- $21.2
million in VYVGART® (efgartigimod alfa-fcab) net product sales
during initial quarter of U.S. commercial launch
- Met
primary endpoint in Phase 3 ADVANCE trial of VYVGART for treatment
of primary immune thrombocytopenia (ITP)
- Japan
commercial launch of VYVGART on track to start this month
-
Management to host conference call today at 2:30 pm CET (8:30 am
ET)
May 5,
2022
Breda, the Netherlands – argenx
SE (Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases, today reported financial results for the first
quarter 2022 and provided a business update.
In a separate press release issued today, argenx
also announced positive results from the Phase 3 ADVANCE trial
evaluating VYVGART for the treatment of adult patients with ITP.
The primary endpoint, demonstrating a significantly higher
proportion of VYVGART-treated patients achieved a sustained
platelet response than patients receiving placebo, and additional
key secondary endpoints were met.
“Our VYVGART commercial launch is off to a
strong start, underscoring the significant unmet need for a new
treatment option in gMG. We are very encouraged by the early demand
from patients and physicians and our team continues to meet the
challenge with outstanding execution and deep engagement with our
key stakeholders. We look forward to our imminent commercial launch
in Japan and an upcoming regulatory decision in Europe, which
support our goal to make VYVGART available worldwide. We are
confident that the relationships we are building today with the gMG
community will establish a strong foundation to continue to deliver
on behalf of patients,” commented Tim Van Hauwermeiren, Chief
Executive Officer of argenx.
“The positive readout from our first
registrational ITP trial highlights the promise of efgartigimod as
a pipeline-in-a-product with the potential to reach a variety of
IgG-mediated autoimmune diseases, even beyond the ten indications
we are currently evaluating. We are on track to achieve our argenx
2025 goal to build the next great immunology company while bringing
breakthrough innovations to patients and creating long-term value
for our stakeholders.”
FIRST QUARTER
2022 AND RECENT BUSINESS
UPDATE
VYVGART Launch ProgressVYVGART
is the first-approved neonatal Fc receptor (FcRn) blocker in the
U.S. and Japan. VYVGART is approved in the U.S. for the treatment
of adult generalized myasthenia gravis (gMG) patients who are
anti-acetylcholine receptor (AChR) antibody positive and in Japan
for adult gMG patients. The global launch strategy is on track to
make VYVGART available in Europe, China and Canada, as well as
select additional regions.
- Generated net product revenues of
$21.2 million for first full quarter of VYVGART commercial launch
in U.S.
- Japan commercial launch to start
this month following addition of VYVGART to National Health
Insurance (NHI) drug price list on April 20, 2022
- Decision from European Medicines
Agency on Marketing Authorization Application expected in second
half of 2022
- Zai Lab to file for approval in
China in mid-2022 and Medison in Israel in second quarter of
2022
Efgartigimod Research and
Developmentargenx is positioned to expand its leadership
position in FcRn blockade to include ten total autoimmune
indications by the end of 2022. Six registrational trials are
ongoing with four new proof-of-concept trials to start this year
across multiple therapeutic franchises.
- Neuromuscular
franchise
- Biologics License Application (BLA)
on track to be filed by end of year for subcutaneous (SC)
efgartigimod for gMG, following positive topline results from Phase
3 ADAPT-SC trial
- Topline data from registrational
ADHERE trial of SC efgartigimod for chronic inflammatory
demyelinating polyneuropathy (CIDP) expected in first quarter of
2023
- Registrational ALKIVIA trial on
track to start this quarter for three subtypes of idiopathic
inflammatory myopathies (myositis), including immune-mediated
necrotizing myopathy, anti-synthetase syndrome and dermatomyositis;
interim analysis planned of first 30 patients of each subtype
- Hematology
franchise
- Positive topline data of VYVGART
for primary ITP reported today
- Primary endpoint was met;
significantly higher proportion of patients receiving VYVGART
achieved a sustained platelet response than patients receiving
placebo
- Statistically significant
separation from placebo in key platelet-derived secondary
endpoints
- Safety and tolerability profile
confirmed in second indication
- Topline data from second
registrational ADVANCE-SC trial of SC efgartigimod for primary ITP
expected in first quarter of 2023
- Dermatology
franchise
- Enrollment expanded in
registrational ADDRESS trial of SC efgartigimod for pemphigus
vulgaris and foliaceus in order to manage ongoing impact of war in
Ukraine; topline data now expected in second half of 2023
- Registrational BALLAD trial ongoing
of SC efgartigimod for bullous pemphigoid with interim analysis
planned of first 40 patients
- Proof-of-concept trials to
be launched in collaboration with Zai Lab and IQVIA
- Zai Lab to launch Phase 2 trials in
lupus nephritis and membranous nephropathy in 2022 with argenx to
lead global registrational programs for each potential
indication
- IQVIA to launch Phase 2 trials in
primary Sjogren’s syndrome in second half of 2022 and
COVID-19-mediated postural orthostatic tachycardia syndrome (POTS)
in mid-2022
Pipeline
Progressargenx is developing ARGX-117 and
ARGX-119, which both have pipeline-in-a-product potential for
multiple autoimmune indications.
- ARGX-117 (C2 inhibitor)
- Proof-of-concept ARDA trial ongoing
to evaluate safety, tolerability, and potential dosing regimen in
multifocal motor neuropathy (MMN)
- Phase 2 proof-of-concept trial
expected to start in 2022 for prevention of delayed graft function
and/or allograft failure after kidney transplantation
- ARGX-119 (muscle-specific kinase
(MuSK) agonist)
- Phase 1 dose-escalation trial in
healthy volunteers expected to start after Clinical Trial
Application filing in fourth quarter of 2022
- A subsequent Phase 1b trial will
assess early signal detection in patients with congenital
myasthenic syndrome and MuSK-associated myasthenia gravis
Upcoming Medical Meeting
Presentations
- 14th Myasthenia Gravis Foundation
of America International Conference on Myasthenia and Related
Disorders (May 10-12, Miami, FL)
- Society for Investigative
Dermatology Annual Meeting (May 18-21, Portland, Oregon)
- Annual Meeting of the Japanese
Society of Neurology (May 18-22, Tokyo, Japan)
- 8th Congress of the European
Academy of Neurology (June 25-28, Vienna, Austria)
- 17th International Congress on
Neuromuscular Diseases (July 5-9, Brussels, Belgium)
FIRST QUARTER
2022 FINANCIAL
RESULTS (CONSOLIDATED)
|
|
Three Months Ended |
|
|
March 31, |
(in thousands of $ except for shares and EPS) |
2022 |
|
2021 |
|
Variance |
Product net sales |
$ |
21,163 |
|
$ |
— |
|
$ |
21,163 |
Collaboration revenue |
|
2,249 |
|
|
158,155 |
|
|
(155,906) |
Other operating income |
|
8,068 |
|
|
20,412 |
|
|
(12,344) |
Total operating
income |
|
31,480 |
|
|
178,567 |
|
|
(147,087) |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
(1,372) |
|
|
— |
|
|
(1,372) |
Research and development
expenses |
|
(151,968) |
|
|
(122,328) |
|
|
(29,640) |
Selling, general and
administrative expenses |
|
(100,866) |
|
|
(56,253) |
|
|
(44,613) |
Total operating
expenses |
|
(254,206) |
|
|
(178,580) |
|
|
(75,626) |
|
|
|
|
|
|
|
|
|
Operating
loss |
$ |
(222,726) |
|
$ |
(13) |
|
$ |
(222,713) |
|
|
|
|
|
|
|
|
|
Financial income |
|
821 |
|
|
764 |
|
|
57 |
Financial expenses |
|
(953) |
|
|
(1,184) |
|
|
231 |
Exchange gains/(losses) |
|
(7,213) |
|
|
(28,817) |
|
|
21,604 |
|
|
|
|
|
|
|
|
|
Loss
before taxes |
$ |
(230,072) |
|
$ |
(29,249) |
|
$ |
(200,823) |
|
|
|
|
|
|
|
|
|
Income tax (expense) /
benefit |
$ |
2,885 |
|
$ |
(11,184) |
|
$ |
14,069 |
|
|
|
|
|
|
|
|
|
Loss
for the period |
$ |
(227,187) |
|
$ |
(40,433) |
|
$ |
(186,754) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding |
|
52,084,335 |
|
|
49,946,515 |
|
|
|
Basic and diluted loss per
share (in $) |
|
(4.36) |
|
|
(0.81) |
|
|
|
Net increase/(decrease) in
cash and cash equivalents and current financial assets compared to
year-end 2021 and 2020 |
$ |
518,656 |
|
$ |
910,903 |
|
|
|
Cash and cash equivalents and
current financial assets at the end of the period |
$ |
2,855,384 |
|
$ |
2,907,355 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
Total operating income for the
three months ended March 31, 2022 was $31.5 million, compared to
$178.6 million for the three months ended March 31, 2021, and
consists of:
- Product
net sales from sales of VYVGART in the U.S. for
the three months ended March 31, 2022 were $21.2 million, following
the approval of VYVGART by the U.S. Food and Drug Administration
(FDA) on December 17, 2021. No product sales were recognized during
the comparable prior period.
-
Collaboration revenue for the three months ended
March 31, 2022 was $2.2 million, compared to $158.2 million for
three months ended March 31, 2021, resulting in a decrease of
$155.9 million. The collaboration revenue for the three months
ended March 31, 2021 was primarily attributable to the closing of
the strategic collaboration for efgartigimod with Zai Lab,
resulting in the recognition of $151.9 million in collaboration
revenue.
-
Other operating income for the three months ended
March 31, 2022 was $8.1 million, compared to $20.4 million for
three months ended March 31, 2021, resulting in a decrease of $12.3
million. During the three months ended March 31, 2021, the fair
value of the argenx profit share in AgomAb Therapeutics NV
increased by $11.2 million. There was no change in the fair value
during the three months ended March 31, 2022.
Total operating
expenses for the three months ended March 31, 2022
were $254.2 million, compared to $178.6 million for the three
months ended March 31, 2021, and consists of:
-
Cost of sales for the three
months ended March 31, 2022 amounted to $1.4 million. The cost of
sales was recognized with respect to the sale of VYVGART in the
U.S. during the first quarter of 2022. There was no cost of sales
recognized in the comparable prior period.
- Research and development
expenses increased by $29.6 million for the three months
ended March 31, 2022 to $152.0 million, compared to $122.3 million
for the three months ended March 31, 2021. The increase resulted
primarily from higher external research and development expenses,
mainly related to the efgartigimod program in various indications
and other clinical and preclinical programs.
- Selling, general and
administrative expenses totaled $100.9 million for the
three months ended March 31, 2022, compared to $56.3 million for
the three months ended March 31, 2021. The increase resulted
primarily from higher professional and marketing fees linked to the
commercialization of VYVGART in the U.S. and Japan and higher
personnel expenses increased due to a planned increase in
headcount.
Exchange losses totaled $7.2
million for the three months ended March 31, 2022, compared to
$28.9 million for the three months ended March 31, 2021 and are
mainly attributable to unrealized exchange rate losses on cash,
cash equivalents and current financial assets position in Euro.
Income tax totaled $2.9 million
of tax income for the three months ended March 31, 2022, compared
to $11.2 million of tax expense for the comparable prior period.
Tax income for the three months ended March 31, 2022 consists of
$5.0 million of income tax expense and $7.9 million of deferred tax
income, compared to $6.2 million of income tax expense and $5
million of deferred tax expense for the comparable prior
period.
Net loss for the three months
ended March 31, 2022 was $227.2 million compared to $40.4 million
for the comparable prior year period. On a per weighted average
share basis, the net loss was $4.36 and $0.81 for the three months
ended March 31, 2022 and 2021, respectively.
Cash, cash equivalents and current
financial assets totaled $2,855.4 million as of March 31,
2022, compared to $2,336.7 million as of December 31, 2021. The
increase in cash and cash equivalents and current financial assets
resulted primarily from the closing of a global offering of shares,
including a U.S. offering and a European private placement, which
resulted in the receipt of $761.0 million in net proceeds in March
2022, partially offset by the net cash flows used in operating
activities, primarily towards the commercial launch of VYVGART in
the U.S. and Japan and continued investment in pipeline
expansion.
FINANCIAL GUIDANCEAs of March
31, 2022, argenx had $2.9 billion in cash, cash equivalents and
current financial assets. Based on current plans to fund
anticipated operating expenses and capital expenditures, argenx
expects to utilize approximately $1 billion of its available cash
in 2022. The increased spend will support the global VYVGART
launches, clinical development of efgartigimod in 10 indications
and ARGX-117 in two indications, investment in the global supply
chain, and continued focus on pipeline expansion through the
Immunology Innovation Program.
EXPECTED 2022 FINANCIAL
CALENDAR
- July 28, 2022: HY 2022 financial
results and business update
- October 27, 2022: Q3 2022 financial
results and business update
CONFERENCE CALL DETAILSThe
first quarter 2022 business update will be discussed during a
conference call and webcast presentation today at 2:30 pm CEST/8:30
am ET. A webcast of the live call may be accessed on the Investors
section of the argenx website at argenx.com/investors. A replay of
the webcast will be available on the argenx website.
Dial-in numbers:Please dial in
15 minutes prior to the live call.
Dial-in numbers:Use the access
code 073235 to join the call. Please dial in 15 minutes prior to
the live call.
Belgium 32
800 548 13United
Kingdom 44 808 189
6484United States
1
844 200 6205All other
locations 1 929 526
1599
About argenxargenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases. Partnering with leading
academic researchers through its Immunology Innovation Program
(IIP), argenx aims to translate immunology breakthroughs into a
world-class portfolio of novel antibody-based medicines. argenx
developed and is commercializing the first-and-only approved
neonatal Fc receptor (FcRn) blocker in the U.S. and Japan. The
Company is evaluating efgartigimod in multiple serious autoimmune
diseases and advancing several earlier stage experimental medicines
within its therapeutic franchises. For more information, visit
www.argenx.com and follow us on LinkedIn, Twitter,
and Instagram.
For further information, please contact:
Media:Kelsey Kirkkkirk@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle Greenblattmgreenblatt@argenx.com
Forward-looking
Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
“believes,” “hope,” “estimates,” “anticipates,” “expects,”
“intends,” “may,” “will,” or “should” and include statements argenx
makes concerning execution of its global launch strategy and
expected therapy delivery to patients in Japan, Europe, China and
Canada; the expected long-term safety, tolerability and efficacy of
VYVGART® (efgartigimod alfa-fcab) in adult patients with Primary
Immune thrombocytopenia; its expectation concerning its development
pipeline and ability to deliver shareholder value as a result
thereof; development of efgartigimod in up to ten indications and
ARGX-117 in up to two indications by end of 2022; expected
advancement of ARGX-119 into first-in-human studies; expected broad
U.S. policy coverage of VYVGART by the end of second quarter 2022;
the estimated number of covered patients in the U.S.; anticipated
pathway for approval in Japan and launch in the second quarter of
2022; plans for Medison to file for approval in Israel in second
quarter of 2022; partnership agreements expected to be announced in
2022; the timing and its expectations with respect to reporting
data from registrational trials; expectations with respect to
expansion of efgartigimod portfolio into ten indications by end of
2022; expected launch and timing of proof of concept trials,
including by Zai Labs and IQVIA, and dose escalation trials in
2022; and its expectations with respect to its use of available
cash and liquidity needs for 2022. A further list and description
of these risks, uncertainties and other risks can be found in
argenx’s U.S. Securities and Exchange Commission (SEC) filings and
reports, including in argenx’s most recent annual report on Form
20-F filed with the SEC as well as subsequent filings and reports
filed by argenx with the SEC. Given these uncertainties, the reader
is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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