$218 million in first quarter VYVGART® (efgartigimod alfa-fcab) global net product sales- VYVGART received marketing authorization in
Israel through partnership with Medison - 88 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 Information
“Throughout 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
FIRST QUARTER 2023 AND RECENT BUSINESS UPDATE
VYVGART Expansion
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the
- Generated global net VYVGART sales of
$218 million in the first quarter of 2023 - Regulatory reviews of SC efgartigimod for gMG ongoing in the
U.S. , EU andJapan - Prescription Drug User Fee Act (PDUFA) target action date of
June 20, 2023 - Marketing authorization application (MAA) filed in
Japan in first quarter of 2023 with approval decision expected by first quarter of 2024 - MAA review underway by
European Medicines Agency with approval decision expected in fourth quarter of 2023
- Prescription Drug User Fee Act (PDUFA) target action date of
- Received VYVGART approval from the
UK Medicines and Healthcare products Regulatory Agency (MHRA) onMarch 15, 2023 and theState of Israel Ministry of Health onApril 24, 2023 through Medison Pharma, marking both the fourth and fifth global approvals for gMG - Pricing and reimbursement discussions ongoing in more than 10 countries in
Europe - Approval decisions expected in 2023 in
Canada and inChina through partnership with Zai Lab
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.
- ADHERE: Requisite events (88) achieved in trial for chronic inflammatory demyelinating polyneuropathy (CIDP); topline data now expected in
July 2023 - ADDRESS: Enrollment complete in trial; topline data in pemphigus expected in fourth quarter of 2023
- ADVANCE-SC: Enrollment complete in trial; topline data from SC trial in ITP expected in fourth quarter of 2023
- BALLAD and ALKIVIA: Interim data in bullous pemphigoid expected in first half of 2024 and in myositis in second half of 2024
- ALPHA and RHO proof-of-concept (POC) trials underway through
IQVIA collaboration in post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS) and primary Sjogren’s syndrome; topline data from ALPHA expected in fourth quarter of 2023 - POC trials underway in membranous nephropathy and lupus nephritis through Zai Lab collaboration
- Registrational trial in thyroid eye disease (TED) and POC trials in ANCA-associated vasculitis (ANCA) and antibody mediated rejection (AMR) in kidney transplant expected to start in fourth quarter of 2023
Pipeline Progress
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.
- ARDA: Interim data from POC trial of ARGX-117 in multifocal motor neuropathy expected mid- 2023
- POC trial of ARGX-117 for prevention of delayed graft function after kidney transplantation expected to start in second half of 2023 following regulatory discussions
- Phase 1 dose-escalation trial of ARGX-119 in healthy volunteers ongoing; subsequent Phase 1b trial to assess early signal detection in patients with congenital myasthenic syndrome
Continued investment in Immunology Innovation Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities
- 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.
- OncoVerity, an asset-centric spin-off company created with the
University of Colorado Anschutz Medical Campus and UCHealth, announced the licensing of cusatuzumab, a first-in-class anti-CD70 antibody; argenx provided funding to advance OncoVerity to next phase of development - Entered multiyear collaboration with Genmab to jointly discover, develop and commercialize antibody therapies; initial two targets identified within immunology and cancer
FIRST QUARTER 2023 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR LOSS
Three Months Ended | |||||||
(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 |
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three months ended
- Product net sales from the sales of VYVGART for the three months ended
March 31, 2023 were$218.0 million , compared to$21.2 million for the same period in 2022
- Collaboration revenue for the three months ended
March 31, 2023 was$1.1 million , compared to$2.2 million for the same period in 2022. The collaboration revenue for the three months endedMarch 31, 2023 primarily relates to the clinical and commercial supply of efgartigimod to Zai Lab. - Other operating income for the three months ended
March 31, 2023 was$10.7 million , compared to$8.1 million for the same period in 2022. The other operating income for the three months endedMarch 31, 2023 primary relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three months ended
- Cost of sales for the three months ended
March 31, 2023 was$18.9 million , compared to$1.4 million for the same period in 2022. - Research and development expenses increased by
$13.9 million for three months endedMarch 31, 2023 to$165.9 million , compared to$152 million for the same period in 2022. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. - Selling, general and administrative expenses for the three months ended
March 31, 2023 were$149.2 million , compared to$100.9 million for the same period in 2022. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to commercialization of VYVGART in theU.S. ,Japan and the EU and personnel expenses. - Loss from investment in joint venture for the three months ended
March 31, 2023 was$0.3 million . The loss recognized was argenx’s share of losses inOncoVerity, Inc. There were no losses from investment in joint venture in the same period in 2022.
Financial income for the three months ended
Exchange gains/losses for the three months ended
Income tax for the three months ended
Net loss for the three months ended
Cash, cash equivalents and current financial assets totaled
FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses, working capital and capital expenditures, argenx expects to utilize up to
EXPECTED 2023 FINANCIAL CALENDAR
July 27, 2023 : HY 2023 financial results and business updateOctober 26, 2023 : Q3 2023 financial results and business update
CONFERENCE CALL DETAILS
The first quarter 2023 financial results and business update will be discussed during a conference call and webcast presentation today at
Dial-in numbers:
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
Japan 81 3 4578 9752
Switzerland 41 43 210 11 32
About argenx
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
For further information, please contact:
Media:
emurphy@argenx.com
Investors:
bdelgiacco@argenx.combdelgiacco@argenx.com
lelton@argenx.com
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 “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
Source: argenx SE
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