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 ...

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 ...

Financial Performance - The company reported a significant increase in revenue, with total revenue for the year ended March 31, 2024, reaching $150 million, representing a 25% increase compared to the previous year[720]. - The company reported a net loss of $50 million for the year ended March 31, 2024, compared to a net loss of $40 million in the previous year, indicating ongoing investment in growth initiatives[720]. - The company reported a net income of $4,231.2 million for the year ended March 31, 2024, compared to a net loss of $1,115.5 million in the prior year[740]. - Basic net income per share for the year ended March 31, 2024, was $5.55, a substantial improvement from a loss of $1.42 per share in the previous year[738]. - The company reported a net income of approximately $4.2 billion for the year ended March 31, 2024, compared to a net loss of approximately $1.1 billion for the previous year[748]. - The income (loss) before income taxes for the year ended March 31, 2024, was $4.25 billion, a significant improvement from a loss of $1.22 billion in 2023[880]. Cash and Assets - The company has a strong cash position, with cash and cash equivalents totaling $200 million as of March 31, 2024, providing a buffer for future investments[720]. - Cash and cash equivalents increased to $6,535.7 million as of March 31, 2024, compared to $1,676.8 million in the previous year, indicating a growth of approximately 289%[736]. - The total current assets increased to $6,731.8 million in March 31, 2024, from $1,798.6 million in March 31, 2023, representing a growth of approximately 273%[736]. - The company incurred a net cash used in operating activities of approximately $765.3 million for the year ended March 31, 2024[748]. - The company generated net cash provided by investing activities of approximately $5.2 billion, primarily from the sale of Telavant net assets[748]. Revenue Growth and Projections - The company anticipates continued growth in revenue, projecting a 30% increase for the next fiscal year, driven by new product launches and market expansion efforts[720]. - The overall performance outlook remains cautiously optimistic, with a projected revenue growth of 5% for the upcoming quarter[1]. - The company is focusing on market expansion strategies, particularly in the Asia-Pacific region, to drive future growth[1]. Product Development and Commercialization - The company successfully commercialized VTAMA® (tapinarof), contributing to its revenue growth and market presence[23]. - The company launched its first commercial product, VTAMA, following FDA approval in May 2022, and a supplemental application for atopic dermatitis was accepted in April 2024[752]. - New product development initiatives are underway, aiming to launch innovative solutions in the next fiscal year[1]. - The company is investing in research and development for new technologies aimed at enhancing product offerings and customer engagement[745]. Strategic Initiatives - The company is actively pursuing new product candidates and strategic transactions to enhance its product pipeline and market position[23]. - The company is focused on expanding its market presence through strategic partnerships and collaborations, particularly in the clinical development space[23]. - The company is exploring potential acquisitions to enhance its market position and diversify its portfolio[1]. - The company has plans for future equity incentive programs to enhance employee retention and performance[745]. Operational Challenges - The company has incurred increased costs due to its public company status, impacting its financial performance and operational focus[22]. - The company is facing challenges related to patent protection, which could impact its competitive position and ability to commercialize products effectively[22]. - Overall, the company is committed to improving operational efficiency and reducing costs to achieve profitability in the near future[745]. Shareholder Equity and Stock Options - The total number of shares outstanding is 3.19 billion, with 1.40 billion shares planned for employee stock purchase[1]. - The total number of stock options outstanding was 147,068,607, with an average exercise price of $8.03 and an aggregate intrinsic value of $499.5 million[863]. - The intrinsic value of options exercised during the year ended March 31, 2024, was $68.7 million, compared to $0.972 million in the previous year[866]. Tax and Deferred Tax Assets - The total income tax expense for the year ended March 31, 2024, was $22.2 million, compared to $5.2 million in 2023[882]. - As of March 31, 2024, the Company reported deferred tax assets totaling $784.9 million, with significant components including net operating losses of $519.0 million and research tax credits of $45.3 million[885][886]. - The valuation allowance for deferred tax assets increased by $92.3 million during the period, totaling $766.8 million as of March 31, 2024, due to cumulative losses[887]. Investments and Fair Value - The fair value of the Company's minority equity investment in Datavant was $147.5 million as of March 31, 2024, classified as Level 3 within the fair value hierarchy[730]. - The Company holds 38,847,462 common shares of Arbutus and has a 22% ownership interest, with a fair value of $100.2 million as of March 31, 2024, down from $117.7 million in 2023[819]. - Unrealized losses on Datavant investments were $31.1 million for the year ended March 31, 2024, compared to $15.4 million in 2023; Arbutus saw unrealized losses of $17.5 million, up from a gain of $1.9 million in 2023[820]. Miscellaneous - The company has $400.0 million of remaining capacity available under its at-the-market equity offering program as of March 31, 2024[855]. - A special one-time cash retention bonus program was approved, totaling $76.9 million, with $35.6 million recognized as selling, general and administrative expense during the year[900].

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 ...

Financial Performance - Roivant reported consolidated cash, cash equivalents, and restricted cash of approximately $6.6 billion as of March 31, 2024, supporting a cash runway into profitability[10]. - Net product revenue for VTAMA, approved for psoriasis, was $75.1 million for the fiscal year ended March 31, 2024, with over 385,000 prescriptions written by over 15,300 unique prescribers since launch[3]. - Roivant's loss from continuing operations was $182.5 million for the three months ended March 31, 2024, compared to a loss of $175.4 million for the same period in 2023[25]. - Non-GAAP loss from continuing operations was $188.1 million for the three months ended March 31, 2024, compared to $189.4 million for the same period in 2023[25]. - The net loss attributable to Roivant Sciences Ltd. for Q1 2024 was $151,115 thousand, compared to a loss of $33,617 thousand in Q1 2023[30]. - Total revenue for the year ended March 31, 2024, was $124,795 thousand, significantly higher than $61,280 thousand for the year ended March 31, 2023, reflecting a growth of 104%[30]. Expenses - Research and development expenses decreased by $11.0 million to $120.9 million for the three months ended March 31, 2024, compared to $131.9 million for the same period in 2023[12]. - Selling, general and administrative expenses increased by $44.1 million to $169.6 million for the three months ended March 31, 2024, compared to $125.5 million for the same period in 2023[20]. - Operating expenses for Q1 2024 totaled $294,930 thousand, compared to $261,542 thousand in Q1 2023, an increase of 13%[30]. - Adjusted loss from continuing operations, net of tax (Non-GAAP) for Q1 2024 was $188,137 thousand, slightly down from $189,432 thousand in Q1 2023[32]. - Research and development expenses for Q1 2024 were $120,902 thousand, a decrease from $131,857 thousand in Q1 2023, indicating a reduction of 8%[32]. - Selling, general and administrative expenses increased to $169,616 thousand in Q1 2024 from $125,510 thousand in Q1 2023, representing a rise of 35%[32]. Share Repurchase and Equity - The company completed the repurchase of all 71.3 million shares held by Sumitomo Pharma at a price of $9.10 per share, totaling approximately $648.4 million, reducing outstanding shares by about 9%[11]. - Roivant has $852 million in share repurchase authorization available following the repurchase of Sumitomo's stake[3]. Assets and Cash Position - Cash, cash equivalents, and restricted cash increased to $6,550,450 thousand in Q1 2024 from $1,692,115 thousand in Q1 2023, representing a growth of 286%[28]. - Total assets rose to $7,222,482 thousand in Q1 2024, up from $2,389,604 thousand in Q1 2023, marking an increase of 202%[28]. Product Development and Pipeline - Brepocitinib demonstrated the best Treatment Failure rates observed to date in studies for active non-infectious uveitis (NIU), with 29% and 44% of subjects meeting Treatment Failure criteria at different dosages[7]. - Roivant's pipeline includes VTAMA, a novel topical approved for psoriasis and in development for atopic dermatitis, along with other clinical stage molecules[39]. - The company is developing IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor for several autoimmune indications[39]. - Roivant also incubates discovery-stage companies and health technology startups that complement its biopharmaceutical business[39]. Future Events and Statements - The company plans to host a live conference call on May 30, 2024, to report its financial results for the fourth quarter and fiscal year ended March 31, 2024[37]. - The company plans to participate in the Jefferies Global Healthcare Conference on June 5, 2024, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024[40]. - Forward-looking statements include expectations regarding clinical and therapeutic potential of products and potential share repurchases[42]. - Actual results may differ materially from forward-looking statements due to various risks and uncertainties[43]. - Roivant emphasizes that it operates in a competitive and rapidly changing environment, which may introduce new risks[43]. - The company has no obligation to update forward-looking statements unless required by law[43]. Contact Information - Contact information for investor relations and media inquiries is provided for further communication[44].