On August 14, 2023 Roivant (Nasdaq: ROIV) reported its financial results for the first quarter ended June 30, 2023, and provided an update on the business (Press release, Roivant Sciences, AUG 14, 2023, View Source [SID1234634379]).

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"This was an incredibly busy quarter with multiple clinical readouts and trial initiations. We reported positive data from the chronic period of the Phase 2b study of RVT-3101 in ulcerative colitis, in addition to positive data from the ADORING 1 trial evaluating VTAMA in patients as young as 2 years old with moderate-to-severe atopic dermatitis. We also initiated two separate trials, the TAHOE Phase 2 study of RVT-3101 in Crohn’s disease and the Phase 1 study of IMVT-1402 in healthy volunteers. We’re incredibly excited about the progress we’ve made in this quarter alone and look forward to announcing additional clinical results in the upcoming months," said Matt Gline, CEO of Roivant. "On the commercial side, we saw another three months of continued product revenue growth for the company from VTAMA sales."

Recent Developments

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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56. In July 2023, Telavant announced the first patient was dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in patients with moderate to severe Crohn’s disease.

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Immunovant: In August 2023, Immunovant reported that initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose).

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Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter. As of August 2023, nearly 200,000 VTAMA prescriptions have been written by approximately 11,500 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 129 million US commercial lives and 87 million government lives and includes coverage by all three of the top pharmacy benefit managers. In May 2023, VTAMA met the primary and all secondary endpoints in ADORING 1, the second of two replicate Phase 3 studies in patients with moderate-to-severe atopic dermatitis. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.

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Priovant: In August 2023, Priovant announced the sixth positive Phase 2 study of oral brepocitinib, out of six conducted, with statistically significant, positive results from the 12-week induction period of Pfizer’s Phase 2 study of brepocitinib in adult patients with moderate to severe Crohn’s disease. The primary and key secondary endpoints were met with safety and tolerability generally consistent with prior brepocitinib studies, further validating TYK2/JAK1 inhibition activity in highly inflammatory autoimmune diseases.

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Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.4B at June 30, 2023, supporting cash runway into the second half of calendar year 2025.

Major Upcoming Milestones

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

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Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in September 2023 and initial data from multiple-ascending dose cohorts in October or November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, are expected in the first half of calendar year 2025. Immunovant also expects to have initial results from period 1 of the Phase 2B clinical trial in chronic inflammatory demyelinating polyneuropathy (CIDP) in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in Graves’ disease (GD) are expected in the fourth quarter of calendar year 2023.

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Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data from the induction portion expected in the fourth quarter of calendar year 2024.

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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also 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.

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Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) patients in the second half of calendar year 2023.

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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.

First Quarter Ended June 30, 2023, Financial Summary

Cash Position

As of June 30, 2023, the company had consolidated cash, cash equivalents and restricted cash of $1.4 billion.

Research and Development Expenses

Research and development (R&D) expenses decreased by $10.7 million to $125.1 million for the three months ended June 30, 2023, compared to $135.8 million for the three months ended June 30, 2022, primarily due to decreases in program-specific costs of $7.8 million and share-based compensation of $4.3 million, partially offset by an increase in other expenses of $2.2 million.

The decrease of $7.8 million in program-specific costs largely reflects the discontinued development of several programs, including ARU-1801, LSVT-1701 and CVT-TCR-01, as well as our reprioritization of drug discovery efforts. These decreases were partially offset by increases reflecting the progression of our programs, including Immunovant’s anti-FcRn franchise, RVT-3101, and namilumab. The asset acquisition of RVT-3101 was completed in November 2022.

Non-GAAP R&D expenses were $115.7 million for the three months ended June 30, 2023, compared to $122.5 million for the three months ended June 30, 2022.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development was $12.5 million for the three months ended June 30, 2023, relating to the achievement of development and regulatory milestones for batoclimab.

Selling, General and Administrative Expenses

Selling, general and administrative expenses (SG&A) increased by $7.1 million to $156.2 million for the three months ended June 30, 2023, compared to $149.1 million for the three months ended June 30, 2022, primarily due to a decrease of $19.4 million of share-based compensation expense partially offset by an increase in selling, general and administrative expenses of $27.1 million at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $113.0 million for the three months ended June 30, 2023, compared to $87.7 million for the three months ended June 30, 2022. The majority of non-GAAP SG&A expenses were related to Dermavant’s SG&A and ongoing VTAMA commercial launch activities.

Net Loss

Net loss was $327.8 million for the three months ended June 30, 2023, compared to $353.8 million for the three months ended June 30, 2022. On a per common share basis, net loss was $0.38 for the three months ended June 30, 2023, and $0.48 for the three months ended June 30, 2022. Non-GAAP net loss was $211.5 million for the three months ended June 30, 2023, compared to $210.7 million for the three months ended June 30, 2022.