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SEC Comment Letter for Legend Biotech Corp (LEGN) (CIK 0001801198) (LEGN) — May 20, 2020

Legend Biotech Corp (LEGN) (CIK 0001801198)
Date: May 20, 2020 · CIK: 0001801198 · Accession: 0000000000-20-004487

AI Filing Summary & Sentiment

File numbers found in text: 333-238232

Date
May 19, 2020
Author
Not clearly detected
Form
UPLOAD
Company
Legend Biotech Corp (LEGN) (CIK 0001801198)

Letter

United States securities and exchange commission logo May 19, 2020 Yuan Xu, Ph.D. Chief Executive Officer Legend Biotech Corporation 2101 Cottontail Lane Somerset, NJ 08873 Re:Legend Biotech Corporation Registration Statement on Form F-1 Filed May 8, 2020 File No. 333-238232 Dear Dr. Xu: We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form F-1 filed May 13, 2020 Prospectus Summary, page 1 1.We note your response to prior comment 1 and that you do not intend to use the data from LEGEND-2 as direct evidence of efficacy or safety in potential future regulatory approval submissions. Please tell us why you do not intend to use the data from LEGEND-2 as direct evidence of efficacy or safety and revise the registration statement, including the summary, accordingly. Collaborative Research and License Agreement with Noile-Immune Biotech Inc. , page 137 2.We note your disclosure that the royalties are payable, on a product by product and country by country basis, until the latest to occur of the expiration of the last to expire valid claim covering such product in such country, the expiration of regulatory exclusivity

FirstName LastNameYuan Xu, Ph.D. Comapany NameLegend Biotech Corporation May 19, 2020 Page 2 FirstName LastNameYuan Xu, Ph.D. Legend Biotech Corporation May 19, 2020 Page 2 for such product in such country, or a specified number of years after the first commercial sale of such product in such country. Please revise your description of this agreement to clarify when the royalty term ends. Competition, page 142 3.We note your response to prior comment 4. To the extent that you are aware of certain patents owned or controlled by potential competitors with claims that could be construed to cover certain of your product candidates, please tell us why the identification of the specific patents and patent applications as well as their holders/applicants would not be material to an investment decision. 5. Revenue, Other Income and Gains, page F-29 4.With regard to your response to comment 6, please revise the disclosure as necessary to more clearly explain that there were two payments and: •clarify that the U.S. right-to-use license amount of $22.2 million was recognized in 2017 by Legend USA and the non-U.S. territories license amount of $7.6 million was recognized in 2018 by Legend Ireland; and •clarify that development services are included within the obligation that is currently labeled “joint steering committee” as you state in your response “it was determined that the largest portion of transaction price should be allocated to the JSC services as the Company is responsible for a significant portion of the development work prior to commercialization”. Labelling the obligation as “joint steering committee” appears to be too narrow. 20. Contract Liabilities, page F-42 5.In order to avoid confusion, please include your response to comment 7 in the disclosure to clarify that: •the $204.4 million balance of contract liabilities at January 1, 2018 represented the amount of $227.5 million to be paid by Janssen to Legend USA less the license revenue and JSC service revenue of $23.1 million recognized in 2017; •the $227.5 million was received in January 2018; •the remaining $122.5 million of the $350 million upfront payment became due in 2018 when Legend Ireland, owner of the non-U.S. license, began its collaboration with Janssen in 2018; and •the $122.5 million was received in March 2018. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff.

FirstName LastNameYuan Xu, Ph.D. Comapany NameLegend Biotech Corporation May 19, 2020 Page 3 FirstName LastName Yuan Xu, Ph.D. Legend Biotech Corporation May 19, 2020 Page 3 Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Jenn Do at 202-551-3743 or Lisa Vanjoske at 202-551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Mark Ballantyne, Esq.

Show Raw Text
United States securities and exchange commission logo
May 19, 2020
Yuan Xu, Ph.D.
Chief Executive Officer
Legend Biotech Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Re:Legend Biotech Corporation
Registration Statement on Form F-1
Filed May 8, 2020
File No. 333-238232
Dear Dr. Xu:
            We have reviewed your registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1 filed May 13, 2020
Prospectus Summary, page 1
1.We note your response to prior comment 1 and that you do not intend to use the data from
LEGEND-2 as direct evidence of efficacy or safety in potential future regulatory approval
submissions.  Please tell us why you do not intend to use the data from LEGEND-2 as
direct evidence of efficacy or safety and revise the registration statement, including the
summary, accordingly.
Collaborative Research and License Agreement with Noile-Immune Biotech Inc. , page 137
2.We note your disclosure that the royalties are payable, on a product by product and
country by country basis, until the latest to occur of the expiration of the last to expire
valid claim covering such product in such country, the expiration of regulatory exclusivity

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 May 19, 2020 Page 2
 FirstName LastNameYuan Xu, Ph.D.
Legend Biotech Corporation
May 19, 2020
Page 2
for such product in such country, or a specified number of years after the first commercial
sale of such product in such country.  Please revise your description of this agreement to
clarify when the royalty term ends.
Competition, page 142
3.We note your response to prior comment 4.  To the extent that you are aware of certain
patents owned or controlled by potential competitors with claims that could be construed
to cover certain of your product candidates, please tell us why the identification of the
specific patents and patent applications as well as their holders/applicants would not be
material to an investment decision.
5. Revenue, Other Income and Gains, page F-29
4.With regard to your response to comment 6, please revise the disclosure as necessary to
more clearly explain that there were two payments and:
•clarify that the U.S. right-to-use license amount of $22.2 million was recognized in
2017 by Legend USA and the non-U.S. territories license amount of $7.6 million was
recognized in 2018 by Legend Ireland; and
•clarify that development services are included within the obligation that is currently
labeled “joint steering committee” as you state in your response “it was determined
that the largest portion of transaction price should be allocated to the JSC services as
the Company is responsible for a significant portion of the development work prior to
commercialization”.   Labelling the obligation as “joint steering committee” appears
to be too narrow.
20. Contract Liabilities, page F-42
5.In order to avoid confusion, please include your response to comment 7 in the disclosure
to clarify that:
•the $204.4 million balance of contract liabilities at January 1, 2018 represented the
amount of $227.5 million to be paid by Janssen to Legend USA less the license
revenue and JSC service revenue of $23.1 million recognized in 2017;
•the $227.5 million was received in January 2018;
•the remaining $122.5 million of the $350 million upfront payment became due in
2018 when Legend Ireland, owner of the non-U.S. license, began its collaboration
with Janssen in 2018; and
•the $122.5 million was received in March 2018.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 May 19, 2020 Page 3
 FirstName LastName
Yuan Xu, Ph.D.
Legend Biotech Corporation
May 19, 2020
Page 3
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            You may contact Jenn Do at 202-551-3743 or Lisa Vanjoske at 202-551-3614 if you have
questions regarding comments on the financial statements and related matters.  Please contact
Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Mark Ballantyne, Esq.