Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage
biopharmaceutical company pursuing novel therapeutics for
nonalcoholic steatohepatitis (NASH), today provides a summary of
recent corporate accomplishments, previews new Phase 3 MAESTRO
study data scheduled for presentation at the AASLD Liver Meeting,
and reports third quarter 2023 financial results.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Over
the last several months, the Madrigal team has made significant
progress advancing key regulatory and commercial activities in
preparation for a potential approval of resmetirom in March 2024.
Our New Drug Application is supported by the largest and most
advanced development program in NASH and our commercial strategy is
grounded in resmetirom’s profile as a liver-directed oral therapy
that treats the underlying drivers of the disease. The $500 million
financing we closed in October provides Madrigal with the resources
necessary to execute a first-to-market launch of resmetirom in the
U.S.”
Becky Taub, M.D., Chief Medical Officer and President of
Research & Development of Madrigal, stated, “In addition to
advancing our regulatory strategy, we are focused on sharing new
data and insights to help clinicians manage patients in the real
world setting following a potential approval of resmetirom. At the
AASLD Liver Meeting next week, we will present a comprehensive
analysis of noninvasive tests and imaging from the MAESTRO-NASH
trial. Resmetirom demonstrated a broad and consistent treatment
response across a range of noninvasive measures, including simple
biomarkers that are widely available to clinicians.”
Recent Corporate Highlights
- Madrigal announced that the FDA accepted its New Drug
Application and granted Priority Review for resmetirom for the
treatment of adult patients with NASH with liver fibrosis. The FDA
assigned a Prescription Drug User Fee Act date for resmetirom of
March 14, 2024. The Agency noted that it is not currently planning
to hold an advisory committee meeting to discuss the
application.
- Bill Sibold was appointed Chief Executive Officer of Madrigal,
succeeding Dr. Paul Friedman, who served as Madrigal’s CEO since
2016 and continues to serve on the Board of Directors. Mr. Sibold
was previously Executive Vice President, Specialty Care of Sanofi
and President, Sanofi North America, where he led a global
organization of approximately 10,000 employees across five
specialty therapeutic areas and served as a member of the Sanofi
Executive Committee. While at Sanofi, Mr. Sibold led the launch of
Dupixent, a first-in-class therapy which has grown into an
industry-leading medicine.
- Madrigal executed a public offering that generated gross
proceeds of $500 million to be used for clinical and commercial
activities in preparation for a potential launch of resmetirom in
the U.S. and for general corporate purposes.
- Positive results from the Phase 3 MAESTRO-NAFLD-1 safety study
were published in Nature Medicine. MAESTRO-NAFLD-1 was a 52-week
multicenter, randomized, placebo-controlled, double-blind Phase 3
study of resmetirom in ~1,200 patients with NAFLD, presumed
NASH.
Resmetirom Data Presentations at AASLD
Multiple Madrigal abstracts have been accepted at the AASLD
Liver Meeting, taking place November 10-14 in Boston:
- Oral presentation: “Relationship of Non-Invasive Measures with
Histological Response in Patients with Nonalcoholic Steatohepatitis
and Fibrosis: 52-Week Data from the Phase 3 MAESTRO-NASH Trial”
[Monday, November 13 at 8:30 AM. Presenter: Rohit Loomba]
- Oral presentation: “Artificial Intelligence to Measure Fibrosis
Change on Liver Biopsy in MAESTRO-NASH: A Phase 3 Serial Liver
Biopsy Study in 966 Patients with NASH Treated with Resmetirom or
Placebo” [Sunday, November 12 at 11:00 AM. Presenter: Stephen
Harrison]
- Late-Breaking poster: “Artificial Intelligence-Based
Measurement of NASH Histology (AIM-NASH) Recapitulates Primary
Results from Phase 3 Study of Resmetirom for Treatment of
NASH/MASH” [Presenter: Janani Iyer]
- Poster of Distinction: “Resmetirom Treatment Helps Restore
Thyroid Hormone Levels in Patients with Nonalcoholic
Steatohepatitis: 52-Week Data from the Phase 3 MAESTRO-NASH Trial”
[Presenter: Stephen Harrison]
- Poster: “Resmetirom Improves the Atherogenic Lipid/Lipoprotein
Profile in Patients with Nonalcoholic Steatohepatitis: 52-Week Data
from the Phase 3 MAESTRO-NASH Trial” [Presenter: Naim
Alkhouri]
- Poster: “The Next Generation of HepQuant Tests Measure
Reduction in Risk for Clinical Events in Compensated NASH Cirrhosis
Subjects Treated with Resmetirom” [Presenter: Michael McRae]
- Poster: “Understanding the Incremental Costs of Nonalcoholic
Steatohepatitis and Diabetes Using Electronic Health Records and
Closed Claims Data” [Presenter: Jesse Fishman]
- Poster: “Characterizing the Management of Patients with NASH
(With Versus Without Cirrhosis) in Real-World Clinical Practice:
Rare Assessment by Hepatologists and Low Frequency of Imaging”
[Presenter: Christina Qian]
Financial Results for the Nine Months Ended September
30, 2023
As of September 30, 2023, Madrigal had cash, cash equivalents
and marketable securities of $232.4 million, compared to $358.8
million at December 31, 2022. In October 2023, we completed a
public offering and received an additional $472.0 million in net
cash proceeds.
Operating expenses were $98.5 million and $263.3 million for the
three month and nine month periods ended September 30, 2023,
compared to $80.4 million and $208.3 million in the comparable
prior year periods.
Research and development expenses for the three and nine month
periods ended September 30, 2023 were $71.0 million and $201.7
million, compared to $68.3 million and $174.7 million in the
comparable prior year periods. The increase is attributable
primarily to additional activities related to the Phase 3 clinical
trials, and an increase in head count.
General and administrative expenses for the three and nine month
periods ended September 30, 2023 were $27.6 million and $61.6
million, compared to $12.1 million and $33.6 million in the
comparable prior year periods. The increase is due primarily to
increases in commercial preparation activities, including an
increase in headcount and an increase in non-cash stock
compensation.
Interest income for the three and nine month periods ended
September 30, 2023 was $3.3 million and $10.6 million, compared to
$0.7 million and $1.1 million in the comparable prior year periods.
These increases in interest income were due primarily to higher
average interest rates in 2023.
Interest expense for the three and nine month periods ended
September 30, 2023 was $3.5 million and $8.7 million, compared to
$1.5 million and $2.3 million in the comparable prior year
periods.
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 significant fibrosis
(F2/F3), the risk of adverse liver outcomes increases dramatically.
NASH is rapidly becoming the leading cause of liver transplantation
in the U.S. 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
This communication 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; resmetirom’s potential to be the first specialty therapy for
NASH patients with significant liver fibrosis; statements
concerning 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, plans, objectives, timing
and support for making for making a Subpart H (Accelerated Approval
of New Drugs for Serious or Life-Threatening Illnesses) submission
to FDA, projections or objectives for obtaining accelerated or full
approval for resmetirom, Madrigal’s primary and key secondary study
endpoints for resmetirom and the potential for achieving such
endpoints and projections, demonstrating clinical benefit to
support accelerated approval, 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.
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; and the uncertainties inherent in clinical
testing. 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, 2022, filed with the SEC on February 23, 2023,
as amended by our Form 10-K/A filed with the SEC on March 3, 2023,
and Part II, Item 1A of its Quarterly Reports on Form 10-Q for the
quarters ended June 30, 2023 and September 30, 2023, and as updated
from time to time by Madrigal’s other filings with the SEC.
Investor Contact Alex Howarth, 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 |
|
Nine Months
Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
Revenues: |
|
|
|
|
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
70,951 |
|
|
68,271 |
|
|
|
201,710 |
|
|
174,699 |
|
|
General and administrative |
|
27,583 |
|
|
12,141 |
|
|
|
61,610 |
|
|
33,573 |
|
|
Total operating expenses |
|
98,534 |
|
|
80,412 |
|
|
|
263,320 |
|
|
208,272 |
|
|
Loss from operations |
|
(98,534 |
) |
|
(80,412 |
) |
|
|
(263,320 |
) |
|
(208,272 |
) |
|
Interest income |
|
3,298 |
|
|
717 |
|
|
|
10,625 |
|
|
1,109 |
|
|
Interest expense |
|
(3,504 |
) |
|
(1,502 |
) |
|
|
(8,741 |
) |
|
(2,282 |
) |
|
Net loss |
$ |
(98,740 |
) |
$ |
(81,197 |
) |
|
$ |
(261,436 |
) |
$ |
(209,445 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(5.34 |
) |
$ |
(4.75 |
) |
|
$ |
(14.27 |
) |
$ |
(12.25 |
) |
|
Basic and diluted weighted average number of common shares
outstanding |
|
18,476,414 |
|
|
17,103,395 |
|
|
|
18,326,154 |
|
|
17,103,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal
Pharmaceuticals, Inc. |
|
|
|
|
Condensed
Consolidated Balance Sheets |
|
|
|
|
(in
thousands) |
|
|
|
|
(unaudited) |
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
232,351 |
|
$ |
358,774 |
|
|
|
|
|
Other
current assets |
|
3,118 |
|
|
2,595 |
|
|
|
|
|
Other
non-current assets |
|
2,495 |
|
|
1,203 |
|
|
|
|
|
Total assets |
$ |
237,964 |
|
$ |
362,572 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current
liabilities |
$ |
99,665 |
|
$ |
115,894 |
|
|
|
|
|
Long-term
liabilities |
|
116,050 |
|
|
49,289 |
|
|
|
|
|
Stockholders’ equity |
|
22,249 |
|
|
197,389 |
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
237,964 |
|
$ |
362,572 |
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals (NASDAQ:MDGL)
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