Madrigal Pharmaceuticals(MDGL) - 2021 Q3 - Quarterly Report

Part I. Financial Information Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements for Madrigal Pharmaceuticals, Inc. as of September 30, 2021, and for the three and nine months then ended, showing the company is in a clinical stage with no revenue, incurring net losses driven by significant research and development expenses for its lead candidate, resmetirom, with its financial position supported by cash, cash equivalents, and marketable securities, bolstered by proceeds from stock offerings Condensed Consolidated Balance Sheets As of September 30, 2021, the company's total assets increased to $304.7 million from $287.0 million at the end of 2020, primarily due to a rise in marketable securities, while total liabilities grew to $69.8 million from $47.0 million, mainly driven by increased accrued expenses related to clinical trial activities, consequently, total stockholders' equity slightly decreased to $234.9 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $49,174 | $54,004 | | Marketable securities | $249,970 | $230,145 | | Total assets | $304,697 | $286,995 | | Liabilities & Equity | | | | Total current liabilities | $69,325 | $46,557 | | Total liabilities | $69,816 | $47,025 | | Total stockholders' equity | $234,881 | $239,970 | Condensed Consolidated Statements of Operations The company reported no revenue for the third quarter and first nine months of 2021, with net loss for the third quarter increasing to $63.1 million from $58.0 million in the prior-year period, and for the nine-month period, net loss widened to $177.3 million from $143.1 million year-over-year, primarily driven by higher research and development (R&D) and general and administrative (G&A) expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | 9 Months 2021 | 9 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $— | $— | $— | $— | | Research and development | $54,873 | $53,292 | $152,275 | $131,380 | | General and administrative | $8,287 | $5,494 | $25,606 | $15,738 | | Loss from operations | $(63,160) | $(58,786) | $(177,881) | $(147,118) | | Net loss | $(63,100) | $(57,963) | $(177,297) | $(143,121) | | Net loss per common share | $(3.79) | $(3.75) | $(10.84) | $(9.27) | Condensed Consolidated Statements of Comprehensive Loss Comprehensive loss for the third quarter of 2021 was $63.1 million, compared to $58.6 million in the same period of 2020, and for the nine months ended September 30, 2021, comprehensive loss was $177.3 million, with figures nearly identical to net loss, reflecting only minor adjustments for unrealized gains or losses on available-for-sale securities Comprehensive Loss Summary (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Three Months Ended Sep 30 | | | | Net Loss | $(63,100) | $(57,963) | | Comprehensive loss | $(63,111) | $(58,623) | | Nine Months Ended Sep 30 | | | | Net Loss | $(177,297) | $(143,121) | | Comprehensive loss | $(177,340) | $(142,916) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased from $240.0 million at year-end 2020 to $234.9 million as of September 30, 2021, primarily due to the cumulative net loss for the nine-month period, partially offset by capital raised from the issuance of common stock through equity offerings and stock option exercises - The change in stockholders' equity was primarily driven by the net loss of $177.3 million for the nine months ended September 30, 2021, which was offset by proceeds from common stock issuances[21] Condensed Consolidated Statements of Cash Flows For the first nine months of 2021, net cash used in operating activities was $135.9 million, an increase from $102.6 million in the prior-year period, while the company generated $151.7 million from financing activities, mainly from stock issuances, and net cash used in investing activities was $20.7 million, resulting in a net decrease in cash and cash equivalents of $4.8 million Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(135,866) | $(102,614) | | Net cash (used in) provided by investing activities | $(20,698) | $164,578 | | Net cash provided by financing activities | $151,734 | $459 | | Net (decrease) increase in cash | $(4,830) | $62,423 | Notes to Condensed Consolidated Financial Statements The notes detail the company's business focus on developing its lead compound, resmetirom, for NASH, confirm that existing cash, cash equivalents, and marketable securities are sufficient to fund operations for at least one year, describe the at-the-market (ATM) sales agreements used to raise capital with significant proceeds generated in 2021, and disclose additional funds raised after the quarter's end as a subsequent event - Madrigal is a clinical-stage pharmaceutical company whose lead compound, resmetirom (MGL-3196), is in two ongoing Phase 3 studies for non-alcoholic steatohepatitis (NASH)[27] - Management believes that its cash, cash equivalents, and marketable securities at September 30, 2021, will be sufficient to fund operations past one year from the issuance of these financial statements[50] - Under its 2020 and 2021 at-the-market (ATM) sales agreements, the company sold a combined 1,347,290 shares in 2021 for approximately $158.9 million in gross proceeds as of September 30, 2021[58][60] - Subsequent to the quarter end, from October 1 through November 2, 2021, the company sold an additional 236,879 shares under its 2021 ATM agreement for gross proceeds of approximately $19.4 million[67] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage focus on developing resmetirom for NASH, highlighting the progress of its two Phase 3 trials, MAESTRO-NASH and MAESTRO-NAFLD-1, attributing the year-over-year increase in operating losses to higher R&D expenses from these trials and increased G&A costs for commercial preparation, and reiterating its belief that current capital resources are sufficient to fund operations for more than a year, supported by proceeds from its at-the-market stock sales - The company's lead candidate, resmetirom, is being evaluated in two pivotal Phase 3 trials: MAESTRO-NASH, which will support a submission for accelerated approval, and MAESTRO-NAFLD-1, which supports the safety database[79][80] Year-over-Year Operating Expense Increases (in thousands) | Expense Category | Q3 2021 vs Q3 2020 | 9M 2021 vs 9M 2020 | | :--- | :--- | :--- | | Research and development | +$1,581 (+3%) | +$20,895 (+16%) | | General and administrative | +$2,793 (+51%) | +$9,868 (+63%) | - The increase in R&D expenses was primarily due to additional activities for the Phase 3 trials and higher headcount[89][90] - The rise in G&A expenses was driven by commercial preparation activities and increased stock compensation[94] - As of September 30, 2021, the company had $299.1 million in cash, cash equivalents, and marketable securities, which it believes is sufficient to fund operations for more than one year[98][99] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk exposure is interest rate risk related to its portfolio of cash, cash equivalents, and marketable securities, which is considered minimal due to the high quality and short-term duration of the investments, and the company does not believe inflation has had a significant impact on its operations - The company's market risk is confined to its cash and marketable securities, and due to the short-term duration of the investment portfolio, management believes an immediate 10% change in interest rates would not have a material effect on its fair market value[105] Controls and Procedures Based on an evaluation conducted by management, including the CEO and CFO, the company's disclosure controls and procedures were deemed effective at a reasonable assurance level as of September 30, 2021, with no material changes to the company's internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of the end of the period[108] - No changes in internal control over financial reporting occurred during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, these controls[110] Part II. Other Information Legal Proceedings The company reports that it is not a party to any material pending legal proceedings - The company is not party to any material pending legal proceedings[112] Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes to the risk factors detailed in the Annual Report on Form 10-K for the year ended December 31, 2020, have occurred[113] Other Items (Items 2, 3, 4, 5, 6) This section confirms there were no unregistered sales of equity securities, no defaults on senior securities, and no other material information to report for the period, with mine safety disclosures not applicable, and concludes by referencing the exhibits filed with the report - The company reported "None" or "Not applicable" for Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), and Item 5 (Other Information)[114][115][116][117]