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Roivant Reports Financial Results for the Second Quarter Ended September 30, 2025, and Provides Business Update

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Roivant (Nasdaq: ROIV) reported Q2 results for the period ended September 30, 2025 and provided a business update.

Clinical highlights: Brepocitinib 30 mg met the primary endpoint and all nine key secondaries in Phase 3 VALOR for dermatomyositis with NDA planned in H1 2026; Phase 3 non-infectious uveitis and PoC cutaneous sarcoidosis trials remain on track for readouts in H1 2027 and H2 2026, respectively. Immunovant reported potentially disease-modifying six-month off-treatment remission data in uncontrolled Graves’ disease; batoclimab TED readouts to be shared concurrently in H1 2026.

Financials: Consolidated cash and marketable securities ~$4.4B; R&D expense $164.6M; loss from continuing operations $166.0M for the quarter.

Roivant (Nasdaq: ROIV) ha riportato i risultati del secondo trimestre per il periodo terminato il 30 settembre 2025 e ha fornito un aggiornamento sull'attività.

Rilevanti clinici: Brepocitinib 30 mg ha raggiunto l'obiettivo primario e tutti i nove secondari chiave nello studio di fase 3 VALOR per la dermatomiosite, con NDA prevista nel primo semestre 2026; i dati delle prove di fase 3 su uveite non infettiva e su sarcoidosi cutanea (PoC) rimangono in linea per la pubblicazione nel primo semestre 2027 e nel secondo semestre 2026, rispettivamente. Immunovant ha riportato dati che potrebbero modificare la malattia con remissio­ne di sei mesi senza trattamento nella malattia di Graves non controllata; i risultati di batoclimab TED saranno condivisi contemporaneamente nel primo semestre 2026.

Finanziari: liquidità consolidata e titoli di mercato circa 4,4 miliardi di dollari; spesa in R&S 164,6 milioni di dollari; perdita dalle operazioni continuative 166,0 milioni di dollari per il trimestre.

Roivant (Nasdaq: ROIV) informó resultados del segundo trimestre para el periodo terminado el 30 de septiembre de 2025 y proporcionó una actualización comercial.

Aspectos clínicos: Brepocitinib 30 mg cumplió el objetivo primario y los nueve criterios secundarios clave en el estudio de fase 3 VALOR para la dermatomiositis, con NDA prevista para el primer semestre de 2026; los ensayos de fase 3 de uveítis no infecciosa y de sarcoidosis cutánea (PoC) siguen en camino para obtener resultados en el primer semestre de 2027 y en el segundo semestre de 2026, respectivamente. Immunovant informó datos potencialmente que modifican la enfermedad en una remisión de seis meses sin tratamiento en la enfermedad de Graves no controlada; los resultados de batoclimab TED serán comunicados simultáneamente en el primer semestre de 2026.

Finanzas: efectivo consolidado y valores de mercado de aproximadamente 4,4 mil millones de dólares; gasto en I+D 164,6 millones de dólares; pérdida de operaciones continuas 166,0 millones de dólares para el trimestre.

로이반트(Roivant) (나스닥: ROIV)는 2025년 9월 30일 종료된 기간의 2분기 실적을 보고하고 비즈니스 업데이트를 제공했습니다.

임상 하이라이트: 브레포시티닙 30 mg이 3상 VALOR 연구의 1차 목표 및 9개의 주요 2차 목표를 달성했고, NDA는 2026년 상반기에 예정되어 있습니다; 비감염성 포이베(UVE) 및 피부사르코이드(PoC) 연구의 3상은 각각 2027년 상반기와 2026년 하반기에 결과를 발표하기 위해 순조롭게 진행 중입니다. Immunovant는 조절되지 않는 그레이브스병에서 치료 중단 없이 6개월 간의 질환 조절 가능성 데이터를 보고했습니다; batoclimab TED의 결과도 2026년 상반기에 동시 공유될 예정입니다.

재무: 연결 현금 및 시가 가능 증권 약 44억 달러; 연구개발비 1억 6,460만 달러; 지속영업손실 1억 6,600만 달러로 분기 보고.

Roivant (Nasdaq: ROIV) a publié les résultats du 2e trimestre pour la période se terminant le 30 septembre 2025 et a fourni une mise à jour commerciale.

Points cliniques: Brepocitinib 30 mg a atteint l'objectif primaire et les neuf critères secondaires clés dans l'étude de phase 3 VALOR pour la dermatomyosite, avec une NDA prévue au premier semestre 2026 ; les essais de phase 3 sur l'uvéite non infectieuse et sur le sarcoïde cutané (PoC) restent en bonne voie pour des résultats au premier semestre 2027 et au second semestre 2026, respectivement. Immunovant a rapporté des données potentiellement modifiant l'évolution de la maladie sur une rémission de six mois sans traitement dans la maladie de Basedow non contrôlée ; les résultats de batoclimab TED seront communiqués simultanément au premier semestre 2026.

Finances : trésorerie et valeurs mobilières consolidées d'environ 4,4 milliards de dollars ; dépenses en R&D 164,6 millions de dollars ; perte des activités continues 166,0 millions de dollars pour le trimestre.

Roivant (Nasdaq: ROIV) berichtete die Ergebnisse des zweiten Quartals für den Zeitraum bis zum 30. September 2025 und gab ein GeschäftUpdate.

Klinische Highlights: Brepocitinib 30 mg hat den primären Endpunkt und alle neun wichtigen sekundären Endpunkte in Phase-3-VALOR-Studie zur Dermatomyositis erreicht, NDA im ersten Halbjahr 2026 geplant; Phase-3-Studien zu nichtinfektiöser Uveitis und PoC-Sarkoidose der Haut bleiben auf Kurs für Ergebnisse im ersten Halbjahr 2027 bzw. im zweiten Halbjahr 2026. Immunovant meldete potenziell krankheitsmodifizierende Remissionsdaten nach sechs Monaten ohne Behandlung bei unbehandeltem Morbus Basedow; Ergebnisse von batoclimab TED werden im ersten Halbjahr 2026 gleichzeitig veröffentlicht.

Finanzen: konsolidierte Barmittel und handelbare Wertpapiere ca. 4,4 Mrd. USD; F&E-Aufwendungen 164,6 Mio. USD; Verluste aus fortgeführten Geschäftsbereichen 166,0 Mio. USD für das Quartal.

روانت (ناسداك: ROIV) أبلغت عن نتائج الربع الثاني للفترة المنتهية في 30 سبتمبر 2025 ووفرت تحديثاً للأعمال.

النقاط السريرية: خضع Brepocitinib 30 ملغ للهدف الابتدائي وجميع النقاط الثانوية التسعة الرئيسية في دراسة المرحلة 3 VALOR لمرض الالتهاب العضلي الجلدي مع وجود NDA مخطط في النصف الأول من 2026؛ ما زالت تجارب المرحلة 3 لالتهاب القزاحية غير المعدي وساركويد الجلد (PoC) على المسار للحصول على قراءات في النصف الأول من 2027 والنصف الثاني من 2026 على التوالي. Immunovant أبلغت عن بيانات محتملة لتعديل المرض في فترة انعدام العلاج لمدة ستة أشهر في مرض غريف غير المسيطر عليه؛ وسيتم مشاركة نتائج batoclimab TED في نفس الفترة في النصف الأول من 2026.

المالية: النقد المجمَّع والأوراق المالية القابلة للتداول حوالي 4.4 مليار دولار؛ إنفاق البحث والتطوير 164.6 مليون دولار؛ خسارة من عمليات التشغيل المستمرة 166.0 مليون دولار لهذا الربع.

Positive
  • Brepocitinib met primary and nine key secondary endpoints in Phase 3 VALOR
  • NDA for brepocitinib planned in the first half of 2026
  • Consolidated cash and marketable securities of approximately $4.4 billion
  • Loss from continuing operations improved to $166.0 million (Q2 2025)
Negative
  • R&D expense increased to $164.6 million for the quarter (up $21.5 million)
  • Change in fair value of investments reduced results by $128.5 million this quarter
  • Total assets declined to $5.06 billion from $5.44 billion as of March 31, 2025

Insights

Strong Phase 3 efficacy in dermatomyositis and multiple near-term readouts materially increase development optionality.

Brepocitinib 30 mg met the primary endpoint and all nine key secondaries in a Phase 3 dermatomyositis study with a consistent safety profile; an NDA filing is planned in first half of calendar year 2026. This outcome converts a late‑stage clinical program into a regulatory pathway and creates a clear near-term milestone (NDA submission) tied to approval timelines.

Other programs show meaningful cadence. Brepocitinib Phase 3 NIU enrollment is rapid with topline expected in first half of calendar year 2027, and a proof‑of‑concept readout in cutaneous sarcoidosis is expected in second half of calendar year 2026. Immunovant reports six‑month off‑treatment remission data in Graves’ disease, and batoclimab TED readouts are being managed to report concurrently in first half of calendar year 2026. Watch NDA filing timing in H1 2026, the safety dataset included in that filing, and the scheduled readouts in H2 2026 and H1 2027 for validation of broader indications; these milestones will materially affect regulatory and commercial prospects within 6–18 months.

Robust liquidity and favorable litigation developments reduce near‑term execution risk and support commercialization planning.

Balance sheet shows consolidated cash and marketable securities of $4.4 billion as of September 30, 2025, which the company cites as supporting a cash runway into profitability; this provides capital to fund launches, registrational programs, and litigation through key milestones. Operating results show higher R&D spend tied to program progression and materially lower G&A on a non‑recurring comparison, contributing to a narrower GAAP loss from continuing operations versus prior year.

Legal posture includes a favorable Markman ruling in related LNP litigation and a March 2026 jury trial date in the Moderna matter, with international hearings expected in H1 2026. Monitor trial outcomes and NDA filing progress closely over the next 6–12 months; these items will drive both upside (approval/commercial optionality) and downside (litigation exposure) within the stated time horizon.

BASEL, Switzerland and LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2025, and provided a business update.

  • Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM), with NDA filing planned for the first half of calendar year 2026

  • Brepocitinib program continues to advance with rapid enrollment in Phase 3 study in non-infectious uveitis (NIU) and proof-of-concept trial in cutaneous sarcoidosis (CS), with readouts expected in the first half of calendar year 2027 and second half of calendar year 2026, respectively

  • Immunovant study in uncontrolled Graves’ disease (GD) patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment data. Immunovant continues to expect the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, Immunovant anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026

  • LNP litigation continues to progress, with the court issuing a favorable Markman ruling in the Pfizer/BioNTech case in September 2025. Jury trial in U.S. Moderna case scheduled for March 2026 and international proceedings continue with first major hearings expected in the first half of calendar year 2026

  • Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.4 billion as of September 30, 2025, supporting cash runway into profitability

  • Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 10, 2025, to report its financial results for the second quarter ended September 30, 2025, and provide a business update

  • Roivant will also host an Investor Day on December 11, 2025

“This quarter unquestionably represents a moment of transformation for Roivant, with the brepocitinib data in DM putting us on a new and exciting trajectory. This is further supported by Immunovant's remission data in Graves' disease, and by strong continued execution and progress across the board,” said Matt Gline, CEO of Roivant. “We look forward to sharing more about our progress and next chapter at our investor day in December.”

Recent Developments

  • Priovant: Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM); safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for the first half of calendar year 2026. Phase 3 trial for brepocitinib in non-infectious uveitis (NIU) is ongoing and on track for topline readout in the first half of calendar year 2027. Proof-of-concept trial for brepocitinib in cutaneous sarcoidosis (CS) is ongoing and on track for topline readout in the second half of calendar year 2026.

  • Immunovant: All clinical development timelines remain on track for IMVT-1402 across six announced indications, including potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). Immunovant study in uncontrolled GD patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment data.

  • Genevant: In September 2025, the court issued a favorable Markman ruling in the Pfizer/BioNTech case.

  • Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.4 billion as of September 30, 2025, supporting cash runway into profitability.

Major Upcoming Milestones

  • Priovant plans to file an NDA for brepocitinib in DM in the first half of calendar year 2026. Topline data from the ongoing Phase 3 trial of brepocitinib in NIU and proof-of-concept trial in CS are expected in the first half of calendar year 2027 and second half of calendar year 2026, respectively.

  • Immunovant expects to report results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and topline results from the proof-of-concept trial of IMVT-1402 in CLE in calendar year 2026. In calendar year 2027, topline results are expected across three indications from the potentially registrational trials of IMVT-1402 in GD, MG and D2T RA. Immunovant continues to expect the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, Immunovant anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026.

  • Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026.

  • Genevant LNP litigation continues to progress, with summary judgment phase ongoing in the U.S. Moderna case and jury trial currently scheduled for March 2026. International proceedings continue as expected with first major hearings expected in the first half of calendar year 2026. Pfizer/BioNTech discovery phase ongoing.

Second Quarter Ended September 30, 2025 Financial Summary

Cash Position and Marketable Securities

As of September 30, 2025, the Company had consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $4.4 billion.

Research and Development Expenses

Research and development (R&D) expenses increased by $21.5 million to $164.6 million for the three months ended September 30, 2025, compared to $143.1 million for the three months ended September 30, 2024. This increase was primarily driven by an increase in program-specific costs of $13.2 million and personnel-related expenses of $7.1 million.

The increase of $13.2 million in program-specific costs was primarily driven by an increase of $10.2 million related to the anti-FcRn franchise and $4.2 million related to brepocitinib, reflecting the progression of our programs.

The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant. The increase of $7.1 million in personnel-related expenses was primarily driven by higher headcount to support additional clinical studies for the anti-FcRn franchise.

Non-GAAP R&D expenses were $152.9 million for the three months ended September 30, 2025, compared to $132.4 million for the three months ended September 30, 2024.

General and Administrative Expenses

General and administrative (G&A) expenses decreased by $59.8 million to $143.1 million for the three months ended September 30, 2025, compared to $202.9 million for the three months ended September 30, 2024. This decrease was due to a decrease in personnel-related expense of $71.9 million, largely as a result of higher expense during the three months ended September 30, 2024 related to one-time cash retention awards from the 2024 Senior Executive Compensation Program.

Non-GAAP G&A expenses were $72.1 million for the three months ended September 30, 2025, compared to $142.3 million for the three months ended September 30, 2024.

Loss from discontinued operations, net of tax

Loss from discontinued operations, net of tax was $43.1 million for the three months ended September 30, 2024 and represents the financial results of Dermavant during this period.

Loss from continuing operations, net of tax

Loss from continuing operations, net of tax was $166.0 million for the three months ended September 30, 2025, compared to $236.8 million for the three months ended September 30, 2024. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.17 and $0.25, respectively, for the three months ended September 30, 2025 and 2024.

Non-GAAP loss from continuing operations, net of tax was $187.8 million for the three months ended September 30, 2025, compared to $218.7 million for the three months ended September 30, 2024.


ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)
 
 September 30, 2025 March 31, 2025
Cash, cash equivalents and restricted cash$1,247,160 $2,725,661
Marketable securities 3,148,825  2,171,480
Total assets 5,062,598  5,436,940
Total liabilities 257,140  249,742
Total shareholders’ equity 4,805,458  5,187,198
Total liabilities and shareholders’ equity 5,062,598  5,436,940


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,
  2025   2024   2025   2024 
Revenue$1,571  $4,475  $3,741  $12,465 
Operating expenses:       
Cost of revenues 111   234   265   447 
Research and development (includes $10,996 and $9,911 of share-based compensation expense for the three months ended September 30, 2025 and 2024 and $22,095 and $20,443 for the six months ended September 30, 2025 and 2024, respectively) 164,568   143,073   317,487   263,580 
General and administrative (includes $70,825 and $59,443 of share-based compensation expense for the three months ended September 30, 2025 and 2024 and $141,904 and $96,284 for the six months ended September 30, 2025 and 2024, respectively) 143,125   202,881   277,144   302,773 
   Total operating expenses 307,804   346,188   594,896   566,800 
Gain on sale of Telavant net assets          110,387 
Loss from operations (306,233)  (341,713)  (591,155)  (443,948)
Change in fair value of investments (128,501)  (48,375)  (109,376)  (63,601)
Change in fair value of liability instruments 20,959   (635)  23,288   515 
Interest income (45,341)  (69,773)  (93,663)  (141,900)
Other expense, net 5,694   1,453   16,902   5,061 
Loss from continuing operations before income taxes (159,044)  (224,383)  (428,306)  (244,023)
Income tax expense 6,995   12,458   11,644   24,421 
Loss from continuing operations, net of tax (166,039)  (236,841)  (439,950)  (268,444)
(Loss) income from discontinued operations, net of tax    (43,083)     46,010 
Net loss (166,039)  (279,924)  (439,950)  (222,434)
Net loss attributable to noncontrolling interests (52,520)  (49,740)  (103,076)  (87,547)
Net loss attributable to Roivant Sciences Ltd.$(113,519) $(230,184) $(336,874) $(134,887)
        
Amounts attributable to Roivant Sciences Ltd.:       
Loss from continuing operations, net of tax$(113,519) $(187,101) $(336,874) $(181,052)
(Loss) income from discontinued operations, net of tax    (43,083)     46,165 
Net loss attributable to Roivant Sciences Ltd.$(113,519) $(230,184) $(336,874) $(134,887)
        
Basic and diluted net (loss) income per common share:       
Basic and diluted loss from continuing operations$(0.17) $(0.25) $(0.49) $(0.25)
Basic and diluted (loss) income from discontinued operations$  $(0.06) $  $0.06 
Basic and diluted net loss per common share$(0.17) $(0.31) $(0.49) $(0.18)
        
Weighted average shares outstanding:       
Basic 680,947,866   735,470,796   680,619,200   735,642,721 
Diluted 680,947,866   735,470,796   680,619,200   735,642,721 


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  2025   2024   2025   2024 
Loss from continuing operations, net of tax  $(166,039) $(236,841)  (439,950)  (268,444)
Adjustments:         
Research and development:         
Share-based compensation(1)  10,996   9,911   22,095   20,443 
Depreciation and amortization(2)  676   724   1,462   1,419 
General and administrative:         
Share-based compensation(1)  70,825   59,443   141,904   96,284 
Depreciation and amortization(2)  246   1,094   558   2,184 
Gain on sale of Telavant net assets(3)           (110,387)
Other:         
Change in fair value of investments(4)  (128,501)  (48,375)  (109,376)  (63,601)
Change in fair value of liability instruments(5)  20,959   (635)  23,288   515 
Estimated income tax impact from adjustments(6)  3,059   (3,986)  2,116   (4,190)
Adjusted loss from continuing operations, net of tax (Non-GAAP)  $(187,779) $(218,665) $(357,903) $(325,777)


   Three Months Ended
September 30,
 Six Months Ended
September 30,
 Note 2025
 2024
 2025
 2024
Research and development expenses  $164,568 $143,073 $317,487 $263,580
Adjustments:         
Share-based compensation(1)  10,996  9,911  22,095  20,443
Depreciation and amortization(2)  676  724  1,462  1,419
Adjusted research and development expenses (Non-GAAP)  $152,896 $132,438 $293,930 $241,718


   Three Months Ended
September 30,
 Six Months Ended
September 30,
 Note 2025
 2024
 2025
 2024
General and administrative expenses  $143,125 $202,881 $277,144 $302,773
Adjustments:         
Share-based compensation(1)  70,825  59,443  141,904  96,284
Depreciation and amortization(2)  246  1,094  558  2,184
Adjusted general and administrative expenses (Non-GAAP)  $72,054 $142,344 $134,682 $204,305


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 gains 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 loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(6)   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 Monday, November 10, 2025, to report its financial results for the second quarter ended September 30, 2025, 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 will also host an investor day on Thursday, December 11, 2025. To attend the event in person or by webcast, 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 (Nasdaq: ROIV) 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 brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. 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, visit https://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


FAQ

What did Roivant (ROIV) report for cash and marketable securities on Nov 10, 2025?

Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $4.4 billion as of September 30, 2025.

What are the brepocitinib clinical and regulatory timelines for ROIV?

Brepocitinib 30 mg met primary and nine key secondary endpoints in Phase 3 VALOR for dermatomyositis and Roivant plans an NDA filing in H1 2026; NIU and CS readouts are expected in H1 2027 and H2 2026, respectively.

How did Roivant's operating loss from continuing operations compare year-over-year in Q2 ended Sept 30, 2025?

Loss from continuing operations, net of tax was $166.0 million for the three months ended Sept 30, 2025 versus $236.8 million in the prior-year quarter.

What clinical milestone did Immunovant announce in the Nov 10, 2025 update for ROIV?

Immunovant reported potentially disease-modifying six-month off-treatment remission data in uncontrolled Graves’ disease patients treated for 24 weeks.

What is the status of LNP litigation mentioned in Roivant's Nov 10, 2025 release?

Genevant/LNP litigation progressed with a favorable Markman ruling in the Pfizer/BioNTech case in Sept 2025 and a U.S. Moderna jury trial scheduled for March 2026; international hearings expected in H1 2026.

When will Roivant (ROIV) host investor events after the Q2 release dated Nov 10, 2025?

Roivant will host a live conference call and webcast on Nov 10, 2025 at 8:00 a.m. ET and an Investor Day on Dec 11, 2025.
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