Reported Earnings • May 22
Full year 2026 earnings released: US$0.43 loss per share (vs US$0.75 loss in FY 2025) Full year 2026 results: US$0.43 loss per share (improved from US$0.75 loss in FY 2025). Net loss: US$299.8m (loss narrowed 45% from FY 2025). Products in clinical trials Phase II: 8 Phase III: 2 Post-clinical trial products Pre-registration: 1 Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has increased by 44% per year, which means it is well ahead of earnings. Board Change • May 21
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 5 experienced directors. 2 highly experienced directors. President, Chief Investment Officer & Director Mayukh Sukhatme was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • May 12
Roivant Sciences Ltd. to Report Q4, 2026 Results on May 20, 2026 Roivant Sciences Ltd. announced that they will report Q4, 2026 results Pre-Market on May 20, 2026 Aankondiging • Apr 02
Roivant Sciences Ltd. Announces Expansion of Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP) and Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED) Roivant Sciences Ltd. announced a new Phase 2b/3 clinical program for brepocitinib in lichen planopilaris (LPP), a highly morbid inflammatory scalp disorder affecting approximately 100,000 adults in the United States, and reported the topline results from Immunovant’s two Phase 3 (GO) clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (TED). LPP inflammation targets the stem cell-rich bulge region of the hair follicle (the permanent portion responsible for hair growth), resulting in generally irreversible hair loss and permanent scarring. LPP is also associated with other burdensome symptoms, including pain, burning, itching, and scaling and an increased risk of comorbidities such as other autoimmune diseases and skin cancers. There are currently no FDA-approved therapies to treat LPP. Priovant recently began enrolling subjects in a seamless Phase 2b/3 study of brepocitinib in LPP, with the first subjects enrolled in March 2026. This program marks Priovant’s fourth indication in late-stage clinical development, alongside dermatomyositis (DM), non-infectious uveitis (NIU) and cutaneous sarcoidosis (CS). The U.S. Food and Drug Administration (FDA) recently granted Priority Review to brepocitinib’s New Drug Application (NDA) for DM and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. Topline Phase 3 data in NIU and Phase 3 study initiation in CS are expected in the second half of calendar year 2026.Based on the pre-specified statistical analysis plan, the studies failed to meet their primary endpoint of =2mm proptosis responder rate at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose batoclimab treatment. Safety results were consistent with previous findings, and no new safety signals were identified. Patients in the TED studies had greater levels of proptosis improvement from baseline after the initial 12-week high-dose period than after the following 12-week low-dose period, supporting the benefit of deeper IgG suppression. The subset of hyperthyroid patients in the TED studies showed similar response rates of thyroid hormone normalization to those seen in the batoclimab Phase 2 study in Graves’ disease. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402, an investigational FcRn blocker, across multiple autoimmune diseases with significant unmet need, with Graves’ disease as a key strategic priority. Recent Phase 2 proof-of-concept data highlighted FcRn blockade as a potentially disease-modifying approach in Graves’ disease. Topline data from the potentially registrational studies of IMVT-1402 in Graves’ disease are expected in calendar year 2027.Immunovant intends to review future plans for the development of batoclimab with its partner HanAll Biopharma Co. Ltd. (HanAll) and to provide an update on the program, in conjunction with HanAll, at a future date. Aankondiging • Feb 06
Pulmovant Announces Completion of Enrollment in the Phase 2 PHocus Study of Mosliciguat in Patients with Interstitial Lung Disease Pulmovant, and a Roivant company announced that it has completed enrollment in the Phase 2 PHocus clinical trial evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD. Pulmovant completed enrollment of the PHocus clinical trial in under 12 months from first patient dosed, an impressive timeline in clinical development of treatments for PH-ILD. Pulmovaant remains on track to report PHocus topline data in the second half of calendar year 2026. The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial assessing the safety and efficacy of mosliciguat in approximately 120 adult participants with PH-ILD.Mosliciguat is also being evaluated in the Phase 2 PHactor clinical study (NCT07333183), an open-label trial evaluating the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD. The Phase 2 PH focus clinical study (NCT0 6635850) is a randomized. double-blind, placebo- controlled, global trial evaluating the safety and efficacy of Mosliciguat in approximately120 adult participants with PH-ILD; Mosliciguat is also be evaluated in the Phase 2 PHact clinical study (NCT0733183), an open- label trial evaluating the tolerability and Safety of inhaled moslicigUat in combination with inhaled Treprostinil in Participants with PH-ILD. PulmOVant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant company. Pulmovant's first investigational candidate, Mosliciguat, is designed to provide a novel, once- daily, inhaled treatment option for patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD). Mosliciguat is an potential first-in-classsoluble guanylate cyclase activator with a differentiated mechanismof action currently being evaluated in the Phase 2PHocus clinical trial in under 12 years. Aankondiging • Jan 24
Roivant Sciences Ltd. to Report Q3, 2026 Results on Feb 06, 2026 Roivant Sciences Ltd. announced that they will report Q3, 2026 results Pre-Market on Feb 06, 2026 Aankondiging • Dec 11
Roivant Highlights Continued Pipeline Progress and Outlook for Company's Next Phase of Growth At 2025 Investor Day Roivant announced positive updates to timing guidance across four key programs: Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in calendar year 2027; Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled with topline data now expected in the second half of calendar year 2026; commercial preparations underway with launch expected early in fiscal year 2027; Bre pocitinib Phase 3 trials in non-infectious uVEitis (NIU) fully enroll with topline data now expects in the first half of calendar year 2026, and a proof-of-concept trial in cutaneous lupus erythematosus (CLE) Mosliciguat: Enrollment in the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track; Pulmovant plans to report topline data in the second half of calendaryear 2026, previously expected in the second half of fiscal year 2026; previously expected Period 1 data in calendar year 2026 and topline data in calendar year 2027; All other clinical development timelines remain on track, including potentially registrational trials in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjogren's disease (SjD), and a proof-of- concept trial in cutaneous lupUS erythematosus ("CLE") Mosliciguat") Enrollment in the ongoing Phase2 trial of moslicigu at pulmonary hypertension associated with interstitial lupus erytheMatosus (CLE). Pulmovant also expects to imminently initiate a Phase 2 study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients with PH-ILD Genevant. In the US Moderna litigation, a jury trial has been scheduled for March 2026. Awaiting court scheduling in the Pfizer/BioNTech litigation. Initial court hearings and rulings in the ex-US Moderna litigation expected in calendar year 2026. Aankondiging • Oct 28
Roivant Sciences Ltd. to Report Q2, 2026 Results on Nov 10, 2025 Roivant Sciences Ltd. announced that they will report Q2, 2026 results on Nov 10, 2025 Aankondiging • Sep 17
Roivant and Priovant Announce Positive Phase 3 Valor Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis Roivant and Priovant Therapeutics announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), even with nearly twice as many patients coming off background steroid on brepocitinib30 mg compared to placebo. More than two thirds of brepocitinib 300 mg patients experienced at least a moderate response (TIS40), and nearly half experienced a major response (TIS60). Consistent dose response was seen between 30 mg and 15 mg dose arms, establishing 30 mg dose as optimal in this setting. Safety profile was consistent with previous brepocitinib and NDA filing is planned for calendar 1H 2026. The observed brepocitinib 25 mg safety profile was consistent with previous bre p<0.0006. The observed brepoc itinib 30 mg safety profile was consistent with previously brepocitinib clinical trials. Adverse events of special interest (AESIs), which included malignancy, cardiovascular events, and thromboembolic events, did not occur with greater frequency in the brepocitinib 50 mg arm than the placebo arm. Priovant plans to file an NDA for brepocit in dermatomyositis in the first half of 2026. Aankondiging • Sep 15
ProofPilot, Inc. acquired Lokavant, Inc. ProofPilot, Inc. acquired Lokavant, Inc. on September 15, 2025.
ProofPilot, Inc. completed the acquisition of Lokavant, Inc. on September 15, 2025. Aankondiging • Aug 12
Roivant Sciences Ltd. (NasdaqGS:ROIV) announces an Equity Buyback for $500 million worth of its shares. Roivant Sciences Ltd. (NasdaqGS:ROIV) announces a share repurchase program. Under the program, the company will repurchase up to $500 million worth of its common shares. Aankondiging • Jul 30
Roivant Sciences Ltd., Annual General Meeting, Sep 10, 2025 Roivant Sciences Ltd., Annual General Meeting, Sep 10, 2025. Location: royal lancaster london hotel, lancaster terrace, london w2 2ty, united kingdom, United Kingdom Aankondiging • Jul 29
Roivant Sciences Ltd. to Report Q1, 2026 Results on Aug 11, 2025 Roivant Sciences Ltd. announced that they will report Q1, 2026 results at 9:30 AM, US Eastern Standard Time on Aug 11, 2025 Aankondiging • May 16
Roivant Sciences Ltd. to Report Q4, 2025 Results on May 29, 2025 Roivant Sciences Ltd. announced that they will report Q4, 2025 results on May 29, 2025 Aankondiging • Feb 22
Roivant Sciences Ltd. Announces Stepping Down of Rakhi Kumar as Principal Accounting Officer Roivant Sciences Ltd. announced stepping down of Rakhi Kumar as Principal Accounting Officer, effective February 20, 2025. Aankondiging • Jan 30
Roivant Sciences Ltd. to Report Q3, 2025 Results on Feb 10, 2025 Roivant Sciences Ltd. announced that they will report Q3, 2025 results on Feb 10, 2025 Aankondiging • Dec 03
Roivant Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis Kinevant Sciences announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis. Primary Endpoint Details: Namilumab failed to meet the primary endpoint of proportion of subjects with a Rescue Event during the double-blind period. Secondary Endpoints Details: Secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient reported King’s Sarcoidosis Questionnaire failed to show a treatment benefit consistent with the primary endpoint. Safety Details: The safety profile of namilumab in RESOLVE-Lung remains similar to previous studies. With these results, Kinevant will be discontinuing further development of namilumab for the treatment of sarcoidosis. Kinevant is committed to publishing the results of RESOLVE-Lung to inform future sarcoidosis research. The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis at sites in the U.S. and Europe. The study enrolled 107 patients with pulmonary sarcoidosis considered to have chronic, active disease not well-controlled despite available therapeutic options. Patients in the study received a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. All patients who complete the 26-week double-blind treatment period were eligible to participate in a 28-week open-label extension treatment period on namilumab. The primary endpoint of this study was proportion of subjects with a Rescue Event during the double-blind period. Rescue Event was defined as clinically significant worsening of a subject’s sarcoidosis requiring treatment, failure to adhere to the protocol defined OCS taper, or premature discontinuation from the study associated with lack of benefit during the double-blind treatment period. Study eligibility did not require subjects to be on high dose corticosteroids. If subjects were on >5mg/day of oral corticosteroid (OCS) at baseline, they were required to taper down to 5mg/day 8-10 weeks after randomization. If patients were on an immunosuppressive therapy (IST), they were required to stop the IST at randomization. Notably, all subjects enrolled had evidence of active pulmonary sarcoidosis disease, defined as a positive HRCT scan, significant lung inflammation on PET, and moderate to severe self-reported breathlessness. Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas (clumps of immune cells) of unknown etiology that can cause breathlessness, fatigue, and pain. The resulting inflammation, if not effectively treated, can result in lung tissue scarring (fibrosis), lung dysfunction, and eventually lung failure. Approximately 50% of diagnosed patients require chronic therapy to treat symptoms and prevent progression. Oral steroids (e.g., prednisone) and off-label immunosuppressive therapies (e.g., methotrexate) are first- and second-line therapies respectively for sarcoidosis; however, these therapeutic options are often not effective or can be accompanied by serious side effects. Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, an immune-mediated inflammatory disease that can affect any organ in the body, with about 90% of cases involving the lung. Granulocyte macrophage colony stimulating factor (GM-CSF) is a pro-inflammatory cytokine over-expressed in several inflammatory diseases, including sarcoidosis. GM-CSF mediated pro-inflammatory signaling is thought to play a central role in recruitment of macrophages and monocytes to the lung and to trigger a granulomatous response, including the fusion of macrophages into multinucleated giant cells. Namilumab is an anti-GM-CSF monoclonal antibody formulated to be administered once-monthly as a subcutaneous injection being investigated for the treatment of pulmonary sarcoidosis. Reported Earnings • Nov 14
Second quarter 2025 earnings released: US$0.25 loss per share (vs US$0.40 loss in 2Q 2024) Second quarter 2025 results: US$0.25 loss per share (improved from US$0.40 loss in 2Q 2024). Revenue: US$4.48m (down 88% from 2Q 2024). Net loss: US$187.1m (loss narrowed 39% from 2Q 2024). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 102% per year but the company’s share price has only increased by 20% per year, which means it is significantly lagging earnings growth. Aankondiging • Oct 30
Roivant Sciences Ltd. to Report Q2, 2025 Results on Nov 12, 2024 Roivant Sciences Ltd. announced that they will report Q2, 2025 results on Nov 12, 2024 Aankondiging • Oct 28
Organon & Co. (NYSE:OGN) completed the acquisition of Dermavant Sciences Ltd. from Roivant Sciences Ltd. (NasdaqGS:ROIV) and others. Organon & Co. (NYSE:OGN) entered into an Agreement and Plan of Merger to acquire Dermavant Sciences Ltd. from Roivant Sciences Ltd. (NasdaqGS:ROIV) and others for approximately $1.2 billion on September 17, 2024. A cash consideration, Organon to acquire Dermavant for aggregate consideration of up to approximately $1.2 billion, comprising (i) a payment of $175 million payable at the closing of the Merger, subject to certain adjustments, (ii) a $75 million milestone payment payable upon FDA approval of VTAMA product for the treatment of atopic dermatitis and (iii) up to $950 million in additional milestone payments payable upon achievement of certain tiered net sales amounts with respect to the Product, each less than or equal to $1 billion. Additionally, Organon has agreed to make tiered royalty payments of (x) low-to-mid single digit percentages with respect to annual net sales of the Product up to $1 billion and (y) 30% with respect to annual net sales of the Product above $1 billion. Upon closing of the transaction, as part of the purchase price consideration, Organon would assume Dermavant liabilities with an approximate value of $286 million reported by Roivant as of June 30, 2024, which would be subject to fair value accounting by Organon. Dermavant owns the rights to VTAMA cream globally excluding China and has out licensed Japan rights. Pursuant to the terms of the Merger Agreement, Dermavant continuing as the surviving company and a wholly owned subsidiary of Organon.
The boards of directors of the Company and of Dermavant each approved the entry into the Merger Agreement and the consummation of the Merger. Concurrently with the entry into the Merger Agreement, the Merger Agreement and the Merger were approved by written consent of shareholders constituting at least 75% of the aggregate voting rights of Dermavant’s issued and outstanding common and preference shares. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to be modestly dilutive to Adjusted EBITDA in 2025, turning accretive in 2026. Organon expects net leverage to be elevated above 4.0x as a result of the transaction. The transaction is not expected to result in a revision to Organon’s capital allocation priorities. Company and Organon has the right to terminate the Merger Agreement and abandon the Merger in the event that the Merger has not been consummated by January 5, 2025 due to failure to satisfy certain antitrust-related conditions. Closing of the transaction is currently expected to take place in the fourth quarter of 2024.
Damien Zoubek, Jenny Hochenberg and Tomas Rua, Jeff Jay, Lori Goodman, Steven Matays, Meghan Rissmiller and Rod Carlton, Charles Ramsey, Christine Lyon and Brock Dahl and Stephanie Brown-Cripps of Freshfields Bruckhaus Deringer LLP acted as legal advisor for Roivant Sciences Ltd and Dermavant Sciences Ltd. Goldman Sachs & Co. LLC acted as financial advisor for Roivant Sciences Ltd. Catherine Dargan and Patrick Manchester of Covington & Burling LLP acted as legal advisor for Organon & Co. Deloitte & Touche LLP acted as accountant to Roivant Sciences Ltd. Conyers Dill & Pearman LLP acted as Bermuda legal advisor for Roivant Sciences Ltd.
Organon & Co. (NYSE:OGN) completed the acquisition of Dermavant Sciences Ltd. from Roivant Sciences Ltd. (NasdaqGS:ROIV) and others on October 28, 2024. Recent Insider Transactions • Sep 26
CEO & Director recently sold €4.6m worth of stock On the 23rd of September, Matthew Gline sold around 433k shares on-market at roughly €10.59 per share. This transaction amounted to 2.4% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Matthew's only on-market trade for the last 12 months. Aankondiging • Sep 18
Organon & Co. (NYSE:OGN) agreed to acquire Dermavant Sciences Ltd. from Roivant Sciences Ltd. (NasdaqGS:ROIV) and others for approximately $1.2 billion. Organon & Co. (NYSE:OGN) agreed to acquire Dermavant Sciences Ltd. from Roivant Sciences Ltd. (NasdaqGS:ROIV) from and others for approximately $1.2 billion on September 18, 2024. A cash consideration will be paid by Organon & Co. Organon has agreed to acquire Dermavant for aggregate consideration of up to approximately $1.2 billion, with an upfront payment of $175 million and a $75 million milestone payment upon regulatory approval in AD, as well as payments of up to $950 million for the achievements of certain commercial milestones. Upon closing of the transaction, as part of the purchase price consideration, Organon would assume Dermavant liabilities with an approximate value of $286 million reported by Roivant as of June 30, 2024, which would be subject to fair value accounting by Organon. In addition, Organon will pay Dermavant shareholders tiered royalties on net sales. Dermavant owns the rights to VTAMA cream globally excluding China and has out licensed Japan rights. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Closing of the transaction is currently expected to take place in the fourth quarter of 2024. The transaction is expected to be modestly dilutive to Adjusted EBITDA in 2025, turning accretive in 2026. Organon expects net leverage to be elevated above 4.0x as a result of the transaction. The transaction is not expected to result in a revision to Organon’s capital allocation priorities.
Freshfields Bruckhaus Deringer LLP acted as legal advisor for Roivant Sciences Ltd. Goldman Sachs & Co. LLC acted as financial advisor for Roivant Sciences Ltd. Covington & Burling LLP acted as legal advisor for Organon & Co. New Risk • Aug 12
New major risk - Earnings quality The company has a high level of non-cash earnings. Accrual ratio: 1,252% This is considered a major risk. Non-cash earnings can arise from many different things. However, if a company consistently has a high level of non-cash earnings, it may be a sign that they are recognizing revenue from customers before the full value of the sales are received as cash or they are not depreciating the value of their assets appropriately. These are practices that inflate earnings, while not providing a similar increase to cash flows. Companies in some select industries naturally have a high level of non-cash earnings and it is not a major concern. However, in the worst case scenario it can be an early sign of performance manipulation by management. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 60% per year for the foreseeable future. High level of non-cash earnings (1,252% accrual ratio). Reported Earnings • Aug 09
First quarter 2025 earnings released: EPS: US$0.13 (vs US$0.38 loss in 1Q 2024) First quarter 2025 results: EPS: US$0.13 (up from US$0.38 loss in 1Q 2024). Revenue: US$55.1m (up 155% from 1Q 2024). Net income: US$95.3m (up US$387.1m from 1Q 2024). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Aankondiging • Jul 29
Roivant Sciences Ltd., Annual General Meeting, Sep 10, 2024 Roivant Sciences Ltd., Annual General Meeting, Sep 10, 2024. Location: royal lancaster london hotel, lancaster terrace, london w2 2ty, united kingdom on, london United States Aankondiging • Jul 26
Roivant Sciences Ltd. to Report Q1, 2025 Results on Aug 08, 2024 Roivant Sciences Ltd. announced that they will report Q1, 2025 results on Aug 08, 2024 Reported Earnings • Jun 04
Full year 2024 earnings released: EPS: US$5.55 (vs US$1.58 loss in FY 2023) Full year 2024 results: EPS: US$5.55 (up from US$1.58 loss in FY 2023). Revenue: US$124.8m (up 104% from FY 2023). Net income: US$4.35b (up US$5.47b from FY 2023). Products in clinical trials Phase I: 1 Phase II: 6 Phase III: 3 Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Valuation Update With 7 Day Price Move • Apr 03
Investor sentiment improves as stock rises 21% After last week's 21% share price gain to €10.66, the stock trades at a forward P/E ratio of 25x. Average trailing P/E is 35x in the Biotechs industry in Europe. Total returns to shareholders of 64% over the past year. Simply Wall St's valuation model estimates the intrinsic value at €15.79 per share. Aankondiging • Apr 03
Roivant Sciences Ltd. (NasdaqGS:ROIV) announces an Equity Buyback for $1,500 million worth of its shares. Roivant Sciences Ltd. (NasdaqGS:ROIV) announces a share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of its common shares. The repurchase program will be funded with available cash and cash equivalents on hand. The program has no expiration date. Aankondiging • Apr 02
Roivant and Priovant Therapeutics Announce Positive Results from the Phase 2 Study for Brepocitinib in NIU Roivant and Priovant Therapeutics announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis (NIU), showing the strongest efficacy data in NIU observed to date. The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily. Patients, physicians, and the study team were blinded to dose. All subjects received a 60 mg/day prednisone burst at study entry for two weeks and were tapered off prednisone per protocol by week 8 (six-week steroid taper). Subjects were evaluated for Treatment Failure, a registrational composite endpoint comprising multiple measures of ocular inflammation and visual acuity, as well as discontinuation due to intercurrent events or initiation of rescue therapy. The study’s primary efficacy endpoint was the Treatment Failure rate at week 24. At week 24, 29% (5/17) of subjects in the brepocitinib 45 mg arm and 44% (4/9) of subjects in the brepocitinib 15 mg arm met Treatment Failure criteria, with lower failure rates reflecting greater treatment benefit. The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. These observed results represent approximately twice the observed benefit as seen in the corresponding registrational study for the only approved non-steroidal therapy in NIU. All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive. Of patients in the brepocitinib 45 mg arm who met the threshold for uveitic macular edema at baseline, 43% achieved resolution of macular edema by week 24. No patients in the brepocitinib 45 mg arm who entered the study without macular edema developed macular edema by week 24. 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. Priovant intends to initiate a Phase 3 program in NIU in the second half of calendar year 2024. The company would like to thank all of the investigators and patients who participated in the NEPTUNE study. The ongoing Phase 3 study evaluating brepocitinib in dermatomyositis is expected to be fully enrolled in the third calendar quarter of 2024, with data expected in calendar year 2025. Reported Earnings • Feb 14
Third quarter 2024 earnings released: EPS: US$6.37 (vs US$0.49 loss in 3Q 2023) Third quarter 2024 results: EPS: US$6.37 (up from US$0.49 loss in 3Q 2023). Revenue: US$37.1m (up 118% from 3Q 2023). Net income: US$5.10b (up US$5.45b from 3Q 2023). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Breakeven Date Change • Feb 13
No longer forecast to breakeven The 12 analysts covering Roivant Sciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$190.5m in 2024. New consensus forecast suggests the company will make a loss of US$726.6m in 2026. Aankondiging • Jan 31
Roivant Sciences Ltd. to Report Q3, 2024 Results on Feb 13, 2024 Roivant Sciences Ltd. announced that they will report Q3, 2024 results on Feb 13, 2024 Breakeven Date Change • Jan 25
Forecast to breakeven in 2024 The 12 analysts covering Roivant Sciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$190.5m in 2024. Earnings growth of 35% is required to achieve expected profit on schedule. Breakeven Date Change • Jan 23
Forecast to breakeven in 2024 The 12 analysts covering Roivant Sciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$179.9m in 2024. Earnings growth of 35% is required to achieve expected profit on schedule. Board Change • Dec 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. President, Chief Investment Officer & Director Mayukh Sukhatme was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Nov 29
Roivant Sciences Ltd. and Priovant Therapeutics, Inc. Announces Results from Phase 2 Study of Oral Brepocitinib in Systemic Lupus Erythematosus Roivant Sciences Ltd. and Priovant Therapeutics Inc. announced the Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) at Week 52. Priovant plans to disclose the study data at a future date. Priovant expects to announced topline results from its own studies, the Phase 2 POC study of brepocitinib in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and the Phase 3 trial in dermatomyositis (DM) in calendar year 2025. Oral brepocitinib has demonstrated statistically significant clinically meaningful benefit in six completed placebo-controlled Phase 2 studies in psoriasis, psoriatic arthritis, alopecia areata, hidradenitis suppurativa, ulcerative colitis, and Crohn’s disease. Reported Earnings • Nov 14
Second quarter 2024 earnings released: US$0.40 loss per share (vs US$0.42 loss in 2Q 2023) Second quarter 2024 results: US$0.40 loss per share. Revenue: US$37.1m (up 196% from 2Q 2023). Net loss: US$304.3m (loss widened 4.4% from 2Q 2023). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Aankondiging • Nov 11
Roivant Appoints Mayukh Sukhatme to its Board of Directors Roivant announced the appointment of Mayukh Sukhatme, M.D., to its Board of Directors, effective immediately. Dr. Sukhatme will fill a newly created Class III seat on the Board of Directors, increasing the Board of Directors to eight members in total. Mayukh Sukhatme, M.D., has served as Roivant’s President and Chief Investment Officer since January 2021, and is responsible for identifying, performing diligence on, devising development strategies for, and transacting on new therapeutic programs for the company. Dr. Sukhatme also informs Roivant’s view of its existing biopharmaceutical subsidiary companies for capital allocation decisions across the Roivant portfolio. Dr. Sukhatmejoined Roivant in 2015 and previously served as President of Roivant Pharma and as its Chief Business Officer. Programs that Dr. Sukhatme has in-licensed or acquired for Roivant have produced all 10 of its positive Phase 3 studies and have garnered 6 FDA approvals. From 2000 to 2015, Dr. Sukhatme was a healthcare-focused analyst and portfolio manager for several large institutional investment firms, including both public markets and venture capital firms. His principal focus was on development-stage biotechnology and pharmaceutical companies, where he led diligence and investment decisions on numerous companies and pharmaceutical compounds across a wide variety of therapeutic areas. Dr. Sukhatme earned his M.D. from Harvard Medical School and his B.S. in Biology and B.S. in Literature from MIT. Aankondiging • Oct 31
Roivant Sciences Ltd. to Report Q2, 2024 Results on Nov 13, 2023 Roivant Sciences Ltd. announced that they will report Q2, 2024 results on Nov 13, 2023 Reported Earnings • Aug 15
First quarter 2024 earnings released: US$0.38 loss per share (vs US$0.48 loss in 1Q 2023) First quarter 2024 results: US$0.38 loss per share (improved from US$0.48 loss in 1Q 2023). Revenue: US$21.6m (up 401% from 1Q 2023). Net loss: US$291.8m (loss narrowed 12% from 1Q 2023). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Aankondiging • Aug 05
Roivant Sciences Ltd. Announces the Resignation of Hiroshi Nomura from Board of Directors, Effective from August 31, 2023 On July 31, 2023, Hiroshi Nomura, a Class III director of Roivant Sciences Ltd. (the “Company”), informed the Company of his intention to resign from his role on the Company’s, to focus on other business affairs. Mr. Nomura’s decision to resign from the Board was not due to any disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices. The Company thanks Mr. Nomura for his service on the Board. Aankondiging • Aug 04
Roivant Sciences Ltd. to Report Q1, 2024 Results on Aug 14, 2023 Roivant Sciences Ltd. announced that they will report Q1, 2024 results on Aug 14, 2023 Aankondiging • Aug 01
Roivant Sciences Ltd., Annual General Meeting, Sep 12, 2023 Roivant Sciences Ltd., Annual General Meeting, Sep 12, 2023, at 09:30 Coordinated Universal Time. Location: Royal Lancaster London Hotel, Lancaster Terrace, London W2 2TY, United Kingdom London United Kingdom Agenda: To elect two directors, Daniel Gold and Meghan FitzGerald, Dr PH, to serve as Class II directors to hold office until the date of the annual general meeting of shareholders following the fiscal year ending March 31, 2026, and until their successors are duly elected and qualified, or until such director's earlier death,resignation or removal;to ratify the appointment of Ernst & Young LLP ( EY") as our independent registered public accounting firm for our fiscal year ending March 31,2024, and to appoint EY as our auditor for statutory purposes under the Bermuda Companies Act 1981, as amended (the Companies Act"), for our fiscal year ending March 31, 2024; and to consider other matters. Board Change • Jul 26
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Meg FitzGerald was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.