Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
July 17 2024 - 7:30AM
Edgar (US Regulatory)
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 17, 2024
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, 2024
Pursuant to the Collaboration
and License Agreement dated as of December 21, 2017 between Legend Biotech Corporation (“Legend Biotech”) and Janssen
Biotech, Inc. (“Janssen”), on July 17, 2024, Legend Biotech announced that CARVYKTI® generated approximately
$186 million in net trade sales during the quarter ended June 30, 2024. 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 their financial statements as of and for the quarter ended June 30, 2024. 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 19, 2024. 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), 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 17, 2024 |
By: |
/s/ Ying Huang |
|
Name: |
Ying Huang, Ph.D. |
|
Title: |
Chief Executive Officer |
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