- $75
million in second quarter VYVGART® (efgartigimod alfa-fcab) global
net product sales from U.S. and Japan commercial launch; approval
in Europe on track for third quarter 2022
-
Biologics License Application (BLA) for VYVGART accepted by China’s
National Medical Products Administration (NMPA) as part of
collaboration with Zai Lab
- BLA for
subcutaneous (SC) efgartigimod on track for filing by end of
2022
-
Management to host conference call today at 2:30 pm CET (8:30 am
ET)
July
28, 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 announced its half year 2022 financial
results and provided a second quarter business update.
“We had a strong second quarter of our global
VYVGART launch reflecting the significant need for effective, safe
treatment options for people living with generalized myasthenia
gravis and the unwavering commitment of our team to deliver our
innovation to patients around the world. We are still in the early
stages of our first commercial launch, but are encouraged by the
initial clinical interest in our first-in-class FcRn blocker and
the feedback we are hearing from patients and their supporters,”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
“Based on our two positive Phase 3 data readouts already in 2022
and our plan to be active in 12 autoimmune indications by the end
of the year across both efgartigimod and ARGX-117, we are confident
that we are only at the beginning of our quest to transform the
treatment of autoimmune disease.”
SECOND QUARTER
2022 AND RECENT BUSINESS
UPDATE
VYVGART Launch ProgressVYVGART
is the first-and-only 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 global net product
revenues of $75 million for second quarter of VYVGART commercial
launch in U.S. and Japan
- European Commission (EC) approval
expected in third quarter 2022 following positive recommendation
from Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA)
- Zai Lab and Medison filed for
approval in China and Israel, respectively
- Entered into VYVGART commercial and
distribution agreement with Medison in Central and Eastern
Europe
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, including registrational trials in
six indications and proof-of-concept trials in four indications
across multiple therapeutic franchises.
- Neuromuscular
franchise
- BLA for SC efgartigimod for gMG on
track to be filed by end of 2022
- Topline data from registrational
ADHERE trial of SC efgartigimod for chronic inflammatory
demyelinating polyneuropathy (CIDP) expected in first quarter of
2023
- Registrational ALKIVIA trial of SC
efgartigimod on track to start in third quarter of 2022 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
- Enrollment expanded in second
registrational ADVANCE-SC trial of SC efgartigimod for primary
immune thrombocytopenia (ITP) based on key learnings from positive
ADVANCE-IV trial; topline data now expected in second half of
2023
- Dermatology
franchise
- Topline data from registrational
ADDRESS trial of SC efgartigimod for pemphigus vulgaris and
foliaceus 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 launch in 2022
in collaboration with Zai Lab and IQVIA
- Zai Lab to launch Phase 2 trials in
lupus nephritis and membranous nephropathy with argenx to lead
global registrational programs for each potential indication
- IQVIA to launch Phase 2 trials in
primary Sjogren’s syndrome and COVID-19-mediated postural
orthostatic tachycardia syndrome (POTS)
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 with subsequent Phase
1b trial to assess early signal detection in patients
Creation of
OncoVerityargenx, the
University of Colorado Anschutz Medical Campus and UCHealth created
an asset-centric spin-off, OncoVerity, Inc., focused on optimizing
and advancing the development of cusatuzumab, a novel anti-CD70
antibody, in acute myeloid leukemia (AML). OncoVerity will be an
entity of co-creation, combining the extensive translational
biology insights from Dr. Clayton Smith, M.D. from the University
of Colorado with the experience from argenx on the CD70/CD27
pathway. OncoVerity is the fourth spin-off company from argenx’s
Immunology Innovation Program.
Nomination of Camilla Sylvest as non-executive director
to Board of Directors
Ms. Sylvest’s appointment is pending approval,
which is expected to occur at an extraordinary general meeting
of shareholders to be held in September 2022. She is the Executive
Vice President of Commercial Strategy and Corporate Affairs at Novo
Nordisk, where she has worked for 26 years.
SECOND QUARTER
2022 FINANCIAL
RESULTS
ARGENX SEUNAUDITED
CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR
LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
|
June 30, |
|
June 30, |
|
(in thousands of $ except for shares and EPS) |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
Product net
sales |
|
|
$ |
74,833 |
|
$ |
— |
|
$ |
95,996 |
|
$ |
— |
Collaboration
revenue |
|
|
|
361 |
|
|
312,243 |
|
|
2,610 |
|
|
470,398 |
Other operating
income |
|
|
|
9,989 |
|
|
7,819 |
|
|
18,057 |
|
|
28,231 |
Total
operating income |
|
|
|
85,183 |
|
|
320,062 |
|
|
116,663 |
|
|
498,629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
(5,010) |
|
|
— |
|
|
(6,382) |
|
|
— |
Research and
development expenses |
|
|
|
(126,919) |
|
|
(151,579) |
|
|
(278,887) |
|
|
(273,907) |
Selling, general
and administrative expenses |
|
|
|
(127,798) |
|
|
(73,346) |
|
|
(228,664) |
|
|
(129,599) |
Total
operating expenses |
|
|
|
(259,727) |
|
|
(224,925) |
|
|
(513,933) |
|
|
(403,506) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income/(loss) |
|
|
$ |
(174,544) |
|
$ |
95,137 |
|
$ |
(397,270) |
|
$ |
95,123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income |
|
|
|
4,912 |
|
|
864 |
|
|
5,733 |
|
|
1,628 |
Financial
expense |
|
|
|
(1,178) |
|
|
(1,189) |
|
|
(2,131) |
|
|
(2,373) |
Exchange
gains/(losses) |
|
|
|
(46,169) |
|
|
10,442 |
|
|
(53,382) |
|
|
(18,375) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit/(Loss) for the period before taxes |
|
|
$ |
(216,979) |
|
$ |
105,254 |
|
$ |
(447,050) |
|
$ |
76,003 |
Income tax
(expense)/benefit |
|
|
$ |
8,229 |
|
$ |
(1,651) |
|
$ |
11,114 |
|
$ |
(12,835) |
Profit/(Loss) for the period |
|
|
$ |
(208,750) |
|
$ |
103,603 |
|
$ |
(435,936) |
|
$ |
63,167 |
Profit/(Loss) for the period attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Owners of the
parent |
|
|
|
(208,750) |
|
|
103,603 |
|
|
(435,936) |
|
|
63,167 |
Weighted average
number of shares outstanding |
|
|
|
54,802,339 |
|
|
51,334,661 |
|
|
53,449,915 |
|
|
50,638,702 |
Basic
profit/(loss) per share (in $) |
|
|
|
(3.81) |
|
|
2.02 |
|
|
(8.16) |
|
|
1.25 |
Diluted
profit/(loss) per share (in $) |
|
|
|
(3.81) |
|
|
1.90 |
|
|
(8.16) |
|
|
1.17 |
Net
increase/(decrease) in cash, cash equivalents and current financial
assets compared to year-end 2021 and 2020 |
|
|
|
|
|
|
|
|
$ |
260,665 |
|
$ |
734,545 |
Cash, cash
equivalents and current financial assets at the end of the
period |
|
|
|
|
|
|
|
|
$ |
2,597,393 |
|
$ |
2,730,997 |
DETAILS OF THE FINANCIAL
RESULTS
Total operating income for the
second quarter and year-to-date in 2022 was $85.2 million and
$116.7 million, respectively, compared to $320.1 million and $498.6
million for the same periods in 2021, and consists of:
- Product net sales
from the sales of VYVGART for the three months ended June 30, 2022
were $74.8 million compared to $21.2 million for three month ended
March 31, 2022, following the approval of VYVGART by the U.S. Food
and Drug Administration (FDA) on December 17, 2021 and
Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on
January 20, 2022. No product net sales were recognized during the
same period in 2021.
-
Collaboration revenue for the second quarter and
year-to-date in 2022 was $0.4 million and $2.6 million,
respectively, compared to $312.2 million and $470.4 million for the
same periods in 2021. The collaboration revenue for the three and
six months ended June 30, 2021 was primarily attributable to the
recognition of the transaction price as a consequence of the
termination of the collaboration agreement with Janssen, resulting
in the recognition of $311 million in collaboration revenue.
-
Other operating income for the second quarter and
year-to-date in 2022 was $10.0 million, and $18.1 million,
respectively, compared to $7.8 million and $28.2 million for the
same periods in 2021. During the three months ended June 30, 2022,
the fair value of the argenx profit share in AgomAb Therapeutics NV
increased by $4.3 million. The increase is a result of the
extension of a Series B financing round by AgomAb for which the
Company maintains a profit share in exchange for granting the
license for the use of HGF-mimetic antibodies from the SIMPLE
Antibody™ platform.
Total operating expenses for
the second quarter and year-to-date in 2022 were $259.7 million and
$513.9 million, respectively, compared to $224.9 million and $403.5
million for the same periods in 2021, and consists of:
-
Cost of sales for the second quarter and
year-to-date in 2022 was $5.0 million and $6.4 million,
respectively. The cost of sales were recognized with respect to the
sale of VYVGART during the first half of 2022. There were no cost
of sales recognized in the comparable prior year periods.
- Research and development
expenses for the second quarter and year-to-date in 2022
were $126.9 million and $278.9 million, respectively, compared to
$151.6 million and $273.9 million for the same periods in 2021. The
research and development expenses mainly relate to external
research and development expenses and personnel expenses incurred
in the clinical development of efgartigimod in various indications
and the expansion of our other clinical and preclinical pipeline
candidates.
- Selling, general and
administrative expenses for the second quarter and
year-to-date in 2022 were $127.8 million and $228.7 million,
respectively, compared to $73.3 million and $129.6 million for the
same periods in 2021. The selling, general and administrative
expenses mainly relate to professional and marketing fees linked to
the commercialization of VYVGART in the U.S. and Japan and
personnel expenses.
Exchange losses for the second
quarter and year-to-date in 2022 were $46.2 million and $53.4
million, respectively, compared to exchange gains of $10.4 million
and exchange loss of $18.4 million for the same periods in 2021.
Exchange losses are mainly attributable to unrealized exchange rate
losses on our cash, cash equivalents and current financial assets
position in Euro.
Income tax for the second
quarter and year-to-date in 2022 was $8.2 million and $11.1 of tax
income, respectively, compared to $1.7 million and $12.8 million of
tax expense for the same periods in 2021. Tax income for the three
months ended June 30, 2022 consists of $2.7 million of income tax
expense and $10.9 million of deferred tax income, compared to $3.2
million of income tax expense and $1.5 million of deferred tax
income for the same period in 2021.
Net loss for the second quarter
and year-to-date in 2022 was $208.7 million and $435.9 million,
respectively, compared to net profit of $103.6 million and $63.2
million for the same periods in 2021.
Cash, cash equivalents and current
financial assets totaled $2,597.4 million as of June 30,
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 net cash flows used in operating
activities.
FINANCIAL GUIDANCEBased on
current plans to fund anticipated operating expenses and capital
expenditures, argenx continues to expect its 2022 cash burn to be
up to $1 billion. This 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
- October 27, 2022: Q3 2022 financial
results and business update
CONFERENCE CALL DETAILSThe
half-year financial results and second 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.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44 800 358
0970United States
1
888 415
4250Japan 81
3 4578
9752Switzerland 41
43 210 11 32
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
bdelgiacco@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 regarding the VYVGART launch strategy to make VYVGART
available in Europe, China, Canada and select other regions, the
expected European Commission (EC) approval in the third quarter of
2022, Zai Lab and Medison’s respective pending approvals in China
and Israel; its position to expand its leadership position in FcRn
blockade to include ten autoimmune indications by the end of 2022;
its expectations about its pipeline progress; its collaboration
with the University of Colorado Anschutz Medical Campus and
UCHealth to create OncoVerity, Inc.; the therapeutic potential of
its product candidates; the intended results of its strategy and
its collaboration partners’, advancement of, and anticipated
clinical development, data readouts and regulatory milestones and
plans, including the timing of planned clinical trials and expected
data readouts; the design of future clinical trials and the timing
and outcome of regulatory filings and regulatory approvals; its
expectation that its 2022 cash burn will be up to $1 billion and
the 2022 business and financial outlook and related plans. By their
nature, forward-looking statements involve risks and uncertainties
and readers are cautioned that any such forward-looking statements
are not guarantees of future performance. argenx’s actual results
may differ materially from those predicted by the forward-looking
statements as a result of various important factors, including the
effects of the COVID-19 pandemic, inflation and deflation and the
corresponding fluctuations in interest rate; regional instability
and conflicts, such as the conflict between Russia and Ukraine,
argenx’s expectations regarding the inherent uncertainties
associated with competitive developments, preclinical and clinical
trial and product development activities and regulatory approval
requirements; argenx’s reliance on collaborations with third
parties; estimating the commercial potential of argenx’s product
candidates; argenx’s ability to obtain and maintain protection of
intellectual property for its technologies and drugs; argenx’s
limited operating history; and argenx’s ability to obtain
additional funding for operations and to complete the development
and commercialization of its product candidates. 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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