Financial Data and Key Metrics Changes - The company reported a loss for continuing operations of $237 million, with an adjusted loss of $219 million [57] - Research and development expenses were $143 million, with adjusted R&D non-GAAP at $132 million [57] - The company ended the quarter with a strong cash position of $5.4 billion, having repurchased $754 million worth of stock as of September 30 [9][58] Business Line Data and Key Metrics Changes - The company is focused on clinical trial execution, with ongoing trials expected to generate significant data in the near future [7] - The NIU Phase 2 study for brepocitinib showed sustained improvement in key metrics at 52 weeks, with only one additional treatment failure in each dose arm [14][25] - The company has initiated a Phase 2 study of mosli in pulmonary hypertension associated with interstitial lung disease [8] Market Data and Key Metrics Changes - The JAK inhibitors market has doubled since 2020 in terms of treated patients and revenue, indicating a growing acceptance among physicians and patients [16] - The prevalence of non-infectious uveitis (NIU) is estimated at 70,000 to 100,000 patients, with high morbidity and limited treatment options available [19] Company Strategy and Development Direction - The company aims to leverage its late-stage pipeline, including IMVT-1402 and batoclimab, to achieve a peak sales portfolio exceeding $10 billion across multiple therapeutic areas [12] - The company is actively pursuing business development opportunities, with multiple negotiations for potential in-licensing of new programs [10] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the upcoming data readouts and the potential for significant value creation in the next 18 months [55] - The company is optimistic about the business development environment and is preparing for future announcements regarding new programs [56] Other Important Information - The company has made progress in its LNP litigation, with a Markman hearing scheduled for December [9] - The company is committed to returning capital to shareholders while being prudent in capital deployment [9] Q&A Session Summary Question: What efficacy is expected in the Phase 3 NIU trial? - Management hopes to see efficacy similar to that observed in Phase 2, with a wide margin relative to competitors like Humira [61][62] Question: What is the latest update on HS? - Management is pleased with the work done on indication expansion for brepocitinib, and HS remains on the radar for potential development [63] Question: Are there specific steroid dose requirements for the CLARITY trial? - There is no specific requirement for steroid doses; patients can be on any background steroid dose up to 40 mg per day [68] Question: What are the thoughts on pricing for brepocitinib? - Pricing is still premature to determine, but management considers a wide range of prices supportable, with benchmarks around $100,000 for similar orphan drugs [72][73] Question: What placebo response is assumed for the uveitis Phase 3 trial? - The base case assumption is a placebo rate similar to that seen in the VISUAL I study, with the study designed to be overpowered to detect differences [75][76] Question: How will brepocitinib be positioned against Humira biosimilars? - The expectation is for brepocitinib to be predominantly used in the TNF refractory population, with a significant unmet need in NIU [91][93]

Financial Results and Business Update for the Quarter Ended September 30, 2024 roivant November 12, 2024 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financia ...

Roivant Sciences Ltd. (ROIV) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.26 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -38.10%. A quarter ago, it was expected that this company would post a loss of $0.21 per share when it actually produced a loss of $0.18, delivering a surprise of 14.29%.Over the last four quarters, the company has s ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40782 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) Bermuda 98-1173944 (State or other jurisdiction of incorporation or organi ...

BASEL, Switzerland and LONDON and NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it 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 business 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" ...

BASEL, Switzerland and LONDON and NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms. V ...

I am a long-term investor focused on growth markets, AI and biotech opportunities in my more volatile portfolio. I try to look for undervalued and under-the-radar stocks with serious potential and good scientific or other background. My ambition here is to cover stocks with considerable growth potential, both in the semiconductor, mining and biotech space. The rest of my investing focus goes to mining, shipping and dividends. I have been investing since 2021, as a solo investor but with a vast network of co ...

Organon & Co OGN has agreed to acquire Roivant Sciences Ltd's ROIV Dermavant Sciences Ltd, which is focused on developing and commercializing therapeutics in immunodermatology. Dermavant's novel product, Vtama (tapinarof) cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the FDA in May 2022. Vtama cream is a once-daily, steroid-free, topical therapy applied to affected areas. Also Read: JP Morgan Shows Most Interest In Teva, Organon As Specialty P ...

Core Insights - Organon has entered into a definitive agreement to acquire Dermavant Sciences for up to approximately $1.2 billion, enhancing its dermatology capabilities in the U.S. market [2][6] - Dermavant's VTAMA cream, a non-steroidal treatment for plaque psoriasis, has been approved by the FDA and is under review for atopic dermatitis, with a decision expected in Q4 2024 [3][6] Company Overview - Organon is a global healthcare company focused on improving women's health, with a diverse portfolio of over 60 medicines and products [12][13] - Dermavant Sciences specializes in developing innovative therapeutics in immuno-dermatology, with a focus on unmet medical needs in skin conditions [17] Product Details - VTAMA cream is a once-daily, steroid-free topical treatment for plaque psoriasis, approved for mild to severe cases, and has no safety label warnings [3][9] - The FDA is currently reviewing VTAMA for atopic dermatitis, with positive results from Phase III clinical trials [3][17] Market Impact - Psoriasis affects over 8 million Americans and 125 million people globally, while atopic dermatitis impacts approximately 16.5 million adults and over 9.6 million children in the U.S. [4] - The acquisition is expected to leverage Organon's market access capabilities and regulatory expertise to enhance the reach of VTAMA cream [5][6] Financial Terms - The acquisition includes an upfront payment of $175 million, a $75 million milestone payment upon regulatory approval for atopic dermatitis, and up to $950 million for achieving commercial milestones [6][7] - Organon will also pay tiered royalties on net sales of VTAMA cream, which Dermavant owns globally except for China [6] Strategic Goals - The acquisition aligns with Organon's objective to invest in treatments that address conditions affecting women differently, enhancing its portfolio in dermatology [5] - The deal is structured to focus on success-based milestones and royalties, reflecting a disciplined approach to capital allocation [5][6]

Roivant Sciences Ltd. (ROIV) closed the last trading session at $12.50, gaining 11.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16.89 indicates a 35.1% upside potential. The mean estimate comprises nine short-term price targets with a standard deviation of $2.62. While the lowest estimate of $12 indicates a 4% decline from the current price level, the most optimistic analyst ...