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[6-K] Legend Biotech Corp Current Report (Foreign Issuer)

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Legend Biotech (LEGN) reported preliminary CARVYKTI sales of approximately $524 million in net trade sales for the quarter ended September 30, 2025. The figure was provided by collaboration partner Janssen under their existing agreement.

Legend Biotech noted it has not independently verified this sales number. The final determination of revenue and gross profit for this period will be made upon completion of its financial statements, and the company’s independent auditors have not audited or reviewed the data. The filing also includes forward‑looking statements language regarding expectations for CARVYKTI sales and profitability.

Legend Biotech (LEGN) ha riportato vendite preliminari di CARVYKTI di circa $524 milioni in vendite nette commerciali per il trimestre chiuso il 30 settembre 2025. La cifra è stata fornita dal partner di collaborazione Janssen in base al loro accordo esistente.

Legend Biotech ha precisato di non avere verificato in autonomia questo numero di vendite. La determinazione finale del reddito e del margine lordo per questo periodo sarà effettuata al completamento delle sue forniture finanziarie, e i revisori indipendenti della società non hanno auditato né esaminato i dati. Anche la presentazione contiene clausole di dichiarazioni previsionali riguardanti le aspettative sulle vendite e sulla redditività di CARVYKTI.

Legend Biotech (LEGN) reportó ventas preliminares de CARVYKTI de aproximadamente $524 millones en ventas netas de comercio para el trimestre finalizado el 30 de septiembre de 2025. La cifra fue proporcionada por el socio de colaboración Janssen bajo su acuerdo existente.

Legend Biotech señaló que no ha verificado de forma independiente este número de ventas. La determinación final de los ingresos y la utilidad bruta para este periodo se realizará al completar sus estados financieros, y los auditores independientes de la empresa no han auditado ni revisado los datos. La presentación también incluye lenguaje de declaraciones a futuro respecto a las expectativas de ventas de CARVYKTI y de su rentabilidad.

Legend Biotech (LEGN)은 CARVYKTI 매출의 예비치를 보고했습니다 대략 $524백만의 순 매출로 2025년 9월 30일 종료 분기에 대한 분기입니다. 이 수치는 기존 계약에 따라 협력 파트너인 Janssen이 제공했습니다.

Legend Biotech는 이 매출 수치를 독립적으로 확인하지 않았다고 밝혔습니다. 이 기간의 수익 및 총이익의 최종 결정은 재무제표 작성이 완료된 후에 이루어지며, 회사의 독립 감사인은 감사 또는 검토를 실시하지 않았다고 합니다. 또한 제출서는 CARVYKTI 매출 및 수익성에 대한 기대치를 다루는 전향적 진술 문구를 포함합니다.

Legend Biotech (LEGN) a publié des ventes préliminaires de CARVYKTI d’environ $524 millions en ventes nettes commerciales pour le trimestre clos le 30 septembre 2025. Le chiffre a été fourni par le partenaire de collaboration Janssen dans le cadre de leur accord existant.

Legend Biotech a précisé qu’il n’a pas vérifié indépendamment ce chiffre de ventes. La détermination finale du chiffre d’affaires et du résultat brut pour cette période sera effectuée lors de l’achèvement de ses états financiers, et les auditeurs indépendants de la société n’ont pas audité ni examiné les données. Le document de dépôt comprend également un langage sur les déclarations prospectives concernant les attentes de ventes de CARVYKTI et leur rentabilité.

Legend Biotech (LEGN) meldete vorläufige CARVYKTI-Umsätze von etwa $524 Millionen in Nettoumsätzen für das Quartal zum 30. September 2025. Die Zahl wurde vom Kooperationspartner Janssen gemäß ihrer bestehenden Vereinbarung bereitgestellt.

Legend Biotech hat darauf hingewiesen, dass es diese Verkaufszahl nicht unabhängig verifiziert hat. Die endgültige Bestimmung von Umsatz und Bruttogewinn für diesen Zeitraum erfolgt mit Abschluss der Finanzberichterstattung, und die unabhängigen Wirtschaftsprüfer des Unternehmens haben dieser Daten weder geprüft noch begutachtet.
Die Einreichung enthält auch Formulierungen zu zukunftsgerichteten Aussagen hinsichtlich der Erwartungen für CARVYKTI-Umsätze und Rentabilität.

Legend Biotech (LEGN) أبلغت عن مبيعات CARVYKTI الأولية بما يقرب من $524 مليون في صافي مبيعات التجارة للربع المنتهي في 30 سبتمبر 2025. وقد قدمت هذه الأرقام من قبل شريك التعاون Janssen بموجب اتفاقهم القائم.

أشارت Legend Biotech إلى أنها لم تتحقق من هذا الرقم بشكل مستقل. ستتم التحديد النهائي للإيرادات والربح الإجمالي لهذه الفترة عند إكمال بياناتها المالية، ولم تقم مدققة الشركة المستقلة بـتدقيق البيانات أو مراجعتها. كما يشمل التسجيل أيضاً نصوص حول تصريحات مستقبلية تتعلق بتوقعات مبيعات CARVYKTI وربحيتها.

Legend Biotech (LEGN) 报告 CARVYKTI 的初步销售,在截至 2025 年 9 月 30 日 的季度中净贸易销售大约为 $524 百万美元。该数字由合作伙伴 Janssen 根据其现有协议提供。

Legend Biotech 指出它未对这一销售数字进行 独立核实。该期间的收入和毛利的最终确定将在完成其财务报表时做出,公司独立审计师也 未对该数据进行审计或复核。提交文件还包含关于 CARVYKTI 销售额和盈利能力预期的前瞻性陈述语言。

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Insights

Preliminary partner-reported CARVYKTI sales of $524M, unaudited.

Legend Biotech disclosed approximately $524 million in CARVYKTI net trade sales for the quarter ended September 30, 2025, based on data from partner Janssen. This reflects product demand but is a partner-reported metric, not yet tied to Legend’s recognized revenue.

The company states it has not independently verified the sales figure, and its auditors have performed no procedures. Recognition of revenue and gross profit will follow the completion of Legend’s financial statements, which could differ from trade sales.

Key dependencies include partner reporting and standard closing procedures. Subsequent filings may provide the recognized revenue and gross profit for the period once management finalizes the accounts.

Legend Biotech (LEGN) ha riportato vendite preliminari di CARVYKTI di circa $524 milioni in vendite nette commerciali per il trimestre chiuso il 30 settembre 2025. La cifra è stata fornita dal partner di collaborazione Janssen in base al loro accordo esistente.

Legend Biotech ha precisato di non avere verificato in autonomia questo numero di vendite. La determinazione finale del reddito e del margine lordo per questo periodo sarà effettuata al completamento delle sue forniture finanziarie, e i revisori indipendenti della società non hanno auditato né esaminato i dati. Anche la presentazione contiene clausole di dichiarazioni previsionali riguardanti le aspettative sulle vendite e sulla redditività di CARVYKTI.

Legend Biotech (LEGN) reportó ventas preliminares de CARVYKTI de aproximadamente $524 millones en ventas netas de comercio para el trimestre finalizado el 30 de septiembre de 2025. La cifra fue proporcionada por el socio de colaboración Janssen bajo su acuerdo existente.

Legend Biotech señaló que no ha verificado de forma independiente este número de ventas. La determinación final de los ingresos y la utilidad bruta para este periodo se realizará al completar sus estados financieros, y los auditores independientes de la empresa no han auditado ni revisado los datos. La presentación también incluye lenguaje de declaraciones a futuro respecto a las expectativas de ventas de CARVYKTI y de su rentabilidad.

Legend Biotech (LEGN)은 CARVYKTI 매출의 예비치를 보고했습니다 대략 $524백만의 순 매출로 2025년 9월 30일 종료 분기에 대한 분기입니다. 이 수치는 기존 계약에 따라 협력 파트너인 Janssen이 제공했습니다.

Legend Biotech는 이 매출 수치를 독립적으로 확인하지 않았다고 밝혔습니다. 이 기간의 수익 및 총이익의 최종 결정은 재무제표 작성이 완료된 후에 이루어지며, 회사의 독립 감사인은 감사 또는 검토를 실시하지 않았다고 합니다. 또한 제출서는 CARVYKTI 매출 및 수익성에 대한 기대치를 다루는 전향적 진술 문구를 포함합니다.

Legend Biotech (LEGN) a publié des ventes préliminaires de CARVYKTI d’environ $524 millions en ventes nettes commerciales pour le trimestre clos le 30 septembre 2025. Le chiffre a été fourni par le partenaire de collaboration Janssen dans le cadre de leur accord existant.

Legend Biotech a précisé qu’il n’a pas vérifié indépendamment ce chiffre de ventes. La détermination finale du chiffre d’affaires et du résultat brut pour cette période sera effectuée lors de l’achèvement de ses états financiers, et les auditeurs indépendants de la société n’ont pas audité ni examiné les données. Le document de dépôt comprend également un langage sur les déclarations prospectives concernant les attentes de ventes de CARVYKTI et leur rentabilité.

Legend Biotech (LEGN) meldete vorläufige CARVYKTI-Umsätze von etwa $524 Millionen in Nettoumsätzen für das Quartal zum 30. September 2025. Die Zahl wurde vom Kooperationspartner Janssen gemäß ihrer bestehenden Vereinbarung bereitgestellt.

Legend Biotech hat darauf hingewiesen, dass es diese Verkaufszahl nicht unabhängig verifiziert hat. Die endgültige Bestimmung von Umsatz und Bruttogewinn für diesen Zeitraum erfolgt mit Abschluss der Finanzberichterstattung, und die unabhängigen Wirtschaftsprüfer des Unternehmens haben dieser Daten weder geprüft noch begutachtet.
Die Einreichung enthält auch Formulierungen zu zukunftsgerichteten Aussagen hinsichtlich der Erwartungen für CARVYKTI-Umsätze und Rentabilität.

 
 

 

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: October 14, 2025

 

Commission File Number: 001-39307

 

 

Legend Biotech Corporation

(Exact Name of Registrant as Specified in its Charter)

 

 

 

2101 Cottontail Lane

Somerset, New Jersey 08873

(Address of principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F  ☒            Form 40-F  ☐

 

 

 

 

 

Legend Biotech Announces Preliminary Sales for CARVYKTI® for the Quarter Ended September 30, 2025

 

Pursuant to the Collaboration and License Agreement dated as of December 21, 2017, as amended, between Legend Biotech USA Inc., Legend Biotech Ireland Limited, Janssen Biotech, Inc. and Janssen Pharmaceutica NV (together, “Janssen”), on October 14, 2025, Legend Biotech Corporation (“Legend Biotech”) announced that CARVYKTI® generated approximately $524 million in net trade sales during the quarter ended September 30, 2025. The net trade sales figure is based on information provided to Legend Biotech by Janssen, and Legend Biotech has not independently verified the accuracy of such sales figure.

 

The sales figure is based on information available to Legend Biotech as of the date of this Form 6-K, and the determination of the amount of any revenue or gross profit to be recorded in Legend Biotech’s consolidated statement of operations is subject to completion by management of Legend Biotech of its financial statements as of and for the period ended September 30, 2025. Legend Biotech’s independent registered public accountants have not audited, reviewed or performed any procedures with respect to this data and accordingly they have not expressed an opinion or provided any other form of assurance with respect thereto.

 

Cautionary Note Regarding Forward-Looking Statements

 

Statements in this report on Form 6-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to CARVYKTI®, including Legend Biotech’s expectations for net trade sales and resulting gross profit of CARVYKTI®. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of the Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Form 6-K as anticipated, believed, estimated or expected. Any forward-looking statements contained in this Form 6-K speak only as of the date of this Form 6-K. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

This report on Form 6-K is hereby incorporated herein by reference in the registration statements of Legend Biotech on Form F-3 (Nos. 333-278050, 333-272222 and 333-257625) and Form S-8 (No. 333-239478 and 333-283217), to the extent not superseded by documents or reports subsequently filed.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    LEGEND BIOTECH CORPORATION
       
Date:  October 14, 2025   By: /s/ Ying Huang
    Name: Ying Huang, Ph.D.
    Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FAQ

What preliminary CARVYKTI sales did LEGN report for Q3 2025?

Legend Biotech reported approximately $524 million in CARVYKTI net trade sales for the quarter ended September 30, 2025.

Who provided the CARVYKTI sales data to LEGN?

The sales figure was provided by Janssen under the companies’ collaboration and license agreement.

Has the $524 million CARVYKTI sales figure been audited or reviewed?

No. Legend Biotech has not independently verified the figure, and its independent auditors have not audited or reviewed it.

Will the $524 million equal LEGN’s recognized revenue for Q3 2025?

Not necessarily. The determination of revenue and gross profit will be made after management completes the company’s financial statements.

What forward-looking statements did LEGN include regarding CARVYKTI?

The company included statements about expectations for net trade sales and resulting gross profit, subject to various risks and uncertainties.

Is this 6-K incorporated by reference into LEGN’s registration statements?

Yes. It is incorporated by reference into Legend Biotech’s Form F-3 and Form S-8 registration statements, to the extent not superseded.
Legend Biotech Corp

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