Core Points - The Annual General Meeting of shareholders for argenx SE is scheduled for May 27, 2025, at 13:00 CET in Amsterdam [1] - The formal notice of the meeting, including details on attendance and e-voting, is available on the argenx website [2] - The company's annual report for the financial year ending December 31, 2024, is now accessible on its investor relations page [3] Agenda Items - The agenda includes the discussion and adoption of the 2024 annual accounts, an advisory vote on the 2024 remuneration report, discharge of directors for their 2024 duties, and authorization for the Board to issue shares [4] - It is proposed to re-appoint Anthony Rosenberg as a non-executive director and to adopt a new remuneration policy [4] Company Overview - argenx is a global immunology company focused on severe autoimmune diseases, partnering with academic researchers to develop novel antibody-based medicines [6] - The company has developed the first approved neonatal Fc receptor (FcRn) blocker and is exploring its potential in various serious autoimmune diseases [6]

Core Viewpoint - The FDA has approved argenx's VYVGART® Hytrulo prefilled syringe for self-injection, providing a new treatment option for adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [1][2][3] Group 1: Product Approval and Features - The VYVGART Hytrulo prefilled syringe allows for a 20-to-30-second subcutaneous injection, which can be administered by patients, caregivers, or healthcare professionals [2][3] - This self-injection option is designed to enhance patient independence and flexibility in treatment administration, allowing patients to choose where and when to receive their treatment [2][3][4] - The approval is supported by studies demonstrating the bioequivalence of the prefilled syringe to the vial formulation, along with successful human factors validation studies [3] Group 2: Patient Impact and Community Response - The new self-injection option is expected to improve convenience and reduce the time required for treatment, thereby enhancing disease management for patients with gMG and CIDP [3][5] - The Myasthenia Gravis Foundation of America and the GBS-CIDP Foundation have expressed support for the approval, highlighting its significance in providing effective treatment options that reduce the need for frequent clinic visits [4][5] Group 3: Company Commitment and Support Programs - argenx is committed to innovating the patient experience by providing individualized, safe, and effective therapies, as evidenced by the introduction of the VYVGART Hytrulo prefilled syringe [6] - The company offers a patient support program, My VYVGART® Path, which includes resources for disease education, access support, and financial assistance for eligible patients [6][7] - argenx aims to translate immunology breakthroughs into a portfolio of novel antibody-based medicines, reinforcing its position as a leader in the immunology sector [19]

Core Insights - argenx SE presented 15 abstracts at the 2025 American Academy of Neurology Annual Meeting, showcasing long-term data for VYVGART and VYVGART Hytrulo, demonstrating sustained disease control in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile [1][2][3] Group 1: VYVGART and VYVGART Hytrulo Efficacy - VYVGART and VYVGART Hytrulo show differentiated efficacy and safety profiles, with long-term studies indicating significant quality of life improvements for gMG and CIDP patients [3][5] - ADAPT-NXT data reveal that 75% of gMG patients achieved sustained efficacy, with over 56.5% experiencing minimal symptom expression during the study [7] - ADHERE+ data demonstrate functional improvements in CIDP patients, with significant increases in disability scores and grip strength at week 36 compared to baseline [5][6] Group 2: Ongoing Studies and Pipeline - argenx is conducting label expansion studies for VYVGART in ocular myasthenia gravis (oMG) and seronegative myasthenia gravis (snMG) to reach a broader patient community [2][16] - First-in-human data for ARGX-119, a new clinical candidate targeting neuromuscular junction disorders, show a favorable safety profile, supporting its further development [2][31] - The company aims to address unmet needs in underserved patient communities through its robust neuromuscular pipeline [9][34] Group 3: Commitment to Patient Outcomes - The data presented at AAN reinforce argenx's commitment to the neuromuscular community and solidify VYVGART as a leading biologic for improving patient outcomes [3][4] - The company emphasizes individualized treatment options for gMG patients, showcasing the flexibility of VYVGART dosing schedules [6][7] - Real-world data from the ADHERE Phase 4 study indicate a low rate of CIDP worsening among patients transitioning from IVIg to VYVGART Hytrulo [8]

Core Insights - Investors are evaluating Jazz Pharmaceuticals (JAZZ) and argenex SE (ARGX) for potential undervalued stock opportunities in the Medical - Biomedical and Genetics sector [1] Valuation Metrics - JAZZ has a Zacks Rank of 2 (Buy), indicating a stronger earnings outlook compared to ARGX, which has a Zacks Rank of 3 (Hold) [3] - JAZZ's forward P/E ratio is significantly lower at 5.27, while ARGX's forward P/E ratio stands at 47.10 [5] - The PEG ratio for JAZZ is 0.72, suggesting better value relative to its expected earnings growth, compared to ARGX's PEG ratio of 1.45 [5] - JAZZ's P/B ratio is 1.82, indicating a more favorable market value to book value comparison than ARGX's P/B ratio of 6.51 [6] - These metrics contribute to JAZZ receiving a Value grade of A, while ARGX has a Value grade of D [6] Earnings Outlook - JAZZ is noted for its improving earnings outlook, which enhances its attractiveness in the Zacks Rank model [7]

Commercialization and Competition - The company currently generates commercial revenue from VYVGART and VYVGART SC for gMG, CIDP, and ITP (Japan only) and faces intense competition from other biopharmaceutical companies[44]. - The company anticipates significant competition for its drug discovery and development efforts, particularly in the autoimmune field, with multiple mAbs and other biologics already marketed or in development[42]. - The company is aware of competitors developing biosimilar products for VYVGART and VYVGART HYTRULO, which could lead to substantial competition and decreased sales[56]. - The commercialization of VYVGART in new indications will require further expansion of the sales and marketing organization and collaboration with third parties[51]. - The company faces significant competition in establishing successful relationships with third-party service providers and collaborative partners[107]. Regulatory and Legislative Environment - The base regulatory exclusivity period for VYVGART and VYVGART HYTRULO is expected to extend until December 2033 in the U.S., while regulatory protection in the EU is expected to expire in August 2032 in the EEA and March 2033 in the UK[55]. - Legislative changes in the U.S., UK, and EU could adversely affect the company's future results of operations, particularly regarding price controls and patient access[60]. - The Inflation Reduction Act (IRA) allows the HHS to negotiate prices for a specified number of high-expenditure drugs, with the first 10 drugs selected for negotiation announced in August 2023, effective in 2026[61]. - The IRA imposes penalties on drug manufacturers for price increases exceeding inflation rates and caps out-of-pocket spending for Medicare Part D enrollees at $2,000 starting in 2025[62]. - The European Commission's proposal to revise pharmaceutical legislation could reduce data and market exclusivity for products in the EEA if adopted[66]. - The UK is not required to align with future EU pharmaceutical legislation, but other regulatory changes may still impact the company's operations[67]. Financial Performance and Capital Needs - The company expects to increase expenses for the foreseeable future and may not be able to raise additional capital or sustain net profitability[38]. - Future profitability is uncertain, as the company must generate significant product net sales to sustain profitability[159]. - The company may need to raise additional capital through equity or debt financing, which could be impacted by market conditions[160]. - The company's investments are subject to various risks, including credit, liquidity, and foreign currency risks, which may adversely affect financial condition[162]. - Revenue from international markets is influenced by foreign exchange rates, particularly the euro and Japanese Yen, impacting net income and expenses[164]. Clinical Development and Regulatory Approval - Regulatory approval for products and candidates is uncertain and can take many years, with clinical trials being expensive and outcomes unpredictable[85]. - Delays in clinical trials can increase costs and jeopardize the ability to commence product sales and generate revenues[90]. - Certain clinical trials have not met primary endpoints, leading to a decision to prioritize the clinical development of efgartigimod in severe autoimmune indications[84]. - The company anticipates submitting applications for approval of VYVGART in new indications, but cannot guarantee acceptance or timely approval[134]. - Delays or failures in obtaining regulatory approvals for VYVGART could materially adversely affect the company's business[135]. Supply Chain and Manufacturing Risks - The company relies on third-party suppliers for raw materials, which poses risks of supply disruptions that could materially impact revenue potential[111]. - The company contracts with Lonza and Fujifilm for manufacturing, and any issues with these CMOs could lead to significant manufacturing delays or product defects[117]. - Regulatory restrictions on biological source materials may limit or delay production, impacting clinical development and commercial activities[112]. - The company operates with a master cell bank for each product, and losing multiple cell banks could significantly impact manufacturing and financial results[229]. Intellectual Property and Legal Risks - The company faces challenges in maintaining, enforcing, and protecting its intellectual property rights, which are critical for its competitive advantage[179]. - There is uncertainty regarding the issuance and scope of patents for the company's product candidates, which could affect market potential[180]. - The company may need to divert substantial resources to enforce its intellectual property rights, and adverse rulings could allow competitors to commercialize similar products[186]. - The upcoming EU Product Liability Directive (Directive (EU) 2024/2853) will expand the definition of "damage" and create rebuttable presumptions to help claimants prove their case, potentially increasing liability claims[168]. - The company may face significant costs and distractions from complex litigation, which could adversely affect its business and operating expenses[170]. Compliance and Operational Risks - Compliance with healthcare laws is critical, as violations could lead to significant penalties and reputational harm[128]. - The company is subject to evolving privacy laws and regulations, which may require significant compliance efforts and associated costs[140]. - The company faces risks related to environmental compliance, which could result in substantial fines and reputational damage[155]. - The company is dependent on accurate financial information from collaboration partners, and any inaccuracies could adversely impact financial reporting[119]. Market and Economic Factors - Global geo- and socio-political threats and macro-economic uncertainties could materially and adversely affect the company's business and financial performance[38]. - Changes in U.S.-Mainland China relations, including tariffs and export controls, may negatively impact collaborations with Chinese biotechnology companies[223]. - The company may face challenges in obtaining favorable pricing and reimbursement terms in foreign markets, which could hinder product commercialization[77]. - The company’s ability to attract and retain key personnel may be challenged by competitive remuneration practices and an inflationary environment[217]. Research and Development - The long-term growth strategy includes developing and marketing additional products and candidates such as efgartigimod, empasibrubart, and ARGX-119, which requires substantial resources[83]. - The company benefits from research and development tax incentives, including tax credits and payroll withholding tax exemptions[230]. - Public health issues may disrupt clinical trials and operations, affecting the ability to recruit patients and obtain regulatory approvals[229].

Annual Report 2024 Annual Report 2024 2024 Annual Report including the Annual Financial Statements for the year ended December 31, 2024 This Annual Report is filed with the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, AFM). The following main items included in our annual report on Form 20-F for the year ended December 31, 2024 (2024 20-F) filed with the United States Securities and Exchange Commission (SEC) on or about the date of this Annual Report have not been inclu ...

argenex SE (ARGX) shares ended the last trading session 4.1% higher at $604.96. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 10.8% loss over the past four weeks.The stock rallied as optimism grew over the company’s marketed product, Vyvgart Hytrulo (efgartigimod), which is approved for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). T ...

Core Insights - argenx SE is presenting clinical trial and real-world data for VYVGART and VYVGART Hytrulo at the American Academy of Neurology Annual Meeting in April 2025, highlighting their commitment to improving the lives of patients with severe autoimmune diseases [1][2]. Group 1: Product Efficacy and Safety - VYVGART has demonstrated long-term benefits for patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), achieving minimal symptom expression and rapid symptom reduction with a favorable safety profile [2][4]. - The largest safety data set for FcRn blocking shows a consistent and favorable safety profile for both VYVGART and VYVGART Hytrulo, supporting individualized treatment approaches [4][5]. - New data from the ADAPT-NXT study indicates sustained clinical improvements in gMG through various dosing regimens over 126 weeks, reinforcing the long-term safety and efficacy of VYVGART [5]. Group 2: Clinical Presentations and Studies - Presentations at the AAN will include interim results from the ADHERE+ study, which supports the long-term efficacy and safety of VYVGART Hytrulo in CIDP [3][5]. - The Phase 4 open-label trial is investigating the transition from intravenous immunoglobulin (IVIg) to VYVGART Hytrulo, aiming to establish effective and safe treatment protocols [5][7]. - The program will feature multiple oral and poster presentations detailing the design and results of various studies related to VYVGART and its applications in treating gMG and CIDP [3][6]. Group 3: Company Overview and Commitment - argenx is dedicated to advancing immunology through innovative antibody-based medicines, focusing on severe autoimmune diseases and collaborating with leading academic researchers [29]. - The company has developed the first approved neonatal Fc receptor (FcRn) blocker, VYVGART, which is now being evaluated for its potential in multiple serious autoimmune diseases [29][24].

Financial Data and Key Metrics Changes - Product net sales for Q4 2024 were $737 million, with full-year sales reaching $2.2 billion, representing a 29% quarter-over-quarter growth and a 98% increase year-over-year [21][22] - Total operating income for Q4 was $761 million, and $2.3 billion for the full year [21] - Gross margin remained at 90%, with cost of sales at $73 million for Q4 and $227 million for the full year [23] - Operating profit for Q4 was $103 million, while the full year showed an operating loss of $22 million [25] - Cash balance at year-end was $3.4 billion, an increase of $200 million in 2024 [27] Business Line Data and Key Metrics Changes - VYVGART has significantly impacted the gMG treatment landscape, with strong early adoption in CIDP patients [10][31] - The company plans to advance 10 Phase III studies and 10 proof-of-concept studies across its pipeline in 2025 [12][18] - The launch of VYVGART Hytrulo in CIDP has seen approximately 1,000 patients on treatment, with 25% of prescribers being first-time users [42][44] Market Data and Key Metrics Changes - Product revenue breakdown: $649 million in the U.S., $27 million in Japan, $49 million in the rest of the world, and $12 million supplied to Zai Lab in China [22] - The company is expanding its market access, now reimbursed in 13 countries in Europe, including 4 out of the 5 major markets [45] Company Strategy and Development Direction - The company aims to maximize growth opportunities through innovation and has set a long-term growth vision influenced by its ability to innovate and stay ahead of competition [19][51] - The introduction of the prefilled syringe for self-administration is expected to drive growth in 2025 [10][36] - The company is committed to addressing unmet needs in the MG community by expanding its label into seronegative and ocular MG [36][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for the prefilled syringe and the potential for continued growth in both MG and CIDP [58][129] - The company anticipates that 2025 will be a year of significant growth, expanding commercial reach and advancing its late-stage pipeline [53] Other Important Information - The company has nominated 4 new molecules for Phase I development, indicating a robust innovation pipeline [16][17] - The recognition of a deferred tax benefit of $802 million contributed to a profit of $774 million in Q4 [26] Q&A Session Summary Question: Can you talk about the pent-up demand for the prefilled syringe (PFS)? - Management noted that there is no significant pent-up demand but expects the PFS to open up new prescriber bases and maintain consistent growth [58][60] Question: How should we think about pricing for the PFS? - Pricing will be discussed closer to the launch, with a focus on providing broad access and sustainability [61][62] Question: What is the expected growth cadence in MG for 2025? - Continued momentum is expected, with Q1 seasonality considered, but overall dynamics remain strong [70][72] Question: How will the expiration of VBAs affect access? - VBAs will need to be renegotiated, and access is expected to remain stable [75] Question: Are physicians assessing improvement in CIDP patients? - Physicians are generally using simple assessments rather than formal scales like INCAT to evaluate patient responses [77] Question: What is the significance of self-administration for VYVGART? - Self-administration has been beneficial in markets outside the U.S., and similar expectations are held for the U.S. market upon approval [84][86] Question: What are the plans for ARGX-213 and its development timeline? - The company is focused on generating Phase I data for ARGX-213, which is expected to provide insights into its potential [102] Question: What are the expectations for proof-of-concept data in CMS? - The company is looking for strong signals that the treatment can effectively address the condition in CMS patients [140]

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