argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update
argenx reported strong financial results for Q2 2024, with global net product sales of $478 million. The company launched VYVGART Hytrulo for CIDP in the US and received NMPA approval for VYVGART SC in China for gMG. argenx unveiled its 'Vision 2030', aiming to reach 50,000 patients globally and achieve 10 labeled indications across approved assets by 2030. The company is advancing its pipeline, with plans to start four additional registrational studies for efgartigimod and empasiprubart by end of 2024. Financial highlights include total operating income of $489 million for Q2 2024, up from $281 million in Q2 2023. R&D expenses increased to $225 million, while SG&A expenses rose to $256 million. argenx ended Q2 with $3.1 billion in cash and equivalents.
argenx ha riportato risultati finanziari solidi per il secondo trimestre del 2024, con vendite nette globali di prodotti pari a 478 milioni di dollari. L'azienda ha lanciato VYVGART Hytrulo per CIDP negli Stati Uniti e ha ricevuto l'approvazione NMPA per VYVGART SC in Cina per gMG. argenx ha presentato la sua 'Vision 2030', con l'obiettivo di raggiungere 50.000 pazienti a livello globale e ottenere 10 indicazioni etichettate su asset approvati entro il 2030. L'azienda sta avanzando nel suo pipeline, con piani di avviare quattro ulteriori studi registrativi per efgartigimod ed empasiprubart entro la fine del 2024. I punti salienti finanziari includono un reddito operativo totale di 489 milioni di dollari per il secondo trimestre del 2024, in aumento rispetto ai 281 milioni di dollari del secondo trimestre del 2023. Le spese per R&D sono aumentate a 225 milioni di dollari, mentre le spese SG&A sono salite a 256 milioni di dollari. argenx ha chiuso il secondo trimestre con 3,1 miliardi di dollari in contanti e equivalenti.
argenx reportó resultados financieros sólidos para el segundo trimestre de 2024, con ventas netas globales de productos de 478 millones de dólares. La compañía lanzó VYVGART Hytrulo para CIDP en EE. UU. y recibió la aprobación de la NMPA para VYVGART SC en China para gMG. argenx presentó su 'Visión 2030', que tiene como objetivo alcanzar 50,000 pacientes a nivel mundial y lograr 10 indicaciones etiquetadas en activos aprobados para 2030. La empresa está avanzando en su pipeline, con planes de comenzar cuatro estudios de registro adicionales para efgartigimod y empasiprubart a finales de 2024. Los aspectos financieros destacados incluyen un ingreso operativo total de 489 millones de dólares para el segundo trimestre de 2024, un aumento respecto a los 281 millones de dólares en el segundo trimestre de 2023. Los gastos de I+D aumentaron a 225 millones de dólares, mientras que los gastos SG&A aumentaron a 256 millones de dólares. argenx terminó el segundo trimestre con 3.1 mil millones de dólares en efectivo y equivalentes.
argenx는 2024년 2분기에 전 세계 순 제품 매출 4억 7,800만 달러라는 강력한 재무 결과를 보고했습니다. 이 회사는 미국에서 CIDP를 위한 VYVGART Hytrulo를 출시했으며, 중국에서 gMG용 VYVGART SC에 대한 NMPA 승인을 받았습니다. argenx는 '비전 2030'을 발표하며, 2030년까지 전 세계적으로 50,000명의 환자와 10개의 라벨링 적응증을 목표로 하고 있습니다. 회사는 파이프라인을 추진하며, 2024년 말까지 efgartigimod 및 empasiprubart에 대한 추가 4개의 등록 연구를 시작할 계획입니다. 재무 하이라이트로는 2024년 2분기에 총 운영 수익 4억 8,900만 달러가 있으며, 이는 2023년 2분기의 2억 8,100만 달러에서 증가한 수치입니다. 연구 및 개발 비용은 2억 2,500만 달러로 증가했으며, 판매 및 관리비는 2억 5,600만 달러로 상승했습니다. argenx는 2분기를 31억 달러의 현금 및 현금성 자산으로 마감했습니다.
argenx a rapporté de solides résultats financiers pour le deuxième trimestre 2024, avec des ventes nettes de produits à l’échelle mondiale de 478 millions de dollars. La société a lancé VYVGART Hytrulo pour le CIDP aux États-Unis et a obtenu l'approbation de la NMPA pour VYVGART SC en Chine pour le gMG. argenx a dévoilé sa 'Vision 2030', visant à atteindre 50 000 patients dans le monde et à obtenir 10 indications étiquetées sur des actifs approuvés d'ici 2030. L'entreprise progresse dans son pipeline, avec des plans pour commencer quatre études d'enregistrement supplémentaires pour efgartigimod et empasiprubart d'ici fin 2024. Les points saillants financiers incluent un revenu d'exploitation total de 489 millions de dollars pour le deuxième trimestre 2024, en hausse par rapport à 281 millions de dollars au deuxième trimestre 2023. Les dépenses en R&D ont atteint 225 millions de dollars, tandis que les dépenses SG&A ont grimpé à 256 millions de dollars. argenx a terminé le deuxième trimestre avec 3,1 milliards de dollars en liquidités et équivalents.
argenx berichtete über starke Finanzergebnisse für das zweite Quartal 2024, mit globalen Nettoproduktverkäufen von 478 Millionen Dollar. Das Unternehmen brachte VYVGART Hytrulo für CIDP in den USA auf den Markt und erhielt die NMPA-Zulassung für VYVGART SC in China für gMG. argenx stellte seine 'Vision 2030' vor, mit dem Ziel, weltweit 50.000 Patienten zu erreichen und bis 2030 10 zugelassene Indikationen für zugelassene Produkte zu erzielen. Das Unternehmen entwickelt seine Pipeline weiter und plant, bis Ende 2024 vier zusätzliche Zulassungsstudien für efgartigimod und empasiprubart zu starten. Zu den finanziellen Höhepunkten gehören ein Gesamtertrag von 489 Millionen Dollar im zweiten Quartal 2024, ein Anstieg von 281 Millionen Dollar im zweiten Quartal 2023. Die F&E-Ausgaben erhöhten sich auf 225 Millionen Dollar, während die SG&A-Ausgaben auf 256 Millionen Dollar stiegen. argenx schloss das zweite Quartal mit 3,1 Milliarden Dollar in Bar- und Cash-Äquivalenten.
- Global net product sales reached $478 million in Q2 2024, a significant increase from $269 million in Q2 2023
- VYVGART Hytrulo launched for CIDP in the US with first patients treated in July
- NMPA approved VYVGART SC for gMG treatment in China
- Total operating income increased to $489 million in Q2 2024 from $281 million in Q2 2023
- Strong cash position of $3.1 billion as of June 30, 2024
- Operating loss of $45 million in Q2 2024
- Net loss of $33 million for the first half of 2024
- Increased R&D expenses to $225 million in Q2 2024 from $196 million in Q2 2023
- Higher SG&A expenses of $256 million in Q2 2024 compared to $162 million in Q2 2023
- Expected combined R&D and SG&A expenses for 2024 to be less than $2 billion, indicating significant spending
Insights
argenx's Q2 2024 results demonstrate strong commercial execution and pipeline progress. Key highlights:
- Global net product sales reached
$478 million in Q2, a significant increase from$269 million in Q2 2023. - Total operating income for Q2 was
$489 million , up from$281 million in the same period last year. - The company reported a profit of
$29 million for Q2 2024, compared to a loss of$94 million in Q2 2023. - Cash position remains strong at
$3.1 billion as of June 30, 2024.
The impressive revenue growth is primarily driven by the successful commercialization of VYVGART and VYVGART SC. However, operating expenses have also increased substantially, with R&D expenses rising to
The company's financial guidance suggests continued heavy investment in R&D and commercialization, with expected combined R&D and SG&A expenses of less than
Overall, argenx's financial performance shows strong momentum in product sales, but investors should monitor the increasing operational costs and their impact on profitability in the long term.
argenx's pipeline progress and regulatory achievements are noteworthy:
- VYVGART Hytrulo launched in CIDP in the U.S. with first patients treated in July, following FDA approval on June 21st.
- VYVGART SC approved for gMG treatment in China through Zai Lab.
- Multiple regulatory submissions for VYVGART SC in CIDP are under review or planned globally.
- New registrational study (ADAPT OCULUS) for VYVGART in ocular MG to start by year-end.
- Advancing efgartigimod in 15 indications, solidifying leadership in FcRn biology.
- Phase 3 study of empasiprubart for MMN to initiate in Q4 2024.
- CIDP nominated as fourth empasiprubart indication.
The company's ambitious 'Vision 2030' aims to reach 50,000 patients globally, achieve 10 labeled indications across approved assets and have five new molecules in Phase 3 development by 2030. This demonstrates a strong commitment to expanding their therapeutic reach and maintaining a robust pipeline.
The breadth of indications being pursued for efgartigimod and the advancement of empasiprubart and ARGX-119 show a diversified approach to autoimmune diseases. The focus on both rare and more common conditions could potentially lead to multiple revenue streams in the future.
The investment in the Immunology Innovation Program, with four new pipeline candidates nominated, indicates a long-term strategy for sustainable growth. However, it's important to note that early-stage candidates carry significant development risks.
Overall, argenx's pipeline progress and regulatory achievements position it well in the autoimmune disease space, but the success of these programs will depend on future clinical results and regulatory approvals.
argenx's market position and growth strategy present several key points for investors:
- The company is rapidly expanding its global reach, with VYVGART now approved in multiple indications and regions.
- The recent launch in CIDP and potential label expansions in MG could significantly increase the addressable patient population.
- argenx is pursuing a 'pipeline-in-a-product' strategy with efgartigimod, potentially maximizing the value of this asset across multiple indications.
- The development of empasiprubart and ARGX-119 demonstrates efforts to diversify beyond FcRn inhibition.
The impressive sales growth of VYVGART and VYVGART SC indicates strong market acceptance and effective commercialization strategies. The
The company's 'Vision 2030' sets ambitious but potentially achievable goals. Reaching 50,000 patients globally would represent significant market penetration in the autoimmune disease space. The target of 10 labeled indications across approved assets by 2030 could provide multiple growth avenues and help mitigate risks associated with any single indication.
However, investors should consider the intensifying competition in the FcRn inhibitor space. While argenx currently leads the market, other companies are advancing their own FcRn inhibitors, which could impact argenx's market share in the future.
The company's investment in early-stage pipeline candidates through the Immunology Innovation Program is a strategic move to ensure long-term growth. However, the success of these programs is uncertain and will require significant time and resources to bring to market.
Overall, argenx's market position appears strong, with significant growth potential in the near to medium term. The company's focus on innovation and pipeline expansion could help maintain its competitive edge in the evolving autoimmune disease market.
First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval
On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
Regulated Information – Inside Information
July 25, 2024 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 announced its half year 2024 results and provided a second quarter business update.
“We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.”
Vision 2030
During its R&D Day on July 16, 2024, argenx unveiled its ‘Vision 2030’ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (FcRn) biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. ‘Vision 2030’ includes the following goals:
- 50,000 patients globally on treatment with an argenx medicine
- 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart and ARGX-119
- Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program
Reaching 50,000 Patients Globally
VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) 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.
- Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of
$478 million in second quarter of 2024 - National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024
- Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia
- Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July
- Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including:
- Regulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025
- Regulatory submission filing in Canada by end of 2024
- Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG
- Regulatory submission filed and under review for VYVGART SC pre-filled syringe (PFS) for gMG and CIDP
Advancing Pipeline to Achieve 10 Labeled Indications by 2030
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).
- Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)
- Advancing development of efgartigimod in primary Sjogren’s disease (SjD) with Phase 3 study to begin by end of 2024
- Following alignment meeting with FDA, confirmatory study of VYVGART (IV) in primary ITP to start by end of 2024 to enable registration in U.S.
- Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM expected in fourth quarter of 2024
- Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
- Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc)
- Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024
- CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients
- Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024
Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030
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 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025
- Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025
SECOND QUARTER 2024 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
| Three Months Ended | Six Months Ended | ||||||||||||
| June 30, | June 30, | ||||||||||||
| (in thousands of $ except for shares and EPS) | 2024 | 2023 | 2024 | 2023 | |||||||||
| Product net sales | $ | 477,635 | $ | 269,313 | $ | 875,918 | $ | 487,335 | |||||
| Collaboration revenue | - | 1,237 | 2,718 | 2,355 | |||||||||
| Other operating income | 11,793 | 10,485 | 23,305 | 21,225 | |||||||||
| Total operating income | $ | 489,428 | $ | 281,035 | $ | 901,941 | $ | 510,915 | |||||
| Cost of sales | $ | (52,383) | $ | (24,024) | $ | (95,561) | $ | (42,359) | |||||
| Research and development expenses | (225,286) | (195,509) | (450,255) | (361,364) | |||||||||
| Selling, general and administrative expenses | (255,699) | (161,977) | (491,694) | (311,149) | |||||||||
| Loss from investment in joint venture | (1,521) | (1,619) | (3,313) | (1,880) | |||||||||
| Total operating expenses | $ | (534,889) | $ | (383,129) | $ | (1,040,823) | (716,752) | ||||||
| Operating loss | $ | (45,461) | $ | (102,094) | $ | (138,882) | $ | (205,837) | |||||
| Financial income | $ | 38,933 | $ | 20,441 | $ | 77,828 | $ | 37,029 | |||||
| Financial expense | (572) | (207) | (1,084) | (395) | |||||||||
| Exchange gains/(losses) | (7,903) | (2,001) | (27,215) | 9,164 | |||||||||
| Loss for the period before taxes | $ | (15,003) | $ | (83,861) | $ | (89,353) | $ | (160,039) | |||||
| Income tax benefit/(expense) | $ | 44,069 | $ | (10,507) | $ | 56,822 | $ | 36,800 | |||||
| Profit/(loss) for the period | $ | 29,066 | $ | (94,368) | $ | (32,531) | $ | (123,239) | |||||
| Profit/(loss) for the period attributable to: | |||||||||||||
| Owners of the parent | $ | 29,066 | $ | (94,368) | $ | (32,531) | $ | (123,239) | |||||
| Weighted average number of shares outstanding | 59,490,437 | 55,828,239 | 59,400,217 | 55,690,873 | |||||||||
| Basic profit/(loss) per share (in $) | 0.49 | (1.69) | (0.55) | (2.21) | |||||||||
| Diluted profit/(loss) per share (in $) | 0.45 | (1.69) | (0.55) | (2.21) | |||||||||
| Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2023 | (77,497) | $ | (195,580) | ||||||||||
| Cash and cash equivalents and current financial assets at the end of the period | 3,102,347 | $ | 1,996,968 | ||||||||||
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and six months ended June 30, 2024 was
- Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2024 were
$478 million and$876 million compared to$269 million and$487 million for the same periods in 2023. - Other operating income for the three and six months ended June 30, 2024 was
$12 million and$23 million compared to$10 million and$21 million for the same periods in 2023. The other operating income for the three and six months ended June 30, 2024 and 2023, primarily relates to research and development tax incentives.
Total operating expenses for the three and six months ended June 30, 2024 were
- Cost of sales for the three and six months ended June 30, 2024 was
$52 million and$96 million compared to$24 million and$42 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 six months ended June 30, 2024 were
$225 million and$450 million compared to$196 million and$361 million for the same periods in 2023. 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 and six months ended June 30, 2024 were
$256 million and$492 million compared to$162 million and$311 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses.
Financial income for the three and six months ended June 30, 2024 was
Exchange losses for the three and six months ended June 30, 2024 were
Income tax for the three and six months ended June 30, 2024 was
Net Result for the three and six months ended June 30, 2024 was
Cash, cash equivalents and current financial assets totalled
FINANCIAL GUIDANCE
Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2024 to be less than
EXPECTED 2024 FINANCIAL CALENDAR
- October 31, 2024: 3Q 2024 financial results and business update
- February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update
CONFERENCE CALL DETAILS
The half-year 2024 financial results and second 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 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 1 888 415 4250
Japan 81 3 4578 9081
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 approved neonatal Fc receptor (FcRn) blocker, globally 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 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,” “anticipates,” “continue,” “expect,” “expand,” “plan,” or “seek” and include statements argenx makes regarding its Vision 2030 plan to develop and deliver continued and sustainable innovation for patients; its long-term commitments; its Vision 2030 goals, including having 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119, and five new molecules in Phase 3 development indicating ongoing investment in the immunology innovation program; its growth opportunity; its plans to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe; the advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the anticipated timing of four additional Phase 3 registrational studies across efgartigimod and empasiprubart, the expected timing of additional VYVGART regulatory decisions on approval for gMG, including in Switzerland, Australia, and Saudi Arabia, the expected timing of additional VYVGART SC regulatory submissions under review or planned for CIDP, including decisions on approval in China, Japan, and Europe and a regulatory submission filing in Canada, the anticipated timing of the initiation of a Phase 3 study for efgartigimod in primary Sjogren’s disease (SjD), the anticipated timing of a confirmatory study of VYVGART (IV) in primary ITP, the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, the anticipated timing of an update on BALLAD study development plan evaluating efgartigimod in BP, the anticipated timing of proof-of-concept studies for efgartigimod in AMR and SSc, the anticipated timing of the initiation of a Phase 3 study of empasiprubart for MMN, the anticipated timing of the initiation of Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS, the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121; its investigational new drug applications for ARGX-2220 and ARGX-109 expected to be filed by the end of 2025; its 2024 research and development and selling, general and administrative expenses and operating expenses; its 2024 cash burn; 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 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 in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; 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.
1 reflects cash, cash equivalents and current financial assets
FAQ
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