Roivant Sciences(ROIV)

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Roivant Sciences(ROIV) - 2023 Q3 - Quarterly Report
2023-02-13 12:31
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 December 31, 2022 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 organiz ...
Roviant Sciences (ROIV) Presents At 41st Annual Healthcare Conference - Slideshow
2023-01-19 15:56
3 JPM 2023 roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. 5 | --- | --- | |----------------------|-----------------| | Psoriasis | $22.3 billion | | Atopic Dermatitis | $12.2 billion | | Crohn's Disease | $9.3 billion | | Ulcerative Colitis | $6.9 billion | | SLE | $3.8 billion | | Rheumatoid Arthritis | $10.2 billion | | | | Indications with active development programs Other indications RVT-3101 ...
Roivant Sciences (ROIV) FY Earnings Call Presentation
2023-01-09 22:15
Pipeline Highlights - VTAMA became the 1 most prescribed branded topical for psoriasis within 8 weeks of launch[10], and a major PBM/payer contract was executed[10] - RVT-3101, an anti-TL1A antibody, is Phase 3-ready for Ulcerative Colitis and Crohn's Disease, with final Phase 2b data expected in 1H 2023[19, 12] - Brepocitinib, a TYK2/JAK1 inhibitor, has initiated a Phase 3 trial in Dermatomyositis and completed enrollment in a global Phase 2B trial in SLE, with topline data expected in 2H 2023[10, 12] - IMVT-1402, a next-generation anti-FcRn, unveiled with initial Phase 1 data expected in mid-2023[10, 12] RVT-3101 Efficacy and Safety - RVT-3101 demonstrated statistically significant and clinically meaningful effects in a UC Phase 2b trial, with a placebo-adjusted delta (Pbo-adj Δ) of 21% for clinical remission and 27% for endoscopic improvement in the all-comers pooled group[22] - In biomarker-positive patients, RVT-3101 showed a Pbo-adj Δ of 41% for clinical remission and 46% for endoscopic improvement at the expected Phase 3 dose[22, 29] - RVT-3101 was well-tolerated in the Phase 2b study, with 45% of participants experiencing AEs in the pooled group, 2% with severe AEs, and 4% with serious AEs[37] VTAMA Market and Clinical Development - VTAMA leads other branded topicals in weekly TRx and became the 1 most prescribed branded topical for psoriasis 8 weeks into launch[44] - Phase 3 trials in atopic dermatitis (ADORING program) are underway, with topline data expected in 1H 2023[12, 48] - In a Phase 2b trial for atopic dermatitis, 49% of patients achieved IGA response and 51% achieved EASI75 response at week 8[56] Anti-FcRn Franchise (Batoclimab and IMVT-1402) - Batoclimab has multiple pivotal trials ongoing in Myasthenia Gravis (MG), Thyroid Eye Disease (TED), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)[63] - IMVT-1402 is designed for maximum IgG reduction with minimal impact on LDL levels, with initial Phase 1 data expected in mid-2023[68, 65] Market Opportunities - Roivant is targeting multiple large I&I markets, including Psoriasis ($223 billion), Atopic Dermatitis ($122 billion), Crohn's Disease ($93 billion), and Ulcerative Colitis ($69 billion)[15]
Roivant Sciences(ROIV) - 2022 Q2 - Earnings Call Transcript
2022-11-14 18:54
Financial Data and Key Metrics Changes - The company reported $5 million in net product revenue for the quarter ending September 30, 2022, with a 12% net yield, indicating strong prescriber enthusiasm for the drug [10][17]. - Adjusted R&D expense was $123 million, and adjusted G&A was $102 million, with the majority of G&A related to the commercial launch of VTAMA [46]. - The company ended the quarter with $1.6 billion in cash, or $1.9 billion after a follow-on offering, indicating a strong financial position [46]. Business Line Data and Key Metrics Changes - The launch of VTAMA has been successful, with over 50,000 prescriptions written and a broad prescriber base of over 6,400 unique prescribers [15][18]. - The company signed its first major PBM/payer contract effective October 1, which is expected to enhance access to patients [11][12]. - The company aims to replace topical steroids as the mainstay of therapy for psoriasis, with a target market of over 90,000 topical prescriptions in psoriasis alone [18][19]. Market Data and Key Metrics Changes - The PBM contract covers about 30% of commercial lives, providing a template for downstream customers [51]. - The company expects to see improvements in gross-to-net (GTN) yield starting in the current quarter, following the effective date of the PBM contract [70]. - The company is actively pursuing health plan coverage in addition to PBM coverage, with constructive discussions ongoing [63]. Company Strategy and Development Direction - The company is focused on expanding the VTAMA franchise, with Phase 3 data in atopic dermatitis expected in the first half of next year [41]. - The company plans to leverage its anti-FcRn franchise, with IMVT-1402 expected to enter pivotal studies shortly after initial Phase 1 data [83]. - The company is looking for high-quality programs for in-licensing opportunities, focusing on later-stage assets that can enhance its portfolio [73]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a commercially attractive P&L and expects to provide steady-state GTN guidance after signing additional contracts [17][40]. - The company anticipates 2023 to be a significant year with multiple catalysts, including data from various studies and continued growth in VTAMA sales [47]. - Management noted that the recent workforce reduction is not expected to impact major programs or key projects [67]. Other Important Information - The company reported favorable safety data from a pediatric study of VTAMA, which is expected to support its commercial strategy [22][24]. - The company is optimistic about its pipeline, with several ongoing pivotal studies and a focus on broad disease biology [26][35]. - The company is also involved in ongoing litigation related to Genevant's IP, with updates expected as the case progresses [39]. Q&A Session Summary Question: Coverage details regarding the PBM contract - Management indicated that the PBM covers about 30% of commercial lives and that downstream contracting will take approximately three to six months to fully implement [51][54]. Question: Process from prescription to fulfillment for VTAMA - The patient experience remains straightforward, with a $0 copay for covered patients under the new PBM contract, enhancing access to the drug [60][62]. Question: Expectations for SLE Phase 2 trial data - Management has set a high bar for success in the SLE trial, focusing on meaningful improvements in key secondary endpoints [66]. Question: Impact of workforce reduction on programs - Management stated that the workforce reduction is not expected to have a meaningful impact on major programs or key projects [67][68]. Question: Competitive dynamics and launch strategy for VTAMA - Management noted that there has been minimal pushback from physicians, and the drug has been well received, indicating a positive launch environment [77]. Question: Pricing strategy for anti-FcRn products - Management is focused on competitive pricing for both first and second-generation anti-FcRn products, aiming for a competitive advantage [88].
Roivant Sciences(ROIV) - 2023 Q2 - Quarterly Report
2022-11-14 13:05
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, 2022 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 ...
Roivant Sciences (ROIV) Investor Presentation - Slideshow
2022-11-12 13:47
| --- | --- | --- | --- | |---------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | Roivant | | | | | November 7, 2022 Overview | | | | | | | | | | | | | | Forward-Looking Statements Forward–Looking Statements This presentation will include 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. Our forwardlooking statements include, but are not limi ...
Roivant Sciences(ROIV) - 2022 Q1 - Earnings Call Transcript
2022-08-15 15:22
Financial Data and Key Metrics Changes - The company reported a total adjusted net loss of $354 million for the quarter, with an adjusted net loss of $211 million [36] - Research and Development (R&D) expenses were $136 million, while adjusted R&D non-GAAP was $123 million [36] - Selling, General and Administrative (SG&A) expenses were $149 million, with adjusted non-GAAP SG&A at $88 million [36] - The company maintained a strong capital position with approximately $2 billion in cash and cash equivalents [8][36] Business Line Data and Key Metrics Changes - The commercial launch of VTAMA is ongoing, with early prescription volume reported as robust [10][12] - VTAMA has become the number one most prescribed branded topical for psoriasis within eight weeks of launch [12] - The company is tracking prescription volume as a key metric, with revenues expected to grow as contracts are established over the next 12 to 18 months [14][36] Market Data and Key Metrics Changes - The company is focused on capturing market share from corticosteroids, which are currently the standard of care for psoriasis [45] - The competitive landscape includes a new topical competitor, ZORYVE, but the company believes its product has meaningful differentiation [46] Company Strategy and Development Direction - The company is leveraging its proprietary QUAISAR platform to enhance its clinical pipeline [8] - The strategy includes focusing on diseases with high unmet needs, such as lupus and dermatomyositis, for its Brepocitinib program [26][72] - The company aims to position VTAMA as a mainstay of therapy rather than just a pre-biologics option [83] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early engagement with patients and physicians regarding VTAMA [44] - The company is preparing for a catalyst-rich period with multiple pivotal programs expected to yield data in the next 12 to 18 months [38][39] - Management acknowledged the challenges in establishing payer contracts but remains confident in the product's positioning [85] Other Important Information - The company plans to hold its Annual Investor Day on September 28, 2022, to provide further updates [35] - The company is actively monitoring the impact of recent drug pricing legislation on its programs [59] Q&A Session Summary Question: Can you discuss the expected ramp of VTAMA and competitive dynamics? - Management is pleased with early prescription data and believes it sets a strong foundation for growth, viewing the market as competitive against corticosteroids rather than other novel agents [44][45] Question: What are your thoughts on gross to net dynamics and cash burn? - Management expects gross to net yields to be low until commercial contracts are in place, with a focus on maintaining a two-year cash runway [48][51] Question: Can you provide more details on the VTAMA launch and prescriber behavior? - The company has seen a broad range of prescribers, including both mild and severe psoriasis patients, and is focused on high-prescribing doctors [57][58] Question: What is the physician feedback on VTAMA? - Feedback has been positive, with physicians excited about having a new effective topical agent, and patients reporting fast onset of efficacy [75][76] Question: How do you view the SLE market landscape for Brepocitinib? - Management sees a significant opportunity in the SLE market due to the high unmet need and believes the dual inhibition of TYK2 and JAK1 will provide a competitive advantage [70][72]
Roivant Sciences(ROIV) - 2022 Q1 - Earnings Call Presentation
2022-08-15 11:31
| --- | --- | |-------|-------| | | | | | | August 15, 2022 Forward-Looking Statements and Non-GAAP Financial Information Forward–Looking Statements This presentation will include 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. Our forwardlooking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, i ...
Roivant Sciences(ROIV) - 2023 Q1 - Quarterly Report
2022-08-15 11:23
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 June 30, 2022 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. Suite 1, 3rd Floor 11-12 St. James's Square London SW1Y 4LB United Kingdom Not Applicable (Address of principal executive offices) (Zi ...
Roivant Sciences(ROIV) - 2021 Q4 - Earnings Call Transcript
2022-06-28 17:38
Financial Data and Key Metrics Changes - As of March 31, 2022, the company reported $2.1 billion in cash and cash equivalents, with a net loss of $291 million for the quarter and an adjusted net loss of $188 million [71][72]. - Research and development expenses were $135 million, while general and administrative expenses were $139 million [71]. Business Line Data and Key Metrics Changes - The commercial launch of VTAMA Cream is ongoing, with strong early prescriptions recorded, although it is still early to forecast its long-term performance [11][12]. - The company has deprioritized certain programs, notably Aruvant in sickle cell disease, to focus on differentiated offerings [14]. Market Data and Key Metrics Changes - The company is focusing on the autoimmune disease market, particularly with the introduction of Priovant, which is developing a dual selective inhibitor of TYK2 and JAK1 [21][27]. - The market opportunity for VTAMA in atopic dermatitis is expected to be significant, with the potential for blockbuster status in multiple indications [11][114]. Company Strategy and Development Direction - The company aims to operate from a strong capital position, maintaining over two years of runway and focusing on cost optimization and portfolio prioritization [13][14]. - The partnership with Pfizer for Priovant is seen as a strategic move to leverage Pfizer's expertise while allowing Roivant to focus on unique indications [82][86]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early demand for VTAMA and the potential for it to become a blockbuster in multiple indications [79][114]. - The company is aware of the high clinical bar for therapies in sickle cell disease and has made the decision to wind down that program to allocate resources more effectively [102][106]. Other Important Information - The company has multiple strategic partnerships that validate its discovery pipeline, including collaborations with Janssen and Blueprint [67]. - Ongoing litigation regarding Genevant's IP portfolio is being monitored, with updates expected as the situation develops [68][70]. Q&A Session Summary Question: Can you discuss the decision for Pfizer to out-license assets to Priovant? - Management indicated that Pfizer remains excited about the program and continues to invest in the Lupus trial alongside Roivant, suggesting a strong partnership dynamic [82][83]. Question: How are script volumes for VTAMA tracking? - Management reported being pleased with early demand and physician feedback, although it is still too early to draw definitive conclusions [79][80]. Question: What factors led to the wind down of the sickle cell program? - The decision was influenced by the high clinical bar for curative therapies in sickle cell disease and the need to allocate resources effectively in the current environment [102][106]. Question: Can you elaborate on the initial physician feedback on the VTAMA label? - Initial feedback has been positive, with excitement and enthusiasm noted among prescribers regarding the label [107]. Question: What is the market opportunity for batoclimab in myasthenia gravis? - Management views the market as large and interesting, with a differentiated development strategy that could provide a competitive edge [110][116]. Question: How does the company view the potential for tapinarof in psoriasis and atopic dermatitis? - The company is optimistic about the readout in atopic dermatitis, supported by compelling Phase II data [113][114]. Question: How does the company approach cash runway and resource allocation? - The company maintains over two years of runway and has flexibility in resource allocation due to a broad portfolio [117].