false 0001157601 0001157601 2024-08-07 2024-08-07

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 7, 2024

 

 

MADRIGAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-33277   04-3508648
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

Four Tower Bridge  
200 Barr Harbor Drive, Suite 200  
West Conshohocken, Pennsylvania   19428
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (267) 824-2827

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, $0.0001 par value per share   MDGL   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On August 7, 2024, Madrigal Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fiscal quarter ended June 30, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit Number    Description
99.1    Press Release of Madrigal Pharmaceuticals, Inc., dated August 7, 2024.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

MADRIGAL PHARMACEUTICALS, INC.
By:  

/s/ Mardi C. Dier

Name:   Mardi C. Dier
Title:   Senior Vice President and Chief Financial Officer

Date: August 7, 2024

Exhibit 99.1

 

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Madrigal Pharmaceuticals Reports Second-Quarter 2024 Financial Results and Provides Corporate Updates

 

   

Second-quarter 2024 net sales of $14.6 million

 

   

Rezdiffra (resmetirom) coverage in place for more than 50 percent of commercial lives; less than 5 percent of Rezdiffra-covered lives require biopsy

 

   

Expert guidelines recommend Rezdiffra as first-line therapy for patients with F2/F3 NASH/MASH

 

   

Plans to directly commercialize resmetirom in Europe following EMA decision expected mid-year 2025

 

   

Reports cash, cash equivalents, restricted cash and marketable securities of $1.1 billion at June 30, 2024

 

   

Company to host conference call today, August 7, 2024, at 8 a.m. EDT

CONSHOHOCKEN, Pa., August 7, 2024 – Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today reports second-quarter 2024 financial results and provides corporate updates.

Bill Sibold, Chief Executive Officer of Madrigal, stated, “We’re off to a strong start with our U.S. launch of Rezdiffra and are encouraged by the high enthusiasm and early demand from physicians and patients, as well as the favorable coverage from payers. Our efforts to help healthcare practices build patient care pathways are progressing well, setting the stage for future growth. Given the strong start in the U.S., we aim to extend Madrigal’s global leadership in NASH by directly commercializing Rezdiffra in Europe next year upon regulatory approval.”

Mr. Sibold continued, “The urgent unmet need in NASH, which is the leading cause of liver transplant among women in the U.S., is driving the strong reception to Rezdiffra as the first and only approved therapy for NASH. Data presented at the EASL Congress demonstrating 91% efficacy in halting or improving liver stiffness, a key noninvasive measure of fibrosis, at three years reinforce the Rezdiffra efficacy profile; and the new EASL guidelines position Rezdiffra as the foundational NASH therapy.”

Second Quarter and Recent Corporate Updates

 

   

Rezdiffra U.S. launch update

 

   

On April 9, 2024, the Company announced U.S. availability of Rezdiffra, a once-daily, oral, liver-directed, THR-b agonist designed to target the underlying causes of NASH, which is the number-one cause of liver transplants for women in the U.S.

 

   

Madrigal is continuing to execute the U.S. launch of Rezdiffra, which is focused on building the foundation for future growth by educating the community on the clinical benefits of Rezdiffra, supporting the creation of care pathways for patients at physician offices, driving breadth and depth of Rezdiffra prescribers, and engaging with payers to increase Rezdiffra coverage.

 

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As of June 30, 2024, coverage for Rezdiffra is in place for more than 50 percent of commercial lives covered by health insurance in the U.S., tracking well towards the Company’s goal of 80 percent of commercial lives covered by year-end 2024. Less than 5 percent of Rezdiffra-covered lives require biopsy for diagnosis and instead accept noninvasive tests, or NITs, in line with current standard of care.

 

   

Driving future growth through European expansion

 

   

Rezdiffra is currently under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and has the potential to become the first therapy for patients with NASH/MASH with liver fibrosis to receive approval in Europe.

 

   

The Company plans to directly commercialize resmetirom in Europe following a decision from the EMA on the Marketing Authorization Application (MAA), which is expected mid-year 2025.

 

   

Expert guidelines recommend Rezdiffra as first-line therapy for NASH/MASH

 

   

In July, updated clinical practice guidelines co-authored by the European Association for the Study of the Liver (EASL), the European Association for the Study of Diabetes (EASD), and the European Association for the Study of Obesity (EASO) for MASH were published in the Journal of Hepatology and recommend Rezdiffra as first-line therapy for patients with F2/F3 NASH/MASH where the medicine is available. The guidelines noted that Rezdiffra is the only disease-specific agent in MASH with positive results from a registrational Phase 3 clinical trial.

 

   

In July, “Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients with MASH/NASH and Moderate to noncirrhotic Advanced Fibrosis” were published in the Journal of Clinical Gastroenterology and Hepatology. These recommendations were written by well-recognized experts in NASH/MASH and provide practical guidance for the appropriate use of Rezdiffra, including patient identification, assessment of response and general monitoring.

 

   

Multiple abstracts presented at the EASL Congress in June

 

   

A late breaking oral presentation that leveraged innovative AI technology provided deeper insight from the Phase 3 MAESTRO-NASH study of the antifibrotic effect of Rezdiffra and the role of THR-b as a suppressor of disease progression.

 

   

New analyses from noninvasive test data pointed to a durable Rezdiffra treatment response through three years including a 91% improvement or stabilization of liver stiffness (a surrogate for fibrosis), and a positive quality-of-life analysis showing the benefit of Rezdiffra treatment on patient worry, health distress and stigma.

 

   

The Company also presented for the first time an analysis of Rezdiffra treatment in patients with probable metabolic dysfunction and alcohol-associated liver disease, known as MetALD, which demonstrated that patients achieved similar rates of fibrosis improvement and steatohepatitis resolution compared to the NASH population.

 

   

Two health economics outcomes research studies in Medicare patients concluded that NASH patients are at a higher risk of progression, which is associated with higher costs, particularly at advanced stages. These studies concluded that interventions that can delay or prevent progression may reduce morbidity and mortality and deliver cost benefits.

 

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Second-Quarter 2024 Financial Results

 

   

Total revenues: The Company shipped Rezdiffra beginning in April and generated second-quarter 2024 net revenues of $14.6 million. No product sales were recognized during the comparable prior year period.

 

   

Cost of sales: Second-quarter 2024 cost of sales were $0.6 million. Cost of sales were not recognized during the comparable prior year period given that no product sales were recorded.

 

   

Operating Expenses: Second-quarter 2024 operating expenses were $177.2 million, compared to $86.5 million in the comparable prior year period.

 

   

R&D Expense: Second-quarter 2024 R&D expense was $71.1 million, compared to $68.6 million in the comparable prior year period. The increase is primarily attributable to an increase related to timing of manufacturing, headcount and stock compensation expense.

 

   

SG&A Expense: Second-quarter 2024 SG&A expense was $105.4 million, compared to $17.8 million in the comparable prior year period. The increase is primarily attributable to increases in prelaunch and launch activities for Rezdiffra, including significant commercial headcount expansion and stock compensation expense.

 

   

Interest Income: Second-quarter 2024 interest income was $14.2 million, compared to $3.6 million in the comparable prior year period. The increase in interest income is due primarily to higher principal balances and interest rates in 2024.

 

   

Interest Expense: Second-quarter 2024 interest expense was $3.7 million, compared to $2.9 million in the comparable prior year period. The increase in interest expense was a result of a higher outstanding principal balance during the period under the Company’s loan facility.

 

   

Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of June 30, 2024, Madrigal had cash, cash equivalents, restricted cash and marketable securities of $1.1 billion, compared to $634.1 million at Dec. 31, 2023. The increase in cash and marketable securities was primarily attributable to $574 million of net proceeds from the Company’s March 2024 public offering partially offset by funding of operations.

Conference Call and Webcast

At 8 a.m. EDT today, August 7, 2024, the Company will host a webcast to review its financial and operating results and provide a general business update. To access the webcast, please visit the investor relations section of the Madrigal website or click here to register. An archived webcast will be available on the Madrigal website following the event.

 

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About NASH

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 moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), 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 moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra.

NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-b agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com.

Forward Looking Statements

This press release 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; and statements regarding: Rezdiffra (resmetirom) and its expected use for treating NASH with moderate to advanced fibrosis; future growth of Rezdiffra sales; projections or objectives for obtaining approval from EMA for Rezdiffra (resmetirom) and

 

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expected commercialization of Rezdiffra (resmetirom) in Europe; the final number of patients who randomize in the MAESTRO-NASH trial, the estimated study duration for such trial and the anticipated timeframe for topline data from such trial; the U.S. opportunity for Rezdiffra in patients with stage 4 fibrosis (F4)/compensated cirrhosis; estimates of patients diagnosed with NASH and market opportunities; 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”, “future” 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; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; 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 Rezdiffra’s (resmetirom’s) mechanism of action; enrollment and trial conclusion uncertainties; market demand for and acceptance of our product; 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; the timing and outcomes of clinical studies of Rezdiffra (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 Part II, Item 1A of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 7, 2024, and as updated from time to time by Madrigal’s other filings with the SEC.

 

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Investor Contact

Tina Ventura, IR@madrigalpharma.com

Media Contact

Christopher Frates, media@madrigalpharma.com

(tables follow)

Madrigal Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2024     2023     2024     2023  

Revenues:

        

Product revenue, net

   $ 14,638     $ —      $ 14,638     $ —   

Operating expenses:

        

Cost of sales

     636       —        636       —   

Research and development

     71,091       68,605       142,328       130,759  

Selling, general and administrative

     105,448       17,845       186,249       34,027  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     177,175       86,450       329,213       164,786  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (162,537     (86,450     (314,575     (164,786

Interest income, net

     14,222       3,551       22,556       7,327  

Interest expense

     (3,656     (2,901     (7,493     (5,237
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (151,971   $ (85,800   $ (299,512   $ (162,696
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (7.10   $ (4.69   $ (14.47   $ (8.91

Basic and diluted weighted average number of common shares outstanding

     21,402,646       18,310,952       20,702,041       18,249,778  

 

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Madrigal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

 

     June 30,
2024
     December 31,
2023
 

Assets

     

Cash, cash equivalents, restricted cash, and marketable securities

   $ 1,062,794      $ 634,131  

Other current assets

     28,934        3,150  

Other non-current assets

     8,061        3,266  
  

 

 

    

 

 

 

Total assets

   $ 1,099,789      $ 640,547  

Liabilities and Equity

     

Current liabilities

   $ 125,162      $ 118,548  

Long-term liabilities

     117,507        116,666  

Stockholders’ equity

     857,120        405,333  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 1,099,789      $ 640,547  

 

7

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Aug. 07, 2024
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Entity Central Index Key 0001157601
Document Type 8-K
Document Period End Date Aug. 07, 2024
Entity Registrant Name MADRIGAL PHARMACEUTICALS, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-33277
Entity Tax Identification Number 04-3508648
Entity Address, Address Line One Four Tower Bridge
Entity Address, Address Line Two 200 Barr Harbor Drive
Entity Address, Address Line Three Suite 200
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Security 12b Title Common Stock, $0.0001 par value per share
Trading Symbol MDGL
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