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

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
6-K

Legend Biotech (LEGN) filed a Form 6-K disclosing preliminary product-level revenue for its BCMA-directed CAR-T therapy, CARVYKTI. Janssen, the commercial partner, reported ≈US$439 million in net trade sales for the June-quarter 2025. Legend has not independently verified the figure and must still complete its own Q2 financial statements; the number could change once gross-to-net adjustments, profit-share calculations and auditor review are finalized.

The filing contains no P&L, cash-flow or margin data, but it does signal continued demand expansion only 2-years post-launch. Management reminds investors that revenue recognition, gross profit and royalty split will be determined during the normal close process. Forward-looking-statement language highlights usual development, regulatory and competitive risks and points users to the 2024 Form 20-F risk factors.

  • The disclosed sales are informational, not yet audited.
  • No guidance update or comparative growth metrics were provided.
  • The filing is automatically incorporated into Legend’s existing F-3 and S-8 registration statements.

Legend Biotech (LEGN) ha presentato un modulo 6-K rivelando i ricavi preliminari a livello di prodotto per la sua terapia CAR-T diretta contro BCMA, CARVYKTI. Janssen, il partner commerciale, ha riportato circa 439 milioni di dollari USA di vendite nette nel trimestre di giugno 2025. Legend non ha ancora verificato in modo indipendente questa cifra e deve completare i propri bilanci finanziari del secondo trimestre; il numero potrebbe variare una volta finalizzati gli aggiustamenti da lordo a netto, i calcoli della ripartizione dei profitti e la revisione del revisore.

Il documento non contiene dati su conto economico, flussi di cassa o margini, ma indica un'espansione continua della domanda a soli 2 anni dal lancio. Il management ricorda agli investitori che il riconoscimento dei ricavi, il profitto lordo e la suddivisione delle royalty saranno determinati durante il normale processo di chiusura. Il linguaggio delle dichiarazioni previsionali evidenzia i consueti rischi di sviluppo, regolamentari e competitivi e rimanda gli utenti ai fattori di rischio del modulo 20-F del 2024.

  • Le vendite comunicate sono informative, non ancora revisionate.
  • Non sono stati forniti aggiornamenti sulle previsioni o metriche di crescita comparativa.
  • Il documento è automaticamente incorporato nelle dichiarazioni di registrazione F-3 e S-8 esistenti di Legend.

Legend Biotech (LEGN) presentó un Formulario 6-K divulgando ingresos preliminares a nivel de producto para su terapia CAR-T dirigida a BCMA, CARVYKTI. Janssen, el socio comercial, reportó aproximadamente 439 millones de dólares estadounidenses en ventas netas comerciales para el trimestre de junio de 2025. Legend aún no ha verificado de forma independiente esta cifra y debe completar sus propios estados financieros del segundo trimestre; el número podría cambiar una vez que se finalicen los ajustes de bruto a neto, los cálculos de participación en ganancias y la revisión del auditor.

La presentación no contiene datos de pérdidas y ganancias, flujo de caja o márgenes, pero indica una expansión continua de la demanda solo 2 años después del lanzamiento. La dirección recuerda a los inversores que el reconocimiento de ingresos, la ganancia bruta y la división de regalías se determinarán durante el proceso normal de cierre. El lenguaje de las declaraciones prospectivas destaca los riesgos habituales de desarrollo, regulatorios y competitivos y remite a los usuarios a los factores de riesgo del Formulario 20-F de 2024.

  • Las ventas divulgadas son informativas, aún no auditadas.
  • No se proporcionó actualización de orientación ni métricas de crecimiento comparativas.
  • La presentación se incorpora automáticamente en las declaraciones de registro F-3 y S-8 existentes de Legend.

Legend Biotech (LEGN)은 BCMA 표적 CAR-T 치료제인 CARVYKTI의 제품별 예비 매출을 공개하는 Form 6-K를 제출했습니다. 상업 파트너인 Janssen은 2025년 6월 분기에 약 4억 3,900만 달러의 순매출을 보고했습니다. Legend는 해당 수치를 독립적으로 검증하지 않았으며 아직 2분기 재무제표를 완성해야 하므로, 총매출에서 순매출로의 조정, 이익 배분 계산 및 감사 검토가 완료되면 수치가 변경될 수 있습니다.

제출 문서에는 손익계산서, 현금 흐름 또는 마진 데이터는 포함되어 있지 않으나, 출시 2년 만에 수요가 계속 확대되고 있음을 시사합니다. 경영진은 투자자들에게 매출 인식, 총이익 및 로열티 분배는 정상적인 마감 절차 중에 결정될 것임을 상기시키고 있습니다. 미래 예측 진술에서는 일반적인 개발, 규제 및 경쟁 위험을 강조하며 2024년 Form 20-F 위험 요소를 참조하도록 안내하고 있습니다.

  • 공개된 매출은 정보 제공용이며 아직 감사되지 않았습니다.
  • 가이던스 업데이트나 비교 성장 지표는 제공되지 않았습니다.
  • 이 제출 문서는 Legend의 기존 F-3 및 S-8 등록 서류에 자동으로 포함됩니다.

Legend Biotech (LEGN) a déposé un formulaire 6-K divulguant les revenus préliminaires au niveau produit pour sa thérapie CAR-T ciblant BCMA, CARVYKTI. Janssen, le partenaire commercial, a rapporté environ 439 millions de dollars US de ventes nettes commerciales pour le trimestre de juin 2025. Legend n'a pas encore vérifié de manière indépendante ce chiffre et doit encore finaliser ses propres états financiers du deuxième trimestre ; le montant pourrait changer une fois les ajustements brut-net, les calculs de partage des bénéfices et la révision par l'auditeur terminés.

Le dépôt ne contient pas de données sur le compte de résultat, les flux de trésorerie ou les marges, mais indique une demande en expansion continue seulement deux ans après le lancement. La direction rappelle aux investisseurs que la reconnaissance des revenus, le bénéfice brut et la répartition des redevances seront déterminés lors du processus normal de clôture. Le langage des déclarations prospectives souligne les risques habituels liés au développement, à la réglementation et à la concurrence et renvoie les utilisateurs aux facteurs de risque du formulaire 20-F de 2024.

  • Les ventes divulguées sont à titre informatif, pas encore auditées.
  • Aucune mise à jour des prévisions ni métriques de croissance comparative n'ont été fournies.
  • Le dépôt est automatiquement incorporé dans les déclarations d'enregistrement F-3 et S-8 existantes de Legend.

Legend Biotech (LEGN) hat ein Formular 6-K eingereicht, das vorläufige Umsatzzahlen auf Produktebene für seine BCMA-gerichtete CAR-T-Therapie CARVYKTI offenlegt. Janssen, der Vertriebspartner, meldete ca. 439 Millionen US-Dollar Nettoumsatz im Juniquartal 2025. Legend hat die Zahl noch nicht unabhängig verifiziert und muss seine eigenen Quartalsfinanzberichte noch abschließen; die Zahl könnte sich ändern, sobald Brutto-Netto-Anpassungen, Gewinnbeteiligungsberechnungen und die Prüfung durch den Wirtschaftsprüfer abgeschlossen sind.

Die Einreichung enthält keine Gewinn- und Verlustrechnung, Cashflow- oder Margendaten, signalisiert jedoch eine weiterhin wachsende Nachfrage nur zwei Jahre nach Markteinführung. Das Management erinnert die Investoren daran, dass Umsatzanerkennung, Bruttogewinn und Lizenzgebührenaufteilung im regulären Abschlussprozess bestimmt werden. Die zukunftsgerichteten Aussagen heben die üblichen Entwicklungs-, regulatorischen und Wettbewerbsrisiken hervor und verweisen auf die Risikofaktoren im Formular 20-F von 2024.

  • Die angegebenen Umsätze sind informativ und noch nicht geprüft.
  • Es wurden keine Aktualisierungen der Prognosen oder Vergleichswachstumskennzahlen bereitgestellt.
  • Die Einreichung wird automatisch in die bestehenden F-3- und S-8-Registrierungserklärungen von Legend aufgenommen.
Positive
  • Approx. US$439 million in Q2 net trade sales for CARVYKTI suggests robust commercial momentum.
  • Sales figure, if confirmed, could exceed prior Street expectations, implying potential revenue upside.
Negative
  • Figure is preliminary and unaudited; final revenue and profit share may differ.
  • No comparative metrics or margin data provided, limiting immediate visibility into earnings impact.

Insights

TL;DR: $439 m Q2 CARVYKTI sales indicate strong uptake, but figure is unaudited and profit share unknown.

The topline number, if confirmed, would annualize above US$1.7 bn, well ahead of many sell-side 2025 forecasts (~US$1.4 bn). That suggests continued capacity expansion and broader prescriber adoption. However, investors cannot translate this directly into Legend revenue: the company receives profit share and milestone economics that are not disclosed here. Without cost of goods or SG&A detail, margin impact is speculative. Still, sheer scale of quarterly sales underscores CARVYKTI’s competitive positioning against BMY/2seventy’s Abecma and may support upward revisions to consensus. Risk remains that final audited sales differ or that manufacturing bottlenecks resurface.

TL;DR: Disclosure is informative but limited; forward-looking risks remain material.

The company prudently flags that numbers are preliminary and unaudited, reducing legal exposure. The forward-looking section reiterates familiar development, regulatory and IP risks, signalling no new red flags. Because only one metric is provided, the filing is not financially comprehensive; absence of YoY comparison blunts immediate valuation impact. Still, a near-half-billion-dollar quarter confirms market traction and may heighten competitive scrutiny and reimbursement pressure. Overall impact: moderately positive but contingent on final Q2 results.

Legend Biotech (LEGN) ha presentato un modulo 6-K rivelando i ricavi preliminari a livello di prodotto per la sua terapia CAR-T diretta contro BCMA, CARVYKTI. Janssen, il partner commerciale, ha riportato circa 439 milioni di dollari USA di vendite nette nel trimestre di giugno 2025. Legend non ha ancora verificato in modo indipendente questa cifra e deve completare i propri bilanci finanziari del secondo trimestre; il numero potrebbe variare una volta finalizzati gli aggiustamenti da lordo a netto, i calcoli della ripartizione dei profitti e la revisione del revisore.

Il documento non contiene dati su conto economico, flussi di cassa o margini, ma indica un'espansione continua della domanda a soli 2 anni dal lancio. Il management ricorda agli investitori che il riconoscimento dei ricavi, il profitto lordo e la suddivisione delle royalty saranno determinati durante il normale processo di chiusura. Il linguaggio delle dichiarazioni previsionali evidenzia i consueti rischi di sviluppo, regolamentari e competitivi e rimanda gli utenti ai fattori di rischio del modulo 20-F del 2024.

  • Le vendite comunicate sono informative, non ancora revisionate.
  • Non sono stati forniti aggiornamenti sulle previsioni o metriche di crescita comparativa.
  • Il documento è automaticamente incorporato nelle dichiarazioni di registrazione F-3 e S-8 esistenti di Legend.

Legend Biotech (LEGN) presentó un Formulario 6-K divulgando ingresos preliminares a nivel de producto para su terapia CAR-T dirigida a BCMA, CARVYKTI. Janssen, el socio comercial, reportó aproximadamente 439 millones de dólares estadounidenses en ventas netas comerciales para el trimestre de junio de 2025. Legend aún no ha verificado de forma independiente esta cifra y debe completar sus propios estados financieros del segundo trimestre; el número podría cambiar una vez que se finalicen los ajustes de bruto a neto, los cálculos de participación en ganancias y la revisión del auditor.

La presentación no contiene datos de pérdidas y ganancias, flujo de caja o márgenes, pero indica una expansión continua de la demanda solo 2 años después del lanzamiento. La dirección recuerda a los inversores que el reconocimiento de ingresos, la ganancia bruta y la división de regalías se determinarán durante el proceso normal de cierre. El lenguaje de las declaraciones prospectivas destaca los riesgos habituales de desarrollo, regulatorios y competitivos y remite a los usuarios a los factores de riesgo del Formulario 20-F de 2024.

  • Las ventas divulgadas son informativas, aún no auditadas.
  • No se proporcionó actualización de orientación ni métricas de crecimiento comparativas.
  • La presentación se incorpora automáticamente en las declaraciones de registro F-3 y S-8 existentes de Legend.

Legend Biotech (LEGN)은 BCMA 표적 CAR-T 치료제인 CARVYKTI의 제품별 예비 매출을 공개하는 Form 6-K를 제출했습니다. 상업 파트너인 Janssen은 2025년 6월 분기에 약 4억 3,900만 달러의 순매출을 보고했습니다. Legend는 해당 수치를 독립적으로 검증하지 않았으며 아직 2분기 재무제표를 완성해야 하므로, 총매출에서 순매출로의 조정, 이익 배분 계산 및 감사 검토가 완료되면 수치가 변경될 수 있습니다.

제출 문서에는 손익계산서, 현금 흐름 또는 마진 데이터는 포함되어 있지 않으나, 출시 2년 만에 수요가 계속 확대되고 있음을 시사합니다. 경영진은 투자자들에게 매출 인식, 총이익 및 로열티 분배는 정상적인 마감 절차 중에 결정될 것임을 상기시키고 있습니다. 미래 예측 진술에서는 일반적인 개발, 규제 및 경쟁 위험을 강조하며 2024년 Form 20-F 위험 요소를 참조하도록 안내하고 있습니다.

  • 공개된 매출은 정보 제공용이며 아직 감사되지 않았습니다.
  • 가이던스 업데이트나 비교 성장 지표는 제공되지 않았습니다.
  • 이 제출 문서는 Legend의 기존 F-3 및 S-8 등록 서류에 자동으로 포함됩니다.

Legend Biotech (LEGN) a déposé un formulaire 6-K divulguant les revenus préliminaires au niveau produit pour sa thérapie CAR-T ciblant BCMA, CARVYKTI. Janssen, le partenaire commercial, a rapporté environ 439 millions de dollars US de ventes nettes commerciales pour le trimestre de juin 2025. Legend n'a pas encore vérifié de manière indépendante ce chiffre et doit encore finaliser ses propres états financiers du deuxième trimestre ; le montant pourrait changer une fois les ajustements brut-net, les calculs de partage des bénéfices et la révision par l'auditeur terminés.

Le dépôt ne contient pas de données sur le compte de résultat, les flux de trésorerie ou les marges, mais indique une demande en expansion continue seulement deux ans après le lancement. La direction rappelle aux investisseurs que la reconnaissance des revenus, le bénéfice brut et la répartition des redevances seront déterminés lors du processus normal de clôture. Le langage des déclarations prospectives souligne les risques habituels liés au développement, à la réglementation et à la concurrence et renvoie les utilisateurs aux facteurs de risque du formulaire 20-F de 2024.

  • Les ventes divulguées sont à titre informatif, pas encore auditées.
  • Aucune mise à jour des prévisions ni métriques de croissance comparative n'ont été fournies.
  • Le dépôt est automatiquement incorporé dans les déclarations d'enregistrement F-3 et S-8 existantes de Legend.

Legend Biotech (LEGN) hat ein Formular 6-K eingereicht, das vorläufige Umsatzzahlen auf Produktebene für seine BCMA-gerichtete CAR-T-Therapie CARVYKTI offenlegt. Janssen, der Vertriebspartner, meldete ca. 439 Millionen US-Dollar Nettoumsatz im Juniquartal 2025. Legend hat die Zahl noch nicht unabhängig verifiziert und muss seine eigenen Quartalsfinanzberichte noch abschließen; die Zahl könnte sich ändern, sobald Brutto-Netto-Anpassungen, Gewinnbeteiligungsberechnungen und die Prüfung durch den Wirtschaftsprüfer abgeschlossen sind.

Die Einreichung enthält keine Gewinn- und Verlustrechnung, Cashflow- oder Margendaten, signalisiert jedoch eine weiterhin wachsende Nachfrage nur zwei Jahre nach Markteinführung. Das Management erinnert die Investoren daran, dass Umsatzanerkennung, Bruttogewinn und Lizenzgebührenaufteilung im regulären Abschlussprozess bestimmt werden. Die zukunftsgerichteten Aussagen heben die üblichen Entwicklungs-, regulatorischen und Wettbewerbsrisiken hervor und verweisen auf die Risikofaktoren im Formular 20-F von 2024.

  • Die angegebenen Umsätze sind informativ und noch nicht geprüft.
  • Es wurden keine Aktualisierungen der Prognosen oder Vergleichswachstumskennzahlen bereitgestellt.
  • Die Einreichung wird automatisch in die bestehenden F-3- und S-8-Registrierungserklärungen von Legend aufgenommen.
 
 

 

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: July 16, 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 June 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 July 16, 2025, Legend Biotech Corporation (“Legend Biotech”) announced that CARVYKTI® generated approximately $439 million in net trade sales during the quarter ended June 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 June 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:  July 16, 2025   By: /s/ Ying Huang
    Name: Ying Huang, Ph.D.
    Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FAQ

How much did CARVYKTI sell in Q2 2025 according to Legend Biotech (LEGN)?

Janssen reported approximately US$439 million in net trade sales for the quarter ended 30 June 2025.

Is the US$439 million CARVYKTI sales figure audited?

No. Legend Biotech states the number is preliminary, unaudited, and subject to change during the Q2 close.

Will Legend Biotech recognize the full US$439 million as revenue?

No. Legend records only its profit-share/royalty portion; that amount will be determined when Q2 financials are finalized.

Does the 6-K include updated earnings guidance for LEGN?

No guidance update was provided; the filing only discloses preliminary product sales.

What risks did Legend Biotech highlight in the 6-K?

The company cited development, regulatory, manufacturing, IP and competitive risks similar to those in its 2024 Form 20-F.
Legend Biotech Corp

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Biotechnology
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United States
Somerset