Financial Data and Key Metrics Changes - The company reported revenues of $18.4 million for the quarter, with a modest increase in GTN yield to 27.6% [19][23] - Pro forma cash and cash equivalents are expected to reach $7 billion following the sale of Telavant to Roche, marking a strong capital position for the company [9][23] Business Line Data and Key Metrics Changes - The VTAMA launch is progressing steadily, although at a slower pace than desired, with expectations for growth in the atopic dermatitis market in the second half of 2024 [37][39] - The anti-FcRn franchise, including Batoclimab and IMVT-1402, is showing promising clinical data, with ongoing mid-stage trials expected to validate the IgG suppression hypothesis [12][14] Market Data and Key Metrics Changes - The company is focusing on the intertriginous psoriasis market, reporting strong data that positions it competitively against other treatments [20][21] - The upcoming launch of VTAMA for atopic dermatitis is anticipated to significantly increase the patient population and market share [38] Company Strategy and Development Direction - The company aims to be patient and strategic in capital deployment, focusing on high-value opportunities rather than rushing into transactions [10][45] - There is a strong emphasis on maximizing the value of the FcRn program, which is seen as a potential cornerstone for future growth [88] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data releases and the potential for significant growth in various therapeutic areas, particularly Graves' disease and SLE [40][94] - The company is committed to maintaining a strong pipeline and is exploring various strategic options to leverage its capital effectively [11][55] Other Important Information - The planned sale of Telavant to Roche for $7.1 billion upfront, with additional milestone payments, is a transformative opportunity for the company [8][9] - The company is actively working on enhancing its commercialization strategies to improve patient access and experience [26][84] Q&A Session Summary Question: What are the prospects for VTAMA scripts and potential growth drivers? - Management acknowledged that VTAMA scripts have flattened but expressed hope for growth ahead of the atopic dermatitis label addition in late 2024 [25][44] Question: How does the company balance capital deployment with the pressure to invest quickly? - Management emphasized the importance of patience in capital deployment, ensuring that investments are made in high-value opportunities rather than rushing into decisions [45][53] Question: What is the market opportunity for Graves' disease? - Management highlighted the significant unmet need in uncontrolled Graves' disease patients, indicating a large potential market for new therapeutic agents [63][64] Question: How does the company plan to compete in a crowded market? - Management stated that the company will focus on capital efficiency and strategic positioning to compete effectively in various indications [59][61] Question: What are the expectations for the upcoming Graves' disease data? - Management indicated that a normalization of thyroid hormone levels in about 50% of patients would be considered clinically meaningful [94]

November 13, 2023 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 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 st ...

Financial Performance - Net revenue for the three months ended September 30, 2023, was $37,101 thousand, a significant increase of 196.5% compared to $12,533 thousand for the same period in 2022[31]. - The company reported a comprehensive loss of $327,516 thousand for the three months ended September 30, 2023, compared to a comprehensive loss of $312,169 thousand for the same period in 2022, indicating an increase of approximately 4.9%[34]. - The company reported a net loss of $331,118,000 for the quarter ending September 30, 2023, compared to a net loss of $327,845,000 for the previous quarter[38]. - For the six months ended September 30, 2023, the company incurred a net loss of approximately $659.0 million, compared to a net loss of $669.7 million for the same period in 2022[48]. - The company reported a net cash provided by financing activities of approximately $215.3 million for the six months ended September 30, 2023, compared to $134.6 million in the prior year[48]. - The company reported a net loss of $331.1 million for the three months ended September 30, 2023, compared to a net loss of $315.9 million in the same period of 2022, reflecting an increase in loss of $15.2 million (5%) year-over-year[196]. Assets and Liabilities - Total assets decreased from $2,389,604 thousand as of March 31, 2023, to $2,065,543 thousand as of September 30, 2023, representing a decline of approximately 13.6%[28]. - Cash and cash equivalents decreased from $1,676,813 thousand as of March 31, 2023, to $1,408,231 thousand as of September 30, 2023, a reduction of about 16.0%[28]. - As of September 30, 2023, total shareholders' equity was $1,325,633,000, reflecting an increase from $1,334,139,000 as of June 30, 2023[38]. - The balance of accumulated deficit increased to $4,368,897,000 as of September 30, 2023, from $4,064,570,000 as of June 30, 2023[38]. - The total long-term debt, net of the debt issued to NovaQuest, was $188.9 million, an increase from $180.7 million as of March 31, 2023, representing a growth of approximately 4.0%[99]. - The total liabilities at fair value increased to $248.1 million as of September 30, 2023, up from $241.3 million as of March 31, 2023[143]. Revenue Breakdown - Product revenue, net for the three months ended September 30, 2023, was $18.4 million, up $13.5 million (272%) from $5.0 million in the same period of 2022, primarily driven by VTAMA sales[196]. - License, milestone, and other revenue increased by $11.1 million (146%) to $18.7 million for the three months ended September 30, 2023, compared to $7.6 million in the same period of 2022[196]. - For the six months ended September 30, 2023, total net revenue was $58.7 million, an increase of $41.9 million (248%) compared to $16.9 million in the same period of 2022[197]. Research and Development - Research and development expenses for the three months ended September 30, 2023, were $131,984 thousand, consistent with $131,995 thousand for the same period in 2022[31]. - The company anticipates an increase in research and development expenses as it advances product candidates and in-licensed assets through clinical trials[180]. - Research and development expenses decreased by $10.7 million to $257.1 million for the six months ended September 30, 2023, compared to $267.8 million for the same period in 2022[207]. Shareholder Equity and Stock Activity - The weighted average shares outstanding for basic and diluted shares increased from 699,888,061 for the three months ended September 30, 2022, to 770,227,849 for the same period in 2023[31]. - The company issued 19,600,685 common shares, net of issuance costs, raising $199,822,000[38]. - The company raised approximately $199.8 million from the issuance of common shares during the six months ended September 30, 2023[48]. - The total number of common shares outstanding increased to 800,792,365 as of September 30, 2023, up from 767,137,861 as of June 30, 2023[38]. Future Outlook and Strategic Plans - The company expects to incur additional losses in the future to fund operations and product research and development[49]. - The company intends to raise additional capital through equity securities or debt financings to support its business plan[50]. - The Roche Transaction is expected to close in Q4 2023 or Q1 2024, subject to regulatory approvals[154]. - The Company expects to receive approximately $5.2 billion in cash proceeds from the Roche Transaction, which involves the sale of Telavant Holdings, Inc.[153]. Legal and Regulatory Matters - The company intends to vigorously defend against a securities class action lawsuit related to Immunovant, with no liability recorded at this time due to uncertainty in estimating possible losses[126]. - Acuitas Therapeutics Inc. filed a lawsuit against Genevant and Arbutus regarding patent infringement related to COMIRNATY, which was voluntarily dismissed on August 4, 2023[127].

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]

| --- | --- | |-------|-------| | | | | | | 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 ...

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 ...

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]

$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 ...

| --- | --- | |----------------------------------------|-------| | | | | 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 ...

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]