Core Viewpoint - The European Commission has approved VYVGART® (efgartigimod alfa) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in therapy options for this rare autoimmune disease [1][4][5]. Company Overview - argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with VYVGART SC being the first therapy approved for CIDP in over 30 years [5][11]. - The company aims to translate immunology breakthroughs into a portfolio of novel antibody-based medicines and is actively working on multiple severe autoimmune diseases [11]. Product Details - VYVGART SC is administered as a subcutaneous injection and is available in vials or prefilled syringes, allowing for administration by patients, caregivers, or healthcare professionals [1]. - The treatment regimen starts with weekly doses, which can be adjusted based on clinical evaluation [1]. Clinical Trial Insights - The approval is based on the ADHERE clinical trial, the largest study of CIDP patients to date, where 66.5% of patients treated with VYVGART SC showed clinical improvement [4][7]. - The trial demonstrated a 61% reduction in the risk of relapse compared to placebo, with a primary endpoint met (p<0.0001) [4][8]. Patient Impact - CIDP is a debilitating condition affecting mobility and sensory functions, with 85% of patients requiring ongoing treatment and nearly 88% experiencing residual impairment [3][9]. - The introduction of VYVGART SC is seen as a major step forward for the patient community, providing a targeted therapy that addresses a key mechanism of the disease [2][4]. Regulatory Approval - The European Commission's approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway, with efforts underway to ensure patient access [5][6].

Core Insights - Exelixis (EXEL) is currently viewed as a more attractive investment compared to argenex SE (ARGX) for value investors due to its stronger earnings outlook and better valuation metrics [3][7]. Valuation Metrics - EXEL has a forward P/E ratio of 17.95, significantly lower than ARGX's forward P/E of 41.38, indicating that EXEL is potentially undervalued [5]. - The PEG ratio for EXEL is 0.85, while ARGX has a PEG ratio of 0.96, suggesting that EXEL offers better value relative to its expected earnings growth [5]. - EXEL's P/B ratio stands at 5.38, compared to ARGX's P/B of 6.39, further supporting the notion that EXEL is more attractively priced [6]. Investment Ratings - EXEL holds a Zacks Rank of 2 (Buy), indicating a positive earnings estimate revision trend, while ARGX has a Zacks Rank of 3 (Hold) [3]. - The Value grade for EXEL is B, whereas ARGX has a Value grade of C, reflecting EXEL's superior valuation metrics [6].

Core Insights - Argenx SE announced positive results from Phase 2 studies of VYVGART® (efgartigimod) for treating Sjogren's disease and idiopathic inflammatory myopathies, presented at EULAR 2025 [1][2][3] - The FDA granted efgartigimod Fast Track designation for primary Sjogren's disease treatment, indicating its potential for expedited development [2] Group 1: Efgartigimod in Myositis - The ALKIVIA Phase 2/3 study showed significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod, with a mean Total Improvement Score (TIS) of 50.45 compared to 35.65 in the placebo group (P=0.0004) [4][5] - 79% of efgartigimod-treated patients achieved moderate improvement (TIS ≥40), while only 47% of placebo patients did [4] - Efgartigimod demonstrated a favorable safety profile, with similar rates of treatment-emergent adverse events between efgartigimod and placebo groups [5][11] Group 2: Efgartigimod in Sjogren's Disease - In the Phase 2 RHO study, 45.5% of efgartigimod-treated patients showed improved outcomes on the CRESS composite primary endpoint at Week 24, compared to 11.1% in the placebo group [9][10] - The median change in clinESSDAI total score was -7.0 for efgartigimod patients versus -4.0 for placebo [9] - Efgartigimod led to a ~60% reduction in IgG levels from Week 4 onwards, indicating its potential for disease biology modulation [10][12] Group 3: Ongoing Studies and Future Directions - The Phase 3 portion of the ALKIVIA study is ongoing to further evaluate efgartigimod's efficacy in myositis [6] - The Phase 3 UNITY trial is assessing efgartigimod's efficacy and safety in moderate to severe Sjogren's disease [11] - Argenx is committed to exploring new therapeutic areas in rheumatology, with ongoing studies in both myositis and Sjogren's disease [8][20]

Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company is known for developing and commercializing the first approved neonatal Fc receptor (FcRn) blocker, with ongoing evaluations of its potential across multiple serious autoimmune diseases [3] Upcoming Event - Karl Gubitz, the Chief Financial Officer of argenx, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 8:40 AM ET in Miami, FL [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]

Core Points - Argenx SE held its Annual General Meeting on May 27, 2025, with 91.1% of the share capital represented [1] - All agenda items received the required majority except for the remuneration policy, which received a 73.0% majority against a required 75% [2] - The company's 2024 remuneration report received a 76.7% majority in favor [4] - The annual report and accounts for the financial year ending December 31, 2024, were approved with a 99.9% majority [4] - Anthony Rosenberg was re-appointed as a non-executive director for a two-year term with a 93.6% majority [4] - The Board of Directors was authorized to issue shares and grant rights to subscribe for shares for up to 10% of the outstanding share capital for 18 months, with a 99.4% majority [4] Company Overview - Argenx is a global immunology company focused on improving the lives of individuals with severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program to develop novel antibody-based medicines [3] - Argenx has developed the first approved neonatal Fc receptor (FcRn) blocker and is exploring its potential in various serious autoimmune diseases [3]

Core Viewpoint - The comparison between Exelixis (EXEL) and argenex SE (ARGX) indicates that EXEL currently presents a better value opportunity for investors based on various financial metrics and analyst outlooks [1][3]. Valuation Metrics - EXEL has a forward P/E ratio of 16.66, significantly lower than ARGX's forward P/E of 43.23, suggesting that EXEL is more undervalued [5]. - The PEG ratio for EXEL is 0.79, while ARGX has a PEG ratio of 1, indicating that EXEL's expected earnings growth is more favorable relative to its price [5]. - EXEL's P/B ratio stands at 5.54 compared to ARGX's P/B of 6.43, further supporting the notion that EXEL is a more attractive investment based on valuation metrics [6]. Analyst Ratings - EXEL holds a Zacks Rank of 2 (Buy), reflecting a strong earnings estimate revision trend, while ARGX has a Zacks Rank of 3 (Hold), indicating a less favorable outlook [3][6]. - The Value grade for EXEL is B, whereas ARGX has a Value grade of C, reinforcing the conclusion that EXEL is the superior value option at this time [6].

Core Viewpoint - Argenx SE (ARGX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Recent Performance and Projections - Argenx is projected to earn $13.02 per share for the fiscal year ending December 2025, reflecting a year-over-year increase of 406.6% [8]. - Over the past three months, the Zacks Consensus Estimate for Argenx has risen by 20%, indicating a positive trend in earnings expectations [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Argenx to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Insights - argenx SE reported $790 million in global product net sales for the first quarter of 2025, marking a 99% increase year-over-year from $398 million in Q1 2024 [4][22] - The company is advancing its "Vision 2030" strategy, aiming to treat 50,000 patients across 10 labeled indications and to progress 10 Phase 2 and 10 Phase 3 studies [2][3] - The recent approval of the VYVGART-SC pre-filled syringe for self-injection in the U.S. and EU is expected to enhance patient access and treatment adoption [4][5] Financial Performance - Total operating income for Q1 2025 was $807 million, up from $413 million in Q1 2024 [15] - Total operating expenses increased to $668 million in Q1 2025 from $506 million in Q1 2024, primarily due to higher research and development costs [16][22] - The company reported a profit of $169 million for Q1 2025, compared to a loss of $62 million in the same period of 2024, resulting in a profit per share of $2.78 [19][22] Product Development and Pipeline - Efgartigimod is being evaluated in 15 severe autoimmune diseases, with ongoing studies in multiple therapeutic areas [6] - Empasiprubart is in registrational studies for multifocal motor neuropathy and CIDP, with proof-of-concept studies in delayed graft function and dermatomyositis [7] - ARGX-119 is being studied for congenital myasthenic syndromes, amyotrophic lateral sclerosis, and spinal muscular atrophy [8] Regulatory and Market Expansion - The company received a positive opinion from the CHMP for VYVGART-SC in the EU, with further approvals expected in Japan and Canada by the end of 2025 [4][5] - The launch of the VYVGART-SC pre-filled syringe is anticipated to support growth in both generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy [4][5] - Ongoing studies aim to expand treatment options for broader patient populations, including seronegative, ocular, and pediatric myasthenia gravis [4][5] Future Outlook - argenx plans to execute 10 registrational and 10 proof-of-concept studies across its pipeline candidates, with key insights expected from various studies by the end of 2025 and into 2026 [2][29] - The company continues to invest in its Immunology Innovation Program, with four new pipeline candidates nominated for development [12][29] - Financial guidance for combined selling, general and administrative expenses and research and development expenses remains unchanged at approximately $2.5 billion [20]

Financial Data and Key Metrics Changes - Total revenue increased by 35% year over year to $265 million, with royalty revenue rising by 39% to $168 million, primarily driven by three blockbusters [12][34] - Adjusted EBITDA increased to $162 million, and non-GAAP EPS rose to $1.11, both representing approximately 40% year over year growth [12][35] - Net income grew by 54% in the quarter to $118 million [12] Business Line Data and Key Metrics Changes - The three key revenue drivers are DARZALEX subcutaneous, FESGO, and VYVGART HETULO, which are projected to continue growing for years [11][13] - Royalty revenue from DARZALEX subcutaneous increased by 22% year over year, with sales reaching $3.2 billion [13] - FESGO sales increased by 52% to approximately $675 million, becoming the number one growth driver in Roche's pharmaceutical portfolio [14] Market Data and Key Metrics Changes - The European approval of a DARZALEX-based quadruplet regimen is expected to support near-term growth, with analyst estimates projecting DARZALEX sales to reach $17 billion by 2028 [14] - FESGO's conversion from Perjeta reached 47% in the 58 launch countries, with expectations to exceed 50% globally in 2025 [15] - VYVGART HETULO's sales reached $2.2 billion in 2024, with continued strong growth anticipated in 2025 [18] Company Strategy and Development Direction - The company aims to grow organically and through serial acquisitions, focusing on licensing disruptive drug delivery platform technologies [8][10] - Plans to repurchase $250 million in shares in 2025, reflecting a commitment to returning value to shareholders [10] - The strategy includes identifying new drug delivery platforms that result in long-lasting revenue streams through royalties [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of DARZALEX subcutaneous, FESGO, and VYVGART HETULO, which are expected to drive growth [39] - The company is optimistic about its robust pipeline and ability to defend intellectual property, which strengthens confidence in sustainable growth [39] - Management noted that the first quarter performance exceeded expectations, leading to an increase in full-year guidance [36] Other Important Information - The company has signed its first development agreement for a high-volume auto injector, indicating progress in its product development pipeline [30] - The company maintains a strong balance sheet with cash and marketable securities of $747.9 million as of March 31, 2025 [36] Q&A Session Summary Question: Can you comment on the expected timelines for the PGR decisions and what action could be taken if the PGR goes in Merck's favor? - The first decision by the patent office on institution will be in early June, and if there is institution, the case will be reviewed about twelve months from then [43] Question: Is there a possibility that the PGR case and your patent infringement lawsuit could be tied together? - The PGR is considered a sideshow, and the company feels confident in prevailing in those PGRs, which will not impact the infringement case [44][45] Question: What area of strength surprised you during the quarter driving the upgrade? - The three blockbuster products, DARZALEX subcutaneous, FESGO, and VYVGART HETULO, have been performing excellently and are expected to continue [48] Question: When might you be in a position to tell us who the partner is for the small volume auto injector? - The timing will depend on the partner, but it is expected that when it enters clinical studies, it might become public [50] Question: Do you see AstraZeneca's Altigen deal as evidence that large pharma companies are willing to accept patent litigation risk? - The company does not expect any partners to pause new target add-ons or renegotiations while watching the litigation play out [56][57] Question: How are you thinking about the implications of the Enhertu frontline breast cancer data for FESGO sales and royalties? - The company is confident that FESGO will continue to demonstrate strong market adoption and uptake due to its convenient administration and patient satisfaction [62] Question: Can you confirm that the outcome of your litigation against Merck will have no impact on your core ENHANZE business? - The company confirmed that the litigation will have no impact on the ENHANZE business, which is seen as a potential upside opportunity [76]

Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program (IIP) to translate immunology breakthroughs into a portfolio of novel antibody-based medicines [3] - argenx has developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, evaluating its potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines [3] Upcoming Event - Tim Van Hauwermeiren, the Chief Executive Officer of argenx, along with members of the management team, will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 4:20 p.m. PT [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]