Market Performance - The three major U.S. stock indices closed lower, with the Dow Jones down 0.25% at 42,319.74 points, the S&P 500 down 0.53% at 5,939.3 points, and the Nasdaq down 0.83% at 19,298.45 points [1] - Most large tech stocks declined, with Tesla dropping over 14%, Apple down more than 1%, Nvidia down over 1%, and Facebook down 0.48%. In contrast, Google rose 0.1%, Amazon increased 0.33%, and Microsoft gained 0.82% [1] Chinese Stocks - Most Chinese stocks saw gains, with Zhihu Group rising nearly 13%, Kingsoft Cloud up over 7%, Lotus Technology increasing over 5%, and GDS Holdings up over 4%. However, some stocks like Linklogis and Bawang Tea fell over 9% [1] European Indices - European major indices showed mixed results, with Germany's DAX index up 0.19% at 24,323.58 points, reaching a new historical high, while France's CAC40 index fell 0.18% to 7,790.27 points, and the UK's FTSE 100 index rose 0.11% to 8,811.04 points [1] Commodity Prices - International precious metal futures closed mixed, with COMEX gold futures down 0.68% at $3,376.1 per ounce, while COMEX silver futures rose 3.31% to $35.795 per ounce [1] - International oil prices increased across the board, with WTI crude oil main contract up 0.64% at $63.25 per barrel and Brent crude oil main contract up 0.66% at $65.29 per barrel [1] Currency and Bond Yields - The U.S. dollar index fell 0.07% to 98.74, while the offshore RMB against the U.S. dollar dropped 38.5 basis points to 7.1755 [1] - U.S. Treasury yields rose across the board, with the 2-year yield up 6.19 basis points to 3.924%, the 3-year yield up 6.82 basis points to 3.894%, the 5-year yield up 7.13 basis points to 3.995%, the 10-year yield up 3.93 basis points to 4.395%, and the 30-year yield up 0.61 basis points to 4.883% [1] - European bond yields also generally increased, with the UK 10-year yield up 1 basis point to 4.614%, France's 10-year yield up 4.7 basis points to 3.248%, Germany's 10-year yield up 5.2 basis points to 2.576%, Italy's 10-year yield up 3.5 basis points to 3.524%, and Spain's 10-year yield up 4 basis points to 3.155% [1]

Core Insights - Legend Biotech Corporation announced long-term results from the CARTITUDE-1 study, showing that 33% of heavily pretreated relapsed/refractory multiple myeloma patients remained progression-free for five years after a single infusion of CARVYKTI [1][4][6] Group 1: Study Results - In the CARTITUDE-1 study, at a median follow-up of 61.3 months, patients treated with CARVYKTI demonstrated a median overall survival (OS) of 60.7 months [4] - Among 97 patients, 32 (33%) remained progression-free for five years or more without further myeloma treatment [4][6] - A subset analysis of 12 patients who underwent minimal residual disease assessments showed all remained progression-free and MRD-negative for five years [3] Group 2: Safety and Efficacy - Safety signals were consistent with the known profile of CARVYKTI, with no new movement or neurocognitive treatment-emergent adverse events reported [5] - Two new cases of second primary malignancies were reported, both solid tumors [5] - The CARTITUDE-4 study indicated that CARVYKTI improved progression-free survival (PFS) and overall survival (OS) compared to standard therapies in high-risk subgroups [7][9] Group 3: Future Developments - Ongoing Phase 1 studies of LB1908 and LB2102 in gastroesophageal and lung cancers, respectively, show promising early results, indicating potential for next-generation cell therapies [8][11] - Legend Biotech entered an exclusive global license agreement with Novartis for certain CAR-T cell therapies targeting DLL3, including LB2102 [15][17]

Industry Investment Rating - The report rates the pharmaceutical industry as "Leading" [1] Core Insights - The ASCO conference has showcased significant data from several domestic innovative drugs, highlighting opportunities for innovation and performance resonance [1][4] - The report emphasizes the increasing competitiveness and international influence of Chinese pharmaceutical companies, with a record number of original research results presented at ASCO [4][5] - The report suggests a positive outlook for the innovative drug sector, driven by favorable policies and low valuations compared to historical averages [4] Summary by Sections Market Performance - The Hang Seng Index fell by 2.4% during the week, while the Hang Seng Healthcare Index decreased by 1.0%, ranking 7th among 12 industry indices [4][22] - Sub-industry performance varied, with life sciences tools and services up by 3.4%, and biotechnology down by 4.9% [4][22] Company Ratings and Valuations - The report provides a detailed valuation summary for various companies, with most rated as "Buy" and a few as "Neutral" or "Sell" [3][42] - Notable companies with "Buy" ratings include: - AstraZeneca (AZN US) with a target price of 93.30 and a current price of 70.96 [3] - BeiGene (6160 HK) with a target price of 208.80 and a current price of 146.00 [3] - Innovent Biologics (1801 HK) with a target price of 60.00 and a current price of 59.55 [3] ASCO Conference Highlights - The 2025 ASCO conference featured 71 original research results from Chinese pharmaceutical companies, with 11 studies presented as Late Breaking Abstracts [5][6] - Companies like Innovent Biologics and Rongchang Biologics showcased promising clinical data for their innovative therapies [5][6] Investment Recommendations - The report recommends focusing on companies with strong growth potential and clear profitability timelines, such as Rongchang Biologics, Kangfang Biologics, and Innovent Biologics [4] - It also highlights the potential for prescription drug companies like Xiansheng Pharmaceutical and Hansoh Pharmaceutical to expand their valuations due to high growth rates [4] Recent Approvals and Developments - Rongchang Biologics received approval for a new indication for its drug in treating myasthenia gravis [20] - Innovent Biologics published positive results for its dual receptor agonist in a prominent medical journal [20] - BeiGene's clinical research for its drug in small cell lung cancer has shown promising results [20]

Core Insights - Legend Biotech Corporation is presenting new data on CARVYKTI (ciltacabtagene autoleucel) for multiple myeloma at the 2025 ASCO and EHA meetings, highlighting its status as a market leader in CAR-T therapy for this condition [1][2] - The company is also showcasing preliminary results from ongoing Phase 1 studies targeting solid tumors, specifically lung and gastric cancers, indicating an expansion of its cell therapy pipeline [1][2] CARVYKTI Data - Long-term data from the CARTITUDE-1 study will be presented, showing that heavily pretreated patients with relapsed or refractory multiple myeloma achieved a median progression-free survival of over 5 years after a single CARVYKTI infusion, with a median follow-up of 60.3 months [3][10] - Data from the CARTITUDE-4 study will support a positive benefit-risk ratio for CARVYKTI across various patient subgroups, including those with high-risk cytogenetics [4][10] Solid Tumor Pipeline - Preliminary results from Phase 1 studies of LB2102 and LB1908, targeting small-cell lung cancer and gastroesophageal adenocarcinoma respectively, will be featured in poster presentations at ASCO [6][10] - LB2102 has been licensed to Novartis for further development, with Legend Biotech responsible for the Phase 1 clinical trial in the U.S. [7][8] Clinical Presentations - The company will present data at ASCO and EHA, including an oral presentation on long-term survival outcomes for CARVYKTI and poster presentations on subgroup analyses and preliminary results from solid tumor studies [10][12]

Company Overview - Legend Biotech Corporation is a global leader in cell therapy and the largest standalone cell therapy company with over 2,600 employees [3] - The company is pioneering CAR-T cell therapy, specifically with its product CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, developed in collaboration with Johnson & Johnson [3] - Legend Biotech aims to maximize patient access and therapeutic potential of CARVYKTI® while driving future innovation across its pipeline of cell therapy modalities [3] Upcoming Event - Legend Biotech will host a live webcast for investors on June 1, 2025, at 6:00 p.m. CT during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL [1] - The webcast will feature Ying Huang, Ph.D., CEO, and Mythili Koneru, M.D., Ph.D., CMO, along with expert clinicians discussing the latest updates from the CARTITUDE development program [2] - Interested parties can join the webcast through a provided weblink or visit Legend Biotech's website under Events and Presentations [2]

Core Viewpoint - After a significant decline in stock price following a failed acquisition, Legend Biotech's stock showed signs of recovery due to strong sales data for its CAR-T product, CARVYKTI, but faced renewed pressure from competitive products and changing valuation logic [1][3][4]. Group 1: Stock Performance and Sales Data - Legend Biotech's stock price fell from a high of $58.90 in August last year to a low of $29.40 in April this year, marking a significant decline [1]. - On April 15, Johnson & Johnson reported that CARVYKTI achieved global sales of $369 million in Q1 2025, a year-over-year increase of 135%, exceeding market expectations of $324 million [1]. - Following the positive sales report, Legend Biotech's stock rose by 5.08% on the same day, contributing to a 3.01% increase in stock price for April [1]. Group 2: Competitive Landscape - The competitive landscape has shifted with Gilead's Kite company entering the market with Anito-cel, which has shown promising clinical data, including a 97% overall response rate in its trials [4][5]. - Anito-cel's data suggests it may offer comparable efficacy to CARVYKTI while potentially having a better safety profile, raising concerns about CARVYKTI's market share and pricing power [4][7]. - On May 14, following the release of Anito-cel's data, Legend Biotech's stock dropped by 10.55%, marking its largest single-day decline of the year [7]. Group 3: Financial Outlook and Production Capacity - Legend Biotech reported a net loss of $177 million for 2024, a significant reduction from a loss of $518.3 million the previous year, with CARVYKTI projected to generate $963 million in sales, a 92.7% increase [8][9]. - The company is expanding its production capacity, with plans to reach an annual capacity of 10,000 doses by the end of 2025 and 20,000 doses by the end of 2027 [9]. - Despite the positive sales outlook, the emergence of competitive products like Anito-cel poses challenges to Legend Biotech's growth strategy, raising questions about its reliance on CARVYKTI as a sole revenue driver [9][11]. Group 4: Product Pipeline and R&D - Legend Biotech has developed a diverse product pipeline, including multiple CAR-T therapies and other innovative treatments, but currently lacks a second product that can generate cash flow [11]. - The company has 11 products in development, indicating a potential delay in bringing additional revenue-generating products to market [11]. - The reliance on a single product for growth may place Legend Biotech at a disadvantage in the long-term market dynamics [11].

Financial Data and Key Metrics Changes - In Q1 2025, the company reported net trade sales of approximately $369 million, representing a 135% year-over-year increase [9][17] - Total revenues reached $195 million, driven by a 137% year-over-year growth in collaboration revenue [21] - The adjusted net loss was EUR 27 million, significantly improved from an operating loss of EUR 118 million in the same period last year [21][22] Business Line Data and Key Metrics Changes - CARVICTI's U.S. net trade sales were $318 million, growing 127% year-over-year and 5% quarter-over-quarter [17] - The company has treated over 6,000 patients with CARVICTI, marking it as the strongest CAR T launch to date [10] - Out-of-U.S. (OUS) sales reached $51 million, more than double compared to the same period last year, driven by expansion in several countries [18] Market Data and Key Metrics Changes - In the U.S., more than half of CARVICTI's utilization is now in the earlier line setting, with a significant increase in physician preference for CARVICTI in early line multiple myeloma [10] - The company is expanding its market presence in Europe, with recent launches in Spain, the UK, Denmark, Belgium, and Israel [18] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVICTI by the end of 2025 and overall profitability in 2026, excluding unrealized foreign exchange gains or losses [9][21] - The focus remains on building out pipeline programs and investing in research and development, particularly in in vivo CAR T delivery [12][13] - The company is also expanding manufacturing capacity in Belgium and New Jersey to meet increasing demand [14][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for the Raritan facility expansion and expects no delays in the approval process [32][46] - The company remains optimistic about its future, with a strong cash position of approximately $1 billion, allowing for continued investment in core differentiators [15][23] Other Important Information - The company has a 97% manufacturing success rate, which is considered the highest in the CAR T industry [19] - The gross margin on net product sales improved to 63%, up from 59% in the previous quarter [22] Q&A Session Summary Question: Price differences between U.S. and ex-U.S. - The price differential is approximately 30%, varying by country [28] Question: Raritan facility approval process - The company is confident in achieving FDA approval based on the CB30 pathway [32] Question: Pipeline asset updates - The first patient dosing for the in vivo CAR T platform is expected in June or July, with preliminary results anticipated by the end of the year [29] Question: Community penetration for CARVICTI - There is high demand for CARVICTI in earlier lines, and efforts are being made to educate community physicians [38] Question: Capacity expectations for Q2 - Modest growth is expected in Q2, with more significant growth anticipated in the latter half of the year [46] Question: High-risk patient definitions - High-risk patients are defined by cytogenetic factors, while functional high-risk patients progress quickly after frontline therapy [48] Question: Outpatient volume trends - Outpatient volume is expected to grow steadily, currently comprising over half of all CARVICTI treatments [93] Question: Community-based CAR T accreditation - Discussions are ongoing to provide a streamlined accreditation process for community centers [89]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported net trade sales of approximately $369 million, representing a 135% year-over-year increase and a 10% increase from Q4 2024 [7][15] - Total revenues for the quarter were $195 million, driven by a 137% year-over-year growth in collaboration revenue [19] - The adjusted net loss was approximately €27 million, while the operating loss was reduced to €51 million from €118 million in the same period last year [19][20] - The gross margin on net product sales improved to 63%, up from 59% in Q4 2024 [20] Business Line Data and Key Metrics Changes - CARVICTI's performance showed strong growth, with U.S. net trade sales of $318 million, a 127% increase year-over-year [15] - The company has treated over 6,000 patients with CARVICTI, marking it as the strongest CAR T launch to date [8][14] - Out-of-U.S. (OUS) sales reached $51 million, more than double compared to the same period last year, driven by expansion in several countries [16] Market Data and Key Metrics Changes - In the U.S., more than half of CARVICTI's utilization is now in earlier treatment lines, with a significant increase in physician preference for CARVICTI in early-line multiple myeloma [8] - The company is expanding its market presence in Europe, with recent launches in Spain, the UK, Denmark, Belgium, and Israel [16] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVICTI by the end of 2025 and overall profitability in 2026, excluding unrealized foreign exchange gains or losses [7][19] - The company is investing in research and development, particularly in in vivo CAR T delivery, which is seen as a significant opportunity for future growth [12] - The company is focused on expanding its manufacturing capacity in Belgium and New Jersey to meet increasing demand [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for the Raritan facility expansion in the second half of 2025, based on current interactions with the FDA [26][32] - Despite macroeconomic uncertainties, the company maintains a strong cash position of approximately $1 billion and is focused on operational efficiency for long-term growth [14][21] Other Important Information - The company has a 97% manufacturing success rate and aims to further reduce turnaround times for CARVICTI delivery [17] - The company is actively working on integrating CAR T therapy into community settings and addressing infrastructure hurdles [102] Q&A Session Summary Question: Price differences between U.S. and ex-U.S. - The price differential is approximately 30%, varying by country [26] Question: Raritan facility approval process - The company is confident in achieving FDA approval without delays [32] Question: Community penetration for CARVICTI - There is high demand for CARVICTI in earlier lines, and the company is increasing efforts to educate community physicians [39] Question: Capacity expectations for Q2 - Modest growth is expected in Q2, with further acceleration anticipated in the latter half of the year [45] Question: Infrastructure hurdles for community adoption - Capacity and staffing are key hurdles, but the company is engaging with centers to address these issues [102] Question: Upcoming clinical data from DLL3 and Claudin 18.2 - Key data will be presented at ASGCT, with further details expected at the conference [105]

CARVYKTI® Performance and Market Position - CARVYKTI® achieved a 135% year-over-year growth in Net Trade Sales, reaching $369 million in Q1 2025 compared to $157 million in Q1 2024[34] - U S CARVYKTI® sales grew 127% year-over-year and 5% quarter-over-quarter, driven by manufacturing performance and capacity expansion, with 114 activated treatment sites[34] - Outside the U S (OUS), CARVYKTI® sales increased by 219% year-over-year and 65% quarter-over-quarter, fueled by capacity expansion and ongoing launches in various countries[34] - The company aims to double commercial supply in 2025, targeting 10,000 annualized doses by the end of 2025 and 20,000 annualized doses by the end of 2027[37] - CARVYKTI® has demonstrated a 97% success rate in CAR-T cell manufacturing and delivers on-time (or before) 95% of the time[38] Financial Highlights - The company's IFRS total revenue increased from $94 million in Q1 2024 to $195 million in Q1 2025[43] - IFRS net loss was $100916000 in Q1 2025, compared to $59793000 in Q1 2024[57] - Adjusted Net Loss (ANL) improved to $26999000 in Q1 2025 from $85257000 in Q1 2024[57] - Adjusted Net Loss per Share improved to -$007 in Q1 2025 from -$023 in Q1 2024[57] Future Outlook - The company anticipates achieving company-wide profitability in 2026, driven by commercial expansion, manufacturing efficiency, and continued margin expansion[51, 52] - Legend Biotech expects its cash position of approximately $1 billion to fund operating and capital expenditures into Q2 2026[50]

Core Insights - Legend Biotech Corporation reported strong commercial performance of CARVYKTI, aiming for company-wide profitability by next year through capacity expansion and global approvals [2][6][10] Regulatory Updates - The European Medicines Agency's CHMP provided a positive opinion for CARVYKTI, highlighting significant improvement in overall survival from the CARTITUDE-4 study [7] - Australia's TGA approved CARVYKTI for second-line treatment in multiple myeloma patients [7] Key Business Developments - Over 6,000 patients have been treated with CARVYKTI to date [6] - Clinical production of CARVYKTI was initiated at the Tech Lane facility in Belgium, with commercial production expected by the end of 2025 [6][7] - The company published its second annual ESG report, aligning with various sustainability standards [7] First Quarter 2025 Financial Results - CARVYKTI net trade sales reached approximately $369 million [6] - Total revenue for Q1 2025 was $195.1 million, up from $94.0 million in Q1 2024 [14] - Collaboration revenue increased to $185.6 million from $78.5 million year-over-year [12] - License revenue decreased to $9.3 million from $12.2 million year-over-year [12] - Net loss for Q1 2025 was $100.9 million, compared to a net loss of $59.8 million in Q1 2024 [12][15] - Cash and cash equivalents stood at $1.0 billion as of March 31, 2025, providing a financial runway into Q2 2026 [6][12]