Full Press Release Details
Reports First Quarter 2023 Financial Results and Provides Business Update
- $218 million in first quarter VYVGART (efgartigimod alfa-fcab) global net product sales
- VYVGART received marketing authorization in Israel through partnership with Medison
events achieved in ADHERE trial; topline data now expected in July 2023
- Enrollment completed in ADVANCE-SC and ADDRESS trials; topline data from both expected in fourth quarter of 2023
- Management to host conference call today at 2:30 pm CET (8:30 am ET)
Regulated Information/Inside
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 first quarter 2023 financial
results and provided a business update.
the first quarter, we made significant progress advancing our mission to redefine what well-controlled
means in the treatment of autoimmune diseases. Our team remains focused on continued expansion within gMG with our planned launch of
SC efgartigimod and upcoming global regulatory approvals, and the key pivotal data readouts we expect starting first with efgartigimod
in CIDP and ARGX-117 in MMN," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "We have an exciting year ahead
as we grow VYVGART as a new standard of care in gMG, leverage its potential in other indications and progress our broader immunology
pipeline, all of which brings us one step closer to achieving our goals and innovating on behalf of patients."
2023 AND RECENT BUSINESS UPDATE
first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. argenx is planning for multi-dimensional expansion
to reach more patients with VYVGART through additional regulatory approvals for generalized myasthenia gravis (gMG), the launch of SC
efgartigimod for gMG, and new autoimmune indications with the VYVGART regulatory submission for immune thrombocytopenia (ITP) in Japan.
Research and Development
solidify its FcRn leadership by expanding the scope of IgG-mediated autoimmune diseases in development and further demonstrating the
potential of FcRn blockade in ongoing clinical trials. By the end of 2023, efgartigimod is expected to be approved, in regulatory review
or in development in 13 severe autoimmune diseases.
a robust portfolio of innovative clinical programs, including ARGX-117 (C2 inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist).
Both programs have the potential to be first-in-class opportunities for multiple severe autoimmune indications.
Continued investment
in Immunology Innovation Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities
FIRST QUARTER 2023 FINANCIAL RESULTS
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR LOSS
| Three Months Ended March 31, | ||||||||||||
| (in thousands of $ except for shares and EPS) | 2023 | 2022 | Variance | |||||||||
| Product net sales | $ | 218,022 | $ | 21,163 | $ | 196,859 | ||||||
| Collaboration revenue | 1,118 | 2,249 | (1,131 | ) | ||||||||
| Other operating income | 10,740 | 8,068 | 2,672 | |||||||||
| Total operating income | 229,759 | 31,480 | 198,279 | |||||||||
| Cost of sales | (18,335 | ) | (1,372 | ) | (16,963 | ) | ||||||
| Research and development expenses | (165,855 | ) | (151,968 | ) | (13,887 | ) | ||||||
| Selling, general and administrative expenses | (149,172 | ) | (100,866 | ) | (48,306 | ) | ||||||
| Loss from investment in joint venture | (261 | ) | - | (261 | ) | |||||||
| Total operating expenses | (333,623 | ) | (254,206 | ) | (79,417 | ) | ||||||
| Operating loss | $ | (103,743 | ) | $ | (222,726 | ) | $ | 118,983 | ||||
| Financial income | 16,588 | 821 | 15,767 | |||||||||
| Financial expense | (188 | ) | (953 | ) | 767 | |||||||
| Exchange gains/(losses) | 11,165 | (7,213 | ) | 18,378 | ||||||||
| Loss for the period before taxes | $ | (76,178 | ) | $ | (230,072 | ) | $ | 153,894 | ||||
| Income tax benefit | $ | 47,307 | $ | 2,885 | $ | 44,422 | ||||||
| Loss for the period | $ | (28,871 | ) | $ | (227,187 | ) | $ | 198,316 | ||||
| Loss for the period attributable to: | ||||||||||||
| Owners of the parent | $ | (28,871 | ) | $ | (227,186 | ) | ||||||
| Weighted average number of shares outstanding | 55,555,186 | 52,084,335 | ||||||||||
| Basis and diluted loss per share (in $) | (0.52 | ) | (4.36 | ) | ||||||||
| Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2021 | (185,035 | ) | 518,656 | |||||||||
| Cash and cash equivalents and current financial assets at the end of the period | 2,007,513 | 2,855,384 |
operating income for the three months ended March 31, 2023 was $229.8 million, compared to $31.5
million for the same period in 2022, and consists of:
operating expenses for the three months ended March 31, 2023 were $333.6 million, compared to
$254.2 million for the same period in 2022, and consists of:
income for the three months ended March 31, 2023 was $16.6 million, compared to $0.8 for the
same period 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.
gains/losses for the three months ended March 31, 2023 were $11.2 million of exchange gains,
compared to $7.2 million exchange losses for the same period in 2022. Exchange gains are mainly attributable to unrealized exchange rate
gains or losses on the cash, cash equivalents and current financial assets position in Euro.
tax for the three months ended March 31, 2023 was $47.3 million of tax benefit, compared to $2.9
million of tax benefit for the same period in 2022. Tax benefit for the three months ended March 31, 2023 consists of $10.8 million of
income tax expense and $58.0 million of deferred tax income, compared to $5.0 million of income tax expense and $7.9 million of deferred
tax income for the comparable prior period.
loss for the three months ended March 31, 2023 was $28,9 million, compared to $227.2 million
for the comparable prior year period. On a per weighted average share basis, the net loss was $0.52 and $4.36 for the three months ended
March 31, 2023 and 2022, respectively.
Cash, cash equivalents
and current financial assets totaled $2.0 billion as of March 31, 2023, compared to $2.2 billion as of December 31, 2022. Cash and
cash equivalents and current financial assets decreased primarily as a result from net cash flows used in operating activities.
plans to fund anticipated operating expenses, working capital and capital expenditures, argenx expects to utilize up to $500 million
2023 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.
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 | 1 888 415 4250 |
| Japan | 81 3 4578 9752 |
| 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-and- only approved neonatal
Fc receptor (FcRn) blocker in the U.S., Japan, the EU and the UK. 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
For further information, please contact:
Forward-looking Statements
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 its expansion strategy
to reach more patients with VYVGART through additional regulatory approvals for generalized myasthenia gravis (gMG), the launch of SC
efgartigimod for gMG, and new autoimmune indications with the VYVGART regulatory submission for immune thrombocytopenia (ITP) in Japan;
pending regulatory reviews of SC efgartigimod for gMG in the U.S., EU and Japan; the Prescription Drug User Fee Act (PDUFA) target action
date; the expected Japan Marketing Authorization Application (MAA) approval by the first quarter of 2024; the expected European Medicines
Agency MAA approval in the fourth quarter of 2023; the expected approval decisions in Canada and through Zai Lab in China in 2023; its
aim to solidify its Fc receptor (FcRn) leadership by expanding the scope of IgG-mediated autoimmune diseases in development and further
demonstrating the potential of FcRn blockade in ongoing clinical trials; its expectation of being approved, in review, or in development
in 13 autoimmune diseases by the end of 2023; its expectations about its pipeline progress; continued investment in its Immunology Innovation
Program to broaden its pipeline for sustained value creation opportunities; its collaborations and their potential benefits; 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 of utilizing up to $500 million cash in 2023; and its 2023 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 rates; 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.