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Roivant Sciences(ROIV) - 2023 Q1 - Earnings Call Transcript
2023-08-15 00:20
Financial Data and Key Metrics Changes - The company reported net revenues of $16.7 million for the quarter, showing solid quarter-on-quarter growth [108] - The gross-to-net yield improved to 26% over the last quarter, indicating better pricing and contracting strategies [109] - The company has approximately $1.5 billion in cash, which is expected to fund operations into the second half of 2025 [91] Business Line Data and Key Metrics Changes - The company has achieved over 11,500 unique prescribers for VTAMA, with over 200,000 prescriptions written since its market launch [99] - The company anticipates steady improvements in gross-to-net yield, aiming for mid- to high 30s by the end of the fiscal year [101] - The company is focused on orphan indications, believing it can differentiate itself in a competitive landscape [20] Market Data and Key Metrics Changes - The company has secured coverage for approximately 130 million lives, which includes nearly 80% of commercial lives and 87 million government lives [106] - The company expects to see a linear progression in GTN (Gross to Net) as it approaches a 50% yield over the next 12 months [101] Company Strategy and Development Direction - The company aims to become a leading oral therapy in lupus by leveraging the dual inhibition of TYK2 and JAK1, which is expected to provide greater efficacy [102] - The company is focusing on specialty rheumatology indications with high unmet needs and blockbuster revenue potential [118] - The company is preparing for a Phase III study in ulcerative colitis and has ongoing studies in Crohn's disease [65][104] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data from brepocitinib, highlighting its potential to show strong clinical efficacy [112] - The management noted that the competitive landscape in IBD (Inflammatory Bowel Disease) is challenging, particularly for JAK inhibitors [19] - Management believes that the current coverage and payer relationships will support successful commercial models moving forward [106] Other Important Information - The company has completed its tenth consecutive positive Phase III trial, leading to six FDA-approved products [90] - The company is preparing for additional filings for VTAMA in atopic dermatitis, expected to occur at the beginning of next year [92] Q&A Session Summary Question: What is the expected timing for the upcoming data releases? - Management indicated that data from the lupus study is expected in mid- to late fourth quarter [25] Question: How does the company view the adoption of the product following government coverage? - Management expects steady improvements in GTN as government lives contribute, but does not anticipate a step function change [27] Question: What are the plans for brepocitinib in various indications? - Management confirmed that brepocitinib is being positioned for multiple specialty rheumatology indications, with a focus on delivering significant efficacy improvements [118]
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
Financial Performance - Total revenue for the year ended March 31, 2023, was $61.28 million, an increase from $55.29 million in 2022, representing an increase of 10.3%[911] - Product revenue for the year was $28.01 million, with license, milestone, and other revenue totaling $33.27 million, down from $55.29 million in the previous year[911] - The net loss for the year was $1.12 billion, compared to a net loss of $924.12 million in 2022, reflecting an increase in losses of about 21.5%[911] - The company reported a comprehensive loss of $1.12 billion for 2023, compared to $926.39 million in 2022, reflecting an increase of approximately 20.9%[915] - The net loss for the year ended March 31, 2023, was $1,115,463, compared to a net loss of $924,116 for the previous year, representing a 20.7% increase in losses[922] - Cash used in operating activities was $843,393 for the year ended March 31, 2023, up from $677,729 in the prior year, indicating a 24.5% increase in cash outflow[922] Cash and Assets - Cash and cash equivalents decreased to $1.68 billion as of March 31, 2023, down from $2.06 billion in 2022, a decline of 18.6%[908] - Total assets decreased to $2.39 billion in 2023 from $2.59 billion in 2022, a reduction of approximately 7.5%[908] - Shareholders' equity attributable to Roivant Sciences Ltd. decreased to $1.16 billion in 2023 from $1.66 billion in 2022, a decline of approximately 30.1%[908] - The company had cash and cash equivalents of approximately $1.7 billion and an accumulated deficit of approximately $3.8 billion as of March 31, 2023[927] Operating Expenses - Total operating expenses decreased to $1.24 billion in 2023 from $1.41 billion in 2022, a reduction of approximately 12%[911] - Share-based compensation expenses decreased to $217,781 from $564,956, a reduction of 61.5% year-over-year[922] Capital and Financing - The company raised $311,981 from the issuance of common shares, net of issuance costs, during the year[922] - The total cash provided by financing activities was $499,462, compared to $306,792 in the previous year, marking an increase of 62.6%[922] - The Company has an aggregate offering price of up to $400.0 million available under the ATM Facility as of March 31, 2023[1058] - In November 2022, the Company completed a public offering of 30,000,000 common shares at $5.00 per share, generating net proceeds of approximately $94.7 million[1060] - In February 2023, the Company completed another public offering of 30,666,665 common shares at $7.50 per share, resulting in net proceeds of approximately $216.9 million[1062] Product Development and Revenue Recognition - The company is actively pursuing new product candidates and aims to enhance its product pipeline through discovery efforts[25] - The company launched its first commercial product, VTAMA®, following FDA approval in May 2022[925] - The Company began recognizing product revenues from VTAMA after FDA approval in May 2022[970] - Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as discounts, rebates, and returns[972] - The Company recognizes revenue from non-refundable upfront fees for licenses of intellectual property when the license is transferred and usable by the licensee[975] Regulatory and Operational Risks - The company acknowledges the unpredictability of regulatory approval processes for new drugs, which could delay commercialization[25] - The company is subject to risks common in the biopharmaceutical industry, including uncertainties related to product commercialization and regulatory approvals[928] - The company anticipates potential difficulties in enrolling and retaining patients for clinical trials, which may affect product development timelines[25] Shareholder and Governance - The company has a significant percentage of its shares controlled by major shareholders, which may influence corporate governance[31] - The company emphasizes the importance of effective communication with investors through various channels, including its investor relations website[28] Research and Development - Research and development costs are expensed as incurred, primarily consisting of preclinical studies and clinical trials[952] - The company has incurred significant losses and negative cash flows from operations since its inception[927] Debt and Liabilities - Total liabilities increased to $782.02 million in 2023, up from $523.70 million in 2022, an increase of about 49.3%[908] - Dermavant's total long-term debt net as of March 31, 2023, was $180.7 million, compared to $177.4 million in the previous year[1042] Investments and Fair Value - The company's equity method investments in Datavant and Arbutus had fair values of $178.6 million and $117.7 million, respectively, as of March 31, 2023[991] - Unrealized losses on investments for Datavant and Arbutus were $15.4 million and $(1.9) million, respectively, for the year ended March 31, 2023[993]
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) 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]