Mosliciguat, a potential first-in-class and best-in-category inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs and once-daily administration, is being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which affects ~200,000 patients in the U.S. and Europe; PH-ILD prevalence is meaningfully greater than that of pulmonary arterial hypertension (PAH) with limited to no treatment options In the Phase 1b ATMOS study, presented today at th ...

Core Insights - Mosliciguat is a potential first-in-class inhaled soluble Guanylate Cyclase (sGC) activator designed for once-daily administration, showing promise in treating pulmonary hypertension (PH) [1][10] - The Phase 1b ATMOS study demonstrated a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% in PH patients, indicating significant efficacy [1][4] - The upcoming Phase 2 "PHocus" study will evaluate mosliciguat in approximately 120 patients with PH associated with interstitial lung disease (PH-ILD), a condition affecting around 200,000 patients in the U.S. and Europe [1][6] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases, with mosliciguat as its lead program [10] - The company aims to provide a convenient once-daily inhaled treatment option for patients suffering from pulmonary hypertension [10] Clinical Development - The Phase 1b ATMOS study was a non-randomized, open-label trial involving 38 patients, which showed that mosliciguat led to clinically meaningful reductions in PVR [4][5] - Mosliciguat has been characterized in a robust Phase 1 program with 170 participants, demonstrating a favorable safety profile and dose-dependent increases in cGMP [2][5] - The Phase 2 PHocus study is set to begin imminently, targeting a patient population with high unmet medical needs and limited treatment options [6][8] Mechanism of Action - Mosliciguat acts as an sGC activator, independent of heme and nitric oxide (NO), which may allow it to retain efficacy in oxidative environments typical of PH [2] - The drug's mechanism may lead to increased vasodilation, reduced inflammation, and anti-fibrotic effects, differentiating it from existing therapies [2][5] Market Opportunity - PH-ILD represents a significant commercial opportunity due to its higher prevalence compared to pulmonary arterial hypertension (PAH) and the lack of approved treatment options [6][9] - The high morbidity and mortality associated with PH-ILD underscores the need for effective therapies, positioning mosliciguat as a potentially transformative treatment [8][9]

Financial Data and Key Metrics Changes - The company reported a net income of $57 million for the quarter, with net revenues of $55 million, including product revenues of approximately $18 million [21] - The company ended the quarter with $5.7 billion in cash and cash equivalents, reflecting a repurchase made in the previous quarter [21] - The carrying value of the company's debt has decreased due to renegotiations [21] Business Line Data and Key Metrics Changes - VTAMA generated $18.4 million in product revenue for the quarter, with script volumes up 20% year-over-year, indicating growth in the psoriasis market [18][19] - The company is preparing for the launch of VTAMA in atopic dermatitis (AD) after expected approval at the end of the year, which is anticipated to significantly increase market presence [19][53] Market Data and Key Metrics Changes - The anti-FcRn market has expanded significantly, with 23 indications in development for anti-FcRn antibodies, addressing a total patient population of 4 million [12] - The company is optimistic about the competitive positioning of its FcRn programs compared to other mechanisms in the autoimmune disease space [14][15] Company Strategy and Development Direction - The company is focused on growth and expansion, with plans to deliver clinical data across multiple franchises, including the anti-FcRn franchise and brepocitinib [3][4] - The company aims to prioritize capital allocation for share buybacks while expanding its pipeline with mid-late-stage programs [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the constructive interaction with the FDA regarding the Phase III design for brepocitinib in non-infectious uveitis (NIU) [24] - The company anticipates a busy catalyst calendar ahead, with significant data releases and program unveilings expected in the coming months [20][22] Other Important Information - The company achieved a $28 million milestone related to the Japanese approval of VTAMA and received $110 million from Roche for Telavant [9] - The company is actively involved in IP litigation regarding COVID vaccines, with a trial expected to begin in September 2025 [8] Q&A Session Summary Question: What is left to be worked out on the Phase III design for brepocitinib? - Management indicated that interactions with the FDA were constructive and that they are confident in the program's direction, with no major dependencies on the 52-week data [24] Question: How does the final enrollment of the VALOR study compare to original expectations? - The final enrollment of 241 patients exceeded the original plan of 225, providing a well-powered study [26] Question: What is the go/no-go decision for the Phase II namilumab data? - Management stated that the bar for progression is meaningful, focusing on consistency across primary and secondary endpoints [28] Question: How does the recent market sell-off affect the search for new assets? - Management noted that it depends on the specific opportunities available, but they remain focused on finding great opportunities at attractive prices [29] Question: Can you provide more color on the LNP litigation? - Management mentioned that they are in the discovery phase and expect a trial to begin in early next year [39] Question: What is the expected evolution of OpEx with new trials? - Management expects OpEx to increase due to the initiation of multiple pivotal studies, estimating costs for Phase 3 programs to range from $80 million to $120 million [45]

Financial Results and Business Update for the Quarter Ended June 30, 2024 roivant August 8, 2024 Speakers Matthew Gline Chief Executive Officer Richard Pulik Chief Financial Officer Frank Torti, MD Vant Chair Eric Venker, MD, PharmD President and Chief Operating Officer Mayukh Sukhatme, MD President and Chief Investment Officer roivant For investor audiences only 2 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that co ...

Roivant Sciences Ltd. (ROIV) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.25 per share when it actually produced a loss of $0.23, delivering a surprise of 8%. Over the last four quarters, the company has surp ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) Bermuda 98-1173944 (State or other jurisdiction of incorporation or organization) 7th Floor 50 Broadway London SW1H 0DB ...

Roivant Sciences Ltd. (NASDAQ:ROIV) Q4 2023 Earnings Conference Call May 30, 2024 8:00 AM ET Company Participants Abby Beier - Principal, Strategic Finance Matt Gline - Chief Executive Officer Frank Torti - Managing Director, Vant Chair Mayukh Sukhatme - President and Chief Investment Officer Conference Call Participants David Risinger - Leerink Partners Louise Chen - Cantor Fitzgerald Allison Bratzel - Piper Sandler Corinne Johnson - Goldman Sachs Brian Cheng - JPMorgan Yaron Werber - TD Cowen Yatin Suneja ...

Roivant Sciences Ltd. (ROIV) came out with a quarterly loss of $0.23 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.20 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 8%. A quarter ago, it was expected that this company would post a loss of $0.27 per share when it actually produced a loss of $0.21, delivering a surprise of 22.22%. Over the last four quarters, the company has surp ...

In March 2024, Immunovant was awarded U.S. Patent No. 11,926,669 covering composition of matter of IMVT-1402 and its binding sequence to FcRn, method of use of the antibody for treating autoimmune disease, and methods for its manufacturing. Not including any potential patent term extension, the issued composition-of-matter patent term will extend until June 2043. • Dermavant: For the fourth quarter and fiscal year ended March 31, 2024, Roivant reported VTAMA net product revenue of $19.3M, and $75.1M, respec ...

BASEL, Switzerland and LONDON and NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provided a business update. Once-daily brepocitinib produced the best Treatment Failure rates observed to date among studies in active non-infectious uveitis (NIU), supporting initiation of a pivotal program in NIU in the second half of calendar year 2024 Brepocitinib is well positioned to support a potential ...