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-β 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.
- 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-β
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.
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 WebcastAt 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.
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 PharmaceuticalsMadrigal
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-β agonist designed to target
key underlying causes of NASH. For more information,
visit www.madrigalpharma.com.
Forward Looking StatementsThis 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 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.
Investor Contact Tina Ventura,
IR@madrigalpharma.com
Media ContactChristopher 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 |
|
Six Months Ended |
|
June 30, |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
December 31, |
|
|
|
|
|
2024 |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
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