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]

SOMERSET, N.J., May 19, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a live webcast event for investors on Sunday, June 1, 2025, at 6:00 p.m. CT (7:00 p.m. ET) during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Jessie Yeung Tel: (732) 956-8271 jessie.yeung@legendbiotech.com PRESS CONTACT: Mary Ann Ondish Tel: (914) 552-4625 media@legendbiotech.com During the webcast, Ying Huang, Ph.D., ...

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]

SOMERSET, N.J., May 13, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its first quarter 2025 unaudited financial results and key corporate highlights. "CARVYKTI, underpinned by its continued strong commercial performance, continues to set the standard for CAR-T therapies in multiple myeloma," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "We believe our achievements from this past quarter, including c ...

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]