argenx Reports Full Year 2024 Financial Results and Provides Fourth Quarter Business Update
argenx reported strong financial results for 2024, with global product net sales reaching $737 million in Q4 and $2.2 billion for the full year. The company received positive CHMP recommendation for VYVGART pre-filled syringe for gMG in the EU, with FDA decisions expected by April 10, 2025.
The company surpassed 10,000 patients across three indications with VYVGART and expects to become profitable in 2025. argenx is advancing its Vision 2030 strategy, aiming to treat 50,000 patients globally, secure 10 labeled indications, and advance five pipeline candidates to Phase 3.
Key developments include 20 ongoing clinical studies (10 Phase 3 and 10 Phase 2) across their pipeline in 2025. The company recognized a one-time tax benefit of $725 million related to previously unrecognized deferred tax assets. Full-year 2024 profit was $833 million, compared to a loss of $295 million in 2023.
argenx ha riportato risultati finanziari solidi per il 2024, con vendite nette globali di prodotti che hanno raggiunto 737 milioni di dollari nel quarto trimestre e 2,2 miliardi di dollari per l'intero anno. L'azienda ha ricevuto una raccomandazione positiva dal CHMP per la siringa pre-riempita VYVGART per gMG nell'UE, con decisioni della FDA attese entro il 10 aprile 2025.
L'azienda ha superato 10.000 pazienti in tre indicazioni con VYVGART e si aspetta di diventare redditizia nel 2025. argenx sta portando avanti la sua strategia Vision 2030, con l'obiettivo di trattare 50.000 pazienti a livello globale, assicurarsi 10 indicazioni etichettate e far avanzare cinque candidati in fase di sviluppo alla Fase 3.
I principali sviluppi includono 20 studi clinici in corso (10 Fase 3 e 10 Fase 2) nel loro pipeline nel 2025. L'azienda ha riconosciuto un beneficio fiscale una tantum di 725 milioni di dollari relativo a beni fiscali differiti precedentemente non riconosciuti. L'utile per l'intero anno 2024 è stato di 833 milioni di dollari, rispetto a una perdita di 295 milioni di dollari nel 2023.
argenx informó resultados financieros sólidos para 2024, con ventas netas globales de productos alcanzando 737 millones de dólares en el cuarto trimestre y 2.2 mil millones de dólares para todo el año. La compañía recibió una recomendación positiva del CHMP para la jeringa precargada VYVGART para gMG en la UE, con decisiones de la FDA esperadas para el 10 de abril de 2025.
La empresa superó 10,000 pacientes en tres indicaciones con VYVGART y espera ser rentable en 2025. argenx está avanzando en su estrategia Vision 2030, con el objetivo de tratar a 50,000 pacientes a nivel global, asegurar 10 indicaciones etiquetadas y avanzar cinco candidatos en desarrollo a Fase 3.
Los desarrollos clave incluyen 20 estudios clínicos en curso (10 Fase 3 y 10 Fase 2) en su pipeline para 2025. La compañía reconoció un beneficio fiscal único de 725 millones de dólares relacionado con activos fiscales diferidos previamente no reconocidos. La ganancia total del año 2024 fue de 833 millones de dólares, en comparación con una pérdida de 295 millones de dólares en 2023.
argenx는 2024년 강력한 재무 결과를 보고했으며, 4분기 글로벌 제품 순매출은 7억 3,700만 달러, 전체 연도는 22억 달러에 달했습니다. 이 회사는 EU에서 gMG를 위한 VYVGART 프리필드 주사기에 대한 긍정적인 CHMP 추천을 받았으며, FDA 결정은 2025년 4월 10일까지 예정되어 있습니다.
회사는 VYVGART로 세 가지 적응증에서 10,000명 이상의 환자를 초과 달성했으며, 2025년에는 수익성이 있을 것으로 예상하고 있습니다. argenx는 50,000명의 환자를 전 세계적으로 치료하고, 10개의 라벨이 붙은 적응증을 확보하며, 5개의 파이프라인 후보를 3상으로 진전시키는 것을 목표로 하는 Vision 2030 전략을 추진하고 있습니다.
주요 개발 사항으로는 2025년 파이프라인에서 20개의 진행 중인 임상 연구 (10상 3 및 10상 2)가 포함됩니다. 이 회사는 이전에 인식되지 않은 이연 세금 자산과 관련하여 7억 2,500만 달러의 일회성 세금 혜택을 인식했습니다. 2024년 전체 연도 이익은 8억 3,300만 달러로, 2023년의 2억 9,500만 달러 손실과 비교됩니다.
argenx a annoncé des résultats financiers solides pour 2024, avec des ventes nettes de produits mondiaux atteignant 737 millions de dollars au quatrième trimestre et 2,2 milliards de dollars pour l'année entière. La société a reçu une recommandation positive du CHMP pour la seringue préremplie VYVGART pour gMG dans l'UE, avec des décisions de la FDA attendues d'ici le 10 avril 2025.
L'entreprise a dépassé 10 000 patients dans trois indications avec VYVGART et s'attend à devenir rentable en 2025. argenx avance avec sa stratégie Vision 2030, visant à traiter 50 000 patients dans le monde, à sécuriser 10 indications étiquetées et à faire progresser cinq candidats en pipeline vers la phase 3.
Les développements clés incluent 20 études cliniques en cours (10 Phase 3 et 10 Phase 2) dans leur pipeline pour 2025. L'entreprise a reconnu un avantage fiscal unique de 725 millions de dollars lié à des actifs fiscaux différés précédemment non reconnus. Le bénéfice total pour l'année 2024 était de 833 millions de dollars, par rapport à une perte de 295 millions de dollars en 2023.
argenx berichtete über starke finanzielle Ergebnisse für 2024, mit globalen Nettoumsätzen von Produkten, die im vierten Quartal 737 Millionen Dollar und im gesamten Jahr 2,2 Milliarden Dollar erreichten. Das Unternehmen erhielt eine positive Empfehlung des CHMP für die vorgefüllte Spritze VYVGART für gMG in der EU, wobei Entscheidungen der FDA bis zum 10. April 2025 erwartet werden.
Das Unternehmen übertraf 10.000 Patienten in drei Indikationen mit VYVGART und erwartet, 2025 profitabel zu werden. argenx verfolgt seine Vision 2030-Strategie, die darauf abzielt, 50.000 Patienten weltweit zu behandeln, 10 zugelassene Indikationen zu sichern und fünf Pipeline-Kandidaten in die Phase 3 voranzubringen.
Wichtige Entwicklungen umfassen 20 laufende klinische Studien (10 Phase 3 und 10 Phase 2) in ihrer Pipeline für 2025. Das Unternehmen erkannte einen einmaligen Steuervergünstigung von 725 Millionen Dollar, die sich auf zuvor nicht erkannte latente Steueransprüche bezieht. Der Gewinn für das gesamte Jahr 2024 betrug 833 Millionen Dollar, verglichen mit einem Verlust von 295 Millionen Dollar im Jahr 2023.
- Strong product sales growth: $2.2B in 2024 vs $1.19B in 2023
- Profitability expected in 2025
- One-time tax benefit of $725M recognized
- Reached 10,000 patients milestone across three indications
- Positive CHMP recommendation for VYVGART pre-filled syringe
- Full-year profit of $833M vs loss of $295M in 2023
- Operating expenses increased to $2.27B from $1.69B in 2023
- Exchange losses of $48M in 2024 vs gains of $14M in 2023
- Collaboration revenue declined to $4M from $36M in 2023
Insights
argenx delivered exceptional commercial performance in 2024 with
The
The positive CHMP recommendation for the VYVGART pre-filled syringe (PFS) in Europe, coupled with pending FDA decisions for both gMG and CIDP indications in April, positions argenx to significantly enhance its competitive advantage. The PFS formulation addresses a critical pain point in patient experience and adherence, potentially expanding market penetration against both legacy therapies and emerging FcRn competitors.
argenx's ambitious clinical program - with 20 mid-to-late stage trials planned for 2025 - demonstrates exceptional R&D productivity and pipeline diversity rarely seen in companies of similar size. The
The company's Vision 2030 strategy outlines a clear path to treat 50,000 patients globally with 10 labeled indications across approved medicines. This long-term planning, backed by concrete development milestones, provides investors with transparent growth metrics beyond typical quarterly results.
argenx's 2024 results demonstrate exceptional commercial execution, with
The positive CHMP recommendation for the pre-filled syringe (PFS) formulation represents more than just an incremental improvement in delivery. This innovation addresses a critical barrier to broader adoption by enabling more convenient self-administration, potentially expanding the addressable patient population beyond those willing to receive infusions or healthcare-administered injections. With regulatory decisions pending in multiple regions throughout 2025, this delivery enhancement could drive further market penetration against both legacy therapies and emerging competitors.
argenx's clinical development strategy demonstrates remarkable scientific breadth and operational execution capability. The company is simultaneously advancing three distinct biological platforms - FcRn modulation (efgartigimod), complement inhibition (empasiprubart), and neuromuscular junction targeting (ARGX-119) - providing multiple independent paths to address autoimmune diseases. Running 20 mid-to-late stage trials concurrently represents exceptional R&D productivity for a company of this size and provides significant risk diversification across the portfolio.
The
argenx's Vision 2030 provides investors with clear, measurable long-term objectives beyond typical quarterly metrics, creating a framework to evaluate strategic progress toward treating 50,000 patients with 10 labeled indications. This transparent long-range planning is relatively rare in the biotech sector and demonstrates management's confidence in their scientific platforms and commercial capabilities.
Received positive CHMP recommendation for VYVGART pre-filled syringe for gMG, enabling launch in the EU; FDA PDUFA (gMG and CIDP) on track for April 10
10 Phase 3 and 10 Phase 2 studies across pipeline ongoing in 2025, positioning for next wave of growth
Recognized one-time tax benefit of
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
February 27, 2025 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 2024 and provided a fourth quarter business update.
"In 2024, we significantly expanded our global patient reach with VYVGART, surpassing 10,000 patients across three indications,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We are extremely proud of the initial launch efforts of VYVGART Hytrulo in CIDP, where the strength of our data has driven early positive feedback from both patients and physicians. This execution has contributed to our position of financial strength as we expect to become a profitable company in 2025. We are now more committed than ever to advancing our mission of transforming the autoimmune treatment landscape by investing in innovation, and leading with our science. Momentum across our business is off to a strong start this year as we continue to execute on our Vision 2030. We are focused on maximizing commercial opportunities in gMG and CIDP, including advancing the pre-filled syringe in multiple regions, expanding our label in MG, and deepening relationships within the CIDP community to explore VYVGART Hytrulo’s long-term potential. With an expansive pipeline, we are also excited to drive forward 10 Phase 3 and 10 Phase 2 studies in 2025 across efgartigimod, empasiprubart, and ARGX-119, to unlock significant opportunities in high unmet need areas.”
Advancing Vision 2030
argenx has established its commercial and clinical strategic priorities to advance “Vision 2030”. Through this vision, argenx aims to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.
Expand the global VYVGART opportunity and launch VYVGART SC as a pre-filled syringe
VYVGART® (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-in-class FcRn blocker approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, and China. argenx plans to drive commercial growth by expanding into new regions; innovating on the patient experience by advancing its pre-filled syringe (PFS) in multiple markets for CIDP and gMG in 2025 and autoinjector in 2027; and reaching broader MG populations with ongoing studies in seronegative, ocular, and pediatric MG.
- Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of
$737 million in fourth quarter and$2.2 billion in full year of 2024 - Multiple VYVGART regulatory submissions completed for gMG, including:
- Ministry of Food and Drug Safety approved VYVGART (IV) for gMG in South Korea through Handok Inc.
- Therapeutic Goods Association (TGA) approved VYVGART (IV and SC) for gMG in Australia
- Four key regulatory decisions on approval for PFS on track for 2025:
- Received positive CHMP recommendation for approval of PFS for gMG, enabling launch in the EU
- FDA review ongoing of PFS for gMG and CIDP with Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2025
- PFS decision on approval for CIDP in the EU expected in first half of 2025
- PFS decision on approval for gMG and CIDP expected in Japan and Canada in second half of 2025
- Evidence generation through Phase 4 and label-enabling studies in MG, CIDP and ITP:
- Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular and pediatric MG (ADAPT-OCULUS, JR)
- Phase 4 switch study ongoing in CIDP to inform treatment decisions when switching patients on IVIg to VYVGART SC
- ADVANCE-NEXT topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications. argenx is solidifying its leadership in FcRn biology with efgartigimod, complement inhibition with empasiprubart and in the role of MuSK at the neuromuscular junction with ARGX-119.
Efgartigimod Development
Efgartigimod is being evaluated in 15 severe autoimmune diseases (including MG, CIDP, and ITP), exploring the significance of FcRn biology across neurology and rheumatology indications, as well as new therapeutic areas.
- Registrational ALKIVIA study ongoing evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM)); topline results expected in second half of 2026
- Two registrational UplighTED studies ongoing in thyroid eye disease (TED); topline results expected in second half of 2026
- Registrational UNITY study ongoing in primary Sjögren’s disease; topline results expected in 2027
- Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected in LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027
- Next nominated indications include autoimmune encephalitis (AIE) and one that is undisclosed
Empasiprubart Development
Empasiprubart is currently being evaluated in four diseases, including registrational studies in multifocal motor neuropathy (MMN) and CIDP and proof-of-concept studies in delayed graft function (DGF) and DM.
- Registrational EMPASSION study ongoing in MMN evaluating empasiprubart head-to-head versus IVIg; topline results expected in second half of 2026
- Registrational EMVIGORATE study in CIDP evaluating empasiprubart head-to-head versus IVIg expected to start in first half of 2025
- Proof-of-concept studies ongoing in DGF and DM; topline results expected for DGF in second half of 2025 and for DM in first half of 2026
ARGX-119 Development
ARGX-119 is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).
- Phase 1b proof-of-concept study ongoing in CMS; topline results expected in second half of 2025
- Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
- SMA proof-of-concept study on track to start in 2025
Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program
argenx continues to invest in its 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, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed.
- Phase 1 results expected for ARGX-109 in second half of 2025 and for ARGX-213 and ARGX-121 in first half of 2026
Don deBethizy to retire as non-executive director, Chair of the Remuneration Committee, and Vice Chair of the Company’s Board of Directors, effective May 27, 2025.
Mr. deBethizy has served as a non-executive director since 2015. He will be succeeded by Ana Cespedes as Chair of the Remuneration Committee and Tony Rosenberg as Vice Chair of the Board of Directors.
“I would like to express my deep gratitude to Don for his significant contributions during his tenure with argenx. He has been a true champion of our culture, guiding us through several key milestones on our growth journey, while supporting our entrepreneurial spirit and commitment to innovation.” commented Mr. Van Hauwermeiren.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
| Three Months Ended | Twelve Months Ended | |||||||||||
| December 31 | December 31 | |||||||||||
| (in thousands of $ except for shares and EPS) | 2024 | 2023 | 2024 | 2023 | ||||||||
| Product net sales | $ | 736,968 | $ | 374,351 | $ | 2,185,883 | $ | 1,190,783 | ||||
| Collaboration revenue | 1,443 | 32,486 | 4,348 | 35,533 | ||||||||
| Other operating income | 22,809 | 11,003 | 61,808 | 42,278 | ||||||||
| Total operating income | 761,220 | 417,840 | 2,252,039 | 1,268,594 | ||||||||
| Cost of sales | $ | (72,656) | $ | (39,477) | $ | (227,289) | $ | (117,835) | ||||
| Research and development expenses | (297,228) | (306,373) | (983,423) | (859,492) | ||||||||
| Selling, general and administrative expenses | (285,945) | (208,826) | (1,055,337) | (711,905) | ||||||||
| Loss from investment in a joint venture | (2,350) | (1,788) | (7,644) | (4,411) | ||||||||
| Total operating expenses | (658,179) | (556,464) | (2,273,693) | (1,693,643) | ||||||||
| Operating profit/(loss) | $ | 103,041 | $ | (138,624) | $ | (21,654) | $ | (425,049) | ||||
| Financial income | $ | 39,095 | $ | 40,308 | $ | 157,509 | $ | 107,386 | ||||
| Financial expense | (704) | (280) | (2,464) | (906) | ||||||||
| Exchange (losses)/gains | (54,923) | 37,418 | (48,211) | 14,073 | ||||||||
| Profit/(loss) for the period before taxes | $ | 86,509 | $ | (61,178) | $ | 85,180 | $ | (304,496) | ||||
| Income tax benefit/(expense) | $ | 687,652 | $ | (37,994) | $ | 747,860 | $ | 9,443 | ||||
| Profit/(loss) for the period | $ | 774,161 | $ | (99,172) | $ | 833,040 | $ | (295,053) | ||||
| Profit/(loss) for the period attributable to: | ||||||||||||
| Owners of the parent | $ | 774,161 | $ | (99,172) | $ | 833,040 | $ | (295,053) | ||||
| Weighted average number of shares outstanding used for basic profit/loss per share | 60,517,968 | 59,118,827 | 59,855,585 | 57,169,253 | ||||||||
| Weighted average number of shares outstanding used for diluted profit/loss per share | 65,661,428 | 59,118,827 | 65,177,815 | 57,169,253 | ||||||||
| Basic profit/(loss) per share (in $) | $ | 12.79 | $ | (1.68) | $ | 13.92 | $ | (5.16) | ||||
| Diluted profit/(loss) per share (in $) | $ | 11.79 | $ | (1.68) | $ | 12.78 | $ | (5.16) | ||||
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and twelve months ended December 31, 2024 was
- Product net sales of VYVGART and VYVGART SC for the three and twelve months ended December 31, 2024 were
$737 million and$2,186 million , respectively, compared to$374 million and$1,191 million for the same periods in 2023. - Collaboration revenue for the three and twelve months ended December 31, 2024 was
$1 million and$4 million , respectively, compared to$32 million and$36 million for the same periods in 2023. Collaboration revenue for 2024 mainly relates to our collaboration with Zai Lab in China. - Other operating income for the three and twelve months ended December 31, 2024 was
$23 million and$62 million , respectively, compared to$11 million , and$42 million for the same periods in 2023. The other operating income primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three and twelve months ended December 31, 2024 were
- Cost of sales for the three and twelve months ended December 31, 2024 was
$73 million and$227 million , respectively, compared to$39 million and$118 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC. - Research and development expenses for the three and twelve months ended December 31, 2024 were
$297 million and$983 million , respectively, compared to$306 million and$859 million for the same periods in 2023. The expenses mainly relate to:- the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases including MG, CIDP and ITP
- the ramp-up of studies for our development of empasiprubart into MMN, DGF, DM and CIDP
- the investments for ARGX-119 in proof-of-concept studies ongoing in ALS and CMS
- other discovery and preclinical pipeline candidates
- Selling, general and administrative expenses for the three and twelve months ended December 31, 2024 were
$286 million and$1,055 million , respectively, compared to$209 million and$712 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.
Financial income for the three and twelve months ended December 31, 2024 was
Exchange losses for the three and twelve months ended December 31, 2024 were
Income tax benefit
The Company recorded a deferred tax benefit of
| Three Months Ended | Twelve Months Ended | |||||||||||
| December 31 | December 31 | |||||||||||
| (in millions of $) | 2024 | 2023 | 2024 | 2023 | ||||||||
| Current tax (expense)/benefit | $ | (25) | 12 | (54) | (12) | |||||||
| Deferred tax benefit/(expense) | 713 | (50) | 802 | 21 | ||||||||
| Income tax benefit/(expense) | $ | 688 | (38) | 748 | 9 | |||||||
Profit for the period of the three and twelve months ended December 31, 2024 was
FINANCIAL GUIDANCE
Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2025 to be approximately
EXPECTED 2025 FINANCIAL CALENDAR
- May 8, 2025: Q1 2025 financial results and business update
- May 27, 2025: Annual General Meeting of Shareholders in Amsterdam, the Netherlands
- July 31, 2025: Half Year and Second Quarter 2025 Financial Results and Business Update
- October 30, 2025: Q3 2025 financial results and business update
CONFERENCE CALL DETAILS
The full year 2024 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 and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.
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
United States 1 800 715 9871
Japan 81 3 4578 9081
Switzerland 41 43 210 11 32
This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
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 approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.
For further information, please contact:
Media:
Ben Petok
bpetok@argenx.com
Investors:
Alexandra Roy (US)
aroy@argenx.com
Lynn Elton (EU)
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 “advance,” “aim,” “believe,” “continue,” “drive,” “expand,” “expect,” “plan,” “position,” “start,” and “strive” and include statements argenx makes regarding its expected profitability in 2025; its mission to transform the autoimmune treatment landscape by investing in innovation and its goal to lead in science; its focus on maximizing commercial opportunities in gMG and CIDP, including by advancing PFS in multiple regions, expanding its label in gMG and deepening relationships within the CIDP community; its plan to unlock significant opportunities in high unmet need areas; its long-term commitments, including its Vision 2030 goals of treating 50,000 patients globally with its medicines, securing 10 labeled indications across all approved medicines, and advancing five pipeline candidates into Phase 3 development by 2030; its plans to drive commercial growth by expanding VYVGART into new regions, advance its PFS in multiple markets for CIDP and MG in 2025 and autoinjector in 2027, and reach broader MG populations with ongoing studies in seronegative, ocular, and pediatric MG; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including: (1) four key regulatory decisions on approval for PFS expected in 2025; (2) PFS decision on approval for gMG and CIDP expected in Japan and Canada in second half of 2025 and for CIDP expected in the EU in first half of 2025; and (3) ongoing evidence generation through Phase 4 and label-enabling studies in MG, CIDP and ITP, including topline results for seronegative gMG expected in second half of 2025 and those for ocular and pediatric MG expected in first half of 2026, ongoing Phase 4 switch study in CIDP, and ongoing ADVANCE-NEXT confirmatory study of VYVGART IV in primary ITP with topline results expected in second half of 2026; its plans to execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 in 2025 to advance the next wave of launches; its plans to develop efgartigimod, including: (1) the ongoing registrational ALKIVIA study evaluating IMNM, ASyS, and DM, with topline results expected in second half of 2026; (2) two ongoing registrational UplighTED studies in TED, with topline results expected in second half of 2026; (3) Registrational UNITY study in primary Sjögren’s disease, with topline results expected in 2027; (4) ongoing proof-of-concept studies in LN, SSc, and AMR, with topline results expected in fourth quarter of 2025, second half of 2026, and 2027, respectively; and (5) the next nominated indications of AIE and one undisclosed disease to enter clinical studies; its plans to develop empasiprubart, including: (1) registrational EMPASSION study in MMN, with topline results expected in second half of 2026; (2) registrational EMVIGORATE study in CIDP, expected to start in first half of 2025; and (3) proof-of-concept studies in DGF and DM, with topline results expected in second half of 2025 and first half of 2026, respectively; its plans to develop ARGX-119, including: (1) proof-of-concept study in CMS, with topline results expected in second half of 2025; (2) Phase 2a proof-of-concept study in ALS, with topline results expected in first half of 2026; and (3) SMA proof-of-concept study, expected to start in 2025; the expected start and timeline of Phase 1 studies of ARGX-109 in second half of 2025 and ARGX-213 and ARGX-121 in first half of 2026; the expected change from Mr. deBethizy to Ms. Cespedes as the Chair of the Remuneration Committee; the potential of its continued investment in its IIP to drive long-term sustainable pipeline growth; its future financial and operating performance, including its anticipated research and development, selling, general and administrative expenses for 2025; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. 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 but not limited to, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. 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.
FAQ
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