number of common shares outstanding |
Year Ended December 31, |
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2022 |
2021 |
2020 |
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Net Loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale |
( |
) | ( |
) | ||||||||
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Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
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Additional paid-in Capital |
Accumulated other comprehensive income (loss) |
Accumulated deficit |
Total stockholders’ equity |
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Preferred stock |
Common stock |
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Shares |
Amount |
Shares |
Amount |
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Balance at December 31, 2019 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs |
— | — | — | — | — | |||||||||||||||||||||||||||
Sale of common shares to related parties and exercise of common stock options, net of transaction costs |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized loss on marketable securities |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
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Balance at December 31, 2020 |
$ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs |
— | — | — | — | — | |||||||||||||||||||||||||||
Sale of common shares to related parties and exercise of common stock options, net of transaction costs |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized loss on marketable securities |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
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Balance at December 31, 2021 |
$ | — | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||||||||
Issuance of common and preferred shares in equity offerings, excluding to related parties, net of transaction costs |
— | — | — | — | ||||||||||||||||||||||||||||
Sale of common shares to related parties and exercise of common stock options, net of transaction costs |
— | — | — | — | — | |||||||||||||||||||||||||||
Compensation expense related to stock options for services |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Unrealized loss on marketable securities |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Hercules warrant |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||
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Balance at December 31, 2022 |
$ | — | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||||||||
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Year Ended December 31, |
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2022 |
2021 |
2020 |
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Cash flows from operating activities: |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation and amortization expense |
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Amortization of debt issuance costs and discount |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
( |
) | ( |
) | ||||||||
Accounts payable |
( |
) | ||||||||||
Accrued expense |
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Accrued interest, net of interest received on maturity of investments |
( |
) | ||||||||||
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Net cash used in operating activities |
( |
) | ( |
) | ( |
) | ||||||
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Cash flows from investing activities: |
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Purchases of marketable securities |
( |
) | ( |
) | ( |
) | ||||||
Sales and maturities of marketable securities |
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Purchases of property and equipment, net of disposals |
( |
) | ( |
) | ( |
) | ||||||
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Net cash provided by (used in) investing activities |
( |
) | ||||||||||
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Cash flows from financing activities: |
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Proceeds from issuances of stock, excluding related parties, net of transaction costs |
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Proceeds from the sale of related party stock and exercise of common stock options, net of transaction costs |
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Proceeds from issuance of loan payable |
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Payment of debt issuance costs |
( |
) | ||||||||||
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Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
( |
) | ||||||||||
Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | $ | $ | |||||||||
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Supplemental disclosure of cash flow information: |
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Obtaining a right-of-use |
$ | $ | $ |
As of December 31, |
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2022 |
2021 |
2020 |
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Common stock options |
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Preferred stock |
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Warrants |
December 31, 2022 |
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Unrealized |
Unrealized |
Fair |
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Cost |
gains |
losses |
value |
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Cash and cash equivalents: |
||||||||||||||||
Cash (Level 1) |
$ | $ | — | $ | — | $ | ||||||||||
Money market funds (Level 1) |
— | — | ||||||||||||||
Total cash and cash equivalents |
— | — | ||||||||||||||
Marketable securities: |
||||||||||||||||
Corporate debt securities due within |
( |
) | ||||||||||||||
Total cash, cash equivalents and marketable securities |
$ | $ | $ | ( |
) | $ | ||||||||||
December 31, 2021 |
||||||||||||||||
Cost |
Unrealized |
Unrealized |
Fair |
|||||||||||||
gains |
losses |
value |
||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Cash (Level 1) |
$ | $ | — | $ | — | $ | ||||||||||
Money market funds (Level 1) |
— | — | ||||||||||||||
Total cash and cash equivalents |
— | — | ||||||||||||||
Marketable securities: |
||||||||||||||||
Corporate debt securities due within |
( |
) | ||||||||||||||
Corporate debt securities due within |
— | ( |
) | |||||||||||||
Total cash, cash equivalents and marketable securities |
$ | $ | $ | ( |
) | $ | ||||||||||
December 31, |
December 31, |
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2022 |
2021 |
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Contract research organization costs |
$ | $ | ||||||
Other clinical study related costs |
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Manufacturing and drug supply |
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Compensation and benefits |
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Professional fees |
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Other |
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Total accrued liabilities |
$ | $ | ||||||
Period Ending December 31, 2022: |
Amount |
|||
2023 |
$ | |||
2024 |
||||
2025 |
||||
Thereafter |
||||
$ | ||||
Less amount representing interest |
( |
) | ||
Less unamortized discount |
( |
) | ||
Loans payable, net of discount |
$ | |||
Shares |
Weighted average exercise price |
Weighted average remaining contractual life (years) |
Aggregate intrinsic value (in thousands) |
|||||||||||||
Outstanding at January 1, 2022 |
$ | |||||||||||||||
Options granted |
||||||||||||||||
Options exercised |
( |
) | ||||||||||||||
Options cancelled |
( |
) | ||||||||||||||
Outstanding at December 31, 2022 |
$ | $ | ||||||||||||||
Exercisable at December 31, 2022 |
$ | $ |
Year Ended December 31, |
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2022 |
2021 |
2020 |
||||||||||
Stock-based compensation expense by type of award: |
||||||||||||
Stock options |
$ | $ | $ | |||||||||
Total stock-based compensation expense |
$ | $ | $ | |||||||||
Effect of stock-based compensation expense by line item: |
||||||||||||
Research and development |
$ | $ | $ | |||||||||
General and administrative |
||||||||||||
Total stock-based compensation expense included in net loss |
$ | $ | $ | |||||||||
Operating Leases |
||||
2023 |
||||
Thereafter |
— | |||
Total minimum payments |
$ | |||
Less: imputed interest |
( |
) | ||
Present value of lease liabilities |
$ | |
For the years ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Deferred Tax Liabilities |
||||||||||||
Unrealized gains on investments |
$ | — | $ | — | $ | |||||||
Total Deferred Tax Liabilities |
$ | — | $ | — | $ | |||||||
Deferred Tax Assets |
||||||||||||
Charitable contributions |
$ | $ | $ | |||||||||
Accrued expenses |
||||||||||||
Intangibles |
||||||||||||
Stock compensation |
||||||||||||
Property, plant & equipment |
||||||||||||
Unrealized loss on investment |
— | |||||||||||
Net operating losses |
||||||||||||
Capitalized R&D |
||||||||||||
R&D credit |
||||||||||||
Total deferred tax assets before valuation allowance |
||||||||||||
Valuation allowance |
( |
) | ( |
) | ( |
) | ||||||
Total deferred tax assets |
— | — | ||||||||||
Net deferred tax assets |
$ | $ | — | $ | — | |||||||
For the years ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Tax benefit at U.S. federal statutory rate |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Stock based compensation |
( |
) | — | ( |
) | |||||||
162M limitation |
— | |||||||||||
Other nondeductible expenses |
||||||||||||
State income taxes benefit before valuation allowance, net of federal benefit |
( |
) | ( |
) | ||||||||
Increase in domestic valuation allowance |
||||||||||||
Research and development credit |
( |
) | ( |
) | ( |
) | ||||||
Other adjustments |
||||||||||||
Income tax expense (benefit) |
$ | $ | $ | |||||||||
Three months ended |
||||||||||||||||
March 31, 2022 |
June 30, 2022 |
September 30, 2022 |
December 31, 2022 |
|||||||||||||
Revenues: |
||||||||||||||||
Total revenues |
$ | — | $ | — | $ | — | $ | — | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
||||||||||||||||
General and administrative |
||||||||||||||||
Total operating expenses |
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Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Interest income |
||||||||||||||||
Interest expense |
( |
) | ( |
) | ( |
) | ||||||||||
Other income |
||||||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Net loss per common share: |
||||||||||||||||
Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Basic and diluted weighted average number of common shares outstanding |
Three months ended |
||||||||||||||||
March 31, 2021 |
June 30, 2021 |
September 30, 2021 |
December 31, 2021 |
|||||||||||||
Revenues: |
||||||||||||||||
Total revenues |
$ | — | $ | — | $ | — | $ | — | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
||||||||||||||||
General and administrative |
||||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Interest income |
||||||||||||||||
Interest expense |
||||||||||||||||
Other income |
||||||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Net loss per common share: |
||||||||||||||||
Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Basic and diluted weighted average number of common shares outstanding |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-256666 and 333-219304) and Form S-8 (Nos. 333-141903, 333-152824, 333-173862, 333-181117, 333-187243, 333-194477, 333-202680, 333-206128, 333-212615, 333-224503, 333-249866 and 333-257506) of Madrigal Pharmaceuticals, Inc. of our report dated February 23, 2023 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP |
Philadelphia, Pennsylvania |
February 23, 2023 |
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13A-14(a) AND 15D-14(a)
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Paul A. Friedman, M.D., certify that:
1. I have reviewed this Annual Report on Form 10-K of Madrigal Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/s/ PAUL A. FRIEDMAN, M.D. |
Paul A. Friedman, M.D. |
Chief Executive Officer and Chairman of the Board (Principal Executive Officer) |
Date: March 3, 2023 |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13A-14(a) AND 15D-14(a)
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Alex G. Howarth, certify that:
1. I have reviewed this Annual Report on Form 10-K of Madrigal Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/s/ ALEX G. HOWARTH |
Alex G. Howarth |
Chief Financial Officer (Principal Financial Officer) |
Date: March 3, 2023 |
Exhibit 32.1
CERTIFICATIONS PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350)), each of the undersigned officers of Madrigal Pharmaceuticals, Inc., a Delaware corporation (the Company), does hereby certify, to such officers knowledge, that:
The Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the Form 10-K) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated March 3, 2023 | /s/ PAUL A. FRIEDMAN, M.D. | |||
Paul A. Friedman, M.D. | ||||
Chief Executive Officer and Chairman of the Board (Principal Executive Officer) | ||||
Dated: March 3, 2023 | /s/ ALEX G. HOWARTH | |||
Alex G. Howarth | ||||
Chief Financial Officer (Principal Financial Officer) |
A signed original of this written statement required by Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350), has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. These certifications accompany the Form 10-K, are not deemed filed with the Securities and Exchange Commission, and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.