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United States securities and exchange commission logo
May 1, 2020
Yuan Xu, Ph.D.
Chief Executive Officer
Legend Biotech Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Re: Legend Biotech
Corporation
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted April 20,
2020
CIK No. 0001801198
Dear Dr. Xu:
We have reviewed your amended draft 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 providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. 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 the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form F-1
Prospectus Summary, page 1
1. We note your response
to prior comment 3. Given that it appears these completed Phase 1
trials were designed to
establish a dose level and assess overall safety, please clarify in
your disclosure the
extent which you can rely on observations relating to efficacy in future
regulatory filings with
the FDA.
Yuan Xu, Ph.D.
FirstName LastNameYuan Xu, Ph.D.
Legend Biotech Corporation
Comapany NameLegend Biotech Corporation
May 1, 2020
Page 2
May 1, 2020 Page 2
FirstName LastName
Risk Factors
Adverse side effects or other safety risks associated with our product
candidates could delay or
preclude approval..., page 25
2. We note your response to prior comments 2 and 6 and your revised
summary disclosure
relating to adverse events. Please revise the summary to clearly
disclose that one patient
died of a CAR-T related toxicity as a result of CRS.
Our Programs, page 119
3. We note your response to prior comment 11. For your completed clinical
trials, please
revise the summary and business sections to describe the primary and
secondary
endpoints.
Competition, page 142
4. We note your response to prior comment 11. Please further revise your
discussion of
competitive conditions by describing the current landscape for patent
protections in your
industry. In this regard, we note that across several risk factors on
pages 53 to 62 you
highlight risks stemming from existing third party patents and patent
applications,
including that you are aware of certain patents owned or controlled by
potential
competitors by third parties with claims that could be construed to
cover certain of your
product candidates, including LCAR-B38M/JNJ-4528. In your discussion
of the
competitive landscape, identify specific patents and patent
applications, if material, as
well as their holders/applicants or advise.
Consolidated Statements Of Profit Or Loss And Other Comprehensive Income, page
F-3
5. Please revise the loss per share of $1.39 cents and $66.49 cents to
avoid confusion with
$1.39 and $66.49 and to be consistent with the presentation on pages
11 and 99 ($0.01 and
$0.66) and since fractions of cents do not exist.
5. Revenue, Other Income and Gains, page F-29
6. We reiterate part of comment 16 as your response does not explain how
you determined
the amounts recognized:
you state in your response "The Company respectfully advises the
Staff that the
amount recognized for the license at inception was $30 million."
Please tell us how
the amount recognized in 2017 of $22,209,000 presented in Note 5
to the financial
statements in the Form DRS submitted March 9, 2020 was
determined;
explains how you determined the $7,570,000 of revenue for the
license in 2018
shown in Note 5 to the financial statements; based on your
response we would expect
the amount of revenue related to the license in 2018 would be $0
since there was no
change in the transaction amount allocated to the license of $30
million;
explains how you determined the $40,534,000 of revenue for joint
steering committee
Yuan Xu, Ph.D.
Legend Biotech Corporation
May 1, 2020
Page 3
in 2018 shown in Note 5; and
quantifies standalone selling prices and how selling prices were
determined, and
explains why the largest portion of the transaction price is
allocated to the joint
steering committee and not the license.
Note 20 Contract Liabilities, page F-43
7. Tell us the components of the $204,410,000 balance of contract
liabilities at January 1,
2018 and when each component was received. We understand that the first
payment of
$350 million was received during 2018.
Note 32. Statement of Financial Position of the Company, page F-59
8. You state on page F-60 "Information about the statement of financial
position of the
Company at the end of the reporting period was prepared using the same
accounting
policies as set out in the Company's consolidated financial statements
except that the
parent company accounts for its investments in subsidiaries, using the
cost method."
Please tell us your basis for using the cost method and revise as
necessary.
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 1, 2020 Page 3
cc: Mark Ballantyne, Esq.
FirstName LastName