Skip to main content

Roivant Sciences Ltd

For the period ended Jun 30, 2024. Filed Aug 9, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 9, 2024

ROIV$38.88+6.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2023-12-31; filed 2024-02-13.

0001140361-24-007260

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-09.

0001140361-24-036642

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 125 previous paragraphs and 110 current paragraphs.

56 unchanged; 33 reworded; 21 added; 28 removed; 8 previous and 0 current paragraphs rearranged.

Tables are not compared: 67 previous and 60 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (21)

Current report

Research and development expenses increased by$8.1 million to$133.2 million for the three months ended June 30, 2024, compared to$125.1 million for the three months ended June 30, 2023. This increase was primarily driven by increases in program-specific costs of$4.3 million, share-based compensation of $3.1 million, and personnel-related expenses of $1.6 million.

Current report

Within program-specific costs, the increase of $4.3 million was primarily driven by an increase in expense of $14.8 million related to the anti-FcRn franchise, partially offset by a decrease in expense of$10.9 million related to RVT-3101 for which the rights to further develop and manufacture were sold to Roche in December 2023.

Current report

Gain on sale of Telavant net assets was approximately$110.4 million for the three months ended June 30, 2024 and resulted from the achievement of a one-time milestone achieved in June 2024. Refer to Note 6, “Recent Transactions and Developments” of our financial statements for further information regarding the milestone.

Current report

Interest expense increased by$4.5 million to$13.4 million for the three months ended June 30, 2024, compared to$8.9 million for the three months ended June 30, 2023. The increase primarily resulted from costs incurred related to the Debt Renegotiation completed in May 2024. Refer to Note 8, “Long-Term Debt” of our financial statements for further information regarding the Debt Renegotiation.

Current report

Income tax expense increased by$10.9 million to$12.7 million for the three months ended June 30, 2024, compared to$1.8 million for the three months ended June 30, 2023. The increase is primarily due to our earnings by legal entity in various jurisdictions, which is driven by an increase in interest income.

Current report

On May 24, 2024, Dermavant entered into a series of agreements to renegotiate its existing debt obligations (the “Debt Renegotiation”). The Debt Renegotiation included amendments to (i) the NovaQuest Agreement (the “NovaQuest Agreement Amendment”), (ii) the Credit Facility (the “Credit Facility Amendment”), and (iii) the RIPSA (the “RIPSA Amendment” and collectively with the NovaQuest Agreement Amendment and the Credit Facility Amendment, the “Amendments”).

Current report

The NovaQuest Agreement Amendment eliminated the fixed quarterly cash payments totaling $176.3 million that would have been due and payable following regulatory approval of tapinarof in the U.S. for atopic dermatitis, if approved. In addition, the NovaQuest Agreement Amendment (i) eliminated cash payments of up to $141.0 million to NovaQuest that would have been due and payable upon achievement of certain commercial milestones by Dermavant and (ii) amended the timing of remaining cash payments, which now total $122.5 million in aggregate, to be paid between the fiscal years ending March 31, 2025 and March 31, 2029, with payments totaling $6.0 million per fiscal year for the fiscal years ending March 31, 2025 and March 31, 2026.

Current report

The Credit Agreement Amendment extended the maturity date of the Credit Facility from May 2026 to May 2028 and increased the interest rate payable on borrowings under the Credit Facility from 10.00% to 12.25% per annum.

Current report

The RIPSA Amendment provided for, among other things, a near-term cap on the royalties currently payable equal to $6.0 million per fiscal year for each of the fiscal years ending March 31, 2025, 2026 and 2027. The RIPSA Amendment did not otherwise amend the amount of the royalty payable, which is based on a capped single-digit revenue interest in net sales of VTAMA for all dermatological indications in the U.S., up to a cap of $344.0 million.

Current report

The Amendments also included certain other modifications to non-economic terms of the NovaQuest Agreement, including certain representations and covenants relating to the continued validity of, and performance by us, under an equity commitment letter (the “Equity Commitment Letter”) entered into in conjunction with the Amendments on May 24, 2024. Under the Equity Commitment Letter, Roivant agreed to contribute $195.0 million (the “Commitment”) to Dermavant in exchange for convertible preferred shares with a 1.5 times liquidation preference on invested capital. Roivant has contributed $125.0 million of the Commitment as of June 30, 2024.

Current report

In connection with the Amendments, Dermavant issued common shares to NovaQuest and the holders of the RIPSA in an aggregate amount equal to approximately 13.2% of Dermavant’s issued and outstanding common and preferred shares (on an as converted basis) pursuant to subscription agreements (the “Subscription Agreements”). The common shares include certain anti-dilution top-up rights tied primarily to our Commitment. The Amendments, together with the Equity Commitment Letter and the Subscription Agreements, constitute the “Debt Renegotiation.”

Current report

As of June 30, 2024, we owned approximately 87% of Dermavant’s issued and outstanding common and preferred shares.

Current report

Our board of directors authorized a common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses). The repurchase program is funded by available cash and cash equivalents on hand and does not have an expiration date. In April 2024, pursuant to the share repurchase program, we entered into a share repurchase agreement with Sumitomo Pharma Co., Ltd. (“Sumitomo”) and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million.

Current report

We enter into agreements with contract service providers to assist in the performance of its research and development activities. Expenditures to contract research organizations and contract manufacturing organizations represent significant costs in the clinical development of its product candidates. Subject to required notice periods and certain obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. We expect to enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.

Current report

For thethree months ended June 30, 2024 and 2023, cash flow from financing activities changed by$668.1 million to net cash used in financing activities of$660.6 million from net cash provided by financing activities of$7.5 million for thethree months ended June 30, 2023. This change in cash flow is primarily due to the repurchase of $648.4 million of our common shares during the three months ended June 30, 2024.

Current report

For information with respect to recently issued accounting standards and the impact of these standards on our unaudited condensed consolidated financial statements, refer to Note 2, “Summary of Significant Accounting Policies” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report.
Removed paragraphs (28)

Previous report

Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7 billion at December 31, 2023.

Previous report

In January 2024, Dermavant announced new positive efficacy and safety data from analyses of ADORING 3, an ongoing open-label, long-term extension Phase 3 trial being conducted to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD for up to 48 weeks of total treatment. The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including:

Previous report

The interim analysis of the ADORING 3 open-label, long-term extension Phase 3 trial demonstrated that 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0). No new safety signals were observed with up to 56 weeks of treatment. Data from these analyses will be included in sNDA submission expected this quarter.

Previous report

Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.

Previous report

Cost of revenues increased by $2.2 million to $11.1 million for the nine months ended December 31, 2023 compared to $9.0 million for the nine months ended December 31, 2022. During the nine months ended December 31, 2023 and 2022, cost of revenues included $2.1 million and $1.0 million, respectively, of costs relating to VTAMA sales as well as amortization expense recognized in connection with milestones capitalized following the FDA approval of VTAMA in May 2022.

Previous report

Research and development expenses decreased by $1.8 million to $123.7 million for the three months ended December 31, 2023, compared to $125.5 million for the three months ended December 31, 2022. Changes in the components of research and development expenses included a decrease in program-specific costs of $10.0 million offset by increases in personnel-related expenses of $6.5 million and other expenses of $1.1 million.

Previous report

Within program-specific costs, the decrease of $10.0 million was primarily driven by a decrease of $9.5 million related to other development and discovery programs due to the deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in August 2023, along with the reprioritization of certain programs and drug discovery efforts, and decreases of $3.1 million each related to RVT-2001 and batoclimab. These decreases were partially offset by an increase in expense of $4.0 million related to RVT-3101, which was acquired in November 2022, and an increase of $3.5 million related to IMVT-1402. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.

Previous report

The increase of $6.5 million in personnel-related expenses was primarily driven by a special one-time cash retention bonus award granted to employees during the three months ended December 31, 2023.

Previous report

Research and development expenses decreased by $12.5 million to $380.8 million for the nine months ended December 31, 2023, compared to $393.4 million for the nine months ended December 31, 2022, primarily due to decreases in program-specific costs of $16.6 million and share-based compensation of $2.2 million, partially offset by an increase in other expenses of $6.1 million.

Previous report

The decrease of $16.6 million in program-specific costs was primarily driven by a decrease of $63.3 million in other development and discovery program expense, which in part resulted from the deconsolidation of Proteovant in August 2023 along with the reprioritization of certain programs and drug discovery efforts. This decrease was partially offset by increases of $33.5 million relating to RVT-3101, which was acquired in November 2022, and $22.6 million relating to IMVT-1402. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.

Previous report

Acquired in-process research and development expenses were $97.7 million for the three months ended December 31, 2022, primarily due to consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million.

Previous report

Selling, general and administrative expenses increased by $42.8 million to $517.8 million for the nine months ended December 31, 2023, compared to $475.0 million for the nine months ended December 31, 2022, primarily due to an increase in selling, general and administrative expenses of $47.2 million at Dermavant as a result of the progression of the commercial launch of VTAMA and an increase in personnel-related expenses of $22.1 million primarily as a result of a special one-time cash retention bonus award granted to employees. These increases were partially offset by a decrease of $37.3 million in share-based compensation expense.

Previous report

Gain on sale of Telavant net assets was approximately $5.3 billion for the three and nine months ended December 31, 2023 and resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion. Refer to Note 5, “Recent Transactions” of our financial statements for further information regarding the Roche Transaction.

Previous report

Change in fair value of investments were unrealized losses of $63.9 million and $53.3 million for the nine months ended December 31, 2023 and 2022, respectively. The change of $10.6 million was primarily driven by changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.

Previous report

Change in fair value of debt and liability instruments were losses of $85.4 million and $90.0 million for the nine months ended December 31, 2023 and 2022, respectively. Change in fair value of debt and liability instruments for the nine months ended December 31, 2023 primarily consisted of a loss of $48.9 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination and a loss of $35.9 million relating to the NovaQuest Facility, which was largely due to the passage of time. The change in fair value of debt and liability instruments for the nine months ended December 31, 2022 primarily consisted of a loss of $55.2 million relating to the NovaQuest facility, which was primarily due to the impact of VTAMA approval in psoriasis, and a loss of $40.7 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination.

Previous report

Gain on deconsolidation of subsidiaries was $17.4 million for the nine months ended December 31, 2023 and resulted from the deconsolidation of VantAI Holdings, Inc. (“VantAI”) in July 2023 and Proteovant in August 2023.

Previous report

Gain on deconsolidation of subsidiaries was $12.5 million and $29.3 million for the three and nine months ended December 31, 2022, respectively, and resulted from the deconsolidation of certain subsidiaries in November 2022 and July 2022.

Previous report

Interest expense increased by $1.0 million to $9.4 million for the three months ended December 31, 2023, compared to $8.4 million for the three months ended December 31, 2022.

Previous report

Interest expense increased by $8.2 million to $27.6 million for the nine months ended December 31, 2023, compared to $19.4 million for the nine months ended December 31, 2022. The increase primarily resulted from Dermavant’s revenue interest purchase and sale agreement (the “RIPSA”), pursuant to which funding of $160.0 million was received in June 2022 following the approval of VTAMA by the FDA in May 2022.

Previous report

In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate of 19,600,685 of our common shares at a purchase price of $10.21 per share. Net proceeds to us were approximately $199.8 million after deducting offering expenses.

Previous report

In October 2023, Immunovant completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by us on the same terms as other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share. Concurrent with the public offering, we purchased 4,473,684 shares of Immunovant’s common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at the same price per share as investors in the public offering of $38.00 per share. The net proceeds to Immunovant were approximately $466.7 million after deducting underwriting discounts and commissions, placement agent fees and offering expenses.

Previous report

On December 14, 2023, we completed the sale of our entire equity interest in our majority-owned subsidiary, Telavant, to Roche. The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among us, Telavant, Pfizer Inc. (“Pfizer”), and Roche. Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”) and Crohn’s disease, in the United States and Japan. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer owned the remaining 25%, in each case on an as-converted basis.

Previous report

Cash flow from investing activities includes proceeds from sale of Telavant net assets, milestone payments, cash decreases upon deconsolidation of subsidiaries, proceeds from sale of subsidiary interests, and purchase of property and equipment.

Previous report

For the nine months ended December 31, 2023, cash provided by financing activities increased by $162.9 million to $452.0 million compared to the nine months ended December 31, 2022. During the nine months ended December 31, 2023, net proceeds were primarily generated by the issuance of common shares of our majority-owned subsidiary Immunovant as well as the issuance of our common shares pursuant to purchase and sale agreements entered with certain institutional investors. During the nine months ended December 31, 2022, proceeds were generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of our common shares and the common shares of our majority-owned subsidiary Immunovant.

Previous report

In April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
Reworded paragraphs (33)

Previous wording

Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several immunoglobulin G (“IgG”) mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Current wording

Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline is concentrated in inflammation and immunology and includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 for the treatment of dermatomyositis and non-infectious uveitis, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Previous wording

Note: All clinical stage drugs in our current pipeline are investigational and subject to health authority approval. Pipeline reflects both ongoing clinical trials and expected upcoming trials.

Current wording

Note: All clinical stage drugs in our current pipeline are investigational and subject to health authority approval. Our pipeline reflects both ongoing clinical trials and expected upcoming trials.

Previous wording

In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth below. In addition, we plan to in-license multiple potentially category-leading drugs per year.

Current wording

We have a robust set of expected near-term catalysts, including the items set forth below. In addition, we plan to in-license multiple potentially category-leading drugs per year.

Previous wording

With the FDA approval of VTAMA for the treatment of plaque psoriasis in adult patients and our initial product launch in May 2022, we began to recognize product revenues. We record product revenue net of estimated chargebacks, discounts, rebates, returns, and other allowances associated with the respective sales.

Current wording

Product revenue, net consists of net product revenues from the sale of VTAMA. We record product revenue net of estimated chargebacks, discounts, rebates, returns, and other allowances associated with the respective sales.

Previous wording

License, milestone and other revenue includes the recognition of upfront payments received in connection with license agreements as well as revenue generated by subscription and service-based fees.

Current wording

License, milestone and other revenue includes the recognition of payments received in connection with license agreements, as well as revenue generated by subscription and service-based fees.

Previous wording

We began to recognize cost of product revenues after the initial launch of VTAMA in May 2022. Cost of product revenues includes the cost of producing and distributing inventories related to product revenue during the respective period, including manufacturing, freight, and indirect overhead costs. Additionally, milestone payments made in connection with regulatory approvals and sales-based milestones are capitalized and amortized to cost of revenue over the remaining useful life of the asset. Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting, and third-party data costs.

Current wording

Cost of product revenues includes the cost of producing and distributing inventories related to VTAMA product revenue during the respective period, including manufacturing, freight, and indirect overhead costs. Additionally, milestone payments made in connection with regulatory approvals and sales-based milestones are capitalized and amortized to cost of revenue over the remaining useful life of the asset. Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting, and third-party data costs.

Previous wording

Consideration for the purchase of IPR&D through asset acquisitions and license agreements includes cash upfront payments, shares and other liability instruments issued, and fair value of future contingent consideration payments.

Current wording

Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued, and the fair value of future contingent consideration payments.

Previous wording

Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation and benefits, for employees engaged in SG&A activities. SG&A employees include those responsible for the identification and acquisition or in-license of new drug candidates as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. SG&A expenses also consist of marketing programs, advertising, legal and accounting fees, consulting services, and other operating costs relating to corporate matters and daily operations. Additionally, SG&A expenses include costs incurred relating to the identification, acquisition or in-license and technology transfer of promising drug candidates along with costs incurred relating to the integration of new technologies.

Current wording

Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation, and benefits, for employees engaged in SG&A activities. SG&A employees include those responsible for the identification and acquisition or in-license of new drug candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. SG&A expenses also consist of marketing programs, advertising, legal and accounting fees, consulting services, and other operating costs relating to corporate matters and daily operations.

Previous wording

We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting VTAMA in the United States following approval by the FDA in May 2022, as well as expected costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the United States or another jurisdiction.

Current wording

We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which promotes VTAMA, as well as expected costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the U.S. or another jurisdiction. Additionally, in July 2024, the Compensation Committee of the Board of Directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Chief Operating Officer. The long-term equity incentive awards granted pursuant to this program may result in significant increases to share-based compensation expense over the vesting period of the awards. Refer to Note 16, "Subsequent Events" of our financial statements for further details.

Previous wording

Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash payable upon the initiation of a Phase 3 trial in UC. The $7.1 billion in closing consideration was paid to all of Telavant’s equity holders, including holders of restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction, and this same treatment will be applied to the one-time milestone payment. We received an upfront payment of approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction. Additionally, we are eligible to receive approximately $110 million for our pro rata portion of the one-time milestone payment if the milestone payment condition is satisfied.

Current wording

Gain on sale of Telavant net assets reflects the gain resulting from the achievement of a one-time milestone in June 2024 related to the sale of our entire equity interest in our majority-owned subsidiary Telavant Holdings, Inc. (“Telavant”) to Roche Holdings, Inc. (“Roche”) (the “Roche Transaction”). In December 2023, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash payable upon the initiation of a Phase 3 trial in UC. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. owned the remaining 25%, in each case on an as-converted basis. The $7.1 billion in closing consideration was paid to all of Telavant’s equity holders, including holders of restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction, and this same treatment will be applied to the one-time milestone payment. We recognized a gain on sale of Telavant net assets of approximately $110 million for our pro rata portion of the one-time milestone consideration during the three months ended June 30, 2024. Refer to Note 6, “Recent Transactions and Developments” for further information regarding the Roche Transaction.

Previous wording

Change in fair value of investments primarily includes the unrealized loss (gain) on equity investments in publicly-traded companies, including Arbutus Biopharma Corporation (“Arbutus”), as well as our equity investment in Heracles Parent, L.L.C., the parent entity of the Datavant business (“Datavant”). We have elected the fair value option to account for these investments.

Current wording

Change in fair value of investments includes the unrealized (gain) loss on equity investments, including Arbutus Biopharma Corporation (“Arbutus”) and Heracles Parent, L.L.C. (“Datavant”). We have elected the fair value option to account for these investments.

Previous wording

Change in fair value of debt and liability instruments primarily includes the loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including debt issued by a wholly-owned subsidiary of Dermavant Sciences Ltd. to NovaQuest Co-Investment Fund VIII, L.P. (the “NovaQuest Facility”), and other liability instruments, including warrant and earn-out share liabilities issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company.

Current wording

Change in fair value of debt and liability instruments primarily includes the (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including debt issued by a wholly-owned subsidiary of Dermavant Sciences Ltd. (“Dermavant”) to NovaQuest Co-Investment Fund VIII, L.P. (the “NovaQuest Facility”), and other liability instruments, including earn-out share liabilities issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company.

Previous wording

Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.

Current wording

Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position and consideration of the available facts and circumstances.

Previous wording

Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. Changes in the amount of net loss attributable to noncontrolling interests are directly impacted by the net loss of our consolidated entities and changes in ownership percentages.

Current wording

Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. We record net loss attributable to noncontrolling interests equal to the noncontrolling interest’s proportionate share of the respective operations.

Previous wording

Comparison of the three and nine months ended December 31, 2023 and 2022

Current wording

Comparison of the three months ended June 30, 2024 and 2023

Previous wording

Variance analysis for three and nine months ended December 31, 2023 and 2022

Current wording

Variance analysis for three months ended June 30, 2024 and 2023

Previous wording

Product revenue, net increased by $41.4 million to $55.7 million for the nine months ended December 31, 2023, compared to $14.4 million for the nine months ended December 31, 2022, primarily due to higher units sold. Product revenue, net consists of net product revenues from VTAMA sales, following the approval of VTAMA for the treatment of plaque psoriasis in adult patients by the FDA in May 2022. License, milestone and other revenue increased by $20.6 million to $40.1 million for the nine months ended December 31, 2023, compared to $19.6 million for the nine months ended December 31, 2022. The increase was primarily driven by $15.0 million of revenue relating to milestone income at Dermavant pursuant to a collaboration and license agreement with Japan Tobacco Inc. during the nine months ended December 31, 2023.

Current wording

Product revenue, net increased by$1.7 million to$18.4 million for the three months ended June 30, 2024, compared to$16.7 million for the three months ended June 30, 2023, primarily due to higher units sold. Product revenue, net consists of net product revenues from VTAMA sales, following the approval of VTAMA for the treatment of plaque psoriasis in adult patients by the FDA in May 2022. License, milestone and other revenue increased by$31.8 million to$36.8 million for the three months ended June 30, 2024, compared to$5.0 million for the three months ended June 30, 2023. The increase was largely due to $28.0 million of milestone income at Dermavant pursuant to a collaboration and license agreement with Japan Tobacco Inc. during the three months ended June 30, 2024.

Previous wording

Cost of revenues increased by $0.1 million to $3.7 million for the three months ended December 31, 2023, compared to $3.6 million for the three months ended December 31, 2022. During the three months ended December 31, 2023 and 2022, cost of revenues included $0.8 million and $0.4 million, respectively, of costs relating to VTAMA sales as well as amortization expense recognized in connection with milestones capitalized following the FDA approval of VTAMA in May 2022.

Current wording

Cost of revenues decreased by$0.2 million to$4.0 million for the three months ended June 30, 2024, compared to$4.2 million for the three months ended June 30, 2023. During the three months ended June 30, 2024 and 2023, cost of revenues included $1.0 million and $0.7 million, respectively, of costs relating to VTAMA sales. Cost of revenues additionally included amortization expense recognized in connection with milestones capitalized following the FDA approval of VTAMA in May 2022.

Previous wording

(1)Certain prior period amounts have been reclassified to conform to current period presentation.

Current wording

(1) Certain prior year amounts have been reclassified to conform to current year presentation.

Previous wording

Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the nine months ended December 31, 2023, compared to $97.7 million for the nine months ended December 31, 2022. The decrease was primarily due to higher consideration for the purchase of IPR&D during the nine months ended December 31, 2022 as a result of consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expenses for the nine months ended December 31, 2023 was driven by $14.0 million of consideration for the purchase of IPR&D relating to an asset acquisition completed by a newly-formed subsidiary and $12.5 million relating to the achievement of development and regulatory milestones for batoclimab.

Current wording

Acquired in-process research and development expenses were$12.5 million for the three months ended June 30, 2023 relating to the achievement of development and regulatory milestones for batoclimab.

Previous wording

Selling, general and administrative expenses increased by $29.0 million to $197.3 million for the three months ended December 31, 2023, compared to $168.3 million for the three months ended December 31, 2022, primarily due to an increase in personnel-related expenses of $27.0 million as a result of a special one-time cash retention bonus award granted to employees.

Current wording

Selling, general and administrative expenses decreased by$7.7 million to$148.5 million for the three months ended June 30, 2024, compared to$156.2 million for the three months ended June 30, 2023, primarily due to a decrease inselling, general and administrative expenses of $16.1 million at Dermavant, which largely resulted from reduced marketing spend. This decrease was partially offset by an increase in personnel-related expenses of $7.3 million, primarily as a result of a special one-time cash retention bonus award granted to employees, following approval in December 2023.

Previous wording

Change in fair value of investments were an unrealized loss of $10.5 million and a gain of $25.9 million for the three months ended December 31, 2023 and 2022, respectively. The change of $36.4 million was primarily driven by changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.

Current wording

Change in fair value of investments was an unrealized gain of$15.2 million and an unrealized loss of$7.6 million for the three months ended June 30, 2024 and 2023, respectively. The change of$22.8 million was primarily driven by changes in the public share price of Arbutus and the change in fair value of our investment in Datavant.

Previous wording

Change in fair value of debt and liability instruments were losses of $9.3 million and $62.4 million for the three months ended December 31, 2023 and 2022, respectively. Change in fair value of debt and liability instruments for the three months ended December 31, 2023 primarily consisted of a loss of $11.8 million relating to the NovaQuest Facility, which was largely due to the passage of time, partially offset by a gain of $2.8 million relating to the earn-out share liabilities issued as part of the Business Combination. Change in fair value of debt and liability instruments for the three months ended December 31, 2022 primarily consisted of a loss of $60.2 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination.

Current wording

Change in fair value of debt and liability instruments was a gain of$118.2 million and a loss of$54.5 million for the three months ended June 30, 2024 and 2023, respectively. Change in fair value of debt and liability instruments for thethree months ended June 30, 2024 primarily consisted of a gain of $119.4 million relating to the NovaQuest Facility, largely as a result of the Debt Renegotiation completed in May 2024. Refer to Note 8, “Long-Term Debt” of our financial statements for further information regarding the Debt Renegotiation. Change in fair value of debt and liability instruments for thethree months ended June 30, 2023 primarily consisted of a loss of $40.0 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination and a loss of $14.3 million relating to the NovaQuest Facility.

Previous wording

Interest income increased by $21.7 million to $32.0 million for the three months ended December 31, 2023, compared to $10.2 million for the three months ended December 31, 2022. The increase is primarily due to higher cash balances in our interest-bearing cash accounts as well as higher interest rates.

Current wording

Interest income increased by$55.4 million to$72.1 million for the three months ended June 30, 2024, compared to$16.7 million for the three months ended June 30, 2023. The increase is primarily due to higher cash balances in our interest-bearing cash accounts and higher interest rates.

Previous wording

For the nine months ended December 31, 2023 and 2022, we incurred net income of approximately $4.4 billion and a net loss of approximately $1.1 billion, respectively. As of December 31, 2023, we had cash and cash equivalents of approximately $6.7 billion and our retained earnings was $727.3 million. Through our subsidiary Dermavant, we launched our first commercial product, VTAMA, following approval by the FDA in May 2022. We began generating product revenue, net from sales of VTAMA in the United States in May 2022. We also have generated revenue through license agreements as well as from subscription and service-based fees. Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.

Current wording

For thethree months ended June 30, 2024 and 2023, we had net income of $57.5 million and a net loss of$327.8 million, respectively. As of June 30, 2024, we had cash and cash equivalents of approximately$5.7 billion and our retained earnings was$671.5 million. Through our subsidiary Dermavant, we launched our first commercial product, VTAMA, and we began generating product revenue, net from sales of VTAMA in the United States in May 2022. We also have generated revenue through license agreements, as well as from subscription and service-based fees. Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.

Previous wording

The above purchase commitments do not represent all of our anticipated purchases, but instead represents only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts. There have been no material changes to the commitments relating to our leases during the three months ended December 31, 2023 outside the ordinary course of business. For further information regarding our lease commitments, refer to Note 15, “Leases” in our Form 10-K.

Current wording

The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts.

Previous wording

Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones, and we will be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements.

Current wording

We have entered into commitments under various asset acquisition and license agreements. Under these agreements, we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events such as the achievement of specified development, regulatory and commercial milestones, and we will be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements. We expect to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.

Previous wording

In the future, we may require significant additional capital to continue our operations, pursue business opportunities or strategic transactions, or respond to challenges, competition or unforeseen circumstances. Until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common shareholder. Any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. If we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our product and product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us.

Current wording

In the future, we may require significant additional capital to continue our operations, pursue business opportunities or strategic transactions, or respond to challenges, competition or unforeseen circumstances. Until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity securities at Roivant or the Vants, our existing shareholders’ ownership, or our ownership in the Vants, may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our products and product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us. The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital or to pursue business opportunities, including potential acquisitions.

Previous wording

If adequate funds are not available to us, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, scale back marketing efforts for our current and future products or be unable to expand operations or otherwise capitalize on business opportunities.

Current wording

If adequate funds are not available to us, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, scale back marketing efforts for our current and future products or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.

Previous wording

Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities as well as our capital structure. We may from time to time use our existing cash to fund such opportunities or to retire outstanding debt obligations or to return capital to shareholders though share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See “Risk Factors—Risks Related to Our Business and Industry—We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management” and “Risk Factors—Risks Related to Our Business and Industry—Our management has broad discretion in respect of use of our cash and cash equivalents, including the proceeds from the Roche Transaction. In the future, we may decide to return capital to shareholders, whether through share repurchases, cash dividends or otherwise, and the amount and timing of such capital returns is subject to the discretion of our board of directors and will vary from time to time. There is no guarantee that such proceeds will be used to increase our operating results or enhance the value of our Common Shares.” for more information.

Current wording

Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities, as well as our capital structure. We may from time to time use our existing cash to fund such opportunities or to retire outstanding debt obligations or to return capital to shareholders though share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See “Risk Factors—Risks Related to Our Business and Industry—We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management” for more information.

Previous wording

The following table sets forth a summary of our cash flows for thenine months ended December 31, 2023 and 2022:

Current wording

The following table sets forth a summary of our cash flows for thethree months ended June 30, 2024 and 2023:

Previous wording

For the nine months ended December 31, 2023, cash used in operating activities decreased by $7.5 million to $656.8 million compared to the nine months ended December 31, 2022.

Current wording

For the three months ended June 30, 2024, cash used in operating activities changed by$57.1 million to$192.8 million compared to $249.9 million for thethree months ended June 30, 2023 due to greater cash requirements to fund operations during the three months ended June 30, 2023.

Previous wording

For the nine months ended December 31, 2023 and 2022, cash flow from investing activities changed by $5.4 billion. For the nine months ended December 31, 2023, net cash provided by investing activities was $5.2 billion, compared to net cash used in investing activities of $157.8 million for the nine months ended December 31, 2022. This change in cash flow is primarily due to proceeds received upon closing of the Roche Transaction during the nine months ended December 31, 2023, partially offset by the milestone payments relating to VTAMA made during the nine months ended December 31, 2022.

Current wording

For thethree months ended June 30, 2024 and 2023, cash flow from investing activities changed by$1.1 million to net cash used in investing activities of$1.0 million from net cash provided by investing activities of$0.1 million for thethree months ended June 30, 2023.
Rearranged previous paragraphs (8)

Previous report — wording carried elsewhere

Gain on sale of Telavant net assets represents the gain resulting from the sale of our entire equity interest in our majority-owned subsidiary, Telavant Holdings, Inc. (“Telavant”), to Roche Holdings, Inc. (“Roche”) in December 2023 (the “Roche Transaction”). Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. (together with Roivant, the “Sellers”) owned the remaining 25%, in each case on an as-converted basis. At closing, we received approximately $5.2 billion in cash. We additionally are eligible to receive approximately $110 million for our portion of a one-time milestone payment if the milestone payment condition is satisfied. Refer to Note 5, “Recent Transactions” of our financial statements for further information regarding the Roche Transaction.

Previous report — wording carried elsewhere

The following table sets forth our results of operations for the nine months ended December 31, 2023 and 2022:

Previous report — wording carried elsewhere

Product revenue, net increased by $11.4 million to $20.7 million for the three months ended December 31, 2023, compared to $9.2 million for the three months ended December 31, 2022, primarily due to higher units sold. Product revenue, net consists of net product revenues from VTAMA sales, following the approval of VTAMA for the treatment of plaque psoriasis in adult patients by the FDA in May 2022. License, milestone and other revenue increased by $8.7 million to $16.5 million for the three months ended December 31, 2023, compared to $7.8 million for the three months ended December 31, 2022. The increase was largely related to an increase in revenues generated from licensing arrangements, primarily at Genevant Sciences Ltd., during the three months ended December 31, 2023.

Previous report — wording carried elsewhere

For the nine months ended December 31, 2023 and 2022, our revenue consisted of the following:

Previous report — wording carried elsewhere

For the nine months ended December 31, 2023 and 2022, our cost of revenues consisted of the following:

Previous report — wording carried elsewhere

For the nine months ended December 31, 2023 and 2022, our research and development expenses consisted of the following:

Previous report — wording carried elsewhere

(1)Certain prior period amounts have been reclassified to conform to current period presentation.

Previous report — wording carried elsewhere

Interest income increased by $45.1 million to $63.0 million for the nine months ended December 31, 2023, compared to $17.9 million for the nine months ended December 31, 2022. The increase is primarily due to higher cash balances in our interest-bearing cash accounts as well as higher interest rates.