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]

Core Viewpoint - Legend Biotech Corporation has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating a positive outlook for the company's stock price [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily driven by changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [2][3]. - The recent upgrade for Legend Biotech suggests an improvement in its earnings outlook, which could lead to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, influenced by institutional investors [5]. - Rising earnings estimates and the corresponding rating upgrade for Legend Biotech imply a positive trend in the company's underlying business, which should be reflected in its stock performance [6]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [8]. - The upgrade of Legend Biotech to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11]. Earnings Estimate Revisions for Legend Biotech - For the fiscal year ending December 2025, Legend Biotech is expected to earn -$0.64 per share, reflecting a year-over-year change of -23.1% [9]. - Over the past three months, the Zacks Consensus Estimate for Legend Biotech has increased by 8.9%, indicating a positive revision trend [9].

Core Viewpoint - Legend Biotech Corporation (LEGN) shows significant upside potential with a mean price target of $79.86, indicating a 135.2% increase from its current price of $33.96 [1] Price Targets - The average of 19 short-term price targets ranges from a low of $55 to a high of $95, with a standard deviation of $11.93, suggesting a variability in estimates [2] - The lowest estimate indicates a 62% increase, while the most optimistic estimate points to a 179.7% upside [2] Analyst Consensus - Analysts have shown strong agreement in revising earnings estimates higher, which is a positive indicator for potential stock upside [4][11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 15.5%, with three estimates moving higher and no negative revisions [12] Zacks Rank - LEGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

Company Overview - Legend Biotech Corporation is a global leader in cell therapy with over 2,500 employees, making it the largest standalone cell therapy company [3] - The company is pioneering treatments that aim to revolutionize cancer care, particularly through its CAR-T cell therapy [3] - CARVYKTI, a one-time treatment for relapsed or refractory multiple myeloma, is developed and marketed in collaboration with Johnson & Johnson [3] Upcoming Events - Legend Biotech will host a conference call for investors on May 13, 2025, at 8:00 am ET to review first-quarter 2025 results [1] - Senior leaders will provide an overview of the company's performance during the call [1] - A replay of the webcast and earnings news release will be available approximately two hours after the call concludes [2]