Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical
company focused on delivering novel therapeutics for nonalcoholic
steatohepatitis (NASH), today reports first-quarter 2024 financial
results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated,
“Madrigal is the first company to deliver an approved therapy for
patients with NASH, which we believe will give us a strong
competitive advantage for many years to come. As a once-daily,
well-tolerated, liver-directed, oral medicine that has demonstrated
unprecedented efficacy in a pivotal Phase 3 trial, Rezdiffra is
well positioned to become the foundational therapy for this serious
disease.” He continued, “We are focused on executing this
first-in-disease launch, where our expert team is partnering with
the NASH community to establish treatment pathways for patients,
laying the groundwork for our long-term leadership. I’m highly
encouraged by the enthusiasm we’re seeing for Rezdiffra across our
key stakeholders in these early weeks of launch.”
Rezdiffra Launch UpdateOn March 14, 2024, the
Company received U.S. Food and Drug Administration (FDA) approval
for Rezdiffra for the treatment of patients with noncirrhotic NASH
with moderate to advanced liver fibrosis (consistent with stages F2
to F3 fibrosis). Rezdiffra is a once-daily, oral, liver-directed,
THR-β agonist designed to target key underlying causes
of NASH.
- Rezdiffra positioned to address significant patient
need as first-ever medicine approved for NASH. NASH with
moderate to advanced liver fibrosis is a serious and progressive
liver disease, and Rezdiffra is the first and only FDA-approved
therapy for the condition. 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 is focused on the approximately 315,000 diagnosed patients
with NASH with moderate to advanced liver fibrosis under
the care of specialist physicians.
- Strong label positions Rezdiffra as a foundational
therapy for NASH. The accelerated approval of Rezdiffra
was based on results from the Phase 3 MAESTRO-NASH trial,
which was published in The New England Journal of
Medicine in February 2024. This includes data demonstrating
Rezdiffra stops or improves fibrosis in more than 80% of patients.
The Rezdiffra prescribing information includes simple, weight-based
dosing, does not include a liver biopsy requirement for diagnosis,
contains no contraindications, no boxed warnings and no monitoring
requirements beyond standard of care.
- Experienced team executing on U.S. specialty
launch. Madrigal built an expert team across sales,
medical affairs, market access and patient support that is
executing on the Rezdiffra launch. The sales team is engaging with
healthcare providers to educate on NASH and Rezdiffra and activate
offices to process prescriptions with the support from Madrigal
patient services. The market access team is meeting with national
and regional payers to establish coverage and increase patient
access to Rezdiffra. Rezdiffra started shipping to customers in
April.
- Expanding access to Rezdiffra outside of the
U.S. In March, the Company announced that its Marketing
Authorization Application (MAA) for resmetirom for the treatment of
NASH/MASH with liver fibrosis was validated and under evaluation
with the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP). Resmetirom has the potential to
become the first therapy for patients with NASH/MASH with liver
fibrosis to receive approval in Europe.
First Quarter and Recent Corporate Updates
- Raised $690 million from upsized public offering and
full over-allotment option exercise. On March 21, 2024,
the Company closed an upsized public offering, which generated
gross proceeds of $600 million. On April 2, 2024, the Company
closed the underwriters’ exercise in full of their option to
purchase additional shares for an additional $90 million gross
proceeds. Total net proceeds were $660 million after deducting fees
and commissions. These proceeds further strengthen the Company’s
balance sheet and fully resource the Rezdiffra launch.
- New appointment to the Madrigal leadership
team. On February 28, 2024, the Company announced the
appointment of Mardi C. Dier as Chief Financial Officer (CFO). Ms.
Dier has spent more than 20 years in executive financial leadership
roles in biotechnology companies, including CFO positions at
Portola Pharmaceuticals, Ultragenyx, and Acelyrin.
- MAESTRO-NASH results published in
NEJM. On Feb. 8, 2024, positive
results from the 52-week pivotal Phase 3 MAESTRO-NASH were
published in The New England Journal of Medicine, including
detailed analyses that reinforce the safety and efficacy profile of
Rezdiffra. MAESTRO-NASH is a multicenter, randomized, double-blind,
placebo-controlled Phase 3 study of Rezdiffra in patients with
liver biopsy-confirmed NASH.
- Health economic abstracts presented at
NASH-TAG. Five Madrigal health economic abstracts were
presented at the NASH-TAG conference, which took place January 4-6,
2024, in Park City, Utah. Abstracts highlighted the serious
clinical burden of uncontrolled NASH and identified opportunities
to improve patient care.
First-Quarter 2024 Financial Results
- Total revenues: The Company shipped Rezdiffra
beginning in April. No revenue was booked in the first
quarter.
- Operating Expenses: First-quarter 2024
operating expenses were $152.0 million, compared to $78.3 million
in the comparable prior year period. The increase is primarily
attributable to expenses incurred related to commercial preparation
activities.
- R&D Expense: First-quarter 2024 R&D
expense was $71.2 million, compared to $62.2 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: First-quarter 2024 SG&A
expense was $80.8 million, compared to $16.2 million in the
comparable prior year period. The increase is primarily
attributable to increases in commercial preparation activities for
the launch of Rezdiffra, including significant commercial headcount
expansion and stock compensation expense.
- Interest Income: First-quarter 2024 interest
income was $8.3 million, compared to $3.8 million in the comparable
prior year period. The increase in interest income is due primarily
to a higher average principal balance in our investment account as
well as higher average interest rate.
- Interest Expense: First-quarter 2024 interest
expense was $3.8 million, compared to $2.3 million in the
comparable prior year period. The increase in interest expense was
a result of the higher outstanding principal balances during the
period under the Company’s loan facility as well as higher average
interest rate.
- Cash, Cash Equivalents and Marketable
Securities: As of March 31, 2024, Madrigal had cash, cash
equivalents and marketable securities of $1.1 billion, compared to
$634.1 million at Dec. 31, 2023. The increase in cash and
marketable securities was attributable to the March 2024 public
offering partially offset by funding of operations.
Conference Call and WebcastAt 8 a.m. EDT today,
May 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; the
initiation of the commercial launch of Rezdiffra, including
statements regarding commercial insurance and the anticipated time
to fill prescriptions; estimates of patients diagnosed
with NASH and market opportunities; the relationship
between NASH progression and adverse patient outcomes;
the estimated clinical burden of uncontrolled NASH; analyses
for patients with NASH with moderate to advanced fibrosis
concerning potential progression to cirrhosis, decompensated
cirrhosis, liver transplant or death; cardiovascular risks,
comorbidities and outcomes; health economics assessments or
projections; indicating Rezdiffra has been shown to improve the
fibrosis that is associated with progression to cirrhosis and its
complications and resolve the underlying inflammation that drives
the disease; projections or objectives for obtaining full approval
for Rezdiffra (resmetirom), including those concerning potential
clinical benefit to support potential full approval; regarding
post-approval requirements and commitments; reduced risk of
progression to cirrhosis, liver failure, need for liver transplant
and premature mortality; treatment paradigm; improved liver
enzymes, fibrosis biomarkers and imaging tests; the potential
efficacy and safety of Rezdiffra (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, the timing and results associated with the
future development of Rezdiffra (resmetirom), the timing and
completion of projected future clinical milestone events, including
enrollment, additional studies, the potential to support an
additional indication for Rezdiffra (resmetirom) in patients with
well-compensated NASH cirrhosis; optimal dosing levels
for Rezdiffra (resmetirom); potential NASH or NAFLD and
potential patient benefits with Rezdiffra (resmetirom), including
future NASH resolution, safety, fibrosis treatment,
cardiovascular effects, lipid treatment, and/or biomarker effects
with Rezdiffra (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,”
“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; 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, Madrigal
Pharmaceuticals, Inc., IR@madrigalpharma.com
Media ContactChristopher Frates, Madrigal
Pharmaceuticals, Inc., 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 |
|
March 31, |
|
|
2024 |
|
|
2023 |
|
Revenues: |
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
Research and development |
|
71,237 |
|
|
62,154 |
|
Selling, general and administrative |
|
80,800 |
|
|
16,182 |
|
Total operating expenses |
|
152,037 |
|
|
78,336 |
|
Loss from operations |
|
(152,037 |
) |
|
(78,336 |
) |
Interest income, net |
|
8,334 |
|
|
3,776 |
|
Interest expense |
|
(3,838 |
) |
|
(2,336 |
) |
Net loss |
$ |
(147,541 |
) |
$ |
(76,896 |
) |
|
|
|
Basic and diluted net loss per common share |
$ |
(7.38 |
) |
$ |
(4.23 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
20,001,569 |
|
|
18,187,924 |
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
March 31, |
December 31, |
|
|
2024 |
|
|
2023 |
|
|
|
|
Assets |
|
|
Cash, cash equivalents and marketable securities |
$ |
1,059,063 |
|
$ |
634,131 |
|
Other current assets |
|
14,889 |
|
|
3,150 |
|
Other non-current assets |
|
8,328 |
|
|
3,266 |
|
Total assets |
$ |
1,082,280 |
|
$ |
640,547 |
|
|
|
|
Liabilities and Equity |
|
|
Current liabilities |
$ |
114,341 |
|
$ |
118,548 |
|
Long-term liabilities |
|
117,180 |
|
|
116,666 |
|
Stockholders’ equity |
|
850,759 |
|
|
405,333 |
|
Total liabilities and stockholders’ equity |
$ |
1,082,280 |
|
$ |
640,547 |
|
|
|
|
Grafico Azioni Madrigal Pharmaceuticals (NASDAQ:MDGL)
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Da Ago 2024 a Set 2024
Grafico Azioni Madrigal Pharmaceuticals (NASDAQ:MDGL)
Storico
Da Set 2023 a Set 2024