SecProbe.io

April 2, 2020
Yuan Xu, Ph.D.
Chief Executive Officer
Legend Biotech Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Re:Legend Biotech Corporation
Draft Registration Statement on Form S-1
Submitted March 9, 2020
CIK No. 0001801198
Dear Dr. Xu:
            We have reviewed your 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.
Draft Registration Statement on Form S-1 submitted March 9, 2020
Prospectus Summary
Overview, page 1
1.Please delete references to your product candidates as potentially "best-in-class."  This
statement implies an expectation of regulatory approval and is inappropriate given the
length of time and uncertainty with respect to securing marketing approval.  If your use of
this term was intended to convey your belief that the products are based on a novel
technology or approach, you may discuss how your technology differs from existing
antibodies.

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 April 2, 2020 Page 2
 FirstName LastName
Yuan Xu, Ph.D.
Legend Biotech Corporation
April 2, 2020
Page 2
2.We note your use of "manageable safety profile" here and throughout the prospectus.
Please revise your disclosure to explain what constitutes a "manageable safety profile."
Please also discuss the specific experiences of your subjects which led you to reach this
conclusion.
3.We note you describe here in the Summary and elsewhere favorable results observed in
LCAR-B38M/JNJ-4528.  Please expand to provide fuller context for these statements by
providing the specific details and parameters of these trials, including the statistical
significance of the observed results.
4.We note that you anticipate that a BLA will be submitted to the FDA and a MAA will be
submitted to the EMA for JNJ-4528 for the treatment of RRMM in the second half of
2020.  However, we note that CARTITUTE-1/2 are in the midst of Phase II and your
Phase III trial, CARTITUDE-4, has not started enrollment.  Please supplementally tell us
why you believe you will be in a position to submit BLA/MAA for JNJ-4528 in the
second half of 2020.
Our Pipeline, page 2
5.The table of your product candidate pipeline on pages 2 and 111 should reflect the actual,
and not the anticipated, status of your pipeline candidates as of the latest practicable date.
The table currently suggests that CARTITUDE-4 trial is in the midst of Phase 3 but your
disclosure indicates that you have not started enrollment.  Please revise to show the actual
status.
Risk Factors
Adverse side effects or other safety risks associated with our product candidates could delay or
preclude approval..., page 24
6.We note the deaths reported in your LEGEND-2 clinical trial.  Please revise to clarify
whether the deaths were treatment related.
Use of Proceeds, page 90
7.We note your statement that the net proceeds from this offering, together with your
existing cash and cash equivalents, may be insufficient to fund any of your product
candidates through regulatory approval, and you anticipate needing to raise additional
capital.  Please revise your use of proceeds to clarify how far along in the development
process of LCAR-B38M/JNJ-4528 you expect the proceeds from this offering, together
with your existing cash and cash equivalents, will take you.

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 April 2, 2020 Page 3
 FirstName LastName
Yuan Xu, Ph.D.
Legend Biotech Corporation
April 2, 2020
Page 3
Research and Development Expenses, page 99
8.You state on page 100 "We track outsourced development costs by product candidate or
preclinical program, but we do not allocate personnel costs, other internal costs or external
consultant costs to specific product candidates or preclinical programs."  Please disclose
costs by product candidate for each period presented or direct us to that disclosure.
Critical Accounting Policies, page 105
Shared-Based Compensation, page 107
9.Please revise to disclose the extent to which any stock-based compensation has been
awarded during 2019 and provide the fair valuations of each award. Once you have an
estimated offering price or range, please explain to us how you determined the fair value
of the common stock underlying your equity issuances and the reasons for any differences
between the recent valuations of your common stock leading up to the initial public
offering and the estimated offering price. This information will help facilitate our review
of your accounting for equity issuances including stock compensation and beneficial
conversion features.
Our Programs, page 116
10.Please describe the International Myeloma Working Group criteria and explain how it is
used to measure patient response.
11.We note that your disclosures throughout this section references "overall response rate,"
"partial response," "very good partial response," "stable disease," and "objective
response."  For your completed clinical trials, please revise your document to describe the
clinical endpoints and clarify what constitutes an overall response rate, objective response,
partial response, and very good partial response. Additionally clarify how you have
measured or concluded that the disease is stable.
Completed Clinical Results
LEGEND-2 (China), page 123
12.We note use of p-values on page 123.  At first use, please explain how "p-value" is used to
measure statistical significance and the relevance of statistical significance to the FDA's
evidentiary standards for drug approval.
Company-Owned Intellectual Property, page 136
13. Please disclose the jurisdictions of your most material foreign patent applications.

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 April 2, 2020 Page 4
 FirstName LastName
Yuan Xu, Ph.D.
Legend Biotech Corporation
April 2, 2020
Page 4
Competition, page 138
14.Please 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.  In your discussion of the competitive landscape,
identify specific patents and patent applications, if material, as well as their
holders/applicants
Jury Trial Waiver, page 198
15.We note your disclosure regarding the waiver of jury trial provision on page 198.  Please
include a risk factor to highlight the material risks related to this provision, including the
possibility of less favorable outcomes, uncertainty regarding its enforceability, the
potential for increased costs to bring a claim, whether it may discourage or limit suits
against you or the depositary and whether the provision applies to purchasers in secondary
transactions. Also disclose whether this provision would apply if the ADS holder were to
withdraw the ordinary shares.
Financial Statements, page F-1
16.Please tell us why you do not include a note to the financial statements regarding the
Janssen Agreement that:
•includes disclosure of the significant judgments underlying your conclusion that the
license granted to Janssen was distinct and represented a right-to-use license, as
addressed in paragraph 123 and 125 of IFRS 15;
•quantifies the amount allocated to each performance obligation at inception and at
each time the transaction price was updated pursuant to paragraph 120 of IFRS 15;
•describes and quantifies the methods and assumptions used to determine standalone
selling price;
•a rollforward of the contract liability account showing increases and decreases to the
balance pursuant to paragraph 118 of IFRS 15;
•discloses the amount recognized for the license at inception and how that amount 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;
•explains how you determined the $40,534,000 of revenue for joint steering committee
in 2018 shown in Note 5;
•explains why you defer milestone payments received;
•discloses how you determined that performing research and development services for
Janssen was not a performance obligation; and
•you disclose that you had contracted but not yet recognized revenue of approximately
$322 million as of December 31, 2018 of which you expect to recognize
approximately 12.5% over the next twelve months and the remainder thereafter

 FirstName LastNameYuan Xu, Ph.D.
 Comapany NameLegend Biotech Corporation
 April 2, 2020 Page 5
 FirstName LastName
Yuan Xu, Ph.D.
Legend Biotech Corporation
April 2, 2020
Page 5
through the remaining collaboration period.   Please tell us how you considered that
these two time bands would be the most appropriate to explain when you expect to
recognize the revenue related to your remaining performance obligations given the
initial band only represents 11% of a 9 year remaining estimated collaboration period.
Refer to paragraph 120(b) of IFRS 15.
17.With regard to the $1,115 million in the Janssen agreement that may be received for the
achievement of specified future development, regulatory and net trade sales milestones:
•we believe additional disclosure would improve information regarding the nature,
amount, timing, and uncertainty of revenue and cash flows arising from your
contracts. Refer to IFRS 15 paragraph 110. Provide disclosure that further
disaggregates the aggregate amount. Given the differences in the nature, timing, and
uncertainty between development, regulatory and net trade sales milestones, we
believe that separate amounts should be provided for those categories.
•also, tell us your consideration of disclosing individually material milestones.
•finally, disclose the triggering event for receipt of the four milestones that have been
received as specified in paragraph 117 of IFRS 15.
24. Reserves, page F-44
18.We note the risk factor on page 69 related to PRC restrictions that could prevent you from
distributing dividends to your foreign subsidiaries and the amount of restricted net assets
as of December 31, 2018 quantified herein. Please tell us how you considered the
requirements under Item 8 of Form F-1 and Article 5-04 of Regulation S-X to provide
condensed financial information of the registrant.
General
19.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
            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.