Full Press Release Details
argenx Reports Full Year 2023 Financial
Results and Provides Fourth Quarter Business Update
$374 million in fourth quarter and $1.2 billion
in full year global net product sales
Hytrulo for CIDP accepted for priority review by FDA with PDUFA target action date of June 21, 2024
On track to report data from six Phase 2 proof-of-concept
trials by end of 2024
Management to host conference call today at
2:30 pm CET (8:30 am ET)
February 29, 2024, 7:00 am CET
Amsterdam, 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 full year 2023 and provided a fourth quarter business update.
"argenx reached thousands of new patients
and their families in 2023 by delivering on our commitment to make VYVGART available to the global MG community," said Tim Van Hauwermeiren,
Chief Executive Officer of argenx. "This expansion demonstrates that VYVGART has the potential to address the high unmet need for
innovation in patients suffering from MG, and moves us closer to sustainability as we build an integrated immunology company. Clinically,
we generated significant data through multiple study readouts, achieving key milestones for both the CIDP and MMN patient communities
and importantly advancing our second molecule, empasiprubart. Looking forward to 2024, we will act with a continued sense of purpose to
expand our patient reach. We will use the learnings and momentum from our gMG launch to strategically lay the groundwork for a potential
CIDP approval, leveraging our current infrastructure and deep relationships in the neurology community to position VYVGART SC for success.
CIDP patients have been waiting for innovation, and we are eager to translate the transformative ADHERE data into potential benefit for
patients as quickly as possible."
FOURTH QUARTER 2023 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 approved in more than 30 countries
globally for the treatment of generalized myasthenia gravis (gMG). 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. argenx is planning to reach more patients commercially through its multi-dimensional expansion
efforts, including patients earlier in the MG treatment paradigm and new patient populations through global regulatory approvals for
MG and the expansion of use to treat additional autoimmune indications.
Advancing Current Pipeline
argenx continues to demonstrate breadth and depth
within its immunology pipeline and is advancing multiple pipeline-in-a-product candidates. With efgartigimod, argenx is solidifying its
leadership in FcRn and is on track to be approved or in development in 15 autoimmune indications by 2025. Beyond efgartigimod, argenx
is 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 Growth
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.
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| (in thousands of $ except for shares and EPS) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Product net sales | $ | 374,351 | $ | 173,396 | $ | 1,190,783 | $ | 400,720 | ||||||||
| Collaboration revenue | 32,486 | 764 | 35,533 | 10,026 | ||||||||||||
| Other operating income | 11,003 | 7,956 | 42,278 | 34,520 | ||||||||||||
| Total operating income | $ | 417,840 | $ | 182,116 | $ | 1,268,594 | $ | 445,267 | ||||||||
| Cost of sales | $ | (39,477 | ) | $ | (12,786 | ) | $ | (117,835 | ) | $ | (29,431 | ) | ||||
| Research and development expenses | (306,373 | ) | (147,798 | ) | (859,492 | ) | (663,366 | ) | ||||||||
| Selling, general and administrative expenses | (208,826 | ) | (135,287 | ) | (711,905 | ) | (472,132 | ) | ||||||||
| Loss from investment in joint venture | (1,788 | ) | (677 | ) | (4,411 | ) | (677 | ) | ||||||||
| Total operating expenses | (556,464 | ) | (296,548 | ) | (1,693,643 | ) | (1,165,607 | ) | ||||||||
| Operating loss | $ | (138,624 | ) | $ | (114,432 | ) | $ | (425,049 | ) | $ | (720,341 | ) | ||||
| Financial income | $ | 40,308 | $ | 13,925 | $ | 107,386 | $ | 27,665 | ||||||||
| Financial expense | (280 | ) | (990 | ) | (906 | ) | (3,906 | ) | ||||||||
| Exchange gains/(losses) | 37,418 | 60,259 | 14,073 | (32,732 | ) | |||||||||||
| Loss for the period before taxes | $ | (61,178 | ) | $ | (41,238 | ) | $ | (304,496 | ) | $ | (729,314 | ) | ||||
| Income tax benefit / (expense) | $ | (37,994 | ) | $ | 2,625 | $ | 9,443 | $ | 19,720 | |||||||
| Loss for the period | $ | (99,172 | ) | $ | (38,613 | ) | $ | (295,053 | ) | $ | (709,594 | ) | ||||
| Loss for the year attributable to: | ||||||||||||||||
| Owners of the parent | $ | (99,172 | ) | $ | (38,613 | ) | $ | (295,053 | ) | $ | (709,594 | ) | ||||
| Weighted average number of shares outstanding | 59,118,827 | 55,364,124 | 57,169,253 | 54,381,371 | ||||||||||||
| Basis and diluted (loss) per share (in $) | (1.68 | ) | (0.70 | ) | (5.16 | ) | (13.05 | ) | ||||||||
| Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2021 | $ | 987,296 | $ | (144,180 | ) | |||||||||||
| Cash and cash equivalents and current financial assets at the end of the period | $ | 3,179,844 | $ | 2,192,548 |
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the fourth quarter
and full year in 2023 was $418 million and $1,269 million, respectively, compared to $182 million and $445 million for the same periods
in 2022, and mainly consists of:
Total operating expenses for the fourth
quarter and full year in 2023 were $556 million and $1,694 million, respectively, compared to $297 million and $1,166 million for the
same periods in 2022, and mainly consists of:
Financial income for the fourth quarter
and full year in 2023 was $40 million and $107 million, respectively, compared to $14 million and $28 million for the same periods in
2022. The increase in financial income is mainly due to an increase in interest income which results from higher interest rates and a
higher amount of current financial assets, cash and cash equivalents as a result of the financing round in July 2023.
Exchange gains for the fourth quarter and
full year in 2023 were $37 million and $14 million respectively, compared to $60 million of exchange gains and $33 million of exchange
losses for the same periods in 2022. 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.
Income tax for the fourth quarter and full
year in 2023 was $38 million of tax expense and $9 million of tax benefit, respectively, compared to $3 million and $20 million of tax
benefit for the same periods in 2022. Tax expense for the fourth quarter in 2023, consists of $12 million of income tax benefit and $50
million of deferred tax expense, compared to $12 million of income tax expense and $15 million of deferred tax benefit for the comparable
Net loss for the fourth quarter and full
year in 2023, was $99 million and $295 million, respectively, compared to $39 million and $710 million over the prior year periods. On
a per weighted average share basis, the net loss was $5.16 and $13.05 for the twelve months ended December 31, 2023 and 2022, respectively.
Cash, cash equivalents and current financial
assets totalled $3.2 billion as of December 31, 2023, compared to $2.2 billion as of December 31, 2022. 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,
which resulted in the receipt of $1.2 billion in net proceeds in July 2023, partially offset by 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 full year 2023 financial results and fourth
quarter 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
| Belgium | 32 800 50 201 |
| France | 33 800 943355 |
| Netherlands | 31 20 795 1090 |
| United Kingdom | 44 800 358 0970 |
| United States | 1 888 415 4250 |
| Japan | 81 3 4578 9081 |
| Switzerland | 41 43 210 11 32 |
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 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 www.argenx.com and follow
us on LinkedIn, Twitter, and Instagram.
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 "plans," "aims," "continues," "anticipates,"
"expects," "will," or "commitment" and include statements argenx makes concerning its utilization
of its learnings and momentum from its gMG launch for a potential CIDP approval and to position VYVGART SC for success; its plans to expand