Roivant Sciences(ROIV)

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Roivant Sciences(ROIV) - 2023 Q1 - Earnings Call Presentation
2023-08-14 15:44
| --- | --- | |-------|-------| | | | | | | August 14, 2023 Forward-Looking Statements 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 financial position, busine ...
Roivant Sciences(ROIV) - 2024 Q1 - Quarterly Report
2023-08-14 11:28
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, 2023 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 organizatio ...
Roivant Sciences(ROIV) - 2023 Q4 - Annual Report
2023-06-28 11:36
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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40782 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or org ...
Roivant Sciences (ROIV) Investor Presentation - Slideshow
2023-02-27 13:48
$900 - $1,300 $1,300 - $1,500($1,325) Topical WAC Price Landscape Rationale for VTAMA Cream WAC Price o Reflects novel mechanism and differentiated profile with strongest on-label remittive effect for a topical Accelerates Launch Velocity & Enables Broad Adoption All trademarks are property of their respective owners. Based on RedBook drug pricing database, extracted May 2022. WAC prices based on 60g tubes, except for Duobrii, which is based on 100g tube. * WAC price for Atopic Dermatitis IGA Score 0 or 1 a ...
Roivant Sciences(ROIV) - 2022 Q3 - Earnings Call Presentation
2023-02-13 19:19
| --- | --- | |----------------------------------------|-------| | | | | Financial Results and Business Update | | February 13, 2023 Forward-Looking Statements 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 ...
Roivant Sciences(ROIV) - 2022 Q3 - Earnings Call Transcript
2023-02-13 19:16
Financial Data and Key Metrics Changes - The company reported a near doubling of revenue for the quarter, with revenues reaching $9.2 million during the second quarter launch [8][25] - Gross to net yield improved from 12% in the first quarter of launch to 18% in the most recent quarter [9][25] - The company ended the quarter with cash and cash equivalents of $1.5 billion, which is expected to increase to about $1.9 billion after recent financing [25][26] Business Line Data and Key Metrics Changes - The commercial launch of VTAMA has been successful, with the product becoming the number one branded topical treatment within eight weeks of launch [10] - The company has seen strong patient and physician demand for VTAMA, with approximately 3,800 scripts reported, indicating a positive trajectory for growth [11][10] - The company has achieved 57% coverage of commercial lives for VTAMA, translating to nearly 95 million lives [13][14] Market Data and Key Metrics Changes - The company anticipates significant growth in script volumes as it continues to expand payer coverage and improve gross to net yields [9][16] - The market for atopic dermatitis is projected to be four times the size of the current psoriasis market, presenting a substantial opportunity for growth [6][11] Company Strategy and Development Direction - The company is focused on building a strong inflammation and immunology franchise, with multiple Phase II and III data readouts expected each year [17][18] - The company aims to leverage its anti-TL1A antibody, RVT-3101, for ulcerative colitis and Crohn's disease, with plans to explore additional indications [19][20] - The company is committed to maintaining high-quality coverage and competitive pricing strategies to enhance market access for its products [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the potential for significant clinical advancements in the inflammation and immunology space [17][18] - The company is confident in its financial position and cash runway, which extends into the second half of 2025, allowing for continued investment in clinical programs [26][25] Other Important Information - The company is preparing for pivotal data from brepocitinib in systemic lupus erythematosus (SLE), which is expected to be some of the best data seen in this indication [8][17] - Management highlighted the importance of patient and physician demand in driving payer negotiations and formulary access [13][14] Q&A Session Summary Question: What should be expected in terms of efficacy at top line for the upcoming readout? - Management indicated that if gross efficacy is in the 40s, it would be considered a grand slam, while mid to high 30s would be a solid home run, and anything in the 30s would be commercially viable [28][29] Question: What is the latest thought on the timing or need to launch a DTC campaign for VTAMA? - Management stated that targeted DTC efforts are ongoing, but a broader campaign will be considered as payer coverage ramps up [30][31] Question: Are formulary additions for 2023 set, or are further additions expected? - Management confirmed that they are not done for the year and expect additional major formulary additions imminently [34][36] Question: How do competitor readouts impact the clinical development program for anti-FcRn? - Management expressed that competitor data will provide valuable insights, particularly regarding the relationship between IgG suppression and clinical efficacy [40][41] Question: What are the criteria for selecting new indications for RVT-3101? - Management indicated that the selection process considers the strength of the biological basis, mechanistic evidence, and commercial opportunities [67][69]
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) - 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 ...