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Madrigal Pharmaceuticals Provides Corporate Updates and Reports Fourth Quarter and Full Year 2023 Financial Results Announced appointment of Mardi C. Dier as Chief Financial Officer Anticipates resmetirom to become the f

Key Takeaway: Madrigal Pharmaceuticals reported its fourth quarter and full year 2023 financial results, highlighting a strong cash position of $634.1 million. The company is preparing for the anticipated March 2024 launch of resmetirom, a therapy targeting nonalcoholic steatohepatitis (NASH) with significant fibrosis. The results included increased operating expenses driven by enhanced R&D efforts and commercialization activities. Despite optimism regarding resmetirom's market potential, Madrigal faces challenges related to rising costs and regulatory uncertainties.

Market Sentiment Analysis

POSITIVE FACTORS

  • Madrigal anticipates a potential launch of resmetirom for NASH in March 2024.
  • The company's financial position improved with cash reserves of $634.1 million.
  • Investments in R&D and commercialization indicate confidence in resmetirom's future.
  • Addressing significant unmet needs in NASH may lead to high market demand.

CONCERNS & RISKS

  • Operating expenses have risen significantly, potentially affecting future profitability.
  • Increased costs from scaling up manufacturing and G&A could strain resources.
  • Risks of regulatory delays or rejections could impact launch timelines.
  • Investors should be aware of ongoing uncertainties related to clinical trials.

Full Press Release Details

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Fourth Quarter and Full
Year 2023 Financial Results
CONSHOHOCKEN, PA, February 28, 2024 Madrigal Pharmaceuticals, Inc.
(NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of corporate updates and reports fourth quarter and full year 2023 financial results.
Bill Sibold, Chief Executive Officer of Madrigal, stated As we approach the March PDUFA date for resmetirom, we remain focused on advancing key
regulatory, operational and commercial activities in preparation for a potential U.S. launch. Our goal is to establish resmetirom as the foundational therapy for NASH with significant fibrosis, a serious disease with significant unmet need that
represents a high burden to patients, their families and the healthcare system.
Recent Corporate Updates
Financial Results for the Three and Twelve Months Ended December 31, 2023
As of December 31, 2023, Madrigal had cash, cash equivalents and marketable securities of $634.1 million, compared to $358.8 million at
December 31, 2022. The increase in cash and marketable securities was primarily from proceeds from our October 2023 public offering partially offset by funding of operations.
Operating expenses were $117.2 million and $380.5 million for the three and twelve month periods ended December 31, 2023, compared to
$85.3 million and $293.6 million in the comparable prior year periods.
Research and development expenses for the three and twelve month periods
ended December 31, 2023, were $70.6 million and $272.4 million, compared to $70.7 million and $245.4 million in the comparable prior year periods. The increases are attributable primarily to a scale up of manufacturing
activities to prepare for the launch of resmetirom as well as an increase in R&D personnel.
General and administrative (G&A) expenses for the
three and twelve month periods ended December 31, 2023 were $46.5 million and $108.1 million, compared to $14.6 million and $48.1 million in the comparable prior year periods. The increases are attributable primarily to
commercial activities in preparation for the expected approval and launch of resmetirom. We expect our G&A expenses to further increase as we expand our operating activities associated with the commercialization of resmetirom.
Interest income for the three and twelve month periods ended December 31, 2023, was $9.0 million and $19.6 million, compared to
$1.1 million and $2.2 million in the comparable prior year periods. The increases in interest income for the latest three and twelve month periods were due primarily to a higher average principal balance in our investment account as well
as higher average interest rate in 2023.
Interest expense for the three and twelve month periods ended December 31, 2023 was $4.0 million and
$12.7 million, compared to $1.7 million and $4.0 million in the comparable prior year periods. The increase in interest expense was as a result of the higher outstanding principal balances during the period under the company s
loan facility as well as higher average interest rate in 2023.
Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and
an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events
and increased morbidity and mortality.
Once patients progress to NASH with significant fibrosis (consistent with fibrosis stages 2 and 3), the risk of
adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S.
Madrigal estimates that
approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with significant fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with significant
fibrosis under the care of the liver specialist physicians during the launch of resmetirom.
There are currently no
FDA-approved therapies available for the treatment of NASH. NASH is also known as metabolic dysfunction-associated steatohepatitis (MASH) following a change in disease nomenclature introduced by
hepatology medical societies in 2023.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis
(NASH), a liver disease with high unmet medical need. Madrigal s lead candidate, resmetirom, is a liver-directed oral therapy that is designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com.
Forward Looking Statements
includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal s beliefs and assumptions and on information currently available to
it, but are subject to factors beyond its control. Forward-looking statements reflect management s current knowledge, assumptions, judgment and expectations regarding future performance or events. Forward-looking statements include: all
statements that are not historical facts; statements referenced by forward-looking statement identifiers, including the examples in the paragraph below; estimates of patients diagnosed with NASH; the relationship between NASH progression and adverse
patient outcomes; the estimated clinical burden of uncontrolled NASH; analyses for patients with NASH with significant fibrosis concerning potential progression to cirrhosis, decompensated cirrhosis, liver transplant or death; cardiovascular risks,
comorbidities and outcomes; health economics assessments or projections; resmetirom s potential to be the first specialty therapy for NASH patients with significant liver fibrosis; projections or objectives for obtaining accelerated or full
approval for resmetirom, including all statements concerning
potential clinical benefit to support accelerated approval and/or potential accelerated approval; and statements or references concerning - the potential efficacy and safety of resmetirom
for noncirrhotic NASH patients and cirrhotic NASH patients, possible or assumed future results of operations and expenses, business strategies and plans (including ex-US. Launch/partnering plans), research and
development activities, and the timing and results associated with the future development of resmetirom, the timing and completion of projected future clinical milestone events, including enrollment, additional studies, top-line data and open label projections, Madrigal s primary and key secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections, the potential to support an
additional indication for resmetirom in patients with well-compensated NASH cirrhosis, optimal dosing levels for resmetirom and projections regarding potential NASH or NAFLD and potential patient benefits with resmetirom, including future NASH
resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment, and/or biomarker effects with resmetirom, and strategies, objectives and commercial opportunities, including potential prospects or results.
Forward-looking statements can be identified by terms such as accelerate, achieve, allow, anticipates,
appear, be, believes, can, confidence, continue, could, demonstrates, design, estimates, expectation,
expects, forecasts, future, goal, help, hopeful, inform, inform, intended, intends, may, might, on
track, planned, planning, plans, positions, potential, powers, predicts, predictive, projects, seeks, should,
will, will achieve, will be, would or similar expressions and the negatives of those terms.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking
statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; risks associated with meeting the objectives of Madrigal s clinical studies, including, but not
limited to Madrigal s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal s studies; any delays or failures in enrollment,
and the occurrence of adverse safety events; risks related to the effects of resmetirom s mechanism of action; the achievement of enrollment objectives concerning patient number, safety database and/or timing for Madrigal s studies;
enrollment and trial conclusion uncertainties; market demand for and acceptance of our products; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to those
arranged in the past; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber attacks,
unauthorized exfiltration of data or other security incidents; the risks of achieving potential benefits in studies that includes substantially more patients, and patients with different disease states, than prior studies; the timing and outcomes of
clinical studies of resmetirom; the uncertainties inherent in clinical testing; and uncertainties concerning analyses or assessments outside of a controlled clinical trial. Undue reliance should not be placed on forward-looking statements, which
speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information,
events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal s submissions filed with the U.S. Securities and Exchange
Commission, or SEC, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and
uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024, and as
updated from time to time by Madrigal s other filings with the SEC.
Tina Ventura, Madrigal Pharmaceuticals, Inc., IR@madrigalpharma.com
Christopher Frates, Madrigal
Pharmaceuticals, Inc., media@madrigalpharma.com
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended December 31, Twelve Months Ended
December 31,
2023 2022 2023 2022
Revenues:
Total revenues $ $ $ $
Operating expenses:
Research and development 70,640 70,742 272,350 245,441
General and administrative 46,536 14,557 108,146 48,130
Total operating expenses 117,176 85,299 380,496 293,571
Loss from operations (117,176 ) (85,299 ) (380,496 ) (293,571 )
Interest income, net 8,953 1,076 19,578 2,185
Interest expense (3,971 ) (1,682 ) (12,712 ) (3,964 )
Net loss $ (112,194 ) $ (85,905 ) $ (373,630 ) $ (295,350 )
Basic and diluted net loss per common share $ (5.68 ) $ (4.98 ) $ (19.99 ) $ (17.23 )
Basic and diluted weighted average number of common shares outstanding 19,760,842 17,237,517 18,687,774 17,137,201
Madrigal Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
December 31, December 31,
2023 2022
Assets
Cash, cash equivalents and marketable securities $ 634,131 $ 358,774
Other current assets 3,150 2,595
Other non-current assets 3,266 1,203
Total assets $ 640,547 $ 362,572
Liabilities and Equity
Current liabilities $ 118,548 $ 115,894
Long-term liabilities 116,666 49,289
Stockholders equity 405,333 197,389
Total liabilities and stockholders equity $ 640,547 $ 362,572

Frequently Asked Questions

What is Madrigal Pharmaceuticals focusing on?

Madrigal Pharmaceuticals is concentrating on developing therapies for nonalcoholic steatohepatitis (NASH).

What are the financial results for Q4 2023?

Madrigal reported operating expenses of $117.2 million for Q4 2023.

What is the current status of resmetirom?

Resmetirom aims to be a foundational therapy for NASH with significant fibrosis.

How much cash did Madrigal have by year-end 2023?

Madrigal had cash and equivalents of $634.1 million as of December 31, 2023.

Who is the CEO of Madrigal Pharmaceuticals?

Bill Sibold is the Chief Executive Officer of Madrigal Pharmaceuticals.

Last updated: Feb 28, 2024