Full Press Release Details
argenx Reports Third
Quarter 2023 Financial Results and Provides Business Update
million in third quarter global net product sales
track to submit VYVGART Hytrulo sBLA for CIDP by year-end 2023
from the ADVANCE-IV study published in The Lancet
to host conference call today at 1:30 pm CET (8:30 am ET)
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 third quarter 2023 financial results and provided a business update
and outlook for the remainder of the year.
to prioritize patient impact with VYVGART and VYVGART Hytrulo, broadening our two gMG products into earlier treatment lines and new geographies.
VYVGART has now been used in thousands of patients over multiple treatment years, and its unique clinical profile has built patient trust
and physician confidence in the brand," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "There is a significant
opportunity before us to transform autoimmunity across multiple indications with VYVGART. Based on the successful ADHERE trial, we are
ready to file the sBLA by the end of 2023 to bring our first-in-class FcRn blocker to CIDP patients as quickly as possible. We are also
on track with two near-term pivotal readouts and an ambitious plan forward over the coming years as we continue to execute and drive
innovation within our FcRn portfolio and across immunology more broadly."
AND RECENT BUSINESS UPDATE
is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn) and is now approved globally in seven countries
or regions (U.S., Japan, EU, UK, Israel, China, Canada) for generalized myasthenia gravis (gMG). VYVGART Hytrulo (subcutaneous (SC)
injection) was approved in the U.S. in June 2023. argenx is planning for multi-dimensional expansion to reach more patients with
gMG and other severe autoimmune diseases through additional global regulatory approvals.
Efgartigimod Research
argenx is solidifying
its leadership in FcRn blockade and demonstrating the broad potential of efgartigimod by advancing its clinical development programs
of IgG-mediated autoimmune diseases. By 2025, efgartigimod is expected to be approved, in regulatory review or in development in 15 severe
a robust portfolio of innovative clinical programs, including empasiprubart (C2 inhibitor) and ARGX-119 (muscle-specific kinase (MuSK)
agonist). Both programs have the potential to be first-in-class opportunities for multiple severe indications.
Immunology Innovation
invest in its discovery engine, the Immunology Innovation Program, to foster a robust innovation ecosystem and drive early-stage pipeline
growth. argenx expects to nominate one new pipeline candidate in 2023.
CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands of $ except for shares and EPS) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Product net sales | $ | 329,097 | $ | 131,329 | $ | 816,432 | $ | 227,325 | ||||||||
| Collaboration revenue | 692 | 6,652 | 3,047 | 9,262 | ||||||||||||
| Other operating income | 10,050 | 8,508 | 31,275 | 26,565 | ||||||||||||
| Total operating income | $ | 339,839 | $ | 146,489 | $ | 850,754 | $ | 263,152 | ||||||||
| Cost of sales | $ | (35,999 | ) | $ | (10,264 | ) | $ | (78,358 | ) | $ | (16,646 | ) | ||||
| Research and development expenses | (191,755 | ) | (236,681 | ) | (553,119 | ) | (515,568 | ) | ||||||||
| Selling, general and administrative expenses | (191,930 | ) | (108,181 | ) | (503,079 | ) | (336,845 | ) | ||||||||
| Loss from investment in joint venture | (743 | ) | - | (2,623 | ) | - | ||||||||||
| Total operating expenses | (420,427 | ) | (355,126 | ) | (1,137,179 | ) | (869,059 | ) | ||||||||
| Operating loss | $ | (80,588 | ) | $ | (208,637 | ) | $ | (286,425 | ) | $ | (605,907 | ) | ||||
| Financial income | $ | 30,049 | $ | 8,007 | $ | 67,078 | $ | 13,740 | ||||||||
| Financial expense | (231 | ) | (785 | ) | (626 | ) | (2,916 | ) | ||||||||
| Exchange gains/(losses) | (32,509 | ) | (39,609 | ) | (23,345 | ) | (92,991 | ) | ||||||||
| Loss for the period before taxes | $ | (83,279 | ) | $ | (241,024 | ) | $ | (243,318 | ) | $ | (688,074 | ) | ||||
| Income tax (expense)/benefit | $ | 10,637 | $ | 5,982 | $ | 47,437 | $ | 17,096 | ||||||||
| Loss for the period | $ | (72,642 | ) | $ | (235,042 | ) | $ | (195,881 | ) | $ | (670,978 | ) | ||||
| Loss for the year attributable to: | ||||||||||||||||
| Owners of the parent | $ | (72,642 | ) | $ | (235,042 | ) | $ | (195,881 | ) | $ | (670,978 | ) | ||||
| Weighted average number of shares outstanding | 58,128,233 | 55,203,655 | 56,512,254 | 54,049,119 | ||||||||||||
| Basis and diluted loss per share (in $) | (1.25 | ) | (4.26 | ) | (3.47 | ) | (12.41 | ) | ||||||||
| Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2021 | $ | 993,035 | $ | 48,813 | ||||||||||||
| Cash and cash equivalents and current financial assets at the end of the period | $ | 3,185,583 | $ | 2,385,541 |
income for the third quarter and year-to-date in 2023 was $339.8 million and $850.8 million, respectively, compared to $146.5 million
and $263.2 million for the same periods in 2022, and mainly consists of:
expenses for the third quarter and year-to-date in 2023 were $420.4 million and $1,137.2 million, respectively, compared to $335.1
million and $869.1 million for the same periods in 2022, and mainly consists of:
for the third quarter and year-to-date in 2023 was $30.0 million and $67.1 million, respectively, compared to $8.0 million and $13.7
million for the same periods in 2022. The increase in financial income is mainly due to an increase in interest income on current financial
assets and cash and cash equivalents attributable to higher interest rates.
for the third quarter and year-to-date in 2023 were $32.5 million and $23.3 million respectively, compared to $39.6 million and $93.0
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 position in Euro.
for the third quarter and year-to-date in 2023 was $10.6 million and $47.4 million of tax benefit, respectively, compared to $6.0 million
and $17.1 million of tax benefit for the same periods in 2022. Tax benefit for the nine months ended September 30, 2023, consists
of $23.8 million of income tax expense and $71.3 million of deferred tax income, compared to $15.0 million of income tax expense and
$32.1 million of deferred tax income for the comparable prior period.
the three and nine-month periods ended September 30, 2023, was $72.6 million and $195.9 million, respectively, compared to $235.0
million and $671.0 million over the prior year periods. On a per weighted average share basis, the net loss was $3.47 and $12.41 for
the nine months ended September 30, 2023 and 2022, respectively.
Cash, cash equivalents
and current financial assets totalled $3.2 billion as of September 30, 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.
EXPECTED 2024 FINANCIAL
2023 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 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.
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 | 1 888 415 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 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
For further information,
Forward-looking Statements
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 its plans to execute and drive innovation within its FcRn portfolio
and across immunology; its plans for multi-dimensional expansion to reach more patients with gMG and other autoimmune diseases through
additional global regulatory approvals; advancement of, and anticipated clinical development, data readouts and regulatory milestones
and plans, including the (1) expected EC approval of SC efgartigimod for gMG in the fourth quarter of 2023, (2) expected approval
decision regarding SC efgartigimod for gMG in Japan by the first quarter of 2024, (3) expected MAA for VYVGART for primary ITP approval
decision in Japan in the first quarter of 2024, (4) expected filing of the sBLA for VYVGART Hytrulo in CIDP by the end of 2023,
(5) expected approval decision regarding SC efgartigimod for gMG in China by end of 2024 through its partnership with Zai Lab; (6) expected
topline data from ITP in the fourth quarter of 2023, (7) expected topline data from ADDRESS and the GO/NO GO decision from BALLAD
around year-end 2023, (8) expected GO/NO GO decision from ALKIVIA in the second half of 2024, (9) expected topline dtaa from
ALPHA in the first quarter of 2024 and RHO in the first half of 2024, (10) expected topline data from Phase 2 ARDA study of ARGX-117
in MMN in 2024, (11) planned Phase 1b trial to assess early signal detection in patients with CMS and ALS and (12) planned nomination
of a new pipeline candidate in 2023; continued investment in its Immunology Innovation Program to foster a robust innovation ecosystem
and drive early-stage pipeline growth; and 2023 business and financial outlook and related plans, the timeline of future releases of
financial results and business updates. 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 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.