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]

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]

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]

May 13, 2025 First Quarter 2025 Financial Results & Corporate Update This presentation is for investor relations purposes only - Not for product promotional purposes 1 Agenda | 1 | Opening Remarks | | --- | --- | | 2 | Q1 2025 Performance Overview | | 3 | Our Pipeline | | 4 | Upcoming Milestones | | 5 | CARVYKTI® Performance Overview | | 6 | Financial Performance | | 7 | Q&A | 2 This presentation is for investor relations purposes only - Not for product promotional purposes Ying Huang, PhD Chief Executive O ...

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]

Group 1 - Legend Biotech Corporation's shares increased by 5.1% to close at $33.74, following a notable trading volume, despite a 15.4% loss over the past four weeks [1] - The surge in stock price is attributed to investor optimism regarding the strong sales of Carvykti, a treatment for relapsed or refractory multiple myeloma, developed in collaboration with Johnson & Johnson [2] - The company is expected to report a quarterly loss of $0.34 per share, reflecting a year-over-year change of -112.5%, while revenues are anticipated to reach $190.47 million, a 102.7% increase from the previous year [2] Group 2 - The consensus EPS estimate for Legend Biotech has been revised 4.6% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - Legend Biotech holds a Zacks Rank of 3 (Hold), while BioMarin Pharmaceutical, another company in the same industry, has a Zacks Rank of 2 (Buy) [4][5] - BioMarin's EPS estimate for the upcoming report has changed by -0.3% to $0.95, representing a year-over-year change of +33.8% [5]