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Should You Buy Legend Biotech (LEGN) Ahead of Earnings?
Zacks Investment Research· 2024-05-09 13:56
Investors are always looking for stocks that are poised to beat at earnings season and Legend Biotech Corporation (LEGN) may be one such company. The firm has earnings coming up pretty soon, and events are shaping up quite nicely for their report.That is because Legend Biotech is seeing favorable earnings estimate revision activity as of late, which is generally a precursor to an earnings beat. After all, analysts raising estimates right before earnings — with the most up-to-date information possible — is a ...
Legend Biotech(LEGN) - 2023 Q4 - Annual Report
2024-03-19 11:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 1 ...
Legend Biotech(LEGN) - 2023 Q4 - Annual Report
2024-03-11 11:52
Legend Biotech Reports Fourth Quarter and Full Year 2023 Results and Recent Highlights SOMERSET, N.J.—March 11, 2024— Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights. "With worldwide sales of half a billion dollars in its first full year of commercialization, our rapid, successful launch of CARVYKTI reinforces its position as a leading CAR-T therapy for p ...
Legend Biotech(LEGN) - 2023 Q3 - Quarterly Report
2023-11-20 11:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________ FORM 6-K ________________________________ Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 Date of Report: November 20, 2023 Commission File Number: 001-39307 ________________________________ Legend Biotech Corporation (Exact Name of Registrant as Specified in its Charter) ________________________________ 2101 Cottontail Lane Somerset, New Jersey 0 ...
Legend Biotech(LEGN) - 2023 Q2 - Earnings Call Transcript
2023-08-15 18:03
Financial Data and Key Metrics Changes - Total sales for CARVYKTI reached approximately $170 million in Q2 2023, representing a 63% sequential growth and a 388% increase compared to Q2 2022 [14][20] - Net loss for Q2 2023 was $199.1 million, or a loss of $0.57 per share, compared to a net loss of $193.2 million, or $0.62 per share for the same period last year [29] - Research and development expenses for Q2 2023 were $95.8 million, up from $68.8 million in the same period last year [15] Business Line Data and Key Metrics Changes - CARVYKTI's net sales in the US were $140 million, with $3 million in the EU, showing strong market penetration [27] - Collaboration revenue from CARVYKTI sales was $58.2 million, contributing to total revenues of $73.3 million for Q2 2023 [47] Market Data and Key Metrics Changes - The number of active US treatment sites for CARVYKTI increased to 54 as of June 30, 2023 [27] - The company anticipates a step-up in capacity and sales in the second half of 2023, following a ramp-up in Q2 [56] Company Strategy and Development Direction - The company aims to expand CARVYKTI's indication for earlier lines of treatment in multiple myeloma, with a PDUFA date set for April 5, 2024 [12][26] - Ongoing investments are being made to increase manufacturing capacity and improve efficiency [21][50] - The company is also advancing its pipeline for solid tumors, including LB1908 targeting Claudin 18.2 in gastric cancer [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance and demand for CARVYKTI, indicating a commitment to making the therapy accessible to more patients [21][31] - The company is focused on capturing the full potential of CARVYKTI while continuing to supply clinical programs [32] - Management noted that the out-of-spec rate has been trending down and is expected to improve further with regulatory approvals [53][108] Other Important Information - The company has a strong cash position of $1.5 billion, providing a runway through 2025 [16][43] - A three-year contract with Novartis was signed to manufacture additional clinical doses of CARVYKTI [42] Q&A Session Summary Question: What is the expectation for the out-of-spec rate with the approval of CARVYKTI for earlier lines? - Management reported that the out-of-spec rate is trending down and is expected to improve further with the FDA's approval of the wider specification [53] Question: What is the expected cadence of slots in the second half of the year? - Management indicated a step-up in capacity and sales in Q3 and Q4, following the ramp-up in Q2 [56] Question: Will the Belgian site be active by year-end for CARTITUDE-6 manufacturing? - Management confirmed that the Ghent facility is expected to be operational by the end of 2023, with plans to start enrollment for CARTITUDE-6 around that time [85] Question: How is the company addressing manufacturing maintenance? - Management stated that they will not shut down facilities for maintenance but will conduct rotations to ensure continuous operation [98] Question: What is the outlook for reimbursement challenges? - Management indicated that reimbursement for CARVYKTI has been favorable and does not foresee any issues moving forward [118]
Legend Biotech(LEGN) - 2023 Q2 - Quarterly Report
2023-05-18 12:30
Exhibit 99.1 Legend Biotech Reports First Quarter 2023 Results and Recent Highlights SOMERSET, N.J.--(BUSINESS WIRE)--May 18, 2023--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its first quarter 2023 unaudited financial results. "We are extremely pleased to announce that we have recently raised $762 million in funding. With this substantial capital in ...
Legend Biotech(LEGN) - 2023 Q1 - Quarterly Report
2023-03-30 20:01
SOMERSET, N.J.--(BUSINESS WIRE)--March 30, 2023--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its full year 2022 audited financial results. Exhibit 99.1 Legend Biotech Reports Full-Year 2022 Results and Recent Highlights "2022 was a year of significant milestones for Legend Biotech, marked by the regulatory approvals of CARVYKTI® in the U.S., Europe, ...
Legend Biotech(LEGN) - 2022 Q4 - Annual Report
2023-03-29 23:43
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR o SHELL COMPANY REPORT PURSUANT TO SECT ...
Legend Biotech(LEGN) - 2022 Q2 - Quarterly Report
2022-06-01 12:30
[First Quarter 2022 Highlights and Recent Events](index=1&type=section&id=First%20Quarter%202022%20Highlights%20and%20Recent%20Events) The first quarter of 2022 was marked by significant regulatory milestones, including U.S. FDA and European Commission approvals for CARVYKTI™ for treating multiple myeloma - Received U.S. Food and Drug Administration (FDA) approval for CARVYKTI™ (cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma, marking the company's **first approved product**[4](index=4&type=chunk)[5](index=5&type=chunk) - The European Commission (EC) granted conditional marketing authorization for CARVYKTI™ for adults with relapsed and refractory multiple myeloma[4](index=4&type=chunk)[5](index=5&type=chunk) - Achieved a **$50 million** milestone payment under its collaboration agreement with Janssen Biotech, Inc. for CARVYKTI™[4](index=4&type=chunk)[5](index=5&type=chunk) - The FDA lifted the clinical hold on Legend Biotech's Phase 1 clinical trial of LB1901, an investigational CAR-T therapy for T-cell lymphoma (TCL)[5](index=5&type=chunk) - Appointed Lori Macomber as Chief Financial Officer, Guowei Fang as Senior Vice President, Global Head of Research and Early Development, and Marc L. Harrison as Vice President and General Counsel[5](index=5&type=chunk) [Financial Results for First Quarter 2022](index=2&type=section&id=Financial%20Results%20for%20First%20Quarter%20Ended%20March%2031%2C%202022) In Q1 2022, Legend Biotech reported revenue of **$40.8 million**, a significant increase from **$13.7 million** in Q1 2021, driven by milestone payments, while net loss narrowed to **$41.1 million** due to a fair value gain on warrant liability Q1 2022 vs Q1 2021 Financial Performance | Metric | Q1 2022 (US$ Million) | Q1 2021 (US$ Million) | Change (US$ Million) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $40.8M | $13.7M | +$27.1M | Milestone achievements | | R&D Expenses | $81.3M | $71.1M | +$10.2M | More clinical trials and R&D activities | | Administrative Expenses | $12.7M | $8.7M | +$4.0M | Expansion of administrative functions | | Selling & Distribution Exp. | $21.3M | $13.4M | +$7.9M | Commercial preparation for cilta-cel | | Net Loss | $41.1M | $80.9M | -$39.8M | Fair value gain on warrant liability | | Loss Per Share | ($0.13) | ($0.30) | +$0.17 | Lower net loss | - As of March 31, 2022, cash, cash equivalents, deposits, and short-term investments totaled approximately **$796.0 million**[6](index=6&type=chunk) - A fair value gain of **$34.9 million** was recognized on a warrant liability, significantly contributing to the reduced net loss, with the warrant's fair value decreasing from **$87.9 million** at year-end 2021 to **$53.0 million** as of March 31, 2022[14](index=14&type=chunk) [Company and Product Overview](index=3&type=section&id=About%20Legend%20Biotech) Legend Biotech is a global biotechnology company focused on developing advanced cell therapies like CAR-T for life-threatening diseases, particularly multiple myeloma, with its lead product CARVYKTI™ recently gaining U.S. and European approvals [About Legend Biotech](index=3&type=section&id=About%20Legend%20Biotech) Legend Biotech is a global biotechnology company headquartered in Somerset, New Jersey, focused on developing advanced cell therapies utilizing various technology platforms with R&D sites globally - The company is dedicated to treating and potentially curing life-threatening diseases through advanced cell therapies[16](index=16&type=chunk) - Key technology platforms include autologous and allogenic chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy[16](index=16&type=chunk) [About CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel)](index=4&type=section&id=About%20CARVYKTI%E2%84%A2%20%28Ciltacabtagene%20autoleucel%3B%20cilta-cel%29) CARVYKTI™ is a BCMA-directed, genetically modified autologous T-cell immunotherapy for treating multiple myeloma, developed in collaboration with Janssen, and recently received FDA and European Commission approvals - CARVYKTI™ is a BCMA-directed autologous T-cell immunotherapy that reprograms a patient's own T-cells to identify and eliminate cells expressing BCMA[18](index=18&type=chunk) - Legend Biotech entered an exclusive worldwide license and collaboration agreement with Janssen in December 2017 to develop and commercialize cilta-cel[18](index=18&type=chunk) - CARVYKTI™ received U.S. FDA approval in February 2022 and European Commission conditional marketing authorization in May 2022[19](index=19&type=chunk) [About Multiple Myeloma](index=4&type=section&id=About%20Multiple%20Myeloma) Multiple myeloma is an incurable blood cancer characterized by excessive plasma cell proliferation in the bone marrow, with patients relapsing after standard therapies facing poor prognoses and limited treatment options - Multiple myeloma is an incurable blood cancer originating in the bone marrow, characterized by excessive plasma cell proliferation[20](index=20&type=chunk) - Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few available treatment options[20](index=20&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements for Q1 2022 show a net loss of **$41.1 million**, an improvement from **$80.9 million** in Q1 2021, with total assets at **$1.04 billion** and total liabilities at **$602.0 million** [Condensed Consolidated Statements of Profit or Loss](index=6&type=section&id=LEGEND%20BIOTECH%20CORPORATION%0ACONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20PROFIT%20OR%20LOSS) For the three months ended March 31, 2022, Legend Biotech reported a net loss of **$41.1 million**, or **$0.13** per share, a significant improvement from a net loss of **$80.9 million**, or **$0.30** per share, in the same period of 2021 Condensed Consolidated Statements of Profit or Loss (Unaudited) | (in thousands, US$) | Three months ended March 31, 2022 (US$ thousands) | Three months ended March 31, 2021 (US$ thousands) | | :--- | :--- | :--- | | **REVENUE** | **40,827** | **13,682** | | Research and development expenses | (81,346) | (71,072) | | Selling and distribution expenses | (21,302) | (13,417) | | Fair value gain of warrant liability | 34,900 | - | | **LOSS FOR THE PERIOD** | **(41,087)** | **(80,899)** | | Loss per share – basic & diluted | (0.13) | (0.30) | [Condensed Consolidated Statements of Financial Position](index=7&type=section&id=LEGEND%20BIOTECH%20CORPORATION%0ACONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20FINANCIAL%20POSITION) As of March 31, 2022, Legend Biotech's total assets were **$1.04 billion**, down from **$1.12 billion** at year-end 2021, mainly due to a decrease in cash and cash equivalents, while total liabilities decreased to **$602.0 million** Condensed Consolidated Statements of Financial Position (Unaudited) | (in thousands, US$) | March 31, 2022 (US$ thousands) | December 31, 2021 (US$ thousands) | | :--- | :--- | :--- | | **Total assets** | **1,040,516** | **1,118,367** | | Cash and cash equivalents | 377,786 | 688,938 | | **Total liabilities** | **601,953** | **647,161** | | Warrant liability | 53,000 | 87,900 | | **Total equity** | **438,563** | **471,206** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=LEGEND%20BIOTECH%20CORPORATION%0ACONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the first quarter of 2022, the company experienced a net decrease in cash and cash equivalents of **$311.2 million**, with **$78.7 million** used in operating activities and **$232.5 million** in investing activities Condensed Consolidated Statements of Cash Flows (Unaudited) | (in thousands, US$) | Three months ended March 31, 2022 (US$ thousands) | Three months ended March 31, 2021 (US$ thousands) | | :--- | :--- | :--- | | CASH FLOWS USED IN OPERATING ACTIVITIES | (78,687) | (26,787) | | CASH FLOWS USED IN INVESTING ACTIVITIES | (232,500) | (17,150) | | NET DECREASE IN CASH AND CASH EQUIVALENTS | (311,162) | (43,730) | | CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | 377,786 | 412,296 | [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section contains standard "forward-looking statements" disclaimers, warning that actual results may differ from expectations due to various risks and uncertainties, and the company disclaims any obligation to update these statements - The press release includes forward-looking statements concerning strategies, objectives, and expectations for CARVYKTI™ and other product candidates[21](index=21&type=chunk) - Actual results may differ due to factors like unexpected clinical trial results, regulatory delays, patent challenges, competition, and the COVID-19 pandemic[21](index=21&type=chunk)
Legend Biotech(LEGN) - 2021 Q4 - Annual Report
2022-03-31 12:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...