Full Press Release Details
argenx Reports First Quarter 2024 Financial Results and
Provides Business Update
$398 million in first quarter global net product sales
FDA review ongoing for CIDP sBLA with PDUFA target action
date of June 21, 2024
On track to submit filing for pre-filled syringe (PFS)
in second quarter 2024
Management to host conference call today at 2:30 PM CET
May 9, 2024, 7:00 AM CET
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 first quarter 2024 results and provided a business update.
"The team at argenx has made significant
progress executing across the ambitious plan we set out at the beginning of the year," said Tim Van Hauwermeiren, Chief Executive
Officer of argenx. "We are driven by our commitment to provide patients with the broadest gMG product offering that consistently
delivers on safety and efficacy. VYVGART SC played a key role in our growth over the quarter, expanding the breadth of our prescriber
base and reaching new patients. The relationships we have built and key market learnings in gMG position us for success as we scale the
organization and prepare for CIDP. After generating the data required for filing, we are also excited to advance the development of our
pre-filled syringe, which should further enhance the patient experience."
"The clinical opportunity ahead is expansive
- we are preparing for registrational trials across multiple programs including empasiprubart in MMN and efgartigimod in Sjogren's
disease, in addition to those already underway in TED and seronegative gMG. We look forward to deepening our understanding of FcRn with
additional Phase 2 data points expected this year, while rapidly working to deliver on our promise of innovation by bringing the next
wave of molecules to the clinic."
FIRST QUARTER 2024 AND RECENT BUSINESS UPDATE
Reaching More Patients with VYVGART
VYVGART (efgartigimod alfa-fcab) is a first-in-class
antibody fragment targeting the neonatal Fc receptor (FcRn), and is now the first FcRn antagonist approved in two indications. VYVGART
is approved in more than 30 countries globally for the treatment of generalized myasthenia gravis (gMG) and is approved in Japan for the
treatment of primary immune thrombocytopenia (ITP). VYVGART subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) is approved in
the U.S. (as VYVGART Hytrulo), Japan (as VYVDURA ) and Europe, making VYVGART the only gMG treatment available as both an IV
and simple SC injection.
Advancing Current Pipeline
argenx continues to demonstrate breadth and depth
within its immunology pipeline and is advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn
biology and expects that efgartigimod will be approved or under evaluation in at least 15 indications by 2025. argenx is also advancing
its earlier stage pipeline programs, including empasiprubart (C2 inhibitor) with Phase 2 studies ongoing in multifocal motor neuropathy
(MMN), delayed graft function (DGF) and dermatomyositis (DM). In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK)
agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).
Leveraging Repeatable Innovation Playbook to Drive Long-Term Pipeline
argenx continues to invest in its discovery engine,
the Immunology Innovation Program (IIP), to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates
have been nominated, including: ARGX-213 targeting FcRn and further solidifying argenx's leadership in this new class of medicine;
ARGX-121 and ARGX-220, which are first-in-class targets broadening argenx's focus across the immune system; and ARGX-109, targeting
IL-6, which plays an important role in inflammation. Investigational new drug (IND) applications for each program are expected to be filed
Appointment of Brian L. Kotzin, MD as Non-executive Director to
Dr. Brian Kotzin has been appointed as non-executive
director to the Board of Directors and Chair of the Research & Development Committee for a term of four years. He is currently
a consultant for companies developing therapeutics for autoimmune and inflammatory diseases. His prior roles include Chief Medical Officer
for Nektar Therapeutics and Vice President of Global Clinical Development, Head of the Inflammation Therapeutic Area and Vice President
and Head of Medical Sciences at Amgen.
FIRST QUARTER 2024 FINANCIAL RESULTS
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT
| Three months ended | ||||||||||||
| March 31, | ||||||||||||
| (in thousands of $ except for shares and EPS) | 2024 | 2023 | Variance | |||||||||
| Product net sales | $ | 398,283 | $ | 218,022 | $ | 180,261 | ||||||
| Collaboration revenue | 2,718 | 1,118 | 1,600 | |||||||||
| Other operating income | 11,512 | 10,740 | 772 | |||||||||
| Total operating income | 412,513 | 229,880 | 182,633 | |||||||||
| Cost of sales | (43,178 | ) | (18,335 | ) | (24,843 | ) | ||||||
| Research and development expenses | (224,969 | ) | (165,855 | ) | (59,114 | ) | ||||||
| Selling, general and administrative expenses | (235,995 | ) | (149,172 | ) | (86,823 | ) | ||||||
| Loss from investment in joint venture | (1,792 | ) | (261 | ) | (1,531 | ) | ||||||
| Total operating expenses | (505,934 | ) | (333,623 | ) | (172,311 | ) | ||||||
| Operating loss | $ | (93,421 | ) | $ | (103,743 | ) | $ | 10,322 | ||||
| Financial income | 38,895 | 16,588 | 22,307 | |||||||||
| Financial expense | (512 | ) | (188 | ) | (324 | ) | ||||||
| Exchange gains/(losses) | (19,312 | ) | 11,165 | (30,477 | ) | |||||||
| Loss for the period before taxes | $ | (74,350 | ) | $ | (76,178 | ) | $ | 1,828 | ||||
| Income tax benefit/(expense) | $ | 12,753 | $ | 47,307 | $ | (34,554 | ) | |||||
| Loss for the period | $ | (61,597 | ) | $ | (28,871 | ) | $ | (32,726 | ) | |||
| Loss for the period attributable to: | ||||||||||||
| Owners of the parent | $ | (61,597 | ) | $ | (28,871 | ) | $ | (32,726 | ) | |||
| Weighted average number of shares outstanding | 59,309,996 | 55,555,186 | 3,754,810 | |||||||||
| Basic and diluted (loss) per share (in $) | (1.04 | ) | (0.52 | ) | (0.52 | ) | ||||||
| Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2023 and 2022 | (75,378 | ) | (185,035 | ) | 109,657 | |||||||
| Cash and cash equivalents and current financial assets at the end of the period | 3,104,466 | 2,007,513 |
DETAILS OF THE FINANCIAL RESULTS
Total operating income for
the three months ended March 31, 2024, was $413 million compared to $230 million for the same period in 2023, and consists of:
Total operating expenses for
the three months ended March 31, 2024, were $506 million compared to $334 million for the same period in 2023, and mainly consists
for the three months ended March 31, 2024, was $39 million compared to $17 million for the same period in 2023. The increase
in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial
assets as a result of the July 2023 financing round.
for the three months ended March 31, 2024, were $19 million compared to $11 million of exchange gains for the same period
in 2023. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current
financial assets denominated in Euro.
the three months ended March 31, 2024, was $13 million of income tax benefit compared to $47 million of income tax benefit for the
same period in 2023. Income tax benefit for the three months ended March 31, 2024, consists of $6 million of current income tax expense
and $19 million of deferred tax benefit, compared to $11 million of current income tax expense and $58 million of deferred tax benefit
for the comparable prior period.
the three months ended March 31, 2024, was $62 million compared to $29 million for the same period in 2023. On a per weighted average
share basis, the net loss was $1.04 and $0.52 for the three months ended March 31, 2024 and 2023, respectively.
Cash, cash equivalents
and current financial assets totalled $3.1 billion as of March 31, 2024, compared to $3.2 billion as of December 31,
2023. The decrease in cash and cash equivalents and current financial assets result from net cash flows used in operating activities.
Based on its current operating plans, argenx expects
its combined Research and development and Selling, general and administrative expenses in 2024 to be less than $2 billion. argenx expects
to utilize up to $500 million of net cash in 2024 on these anticipated operating expenses as well as working capital and capital expenditures.
EXPECTED 2024 FINANCIAL CALENDAR
CONFERENCE CALL DETAILS
The first quarter 2024 financial results and business update will
be discussed during a conference call and webcast presentation today at 2:30 PM CET/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.
Please dial in 15 minutes prior to the live call.
| Belgium | 32 800 50 201 |
| France | 33 800 943355 |
| Netherlands | 31 20 795 1090 |
| United Kingdom | 44 800 358 0970 |
| United States | 1 800 715 9871 |
| Japan | 81 3 4578 9081 |
| Switzerland | 41 43 210 11 32 |
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 approved neonatal Fc receptor (FcRn) blocker, globally
in the U.S., Japan, Israel, the EU, the UK, China and Canada. 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
For further information, please contact:
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 "aim," "anticipates,"
"believes," "continue," "expects," "will," "plan,"
"prepare," or "should" and include statements argenx makes regarding its commitment to provide patients with
the broadest generalized myasthenia gravis (gMG) product offerings; the ability to scale the organization and prepare for CIDP; the
preparation for registrational trials across multiple programs including empasiprubart in MMN and efgartigimod in Sjogren's disease;
the pending regulatory decisions for gMG in Switzerland, Australia, Saudi Arabia and South Korea, and VYVGART SC in China through
Zai Lab; regulatory submissions in Europe and Canada; its plans to expand label for VYVGART in seronegative gMG patients into
broader MG populations; the planned FDA submission for VYVGART SC prefilled syringe for gMG and CIDP in second quarter of 2024; its