Full Press Release Details
Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provides Business Update
BASEL, Switzerland and LONDON and NEW YORK, May 30, 2024 - Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provided a business update.
"We finished our fiscal year with yet another productive quarter for the company," said Matt Gline, CEO of Roivant. "The Priovant team announced
outstanding data for patients with NIU, reaffirming our view on the blockbuster potential of brepocitinib, which we expect will continue to deliver benefit to patients with unmet need. Our board has approved a significant buyback program, allowing
us to return capital to shareholders and to increase exposure to our most exciting current and future programs. I could not be more excited for what we've accomplished and what I believe we will deliver in our next chapter ahead."
In March 2024, Immunovant was awarded U.S. Patent No. 11,926,669 covering composition of matter of IMVT-1402 and its binding
sequence to FcRn, method of use of the antibody for treating autoimmune disease, and methods for its manufacturing. Not including any potential patent term extension, the issued composition-of-matter patent term will extend until June 2043.
In April 2024, Dermavant announced FDA acceptance of VTAMA's sNDA submission for the treatment of atopic
dermatitis in adults and children 2 years of age and older. PDUFA action is expected in the fourth quarter of calendar year 2024.
In May 2024, Roivant renegotiated Dermavant's debt obligations, reducing potential
cash payments due by over $300M in the aggregate. Approximately $225M of this reduction is expected to be achieved over the next three fiscal years.
Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.6B at March 31, 2024. Giving effect to the
Sumitomo share repurchase, Roivant's cash, cash equivalents and restricted cash at March 31, 2024 would have been approximately $5.9B.
Major Upcoming Milestones
Fourth Quarter and Fiscal Year Ended March 31, 2024 Financial Summary
As of March 31, 2024, the company had cash, cash equivalents and restricted cash of
approximately $6.6 billion.
Research and Development Expenses
Research and development (R&D) expenses decreased by $11.0 million to $120.9 million for
the three months ended March 31, 2024, compared to $131.9 million for the three months ended March 31, 2023, primarily due to a decrease in program-specific costs of $25.8 million, partially offset by increases in share-based compensation of $5.9
million, other expenses of $4.6 million, and personnel-related expenses of $4.3 million.
The decrease of $25.8 million in program-specific costs was primarily driven by a decrease of $19.8 million in other development and discovery
programs, which in part resulted from the deconsolidation of Proteovant in August 2023 along with the reprioritization of certain programs and drug discovery efforts. The change also included a decrease of $5.9 million relating to RVT-3101 as a
result of the sale of the rights to further develop and manufacture RVT-3101 to Roche in December 2023.
Non-GAAP R&D expenses were $109.7 million for the three months ended March 31, 2024, compared to $126.0 million for the three months ended March 31, 2023.
Research and development expenses decreased by $23.5 million to $501.7 million for the year ended March 31, 2024, compared to $525.2 million for the year ended March 31, 2023, primarily due to a decrease in program-specific costs of $42.4 million, partially offset by increases in other expenses of $10.7 million, personnel-related expenses of $4.5 million, and share-based compensation of $3.7 million.
The decrease of $42.4 million in program-specific costs was primarily driven by a decrease of $83.1 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 $32.8 million relating to IMVT-1402 and $27.6 million relating to RVT-3101, which was acquired in November 2022. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.
Non-GAAP R&D expenses were $462.6 million for the year ended March 31, 2024, compared to $489.2 million for the year
ended March 31, 2023.
Acquired In-Process Research and Development Expenses
There was no acquired in-process research and development (IPR&D) expense for the three months
ended March 31, 2024 and 2023.
Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the year ended March 31, 2024, compared to $97.7 million for the year ended March 31, 2023. The decrease was primarily due to higher consideration for the purchase of IPR&D
during the year ended March 31, 2023 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 year ended March 31, 2024 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.
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses increased by $44.1 million to $169.6 million
for the three months ended March 31, 2024, compared to $125.5 million for the three months ended March 31, 2023. The increase was primarily due to an increase in share-based compensation of $15.6 million, an increase in SG&A expenses at Dermavant of
$8.5 million due to the progression of the commercial launch of VTAMA, and an increase of $8.5 million resulting from a special one-time cash retention bonus award granted to
Non-GAAP SG&A expenses were $131.3 million for the three months ended March 31, 2024, compared to $102.6 million for the three months ended March 31, 2023.
Selling, general and administrative expenses increased by $86.9 million to $687.4 million for the year ended March 31, 2024, compared to $600.5 million for the year ended March 31, 2023. The increase was primarily due to an increase in selling, general and administrative
expenses of $55.7 million at Dermavant as a result of the progression of the commercial launch of VTAMA and an increase in personnel-related expenses of $25.1 million, primarily as a result of a special one-time cash retention bonus award granted
Non-GAAP SG&A expenses were $514.8 million for the year ended March 31, 2024, compared to $407.6 million for the year
ended March 31, 2023. A majority of the non-GAAP SG&A expenses of $514.8 million were related to Dermavant's SG&A and ongoing VTAMA commercial launch activities.
Gain on Sale of Telavant Net Assets
Gain on sale of Telavant net assets was approximately $5.3 billion for the year ended March 31, 2024 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.
Income (Loss) from Continuing Operations
Loss from continuing operations was $182.5 million for the three months ended March 31, 2024, compared to $175.4 million for the three months ended March 31, 2023. On a per common share basis, loss from continuing operations was $0.19 and $0.20 for the three months ended March 31, 2024 and 2023, respectively. Non-GAAP loss from continuing operations was $188.1 million for the three months ended March 31, 2024, compared to $189.4 million for the three months ended March 31, 2023.
Income from continuing operations was approximately $4.2 billion for the year ended March 31, 2024, compared to a loss from continuing operations of $1.2 billion for the year ended March 31, 2023. On a basic and diluted per common share basis, income from continuing operations was $5.55 and $5.23, respectively, for the year ended March 31, 2024. On a per common
share basis, loss from continuing operations was $1.58 for the year ended March 31, 2023. Non-GAAP
loss from continuing operations was $799.9 million for the year ended March 31, 2024, compared to
$924.3 million for the year ended March 31, 2023.
ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
| March 31, 2024 | March 31, 2023 | |||||||
| Cash, cash equivalents and restricted cash | $ | 6,550,450 | $ | 1,692,115 | ||||
| Total assets | 7,222,482 | 2,389,604 | ||||||
| Total liabilities | 773,953 | 782,017 | ||||||
| Total shareholders' equity | 6,448,529 | 1,607,587 | ||||||
| Total liabilities and shareholders' equity | 7,222,482 | 2,389,604 |
ROIVANT SCIENCES LTD.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended March 31, | Years Ended March 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 19,308 | $ | 13,657 | $ | 75,057 | $ | 28,011 | ||||||||
| License, milestone and other revenue | 9,622 | 13,719 | 49,738 | 33,269 | ||||||||||||
| Revenue, net | 28,930 | 27,376 | 124,795 | 61,280 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues | 4,412 | 4,175 | 15,560 | 13,128 | ||||||||||||
| Research and development (includes $10,290 and $4,366 of share-based compensation expense for the three months ended March 31, 2024 and 2023, respectively, and $34,595 and $30,914 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively) | 120,902 | 131,857 | 501,736 | 525,215 | ||||||||||||
| Acquired in-process research and development | - | - | 26,450 | 97,749 | ||||||||||||
| Selling, general and administrative (includes $36,396 and $20,832 of share-based compensation expense for the three months ended March 31, 2024 and 2023, respectively, and $164,841 and $186,603 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively) | 169,616 | 125,510 | 687,443 | 600,506 | ||||||||||||
| Total operating expenses | 294,930 | 261,542 | 1,231,189 | 1,236,598 | ||||||||||||
| Gain on sale of Telavant net assets | - | - | 5,348,410 | - | ||||||||||||
| (Loss) income from operations | (266,000 | ) | (234,166 | ) | 4,242,016 | (1,175,318 | ) | |||||||||
| Change in fair value of investments | (15,907 | ) | (32,462 | ) | 47,973 | 20,815 | ||||||||||
| Change in fair value of debt and liability instruments | (6,433 | ) | (12,031 | ) | 78,943 | 78,001 | ||||||||||
| Gain on deconsolidation of subsidiaries | (15,418 | ) | - | (32,772 | ) | (29,276 | ) | |||||||||
| Interest income | (83,458 | ) | (14,284 | ) | (146,425 | ) | (32,184 | ) | ||||||||
| Interest expense | 7,175 | 8,575 | 34,778 | 27,968 | ||||||||||||
| Other expense (income), net | 39,494 | (4,748 | ) | 6,089 | (15,808 | ) | ||||||||||
| (Loss) income from continuing operations before income taxes | (191,453 | ) | (179,216 | ) | 4,253,430 | (1,224,834 | ) | |||||||||
| Income tax (benefit) expense | (8,957 | ) | (3,793 | ) | 22,224 | 5,190 | ||||||||||
| (Loss) income from continuing operations, net of tax | (182,496 | ) | (175,423 | ) | 4,231,206 | (1,230,024 | ) | |||||||||
| Income from discontinued operations, net of tax | - | 114,561 | - | 114,561 | ||||||||||||
| Net (loss) income | (182,496 | ) | (60,862 | ) | 4,231,206 | (1,115,463 | ) | |||||||||
| Net loss attributable to noncontrolling interests | (31,381 | ) | (27,245 | ) | (117,720 | ) | (106,433 | ) | ||||||||
| Net (loss) income attributable to Roivant Sciences Ltd. | $ | (151,115 | ) | $ | (33,617 | ) | $ | 4,348,926 | $ | (1,009,030 | ) | |||||
| Amounts attributable to Roivant Sciences Ltd.: | ||||||||||||||||
| (Loss) income from continuing operations, net of tax | $ | (151,115 | ) | $ | (148,178 | ) | $ | 4,348,926 | $ | (1,123,591 | ) | |||||
| Income from discontinued operations, net of tax | - | 114,561 | - | 114,561 | ||||||||||||
| Net (loss) income attributable to Roivant Sciences Ltd. | $ | (151,115 | ) | $ | (33,617 | ) | $ | 4,348,926 | $ | (1,009,030 | ) | |||||
| Net (loss) income per common share, basic: | ||||||||||||||||
| (Loss) income from continuing operations | $ | (0.19 | ) | $ | (0.20 | ) | $ | 5.55 | $ | (1.58 | ) | |||||
| Income from discontinued operations, net of tax | $ | - | $ | 0.15 | $ | - | $ | 0.16 | ||||||||
| Net (loss) income | $ | (0.19 | ) | $ | (0.05 | ) | $ | 5.55 | $ | (1.42 | ) | |||||
| Net (loss) income per common share, diluted: | ||||||||||||||||
| (Loss) income from continuing operations | $ | (0.19 | ) | $ | (0.20 | ) | $ | 5.23 | $ | (1.58 | ) | |||||
| Income from discontinued operations, net of tax | $ | - | $ | 0.15 | $ | - | $ | 0.16 | ||||||||
| Net (loss) income | $ | (0.19 | ) | $ | (0.05 | ) | $ | 5.23 | $ | (1.42 | ) | |||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 802,859,062 | 742,541,052 | 783,248,906 | 712,791,115 | ||||||||||||
| Diluted | 802,859,062 | 742,541,052 | 831,049,444 | 712,791,115 |
ROIVANT SCIENCES LTD.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited, in thousands)
| Three Months Ended March 31, | Years Ended March 31, | ||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| (Loss) income from continuing operations, net of tax | $ | (182,496 | ) | $ | (175,423 | ) | $ | 4,231,206 | $ | (1,230,024 | ) | ||||||||
| Adjustments: | |||||||||||||||||||
| Cost of revenues: | |||||||||||||||||||
| Amortization of intangibles | (1) | 2,421 | 2,298 | 9,632 | 7,468 | ||||||||||||||
| Share-based compensation | (2) | 38 | 37 | 191 | 95 | ||||||||||||||
| Research and development: | |||||||||||||||||||
| Share-based compensation | (2) | 10,290 | 4,366 | 34,595 | 30,914 | ||||||||||||||
| Depreciation and amortization | (3) | 873 | 1,539 | 4,590 | 5,097 | ||||||||||||||
| Selling, general and administrative: | |||||||||||||||||||
| Share-based compensation | (2) | 36,396 | 20,832 | 164,841 | 186,603 | ||||||||||||||
| Depreciation and amortization | (3) | 1,912 | 2,116 | 7,814 | 6,292 | ||||||||||||||
| Gain on sale of Telavant net assets | (4) | - | - | (5,348,410 | ) | - | |||||||||||||
| Other: | |||||||||||||||||||
| Change in fair value of investments | (5) | (15,907 | ) | (32,462 | ) | 47,973 | 20,815 | ||||||||||||
| Change in fair value of debt and liability instruments | (6) | (6,433 | ) | (12,031 | ) | 78,943 | 78,001 | ||||||||||||
| Gain on deconsolidation of subsidiaries | (7) | (15,418 | ) | - | (32,772 | ) | (29,276 | ) | |||||||||||
| Estimated income tax impact from adjustments | (8) | (19,813 | ) | (704 | ) | 1,538 | (294 | ) | |||||||||||
| Adjusted loss from continuing operations, net of tax (Non-GAAP) | $ | (188,137 | ) | $ | (189,432 | ) | $ | (799,859 | ) | $ | (924,309 | ) |
| Three Months Ended March 31, | Years Ended March 31, | ||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Research and development expenses | $ | 120,902 | $ | 131,857 | $ | 501,736 | $ | 525,215 | |||||||||||
| Adjustments: | |||||||||||||||||||
| Share-based compensation | (2) | 10,290 | 4,366 | 34,595 | 30,914 | ||||||||||||||
| Depreciation and amortization | (3) | 873 | 1,539 | 4,590 | 5,097 | ||||||||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 109,739 | $ | 125,952 | $ | 462,551 | $ | 489,204 |
| Three Months Ended March 31, | Years Ended March 31, | ||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Selling, general and administrative expenses | $ | 169,616 | $ | 125,510 | $ | 687,443 | $ | 600,506 | |||||||||||
| Adjustments: | |||||||||||||||||||
| Share-based compensation | (2) | 36,396 | 20,832 | 164,841 | 186,603 | ||||||||||||||
| Depreciation and amortization | (3) | 1,912 | 2,116 | 7,814 | 6,292 | ||||||||||||||
| Adjusted selling, general and administrative expenses (Non-GAAP) | $ | 131,308 | $ | 102,562 | $ | 514,788 | $ | 407,611 |
Notes to non-GAAP financial measures:
(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.
(2) Represents non-cash share-based compensation expense.
(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with
regulatory approvals.
(4) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023.
(5) Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in
(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss relating to the measurement and
recognition of fair value on a recurring basis of certain liabilities.
(7) Represents the one-time gain on deconsolidation of subsidiaries.
(8) Represents the estimated tax effect of the adjustments.
Roivant will also present at two additional upcoming investor conferences:
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 30, 2024, to report its financial results for the fourth quarter and fiscal year
ended March 31, 2024, and provide a corporate update.
To access the conference call by phone, please register online using this registration link. The presentation
and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the
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; 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 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. For more information, www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered
forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of
words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may
identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements
contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies
regarding the future, and statements that are not historical facts, including statements about potential share repurchases, the clinical and therapeutic potential of our products and product candidates, the availability and success of topline
results from our ongoing clinical trials, any commercial potential of our products and product candidates and the benefits expected to be realized from Dermavant's renegotiation of its existing debt obligations. In addition, any statements that