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Legend Biotech (LEGN) reports about $555M CARVYKTI Q4 2025 net sales

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(Neutral)
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Form Type
6-K

Rhea-AI Filing Summary

Legend Biotech Corporation reported preliminary net trade sales for its CAR-T therapy CARVYKTI®, with approximately $555 million in net trade sales for the quarter ended December 31, 2025. This figure was provided by collaboration partner Janssen under their existing collaboration and license agreement, and Legend Biotech has not independently verified it.

The company noted that the final amount of revenue and gross profit to be recorded in its consolidated financial statements will be determined as management completes the financial statements for the period. The data has not been audited, reviewed, or otherwise examined by Legend Biotech’s independent registered public accountants, and they have not expressed any assurance regarding these figures. The company also cautioned that forward-looking statements about CARVYKTI® sales and resulting gross profit are subject to numerous risks and uncertainties, including product development, regulatory actions, partner performance, intellectual property challenges, competition, and pricing pressures.

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Insights

Legend Biotech flags strong preliminary CARVYKTI® sales but stresses they are unaudited and subject to change.

The disclosure that CARVYKTI® generated approximately $555 million in net trade sales for the quarter ended December 31, 2025 highlights the commercial importance of this product for Legend Biotech. The figure is based on data from collaboration partner Janssen under their license and collaboration agreement, underscoring that commercial execution and reporting depend heavily on this partner.

Management clearly states that the determination of revenue and gross profit in Legend Biotech’s own financial statements remains pending until the period close process is completed. In addition, the company emphasizes that its independent registered public accountants have not audited or reviewed these sales figures, so they could change as part of the normal reporting cycle.

The extensive forward-looking statement disclaimer reminds readers that expectations around net trade sales and gross profit from CARVYKTI® are sensitive to clinical outcomes, regulatory decisions, partner performance, intellectual property disputes, competition, and pricing pressures. Subsequent filings, including the full-period financial statements for the period ended December 31, 2025, will give a clearer view of how much of the reported net trade sales translate into recognized revenue and profit for Legend Biotech.

 
 

 

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: January 21, 2026

 

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 December 31, 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 January 21, 2026, Legend Biotech Corporation (“Legend Biotech”) announced that CARVYKTI® generated approximately $555 million in net trade sales during the quarter ended December 31, 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 December 31, 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:  January 21, 2026 By: /s/ Ying Huang
  Name: Ying Huang, Ph.D.
  Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

FAQ

What preliminary CARVYKTIae sales did Legend Biotech (LEGN) report for the quarter ended December 31, 2025?

Legend Biotech reported that CARVYKTIae generated approximately $555 million in net trade sales for the quarter ended December 31, 2025, based on information provided by Janssen.

Are Legend Biotechae's reported CARVYKTIae sales for Q4 2025 audited?

No. Legend Biotech stated that its independent registered public accountants have not audited, reviewed or performed procedures on the CARVYKTIae sales data and have not provided any assurance on these figures.

How will the CARVYKTIae sales figure affect Legend Biotech (LEGN) revenue and profit?

Legend Biotech explained that the determination of the revenue and gross profit it will record from CARVYKTIae in its consolidated statement of operations will be made after management completes the financial statements for the period ended December 31, 2025.

Who provided the CARVYKTIae net trade sales data to Legend Biotech (LEGN)?

The approximately $555 million CARVYKTIae net trade sales figure was provided by Janssen under the existing collaboration and license agreement, and Legend Biotech has not independently verified it.

What risks and uncertainties does Legend Biotech (LEGN) highlight regarding CARVYKTIae expectations?

Legend Biotech cites risks including drug development uncertainties, unexpected clinical data, regulatory actions or delays, partner performance, intellectual property challenges, competition, and pricing and political pressures, which could cause actual results to differ materially from expectations.

Is the January 21, 2026 Legend Biotech (LEGN) 6-K incorporated into its existing registration statements?

Yes. Legend Biotech stated that this report on Form 6-K is incorporated by reference into its registration statements on Form F-3 (Nos. 333-278050, 333-272222 and 333-257625) and Form S-8 (Nos. 333-239478 and 333-283217), to the extent not superseded by later filings.
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United States
Somerset