On February 13, 2023 Roivant Sciences (Nasdaq: ROIV) reported its financial results for the third quarter ended December 31, 2022, and provided an update on the Company’s operations (Press release, Roivant Sciences, FEB 13, 2023, View Source [SID1234627107]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "This past quarter was a significant one for the company. We announced the in-licensing of our potentially first-in-class and best-in-class TL1A program RVT-3101 along with highly encouraging Phase 2 induction data. Earlier this month we completed a $230M equity financing to further advance our TL1A programs in Phase 3 and Phase 2 for ulcerative colitis and Crohn’s disease, respectively. Additionally, we reported strong growth in VTAMA net revenue and made significant progress on payor coverage with a majority of commercial lives now covered. These recent developments and our strengthened balance sheet continue to support Roivant’s growing leadership in immunological and inflammatory diseases and point to an incredibly catalyst-rich year ahead."

Recent Developments

Roivant: In February, Roivant completed an upsized primary equity offering for $230M in gross proceeds, including the exercise in full of the underwriters’ overallotment option following strong investor demand. The company plans to use the net proceeds from the offering principally to fund additional studies of RVT-3101, including the initiation of Phase 3 development in ulcerative colitis and Phase 2 development in other indications. Roivant had consolidated cash, cash equivalents and restricted cash of $1.5B at December 31, 2022, or $1.9B after giving effect to the receipt of the anticipated proceeds from the sale of Myovant equity rights to Sumitomo and the net proceeds from the offering, supporting cash runway into the second half of calendar year 2025.

Dermavant: Through February 10, 2023, nearly 100,000 VTAMA prescriptions have been written by approximately 8,600 unique prescribers, based on IQVIA data. For the quarter ended December 31, 2022, Roivant reported VTAMA net product revenue of $9.2 million, representing a gross-to-net yield of approximately 18%. There has been significant progress on payor coverage with the majority of commercial lives, 57%, now covered. Tapinarof Phase 3 trials in atopic dermatitis, ADORING 1 and ADORING 2, are fully enrolled.

Immunovant: In November 2022, Immunovant initiated a Phase 3 trial to evaluate batoclimab as a treatment for Thyroid Eye Disease (TED). Additionally, in December 2022, IMVT initiated a pivotal Phase 2b trial of batoclimab as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

RVT-3101: In December, Roivant announced a collaboration with Pfizer to develop and commercialize RVT-3101, a potentially first in class, fully human monoclonal antibody that blocks tumor necrosis factor-like ligand 1A (TL1A). In January, Roivant announced data from the induction period of TUSCANY-2, a large 245-patient global Phase 2b study of RVT-3101 against placebo for the treatment of ulcerative colitis. TUSCANY-2 is a 52-week study, with a 12-week induction period comparing different doses of RVT-3101 against placebo, and a 40-week chronic therapy period during which all subjects receive RVT-3101. In the induction period of the TUSCANY-2 study, RVT-3101 demonstrated statistically significant and clinically meaningful efficacy at each dose tested. At the expected Phase 3 dose, 31% of patients achieved clinical remission (modified Mayo) (p=0.01, 20% delta compared to 12% placebo) and 40% of patients achieved endoscopic improvement (p=0.01, 22% delta compared to 19% placebo). At the expected Phase 3 dose, among patients who were positive for a biomarker that was prospectively defined in TUSCANY-2, clinical remission (modified Mayo) and endoscopic improvement rates were 40% (p=0.02, 30% delta compared to 10% placebo) and 56% (p=0.0005, 46% delta compared to 10% placebo), respectively. Approximately 60% of patients were identified as positive for this biomarker. Across all doses and patient groups, RVT-3101 was well tolerated and showed a favorable safety profile.

Major Upcoming Milestones

Roivant plans to announce data from the chronic therapy period of the ongoing TUSCANY-2 study of RVT-3101 for ulcerative colitis in the first half of calendar year 2023.

Dermavant expects to report topline data from the first Phase 3 trial of VTAMA for the treatment of atopic dermatitis in March 2023, with topline data from the second Phase 3 trial expected in May 2023.

Immunovant plans to initiate a Phase 1 clinical trial for IMVT-1402 in early calendar year 2023 contingent on clearance of its Investigational New Drug ("IND") application, with initial data results from this Phase 1 trial expected to be available in mid-calendar year 2023. Immunovant expects to have top-line results from the ongoing MG trial in the second half of calendar year 2024 and from the TED program, consisting of two Phase 3 clinical trials, in the first half of calendar year 2025. Immunovant also expects initial data from period 1 of the Phase 2B trial in CIDP to be available in the first half of calendar year 2024. Immunovant expects to initiate a Phase 2 clinical trial to evaluate batoclimab for the treatment of Graves’ disease in early calendar year 2023 with initial results expected in the second half of calendar year 2023.

Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 3 trial in DM in calendar year 2025.

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 MDS patients in the second half of calendar year 2023.

Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.

Third Quarter Ended December 31, 2022 Financial Summary

Cash Position

As of December 31, 2022, the company had cash, cash equivalents and restricted cash of approximately $1.5 billion. Giving effect to Roivant’s February 2023 follow-on offering for $230 million in gross proceeds, and $115 million in expected proceeds from the planned sale of the Myovant top-up shares in connection with the pending acquisition of Myovant by Sumitomo Pharma, Roivant’s consolidated cash, cash equivalents and restricted cash would have been approximately $1.9 billion. The Myovant transaction is expected to close in the quarter ending March 2023, subject to customary closing conditions.

Research and Development Expenses

Research and development (R&D) expenses decreased by $11.8 million to $125.5 million for the three months ended December 31, 2022 compared to $137.3 million for the three months ended December 31, 2021, primarily due to decreases in share-based compensation of $10.8 million and program-specific costs of $8.0 million, partially offset by increases in personnel-related expenses of $4.1 million and other expenses of $2.8 million.

The decrease of $8.0 million in program-specific costs largely reflects the discontinued development of several programs, including ARU-1801, LSVT-1701, DMVT-502, DMVT-503, DMVT-504, and CVT-TCR-01. These decreases were partially offset by increases reflecting the progression of our programs, including Immunovant’s anti-FcRn franchise.

Non-GAAP R&D expenses were $117.4 million for the three months ended December 30, 2022, compared to $118.9 million for the three months ended December 30, 2021.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development increased by $81.6 million to $97.7 million for the three months ended December 31, 2022, compared to $16.1 million for the three months ended December 31, 2021, primarily due to consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 by a newly formed subsidiary in November 2022. Additionally, the achievement of a development milestone relating to Immunovant’s batoclimab program resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expense for the three months ended December 31, 2021 was primarily driven by consideration for the purchase of IPR&D of $14.1 million relating to the acquisition of RVT-2001 by Hemavant.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $52.7 million to $168.3 million for the three months ended December 31, 2022, compared to $115.5 million for the three months ended December 31, 2021, primarily due to higher selling, general and administrative expenses at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $115.9 million for the three months ended December 31, 2022, compared to $61.4 million for the three months ended December 30, 2021. The majority of non-GAAP SG&A expenses of $115.9 million were related to Dermavant’s SG&A and ongoing VTAMA commercial launch activities.

Net Loss

Net loss was $384.9 million for the three months ended December 31, 2022, compared to $306.1 million for the three months ended December 31, 2021. On a per common share basis, net loss was $0.49 for the three months ended December 31, 2022 and $0.41 for the three months ended December 31, 2021. Non-GAAP net loss was $297.5 million for the three months ended December 31, 2022, compared to $173.1 million for the three months ended December 31, 2021.