Roivant Reports Financial Results for the Second Quarter Ended September 30, 2024, and Provides Business Update
Roivant Sciences reported Q2 2024 financial results and business updates. Key highlights include positive 52-week data from brepocitinib Phase 2 NEPTUNE study in non-infectious uveitis, FDA clearance of five IND applications for IMVT-1402, and the introduction of mosliciguat for pulmonary hypertension. The company closed Dermavant's sale to Organon for $184M cash, with potential additional milestone payments. Financial results show consolidated cash and marketable securities of $5.4B, R&D expenses of $143.1M (up from $114.8M YoY), and a net loss from continuing operations of $236.8M. The company continued share repurchases with $106M for the quarter.
Roivant Sciences ha riportato i risultati finanziari e gli aggiornamenti aziendali del secondo trimestre del 2024. I punti salienti includono dati positivi a 52 settimane dallo studio NEPTUNE di Fase 2 su brepocitinib per l'uveite non infettiva, l'approvazione da parte della FDA di cinque domande IND per IMVT-1402 e l'introduzione di mosliciguat per l'ipertensione polmonare. L'azienda ha concluso la vendita di Dermavant a Organon per 184 milioni di dollari in contante, con potenziali ulteriori pagamenti legati a milestone. I risultati finanziari mostrano un totale di 5,4 miliardi di dollari in contante e titoli facilmente vendibili, spese per R&S di 143,1 milioni di dollari (in aumento rispetto ai 114,8 milioni di dollari dell'anno precedente) e una perdita netta dalle operazioni continuative di 236,8 milioni di dollari. L'azienda ha continuato il riacquisto di azioni con 106 milioni di dollari nel trimestre.
Roivant Sciences reportó los resultados financieros y las actualizaciones comerciales del segundo trimestre de 2024. Los principales aspectos destacados incluyen datos positivos de 52 semanas del estudio NEPTUNE de Fase 2 sobre brepocitinib en uveítis no infecciosa, la aprobación de cinco solicitudes IND por parte de la FDA para IMVT-1402, y la introducción de mosliciguat para la hipertensión pulmonar. La compañía cerró la venta de Dermavant a Organon por 184 millones de dólares en efectivo, con posibles pagos adicionales por hitos. Los resultados financieros muestran un total consolidado de 5,4 mil millones de dólares en efectivo y valores negociables, gastos de I+D de 143,1 millones de dólares (un aumento respecto a los 114,8 millones de dólares del año anterior), y una pérdida neta de las operaciones continuas de 236,8 millones de dólares. La compañía continuó con la recompra de acciones, invirtiendo 106 millones de dólares en el trimestre.
Roivant Sciences는 2024년 2분기 재무 결과 및 사업 업데이트를 발표했습니다. 주요 하이라이트로는 비감염성 포도막염에서의 brepocitinib 2상 NEPTUNE 연구의 52주 긍정적 데이터, IMVT-1402에 대한 FDA의 다섯 개 IND 신청 승인, 그리고 폐고혈압 치료를 위한 mosliciguat 도입이 포함됩니다. 회사는 Dermavant를 Organon에 1억 8400만 달러 현금으로 판매를 완료했으며, 잠재적인 추가 이정표 지급이 있습니다. 재무 결과는 54억 달러의 현금 및 유동 자산, 1억 4310만 달러의 R&D 비용(전년 대비 1억 1480만 달러에서 증가) 및 지속 운영에 대한 순손실 2억 3680만 달러를 보여줍니다. 회사는 이번 분기에 1억 600만 달러의 자사주 매입을 지속했습니다.
Roivant Sciences a annoncé ses résultats financiers et ses mises à jour commerciales pour le deuxième trimestre de 2024. Les faits marquants comprennent des données positives sur 52 semaines de l'étude NEPTUNE de Phase 2 concernant le brepocitinib pour l'uvéite non infectieuse, l'approbation par la FDA de cinq demandes IND pour l'IMVT-1402, et l'introduction de mosliciguat pour l'hypertension pulmonaire. L'entreprise a finalisé la vente de Dermavant à Organon pour 184 millions de dollars en espèces, avec des paiements d'étape potentiels supplémentaires. Les résultats financiers montrent un total consolidé de 5,4 milliards de dollars en liquidités et titres négociables, des dépenses en R&D de 143,1 millions de dollars (en hausse par rapport à 114,8 millions de dollars l'année précédente) et une perte nette des opérations continues de 236,8 millions de dollars. L'entreprise a continué à racheter ses actions avec 106 millions de dollars pour le trimestre.
Roivant Sciences hat die Finanzzahlen und Geschäftsnachrichten für das zweite Quartal 2024 veröffentlicht. Zu den wichtigsten Punkten gehören positive 52-Wochen-Daten aus der NEPTUNE-Studie der Phase 2 zu brepocitinib bei nicht-infektiöser Uveitis, die Genehmigung von fünf IND-Anträgen durch die FDA für IMVT-1402 und die Einführung von mosliciguat zur Behandlung von pulmonaler Hypertonie. Das Unternehmen hat den Verkauf von Dermavant an Organon für 184 Millionen US-Dollar in bar abgeschlossen, mit möglichen zusätzlichen Milestone-Zahlungen. Die Finanzergebnisse zeigen konsolidierte Bar- und marktgängige Wertpapiere in Höhe von 5,4 Milliarden US-Dollar, F&E-Ausgaben von 143,1 Millionen US-Dollar (ein Anstieg von 114,8 Millionen US-Dollar im Jahresvergleich) und einen Nettoverlust aus laufenden Betrieben von 236,8 Millionen US-Dollar. Das Unternehmen setzte die Aktienrückkäufe im Quartal mit 106 Millionen US-Dollar fort.
- Strong cash position with $5.4B in consolidated cash and marketable securities
- Received $184M cash from Dermavant sale with potential $75M milestone payment
- Additional potential payments up to $950M from commercial milestones
- Completed $754M in cumulative share repurchases through September 2024
- Increased R&D expenses by $28.3M to $143.1M compared to prior year
- G&A expenses increased by $114.3M to $202.9M year-over-year
- Net loss from continuing operations of $236.8M
- Loss from discontinued operations of $43.1M
Insights
The Q2 FY2024 results show mixed financial performance. Key metrics include
Notable developments include
Several promising clinical developments stand out: Brepocitinib's 52-week data in non-infectious uveitis showed sustained efficacy with
The pipeline expansion continues with 5 new IND clearances for IMVT-1402 and multiple potentially registrational trials planned. This broad clinical development strategy across multiple indications reduces program-specific risks while targeting significant market opportunities.
BASEL, Switzerland and LONDON and NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2024, and provided a business update.
- Brepocitinib 52-week data from the Phase 2 NEPTUNE study in non-infectious uveitis (NIU) showed potential best-in-indication efficacy sustained to one year; first patients enrolled in Phase 3 NIU program
- IMVT-1402 cleared five Investigational New Drug (IND) applications across a range of therapeutic areas and FDA divisions, including the potentially registrational trial for difficult-to-treat rheumatoid arthritis (D2T RA) expected to initiate by March 31, 2025
- Batoclimab proof of concept data in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year end
- Mosliciguat, a once-daily inhaled soluble guanylate cyclase (sGC) activator, unveiled as new pipeline program. Mosliciguat Phase 1b data in pulmonary hypertension (PH) patients demonstrated some of the highest pulmonary vascular resistance (PVR) reductions (~
38% ) in PH trials to date. The global Phase 2 PHocus trial for mosliciguat has been initiated in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) - Roivant continued to return capital through share repurchases with
$106M purchased for the quarter, resulting in$754M cumulative share repurchases (inclusive of Sumitomo) through September 30, 2024 - Dermavant transaction with Organon closed on October 28, 2024. At closing, Roivant received
$184M in cash, and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of$336M as of September 30, 2024. In addition, Organon will pay Roivant a$75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in Q1 2025 - Roivant reported consolidated cash, cash equivalents and marketable securities of approximately
$5.4B at September 30, 2024
“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.”
Recent Developments
- Immunovant:
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 of77% leading to a76% 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 of65% (vs.77% on 680mg dose) with a correspondingly lower responder rate of68% . In addition, a lower ATD-Free Response rate of36% was also observed in the second 12 weeks. Patients who achieved at least a70% 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 a60% 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.
Neurology Program
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 by March 31, 2025.
- Priovant: In September 2024, Priovant announced receipt of Fast Track designation from FDA for brepocitinib in NIU and enrolled the first patients in the Phase 3 program. New 52-week data from the Phase 2 NEPTUNE study of brepocitinib in NIU showed potential best-in-indication efficacy sustained to one year. Treatment failure rate in the 45 mg dose arm was
35% at week 52 vs.29% at week 24. Treatment failure rate in the 15 mg dose arm was56% vs.44% at week 24. In each treatment arm only one additional patient failed from week 24 to 52. Other important efficacy measurements at week 52 were consistent with the week 24 data, including measurements of retinal vascular leakage and prevention and treatment of macular edema. Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors.
- Pulmovant: In September 2024, Roivant unveiled mosliciguat, a potential first-in-class and best-in-category inhaled once-daily sGC activator. Mosliciguat is being developed for PH-ILD, which affects ~200,000 patients in the U.S. and Europe with limited or no treatment options.
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: In October 2024, Roivant reported the close of Organon’s acquisition of Dermavant. At closing, Roivant received
$184M in cash and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of$336M as of September 30, 2024. In addition, Organon will pay Roivant a$75M milestone upon FDA approval for VTAMA in atopic dermatitis, with a target action date in the first quarter of calendar year 2025. The transaction also includes payments of up to$950 million for the achievements of certain commercial milestones, in addition to the tiered royalties on net sales that Organon will pay Dermavant shareholders.
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 September 30, 2024.
Roivant reported consolidated cash, cash equivalents and marketable securities of approximately$5.4B at September 30, 2024.
Major Upcoming Milestones
- Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the fourth quarter of calendar year 2024.
- Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025, and plans to have initiated studies in a total of 10 indications by March 31, 2026, for IMVT-1402. In pursuit of this goal, Immunovant now has active INDs in Graves’ Disease and difficult-to-treat rheumatoid arthritis and expects to initiate potentially registrational trials in these indications by December 31, 2024 and March 31, 2025 respectively. Topline data from the batoclimab trial in MG is expected by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which is expected to initiate by March 31, 2025. Data from the batoclimab trial in CIDP is expected by March 31, 2025 and will be used to inform the trial design for a potentially registrational program for IMVT-1402. Topline data from the current pivotal program evaluating batoclimab in thyroid eye disease (TED) now expected in the second half of calendar year 2025.
- Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025.
- Genevant Markman hearing in Pfizer / BioNTech action scheduled for December 2024. Summary judgment phase of Moderna action scheduled for second and third quarter of calendar year 2025; Moderna trial scheduled for September 2025.
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
Research and Development Expenses
Research and development (R&D) expenses increased by
Within program-specific costs, the increase of
Non-GAAP R&D expenses were
General and Administrative Expenses
General and administrative (G&A) expenses increased by
Non-GAAP G&A expenses were
Loss from continuing operations, net of tax
Loss from continuing operations, net of tax was
| 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 | 143,073 | 114,790 | 263,580 | 224,206 | |||||||||||
| Acquired in-process research and development | — | 13,950 | — | 26,450 | |||||||||||
| General and administrative (includes | 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.
About Roivant
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.
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
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