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Roivant Unveils New Pipeline Program Mosliciguat, A Potential First-In-Class and Best-In-Category Inhaled Once-Daily Soluble Guanylate Cyclase (sGC) Activator
GlobeNewswire News Room· 2024-09-10 10:30
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 ...
Roivant Sciences(ROIV) - 2025 Q1 - Quarterly Report
2024-08-09 20:32
Revenue and Income - Product revenue for the three months ended June 30, 2024, was $18,367,000, an increase from $16,659,000 in the same period of 2023, representing a growth of 10.2%[20] - License, milestone, and other revenue surged to $36,765,000 for the three months ended June 30, 2024, compared to $4,965,000 in the prior year, marking a significant increase of 639.5%[20] - Total revenue for the quarter reached $55,132,000, up from $21,624,000 in the same quarter of 2023, reflecting a growth of 155.5%[20] - The net income attributable to Roivant Sciences Ltd. for the quarter was $95,297,000, a turnaround from a net loss of $291,816,000 in the same quarter of the previous year[20] - Basic net income per common share was $0.13 for the three months ended June 30, 2024, compared to a loss of $0.38 per share in the same period of 2023[20] - Comprehensive income for the quarter was $43,658,000, compared to a comprehensive loss of $331,993,000 in the same quarter of 2023[21] - For the three months ended June 30, 2024, the company reported a net income of approximately $57.5 million, compared to a net loss of approximately $327.8 million for the same period in 2023[29] Expenses - Operating expenses totaled $285,705,000 for the three months ended June 30, 2024, a decrease from $298,037,000 in the same period of 2023, indicating a reduction of 4.1%[20] - Research and development expenses for the quarter were $133,208,000, up from $125,133,000 in the same period of 2023, reflecting an increase of 6.7%[20] - Selling, general and administrative expenses decreased by $7.7 million to $148.5 million for the three months ended June 30, 2024, compared to $156.2 million for the same period in 2023[152] - The increase in research and development expenses was primarily driven by program-specific costs, share-based compensation, and personnel-related expenses[149] Cash and Liquidity - As of June 30, 2024, the company had cash and cash equivalents of approximately $5.7 billion, with retained earnings of approximately $671.5 million[29] - The company incurred net cash used in operating activities of approximately $192.8 million for the three months ended June 30, 2024, compared to $249.9 million for the same period in 2023[26] - The company’s cash, cash equivalents, and restricted cash at the end of the period were approximately $5.7 billion, down from $6.6 billion at the beginning of the period[26] - The company expects its existing cash and cash equivalents to be sufficient to fund its committed operating expenses and capital expenditure requirements for at least the next 12 months[30] - As of June 30, 2024, the company had cash, cash equivalents, and restricted cash of approximately $5.7 billion, with no material effect on liquidity from a hypothetical 10% change in interest rates[185] Investments and Assets - The fair value of the company's investment in Arbutus was $120.0 million as of June 30, 2024, reflecting an unrealized gain of $19.8 million compared to $100.2 million as of March 31, 2024[50] - The fair value of the company's investment in Datavant was $142.9 million as of June 30, 2024, with an unrealized loss of $4.6 million recognized during the same period[51] - The company's intangible assets had a net book value of $136.0 million as of June 30, 2024, with amortization expense recorded at $2.4 million for the three months ended June 30, 2024[56] - Total assets at fair value as of June 30, 2024, were $5,646,728,000, a decrease from $5,789,668,000 as of March 31, 2024[105] Shareholder Activities - The company authorized a share repurchase program of up to $1.5 billion, with a significant repurchase of 71,251,083 shares from Sumitomo Pharma for approximately $648.4 million[79] - The company completed the sale of its entire equity interest in Telavant Holdings, Inc., receiving approximately $5.2 billion in cash[29] - The company completed the sale of its equity interest in Telavant to Roche for approximately $7.1 billion in cash, receiving about $5.2 billion as its pro rata portion upon closing[58] Future Outlook and Strategy - The company plans to in-license multiple potentially category-leading drugs per year, with ongoing updates on mid/late-stage in-licensing announcements[129] - The company anticipates requiring significant additional capital in the future to continue operations and pursue business opportunities, which may involve dilution of existing shareholders' ownership[173] - The company regularly evaluates new acquisition and in-licensing opportunities as part of its ongoing business strategy[175] Tax and Accounting - The effective tax rate for the three months ended June 30, 2024 was 18.0%, significantly higher than the (0.5)% rate for the same period in 2023[87] - The company has not adopted any material accounting pronouncements during the three months ended June 30, 2024[44] - The company is currently evaluating the impact of recently issued accounting pronouncements on its consolidated financial statements[45][46]
Roivant Sciences(ROIV) - 2025 Q1 - Earnings Call Transcript
2024-08-09 16:03
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]
Roivant Sciences(ROIV) - 2024 Q1 - Earnings Call Presentation
2024-08-08 20:05
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) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2024-08-08 13:21
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 ...
Roivant Sciences(ROIV) - 2025 Q1 - Quarterly Results
2024-08-08 11:15
Exhibit 99.1 Roivant Reports Financial Results for the First Quarter Ended June 30, 2024, and Provides Business Update BASEL, Switzerland and LONDON and NEW YORK, August 8, 2024 – Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2024, and provided a business update. • Immunovant completed enrollment in batoclimab pivotal myasthenia gravis (MG) trial; topline results and initiation of a potentially registrational program in MG for IMVT-1402 on track for fiscal ...
Roivant Sciences(ROIV) - 2024 Q4 - Annual Report
2024-05-30 20:46
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(ROIV) - 2023 Q4 - Earnings Call Transcript
2024-05-30 16:23
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) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2024-05-30 13:21
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 ...
Roivant Sciences(ROIV) - 2024 Q4 - Annual Results
2024-05-30 11:15
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 ...