Roivant Reports Financial Results for the Third Quarter Ended December 31, 2023, and Provides Business Update
Roivant (ROIV) reports strong financial results for Q3 2023, completes $7.1B sale of Telavant to Roche, and achieves positive clinical trial results for Batoclimab and VTAMA products. The company maintains a healthy cash position of $6.7B, supporting future growth and profitability.
Positive
Roivant's financial results for Q3 2023 showcase a robust performance.
The sale of Telavant to Roche for $7.1B, with additional cash milestones, demonstrates successful business transactions.
Batoclimab delivers positive results in Graves' disease trials, exceeding response rate expectations.
VTAMA product revenue reaches $20.7M, with significant prescription numbers, indicating strong market acceptance.
Positive long-term efficacy and safety data for VTAMA in atopic dermatitis bodes well for future regulatory submissions.
Brepocitinib's upcoming Phase 2 trial data release for non-infectious uveitis is eagerly anticipated.
Roivant's solid cash position of $6.7B ensures financial stability and supports future growth initiatives.
The sale of Telavant to Roche for $7.1 billion, with an additional $150 million contingent on a near-term milestone, represents a significant liquidity event for Roivant. This transaction not only bolsters Roivant's balance sheet but also underscores the value of its biopharmaceutical assets. With a consolidated cash position of $6.7 billion, Roivant appears well-capitalized to fund ongoing operations and R&D efforts. The cash runway into profitability suggests a strategic cushion, potentially reducing the need for near-term capital raises and dilution of shareholder value. However, investors should monitor how efficiently Roivant allocates this capital to drive growth and how it may affect future valuations.
Roivant's announcement of positive results from the Phase 2 trial of Batoclimab in treating Graves’ disease could have significant implications for the drug's commercial potential and Roivant's pipeline value. Graves' disease, an autoimmune disorder affecting the thyroid, has limited treatment options and a new therapy with high response rates could meet a substantial unmet need. The reported response rates exceeding 50% in the initial cohort are promising, but it is crucial to understand the regulatory pathway and the size of the addressable market to fully assess the impact. Long-term safety and efficacy data will be pivotal in determining the drug's marketability and competitive edge.
VTAMA® cream's reported net product revenue of $20.7 million and its prescription volume since launch indicate a successful market penetration, particularly in the atopic dermatitis space. The positive long-term efficacy and safety data from the ADORING Phase 3 program could enhance VTAMA's market position, subject to regulatory approval of the supplemental New Drug Application (sNDA). The anticipation of topline data from the Phase 2 trial of Brepocitinib in non-infectious uveitis (NIU) further contributes to the potential expansion of Roivant's market presence. These developments suggest Roivant's strategic focus on delivering innovative treatments and expanding its dermatology and immunology portfolio, which could have a substantial impact on its market share and investor sentiment.
02/13/2024 - 07:00 AM
BASEL, Switzerland and LONDON and NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2023, and provided a business update.
Roivant completed the sale of Telavant to Roche for $7.1B with an additional $150M in cash payable upon the completion of a near-term milestone Batoclimab produced positive results in Graves’ disease with response rates meaningfully exceeding 50% in the initial cohort of an ongoing 24-week Phase 2 trial VTAMA® (tapinarof) cream, 1% net product revenue was $20.7M for the quarter ended December 31, 2023, with over 300,000 prescriptions written by approximately 14,000 unique prescribers since launch New VTAMA positive long-term efficacy and safety data announced from analyses of the ADORING Phase 3 program in atopic dermatitis. Data from these analyses will be included in sNDA submission expected this quarter Brepocitinib topline data from the Phase 2 trial in patients with non-infectious uveitis (NIU) is expected this quarter Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7B at December 31, 2023, supporting cash runway into profitability “This was another productive quarter across the company - we were pleased to announce the closing of the Telavant transaction with Roche in December. I am proud of our continued progress in clinical development, with another positive result generated by the Immunovant team in Graves’ disease. The positive initial data continues to support our view of the broad applicability of FcRn and the potentially meaningful clinical benefits associated with deeper IgG suppression,” said Matt Gline, CEO of Roivant. “Looking ahead, we are excited about multiple upcoming clinical data readouts and other catalysts expected this year, as well as the prospect of expanding our clinical pipeline. 2024 will be a year of growth for Roivant.”
Recent Developments
Roivant: In December 2023, Roivant announced the completion of the sale of Telavant to Roche for an upfront payment of approximately $7.1 billion with an additional $150 million in cash payable upon the completion of a near-term milestone. Under the terms of the agreement, Roche gained the rights to develop, manufacture and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially other diseases. Prior to the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant and Pfizer owned the remaining 25% , in each case on an as-converted basis. Roivant’s net cash proceeds from the transaction are approximately $5.2 billion . Approximately $110 million of the additional milestone payment will be payable to Roivant.$6.7 billion at December 31, 2023.Immunovant: In November 2023, Immunovant reported IMVT-1402, a second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn), continued to show potentially best-in-class profile in a Phase 1 clinical trial in healthy adults. Initial data from the 600 mg MAD cohort showed that four subcutaneously administered doses of 600 mg IMVT-1402 reduced total immunoglobulin G (IgG) levels by a mean of 74% , very similar to the 76% IgG reduction after four weekly injections of 680 mg batoclimab, but with no or minimal changes in serum albumin and LDL cholesterol, consistent with observations in placebo.Dermavant : For the third quarter ended December 31, 2023, Roivant reported VTAMA net product revenue of $20.7M , representing a 28.5% gross-to-net yield for the quarter. As of February 2024, over 300,000 VTAMA prescriptions1 have been written by approximately 14,000 unique prescribers for psoriasis2 , based on IQVIA data. VTAMA is covered for 137 million US commercial lives, including coverage by all three of the top pharmacy benefit managers.1% in patients with AD for up to 48 weeks of total treatment. The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including:vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included 80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75)77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0). No new safety signals were observed with up to 56 weeks of treatment. Data from these analyses will be included in sNDA submission expected this quarter.Hemavant: We have discontinued the development of RVT-2001 after an interim data analysis from the Phase 1/2 study.Major Upcoming Milestones
Immunovant expects initial results from period 1 of the Phase 2b clinical trial of batoclimab in CIDP in the second or third quarter of calendar year 2024, while top-line data from the Phase 3 clinical trials of batoclimab in MG and TED are on track and expected in the second half of calendar year 2024 and the first half of calendar year 2025, respectively. For IMVT-1402, Immunovant plans to initiate 4-5 potentially registrational programs by March 31, 2025 and plans to initiate trials in 10 indications by March 31, 2026 (inclusive of the 4-5 potentially registrational programs).Priovant expects to announce topline results from the Phase 2 POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.Third Quarter Ended December 31, 2023 Financial Summary Cash Position $6.7 billion .
Research and Development Expenses $1.8 million to $123.7 million for the three months ended December 31, 2023, compared to $125.5 million for the three months ended December 31, 2022. Changes in the components of research and development expenses included a decrease in program-specific costs of $10.0 million offset by increases in personnel-related expenses of $6.5 million and other expenses of $1.1 million .
Within program-specific costs, the decrease of $10.0 million was primarily driven by a decrease of $9.5 million related to other development and discovery programs due to the deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in August 2023, along with the reprioritization of certain programs and drug discovery efforts, and decreases of $3.1 million each related to RVT-2001 and batoclimab. These decreases were partially offset by an increase in expense of $4.0 million related to RVT-3101, which was acquired in November 2022, and an increase of $3.5 million related to IMVT-1402. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.
The increase of $6.5 million in personnel-related expenses was primarily driven by a special one-time cash retention bonus award granted to employees during the three months ended December 31, 2023.
Non-GAAP R&D expenses were $115.2 million for the three months ended December 31, 2023, compared to $117.4 million for the three months ended December 31, 2022.
Selling, General and Administrative Expenses $29.0 million to $197.3 million for the three months ended December 31, 2023, compared to $168.3 million for the three months ended December 31, 2022, primarily due to an increase in personnel-related expenses of $27.0 million as a result of a special one-time cash retention bonus award granted to employees.
Non-GAAP SG&A expenses were $148.4 million for the three months ended December 31, 2023, compared to $115.9 million for the three months ended December 31, 2022.
Gain on Sale of Telavant Net Assets $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million . This resulted in a gain of approximately $5.3 billion .
Net Income (Loss) $5.1 billion for the three months ended December 31, 2023, compared to a net loss of $384.9 million for the three months ended December 31, 2022. On a basic and diluted per common share basis, net income was $6.37 and $6.03 , respectively, for the three months ended December 31, 2023. Basic and diluted net loss per common share was $0.49 for the three months ended December 31, 2022. Non-GAAP net loss was $174.9 million for the three months ended December 31, 2023, compared to $297.5 million for the three months ended December 31, 2022.
ROIVANT SCIENCES LTD. Selected Balance Sheet Data (unaudited, in thousands) December 31, 2023 March 31, 2023 Cash, cash equivalents and restricted cash $ 6,685,458 $ 1,692,115 Total assets 7,312,679 2,389,604 Total liabilities 728,097 782,017 Total shareholders’ equity 6,584,582 1,607,587 Total liabilities and shareholders’ equity 7,312,679 2,389,604
ROIVANT SCIENCES LTD. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share amounts) Three Months Ended Nine Months Ended 2023 2022 2023 2022 Revenues: Product revenue, net $ 20,666 $ 9,244 $ 55,749 $ 14,354 License, milestone and other revenue 16,474 7,808 40,116 19,550 Revenue, net 37,140 17,052 95,865 33,904 Operating expenses: Cost of revenues 3,668 3,586 11,148 8,953 Research and development (includes $7,475 and $6,888 of share-based compensation expense for the three months ended December 31, 2023 and 2022 and $24,305 and $26,548 for the nine months ended December 31, 2023 and 2022, respectively) 123,717 125,533 380,834 393,358 Acquired in-process research and development — 97,749 26,450 97,749 Selling, general and administrative (includes $46,944 and $50,741 of share-based compensation expense for the three months ended December 31, 2023 and 2022 and $128,445 and $165,771 for the nine months ended December 31, 2023 and 2022, respectively) 197,282 168,261 517,827 474,996 Total operating expenses 324,667 395,129 936,259 975,056 Gain on sale of Telavant net assets 5,348,410 — 5,348,410 — Income (loss) from operations 5,060,883 (378,077 ) 4,508,016 (941,152 ) Change in fair value of investments 10,467 (25,948 ) 63,880 53,277 Change in fair value of debt and liability instruments 9,331 62,360 85,376 90,032 Gain on deconsolidation of subsidiaries — (12,514 ) (17,354 ) (29,276 ) Interest income (31,953 ) (10,249 ) (62,967 ) (17,900 ) Interest expense 9,444 8,446 27,603 19,393 Other income, net (34,743 ) (18,095 ) (33,405 ) (11,060 ) Net income (loss) before income taxes 5,098,337 (382,077 ) 4,444,883 (1,045,618 ) Income tax expense 25,672 2,819 31,181 8,983 Net income (loss) 5,072,665 (384,896 ) 4,413,702 (1,054,601 ) Net loss attributable to noncontrolling interests (23,519 ) (32,882 ) (86,339 ) (79,188 ) Net income (loss) attributable to Roivant Sciences Ltd. $ 5,096,184 $ (352,014 ) $ 4,500,041 $ (975,413 ) Net income (loss) per common share: Basic $ 6.37 $ (0.49 ) $ 5.79 $ (1.39 ) Diluted $ 6.03 $ (0.49 ) $ 5.46 $ (1.39 ) Weighted average shares outstanding: Basic 800,587,716 713,319,399 776,759,728 703,054,773 Diluted 844,461,685 713,319,399 824,310,013 703,054,773
ROIVANT SCIENCES LTD. Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in thousands) Three Months Ended Nine Months Ended Note 2023 2022 2023 2022 Net income (loss) $ 5,072,665 $ (384,896 ) $ 4,413,702 $ (1,054,601 ) Adjustments: Cost of revenues Amortization of intangible assets (1) 2,442 2,228 7,211 5,170 Share-based compensation (2) 55 — 153 — Research and development: Share-based compensation (2) 7,475 6,888 24,305 26,548 Depreciation and amortization (3) 1,023 1,258 3,717 3,558 Selling, general and administrative: Share-based compensation (2) 46,944 50,741 128,445 165,771 Depreciation and amortization (3) 1,956 1,664 5,902 4,176 Gain on sale of Telavant net assets (4) (5,348,410 ) — (5,348,410 ) — Other: Change in fair value of investments (5) 10,467 (25,948 ) 63,880 53,277 Change in fair value of debt and liability instruments (6) 9,331 62,360 85,376 90,032 Gain on deconsolidation of subsidiaries (7) — (12,514 ) (17,354 ) (29,276 ) Estimated income tax impact from adjustments (8) 21,199 756 21,351 410 Adjusted net loss (Non-GAAP) $ (174,853 ) $ (297,463 ) $ (611,722 ) $ (734,935 )
Three Months Ended Nine Months Ended Note 2023 2022 2023 2022 Research and development expenses $ 123,717 $ 125,533 $ 380,834 $ 393,358 Adjustments: Share-based compensation (2) 7,475 6,888 24,305 26,548 Depreciation and amortization (3) 1,023 1,258 3,717 3,558 Adjusted research and development expenses (Non-GAAP) $ 115,219 $ 117,387 $ 352,812 $ 363,252
Three Months Ended Nine Months Ended Note 2023 2022 2023 2022 Selling, general and administrative expenses $ 197,282 $ 168,261 $ 517,827 $ 474,996 Adjustments: Share-based compensation (2) 46,944 50,741 128,445 165,771 Depreciation and amortization (3) 1,956 1,664 5,902 4,176 Adjusted selling, general and administrative expenses (Non-GAAP) $ 148,382 $ 115,856 $ 383,480 $ 305,049
(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.
(2) Represents non-cash share-based compensation expense.
(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.
(4) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023.
(5) Represents the unrealized loss on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.
(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.
(7) Represents the one-time gain on deconsolidation of subsidiaries.
(8) Represents the estimated tax effect of the adjustments.
To access the conference call by phone, please register online using this registration link . The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
About Roivant ® , a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com.
Roivant Forward-Looking Statements
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our products and product candidates, plans to develop our product candidates for particular indications, the availability and success of topline results from our ongoing clinical trials, cash runway and profitability and any commercial potential of our products and product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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1 IQVIA National Prescription Audit (NPA) for the 3-month period ending 1/26/2024, reflecting estimates of real-world activity. All rights reserved.2 NPA for the period 5/20/22 to 1/19/2024, reflecting estimates of real-world activity. All rights reserved.
Roivant reported strong financial results for the third quarter of 2023.
Roivant completed the sale of Telavant to Roche for $7.1B.
Batoclimab produced positive results in Graves' disease trials, with response rates exceeding 50%.
VTAMA cream generated $20.7M in net product revenue for the quarter ended December 31, 2023.
Roivant reported consolidated cash, cash equivalents, and restricted cash of $6.7B as of December 31, 2023.
