I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum.Argenx (NASDAQ: ARGX ) reported strong third quarter results, beating co ...

Financial Data and Key Metrics Changes - Total operating income for Q3 2024 was $589 million, comprising $573 million in product net sales and $16 million in other operating income, reflecting a 20% quarter-over-quarter growth and a 74% increase year-over-year [20][21] - Operating expenses for Q3 totaled $575 million, an increase of $40 million compared to Q2 2024, driven by higher SG&A and R&D expenses [22][23] - The company reported an operating profit of $14 million for Q3, while the year-to-date operating loss stood at $125 million [23] Business Line Data and Key Metrics Changes - Product revenue breakdown: $492 million from the U.S., $24 million from Japan, $46 million from the rest of the world, and $11 million from product supply to Zai Lab in China [21] - The CIDP launch has successfully reached over 300 patients, with revenue approaching that of the first quarter of the MG launch [10][32] Market Data and Key Metrics Changes - The company has secured favorable payer policies covering approximately 54% of U.S. commercial lives for CIDP, with most policies requiring prior IVIg utilization [28] - VYVGART is now available to over 80% of the gMG population in the EU, with ongoing regulatory reviews in China, Japan, and Europe for CIDP [37] Company Strategy and Development Direction - The company is focused on expanding its commercial presence and advancing its pipeline, with a Vision 2030 strategy aimed at addressing unmet needs in neuromuscular medicine [7][15] - The decision to discontinue the development of efgartigimod in MN reflects a strategic shift to prioritize programs with higher potential for patient impact [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the CIDP launch trajectory, noting that patient starts have been relatively linear and in line with expectations [43][44] - The company is optimistic about the potential to reach 50,000 patients by 2030, leveraging growth in both MG and CIDP, as well as future pipeline expansions [68] Other Important Information - The company has over $3.4 billion in cash and equivalents, with cash guidance for 2024 no longer applicable [23][24] - The upcoming PDUFA date for the prefilled syringe (PFS) is in April 2025, which is expected to enhance patient convenience and drive growth [102] Q&A Session Summary Question: Trajectory of the CIDP launch - Management indicated that CIDP patient starts have been relatively linear, with most starts occurring in September as payer policies came online [43][44] Question: Update on payer formulary and treatment timelines - Management confirmed that the time from prescription to treatment is in line with expectations, with smooth transitions for patients getting on therapy [49][50] Question: Breakdown of sales from CIDP and MG - Management confirmed that most sales were still driven by MG, with CIDP contributing approximately $20 million, primarily in the last month of the quarter [52][54] Question: Patients not switching from IVIg - Management noted that the majority of CIDP patients are switching from IVIg, with the remaining patients primarily coming from steroids or other immunosuppressants [59] Question: Dosing frequency for CIDP patients - Management stated it is too early to determine dosing frequency trends, as most patients are just starting therapy [80][81] Question: Expected price for Hytrulo in CIDP - Management reiterated that the expected price for Hytrulo is $450,000, but real-world utilization will determine the final cost [84] Question: Pipeline news flow expectations - Management indicated that a detailed clinical calendar for 2025 will be announced at the start of the new year, with significant activity expected across multiple trials [92]

| --- | --- | --- | --- | --- | --- | --- | |-------------|-------|-------|-------------------------|-----------------------------------------------------|-----------|-------| | | | | | | | | | | | | | | | | | 3 Q 2 0 2 | 4 | | E A R N I N G S C A L L | Reaching Patients Through \| O c t o b e r 3 1 | , 2 0 2 4 | | | | | | | Immunology Innovation | | | | | | | | | | | Forward Looking Statements This presentation has been prepared by argenx se ("argenx" or the "company") for informational purposes only and n ...

October 24, 2024Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 31, 2024 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2024 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/inv ...

VYVGART and VYVGART Hytrulo Efficacy and Safety - VYVGART demonstrates rapid, deep, and sustained responses in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [4] - More than 50% of gMG patients show substantial and sustained reduction in steroid use after VYVGART initiation [1] - VYVGART Hytrulo shows sustained functional benefit in motor function and muscle strength in CIDP patients, regardless of prior treatment [5] - VYVGART has a consistent and favorable safety profile with over 8,000 patient years of safety data [6] Real-World Data and Clinical Studies - Real-world data show 55% of gMG patients reduced corticosteroid use by ≥5 mg/day one year post VYVGART initiation [5] - 42% of gMG patients achieved steroid doses of ≤5mg/day after one year of VYVGART treatment [5] - Phase 3 studies are ongoing for seronegative and ocular MG populations, showing consistent and clinically meaningful improvements [5] Pipeline Expansion in Neurology - argenx is advancing empasiprubart for multifocal motor neuropathy (MMN) and ARGX-119 for amyotrophic lateral sclerosis (ALS) and congenital myasthenic syndromes (CMS) [9] - Phase 2 ARDA study shows empasiprubart reduces IVIg retreatment risk by 91% and improves grip strength in MMN patients [10] - A Phase 3 study of empasiprubart in MMN is set to start by the end of 2024 [10] Immunology Pipeline Highlights - argenx is evaluating empasiprubart in multiple autoimmune indications, including delayed graft function, dermatomyositis, and CIDP [32] - ARGX-119, a muscle-specific kinase (MuSK) agonist, is being developed for neuromuscular diseases [34] - The company continues to expand its neurology pipeline to deliver transformative outcomes for patients [3] Market and Regulatory Position - VYVGART is the first approved FcRn blocker in the US, EU, China, and Canada for gMG treatment [28] - VYVGART Hytrulo is the first-and-only approved FcRn blocker administered by subcutaneous injection [29] - argenx is committed to improving the lives of patients with severe autoimmune diseases through its immunology pipeline [38]

After grappling with recession fears, the Federal Reserve’s jumbo interest rate cuts helped the broader S&P 500 to defy the odds of a notorious September and notch record highs. The S&P 500 posted its best three-quarters of the 21st century, and if history is any guide, the index is well-poised to continue its winning streak over the next three months. The 30-stock Dow and the tech-laden Nasdaq also closed in the green in the first nine months of 2024. Thus, it’s judicious for astute investors to place thei ...

I specialize in biotech and healthcare investment analysis, integrating clinical expertise with a solid foundation in business strategy. My approach leverages detailed risk-return charts and DCF analyses to clearly communicate the investment potential and associated risks. I advocate for a barbell portfolio strategy, with 90% allocated to secure assets such as Treasuries and broad-market ETFs, and 10% to high-alpha stocks. This balanced approach ensures that all recommendations are made within a context of ...

ADHERE was largest and most innovative clinical trial of CIDP patients to date VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrated reduction in disease progression, reduced risk of relapse and rapid onset of action VYVGART Hytrulo is first and only neonatal Fc receptor (FcRn) blocker FDA-approved to treat CIDP September 19, 2024 – 7:00 am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people sufferi ...

argenex SE (ARGX) shares rallied 4% in the last trading session to close at $548.49. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 6.1% gain 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 ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has argenex SE (ARGX) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.argenex SE is a member of the Medical sector. This group includes 1019 individual stocks and currently holds a Zacks Sector Rank of #3. The Zacks Sector Rank gauges the strength ...