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

Rhea-AI Filing Summary

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.

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

Equity Research Analyst

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.

Pharmaceutical Industry Risk Analyst

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.

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.