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United States securities and exchange commission logo
June 15, 2021
Matthew Gline
Chief Executive Officer
Roivant Sciences Ltd.
Suite 1, 3rd Floor
11-12 St. James Square
London SW1Y4LB
United Kingdom
Re: Roivant Sciences
Ltd.
Registration
Statement on Form S-4
Filed May 14, 2021
File No. 333-256165
Dear Mr. Gline:
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 S-4
Market, Industry, and Other Data , page 1
1. We note your statement
regarding market data used in the prospectus in which you
explain that your
estimates are derived from your review and interpretation of certain
sources and that
investors are cautioned "not to give undue weight" to these estimates.
Please revise this
statement to eliminate any implication that investors are not entitled to
rely on the information
included in your registration statement.
Summary of the Proxy Statement/Prospectus
Roivant Sciences Ltd., page 14
Matthew Gline
FirstName LastNameMatthew Gline
Roivant Sciences Ltd.
Comapany
June NameRoivant Sciences Ltd.
15, 2021
June 15,
Page 2 2021 Page 2
FirstName LastName
2. Please disclose Riovant's history of net losses and lack of commercial
revenue in this
summary section.
3. Please clarify how you define "mid-to late-stage clinical development"
and what factors
you use to define your Phase 3 trials as "successful." Please quantify
the number of drug
candidates being tested in the nine International Phase 3 trials and
the eight Phase 3 trials
you deemed "successful." Additionally, clarify the current status of
development for the
the candidates for which you completed successful Phase 3 trials.
Interests of Certain MAAC Persons in the Business Combination , page 19
4. Please quantify the aggregate dollar amounts contributed by the
sponsor and affiliates and
describe the nature of what the sponsor and the affiliates have at
risk and are dependent on
the completion of the business combination. Include the current value
of the securities
held, loans extended, fees due and out of pocket expenses for which
the sponsor and
affiliates are awaiting reimbursement. Provide similar disclosure for
officers and
directors, if material. Provide similar information in your risk
factor section and "Interests
of Certain MAAC Persons in the Business Combination" beginning on page
161.46
Milestone and Royalty payments that we are obligated to pay may be greater than
anticipated.,
page 36
5. Given that the milestone and royalty payments are provided for in your
licensing
agreements, it is not clear why they might be greater than you
anticipate. Please revise to
further explain this risk and why the amount of the payments and
describe the types of
payments that might unexpectedly come due prior to generating product
sales.
Risks Related to MAAC and the Business Combination, page 98
6. Please highlight the risk that the sponsor will benefit from the
completion of a business
combination and may be incentivized to complete an acquisition of a
less favorable
company or on term less favorable to shareholders rather than
liquidate.
7. Please highlight the sponsors and public shareholders have different
rates of return and
clarify if the sponsors and affiliates can earn a positive rate of
return on their investment,
even if the other SPAC shareholders experience a negative rate of
return in the post
business combination company.
Since MAAC sponsor and MAAC's officers and directors will not be eligible to be
reimbursed
for their out of pocket expenses..., page 101
8. Please quantify the out of pocket expenses incurred to date.
Subsequent to the Consummation of the Business Combination, MAAC may be
required to...,
Matthew Gline
FirstName LastNameMatthew Gline
Roivant Sciences Ltd.
Comapany
June NameRoivant Sciences Ltd.
15, 2021
June 15,
Page 3 2021 Page 3
FirstName LastName
page 102
9. Please highlight the risk presented by taking the company public
through a merger rather
than an underwritten offering by highlighting that an underwriter
would be subject to
liability for any material misstatements or omissions in a
registration statement.
Our warrant agreement designates the courts of the State of New York or the
United States
District Court for the Southern District. . . ., page 105
10. Please revise this risk factor to disclose that there is also a risk
that your exclusive forum
provision may result in increased costs for investors to bring a
claim.
Background of the Business Combination, page 161
11. Please identify the third party advisor and expand your disclosure to
more specifically
explain its role with respect to evaluations, analysis and due
diligence.
12. Explain how you narrowed the potential targets from 70 to seven,
describe each of the
seven potential targets that entered into non-disclosure agreements
with you and explain
why and when each was eliminated as a potential target.
13. Describe the analyses prepared by the third party advisor for each of
the three remaining
candidates.
14. Disclose the proposed terms Roivant provided MAAC on January 10, 2021
and explain
how the terms changed during the course of your negotiations.
Business of Roivant
Vants , page 203
15. Please enlarge this figure, the development pipeline on page 203.1 and
the graphic on
page 207, as the text is too small to be legible. Additionally,
indicate which of these Vants
are publicly held.
16. We note that some of the product candidates in your pipeline table on
page 2.3.1 are being
developed by vants that you do not control, such products being
developed by Sio Gene
Therapies and Arbutus. For each of these candidates describe your
economic interests in
the product candidate, such as receipt of potential milestone
payments, royalty rights,
commercialization rights. To the extent that your rights are limited
to the potential
appreciation in the value of your shares in the company, please remove
them from this
pipeline table and the individual vant pipeline tables beginning on
page 241.1.
Our Degrader Strategy, page 210
17. Please remove the reference to "potentially best-and first-in-class"
as this statement
implies an expectation of regulatory approval and is inappropriate
given the stage of
development for your programs. Ensure that similar disclosures
concerning "best-in-
class" and/or "first-in-class," which we note repeated numerous times
in this section of the
Matthew Gline
FirstName LastNameMatthew Gline
Roivant Sciences Ltd.
Comapany
June NameRoivant Sciences Ltd.
15, 2021
June 15,
Page 4 2021 Page 4
FirstName LastName
filing, are also removed.
Platform Validation , page 212
18. Please remove your statement on page 213 that you believe that
Sumitomo s decision to
partner with Roivant serves to validate t the drug candidates that
have been, and will be,
generated by your technology. Efficacy determinations are the sole
authority of the FDA
and equivalent foreign regulators, implying that Sumitomo's decision
validates the
candidates is not appropriate.
Arbutus Overview
Clinical data, page 283
19. Please remove your disclosure that "AB-729 has been safe" in your
Phase 1a/1b trial, as
safety determinations are the exclusive purview of the FDA or other
regulators.
Asset Acquisitions and License Arrangements, page 286
20. Please disclose the expected expiry of the last-to-expire patent
licensed under the
Michigan Research Agreement and the Cross-License Agreement with
Arbutus
Biopharma Corporation;and revise the descriptions of your strategic
agreement with
Japan Tobacco to include a royalty range within ten percentage points
for product sales of
tapinarof.
Legal Proceedings, page 320
21. We note your disclosure on page 81 indicating that you have ongoing
litigation related to
patent disputes. These disclosures appear to conflict with your
disclosure in this section
that you are not presently a party to any material legal proceedings.
Please revise your
disclosure or tell us why you believe disclosure related to these
legal proceedings is not
required.
Contractual Obligations and Commitments, page 338
22. Please file the loan and security agreement between Dermavant and
Hercules as an exhibit
or tell us why you believe such filing is not required. Refer to Item
601(b)(10) of
Regulation S-K.
Financial Statements of Roivant Sciences Ltd for the Nine Months Ended December
31, 2020
and 2019
Notes to Condensed Consolidated Financial Statements
Note 9-Shareholders' Equity and Redeemable Non-Controlling Interest, page F-87
23. You disclose on pages F-49 and F-50 that you consolidate Immunovant.
Please clarify the
percentage owned after Immunovant issued additional shares as
discussed on page F-87
and if the additional share issuances by Immunovant in the nine months
ended December
31, 2020 affected the accounting treatment in Roivant's financial
statements.
Matthew Gline
Roivant Sciences Ltd.
June 15, 2021
Page 5
Note 16-Subsequent Events
Acquisition of Silicon Therapeutics, page F-95
24. We note that in March 2021 Roivant acquired Silicon Therapeutics, LLC
for consideration
of approximately $450.0 million, with additional cash payments payable
subject to the
satisfaction of certain regulatory and commercial milestones. Please
tell us why the
financial statements of Silicon Therapeutics are not significant to
Roivant's financial
statements such that the omission of those financial statements
renders Roivant's financial
statements substantially incomplete or misleading. In this regards,
also please tell us your
consideration of including the acquisition in the pro forma
information on page 163.
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.
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 Ibolya Ignat at 202-551-3636 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Suzanne Hayes at 202-551-3675 with any
other
questions.
FirstName LastNameMatthew Gline Sincerely,
Comapany NameRoivant Sciences Ltd.
Division of
Corporation Finance
June 15, 2021 Page 5 Office of Life
Sciences
FirstName LastName