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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.
  
  Roivant reported its consolidated cash, cash equivalents and restricted cash of $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.
  
  In December 2023, Immunovant reported in an open-label Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease, response rates from an initial cohort of patients who were hyperthyroid despite treatment with an anti-thyroid medication for more than 12 weeks were meaningfully higher than 50 percent, after receiving once-weekly subcutaneous injections of 680 mg batoclimab for 12 weeks. This trial is ongoing.
• 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.
  
  In January 2024, Dermavant announced new positive efficacy and safety data from analyses of ADORING 3, an ongoing open-label, long-term extension Phase 3 trial being conducted to evaluate the safety and efficacy of VTAMA cream, 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-NRS
  • 92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score

The interim analysis of the ADORING 3 open-label, long-term extension Phase 3 trial demonstrated that 51.2% (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
As of December 31, 2023, the Company had consolidated cash, cash equivalents and restricted cash of $6.7 billion.

Research and Development Expenses
Research and development expenses decreased by $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
Selling, general and administrative expenses increased by $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
Gain on sale of Telavant net assets resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $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)
Net income was approximately $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.