|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
Not Applicable
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
||
The |
|
☒
|
Accelerated filer
|
☐
|
|
Non-accelerated filer
|
☐
|
Smaller reporting company
|
||
Emerging growth company
|
Page
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1.
|
5 | |
5 | ||
6 | ||
7 | ||
8 | ||
10 | ||
11 | ||
Item 2.
|
30 |
|
Item 3.
|
44 |
|
Item 4.
|
45 |
|
PART II—OTHER INFORMATION
|
||
Item 1.
|
46 |
|
Item 1A.
|
46 |
|
Item 2.
|
102 |
|
Item 3.
|
102 |
|
Item 4.
|
102 |
|
Item 5.
|
102 |
|
Item 6.
|
103 |
|
104 |
•
|
Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may
make it difficult for us to execute on our business model and for you to assess our future viability.
|
•
|
We may never achieve sustained profitability.
|
•
|
We may not be successful in our efforts to acquire or in-license new product candidates, and newly acquired or in-licensed product candidates may not perform
as expected in clinical trials or be successful in eventually achieving marketing approvals.
|
•
|
We face risks associated with the allocation of capital and personnel across our businesses.
|
•
|
We face risks associated with the Vant structure.
|
•
|
We face risks associated with potential future payments related to our product candidates.
|
•
|
We face risks associated with strategic transactions and partnerships and we may not realize the expected benefits of those strategic transactions and
partnerships.
|
•
|
We face risks associated with the use of our cash, cash equivalents and marketable securities, including any return of capital to shareholders.
|
•
|
Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter
substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all.
|
•
|
We may encounter difficulties enrolling and retaining patients in clinical trials, and clinical development activities could thereby be delayed or otherwise
adversely affected.
|
•
|
The results of our preclinical studies and clinical trials may not support our proposed claims for our product candidates or regulatory approvals on a timely
basis or at all, and the results of earlier studies and trials may not be predictive of future trial results.
|
•
|
Interim, top-line or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available
and are subject to audit and verification procedures that could result in material changes in the final data.
|
•
|
Obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or another regulator may delay, limit or
deny approval. If we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates, our business will be substantially harmed.
|
•
|
Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their
intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.
|
•
|
Our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval, cause us to suspend or
discontinue clinical trials, abandon further development or limit the scope of any approved label or market acceptance.
|
•
|
We depend on the knowledge and skills of our senior leaders and may not be able to manage our business effectively if we are unable to attract and retain key
personnel.
|
•
|
If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates, or if the scope of the
intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
|
•
|
If the patent applications we hold or have in-licensed with respect to our product candidates fail to issue, if their breadth or strength of protection is
threatened, or if they fail to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize our product candidates
following regulatory approval. Any such outcome could have a materially adverse effect on our business. Our pending patent applications cannot be enforced against third parties practicing the claims in such applications unless and until a
patent issues from such applications.
|
•
|
The length of our patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.
|
•
|
If our performance does not meet market expectations, the price of our securities may decline.
|
•
|
We have incurred and will continue to incur increased costs as a result of operating as a public company and our management has devoted and will continue
to devote a substantial amount of time to new compliance initiatives.
|
•
|
If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements
could be impaired, investors may lose confidence in our financial reporting and the trading price of our common shares may decline.
|
•
|
Anti-takeover provisions in our memorandum of association and bye-laws, as well as provisions of Bermuda law, could delay or prevent a change in control,
limit the price investors may be willing to pay in the future for our common shares and could entrench management.
|
•
|
Our largest shareholders own a significant percentage of our common shares and are able to exert significant control over matters subject to shareholder
approval.
|
•
|
Future sales, or the perception of future sales, of our common shares by us or our existing shareholders could cause the market price for our common
shares to decline and impact our ability to raise capital in the future.
|
•
|
our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and
commercialization;
|
•
|
our ability to acquire or in-license new product candidates;
|
•
|
the allocation of capital and personnel across our business;
|
•
|
our Vant structure
and the potential that we may fail to capitalize on certain development opportunities;
|
•
|
potential future payments related to our product candidates;
|
•
|
our ability to consummate and realize the benefits from strategic transactions and partnerships, including the
Dermavant Transaction;
|
•
|
the use of our cash, cash equivalents and marketable securities;
|
•
|
clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement
and involve uncertain outcomes;
|
•
|
the novelty, complexity and difficulty of manufacturing certain of our product candidates, including any
manufacturing problems that result in delays in development or commercialization of our product candidates;
|
•
|
difficulties we may face in enrolling and retaining patients in clinical trials, which could adversely affect or
otherwise delay clinical development activities;
|
•
|
the results of our clinical trials not supporting our proposed claims for a product candidate;
|
•
|
interim, top-line or preliminary data from our clinical trials changing as more data become available or data being
delayed due to audit or verification processes;
|
•
|
changes in product candidate manufacturing or formulation that could lead to the incurrence of costs or delays;
|
•
|
the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials or to
otherwise perform in a satisfactory manner or to comply with applicable legal, regulatory or other requirements;
|
•
|
the fact that obtaining approvals for new drugs is an extensive, lengthy, expensive and inherently uncertain process
that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions;
|
•
|
the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our product
candidates;
|
•
|
our inability to obtain regulatory approval for a product candidate in certain jurisdictions, even if we are able to
obtain approval in certain other jurisdictions;
|
•
|
our ability to effectively manage growth and to attract and retain key personnel;
|
•
|
any business, legal, regulatory, political, operational, financial and economic risks associated with conducting
business globally;
|
•
|
our ability to obtain and maintain patent and other intellectual property protection for our technology, product
candidates;
|
•
|
the inadequacy of patent terms and their scope to protect our competitive position;
|
•
|
the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful
exclusivity for our product candidates of our patent applications that we hold or have in-licensed;
|
•
|
the fact that our largest shareholders own a significant percentage of our stock and will be able to exert
significant control over matters subject to shareholder approval;
|
•
|
future sales of securities by us or our largest shareholders, or the perception of such sales, and the impact
thereof on the price of our common shares;
|
•
|
the outcome of any pending or potential litigation, including but not limited to our expectations regarding the
outcome of any such litigation and costs and expenses associated with such litigation;
|
•
|
changes in applicable laws or regulations;
|
•
|
the possibility that we may be adversely affected by other economic, business or competitive factors; and
|
•
|
any other risks and uncertainties, including those described under Part II, Item 1A. “Risk Factors.”
|
September 30, 2024
|
March 31, 2024
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Marketable securities |
||||||||
Other current assets
|
|
|
||||||
Current assets of discontinued operations (Note 6) |
||||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Operating lease right-of-use assets
|
|
|
||||||
Investments measured at fair value
|
|
|
||||||
Other assets
|
|
|
||||||
Noncurrent assets of discontinued operations (Note 6) |
||||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities and Shareholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Operating lease liabilities
|
|
|
||||||
Other current liabilities
|
|
|
||||||
Current liabilities of discontinued operations (Note 6) |
||||||||
Total current liabilities
|
|
|
||||||
Liability instruments measured at fair value
|
|
|
||||||
Operating lease liabilities, noncurrent
|
|
|
||||||
Other liabilities
|
|
|
||||||
Noncurrent liabilities of discontinued operations (Note 6) |
||||||||
Total liabilities
|
|
|
||||||
Commitments and contingencies (Note 11)
|
||||||||
Shareholders’ equity:
|
||||||||
Common shares, par value $
|
|
|
||||||
Additional paid-in capital
|
|
|||||||
Retained earnings
|
|
|
||||||
Accumulated other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Shareholders’ equity attributable to Roivant Sciences Ltd.
|
|
|
||||||
Noncontrolling interests
|
|
|
||||||
Total shareholders’ equity
|
|
|
||||||
Total liabilities and shareholders’ equity
|
$
|
|
$
|
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||
2024
|
2023
|
2024 |
2023 |
|||||||||||||
Revenue, net
|
$ |
$ |
$ |
$ |
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of revenues
|
|
|
||||||||||||||
Research and development (includes $
|
|
|
||||||||||||||
Acquired in-process research and development
|
|
|
||||||||||||||
General and administrative (includes $
|
|
|
||||||||||||||
Total operating expenses
|
|
|
||||||||||||||
Gain on sale of Telavant net assets
|
||||||||||||||||
Loss from operations |
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Change in fair value of investments
|
(
|
)
|
|
( |
) | |||||||||||
Change in fair value of liability instruments
|
(
|
)
|
|
|||||||||||||
Gain on deconsolidation of subsidiaries |
( |
) | ( |
) | ||||||||||||
Interest income |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other expense, net
|
|
|
||||||||||||||
Loss from continuing operations before income taxes
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Income tax expense
|
|
|
||||||||||||||
Loss from continuing operations, net of tax |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
(Loss) income from discontinued operations, net of tax
|
( |
) | ( |
) | ( |
) | ||||||||||
Net loss |
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Net loss attributable to noncontrolling interests
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Net loss attributable to Roivant Sciences Ltd.
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Amounts attributable to Roivant Sciences Ltd.: |
||||||||||||||||
Loss from continuing operations, net of tax | $ |
( |
) | $ |
( |
) | $ |
( |
) | $ |
( |
) | ||||
(Loss) income from discontinued operations, net of tax
|
( |
) | ( |
) | ( |
) | ||||||||||
Net loss attributable to Roivant Sciences Ltd. |
$ |
( |
) | $ |
( |
) | $ |
( |
) | $ |
( |
) | ||||
Basic and diluted net (loss) income per common share:
|
||||||||||||||||
Basic and diluted loss from continuing operations
|
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Basic and diluted (loss) income from discontinued operations
|
$ |
( |
) | $ |
( |
) | $ |
$ |
( |
) | ||||||
Basic and diluted net loss per common share
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Weighted average shares outstanding:
|
||||||||||||||||
Basic
|
||||||||||||||||
Diluted
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||
2024
|
2023
|
2024 | 2023 | |||||||||||||
Net loss |
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) | ||||
Other comprehensive income (loss): | ||||||||||||||||
Change in fair value of debt due to change in subsidiary credit risk
|
( |
) | ||||||||||||||
Foreign currency translation adjustment
|
(
|
)
|
|
( |
) | ( |
) | |||||||||
Total other comprehensive income (loss)
|
|
|
( |
) | ( |
) | ||||||||||
Comprehensive loss
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Comprehensive loss attributable to noncontrolling interests
|
(
|
)
|
(
|
)
|
( |
) | ( |
) | ||||||||
Comprehensive loss attributable to Roivant Sciences Ltd.
|
$
|
(
|
)
|
$
|
(
|
)
|
$ | ( |
) | $ | ( |
) |
Shareholders’ Equity
|
||||||||||||||||||||||||||||
Common Stock |
Additional
Paid-in
Capital
|
Accumulated
Other
Comprehensive
Loss
|
Retained
Earnings
|
Noncontrolling
Interests
|
Total
Shareholders’
Equity
|
|||||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||||||
Balance at March 31, 2024
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
||||||||||||||
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments
|
( |
) | ( |
) | ||||||||||||||||||||||||
Issuance of subsidiary common shares, net
|
||||||||||||||||||||||||||||
Subsidiary stock options exercised
|
—
|
|
|
|
|
|
|
|||||||||||||||||||||
Cash contributions to majority-owned subsidiaries
|
— | ( |
) | |||||||||||||||||||||||||
Repurchase of common shares
|
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||
Share-based compensation
|
—
|
|
|
|
|
|
|
|||||||||||||||||||||
Change in fair value of debt due to change in subsidiary credit risk
|
— | ( |
) | ( |
) | |||||||||||||||||||||||
Foreign currency translation adjustment
|
—
|
|
|
(
|
)
|
|
|
(
|
)
|
|||||||||||||||||||
Net income (loss)
|
—
|
|
|
|
|
(
|
)
|
|
||||||||||||||||||||
Balance at June 30, 2024
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
||||||||||||||
Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments
|
( |
) | ( |
) | ||||||||||||||||||||||||
Subsidiary stock options exercised
|
— | |||||||||||||||||||||||||||
Issuance of the Company’s common shares under employee stock purchase plan
|
||||||||||||||||||||||||||||
Cash contributions to majority-owned subsidiaries
|
— | ( |
) | |||||||||||||||||||||||||
Repurchase of common shares
|
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||
Share-based compensation
|
— | |||||||||||||||||||||||||||
Change in fair value of debt due to change in subsidiary credit risk
|
— | |||||||||||||||||||||||||||
Foreign currency translation adjustment
|
— | ( |
) | ( |
) | |||||||||||||||||||||||
Net loss
|
— | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
Balance at September 30, 2024
|
$ | $ | $ | ( |
) | $ | $ | $ |
Shareholders’ Equity
|
||||||||||||||||||||||||||||
Common Stock |
Additional
Paid-in
Capital
|
Accumulated
Other
Comprehensive
Loss
|
Accumulated
Deficit
|
Noncontrolling
Interests
|
Total
Shareholders’
Equity
|
|||||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||||||
Balance at March 31, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Subsidiary stock options exercised
|
—
|
|
|
|
|
|
|
|||||||||||||||||||||
Cash contributions to majority-owned subsidiaries
|
— | ( |
) | |||||||||||||||||||||||||
Dividend declared by subsidiary
|
— | ( |
) | ( |
) | |||||||||||||||||||||||
Share-based compensation
|
—
|
|
|
|
|
|
|
|||||||||||||||||||||
Foreign currency translation adjustment
|
—
|
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||
Net loss
|
—
|
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||||||||
Balance at June 30, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Issuance of the Company’s common shares, net of issuance costs
|
||||||||||||||||||||||||||||
Issuance of the Company’s common shares related to settlement of warrants
|
||||||||||||||||||||||||||||
Issuance of the Company’s common shares under employee stock purchase plan
|
||||||||||||||||||||||||||||
Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments
|
||||||||||||||||||||||||||||
Deconsolidation of subsidiaries
|
— | ( |
) | ( |
) | |||||||||||||||||||||||
Subsidiary stock options exercised
|
— | |||||||||||||||||||||||||||
Cash contributions to majority-owned subsidiaries
|
— | ( |
) | |||||||||||||||||||||||||
Share-based compensation
|
— | |||||||||||||||||||||||||||
Foreign currency translation adjustment
|
— | |||||||||||||||||||||||||||
Net loss
|
— | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
Balance at September 30, 2023
|
$ | $ | $ | ( |
) | $ | ( |
) | $ | $ |
Six Months Ended September 30,
|
||||||||
2024
|
2023
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Share-based compensation
|
|
|
||||||
Change in fair value of investments
|
(
|
)
|
|
|||||
Change in fair value of debt and liability instruments
|
(
|
)
|
|
|||||
Gain on deconsolidation of subsidiaries
|
( |
) | ||||||
Gain on sale of Telavant net assets
|
( |
) | ||||||
Accretion of discount and amortization of premium on marketable securities, net
|
( |
) | ||||||
Depreciation and amortization
|
||||||||
Non-cash lease expense
|
||||||||
Other
|
(
|
)
|
|
|||||
Changes in assets and liabilities, net of effects from acquisition and divestiture:
|
||||||||
Other current assets
|
( |
) | ( |
) | ||||
Accounts payable
|
(
|
)
|
|
|||||
Accrued expenses
|
(
|
)
|
(
|
)
|
||||
Operating lease liabilities
|
(
|
)
|
(
|
)
|
||||
Other
|
(
|
)
|
|
|||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchase of marketable securities
|
( |
) | ||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Proceeds from sale of subsidiary interests
|
||||||||
Cash decrease upon deconsolidation of subsidiaries
|
( |
) | ||||||
Other
|
||||||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of the Company’s common shares, net of issuance costs paid
|
||||||||
Payment of subsidiary dividend
|
( |
) | ||||||
Repayment of debt by subsidiary
|
(
|
)
|
(
|
)
|
||||
Payments on principal portion of finance lease obligations
|
( |
) | ( |
) | ||||
Proceeds from exercise of the Company’s and subsidiary stock options
|
||||||||
Taxes paid related to net settlement of equity awards
|
(
|
)
|
(
|
)
|
||||
Repurchase of common shares
|
( |
) | ||||||
Proceeds from issuance of the Company’s common shares under employee stock purchase plan
|
||||||||
Proceeds from exercise of the Company’s warrants
|
||||||||
Payment for redemptions of the Company’s warrants
|
( |
) | ||||||
Net cash (used in) provided by financing activities
|
(
|
)
|
|
|||||
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
|
( |
) | ||||||
Net change in cash, cash equivalents and restricted cash
|
(
|
)
|
(
|
)
|
||||
Cash, cash equivalents and restricted cash at beginning of period
|
|
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
|
$
|
|
||||
Non-cash investing and financing activities:
|
||||||||
Cashless exercise of the Company’s warrants
|
$ |
$ |
||||||
Issuance of subsidiary shares in connection with Debt Renegotiation
|
$ | $ | ||||||
Other
|
$
|
|
$
|
|
September 30, 2024
|
March 31, 2024
|
|||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash (included in “Other current assets”)
|
|
|
||||||
Restricted cash (included in “Other assets”)
|
||||||||
Cash, cash equivalents and restricted cash
|
$
|
|
$
|
|
•
|
Level 1-Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
|
•
|
Level 2-Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models
for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3-Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.
|
September 30, 2024
|
March 31, 2024
|
|||||||
Cash and cash equivalents
|
||||||||
Cash
|
$
|
|
$
|
|
||||
Money market funds
|
|
|
||||||
U.S. Treasury securities
|
|
|
||||||
Total cash and cash equivalents
|
$
|
|
$
|
|
||||
Marketable securities
|
||||||||
U.S. Treasury securities
|
$
|
|
$
|
|
||||
Total marketable securities
|
$
|
|
$
|
|
||||
Total cash, cash equivalents, and marketable securities
|
$
|
|
$
|
|
As of September 30, 2024
|
||||||||||||||||
Amortized Cost
|
Gross Unrealized Gains
|
Gross Unrealized Losses
|
Fair Value
|
|||||||||||||
U.S. Treasury securities
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
2024
|
2023
|
2024 | 2023 | |||||||||||||
Revenue
|
$ | $ | $ | $ | ||||||||||||
Loss from operations | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Net loss
|
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) |
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
Product revenue, net
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
License, milestone and other revenue
|
|
|
|
|
||||||||||||
Revenue, net
|
|
|
|
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of revenues
|
|
|
|
|
||||||||||||
Research and development
|
|
|
|
|
||||||||||||
Selling, general and administrative
|
|
|
|
|
||||||||||||
Total operating expenses
|
|
|
|
|
||||||||||||
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Change in fair value of debt
|
|
|
(
|
)
|
|
|||||||||||
Interest expense(1)
|
|
|
|
|
||||||||||||
Other (income) expense, net
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|||||||||
(Loss) income from discontinued operations before income taxes
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
Income tax expense
|
|
|
|
|
||||||||||||
(Loss) income from discontinued operations, net of tax
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|||||
Loss from discontinued operations before income taxes attributable to noncontrolling interests
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
(Loss) income from discontinued operations before income taxes attributable to Roivant Sciences Ltd.
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
(Loss) income from discontinued operations before income taxes
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
(1)
|
|
September 30, 2024
|
March 31, 2024(1)
|
|||||||
Assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Property and equipment, net
|
|
|
||||||
Operating lease right-of-use assets
|
|
|
||||||
Intangible assets, net
|
|
|
||||||
Other assets
|
|
|
||||||
Total assets of discontinued operations
|
$
|
|
$
|
|
||||
Liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Operating lease liabilities
|
|
|
||||||
Long-term debt
|
|
|
||||||
Other liabilities
|
|
|
||||||
Total liabilities of discontinued operations
|
$
|
|
$
|
|
(1)
|
|
Six Months Ended September 30,
|
||||||||
2024
|
2023
|
|||||||
Share-based compensation
|
$
|
|
$
|
|
||||
Change in fair value of debt
|
$
|
(
|
)
|
$
|
|
|||
Depreciation and amortization
|
$
|
|
$
|
|
September 30, 2024
|
March 31, 2024
|
|||||||
Prepaid expenses
|
$
|
|
$
|
|
||||
Trade receivables, net
|
|
|
||||||
Restricted cash | ||||||||
Income tax receivable
|
|
|
||||||
Interest receivable | ||||||||
Other
|
|
|
||||||
Total other current assets
|
$
|
|
$
|
|
September 30, 2024
|
March 31, 2024
|
|||||||
Research and development expenses
|
$
|
|
$
|
|
||||
Compensation-related expenses
|
|
|
||||||
Other expenses
|
|
|
||||||
Total accrued expenses
|
$
|
|
$
|
|
September 30, 2024
|
March 31, 2024
|
|||||||
Deferred revenue
|
$
|
|
$
|
|
||||
Income tax payable
|
|
|
||||||
Other
|
|
|
||||||
Total other current liabilities
|
$
|
|
$
|
|
Number of Options
|
||||
Options outstanding at March 31, 2024
|
|
|||
Granted
|
|
|||
Exercised |
( |
) | ||
Forfeited/Canceled |
( |
) | ||
Options outstanding at September 30, 2024
|
|
|||
Options exercisable at September 30, 2024
|
|
Number of Shares
|
||||
Non-vested balance at March 31, 2024
|
|
|||
Granted
|
|
|||
Vested
|
(
|
)
|
||
Forfeited
|
(
|
)
|
||
Non-vested balance at September 30, 2024
|
|
Executive
|
Title
|
Performance
Restricted Stock Units
(at max)
|
Restricted Stock
Units
|
Stock
Options
|
||||||||||
Matthew Gline
|
Chief Executive Officer
|
|
|
|
||||||||||
Mayukh Sukhatme
|
President and Chief Investment Officer
|
|
|
|
||||||||||
Eric Venker
|
President and Chief Operating Officer
|
|
|
|
|
*
|
|
Tranche
|
% of PSUs
|
Share Price Hurdle
(per share)
|
||||||
First Tranche
|
|
%
|
$
|
|
||||
Second Tranche
|
|
%
|
$
|
|
||||
Third Tranche
|
|
%
|
$
|
|
||||
Fourth Tranche
|
|
%
|
$
|
|
||||
Fifth Tranche
|
|
%
|
$
|
|
||||
Sixth Tranche
|
|
%
|
$
|
|
Assumptions
|
||||
Expected stock price volatility
|
|
%
|
||
Expected risk free interest rate
|
|
%
|
||
Stock price
|
$
|
|
Number of CVARs
|
||||
Non-vested balance at March 31, 2024
|
|
|||
Vested
|
(
|
)
|
||
Forfeited
|
(
|
)
|
||
Non-vested balance at September 30, 2024
|
|
Executive
|
Title
|
Cash Awards
(in thousands)
|
||||
Matthew Gline
|
Chief Executive Officer
|
$
|
|
|||
Mayukh Sukhatme
|
President and Chief Investment Officer
|
$
|
|
|||
Eric Venker
|
President and Chief Operating Officer
|
$
|
|
•
|
|
• |
• |
The remaining number of common shares issued to the MAAC Sponsor and each of MAAC’s independent directors are not subject to the vesting conditions described above (the “Retained Shares”).
|
As of September 30, 2024
|
As of March 31, 2024
|
|||||||||||||||||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Balance as of
September 30,
2024
|
Level 1
|
Level 2
|
Level 3
|
Balance as
of March 31,
2024
|
|||||||||||||||||||||||||
Assets:
|
||||||||||||||||||||||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||||||
Investment in Datavant Class A units
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Investment in Arbutus common shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Total assets at fair value
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||||||
Liabilities:
|
||||||||||||||||||||||||||||||||
Liability instruments measured at fair value(1)
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
||||||||||||||||
Total liabilities at fair value
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
(1)
|
|
Balance at March 31, 2023
|
$ | |||
|
( |
) | ||
Balance at September 30, 2023
|
$ | |||
|
||||
Balance at March 31, 2024
|
$
|
|
||
|
|
|||
Balance at September 30, 2024
|
$
|
|
Balance at March 31, 2023
|
$
|
|
||
Exercise of Private
Placement Warrants
|
( |
) | ||
|
|
|||
Balance at September 30, 2023
|
$
|
|
||
|
||||
Balance at March 31, 2024
|
$
|
|
||
|
||||
Balance at September 30, 2024
|
$ |
Point Estimate Used
|
||||||||
Input
|
As of September 30, 2024
|
As of March 31, 2024
|
||||||
Volatility
|
|
|
|
|
||||
Risk-free rate
|
|
|
|
|
Point Estimate Used
|
||||||||
Input
|
As of September 30, 2024
|
As of March 31, 2024
|
||||||
Volatility
|
|
|
|
|
||||
Risk-free rate
|
|
|
|
|
September 30, 2024
|
September 30, 2023
|
|||||||
Stock options and performance stock options
|
|
|
||||||
Restricted stock units and performance stock units (non-vested)
|
|
|
||||||
March 2020 CVARs(1)
|
|
|
||||||
November 2021 CVARs (non-vested)
|
|
|
||||||
Restricted common stock (non-vested)
|
|
|
||||||
Earn-Out Shares (non-vested)
|
|
|
||||||
Other stock based awards and instruments issued
|
(1)
|
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
Product Candidate
|
|
Indication
|
|
Vant
|
|
Modality
|
|
Phase
|
IMVT-1402
|
Graves’ Disease
|
Immunovant
|
Biologic
|
Phase 2/3*
|
||||
IMVT-1402
|
Difficult-to-Treat Rheumatoid Arthritis
|
Immunovant
|
Biologic
|
Phase 2/3*
|
||||
IMVT-1402
|
Myasthenia Gravis
|
Immunovant
|
Biologic
|
Phase 2/3*
|
||||
IMVT-1402
|
Chronic Inflammatory Demyelinating Polyneuropathy
|
Immunovant
|
Biologic
|
Phase 2/3*
|
||||
IMVT-1402
|
Indication 5
|
Immunovant
|
Biologic
|
Phase 2/3*
|
||||
Batoclimab
|
|
Myasthenia Gravis
|
|
Immunovant
|
|
Biologic
|
|
Phase 3*
|
Batoclimab
|
|
Thyroid Eye Disease
|
|
Immunovant
|
|
Biologic
|
|
Phase 3*
|
Batoclimab
|
|
Chronic Inflammatory Demyelinating Polyneuropathy
|
|
Immunovant
|
|
Biologic
|
|
Phase 2b*
|
Brepocitinib
|
|
Dermatomyositis
|
|
Priovant
|
|
Small Molecule
|
|
Phase 3*
|
Brepocitinib
|
|
Non-Infectious Uveitis
|
|
Priovant
|
|
Small Molecule
|
|
Phase 3*
|
Brepocitinib
|
|
Other Indications
|
|
Priovant
|
|
Small Molecule
|
|
Phase 2
|
Namilumab
|
|
Sarcoidosis
|
|
Kinevant
|
|
Biologic
|
|
Phase 2*
|
Mosliciguat
|
|
Pulmonary Hypertension associated with Interstitial Lung Disease
|
|
Pulmovant
|
|
Inhaled
|
|
Phase 2
|
Roivant Ownership
|
||||||||
Vant / Milestones & Royalties
|
Basic1
|
Fully
Diluted2
|
||||||
Immunovant
|
54
|
%3
|
48
|
%3
|
||||
Priovant
|
75
|
%
|
67
|
%
|
||||
Genevant
|
83
|
%
|
64
|
%
|
||||
Kinevant
|
99
|
%
|
98
|
%
|
||||
Pulmovant
|
100
|
%
|
93
|
%
|
||||
Covant
|
100
|
%
|
87
|
%
|
||||
Psivant
|
48
|
%
|
44 |
%
|
||||
Arbutus
|
21
|
%3
|
19
|
%3
|
||||
Lokavant
|
57
|
%
|
50
|
%
|
||||
VantAI
|
60
|
%
|
49
|
%
|
||||
Datavant
|
†
|
†
|
||||||
VTAMA Milestones & Royalties4
|
86
|
%4 |
81
|
%4
|
1. |
Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity.
|
2. |
Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs as well as options and warrants, in each case whether vested or
unvested.
|
3. |
Denotes entities that are publicly traded.
|
4. |
Amounts shown as of the closing of the Dermavant Transaction on October 28, 2024. At closing of the Dermavant Transaction, we received cash consideration of $183.6 million and are entitled to receive an
additional cash payment of $75.0 million upon FDA approval of VTAMA for the treatment of atopic dermatitis (the “AD Approval Milestone”). In addition to the foregoing, at closing, all former Dermavant equity holders, including Roivant,
received the right to receive their pro rata portion of (i) milestone payments of up to $950 million for the achievements of certain tiered net sales amounts with respect to VTAMA, each less than or equal to $1 billion and (ii) and tiered
royalties of (x) low-to-mid single digit percentages with respect to annual net sales of VTAMA up to $1 billion and (y) 30% with respect to annual net sales of VTAMA above $1 billion. Roivant’s ownership interest in these potential future
milestones and royalties consists of (i) 100% of the first $270 million in upfront, milestone and royalty payments (inclusive of the upfront payment made at closing and the potential AD Approval Milestone) and (ii) between 86% and 81% of
subsequent milestone and royalty payments. For more information on the Dermavant Transaction, please refer to Note 6—Discontinued Operations to Roivant’s unaudited condensed consolidated financial statements included in this Quarterly
Report on Form 10-Q.
|
† |
As of September 30, 2024, the Company’s minority equity interest in Datavant represented approximately 9% of the outstanding Class A units. Datavant’s capital structure includes several classes of preferred
units that, among other features, have liquidation preferences and conversion features. Upon conversion of such preferred units into Class A units, the Company’s ownership interest would be diluted. For more information on Roivant’s
ownership interest in Datavant, please refer to Note 4—Equity Method Investments to Roivant’s unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
|
Program
|
|
Vant
|
|
Catalyst
|
|
Expected Timing
|
Roivant pipeline growth
|
|
Roivant
|
|
New mid/late-stage in-licensing announcements
|
|
Ongoing
|
Namilumab
|
|
Kinevant
|
|
Topline data from Phase 2 trial in sarcoidosis
|
|
4Q 2024
|
LNP Platform
|
Genevant
|
Markman hearing in Pfizer/BioNTech case
|
4Q 2024
|
|||
Batoclimab
|
|
Immunovant
|
|
Topline data from Phase 3 trial in myasthenia gravis
|
|
By FY End
|
Batoclimab
|
|
Immunovant
|
|
Initial data from period 1 of Phase 2B trial in chronic inflammatory demyelinating polyneuropathy
|
By FY End
|
|
LNP Platform
|
Genevant
|
Summary judgment phase in Moderna case
|
2Q-3Q 2025
|
|||
LNP Platform
|
Genevant
|
Trial in Moderna case
|
2H 2025
|
|||
Batoclimab
|
|
Immunovant
|
|
Topline data from Phase 3 trials in thyroid eye disease
|
|
2H 2025
|
Brepocitinib
|
|
Priovant
|
|
Topline data from Phase 3 trial in dermatomyositis
|
|
2H 2025
|
Mosliciguat
|
|
Pulmovant
|
|
Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease
|
|
2H 2026
|
• |
Immunovant:
|
• |
Priovant: In September 2024, Priovant announced receipt of Fast
Track designation from FDA for brepocitinib in NIU and enrolled the first patients in the Phase 3 program. New 52-week data from the Phase 2 NEPTUNE study of brepocitinib in NIU showed potential best-in-indication efficacy sustained to
one year. Treatment failure rate in the 45 mg dose arm was 35% at week 52 vs. 29% at week 24. Treatment failure rate in the 15 mg dose arm was 56% vs. 44% at week 24. In each treatment arm only one additional patient failed from week
24 to 52. Other important efficacy measurements at week 52 were consistent with the week 24 data, including measurements of retinal vascular leakage and prevention and treatment of macular edema. Safety and tolerability were consistent
with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely
prescribed JAK inhibitors.
|
• |
Pulmovant: In September 2024, Roivant unveiled mosliciguat, a
potential first-in-class and best-in-category inhaled once-daily sGC activator. Mosliciguat is being developed for PH-ILD, which affects ~200,000 patients in the U.S. and Europe with limited or no treatment options.
|
• |
Roivant: In October 2024, Roivant reported the close of Organon’s
acquisition of Dermavant. At closing, Roivant received $184M in cash and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying
value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in the first quarter of calendar year 2025. The transaction also
includes payments of up to $950 million for the achievements of certain commercial milestones, in addition to the tiered royalties on net sales that Organon will pay Dermavant shareholders.
|
• |
Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”),
manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator
grants, sponsored research, and any other third-party expenses directly attributable to the development of our product candidates.
|
• |
Unallocated internal costs, including:
|
◦ |
employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and
|
◦ |
other expenses that are not allocated to a specific program.
|
• |
the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates, and other research and development activities that we may conduct;
|
• |
the number and scope of preclinical and clinical programs we decide to pursue;
|
• |
the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;
|
• |
the number of doses that patients receive;
|
• |
the countries in which the trials are conducted;
|
• |
our ability to secure and leverage adequate CRO support for the conduct of clinical trials;
|
•
|
our ability to establish an appropriate safety and efficacy profile for our product candidates;
|
•
|
the timing, receipt and terms of any approvals from applicable regulatory authorities;
|
•
|
the potential additional safety monitoring or other studies requested by regulatory agencies;
|
•
|
the significant and changing government regulation and regulatory guidance;
|
•
|
our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully;
|
•
|
the impact of any business interruptions to our operations due to the COVID-19 pandemic or other epidemics; and
|
•
|
our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates.
|
Three Months Ended September 30,
|
||||||||||||
2024
|
2023
|
Change
|
||||||||||
(in thousands)
|
||||||||||||
Revenue, net
|
$
|
4,475
|
$
|
3,648
|
$
|
827
|
||||||
Operating expenses:
|
||||||||||||
Cost of revenues
|
234
|
223
|
11
|
|||||||||
Research and development
|
143,073
|
114,790
|
28,283
|
|||||||||
Acquired in-process research and development
|
—
|
13,950
|
(13,950
|
)
|
||||||||
General and administrative
|
202,881
|
88,576
|
114,305
|
|||||||||
Total operating expenses
|
346,188
|
217,539
|
128,649
|
|||||||||
Loss from operations
|
(341,713
|
)
|
(213,891
|
)
|
(127,822
|
)
|
||||||
Change in fair value of investments
|
(48,375
|
)
|
45,849
|
(94,224
|
)
|
|||||||
Change in fair value of liability instruments
|
(635
|
)
|
11,789
|
(12,424
|
)
|
|||||||
Gain on deconsolidation of subsidiaries
|
—
|
(17,354
|
)
|
17,354
|
||||||||
Interest income
|
(69,773
|
)
|
(14,299
|
)
|
(55,474
|
)
|
||||||
Other expense, net
|
1,453
|
1,530
|
(77
|
)
|
||||||||
Loss from continuing operations before income taxes
|
(224,383
|
)
|
(241,406
|
)
|
17,023
|
|||||||
Income tax expense
|
12,458
|
3,236
|
9,222
|
|||||||||
Loss from continuing operations, net of tax
|
(236,841
|
)
|
(244,642
|
)
|
7,801
|
|||||||
Loss from discontinued operations, net of tax
|
(43,083
|
)
|
(86,476
|
)
|
43,393
|
|||||||
Net loss
|
(279,924
|
)
|
(331,118
|
)
|
51,194
|
|||||||
Net loss attributable to noncontrolling interests
|
(49,740
|
)
|
(26,791
|
)
|
(22,949
|
)
|
||||||
Net loss attributable to Roivant Sciences Ltd.
|
$
|
(230,184
|
)
|
$
|
(304,327
|
)
|
$
|
74,143
|
Six Months Ended September 30,
|
||||||||||||
2024
|
2023
|
Change
|
||||||||||
(in thousands)
|
||||||||||||
Revenue, net
|
$
|
12,465
|
$
|
8,131
|
$
|
4,334
|
||||||
Operating expenses:
|
||||||||||||
Cost of revenues
|
447
|
1,206
|
(759
|
)
|
||||||||
Research and development
|
263,580
|
224,206
|
39,374
|
|||||||||
Acquired in-process research and development
|
—
|
26,450
|
(26,450
|
)
|
||||||||
General and administrative
|
302,773
|
179,858
|
122,915
|
|||||||||
Total operating expenses
|
566,800
|
431,720
|
135,080
|
|||||||||
Gain on sale of Telavant net assets
|
110,387
|
—
|
110,387
|
|||||||||
Loss from operations
|
(443,948
|
)
|
(423,589
|
)
|
(20,359
|
)
|
||||||
Change in fair value of investments
|
(63,601
|
)
|
53,413
|
(117,014
|
)
|
|||||||
Change in fair value of liability instruments
|
515
|
51,967
|
(51,452
|
)
|
||||||||
Gain on deconsolidation of subsidiaries
|
—
|
(17,354
|
)
|
17,354
|
||||||||
Interest income
|
(141,900
|
)
|
(31,014
|
)
|
(110,886
|
)
|
||||||
Other expense, net
|
5,061
|
4,357
|
704
|
|||||||||
Loss from continuing operations before income taxes
|
(244,023
|
)
|
(484,958
|
)
|
240,935
|
|||||||
Income tax expense
|
24,421
|
4,911
|
19,510
|
|||||||||
Loss from continuing operations, net of tax
|
(268,444
|
)
|
(489,869
|
)
|
221,425
|
|||||||
Income (loss) from discontinued operations, net of tax
|
46,010
|
(169,094
|
)
|
215,104
|
||||||||
Net loss
|
(222,434
|
)
|
(658,963
|
)
|
436,529
|
|||||||
Net loss attributable to noncontrolling interests
|
(87,547
|
)
|
(62,820
|
)
|
(24,727
|
)
|
||||||
Net loss attributable to Roivant Sciences Ltd.
|
$
|
(134,887
|
)
|
$
|
(596,143
|
)
|
$
|
461,256
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Revenue, net
|
$
|
4,475
|
$
|
3,648
|
$
|
827
|
$
|
12,465
|
$
|
8,131
|
$
|
4,334
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Cost of revenues
|
$
|
234
|
$
|
223
|
$
|
11
|
$
|
447
|
$
|
1,206
|
$
|
(759
|
)
|
Three Months Ended September 30,
|
||||||||||||
2024
|
2023(1)
|
Change
|
||||||||||
(in thousands)
|
||||||||||||
Program-specific costs:
|
||||||||||||
Anti-FcRn franchise—neurological diseases
|
$
|
29,614
|
$
|
5,133
|
$
|
24,481
|
||||||
Anti-FcRn franchise—endocrine diseases
|
14,887
|
8,431
|
6,456
|
|||||||||
Anti-FcRn franchise—rheumatology diseases
|
7,219 |
— |
7,219 |
|||||||||
Anti-FcRn franchise—other clinical and nonclinical
|
7,903
|
11,875
|
(3,972 | ) | ||||||||
Brepocitinib
|
10,517
|
8,755
|
1,762
|
|||||||||
Mosliciguat
|
6,184
|
234
|
5,950
|
|||||||||
Namilumab
|
3,491
|
3,331
|
160
|
|||||||||
RVT-2001
|
216
|
3,739
|
(3,523
|
)
|
||||||||
RVT-3101
|
—
|
18,553
|
(18,553
|
)
|
||||||||
Other development and discovery programs
|
9,972
|
10,761
|
(789
|
)
|
||||||||
Total program-specific costs
|
90,003
|
70,812
|
19,191
|
|||||||||
Unallocated internal costs:
|
||||||||||||
Share-based compensation
|
9,911
|
8,309
|
1,602
|
|||||||||
Personnel-related expenses
|
33,577
|
26,411
|
7,166
|
|||||||||
Other expenses
|
9,582
|
9,258
|
324
|
|||||||||
Total research and development expenses
|
$
|
143,073
|
$
|
114,790
|
$
|
28,283
|
(1)
|
Certain prior year amounts have been reclassified to conform to current year presentation.
|
Six Months Ended September 30,
|
||||||||||||
2024
|
2023(1)
|
Change
|
||||||||||
(in thousands)
|
||||||||||||
Program-specific costs:
|
||||||||||||
Anti-FcRn franchise—neurological diseases
|
$
|
47,956
|
$
|
16,376
|
$
|
31,580
|
||||||
Anti-FcRn franchise—endocrine diseases
|
30,937
|
14,750
|
16,187
|
|||||||||
Anti-FcRn franchise—rheumatology diseases
|
7,219 |
— |
7,219 |
|||||||||
Anti-FcRn franchise—other clinical and nonclinical
|
14,304 |
21,705
|
(7,401
|
)
|
||||||||
Brepocitinib
|
21,111
|
16,518
|
4,593
|
|||||||||
Mosliciguat
|
9,164
|
234
|
8,930
|
|||||||||
Namilumab
|
7,868
|
6,633
|
1,235
|
|||||||||
RVT-2001
|
1,875
|
7,561
|
(5,686
|
)
|
||||||||
RVT-3101
|
—
|
29,478
|
(29,478
|
)
|
||||||||
Other development and discovery programs
|
19,451
|
20,138
|
(687
|
)
|
||||||||
Total program-specific costs
|
159,885
|
133,393
|
26,492
|
|||||||||
Unallocated internal costs:
|
||||||||||||
Share-based compensation
|
20,443
|
15,726
|
4,717
|
|||||||||
Personnel-related expenses
|
65,122
|
56,596
|
8,526
|
|||||||||
Other expenses
|
18,130
|
18,491
|
(361
|
)
|
||||||||
Total research and development expenses
|
$
|
263,580
|
$
|
224,206
|
$
|
39,374
|
(1)
|
Certain prior year amounts have been reclassified to conform to current year presentation.
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Acquired in-process research and development
|
$
|
—
|
$
|
13,950
|
$
|
(13,950
|
)
|
$
|
—
|
$
|
26,450
|
$
|
(26,450
|
)
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
General and administrative
|
$
|
202,881
|
$
|
88,576
|
$
|
114,305
|
$
|
302,773
|
$
|
179,858
|
$
|
122,915
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Gain on sale of Telavant net assets
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
110,387
|
$
|
—
|
$
|
110,387
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Change in fair value of investments
|
$
|
(48,375
|
)
|
$
|
45,849
|
$
|
(94,224
|
)
|
$
|
(63,601
|
)
|
$
|
53,413
|
$
|
(117,014
|
)
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Change in fair value of liability instruments
|
$
|
(635
|
)
|
$
|
11,789
|
$
|
(12,424
|
)
|
$
|
515
|
$
|
51,967
|
$
|
(51,452
|
)
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Gain on deconsolidation of subsidiaries
|
$
|
—
|
$
|
(17,354
|
)
|
$
|
17,354
|
$
|
—
|
$
|
(17,354
|
)
|
$
|
17,354
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Interest income
|
$
|
(69,773
|
)
|
$
|
(14,299
|
)
|
$
|
(55,474
|
)
|
$
|
(141,900
|
)
|
$
|
(31,014
|
)
|
$
|
(110,886
|
)
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
Income tax expense
|
$
|
12,458
|
$
|
3,236
|
$
|
9,222
|
$
|
24,421
|
$
|
4,911
|
$
|
19,510
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||||||
2024
|
2023
|
Change
|
2024
|
2023
|
Change
|
|||||||||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||||||||||
(Loss) income from discontinued operations, net of tax
|
$
|
(43,083
|
)
|
$
|
(86,476
|
)
|
$
|
43,393
|
$
|
46,010
|
$
|
(169,094
|
)
|
$
|
215,104
|
• |
obligations under our leases. Refer to Note 13, “Leases” in our Annual Report on Form 10-K for the year ended March 31, 2024 for further information
regarding our lease commitments. In September 2024, our subsidiary, Roivant Sciences, Inc. (“RSI”), entered into a lease agreement (the “RSI Lease Agreement”) with One Penn Plaza LLC for office space in New York, NY to serve as the future
U.S. corporate headquarters of RSI. The RSI Lease Agreement has an expected commencement date on or after December 14, 2024 and will expire on or after July 31, 2041 with an option to extend. The approximate future minimum obligation
under this lease is $115.0 million, and RSI is eligible to receive a credit of $1.8 million. As of September 30, 2024, a lease commencement date in accordance with ASC 842, Leases, had not occurred. As such, no lease liability or
right-of-use asset relating to the RSI Lease Agreement has been recorded.
|
• |
certain commitments to Samsung Biologics Co., Ltd. (“Samsung”) pursuant to a Product Service Agreement (“PSA”) entered between Immunovant and Samsung pursuant to which Samsung will manufacture and supply
Immunovant with batoclimab drug substance for commercial sale, if approved, and perform other manufacturing-related services with respect to batoclimab. Upon execution of the PSA, Immunovant committed to purchase process performance
qualification batches of batoclimab and pre-approval inspection batches of batoclimab which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition, Immunovant has a minimum obligation to
purchase further batches of batoclimab in the four-year period of 2026 through 2029. As of September 30, 2024, the remaining minimum purchase commitment related to this agreement was estimated to
be approximately $43.6 million.
|
• |
fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future;
|
• |
fund the manufacturing of drug substance and drug product of our product candidates in development;
|
• |
seek to identify, acquire, develop and commercialize additional product candidates;
|
• |
invest in activities related to the discovery of novel drugs and advancement of our internal programs;
|
• |
integrate acquired technologies into a comprehensive regulatory and product development strategy;
|
• |
maintain, expand and protect our intellectual property portfolio;
|
• |
hire scientific, clinical, quality control and administrative personnel;
|
• |
add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
|
• |
achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;
|
• |
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and
|
• |
operate as a public company.
|
Six Months Ended September 30,
|
||||||||
2024
|
2023
|
|||||||
(in thousands)
|
||||||||
Net cash used in operating activities
|
$
|
(459,635
|
)
|
$
|
(446,359
|
)
|
||
Net cash used in investing activities
|
$
|
(3,294,559
|
)
|
$
|
(36,346
|
)
|
||
Net cash (used in) provided by financing activities
|
$
|
(769,690
|
)
|
$
|
215,349
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 1. |
Legal Proceedings.
|
Item 1A. |
Risk Factors.
|
• |
successfully complete ongoing clinical trials and obtain regulatory approvals for our product candidates;
|
• |
identify new acquisition or in-licensing opportunities;
|
• |
realize the benefits of our strategic partnerships and other collaborations, including the Dermavant Transaction;
|
• |
launch commercial sales of our product candidates following regulatory approvals, whether alone or in collaboration with others, including establishing sales, marketing and distribution systems;
|
• |
attract and retain experienced management teams and operational personnel to support our ongoing clinical development efforts, including at newly formed Vants, and successfully prepare for the commercialization of our product
candidates following regulatory approvals;
|
• |
initiate and maintain relationships with third-party suppliers and manufacturers and have commercial quantities of product candidates, following regulatory approvals, manufactured at acceptable cost and quality levels and in compliance
with FDA and other regulatory requirements;
|
• |
set acceptable prices for our product candidates following regulatory approvals and obtain coverage and adequate reimbursement from third-party payors;
|
• |
achieve market acceptance of product candidates following regulatory approvals in the medical community and with third-party payors and consumers;
|
• |
raise additional funds when needed and on terms acceptable to us;
|
• |
successfully grow our healthcare technology Vants and market the products and services offered by those Vants;
|
• |
successfully identify new product candidates through our discovery efforts and advance those product candidates into preclinical studies and clinical trials; and
|
• |
maintain, expand and protect our intellectual property portfolio.
|
• |
the time and costs necessary to complete our ongoing, planned and future clinical trials for our product candidates;
|
• |
the time and costs necessary to pursue regulatory approvals for our product candidates;
|
• |
the costs associated with future acquisitions or in-licensing transactions;
|
• |
the approval, progress, timing, scope and costs of our preclinical studies, clinical trials and other related activities, including the ability to enroll patients in a timely manner for our ongoing and planned clinical trials and
potential future clinical trials for our product candidates;
|
• |
the costs associated with our ongoing, planned and future preclinical studies and other drug discovery activities;
|
• |
our ability to successfully identify and negotiate acceptable terms for third-party supply and contract manufacturing agreements with contract manufacturing organizations (“CMOs”);
|
• |
the costs of obtaining adequate clinical and commercial supplies of raw materials and drug products for our product candidates;
|
• |
the timing and amount of proceeds realized from the contingent future payments owed to us in connection with the Dermavant Transaction;
|
• |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights, including current and future patent infringement actions brought against third parties, for our product candidates;
|
• |
the cost of pursuing and defending potential intellectual property disputes, including patent infringement actions with third parties, relating to our product candidates; and
|
• |
our ability to hire, attract and retain qualified personnel.
|
• |
failure to obtain regulatory authorization to commence a clinical trial or reaching consensus with regulatory authorities regarding the design or implementation of our studies;
|
• |
other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds, or complete response letters or similar communications/objections by other regulatory
authorities;
|
• |
unforeseen safety issues, or subjects experiencing severe or unexpected adverse events;
|
• |
occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors;
|
• |
lack of effectiveness during clinical trials;
|
• |
resolving any dosing issues, including those raised by the FDA or other regulatory authorities;
|
• |
inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
• |
slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial;
|
• |
failure to add a sufficient number of clinical trial sites;
|
• |
unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities;
|
• |
inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements;
|
• |
an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
|
• |
premature discontinuation of study participants from clinical trials or missing data;
|
• |
failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality
standards, for use in clinical trials;
|
• |
inability to monitor patients adequately during or after treatment; or
|
• |
inappropriate unblinding of trial results.
|
• |
inability to meet our product specifications and quality requirements consistently;
|
• |
delay or inability to procure or expand sufficient manufacturing capacity;
|
• |
manufacturing and product quality issues related to scale-up of manufacturing;
|
• |
costs and validation of new equipment and facilities required for scale-up;
|
• |
failure to comply with applicable laws, regulations and standards, including cGMP and similar standards;
|
• |
deficient or improper record-keeping;
|
• |
inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
|
• |
termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
|
• |
reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our
product candidates following regulatory approval in a timely fashion, in sufficient quantities or under acceptable terms;
|
• |
lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
|
• |
operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or other regulatory sanctions related to the
manufacturer of another company’s product candidates;
|
• |
carrier disruptions or increased costs that are beyond our control; and
|
• |
failure to deliver our product candidates under specified storage conditions and in a timely manner.
|
• |
we may not be able to demonstrate that a product candidate is safe and effective as a treatment for the targeted indications, and in the case of our product candidates regulated as biological products, that the product candidate is
safe, pure and potent for use in its targeted indication, to the satisfaction of the FDA or other relevant regulatory authorities;
|
• |
the FDA or other relevant regulatory authorities may require additional pre-approval studies or clinical trials, which would increase costs and prolong development timelines;
|
• |
the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or other relevant regulatory authorities for marketing approval;
|
• |
the FDA or other relevant regulatory authorities may disagree with the number, design, size, conduct or implementation of clinical trials, including the design of proposed preclinical and early clinical trials of any future product
candidates;
|
• |
the CROs that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that adversely impact the clinical trials and ability to obtain marketing approvals;
|
• |
the FDA or other relevant regulatory authorities may not find the data from nonclinical, preclinical studies or clinical trials sufficient to demonstrate that the clinical and other benefits of a product candidate outweigh its safety
risks;
|
• |
the FDA or other relevant regulatory authorities may disagree with an interpretation of data or significance of results from nonclinical, preclinical studies or clinical trials or may require additional studies;
|
• |
the FDA or other relevant regulatory authorities may not accept data generated at clinical trial sites, including in situations where the authorities deem that the data was not generated in compliance with GCP, ethical standards or
applicable data protection laws;
|
• |
if an NDA, BLA or a similar application is referred for review by an advisory committee, the FDA or other relevant regulatory authority, as the case may be, may have difficulties scheduling an advisory committee meeting in a timely
manner or the advisory committee may recommend against approval of our application or may recommend that the FDA or other relevant regulatory authorities, as the case may be, require, as a condition of approval, additional nonclinical,
preclinical studies or clinical trials, limitations on approved labelling or distribution and use restrictions;
|
• |
the FDA or other relevant regulatory authorities may require development of a risk evaluation and mitigation strategy (“REMS”) drug safety program or its equivalent, as a condition of approval;
|
• |
the FDA or other relevant regulatory authorities may require additional post-marketing studies and/or patient registries for product candidates;
|
• |
the FDA or other relevant regulatory authorities may find the chemistry, manufacturing and controls data insufficient to support the quality of our product candidates;
|
• |
the FDA or other relevant regulatory authorities may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers; or
|
• |
the FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations.
|
• |
regulatory authorities may withdraw, revoke, suspend, vary, or limit their approval of the product candidate or require a REMS (or equivalent outside the U.S.) to impose restrictions on its distribution or other risk management
measures;
|
• |
regulatory authorities may request or require that we recall a product candidate;
|
• |
additional restrictions being imposed on the distribution, marketing or manufacturing processes of our product candidates or any components thereof, including a “black box” warning or contraindication on product labels or
communications containing warnings or other safety information about the product candidate;
|
• |
regulatory authorities may require the addition of labelling statements, such as warnings or contraindications, require other labelling changes of a product candidate or require field alerts or other communications to physicians,
pharmacies or the public;
|
• |
we may be required to change the way a product candidate is administered or distributed, conduct additional clinical trials, change the labelling of a product candidate or conduct additional post-marketing studies or surveillance;
|
• |
we may be required to repeat preclinical studies or clinical trials or terminate programs for a product candidate, even if other studies or trials related to the program are ongoing or have been successfully completed;
|
• |
we may be sued and held liable for harm caused to patients, or may be subject to fines, restitution or disgorgement of profits or revenues;
|
• |
physicians may stop prescribing a product candidate;
|
• |
reimbursement may not be available for a product candidate;
|
• |
we may elect to discontinue the sale of a product candidate;
|
• |
our product candidates may become less competitive; and
|
• |
our reputation may suffer.
|
• |
restrictions on the manufacture of such product candidates;
|
• |
restrictions on the labelling or marketing of such product candidates, including a “black box” warning or contraindication on the product label or communications containing warnings or other safety information about the product;
|
• |
restrictions on product distribution or use;
|
• |
requirements to conduct post-marketing studies or clinical trials, or any regulatory holds on our clinical trials;
|
• |
requirement of a REMS (or equivalent outside the U.S.);
|
• |
Warning or Untitled Letters or similar communications from other relevant regulatory authorities;
|
• |
withdrawal of the product candidates from the market;
|
• |
refusal to approve pending applications or supplements to approved applications that we submit;
|
• |
recall of product candidates;
|
• |
fines, restitution or disgorgement of profits or revenues;
|
• |
suspension, variation, revocation or withdrawal of marketing approvals;
|
• |
refusal to permit the import or export of our product candidates;
|
• |
seizure of our product candidates; or
|
• |
lawsuits, injunctions or the imposition of civil or criminal penalties.
|
• |
monitoring and assuring regulatory compliance for clinical trials, manufacturing and testing of good applicable practice (“GxP”) (e.g., GCP, GLP and GMP regulated) products;
|
• |
monitoring and providing oversight of all GxP suppliers (e.g., contract development manufacturing organizations and CROs);
|
• |
establishing and maintaining an integrated, robust quality management system for clinical, manufacturing, supply chain and distribution operations; and
|
• |
cultivating a proactive, preventative quality culture and employee and supplier training to ensure quality.
|
• |
the efficacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals;
|
• |
the potential and perceived advantages compared to alternative treatments, including any similar generic treatments;
|
• |
the ability to offer these products for sale at competitive prices;
|
• |
the ability to offer appropriate patient financial assistance programs, such as commercial insurance co-pay assistance;
|
• |
convenience and ease of dosing and administration compared to alternative treatments;
|
• |
the clinical indications for which the product candidate is approved by FDA or comparable non-U.S. regulatory agencies;
|
• |
product labelling or product insert requirements of the FDA or other comparable non-U.S. regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labelling;
|
• |
restrictions on how the product candidate is dispensed or distributed;
|
• |
the timing of market introduction of competitive products;
|
• |
publicity concerning these product candidates or competing products and treatments;
|
• |
the strength of marketing and distribution support;
|
• |
favorable third-party coverage and sufficient reimbursement; and
|
• |
the prevalence and severity of any side effects or adverse events.
|
• |
the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel;
|
• |
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved products;
|
• |
the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors;
|
• |
the inability to price products at a sufficient price point to ensure an adequate and attractive level of profitability;
|
• |
restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population;
|
• |
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
• |
unforeseen costs and expenses associated with creating an independent commercialization organization.
|
• |
the federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash
or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part,
under a federal healthcare program (such as Medicare and Medicaid). The term “remuneration” has been broadly interpreted by the federal government to include anything of value. Although there are a number of statutory exceptions and
regulatory safe harbors protecting certain activities from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available
exception or safe harbor. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. A
person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services
resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to
$100,000 for each violation. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can also result in criminal penalties, including criminal fines and imprisonment of up to 10 years.
Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid;
|
• |
the federal false claims laws, including the False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be
presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim; or knowingly making or
causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. The False Claims Act provides for suit by the federal government or private parties (qui tam relator) and when an entity is determined to have violated the federal civil False Claims Act, the government may impose significant civil fines and penalties for each false claim or statement for penalties
assessed after January 30, 2023, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
|
• |
the federal health care fraud statute (established by Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or
attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have
actual knowledge of the statute or specific intent to violate it to have committed a violation;
|
• |
the Administrative Simplification provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which impose obligations, including mandatory
contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information on health plans, health care clearing houses and most healthcare providers (collectively, “covered
entities”), and such covered entities’ “business associates,” defined as independent contractors or agents of covered entities that create, receive or obtain personally identifiable health information in connection with providing a
service for or on behalf of the covered entity;
|
• |
various privacy, cybersecurity and data protection laws, rules and regulations at the international, federal, state and local level, which impose obligations with respect to safeguarding the privacy, security, and cross-border
transmission of personally identifiable data, including personal health information;
|
• |
the federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity that engages in activities including, among others (1) knowingly presenting, or causing to be
presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal health care programs
to provide items or services reimbursable by a federal health care program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment;
|
• |
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program
(with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians, certain other healthcare providers, and teaching hospitals, and requires applicable
manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value”
to such physician owners (covered manufacturers are required to submit reports to the government by the 90th day of each calendar year);
|
• |
analogous state and EU and foreign national laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales, and marketing
arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential
referral sources; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, and state laws
that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;
|
• |
U.S. federal drug price reporting and government contracting statutes and regulations, the violation of which can lead to civil penalties, debarment, and/or enforcement under the federal False Claims Act, and certain local and state
laws that require disclosures to state agencies or boards and/or commercial purchasers, for example, with respect to certain price increases, some of which contain ambiguous requirements that government officials have not yet clarified;
and
|
• |
EU and foreign national laws prohibiting promotion of prescription-only medicinal products to individuals other than healthcare professionals, governing strictly all aspects of interactions with healthcare professionals and healthcare
organizations, including prior notification, review and/or approval of agreements with healthcare professionals, and requiring public disclosure of transfers of value made to a broad range of stakeholders, including healthcare
professionals, healthcare organizations, medical students, physicians associations, patient organizations and editors of specialized press.
|
• |
the demand for our product candidates following regulatory approval;
|
• |
our ability to receive or set a price that we believe is fair for our product candidates following regulatory approval;
|
• |
our ability to generate revenue and achieve sustained profitability;
|
• |
the amount of taxes that we are required to pay; and
|
• |
the availability of capital.
|
• |
multiple conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and
licenses;
|
• |
failure by us or our collaborators to obtain appropriate licenses or regulatory approvals for the sale or use of our product candidates in various countries;
|
• |
difficulties in managing operations in different jurisdictions;
|
• |
complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;
|
• |
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to currency exchange rate fluctuations;
|
• |
varying protection for intellectual property rights;
|
• |
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and
|
• |
failure to comply with the U.S. Foreign Corrupt Practices Act (the “FCPA”), including its books and records provisions and its anti-bribery provisions, the United Kingdom Bribery Act 2010 (the “U.K. Bribery Act”), and similar
anti-bribery and anti-corruption laws in other jurisdictions, for example by failing to maintain accurate information and control over sales or distributors’ activities.
|
• |
VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), neonatal Fc receptor blockers, potential competitors to IMVT-1402 and batoclimab;
|
• |
Nipocalimab and RYSTIGGO (rozanolixizumab-noli), anti-FcRn antibodies, potential competitors to IMVT-1402 and batoclimab;
|
• |
TEPEZZA (teprotumumab-trbw), an insulin-like growth factor-1 receptor inhibitor, a potential competitor to batoclimab; and
|
• |
Dazukibart, an interferon beta (IFN-beta) inhibitor, a potential competitor to brepocitinib.
|
• |
delays in or an inability to commercialize any future product candidates for which we obtain marketing approval;
|
• |
impairment of our business reputation and significant negative media attention;
|
• |
delay or termination of clinical trials, or withdrawal of participants from our clinical trials;
|
• |
significant costs to defend the related litigation;
|
• |
distraction of management’s attention from our primary business;
|
• |
substantial monetary awards to patients or other claimants;
|
• |
product recalls, withdrawals or labelling, marketing or promotional restrictions;
|
• |
decreased demand for our product candidates following regulatory approval; and
|
• |
loss of revenue.
|
• |
the scope of rights granted under the license agreement and other interpretation-related issues;
|
• |
our financial or other obligations under the license agreement;
|
• |
the extent to which our technology or product candidates infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
• |
the sublicensing of patent and other rights;
|
• |
our diligence obligations under the license agreements and what activities satisfy those diligence obligations;
|
• |
the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
|
• |
the priority of invention of patented technology.
|
• |
others may be able to make formulations or compositions that are the same as or similar to our product candidates, but that are not covered by the claims of the patents that we own;
|
• |
others may be able to make drugs that are similar to our product candidates that we intend to commercialize that are not covered by the patents that we exclusively licensed and have the right to enforce;
|
• |
we, our licensor or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed;
|
• |
we or our licensor or any collaborators might not have been the first to file patent applications covering certain of our inventions;
|
• |
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
|
• |
it is possible that our pending patent applications will not lead to issued patents;
|
• |
issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
|
• |
our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where
we do not have patent rights, and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial markets; and we may not develop additional proprietary technologies that
are patentable;
|
• |
third parties performing manufacturing or testing for us using our products, product candidates or technologies could use the intellectual property of others without obtaining a proper license;
|
• |
parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property;
|
• |
we may not develop or in-license additional proprietary technologies that are patentable;
|
• |
we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all;
|
• |
the patents of others may harm our business; and
|
• |
we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.
|
• |
actual or anticipated fluctuations in our quarterly and annual financial results or the quarterly and annual financial results of companies perceived to be similar to it;
|
• |
changes in the market’s expectations about operating results;
|
• |
our operating results failing to meet market expectations in a particular period;
|
• |
a Vant’s operating results failing to meet market expectations in a particular period, which could impact the market prices of shares of a public Vant or the valuation of a private Vant, and in turn adversely impact the trading price
of our common shares;
|
• |
receipt of marketing approval for a product candidate in one or more jurisdictions, or the failure to receive such marketing approval;
|
• |
the results of clinical trials or preclinical studies conducted by us and the Vants;
|
• |
changes in financial estimates and recommendations by securities analysts concerning us, the Vants or the biopharmaceutical industry and market in general;
|
• |
operating and stock price performance of other companies that investors deem comparable to us;
|
• |
changes in laws and regulations affecting our and the Vants’ businesses;
|
• |
the outcome of litigation or other claims or proceedings, including governmental and regulatory proceedings, against us or the Vants;
|
• |
changes in our capital structure, such as future issuances of securities or the incurrence of debt;
|
• |
the volume of our common shares available for public sale and the relatively limited free float of our common shares;
|
• |
any significant change in our board of directors or management;
|
• |
sales of substantial amounts of our common shares by directors, executive officers or significant shareholders or the perception that such sales could occur; and
|
• |
general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism.
|
• |
a classified board of directors with staggered three-year terms;
|
• |
the ability of our board of directors to determine the powers, preferences and rights of preference shares and to cause us to issue the preference shares without shareholder approval; and
|
• |
requiring advance notice for shareholder proposals and nominations and placing limitations on convening shareholder meetings.
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds.
|
Period
|
Total Number of
Common Shares
Purchased(1)
|
Average Price Paid per
Common Share
|
Total Number of
Common Shares
Purchased as Part of
Publicly Announced
Program(2)
|
Approximate Dollar
Value of Common
Shares that May Yet
Be Purchased Under
the Program(2)
|
||||||||||||
(in millions)
|
||||||||||||||||
July 1 – 31, 2024
|
—
|
—
|
—
|
$
|
851.6
|
|||||||||||
August 1 – 31, 2024
|
1,150,573
|
$
|
11.29
|
1,150,573
|
$
|
838.6
|
||||||||||
September 1 – 30, 2024
|
8,833,777
|
$
|
11.76
|
8,833,777
|
$
|
734.7
|
||||||||||
Total
|
9,984,350
|
9,984,350
|
(1) |
The total number of common shares purchased set forth in this column is based on the trade date of the repurchase transaction (not the settlement date of the repurchase transaction), including 960,692 common shares which were
repurchased on September 30, 2024 with a settlement date of October 1, 2024.
|
(2) |
On April 2, 2024, we announced that our board of directors had authorized a common share repurchase program, allowing for repurchases of Roivant common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses).
The timing and total amount of common shares repurchased depends on several factors, including the market price of our common shares, general business, macroeconomic and market conditions and other investment opportunities. Under the
repurchase program, purchases may be conducted through open market transactions, tender offers or privately negotiated transactions, including the use of trading plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended.
See Note 8–Shareholders’ Equity in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information related to share repurchases. Table excludes fees and commissions payable in connection with common share repurchases.
|
* |
In addition to the repurchase transactions set forth above, during the six months ended September 30, 2024, we withheld 2,384,468 common shares associated with net share settlements to cover (i) tax withholding obligations upon the
vesting and settlement of equity incentive awards issued under our equity incentive plans, including RSUs and CVARs, and (ii) the payment of the exercise price of certain stock options.
|
Item 3. |
Defaults Upon Senior Securities.
|
Item 4. |
Mine Safety Disclosures.
|
Item 5. |
Other Information.
|
Incorporated by Reference
|
|||||
Exhibit
Number
|
Description
|
Form
|
File No.
|
Exhibit
|
Filing Date
|
Agreement and Plan of Merger, dated September 17, 2024, by and among Dermavant Sciences Ltd., Organon & Co., Organon Bermuda Ltd. and Roivant Sciences Ltd.
|
8-K
|
001-40782
|
2.1
|
September 23, 2024
|
|
License Agreement by and between Bayer Aktiengesellschaft and Pulmovant, Inc., dated as of July 27, 2023.
|
—
|
—
|
—
|
Filed herewith
|
|
First Amendment to the License Agreement by and between Bayer Aktiengesellschaft and Pulmovant, Inc., dated as of September 22, 2023.
|
—
|
—
|
—
|
Filed herewith
|
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
—
|
—
|
—
|
Filed herewith
|
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
—
|
—
|
—
|
Filed herewith
|
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
—
|
—
|
—
|
Filed herewith
|
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
—
|
—
|
—
|
Filed herewith
|
|
101.INS
|
Inline XBRL Instance Document
|
—
|
—
|
—
|
Filed herewith
|
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
—
|
—
|
—
|
Filed herewith
|
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
—
|
—
|
—
|
Filed herewith
|
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
—
|
—
|
—
|
Filed herewith
|
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
—
|
—
|
—
|
Filed herewith
|
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
—
|
—
|
—
|
Filed herewith
|
104
|
Cover Page Interactive Data (formatted as Inline XBRL and contained in Exhibit 101)
|
—
|
—
|
—
|
Filed herewith
|
* |
Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the omitted exhibits and schedules upon request by the SEC; provided,
however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any exhibits or schedules so furnished.
|
# |
Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
|
Dated: November 12, 2024
|
ROIVANT SCIENCES LTD.
|
|
By:
|
/s/ Matthew Gline
|
|
Name: Matthew Gline
|
||
Title: Principal Executive Officer
|
||
By:
|
/s/ Richard Pulik
|
|
Name: Richard Pulik
|
||
Title: Principal Financial Officer
|
||
By:
|
/s/ Matt Maisak
|
|
Name: Matt Maisak
|
||
Title: Authorized Signatory
|
1. |
DEFINITIONS
|
(a) |
all national, regional and international patents, certificates of invention, applications for certificates of invention, priority patent filings, patent applications, utility models, design patents and design rights filed in any country
of the world including provisional patent applications;
|
(b) |
all patents, patent applications, utility models, design patents and design rights filed either from such patents, patent applications, utility models, design patents, design rights or provisional patent applications or claiming priority
from any of these, including any continuation, continuation-in part, division, provisional, converted provisional and continued prosecution applications, or any substitute application;
|
(c) |
any patent issued with respect to or in the future issued from any such patent applications;
|
(d) |
any and all extensions or restorations by existing or future extension or restoration mechanisms, including reissues, re-examinations, renewals, extensions (including any supplementary protection certificates and the like),
substitutions, confirmations, registrations, revalidations, revisions and additions of the foregoing patents, patent applications, utility models, design patents and design rights; and
|
(e) |
any foreign counterparts of the foregoing.
|
(a) |
establish the risk benefit profile of the product;
|
(b) |
define warnings, precaution and adverse reactions that are associated with the product; and
|
(c) |
support Marketing Authorization of such product; or a similar clinical study prescribed by the regulatory authorities, from time to time, pursuant to applicable law or otherwise, including the trials referred to in US Code Title 21 CFR.
§312.21(c), as amended from time to time, or, in a country other than the United States, a similar clinical study prescribed by the applicable Regulatory Authority.
|
Defined Term
|
Section Reference
|
||
Acquired Competing Program
|
Section 3.3.2(b)
|
||
Alliance Manager
|
Section 3.1
|
||
API
|
Section 7.1.2
|
||
ARDS-Field
|
Section 3.3.1
|
||
[***]
|
Section 6.4.3.2
|
||
Auditor
|
Section 5.9.1(i)
|
||
[***]
|
Section 1.31
|
||
Bayer Exclusivity Period
|
Section 3.3.2(a)
|
||
Bayer Indemnitee
|
Section 10.2
|
||
Breach Notice
|
Section 11.3
|
||
Commercialization Wind-Down Period
|
Section 11.6.4(e)(i)
|
Competing Program
|
Section 3.3.2(a)
|
||
Confidential Information
|
Section 6.1.1
|
||
Country List
|
Section 9.2.2
|
||
Cure Plan
|
Section 11.3
|
||
Disclosing Party
|
Section 6.1.1
|
||
Disputed Matter
|
Section 12.1
|
||
Document Transfer Deficiency Notice
|
Section 2.3(ii)
|
||
Documentation Review Date
|
Section 2.3(ii)
|
||
DSUR
|
Section 2.3(iii)(a)
|
||
Employee Data
|
Section 13.3
|
||
GDPR
|
Section 13.1
|
||
Human Data
|
Section 13.4
|
||
IND Transfer Date
|
Section 3.4.1
|
||
Indemnified Party
|
Section 10.3.1
|
||
Indemnifying Party
|
Section 10.3.1
|
||
Losses
|
Section 10.1
|
||
Licensee Indemnitee
|
Section 10.1
|
||
New Agreement
|
Section 11.6.4(f)
|
||
Patent Challenge
|
Section 11.5
|
||
Payee
|
Section 5.5.1
|
||
Paying Party
|
Section 5.5.1
|
||
Pharmacovigilance Agreement
|
Section 2.3(iii)
|
||
Qualified Assignment
|
Section 14.4.1(c)
|
||
Receiving Party
|
Section 6.1.1
|
||
Regulatory Transfer Period
|
Section 3.4.2
|
Royalty Payment
|
Section 4.3.1
|
||
Royalty Rate
|
Section 4.3.1
|
||
Royalty Term
|
Section 4.3.2
|
||
Rules
|
Section 12.2
|
||
Semi-Annually
|
Section 3.5.1
|
||
Solvent
|
Section 14.4.1(c)(iii)
|
||
Term
|
Section 11.1
|
||
Third Party Claim
|
Section 10.1
|
||
Transfer Tax
|
Section 5.7
|
||
VAT
|
Section 5.4
|
||
VDR
|
Section 8.3
|
||
Withholding Tax
|
Section 5.5.1
|
||
Yearly
|
Section 3.5.1
|
2. |
LICENSES, TECHNOLOGY TRANSFER
|
(i) |
Within the applicable period after the Effective Date specified in Exhibit 2.3, [***], transfer the Licensed Know-How and related materials to Licensee specified in Exhibit 2.3. For a period of [***] after the Effective
Date, [***] Bayer shall provide Licensee with such Know-How (which, for clarity, constitutes Licensed Know-How) in a manner consistent with that specified in Exhibit 2.3 for similar Licensed Know-How. Notwithstanding the foregoing,
at any time following such [***] period and upon Licensee’s request, Bayer shall use reasonable efforts, [***], to provide additional documents or material that embody Licensed Know-How specifically related to the Development or
Commercialization of the Licensed Compounds and Licensed Products in the Field in Bayer or any of its Affiliates’ possession and owned or Controlled by it to Licensee [***]. [***].
|
(ii) |
Licensee will have [***] following receipt of all documents specified in [***] to review whether such documents are complete for such purpose, and if not, provide written notice (a “Document Transfer Deficiency Notice”) to Bayer
thereof, including the document title and a brief description of items missing or incomplete. Following the receipt of such notice from Licensee, Bayer shall use reasonable efforts to [***] provide the applicable documents to Licensee (in
any event within [***]). If Licensee does not provide a Document Transfer Deficiency Notice to Bayer, the documents will be deemed acceptable upon the conclusion of such [***] period (such date or the date on which Bayer provides to
Licensee all documents set forth in a Document Transfer Deficiency Notice, the “Documentation Review Date”). [***].
|
(iii) |
Within [***] after the Effective Date, the Parties will negotiate in good faith and execute a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) covering:
|
(iv) |
Bayer will use reasonable efforts to respond [***], and in any event within [***], to Licensee’s reasonable requests during Bayer’s normal business hours for Bayer to provide to Licensee, for a period of [***] following the Effective
Date [***], technology transfer and enablement assistance (via virtual meetings with pre-aligned agendas and answering questions by email) related to the Licensed Know-How (excluding Manufacturing Know-How which is exhaustively covered by
Section 7.2) as is reasonably necessary to carry out the activities specified in this Section 2.3 (i) and (ii); [***].
|
3. |
ALLIANCE MANAGERS / DEVELOPMENT / DILIGENCE
|
3.2.1 |
Licensee shall use Commercially Reasonable Efforts to Develop, obtain and maintain Marketing Authorization, and, following receipt of Marketing Authorization, Commercialize [***]. Licensee shall have the sole responsibility, at its sole
cost, for the Development, Commercialization and, subject to Section 7.2, Manufacture of the Licensed Compounds and Licensed Products. All INDs and all NDAs will be submitted in the name of a Licensee Party, and all Marketing
Authorizations will be held and owned by a Licensee Party. Failure by Licensee to use Commercially Reasonable Efforts as described in this Section 3.2.1 will constitute a breach of material obligation and, for clarity Section 11.3 applies.
|
3.2.2 |
As soon as Licensee anticipates to suspend the Development of Licensed Products for a period of at least [***], Licensee will notify Bayer in writing [***]. Bayer shall then have the right to request a meeting (either via telephone,
video or in-person) which shall take place no later than [***] after such meeting has been requested, and Licensee shall make available for such meeting such employees and representatives with appropriate expertise and knowledge regarding
the Development activities. Such meeting shall be set-up by the Alliance Managers of the Parties [***].
|
3.4.1 |
No later than [***] following the Documentation Review Date, [***], Bayer shall initiate to assign, on behalf of itself and its Affiliates, and shall cause its Affiliates to assign, to Licensee all of its and its Affiliates’ rights,
title and interest in and to the IND having the number [***]. The Parties shall cooperate in executing such assignment, with the effective date of assignment to occur on a date mutually agreed by the Parties (the “IND Transfer Date”).
|
3.4.2 |
For the period beginning on the Effective Date and ending on the IND Transfer Date (the “Regulatory Transfer Period”), Bayer shall continue to maintain regulatory filings for the Licensed Compound at Licensee’s direction. [***];
provided that Bayer shall not be required to take any action on behalf of Licensee that is not in compliance with applicable Laws, or otherwise not in compliance with Bayer’s internal policies and standards.
|
3.4.3 |
In the event of failure to obtain the assignment contemplated under Section 3.4.1, Bayer, on behalf of itself and its Affiliates, hereby grants to Licensee, its Affiliates and its Sublicensees (without any further action required on the
part of Bayer and its Affiliates, whose authorization to file this consent with any Regulatory Authority of the Territory is hereby granted effective as of the Effective Date), an authorization to copy, access, reference, and otherwise use
(at no cost to Licensee), the IND application and filing referenced in Section 3.4.1 made by or on behalf of Bayer or any of its Affiliates with or to the FDA [***]. Bayer shall provide to Licensee a signed statement to the effect of the
foregoing and, solely if required by the FDA, shall take such actions as may be reasonably requested by Licensee to give effect to the intent of this Section 3.4.3.
|
3.4.4 |
Subject to Section 3.4.2, Section 2.3(ii) and the terms of the Pharmacovigilance Agreement, as between the Parties, Licensee shall be responsible, and act as the sole point of contact, for communications with Regulatory Authorities in
connection with the Development, Commercialization, and Manufacturing of the Licensed Compounds and the Licensed Products in the Field in the Territory. [***].
|
3.5.1
|
Reports. Licensee shall keep Bayer informed by providing to the Alliance Manager of Bayer [***].
|
3.5.2
|
Discussion of the Reports. If requested in writing by the Alliance Manager of Bayer upon the receipt of any report delivered by Licensee pursuant to Section 3.5.1, and upon reasonable advance
notice, Licensee shall make available to Bayer representatives of Licensee with the appropriate expertise and knowledge of the activities undertaken to perform the Development and/or Commercialization to answer reasonable questions posed
by Bayer [***] (either via telephone, video or in-person) per such report, such meeting to be held upon request by Bayer and be set-up by the Alliance Managers of the Parties; for clarity, the aforementioned representatives of Licensee
shall participate in such meeting. [***].
|
4. |
CONSIDERATION
|
4.2.1 |
Subject to the remainder of this Section 4.2, in partial consideration of the rights granted to it by Bayer under this Agreement, upon the first (1st) achievement of the corresponding
development or regulatory milestone event by a Licensed Product or sales milestones event for all Licensed Products by all Licensee Parties, Licensee shall make the following one-time payments to Bayer:
|
Milestone
|
Amount
|
||||
1
|
[***]
|
[***]
|
|||
2
|
[***]
|
[***]
|
|||
3
|
[***]
|
[***]
|
|||
4
|
[***]
|
[***]
|
|||
5
|
[***]
|
[***]
|
|||
6
|
[***]
|
[***]
|
|||
7
|
[***]
|
[***]
|
|||
8
|
[***]
|
[***]
|
|||
9
|
[***]
|
[***]
|
|||
10
|
[***]
|
[***]
|
4.2.2 |
Licensee shall provide written notice to Bayer (a) of any occurrence of any of the development or regulatory milestone events set forth above (1-6) no later than [***] after the occurrence of the relevant milestone event has been
achieved and (b) of any occurrence of any of the sales milestone events set forth above (7-10) no later than [***] after the end of the applicable [***] in which the relevant milestone event has been achieved, in each case (a) and (b) in
accordance with Section 4.2.1. Following such notice, Bayer shall (i) in the case of a development or regulatory milestone event, [***] and (ii) in the case of a sales milestone even, [***], issue an invoice for the corresponding milestone
payment, and Licensee shall pay to Bayer the invoiced milestone payment, in accordance with Section 5.1.
|
4.2.3 |
All of the foregoing milestone payments will be paid to Bayer by Licensee only one-time irrespective of how many Licensed Products achieve a milestone event and no milestone payments will be payable to Bayer under this Agreement for
Indications subsequent to the second Indication.
|
4.3.1 |
Royalty Rate. Subject to the remainder of this Section 4.3, in partial consideration of the rights granted to it by Bayer under this Agreement, on a Licensed Product-by-Licensed Product basis, Licensee shall pay to Bayer royalty
payments on the Annual Net Sales of such Licensed Product sold in the Territory by or on behalf of the Licensee Parties during the Royalty Term for such Licensed Product (“Royalty Payments”) at the applicable royalty rate set forth
below (each, a “Royalty Rate”).
|
Portion of Annual Net Sales of a Licensed Product
|
Royalty Rate
|
||
[***]
|
[***]
|
||
[***]
|
[***]
|
4.3.2 |
Royalty Term. Royalties Payments shall be paid on Net Sales on a Licensed Product-by-Licensed Product and country-by-country basis from the First Commercial Sale of such Licensed Product in such country in the Territory by or on
behalf of Licensee or its Affiliates or Sublicensees until the later of (a) the expiration of the last to expire Valid Claim of a Licensed Patent Right in such country, (b) the expiration of Regulatory Exclusivity for such Licensed Product
in such country, and (c) [***] after the date of the First Commercial Sale of such Licensed Product in such country (the “Royalty Term”). For the avoidance of doubt, (i) the Net Sales value shall be reset on an Annual basis, and
(ii) from and after the expiration of the Royalty Term for a Licensed Product in a country, Net Sales of such Licensed Product in such country shall be excluded for purposes of calculating the Net Sales thresholds set forth in the table of
Section 4.2.1.
|
4.3.3 |
Royalty Reductions.
|
(a) |
Generic Entry. Subject to Section 4.3.3(d), if, on a country-by-country and Licensed Product-by-Licensed Product basis, a Third Party that is not a Licensee Party receives Marketing Authorization for and commences commercial sale
of a Generic Product, the applicable Royalty Rates for such Licensed Product in such country shall be reduced by [***] beginning with the first [***] in which Net Sales of such Licensed Product in such country shall have for the first time
decreased by [***] compared to the Net Sales of such Licensed Product in such country in the immediately preceding [***].
|
(b) |
Patent Expiry. Subject to Section 4.3.3(d), if the Royalty Term for a particular Licensed Product in a country extends beyond the time period set forth in Section 4.3.2(a), then the applicable Royalty Rates shall be reduced by
[***] for such Licensed Product in such country during the portion of the Royalty Term that extends beyond the time period set forth in Section 4.3.2(a).
|
(c) |
Third Party Licenses. Subject to Section 4.3.3(d), if Licensee or its Affiliate or Sublicensee enters into an agreement with a Third Party in order to obtain a license or other right under any Third Party IP with respect to a
Licensed Product in one or more countries in the Territory, Licensee or such Affiliate or Sublicensee shall be entitled to deduct from any Royalty Payments with respect to such Licensed Product in such country(ies) [***] of all amounts paid
to such Third Party pursuant to the terms of such agreement, in each case to the extent reasonably allocable to such rights in such country.
|
(d) |
Royalty Floor. Notwithstanding anything to the contrary in the foregoing Sections 4.3.3(a) through (c), with respect to any Licensed Product in any [***], the operation of Sections 4.3.3(a) through (c) above, individually or in
combination, shall not reduce by more than [***] the Royalty Payments that would otherwise have been due under Section 4.3.1 with respect to Net Sales of such Licensed Product in the applicable country(ies) during such [***]. Licensee
shall have the right to carry forward on a country-by-country basis for a total of [***] any amounts that it was not able to credit on account of the royalty floor set forth in this Section 4.3.3(d) towards
any Royalty Payments owed to Bayer in each such [***].
|
4.3.4 |
Royalty Reports. Starting from the date of First Commercial Sale of any Licensed Product in any country, Licensee shall submit within [***] after the end of each [***] a Microsoft Excel file showing: [***]. All amounts payable
to Bayer pursuant to Section 4.3.1 will be paid within [***] after Licensee’s receipt from Bayer of an invoice for such payment by wire transfer to the account specified in Section 5.1.
|
5. |
PAYMENTS
|
5.5.1 |
Any Party required to make a payment pursuant to this Agreement (hereinafter “Paying Party”) to the other Party (hereinafter “Payee”) shall be entitled to deduct and withhold from the amount payable the tax for which Paying
Party is or may be held liable on behalf or for the account of Payee or in relation to taxes of Payee under any provisions of law (“Withholding Tax”).
|
5.5.2 |
The Licensee herewith confirms that the licensed intellectual property is not allocated to a permanent establishment of the Licensee in Germany. The licensee will inform Payee in case the licensed intellectual property will be allocated
to a permanent establishment of the licensee in Germany in the future.
|
5.5.3 |
If the tax rate for the Withholding Tax is actually reduced according to an applicable double taxation treaty or local law, no deduction shall be made or any deductions shall only be made at a reduced amount, as the case may be, only if
Paying Party is timely furnished with the necessary documents by Payee (and, if required by the relevant jurisdiction, issued from the competent tax authority) which certify that the payment is exempt from tax or subject to a reduced tax
rate.
|
5.5.4 |
The Paying Party shall use commercially reasonable efforts to notify Payee reasonably in advance of any payment with respect to which it takes the view that the requirements for a deduction and withholding are satisfied and it intends to
make such deduction of Withholding Tax.
|
5.5.5 |
If a Withholding Tax deduction is required by Laws, Paying Party and Payee shall cooperate in good faith (i) to comply with all procedures in order to achieve an exemption / release from such deduction and withholding and (ii) to resolve
any disagreement as to the Laws (if any). Any withheld Withholding Tax shall be treated as having been paid by Paying Party to Payee for all purposes of this Agreement. Paying Party shall timely forward the receipts certifying the
payments of Withholding Tax to Payee. Any Withholding Taxes due to the assignment of this Agreement that would not have applied without such assignment shall be borne by the assigning Party unless the other Party has requested this
assignment or approved the assignment (and the assigning Party has not otherwise agreed to compensate the non-assigning Party for such Withholding Taxes).
|
5.9.1 |
To validate Licensee’s compliance with the Agreement in connection with its financial obligations under this Agreement, Bayer may, during the course of this Agreement and for [***] after termination of this Agreement, appoint an auditor,
[***], to carry out an audit of Licensee’s practices, procedures and records from time to time. Licensee shall cause any Sublicensee to allow Bayer to carry out an audit directly of such Sublicensee in accordance with this Section 5.9.
Audits may be undertaken solely subject to the following conditions.
|
(i) |
Any such audits shall be undertaken by an independent certified public accountant, [***] (the “Auditor”).
|
(ii) |
Any such audits shall be permitted to be conducted [***].
|
(iii) |
The Licensee Party will nominate a representative, familiar with all aspects of the Licensee Party’s compliance with the Agreement in connection with the financial obligations of this Agreement to assist the auditor. The representative
will provide prompt and reasonable access to all records and other information, as reasonably requested by the Auditor to assess Licensee’s compliance with the Agreement in connection with its financial obligations under this Agreement.
|
(iv) |
The Auditor will enter a confidentiality agreement [***] governing the use and disclosure of such audited Licensee Party’s information disclosed to the Auditor, [***].
|
(v) |
If an audit reveals that Licensee has underpaid royalties due, Bayer shall invoice Licensee for the underpaid amount; if the audit reveals that Licensee has overpaid royalties due, Bayer shall credit Licensee for the overpaid amount.
For the avoidance of doubt, late payment interest shall be due on any underpaid amounts, calculated in accordance with Section 5.2.
|
(vi) | [***] |
5.9.2 |
Any disputes with respect to the findings of such auditor [***].
|
6. |
CONFIDENTIALITY; PUBLICATIONS, AND OTHER PUBLIC DISCLOSURES
|
6.1.1 |
As used herein, a Party’s “Confidential Information” means all confidential or proprietary Know-How and other information and materials related to the Licensed Compound or Licensed Products
and disclosed under this Agreement by or on behalf of such Party or its Affiliates (such Party together with its Affiliates the “Disclosing Party”) to the other Party or its Affiliates (such Party together with its Affiliates, the “Receiving Party”) in written, graphical, physical, electronic, oral or any other form. For the avoidance of doubt: Bayer’s Confidential Information includes the Licensed Know-How and any
unpublished Licensed Patent Right.
|
6.1.2 |
Further, the terms and conditions of this Agreement shall be deemed both Parties’ Confidential Information hereunder and, with regard thereto, both Parties shall be subject to the obligations of confidentiality and non-use as per this
Section 6.
|
6.1.3 |
Confidential Information does not include information which the Receiving Party can prove:
|
(a) |
is at the time of disclosure part of the public domain or becomes thereafter part of the public domain other than by an unauthorized disclosure of the Receiving Party in breach of this Agreement; for the sake of clarity, information
shall not be deemed to be in, or have come into, the public domain merely because any part of such information is embodied in general information which is or becomes publicly known or because individual features, components or combinations
thereof are or become publicly known;
|
(b) |
has been obtained by the Receiving Party from a Third Party prior to or after its disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; provided that such information was not obtained by said Third
Party, directly or indirectly, from the Disclosing Party under an obligation of confidentiality; or
|
(c) |
was developed by or on behalf of the Receiving Party independently of the Confidential Information provided by the Disclosing Party, as documented by the Receiving Party’s business records, and without breach of the terms of this
Agreement.
|
6.2.1 |
Obligation of Confidentiality and Non-Use. Each Party agrees, with regard to Confidential Information received from the Disclosing Party, that during the Term and for a period of [***]
thereafter it shall:
|
(i) |
keep such Confidential Information strictly confidential and reasonably protected against disclosure;
|
(ii) |
not use the Confidential Information, for any purposes other than those expressly permitted under this Agreement; and
|
(iii) |
not disclose Confidential Information to any person or entity other than as permitted by Section 6.2.3 and Section 6.4.
|
6.2.2
|
In case of concern relating to the other Party’s technical and organizational measures for the protection of Confidential Information (including suspicion of, or actual, loss or leakage of the requesting
Party’s Confidential Information), a Party shall have the right upon [***] prior notice and during regular business hours of the other Party to :
|
(i) |
request the disclosure of such other Party’s self-reported information for the requesting Party’s review; and
|
(ii) |
have calls/video meetings with the other Party’s relevant personnel that such other Party makes available to respond to the requesting Party’s questions, provided that such right may not be exercised in a manner that interferes with the
normal operations and activities of such other Party’s personnel.
|
6.2.3 |
Exceptions from the Obligation of Confidentiality and Non-Use. A Receiving Party may disclose Confidential Information disclosed to it as follows:
|
(i) |
Confidential Information may be disclosed to the following persons and entities if such have a need to know and are bound by an obligation (contractual, fiduciary or otherwise) of confidentiality, non-use and non-disclosure at least as
restrictive as set forth herein: (a) the Receiving Party’s and its Affiliates’ officers, directors and employees; (b) any Third Party to the extent reasonably necessary or appropriate to exercise the Receiving Party’s rights or perform the
Receiving Party’s obligations under this Agreement, including, solely in the case of Licensee as the Receiving Party, to subcontractors and Sublicensees; and (c) bona fide actual or prospective:
investors, investment bankers, lenders, other financing sources for the purpose of Licensee’s financing, merger partners, acquirers of a Party or substantially all of its assets referring to the Licensed Compound and all Licensed Products;
provided that, in each case (a) – (c), the Receiving Party shall remain responsible for any failure by any person who receives Confidential Information pursuant to this Section 6.2.3(i)
|
(ii) |
Confidential Information may be disclosed (a) in the case of either Party as the Receiving Party, to Governmental Authorities in order to obtain, maintain or defend Patent Rights as permitted under Section 9 and (b) solely in the case of
Licensee as the Receiving Party, to Regulatory Authorities or other governmental authorities to seek and obtain approval to conduct clinical trials, file, obtain and maintain Marketing Approval or Pricing Approval with respect to a Licensed
Product and to otherwise Exploit the Licensed Compounds and Licensed Products, provided, however, that Licensee shall be obliged to take reasonably diligent efforts to adequately protect Bayer’s Confidential Information in any clinical
trial applications and any other submission to Regulatory Authorities or other governmental authorities.
|
(iii) |
Confidential Information may be disclosed if and only to the extent such disclosure is required by Laws (for clarity, including (a) as required pursuant to a validly issued request for information from a Regulatory Authority and (b) as
required pursuant to the rules and regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange of listing entity); provided that and
without limiting clause (ii) above, [***], but in any case, if reasonably possible, not later than [***] prior to any such disclosure, to the extent permitted by Laws, the Receiving Party shall notify the Disclosing Party and give
reasonable opportunity to review and comment on the proposed disclosure and/or seek a protective order or other appropriate remedy and the Receiving Party shall consider in good faith any comments timely provided by the Disclosing Party.
To the fullest extent permitted by Laws, the Receiving Party shall seek confidential treatment of any Confidential Information disclosed to it under this Section 6.2.3(iii).
|
6.4.1 |
Except as otherwise required by Laws, neither Party shall issue a press release or make any other public disclosure concerning the terms and conditions of this Agreement (including the Effective Date and maximum financial obligations)
without the prior written approval of such press release or public disclosure by the other Party, which shall not be unreasonably withheld, conditioned or delayed.
|
6.4.2 |
For any press release or public disclosure concerning the terms and conditions of this Agreement, the following shall apply.
|
(i) |
Each Party shall submit the content proposed for inclusion in any such press release or other public disclosure to the other Party for review and comment no less than [***] prior to the anticipated date of publication. The Parties shall
cooperate in good faith to address any comments, concerns or objections within such period. After the applicable content in such press release or other public disclosure has been approved by the reviewing Party, it shall not be modified,
altered, amended or adjusted in any material way by the publishing Party. The contents of any press release or other public disclosure that has been reviewed and approved by the reviewing Party can be re-released by either Party without a
requirement for re-approval by the original reviewing Party.
|
(ii) |
The principles to be observed by Bayer and Licensee in such press releases and other public disclosures with respect to this Agreement shall be: accuracy, compliance with Laws, and the requirements of confidentiality under this Section
6. Notwithstanding the foregoing, either Party may issue a press releases or other public disclosure as it determines, based on advice of counsel, are reasonably necessary to comply with Laws or for appropriate market disclosure in
accordance with the terms of Section 6.2.3(iii).
|
6.4.3 |
Public disclosure regarding data, information or results related to the Licensed Compounds or the Licensed Products.
|
6.4.3.1 |
By Licensee. Subject to Section 6.4.3.2 and Section 6.4.4, Licensee shall have the exclusive right to, at its sole discretion and without Bayer’s written consent, publicly disclose (including
through a public announcement, press release, or Publication) any data, information or results related to the Licensed Compounds or the Licensed Products; provided that, for any Publication,, Licensee allows Bayer to review and comment in
accordance with Section 6.4.3.3.
|
6.4.3.2 |
By Bayer. Bayer shall have the right, but not the obligation, to make Publications on the Development work completed by Bayer prior to the Effective Date; [***], and subject to the procedure and
the Parties’ compliance with Section 6.4.3.3; provided, further, that for any such Publication related to [***], Bayer shall also share a preliminary draft with Licensee as far in advance of Bayer’s intended submission as reasonably
practicable, and the Parties shall cooperate in good faith to address any comments, concerns or objections of Licensee on the draft.
|
6.4.3.3 |
Good faith cooperation. Each Party shall send the other Party any planned Publication for review no later than [***] before submission for publication or presentation. The other (reviewing) Party
may provide comments within [***] of its receipt of such written copy, and the Parties shall cooperate in good faith to address any comments, concerns or objections prior to submission. The Parties will comply with International Committee
of Medical Journal Editors standards regarding authorship and contributions for each such publication or presentation.
|
6.4.4 |
Clinical Trial Transparency. Bayer shall have the right to disclose to the EU Clinical Trials Register and to publish on its internet page a summary of the results of [***] and a plain language summary in accordance with existing
industry commitments as announced in the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases” by EFPIA, PhRMA, JPMA and IFPMA on January 6th 2005 and effective as of Jan 6th, 2005 (as
amended from time to time), and in accordance with Bayer’s Clinical Trial Transparency Policy (https://clinicaltrials.bayer.com/transparency-policy/); provided that Bayer shall not make such
disclosure prior to the earlier of [***]. At least [***] before Bayer makes a disclosure under this Section 6.4.4, Bayer shall send a final draft of the information to be published to Licensee for review to be reasonably considered by
Bayer so long as such comments are in compliance with Laws, with the above-mentioned industry commitments, Bayer’s Clinical Trial Transparency Policy and the International Committee of Medical Journal Editors (ICMJE) guidelines. If no
comment by Licensee is received within [***] after Licensee having received the information to be published, Bayer shall be free to make the disclosure.
|
7. |
MANUFACTURE AND SUPPLY
|
7.1.1 |
Responsibility. Subject to the terms and conditions of this Agreement, Licensee shall be solely responsible for and bear all costs of the manufacture and supply of the Licensed Product(s) in the Field in the Territory.
|
7.1.2 |
[***]
|
(i) |
Within the time periods specified in Exhibit 7.2, Bayer shall, [***], deliver to the Licensee the information and materials relating to the manufacturing process of the API and Licensed Product as specified in Exhibit 7.2.
During the Transfer Period as defined in Exhibit 7.2, [***], Bayer shall provide Licensee with such Know-How (which, for clarity, constitutes Licensed Know-How) in a manner consistent with that specified in Exhibit 7.2 for similar
Licensed Know-How. [***].
|
(ii) |
[***]
|
8. |
REPRESENTATIONS AND WARRANTIES
|
9. |
INTELLECTUAL PROPERTY
|
9.2.1 |
Licensed Patent Rights A. Licensee shall be responsible for the filing, prosecution and maintenance (including by way of patent term extensions such as supplementary protection certificates, pediatric extensions, and any other
extensions that are now or become available in the future, wherever applicable) of the Licensed Patent Rights A [***]. Licensee shall (a) keep Bayer reasonably and timely informed as to the filing, prosecution and maintenance of any
Licensed Patent Rights A, including the status thereof, and provide to Bayer copies of all material correspondence to or from any patent office related thereto including copies of any documents from any patent office important for any
action to be taken related to the filing, prosecution and maintenance; (b) provide Bayer with copies of any material communications intended for submission to any patent office, including any divisional, continuation or continuation-in-part
patent application of any Licensed Patent Right A with reasonable time – [***] - to review and comment prior to such submission; (c) furnish to Bayer copies of all documents related to any filing, prosecution and maintenance of such
Licensed Patent Rights A, including a copy of each patent application or other submission as filed, together with notice of its filing date and serial number; and (d) incorporate reasonable and timely comments of Bayer on documents to be
filed with any patent office that would affect Bayer's rights in such Licensed Patent Rights A hereunder. Bayer shall provide prompt and reasonable assistance with respect to the preparation, filing, prosecution and/or maintenance of
Licensed Patent Rights A, as requested by Licensee and at Licensee’s cost and expense, including by providing documentation and declarations that are reasonably required or useful for filing patent term extensions.
|
9.2.2 |
[***].
|
9.2.3 |
[***].
|
9.3.2 |
[***].
|
9.3.3 |
[***].
|
9.3.4 |
[***].
|
9.5.1 |
Notification of Infringement. If any Licensed Patent Right is or might be infringed by a Third Party, the Party first having knowledge thereof shall promptly notify the other Party in writing. Such notice shall set forth the
facts of the infringement in reasonable detail and to the extent known by the notifying Party. Neither Party shall notify a Third Party of the infringement of a Licensed Patent Right without the
written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed. The Parties shall use reasonable efforts and cooperation to terminate the infringement of a Licensed Patent Right without litigation.
|
9.5.2 |
Enforcement of Licensed Patent Rights in the event of unexpired patent claims of Licensed Patent Rights B.
|
9.5.2.1 |
Bayer Right to Enforce. [***]
|
9.5.2.2 |
Licensee Right to Enforce. [***]
|
9.5.3 |
Enforcement of Licensed Patent Rights A in the Event of expired patent claims of Licensed Patent Right B.
|
9.5.3.1 |
Licensee Right to Enforce. [***]
|
9.5.3.2 |
Bayer Right to Enforce. [***]
|
9.5.4 |
Hatch Waxman.
|
9.5.4.1 |
Notice. If either Party receives any application, submission or notice under Section 505(b)(3) or 505(j)(2)(B) of the FD&C Act (e.g., the filing of an ANDA under Section 505(j) of the FD&C Act or an application under
Section 505(b)(2) of the FD&C Act naming a Licensed Product as a reference listed drug and including a certification under Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(IV), respectively), or otherwise becomes aware of the submission to
a Regulatory Authority of an application for a product referencing a Licensed Product, it shall promptly notify the other Party in writing to that effect and provide a copy of such communication.
|
9.5.4.2 |
Enforcement.
|
(a) |
[***]
|
(b) |
[***]
|
(c) |
[***]
|
9.5.4.3 |
Cooperation. [***]
|
9.5.5
|
Third Party Actions. Each Party will immediately notify the other Party in the event that a Third Party Action is brought against any of the Licensed Patent Rights by a Third Party. [***]
|
9.5.6 |
Recovery. [***]
|
9.5.7 |
Cooperation. Each Party agrees to cooperate in any action under this Section 9 which is controlled by the other Party.
|
9.5.8 |
Settlement. [***]
|
10. |
INDEMNIFICATION / LIMITATION OF LIABILITY
|
10.3.6 |
[***].
|
11. |
TERM AND TERMINATION
|
11.6.1 |
In case of any termination in its entirety or expiration of this Agreement, all rights and obligations of the Parties shall cease immediately, unless otherwise indicated in this Agreement.
|
11.6.2 |
Expiration or termination in its entirety of this Agreement shall not relieve the Parties of any obligation accrued prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party
from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement nor prejudice any Party’s right to obtain performance of any obligation. It is understood and agreed that
monetary damages may not be a sufficient remedy for any breach of this Agreement and that the non-breaching Party may be entitled to injunctive relief as a remedy for any such breach.
|
11.6.3 |
Upon termination in its entirety or expiration of this Agreement, upon the request of the Disclosing Party, the Receiving Party shall promptly return to the Disclosing Party or destroy the Disclosing Party's Confidential Information,
including all copies thereof, except to the extent that retention of such Confidential Information is reasonably necessary for the Receiving Party to Exploit any continuing rights it may have and/or to fulfill its obligations contemplated
herein, including one copy of the Confidential Information stored in a secure place for the sole purpose of evidence. The return and/or destruction of such Confidential Information as provided above shall not relieve the Receiving Party of
its obligations under this Agreement. The provisions of this section shall not apply to copies of electronically exchanged Confidential Information made as a matter of routine information technology backup and to Confidential Information
or copies thereof which must be stored by the Receiving Party according to provisions of Law.
|
11.6.4 |
Termination by Licensee under Section 11.2 or by Bayer under Section 11.3, 11.4 or 11.5. Exept as otherwise provided in this Section 11.6.4, the following provisions shall apply if Licensee terminates this Agreement pursuant to
Section 11.2 or if Bayer terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5.
|
(a) |
Licensee shall grant, and hereby does grant, to Bayer, effective as of the effective date of such termination, an exclusive, royalty-free, sublicensable, through multiple tiers of sublicensees, license under the Reversion Technology to
Develop, Manufacture and Commercialize the Reversion Products in the Field in the Territory; [***].
|
(b) |
As promptly as practicable (and in any event within [***]) after the effective date of such termination, to the extent permitted by applicable Law, Licensee shall [***]: (i) deliver to Bayer or its designee true, correct and complete
copies of all regulatory submissions, filings, registrations and approvals (including NDAs and Marketing Authorizations) for any Reversion Product owned or Controlled by Licensee, any of its Affiliates or, subject to Section 11.6.4(f),
Sublicensees; (ii) transfer or assign, or cause to be transferred or assigned, to Bayer or its designee (or to the extent not so assignable, take all reasonable actions to make available to Bayer or its designee the benefits of) all
regulatory submissions, filings, registrations and approvals (including NDAs and Marketing Authorizations) for any Reversion Product owned or Controlled by Licensee, any of its Affiliates or, subject to Section 11.6.4(f), Sublicensees;
(iii) transfer, or cause to be transferred, to Bayer or its designee all data, reports, records, written materials and information, owned or Controlled by Licensee, any of its Affiliates or, subject to Section 11.6.4(f), Sublicensees to the
extent that such data, reports, records, written materials or other information solely relates to the Reversion Product and is included within the Reversion Technology licensed to Bayer under Section 11.6.4(a); and (iv) take such other
actions and execute such other instruments, assignments and documents as may be reasonably necessary to effect, evidence, register and record the transfer, assignment or other conveyance to Bayer or its designee of rights under this Section
11.6.4(b). Further, for a period of [***] after the date of such transfer, Licensee shall, or cause its Affiliates to, provide assistance to Bayer or its designee as reasonably necessary for the technical enablement of the Reversion
Technology, [***].
|
(c) |
Licensee shall, as directed by Bayer, either (i) wind-down any ongoing clinical Development activities (including clinical trials) with respect to any Reversion Product in an orderly fashion or (ii) promptly transition ongoing
Development activities to Bayer or its designee, in each case ((i) and (ii)), with due regard for patient safety and in compliance with all Laws. [***].
|
(d) |
If this Agreement is terminated prior to a First Commercial Sale of a Licensed Product, (i) Bayer (or a designee as nominated by Bayer) shall have the right, but not the obligation, to purchase from Licensee any or all usable clinical
inventory of any Reversion Product in Licensee’s or its Affiliates’ possession as of the effective date of such termination, [***], and (ii) Licensee will use Commercially Reasonable Efforts to cause any terminated Sublicensee to offer to
Bayer (or a designee as nominated by Bayer) for purchase any or all usable clinical inventory of any Reversion Product in such Sublicensee’s possession as of the effective date of such termination [***].
|
(e) |
If this Agreement is terminated after to a First Commercial Sale of a Licensed Product:
|
(i) |
in case Licensee or any of its Affiliates or Sublicensees is then selling any Licensed Products, Licensee, its Affiliates and its Sublicensees shall have the right to sell any inventory of such Licensed Products intended for
Commercialization in the Territory existing as of the effective date of such termination for up to [***] after the effective date of such termination (the “Commercialization Wind-Down Period”), [***].
|
(ii) |
Any Licensed Product sold or disposed of by Licensee, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-Down Period under Section 11.6.4(e)(i) shall be subject to all obligations by Licensee applicable
to sales of Licensed Products under the Agreement, including the consideration, payment and reporting obligations under Section 4 (Consideration) and Section 5 (Payments) and all related rights by Bayer including the right to audit under
Section 5.9.
|
(f) |
Survival of Sublicenses. [***]
|
12. |
DISPUTE RESOLUTION
|
13. |
DATA PRIVACY
|
14. |
MISCELLANEOUS
|
14.1.1 |
The headings of sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction.
|
14.1.2 |
All references in this Agreement to the singular shall include the plural where applicable.
|
14.1.3 |
The use of any gender is applicable to all genders.
|
14.1.4 |
Unless otherwise specified, references in this Agreement to any section shall include all subsections and paragraphs in such section, and references in this Agreement to any subsection shall include all paragraphs in such subsection.
|
14.1.5 |
Any list or examples following the word “including” shall be interpreted without prejudice to the generality of the preceding words.
|
14.1.6 |
The word “will” will be construed to have the same meaning and effect as the word “shall.
|
14.1.7 |
The word “or” means “and/or” unless the context dictates otherwise because the subjects of the conjunction are or intended to be mutually exclusive.
|
14.1.8 |
The words “herein,” “hereof,” and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular section or other subdivision.
|
14.1.9 |
All references to days or years in this Agreement shall mean calendar days or calendar years, as the case may be, unless otherwise specified.
|
14.1.10 |
References herein to any law or regulation are to such law or regulation as amended, modified, codified, reenacted, supplemented or superseded in whole or in part, and in effect from time to time.
|
14.1.11 |
This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other
communications between the Parties regarding this Agreement shall be in the English language.
|
14.4.1 |
Subject to Sections (a)-(e) below, this Agreement will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns, each of which such successors and permitted assigns will be
deemed to be a Party hereto for all purposes hereof.
|
(a) |
No Party may assign or otherwise transfer either this Agreement or any of its rights, interests, or obligations hereunder without the prior written approval of the other Party. Any attempted assignment by Bayer or Licensee in violation
of this Section 14.4.1 shall be null and void and of no legal effect.
|
(b) |
Notwithstanding clause (a) above, either Party, upon providing written notice to the other Party, may without the consent of such other Party, assign or otherwise transfer this Agreement or any right or obligation hereunder to one or
more of its Affiliates, and so long as the assigning Party is not relieved of any liability accrued hereunder prior to such assignment hereunder.
|
(c) |
Notwithstanding clause (a) above, each Party (or its permitted successive assignees or transferees hereunder), upon providing the other Party prior written notice, may without the consent of the other Party, assign or transfer this
Agreement as a whole to an entity that succeeds to all or substantially all of the business or assets of such Party related to the subject matter of this Agreement, so long as the assigning Party is not relieved of any obligation accrued
hereunder prior to such assignment and such assignment is a Qualified Assignment.
|
(i) |
is made in compliance with Laws, including securities, tax and corporation laws;
|
(ii) |
includes the assignee’s written acknowledgement of and agreement to all of the assigning Party’s obligations under the Agreement;
|
(iii) |
is made to an assignee that is, and will be after giving effect to the relevant assignment, Solvent;
|
(iv) |
is made to an assignee that is not subject at the time of such assignment to any order, decree or petition providing for (A) the winding-up or liquidation of such Person, (B) the appointment of a receiver over the whole or part of the
assets of such Person or (C) the bankruptcy or administration of such Person;
|
(v) |
is not a voidable fraudulent conveyance;
|
(vi) |
is made to an assignee that is at the time of such assignment not debarred under 21 U.S.C. §30 or under investigation or threatened to be debarred under 21 U.S.C. §30; and
|
(vii) |
will not cause a material increase in taxes, costs or expenses to the non-assigning Party (unless the assigning Party or the assignee has agreed to compensate the non-assigning Party for the same).
|
(d) |
Notwithstanding clause (a) above, each Party may at any time assign its rights, interests and obligations provided for hereunder to any Person by merger or with the prior written consent of the other Party.
|
(e) |
Notwithstanding clause (a) above, Bayer may assign its right to receive payments hereunder, in whole or in part and in their entirety or in portions, to a Third Party, without the written consent of Licensee, provided that Bayer shall
provide reasonable (and at least [***]) prior written notice to Licensee before entering into any such transaction. Without limiting Bayer’s notice obligation under the foregoing sentence, in the event Bayer closes any transaction
effectuating any such assignment of such rights, Bayer agrees to further notify Licensee promptly after such assignment of the name and address of the assignee and the name, address, telephone number and email address, if any, of the
individual employee of the assignee who shall be the initial contact person with respect to such payment obligations under this Agreement.
|
14.4.2 |
Notwithstanding anything to the contrary in Section 14.4.1 or elsewhere in this Agreement, Licensee may grant or permit any encumbrance on or assignment of all or part of its rights under this Agreement to any Person in connection with a
financing for Licensee from time to time.
|
If to Licensee:
|
Pulmovant, Inc.
[***]
|
With a copy to (which shall not constitute notice):
|
legalnotices@roivant.com
|
If to Bayer:
|
Bayer AG
[***]
|
With a copy to (which shall not constitute notice):
|
Bayer AG
[***]
|
Bayer Aktiengesellschaft
|
Pulmovant, Inc. | ||||
Date: | Date: | ||||
By: | ppa. | [***] | By: | [***] | |
Print Name: | [***] | Print Name: | [***] | |
Title: | [***] | Title: | [***] |
Date: | |||
By: | i.V. | [***] | |
Print Name: | [***] | |
Title: | [***] |
1. |
DEFINITIONS; COMING INTO FORCE
|
2. |
[***]
|
3. |
MISCELLANEOUS
|
Bayer Aktiengesellschaft
|
Pulmovant, Inc. | ||||
Date: | Date: | ||||
By: | ppa. | [***] | By: | [***] | |
Print Name: | [***] | Print Name: | [***] | |
Title: | [***] | Title: | [***] |
Date: | |||
By: | i.V. | [***] | |
Print Name: | [***] | |
Title: | [***] |
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Roivant Sciences Ltd.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter
(the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial
reporting.
|
/s/ Matthew Gline
|
|
Matthew Gline
|
|
Principal Executive Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Roivant Sciences Ltd.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter
(the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial
reporting.
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/s/ Richard Pulik
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Richard Pulik
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Principal Financial Officer
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic
Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Matthew Gline
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Matthew Gline
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Principal Executive Officer
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, to which this Certification is attached as Exhibit 32.2 (the “Periodic
Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Richard Pulik
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Richard Pulik
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Principal Financial Officer
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