Earnings Release • Mar 2, 2023
Earnings Release
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\$173 million in fourth quarter and \$401 million in full year 2022 VYVGART® (efgartigimod alfa-fcab) global net product sales
FDA review ongoing for SC efgartigimod BLA with PDUFA target action date of June 20, 2023; MAA filed in Japan with approval decision expected by first quarter of 2024
ADHERE topline results continue to be expected in second quarter of 2023
Karen Massey appointed as Chief Operating Officer as part of planned transition; Keith Woods to retire and serve as advisor on Board of Directors
Management to host conference call today at 2:30 pm CET (8:30 am ET)
Amsterdam, the Netherlands – argenx (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 2022 and provided a fourth quarter business update.
In a separate press release, argenx also announced today the appointment of Karen Massey to Chief Operating Officer as part of a planned transition. Ms. Massey will succeed Keith Woods who will remain at the Company through the launch of subcutaneous (SC) efgartigimod after which he will retire and serve as a strategic advisor on the argenx Board of Directors.
"We began 2023 from a position of strength following the successful first year of our VYVGART launch where we were able to reach more than 3,000 gMG patients globally with our transformative therapy. Our focus for the year ahead is expansion; both through upcoming regulatory approvals and launches, and more broadly by reaching additional patient segments with the planned launch of SC efgartigimod and through our ongoing stakeholder engagement efforts," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Looking ahead, we have the opportunity this year to showcase the innovation within our pipeline through multiple data catalysts, including three pivotal data readouts from efgartigimod and the first clinical efficacy data from ARGX-117, our next pipeline-in-a-product candidate. We are wellequipped to build on this significant momentum as we advance our mission to redefine the treatment of autoimmune disease."
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. argenx is planning for multidimensional 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.
argenx aims to 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.
Multiple data readouts expected from ongoing efgartigimod trials in 2023 and 2024:
expected in 2024
POC trials underway in membranous nephropathy and lupus nephritis through Zai Lab collaboration
Clinical trials of efgartigimod in additional autoimmune indications to start this year:
argenx is advancing 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.
argenx continues to 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 development candidate in 2023.
| Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| (in thousands of \$ except for shares and EPS) | 2022 | 2021 | 2022 | 2021 | ||||
| Product net sales | \$ | 173,396 | \$ | — \$ |
400,720 | \$ | — | |
| Collaboration revenue | 764 | 26,022 | 10,026 | 497,277 | ||||
| Other operating income | 7,956 | 7,662 | 34,520 | 42,141 | ||||
| Total operating income | 182,116 | 33,684 | 445,267 | 539,418 | ||||
| Cost of sales | (12,786) | — | (29,431) | — | ||||
| Research and development expenses | (147,798) | (167,173) | (663,366) | (580,520) | ||||
| Selling, general and administrative expenses | (135,287) | (97,422) | (472,132) | (307,644) | ||||
| Loss from investment in joint venture | (677) | — | (677) | — | ||||
| Total operating expenses | (296,548) | (264,596) | (1,165,607) | (888,164) | ||||
| Operating loss | \$ (114,432) | \$ (230,912) \$ | (720,341) | \$ | (348,746) | |||
| Financial income | 13,925 | 1,199 | 27,665 | 3,633 | ||||
| Financial expense | (990) | (1,104) | (3,906) | (4,578) | ||||
| Exchange gains/(losses) | 60,259 | (14,063) | (32,732) | (50,053) | ||||
| Loss for the period before taxes | \$ | (41,238) | \$ (244,880) \$ | (729,314) | \$ | (399,743) | ||
| Income tax (expense)/benefit | \$ | 2,625 | \$ | 7,062 \$ | 19,720 | \$ | (8,522) | |
| Loss for the period | \$ | (38,613) | \$ (237,818) \$ | (709,594) | \$ | (408,265) | ||
| Loss for the period attributable to: | ||||||||
| Owners of the parent | (38,613) | (237,818) | (709,594) | (408,265) | ||||
| Weighted average number of shares outstanding Basic loss per share (in \$) |
55,364,124 (0.70) |
51,538,191 (4.61) |
54,381,371 (13.05) |
51,075,827 (7.99) |
||||
| Diluted loss per share (in \$) | (0.70) | (4.61) | (13.05) | (7.99) |
Net increase/(decrease) in cash, cash equivalents and
| current financial assets compared to year-end 2021 and 2020 |
\$ (144,180) |
\$ 340,276 |
|---|---|---|
| Cash, cash equivalents and current financial assets at the end of the period |
\$ 2,192,548 |
\$ 2,336,728 |
Total operating income for the fourth quarter and year-to-date in 2022 was \$182.1 million and \$445.3 million, respectively, compared to \$33.7 million and \$539.4 million for the same periods in 2021, and consists of:
Total operating expenses for the fourth quarter and year-to-date in 2022 were \$296.5 million and \$1,165.6 million, respectively, compared to \$264.6 million and \$888.2 million for the same periods in 2021, and consists of:
Financial income for the fourth quarter and year-to-date in 2022 were \$13.9 million and \$27.7 million respectively, compared to \$1.2 million and \$3.6 million for the same periods in 2021. 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.
Exchange gains/losses for the fourth quarter and year-to-date in 2022 were \$60.3 million of gains and \$32.7 million of losses, respectively, compared to \$14.1 million and \$50.1 million of exchange losses for the same periods in 2021. Exchange gains/losses are mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in Euro.
Income tax for the fourth quarter and year-to-date in 2022 was \$2.6 million and \$19.7 million of tax benefit, respectively, compared to \$7.1 million of tax benefit and \$8.5 million of tax expense for the same periods in 2021. Tax benefit for the three months ended December 31, 2022 consists of \$12.1 million of income tax expense and \$14.7 million of deferred tax income, compared to \$1.2 million of income tax expense and \$8.2 million of deferred tax income for the same period in 2021.
Net loss for the fourth quarter and year-to-date in 2022 was \$38.6 million and \$709.6 million, respectively, compared to net loss of \$237.8 and \$408.3 million for the same periods in 2021.
Cash, cash equivalents and current financial assets totaled \$2.2 billion as of December 31, 2022, compared to \$2.3 billion as of December 31, 2021. Net change in Cash and cash equivalents and current financial assets is primarily a result of the closing of a global offering of shares, which resulted in the receipt of \$761.0 million in net proceeds in March 2022, offset by net cash flows used in operating activities.
Based on current plans to fund anticipated operating expenses, working capital and capital expenditures, argenx expects to utilize up to \$500 million cash in 2023.
The full year 2022 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 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 |
argenx 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, and the EU. 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.
Media: Erin Murphy [email protected]
Investors: Beth DelGiacco [email protected]
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forwardlooking 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 impact of the transition of the chief operating officer; its launch strategy to make VYVGART available in the EU, China, Canada and select other regions; the VYVGART multi-dimensional expansion strategy; its expansion through potential regulatory approvals and launches and the planned launch of SC efgartigimod, if approved; the timing of data readouts and new clinical efficacy data; the regulatory reviews and regulatory approval timing in the United States, EU and Japan for SC efgartigimod for the treatment of gMG and the long-term safety and tolerability of SC efgartigimod; the therapeutic potential of its product candidates; the intended results of its strategy and its collaboration partners', advancement of, and anticipated clinical development and regulatory milestones and plans, including the timing of planned clinical trials; and the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forwardlooking 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.
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