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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
Yuan Xu, Ph.D.
FirstName LastNameYuan Xu, Ph.D.
Legend Biotech Corporation
Comapany NameLegend Biotech Corporation
May 19, 2020
May 19, 2020 Page 2
Page 2
FirstName LastName
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.
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,
FirstName LastNameYuan Xu, Ph.D.
Division of
Corporation Finance
Comapany NameLegend Biotech Corporation
Office of Life
Sciences
May 19, 2020 Page 3
cc: Mark Ballantyne, Esq.
FirstName LastName