Full Press Release Details
Roivant Reports Financial Results for the Second Quarter Ended September 30, 2024, and Provides Business Update
BASEL, Switzerland and LONDON and NEW YORK, November 12, 2024 -
Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2024, and provided a business update.
"I am pleased to finish out another quarter with continued clinical execution, including positive data in Graves' Disease and FDA's clearance of INDs in 5
indications at Immunovant," said Matt Gline, CEO of Roivant. "I am also excited today to present the 52-week data from our Phase 2 study of brepocitinib in NIU. The sustained treatment benefits observed further our belief that brepocitinib is a
potentially compelling and durable agent for a disease that is poorly treated today. We have a busy year ahead with major data expected in 2025 from Immunovant and Priovant, along with continued execution across other programs."
Endocrinology Program
In September 2024, Immunovant reported additional positive results from the Phase 2a trial of batoclimab in Graves' Disease. Participants in the trial
received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to
a 76% Response rate. In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response. During Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680mg dose) with a
correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response rate of 36% was also observed in the second 12 weeks. Patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher
ATD-Free Response rate than those who did not (60% vs. 23%). Batoclimab was well tolerated with no new safety signals identified.
In November 2024, additional data on the efficacy and safety of batoclimab in Graves' thyroidal and extrathyroidal disease were presented in an oral
presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2,
demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported
Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants.
In November 2024, Immunovant announced completion of enrollment for patients included in Period 1 of the Phase 2b trial of batoclimab in CIDP, with data
expected by March 31, 2025, to inform the trial design for a potentially registrational program with IMVT-1402.
Rheumatology Program
In November 2024, Immunovant also announced FDA clearance of the IND for IMVT-1402 in D2T RA and expects to initiate a potentially registrational trial
In September 2024, Pulmovant also presented data from the Phase 1b ATMOS study showing a
single dose of inhaled mosliciguat in PH patients (N=38) led to sustained, clinically meaningful mean-max reductions in PVR of up to ~38%, one of the highest reductions seen in PH trials to date. Mosliciguat was generally well-tolerated, with low
rates of treatment-emergent adverse events (TEAEs).
Pulmovant initiated the global Phase 2 PHocus trial of mosliciguat in patients with PH-ILD.
Roivant continued to return capital through share repurchases with $106M purchased for the quarter ending September 30, 2024, resulting in $754M cumulative share repurchases (inclusive of the repurchase of Sumitomo's stake in April 2024) through
Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024.
Major Upcoming Milestones
Second Quarter Ended September 30, 2024 Financial Summary
Cash and Marketable Securities
As of September 30, 2024, the Company had consolidated cash, cash equivalents,
restricted cash and marketable securities of approximately $5.4 billion.
Research and Development Expenses
Research and development (R&D) expenses increased by $28.3 million to $143.1 million for the three months ended September 30, 2024, compared to $114.8 million for the three months ended September 30, 2023. This increase was
primarily driven by increases in program-specific costs of $19.2 million, personnel-related expenses of $7.2 million, and share-based compensation of $1.6 million.
Within program-specific costs, the increase of $19.2 million was primarily driven by
an increase in expense of $34.2 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $18.6 million related to RVT-3101, which
was sold to Roche in December 2023.
Non-GAAP R&D expenses were $132.4 million for the three months ended September 30, 2024, compared to $105.3 million for the three months ended September 30, 2023.
General and Administrative Expenses
General and administrative (G&A) expenses increased by $114.3 million to $202.9 million for the three months ended September 30, 2024, compared to $88.6 million for the three months ended September 30, 2023. This increase was
primarily due to an increase in personnel-related expenses of $87.0 million, of which $79.1 million related to the one-time cash retention awards approved in July 2024 for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and
Chief Investment Officer; and Eric Venker, President and Chief Operating Officer (the "2024 Senior Executive Compensation Program") and $6.6 million related to the special one-time cash retention bonus award granted to employees, following approval
in December 2023. The increase was also driven by an increase in share-based compensation expense of $21.7 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation
Non-GAAP G&A expenses were $142.3 million for the three months ended September 30, 2024, compared to $49.6 million for the three months ended September 30, 2023.
Loss from continuing operations, net of tax
Loss from continuing operations, net of tax was $236.8 million for the three months
ended September 30, 2024, compared to a loss from continuing operations, net of tax of $244.6 million for the three months ended September 30, 2023. On a basic and diluted per common share basis, loss from continuing operation was
$0.25 and $0.28, respectively, for the three months ended September 30, 2024 and September 30, 2023. Non-GAAP loss from continuing
operations, net of tax was $218.7 million for the three months ended September 30,
2024, compared to $154.8 million for the three months ended September 30,
ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)
| September 30, 2024 | March 31, 2024 | |||||||
| Cash, cash equivalents and restricted cash | $ | 1,969,914 | $ | 6,506,189 | ||||
| Marketable securities | 3,428,021 | - | ||||||
| Total assets | 6,206,028 | 7,222,482 | ||||||
| Total liabilities | 625,986 | 773,953 | ||||||
| Total shareholders' equity | 5,580,042 | 6,448,529 | ||||||
| Total liabilities and shareholders' equity | 6,206,028 | 7,222,482 |
ROIVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue, net | $ | 4,475 | $ | 3,648 | $ | 12,465 | $ | 8,131 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues | 234 | 223 | 447 | 1,206 | ||||||||||||
| Research and development (includes $9,911 and $8,309 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $20,443 and $15,726 for the six months ended September 30, 2024 and 2023, respectively) | 143,073 | 114,790 | 263,580 | 224,206 | ||||||||||||
| Acquired in-process research and development | - | 13,950 | - | 26,450 | ||||||||||||
| General and administrative (includes $59,443 and $37,755 of share-based compensation expense for the three months ended September 30, 2024 and 2023 and $96,284 and $76,472 for the six months ended September 30, 2024 and 2023, respectively) | 202,881 | 88,576 | 302,773 | 179,858 | ||||||||||||
| Total operating expenses | 346,188 | 217,539 | 566,800 | 431,720 | ||||||||||||
| Gain on sale of Telavant net assets | - | - | 110,387 | - | ||||||||||||
| Loss from operations | (341,713 | ) | (213,891 | ) | (443,948 | ) | (423,589 | ) | ||||||||
| Change in fair value of investments | (48,375 | ) | 45,849 | (63,601 | ) | 53,413 | ||||||||||
| Change in fair value of liability instruments | (635 | ) | 11,789 | 515 | 51,967 | |||||||||||
| Gain on deconsolidation of subsidiaries | - | (17,354 | ) | - | (17,354 | ) | ||||||||||
| Interest income | (69,773 | ) | (14,299 | ) | (141,900 | ) | (31,014 | ) | ||||||||
| Other expense, net | 1,453 | 1,530 | 5,061 | 4,357 | ||||||||||||
| Loss from continuing operations before income taxes | (224,383 | ) | (241,406 | ) | (244,023 | ) | (484,958 | ) | ||||||||
| Income tax expense | 12,458 | 3,236 | 24,421 | 4,911 | ||||||||||||
| Loss from continuing operations, net of tax | (236,841 | ) | (244,642 | ) | (268,444 | ) | (489,869 | ) | ||||||||
| (Loss) income from discontinued operations, net of tax | (43,083 | ) | (86,476 | ) | 46,010 | (169,094 | ) | |||||||||
| Net loss | (279,924 | ) | (331,118 | ) | (222,434 | ) | (658,963 | ) | ||||||||
| Net loss attributable to noncontrolling interests | (49,740 | ) | (26,791 | ) | (87,547 | ) | (62,820 | ) | ||||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (230,184 | ) | $ | (304,327 | ) | $ | (134,887 | ) | $ | (596,143 | ) | ||||
| Amounts attributable to Roivant Sciences Ltd.: | ||||||||||||||||
| Loss from continuing operations, net of tax | $ | (187,101 | ) | $ | (218,226 | ) | $ | (181,052 | ) | $ | (427,784 | ) | ||||
| (Loss) income from discontinued operations, net of tax | (43,083 | ) | (86,101 | ) | 46,165 | (168,359 | ) | |||||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (230,184 | ) | $ | (304,327 | ) | $ | (134,887 | ) | $ | (596,143 | ) | ||||
| Basic and diluted net (loss) income per common share: | ||||||||||||||||
| Basic and diluted loss from continuing operations | $ | (0.25 | ) | $ | (0.28 | ) | $ | (0.25 | ) | $ | (0.56 | ) | ||||
| Basic and diluted (loss) income from discontinued operations | $ | (0.06 | ) | $ | (0.11 | ) | $ | 0.06 | $ | (0.22 | ) | |||||
| Basic and diluted net loss per common share | $ | (0.31 | ) | $ | (0.40 | ) | $ | (0.18 | ) | $ | (0.78 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 735,470,796 | 770,227,849 | 735,642,721 | 764,780,630 | ||||||||||||
| Diluted | 735,470,796 | 770,227,849 | 735,642,721 | 764,780,630 |
ROIVANT SCIENCES LTD.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited, in thousands)
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||
| Loss from continuing operations, net of tax | $ | (236,841 | ) | $ | (244,642 | ) | $ | (268,444 | ) | $ | (489,869 | ) | ||||||||
| Adjustments: | ||||||||||||||||||||
| Research and development: | ||||||||||||||||||||
| Share-based compensation | (1) | 9,911 | 8,309 | 20,443 | 15,726 | |||||||||||||||
| Depreciation and amortization | (2) | 724 | 1,205 | 1,419 | 2,694 | |||||||||||||||
| General and administrative: | ||||||||||||||||||||
| Share-based compensation | (1) | 59,443 | 37,755 | 96,284 | 76,472 | |||||||||||||||
| Depreciation and amortization | (2) | 1,094 | 1,235 | 2,184 | 2,485 | |||||||||||||||
| Gain on sale of Telavant net assets | (3) | - | - | (110,387 | ) | - | ||||||||||||||
| Other: | ||||||||||||||||||||
| Change in fair value of investments | (4) | (48,375 | ) | 45,849 | (63,601 | ) | 53,413 | |||||||||||||
| Change in fair value of liability instruments | (5) | (635 | ) | 11,789 | 515 | 51,967 | ||||||||||||||
| Gain on deconsolidation of subsidiaries | (6) | - | (17,354 | ) | - | (17,354 | ) | |||||||||||||
| Estimated income tax impact from adjustments | (7) | (3,986 | ) | 1,100 | (4,190 | ) | 369 | |||||||||||||
| Adjusted loss from continuing operations, net of tax (Non-GAAP) | $ | (218,665 | ) | $ | (154,754 | ) | $ | (325,777 | ) | $ | (304,097 | ) |
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||
| Research and development expenses | $ | 143,073 | $ | 114,790 | $ | 263,580 | $ | 224,206 | ||||||||||||
| Adjustments: | ||||||||||||||||||||
| Share-based compensation | (1) | 9,911 | 8,309 | 20,443 | 15,726 | |||||||||||||||
| Depreciation and amortization | (2) | 724 | 1,205 | 1,419 | 2,694 | |||||||||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 132,438 | $ | 105,276 | $ | 241,718 | $ | 205,786 |
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||
| General and administrative expenses | $ | 202,881 | $ | 88,576 | $ | 302,773 | $ | 179,858 | ||||||||||||
| Adjustments: | ||||||||||||||||||||
| Share-based compensation | (1) | 59,443 | 37,755 | 96,284 | 76,472 | |||||||||||||||
| Depreciation and amortization | (2) | 1,094 | 1,235 | 2,184 | 2,485 | |||||||||||||||
| Adjusted general and administrative expenses (Non-GAAP) | $ | 142,344 | $ | 49,586 | $ | 204,305 | $ | 100,901 |
Notes to non-GAAP financial measures:
(1) Represents non-cash share-based compensation expense.
(2) Represents non-cash depreciation and amortization expense.
(3) Represents a gain on the sale of Telavant net assets to Roche due to achievement of a one-time milestone in June 2024.
(4) Represents the unrealized (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.
(5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and
recognition of fair value on a recurring basis of certain liabilities.
(6) Represents the one-time gain on deconsolidation of subsidiaries.
(7) Represents the estimated tax effect of the adjustments.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, November 12, 2024, to report its financial results for the second quarter ended September
30, 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 conference call.
Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's
pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the
treatment of dermatomyositis and non-infectious uveitis; mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease; and namilumab, an anti-GM-CSF monoclonal antibody in development for
the treatment of pulmonary sarcoidosis. 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 the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any
commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying
assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no
assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks,
uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing
environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.