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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 ...
Legend Biotech(LEGN) - 2022 Q1 - Quarterly Report
2022-03-18 20:10
Exhibit 99.1 Legend Biotech Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights SOMERSET, N.J.--(BUSINESS WIRE)--March 18, 2022--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies, today reported unaudited financial results for the fourth quarter of 2021. "Legend Biotech ended the fourth quarter with strong data on our lead product candidate and nearly $900 million in cash," sa ...
Legend Biotech (LEGN) Investor Presentation - Slideshow
2021-12-13 20:16
Inspired by the human element to advance cell therapy December 2021 Unleashing the power of patients Disclaimer 2 This presentation has been prepared by Legend Biotech Corporation ("Legend Biotech" or the "Company") solely for information purpose and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established. There is no guarantee that the agents will receive health authorit ...
Legend Biotech (LEGN) Investor Presentation - Slideshow
2021-10-07 17:23
Inspired by the human element to advance cell therapy October 2021 Unleashing the power of patients Disclaimer 2 This presentation has been prepared by Legend Biotech Corporation ("Legend Biotech" or the "Company") solely for information purpose and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established. There is no guarantee that the agents will receive health authority ...
Legend Biotech Corporation (LEGN) Investor Presentations - Slideshow
2021-09-02 19:24
Inspired by the human element to advance cell therapy September 2021 Unleashing the power of patients Disclaimer 2 This presentation has been prepared by Legend Biotech Corporation ("Legend Biotech" or the "Company") solely for information purpose and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established. There is no guarantee that the agents will receive health authori ...
Legend Biotech (LEGN) Investor Presentation - Slideshow
2021-05-15 00:17
Inspired by the human element to advance cell therapy May 2021 Unleashing the power of patients Disclaimer 2 This presentation has been prepared by Legend Biotech Corporation ("Legend Biotech" or the "Company") solely for information purpose and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established. There is no guarantee that the agents will receive health authority app ...
Legend Biotech(LEGN) - 2020 Q4 - Annual Report
2021-04-02 12:10
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, 2020 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 ...
Legend Biotech(LEGN) - 2020 Q4 - Earnings Call Transcript
2021-03-18 13:43
Legend Biotech Corporation (NASDAQ:LEGN) Q4 2020 Earnings Conference Call March 18, 2021 8:00 AM ET Company Participants Jessie Yeung - Head of Corporate Finance & Investor Relations Ying Huang - Chief Executive Officer & Chief Financial Officer Conference Call Participants Matthew Harrison - Morgan Stanley Biren Amin - Jefferies Operator Ladies and gentlemen, thank you for standing by and welcome to the Legend Biotech Reports Fourth Quarter 2020 Financial Results. At this time, all participant lines are in ...