Financial Data and Key Metrics - CARVYKTI net trade sales in Q3 2024 were approximately $286 million, representing an 87.6% year-over-year increase and a 53.2% quarter-over-quarter increase [13] - Total revenues for Q3 2024 were $160 million, consisting of $143 million in collaboration revenue and $17 million in license revenue [23] - Net loss for Q3 2024 was $125 million, or $0.34 per share, compared to a net loss of $62 million, or $0.17 per share, in the same period last year [24] - Unrealized foreign exchange losses of $63 million were incurred in Q3 2024, primarily due to intercompany transactions between U S and non-U S legal entities [24] Business Line Data and Key Metrics - CARVYKTI achieved a 45% reduction in the risk of death compared to standard therapies after a three-year follow-up period, marking a significant milestone in multiple myeloma treatment [8] - CARVYKTI maintained significant improvement in progression-free survival compared to standard of care [9] - Over 4,000 patients have been treated with CARVYKTI, with a very low incidence of parkinsonism [10] - CARVYKTI received approval from China's National Medical Products Administration for fourth-line plus treatment [11] Market Data and Key Metrics - CARVYKTI is commercially available in Switzerland, the United States, Germany, Austria, and Brazil [15] - Outpatient treatment now comprises up to 48% of CARVYKTI volume, representing a significant growth opportunity [16] - CARVYKTI has achieved nearly 90% market share in the BCMA CAR-T class of sales in the U S and Germany [16] - OUS sales increased over 100% year-over-year and 35% quarter-over-quarter, driven by capacity expansion and launch efforts [14] Company Strategy and Industry Competition - The company is focusing on expanding CARVYKTI's market share in earlier lines of treatment, with expectations that the majority of patients will be treated in the CARTITUDE-4 population by next year [51] - A new research facility in Philadelphia is being built to expedite innovative cell therapy research, with operations expected to begin in summer 2025 [20] - The company is prioritizing markets such as the U S and Europe over China due to supply constraints and availability of lentiviral vector [103] - CARVYKTI's delayed CRS onset profile allows for extensive outpatient administration, providing a competitive advantage [16][73] Management Commentary on Operating Environment and Future Outlook - Management expects sequential growth in Q4 2024, driven by continued demand and manufacturing efficiencies [14] - The company plans to submit CARTITUDE-4 overall survival results to regulatory authorities in the U S and Europe to update the label [10] - Management highlighted the importance of outpatient treatment as a key differentiator for CARVYKTI, especially as the number of patients increases [16] - The company believes it has sufficient capital to fund operating and capital expenditures into 2026, when it expects to achieve operating profitability [31] Other Important Information - The company appointed Alan Bash as President of the CARVYKTI business unit to oversee its continued growth [17] - Enrollment for the CARTITUDE-5 trial is complete, and enrollment for CARTITUDE-6 is expected to be completed next year [19] - The company is exploring the use of MRD negativity as a potential endpoint for CARTITUDE-6, with plans to discuss this with the FDA [91] - The company is actively engaging with patient advocacy groups and community DPOs to expand CARVYKTI's reach in the outpatient setting [121] Q&A Session Summary Question: What are the key data points to focus on for the upcoming ASH update? - The company emphasized the importance of durability and progression-free survival (PFS) in evaluating CARVYKTI's efficacy, with nearly three years of PFS demonstrated in the CARTITUDE-1 trial [38] - Safety data, particularly the low incidence of neurotoxicity and parkinsonism, was highlighted as a key focus area [39] Question: How should we think about quarter-over-quarter growth in Q4 2024? - Management confirmed expectations of sequential growth in Q4 2024, driven by continued demand and manufacturing efficiencies [46] Question: What are the drivers of outpatient adoption for CARVYKTI? - Outpatient adoption is driven by the delayed CRS onset profile of CARVYKTI, which allows for remote monitoring and reduces hospital burden [55][73] Question: What are the expectations for Europe following the approval of commercial production in Belgium? - Europe's adoption of CAR-T therapies has been slower due to pricing negotiations, but the company expects growth in key markets like Germany [83][84] Question: What is the timeline for updates on CARTITUDE-2 cohorts E and F? - Longer follow-up is needed for CARTITUDE-2 cohorts E and F, as these patients typically have prolonged courses, including extensive PFS [90][111] Question: How is the company managing neurotoxicity concerns in earlier lines of treatment? - The company is exploring the use of steroids and ALC monitoring to mitigate neurotoxicity, with plans to incorporate these strategies into future trials [94][99] Question: What are the company's plans for the China launch? - The company is prioritizing U S and European markets due to supply constraints, with ongoing discussions with Johnson & Johnson regarding the China launch [103] Question: What are the implications of the FDA reconsidering black box warnings on CAR-T products? - The company has not had specific discussions with the FDA regarding secondary primary malignancies but noted that the incidence rate is similar to standard therapies [107][108] Question: What are the drivers of the accelerated approval for commercial production in Belgium? - The approval was driven by the quality of the manufacturing operation at the Obelisc facility, with no additional regulatory requirements needed for commercial production in Europe [116][117]

Core Insights - Legend Biotech Corporation reported $160.21 million in revenue for Q3 2024, a year-over-year increase of 66.9% [1] - The EPS for the same period was -$0.34, compared to -$0.17 a year ago, indicating a decline in profitability [1] - The revenue exceeded the Zacks Consensus Estimate of $144.7 million by 10.72%, while the EPS surprise was +39.29% against the consensus estimate of -$0.56 [1] Revenue Breakdown - Collaboration revenues were $142.83 million, surpassing the average estimate of $132.16 million from seven analysts [3] - License revenues reached $17.10 million, exceeding the average estimate of $13.90 million from five analysts [3] - Other revenues were $0.28 million, falling short of the estimated $2.46 million from two analysts [3] Stock Performance - Over the past month, Legend Biotech's shares have returned -19.4%, contrasting with the Zacks S&P 500 composite's +3.3% change [4] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for outperformance in the near term [4]

Revenue Performance - Total revenue for the nine months ended September 30, 2024, was $440.72 million, a 114% increase from $205.68 million in the same period of 2023[14] - License revenue reached $120.12 million, up from $35.17 million year-over-year, representing a 241% increase[14] - Collaboration revenue increased to $314.56 million, compared to $170.37 million in the prior year, marking an 84% growth[14] - Total revenue for the nine months ended September 30, 2024, was $440.7 million, a significant increase of $235.0 million compared to $205.7 million for the same period in 2023[69] - License revenue increased to $120.1 million for the nine months ended September 30, 2024, up from $35.2 million in 2023, driven by $40.0 million from milestones under the Janssen Agreement and $45.0 million from the Novartis License Agreement[70][71] - Collaboration revenue rose to $314.6 million in 2024, compared to $170.4 million in 2023, primarily due to increased sales of CARVYKTI under the Janssen Agreement[72] Financial Loss and Improvement - The loss for the period was $203.31 million, a significant improvement from a loss of $373.44 million in the same period of 2023[14] - Basic and diluted loss per share improved to $0.56 from $1.07 year-over-year[14] - The loss for the nine months ended September 30, 2024, is $203.3 million, compared to a loss of $373.4 million for the same period in 2023, representing a 45.6% improvement[23] - Net loss for the period was $203.3 million, or ($0.56) per share, compared to a net loss of $373.4 million, or ($1.07) per share, for the same period in 2023, indicating improved financial performance[84] Assets and Liabilities - Total assets as of September 30, 2024, were $1.74 billion, down from $1.85 billion at the end of 2023[16] - Total liabilities increased to $619.72 million from $597.24 million at the end of 2023[16] - Total equity as of September 30, 2024, is $1,116.1 million, a decrease from $1,339.6 million as of September 30, 2023[19] - Cash and cash equivalents decreased to $459.28 million from $1.28 billion at the end of 2023[16] - Cash and cash equivalents as of September 30, 2024, totaled approximately $0.46 billion, with time deposits of approximately $0.76 billion, providing liquidity to fund operations into 2026[87][85] Cash Flow and Investment Activities - Cash used in operating activities for the nine months ended September 30, 2024, is $61.96 million, significantly reduced from $297.63 million in 2023[25] - Net cash used in investing activities for the nine months ended September 30, 2024, is $762.70 million, compared to $314.72 million in 2023, indicating increased investment activity[25] - Net cash provided by financing activities for the nine months ended September 30, 2024, was $6.0 million, a decrease from $790.6 million in 2023, reflecting reduced capital raising activities[95][96] Expenses - Research and development expenses rose to $309.11 million, compared to $276.54 million in the prior year, reflecting a 12% increase[14] - Administrative expenses increased to $102.58 million from $78.06 million year-over-year, a 31% rise[14] - The company recognized equity-settled share-based compensation expense of $55.55 million for the nine months ended September 30, 2024, compared to $35.09 million in 2023, reflecting increased compensation costs[25] - Research and development expenses for the nine months ended September 30, 2024, were $309.1 million, an increase of $32.6 million from $276.5 million in 2023, reflecting ongoing investment in cilta-cel and solid tumor programs[76] Inventory and Receivables - The company experienced a decrease in trade receivables of $99.34 million in the nine months ended September 30, 2024, compared to a minimal change in 2023[23] - The company reported a provision for inventory reserve of $6.83 million for the nine months ended September 30, 2024, compared to $1.34 million in 2023, indicating increased inventory risk management[23] - The reserve for inventory increased to $15.8 million as of September 30, 2024, compared to $8.9 million at the end of 2023, indicating higher expired materials[47] Shareholder and Financing Activities - The company issued ordinary shares resulting in a total increase in equity of $234.41 million from private placements and $349.28 million from registered direct offerings during the nine months ended September 30, 2023[19] - The weighted average number of ordinary shares in issue increased to 365,268,372 for the nine months ended September 30, 2024, from 348,293,363 in the prior year[40] - The company issued and fully paid 366,901,007 ordinary shares as of September 30, 2024, an increase from 363,822,069 shares as of December 31, 2023[55] Future Outlook and Plans - The company expects to incur significant capital expenditures in the coming years to ramp up manufacturing capabilities for CARVYKTI and advance clinical development programs[85] - The company expects expenses to increase due to ongoing research and development, clinical trials, and commercialization efforts for CARVYKTI, necessitating substantial additional funding[97] - Existing cash and cash equivalents are projected to fund operating expenses and capital expenditures for at least the next 12 months, despite potential fluctuations in cash requirements[98] - The company has a broad portfolio of earlier-stage product candidates, but may not generate necessary data for marketing approval, requiring continued reliance on additional financing[99] - Financing needs will be met through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing shareholders[100] Regulatory and Market Developments - The company received China's NMPA approval for CARVYKTI for the treatment of fourth-line plus multiple myeloma[66] - The company initiated commercial production at the Obelisc facility in Ghent, Belgium, and launched CARVYKTI in Switzerland during the third quarter[66] - The Novartis License Agreement, effective December 28, 2023, includes an upfront payment of $100 million and potential milestone payments of up to $1.01 billion[36] Economic and Risk Factors - The company has not experienced material impacts on its supply chain due to inflation and rising interest rates, maintaining robust sourcing strategies[67] - Inflation has not materially affected the company's financial condition or results of operations during the nine months ended September 30, 2024 and 2023[105] - The company does not believe it is exposed to any material foreign currency exchange rate risk[106]

Core Viewpoint - Shares of Legend Biotech Corporation (LEGN) have recently declined by 9.8% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1] Group 1: Technical Analysis - The hammer chart pattern indicates that the stock may have found support, signaling a possible bottom and a reversal in trend [1] - A hammer pattern forms when there is a small candle body with a long lower wick, suggesting that bears may be losing control over the price during a downtrend [2] - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors, although it should be used alongside other bullish indicators for confirmation [2] Group 2: Fundamental Analysis - Recent upward revisions in earnings estimates for LEGN serve as a bullish indicator, with the consensus EPS estimate increasing by 1.9% over the last 30 days, reflecting analysts' agreement on the company's improved earnings potential [3] - LEGN holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [3] - The Zacks Rank is recognized as an effective timing indicator, suggesting that LEGN's prospects are beginning to improve, further supporting the case for a potential turnaround [3]

New data will showcase significantly increased and sustained minimal residual disease (MRD) negativity rates, reinforcing the potential of CARVYKTI to transform outcomes in refractory multiple myeloma MRD data to be featured in oral presentation at the 66th Annual American Society of Hematology (ASH) Annual Meeting SOMERSET, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will present new data on minimal residual disease (M ...

Core Insights - Legend Biotech Corporation has appointed Alan Bash as the President of CARVYKTI®, a newly created role aimed at managing the growth of the CARVYKTI® franchise [1][2] - The appointment follows recent successes for CARVYKTI®, including approvals from the U.S. FDA and European Commission for label expansion [2] - Alan Bash brings extensive experience in oncology, having previously served as CEO for two biotech companies and held leadership roles at Bristol Myers Squibb [2][3] Company Overview - Legend Biotech is a global biotechnology company focused on developing advanced cell therapies for life-threatening diseases [4] - The company operates from its headquarters in Somerset, New Jersey, and has three R&D sites worldwide [4] - Legend Biotech is engaged in various technology platforms, including CAR-T cell therapies and other immunotherapies [4] Leadership and Strategy - Alan Bash's role will encompass overseeing commercial, technical operations, and quality functions related to CARVYKTI® [1][2] - The company aims to leverage Bash's operational knowledge to strengthen its leadership in multiple myeloma treatment [2] - CARVYKTI® is noted as the fastest launched CAR-T product on the market, indicating strong market momentum [3] Future Outlook - The company expresses confidence in CARVYKTI®'s potential to transform treatment paradigms for multiple myeloma [3] - Collaboration with Johnson & Johnson is highlighted as a key partnership in fulfilling CARVYKTI®'s potential [3]

Legend Biotech Corporation Sponsored ADR (LEGN) closed the last trading session at $43.95, gaining 0.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $83.87 indicates a 90.8% upside potential.The average comprises 19 short-term price targets ranging from a low of $60 to a high of $95, with a standard deviation of $9.51. While the lowest estimate indicates an increase of 36.5% fro ...

Investment Rating - The report maintains a "Buy" rating for the company, Legend Biotech (LEGN US), with a target price of $76, indicating a potential upside of 53% from the current price of $49.68 [4]. Core Insights - The sales of CARVYKTI® (cilta-cel) in Q3 2024 exceeded expectations, recording $286 million, a year-on-year increase of 88% and a quarter-on-quarter increase of 54%. This performance surpassed market consensus expectations of $241 million and the report's own forecast of $274 million [1]. - The significant growth in sales is attributed to the increasing treatment demand following the approval of early relapsed multiple myeloma indications, improved clinical data driving market share gains, and the gradual release of new production capacity [1]. - The report anticipates that the momentum in sales will continue into Q4 2024, with a projected sales figure of $322 million for that quarter, representing a 13% increase from Q3 2024 [1]. - CARVYKTI® was approved for sale in China in August 2024, which is expected to contribute significantly to future sales growth [1]. - The report maintains its full-year sales forecast for CARVYKTI® at $951 million, with a peak sales expectation exceeding $7 billion [1]. Summary by Sections - **Sales Performance**: Q3 2024 sales of CARVYKTI® reached $286 million, up 88% year-on-year and 54% quarter-on-quarter, driven by increased demand and market share gains [1]. - **Production Capacity**: The report notes that production capacity is steadily being released, with Johnson & Johnson confirming the approval of commercial production capacity in Ghent, Belgium [1]. - **Future Outlook**: The report expresses confidence in the continued outperformance of CARVYKTI® sales, supported by strong clinical data and the recent approval in China, projecting a robust long-term market potential [1].

Core Insights - Legend Biotech Corporation is establishing a new R&D facility in Philadelphia, Pennsylvania, to enhance its next-generation cell therapies portfolio [1][2] - The new facility will support Legend's commitment to R&D and strengthen its position in cell therapy innovation [2][3] Company Expansion - The Philadelphia facility will be 31,000 square feet and is expected to be completed in Q3 2025 [2] - Legend Biotech currently has over 1,200 employees in the U.S. and plans to employ 55 full-time staff at the new site [2] Strategic Importance - The new facility will allow Legend to leverage its proximity to leading academic institutions in Philadelphia, enhancing collaboration and innovation in medical breakthroughs [3] - The expansion builds on Legend's existing R&D presence in the U.S., including a facility in Piscataway, New Jersey [2]

Landmark CARTITUDE-4 study results show CARVYKTI® reduced the risk of death by 45 percent after three-year follow-up Late-breaking data featured in an oral presentation at the 21st International Myeloma Society Annual Meeting SOMERSET, N.J., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced late-breaking three-year follow-up data from the Phase 3 CARTITUDE-4 study that shows a single infusion of CARVYKTI® (ciltacab ...