Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
fourth quarter and full year 2019 financial results and highlights:
“Madrigal made significant progress during 2019 in executing our
business strategy and advancing the development of resmetirom. We
initiated two Phase 3 studies in NASH: the liver biopsy endpoint
study, MAESTRO-NASH, and a non-invasive study in NAFLD patients
with presumed NASH, MAESTRO-NAFLD-1,” stated Paul Friedman, M.D.,
Chief Executive Officer of Madrigal. “We filled vital
organizational needs including expansion of our medical operations
team and the addition of Jim Daly, who has deep commercial
expertise, to our Board. Further, we believe we have
sufficient financial resources to fund our two ongoing Phase 3
clinical studies.”
Becky Taub, M.D., CMO and President, Research & Development
of Madrigal added, “According to plan, we initiated our Phase 3
MAESTRO-NASH clinical study in the first quarter, and our Phase 3
MAESTRO-NAFLD-1 study in the fourth quarter. Both Phase 3
studies are on track to complete enrollment this year for the 52
week readout by the end of 2021. In addition, MAESTRO-NAFLD-1
includes an open label active treatment arm that will provide data
on lipids and non-invasive NASH biomarkers in 2020. We were
also pleased with the publication of our successful Phase 2 NASH
study in The Lancet in 2019. We continue to believe
resmetirom has the potential to resolve NASH and reduce liver
fibrosis while decreasing cardiovascular risk, through reduction of
levels of multiple atherogenic lipids including LDL-C and
triglycerides, and through the reduction of inflammatory fat in the
liver. Realization of this potential could provide an
important new therapy that delivers benefit to patients across the
spectrum of early and late-stage NASH.”
Financial Results for the Three Months and Twelve Months
Ended December 31, 2019
As of December 31, 2019, Madrigal had cash, cash equivalents and
marketable securities of $439.0 million, compared to $483.7 million
at December 31, 2018. The decrease in cash and marketable
securities resulted primarily from cash used in operations of $41.6
million.
Operating expenses were $30.0 million and $95.0 million,
respectively, for the three month and twelve month periods ended
December 31, 2019, compared to $14.5 million and $40.7 million in
the comparable prior year periods.
Research and development expenses for the three month and twelve
month periods ended December 31, 2019 were $24.9 million and $72.3
million, respectively, compared to $8.9 million and $25.4 million
in the comparable prior year periods. The increases are primarily
attributable to increases in clinical costs resulting from
initiation of our Phase 3 studies, and personnel costs, including
non-cash stock compensation.
General and administrative expenses for the three month and
twelve month periods ended December 31, 2019 were $5.0 million and
$22.6 million, respectively, compared to $5.6 million and $15.3
million in the comparable prior year periods. The decrease in
general and administrative expenses for the latest three month
period was due primarily to lower stock compensation expense, the
effect of which was partially offset by higher personnel
costs. The increase in general and administrative expenses
for the latest twelve month period was due primarily to higher
stock compensation, and personnel costs.
Interest income for the three month and twelve month periods
ended December 31, 2019 was $2.2 million and $11.0 million,
respectively, as compared to $3.0 million and $7.7 million in the
comparable prior year periods. The decrease in interest income for
the latest three month period was due primarily to lower average
principal balances in our investment accounts in 2019, and lower
interest rates. The increase in interest income for 2019 was
due primarily to higher average principal balances in our
investment accounts, the effects of which were partially offset by
lower interest rates.
About resmetirom (MGL-3196) Among its many
functions in the human body, thyroid hormone, through activation of
its beta receptor, plays a central role in controlling lipid
metabolism, impacting a range of health parameters from levels of
serum cholesterol and triglycerides to the pathological buildup of
fat in the liver. Attempts to exploit this pathway for therapeutic
purposes in cardio-metabolic and liver diseases have been hampered
by the lack of selectivity of older compounds for the thyroid
hormone receptor (THR)-β, chemically-related toxicities and
undesirable distribution in the body.
Madrigal recognized that greater selectivity for thyroid hormone
receptor (THR)-β and liver targeting might overcome these
challenges and deliver the full therapeutic potential of THR-β
agonism. Madrigal believes that resmetirom is the first orally
administered, small-molecule, liver-directed, truly β-selective THR
agonist.
Based on the positive Phase 2 clinical study results in patients
with NASH (Phase 2 NASH 36-Week Results Press Release), Madrigal
initiated a Phase 3 multinational, double-blind, randomized,
placebo-controlled study of resmetirom in patients with
non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH
and reduce progression to cirrhosis and/or hepatic decompensation
(Phase 3 MAESTRO-NASH Initiation Press Release and
ClinicalTrials.gov NCT03900429). Additionally, in both the NASH
Phase 2 study, and a second positive Phase 2 clinical study in
patients with heterozygous familial hypercholesterolemia (Phase 2
HeFH Results Press Release Phase 2 HeFH Results Press Release),
significant reductions in multiple atherogenic lipids were
observed. Based on the foregoing positive results, Madrigal also
initiated MAESTRO-NAFLD-1, a 52-week, double-blind, placebo
controlled Phase 3 clinical study in patients with biopsy-confirmed
or presumed NASH (Phase 3 MAESTRO-NAFLD-1 Initiation Press Release
and ClinicalTrials.gov NCT04197479). Key MAESTRO-NAFLD-1
endpoints are safety, including safety biomarkers, LDL cholesterol,
lipid biomarkers, and fibrosis biomarkers. Except for serial liver
biopsies, the study protocol is similar to the MAESTRO-NASH study
and includes key secondary lipid, MRI-PDFF and NASH biomarker
endpoints. In addition, MAESTRO-NAFLD-1 includes an open label arm
in which up to 100 patients will be dosed with 100 mg
resmetirom. The MAESTRO -NAFLD-1 study will help support the
adequacy of the safety database at the time of NDA submission for
subpart H approval for treatment of NASH in patients with F2 or F3
fibrosis (MAESTRO-NASH, NASH resolution surrogate endpoint).
About Madrigal Pharmaceuticals Madrigal
Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage
biopharmaceutical company pursuing novel therapeutics that target a
specific thyroid hormone receptor pathway in the liver, which is a
key regulatory mechanism common to a spectrum of cardio-metabolic
and fatty liver diseases with high unmet medical need. Madrigal’s
lead candidate, resmetirom, is a first-in- class, orally
administered, small-molecule, liver-directed, thyroid hormone
receptor (THR)-β selective agonist. For more information, visit
www.madrigalpharma.com.
Forward-Looking Statements This communication
contains “forward-looking statements” made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, that are based on our beliefs and assumptions and on
information currently available to us. Forward-looking statements
include but are not limited to statements or references concerning:
our clinical trials, research and development activities, and the
timing and results associated with the future development of our
lead product candidate, MGL-3196 (resmetirom); our primary and
secondary study endpoints for resmetirom and the potential for
achieving such endpoints and projections; optimal dosing levels for
resmetirom; projections regarding potential future NASH resolution,
safety, fibrosis treatment, cardiovascular effects and lipid
treatment with resmetirom; the achievement of enrollment objectives
concerning patient number, safety database and/or timing for our
studies; the risks attendant with conducting trials that are
substantially larger than our past trials; potential NASH or NAFLD
patient risk profile benefits with resmetirom; our possible or
assumed future results of operations and expenses, business
strategies and plans, capital needs and financing plans, trends,
market sizing, competitive position, industry environment and
potential growth opportunities, among other things. Forward-looking
statements: reflect management’s current knowledge, assumptions,
judgment and expectations regarding future performance or events;
include all statements that are not historical facts; and can be
identified by terms such as “anticipates,” “be,” “believes,”
“continue,” “could,” “estimates,” “expects,” “forecasts,” “future,”
“goal,” “intends,” “may,” “might,” “plans,” “potential,”
“predicts,” “projects,” “seeks,” “should,” “will,” “would” or
similar expressions and the negatives of those terms.
Although management presently believes that the expectations
reflected in such forward-looking statements are reasonable, it can
give no assurance that such expectations will prove to be correct
and you should be aware that actual results could differ materially
from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to, our clinical
development of resmetirom, enrollment uncertainties, outcomes or
trends from competitive studies, the risks of achieving potential
benefits in a study that includes substantially more patients than
our prior study, 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 filings with the U.S. Securities and Exchange
Commission 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. We specifically
discuss these risks and uncertainties in greater detail in the
section entitled "Risk Factors" in Part I, Item 1A of our Annual
Report on Form 10-K for the year ended December 31, 2019, as well
as in our other filings with the SEC.
Investor Contact: Marc Schneebaum, Madrigal
Pharmaceuticals, Inc. IR@madrigalpharma.com
Media Contact: Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com 312 961 2502
(Tables Follow)
|
|
Madrigal
Pharmaceuticals, Inc. |
|
Condensed
Consolidated Statements of Operations |
|
(in
thousands, except share and per share amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Twelve
Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
2019 |
|
|
2018 |
|
|
Revenues: |
|
|
|
|
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
24,910 |
|
|
8,871 |
|
|
|
72,324 |
|
|
25,389 |
|
|
General and administrative |
|
5,044 |
|
|
5,583 |
|
|
|
22,648 |
|
|
15,293 |
|
|
Total operating expenses |
|
29,954 |
|
|
14,454 |
|
|
|
94,972 |
|
|
40,682 |
|
|
Loss from operations |
|
(29,954 |
) |
|
(14,454 |
) |
|
|
(94,972 |
) |
|
(40,682 |
) |
|
Interest income (expense), net |
|
2,214 |
|
|
2,979 |
|
|
|
11,024 |
|
|
7,671 |
|
|
Other income |
|
- |
|
|
- |
|
|
|
- |
|
|
200 |
|
|
Net loss |
$ |
(27,740 |
) |
$ |
(11,475 |
) |
|
$ |
(83,948 |
) |
$ |
(32,811 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(1.80 |
) |
$ |
(0.75 |
) |
|
$ |
(5.45 |
) |
$ |
(2.22 |
) |
|
Basic and diluted weighted average number of common shares
outstanding |
|
15,429,154 |
|
|
15,348,358 |
|
|
|
15,394,659 |
|
|
14,796,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal
Pharmaceuticals, Inc. |
|
Condensed
Consolidated Balance Sheets |
|
(in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
December
31, |
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
439,045 |
|
$ |
483,718 |
|
|
|
|
|
Other
current assets |
|
1,152 |
|
|
1,483 |
|
|
|
|
|
Other
non-current assets |
|
1,859 |
|
|
227 |
|
|
|
|
|
Total assets |
$ |
442,056 |
|
$ |
485,428 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current
liabilities |
$ |
25,130 |
|
$ |
8,444 |
|
|
|
|
|
Long-term
liabilities |
|
361 |
|
|
- |
|
|
|
|
|
Stockholders’ equity |
|
416,565 |
|
|
476,984 |
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
442,056 |
|
$ |
485,428 |
|
|
|
|
|
|
|
|
|
|
|
|
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