On November 14, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV) reported its financial results for the second quarter ended September 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, NOV 14, 2022, View Source [SID1234624023]).

Roivant’s chief executive officer, Matt Gline, noted: "This has been a great quarter for Roivant. In addition to VTAMA’s strong performance and the enthusiastic feedback we’ve received from patients and providers, we executed our first major PBM contract. This provides immediate coverage for millions of lives associated with that PBM, establishes a national template for unrestricted access to VTAMA, and supports a paradigm shift to VTAMA as the mainstay of psoriasis therapy. Our fully enrolled potentially registrational SLE study for brepocitinib, which reads out next year, and Immunovant’s broadened anti-FcRn portfolio, represent notable progress in our immunology pipeline. Between cost reduction and multiple recent infusions of capital, we’ve extended our runway into the second half of calendar year 2025 – and we’re looking forward to multiple key catalysts between now and then, including many in the next year."

Recent Developments

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•Roivant: On November 8, priced $150 million total gross primary and secondary offering, consisting of gross primary proceeds to Roivant of $100 million. Roivant continued its cost optimization and pipeline reprioritization initiatives initially announced in June 2022 in order to focus capital on the most valuable and meaningful opportunities in the pipeline, while maintaining the financial flexibility to opportunistically in-license assets. Roivant expects that its consolidated cash, cash equivalents and restricted cash of $1.6 billion at September 30, 2022, or $1.9 billion after giving effect to subsequent Roivant and Immunovant follow-on offerings and anticipated proceeds from the sale of Myovant equity rights to Sumitomo Pharma, along with continued cost savings initiatives, support cash runway into second half of calendar year 2025.

•Dermavant: Through November 4, VTAMA has had over 54,000 prescriptions written by approximately 6,400 unique prescribers, based on IQVIA data. For the quarter ended September 30, 2022, Roivant reported VTAMA net product revenue of $5.0 million, representing a gross-to-net yield of approximately 12%. Dermavant also entered into a reimbursement contract with one of the three largest PBMs, effective October 1, 2022. Finally, Dermavant announced results from its maximal use pharmacokinetic study of VTAMA in atopic dermatitis, which showed minimal to no systemic absorption and favorable tolerability when used in pediatric patients down to age two.

•Priovant: Completed enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. With over 1,000 patients exposed in these studies, brepocitinib showed a safety and tolerability profile in line with other class agents. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single potentially registrational Phase 3 trial.

•Immunovant: At Roivant’s Investor Day on September 28, Immunovant unveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL levels in a head-to-head animal study with batoclimab and placebo. Additionally, on September 7 Immunovant unveiled two new development programs for batoclimab in Graves’ disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Immunovant also completed a $75.0 million follow-on offering in October, with leading life sciences investors including Logos Capital, Deep Track Capital, Frazier Life Sciences, TCGX, BVF Partners, and Commodore Capital participating.

•Genevant: On November 2, the federal district court in Delaware issued an opinion and order in the patent infringement suit brought by Genevant and Arbutus against Moderna. The court denied Moderna’s partial motion to dismiss the suit based on the government-contractor defense under 28 U.S.C. Section 1498, which was an attempt by Moderna to shift liability for an unspecified portion its alleged infringement to the US government and taxpayers. The case is now expected to proceed to the pre-trial discovery phase.

•Proteovant: Disclosed today data from its preclinical estrogen receptor (ER) degrader demonstrating equal or better tumor reduction in an in vivo model in a head-to-head comparison with the most advanced degrader in its class.

•Affivant: Affivant and Affimed jointly unveiled AFVT-2101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Boston on November 8. AFVT-2101 is a tetravalent, bispecific ICE (innate cell engager) that selectively targets folate receptor alpha (FRα) and CD16A (FcγR3A). AFVT-2101 directs innate immune cells to kill tumor cells selectively and potently with a wide range of FRα expression. Due to the high avidity for CD16A, AFVT-2101 is more efficacious and potent in both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays than farletuzumab, a monoclonal antibody targeting FRα.

Major Upcoming Milestones

•Dermavant: Expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first 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 second half of calendar year 2023.

•Immunovant: Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and expects to have top-line results from the MG trial in the second half of calendar year 2024 and from the two TED trials in the first half of calendar year 2025. A pivotal Phase 2b trial in CIDP is planned to be initiated by the end of calendar year 2022, with initial results from the open label period expected in the first half of calendar year 2024. In Graves’ disease, a Phase 2 trial is planned to be initiated in early calendar year 2023 with initial results expected in the second half of calendar year 2023. Immunovant plans to finalize the lead asset and trial design in WAIHA following an expected engagement with the hematology division of the FDA before the end of calendar year 2022. Immunovant plans to submit an IND and initiate a Phase 1 study for IMVT-1402 in early 2023 with initial human data expected in mid-2023; Immunovant believes these Phase 1 results together with strong IgG biomarker data from batoclimab may accelerate the development program for 1402.

•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.

Second Quarter Ended September 30, 2022 Financial Summary

Cash Position

As of September 30, 2022, we had cash, cash equivalents and restricted cash of approximately $1.6 billion. Giving effect to Immunovant’s October 2022 follow-on offering for $75 million in gross proceeds, Roivant’s November follow-on offering for $100 million in gross primary 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 first calendar quarter of 2023, subject to customary closing conditions.

Research and Development Expenses

Research and development (R&D) expenses were $132.0 million for the three months ended September 30, 2022 compared to $132.1 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was offset by increases in personnel-related expenses and program-specific costs, reflecting the progression of our programs and drug discovery. Non-GAAP R&D expenses were $123.3 million for the three months ended September 30, 2022 compared to $103.2 million for the three months ended September 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $157.7 million for the three months ended September 30, 2022 compared to $437.8 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense, partially offset by higher selling, general and administrative expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was partially offset by continued vesting of the equity instruments. Non-GAAP SG&A expenses were $101.5 million for the three months ended September 30, 2022 compared to $68.0 million for the three months ended September 30, 2021.

Net Loss

Net loss was $315.9 million for the three months ended September 30, 2022 compared to $225.6 million for the three months ended September 30, 2021. On a per common share basis, net loss was $0.42 for the three months ended September 30, 2022 and $0.32 for the three months ended September 30, 2021. Non-GAAP net loss was $226.8 million for the three months ended September 30, 2022 compared to $290.0 million for the three months ended September 30, 2021.

(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 the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.

(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(7) Represents the one-time gain on termination of the options held by Sumitomo Dainippon Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(8) Represents the one-time gain on deconsolidation of a subsidiary.

(9) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three and six months ended September 30, 2022. For the three and six months ended September 30, 2021, acquired IPR&D expense was $122.2 million and $122.3 million, respectively.

Roivant also announced today that it will participate in three additional upcoming investor conferences:

Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference in Miami from December 7-8. CFO Richard Pulik will participate in the panel "Commercial Successes, Current & Upcoming Launches" at 9:00 a.m. EST on Thursday, December 8

Jefferies Healthcare Summit in Denver from December 14-15

41st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. EST on Monday, November 14, 2022 to report its financial results for the fiscal quarter ended September 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call 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.