On November 15, 2021 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the second fiscal quarter ended September 30, 2021 and provided an update on the Company’s operations (Press release, Roivant Sciences, NOV 15, 2021, View Source [SID1234595619]).
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Roivant’s Chief Executive Officer, Matt Gline, noted: "We are looking forward to this new phase of growth as we prepare to launch potential blockbuster tapinarof in psoriasis, with registrational studies in atopic dermatitis also underway. In addition to the studies underway at Dermavant, we expect at least four other programs will enter Phase 2 or Phase 3 trials in 2022, and we are excited to continue advancing our protein degrader programs towards the clinic, as well."
Recent Developments
Roivant: Roivant closed its business combination with Montes Archimedes Acquisition Corp. ("MAAC") and concurrent PIPE financing, and Roivant began trading on Nasdaq under the ticker "ROIV." Roivant also announced the appointment of its new Chief Financial Officer, Richard Pulik, who previously served as the Global Head of Business Development & Licensing and Portfolio Management, Oncology at Novartis.
Dermavant: At the 30th EADV Virtual Congress, Dermavant presented final results from the Phase 3 PSOARING 3 long-term extension study of tapinarof in patients with plaque psoriasis. The study results demonstrated that tapinarof was generally well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. The study demonstrated a high rate of complete disease clearance, with 58.2% of patients who entered the study with a PGA score ≥2 achieving a PGA score of 0 or 1. The study also demonstrated improved and durable results for up to 52 weeks and a median remittive effect off-therapy of approximately four months for patients entering with a PGA score of 0.
Aruvant: At Roivant’s Annual R&D Day, Aruvant released clinical data from the third and fourth patients dosed in its ongoing Phase 1/2 trial of ARU-1801 in sickle cell disease. These patients, the first to be dosed with Aruvant’s updated manufacturing process, have had zero vaso-occlusive events 18 and 12 months after dosing, respectively. Punam Malik, M.D., Director of the Cincinnati Comprehensive Sickle Cell Center and Program Leader of the Hematology and Gene Therapy Program at the Cincinnati Children’s Hospital Medical Center, will present ARU-1801 data at 6:00 to 8:00 PM ET on December 13, 2021 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Sio Gene Therapies: Sio Gene Therapies announced positive interim safety and biomarker data from its ongoing Phase 1/2 clinical trial of AXO-AAV-GM1 in GM1 gangliosidosis, showing consistent dose-dependent improvements across biomarker measures and no overt disease progression in six out of seven patients treated across low- and high-dose cohorts.
Major Upcoming Milestones
Dermavant: We expect a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second quarter of calendar year 2022. We also expect to report topline data from Dermavant’s Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
Immunovant: Contingent upon FDA feedback, Immunovant plans to initiate a pivotal trial evaluating batoclimab for the treatment of myasthenia gravis in the early part of calendar year 2022, and re-initiate its programs in thyroid eye disease and warm autoimmune hemolytic anemia. Immunovant also plans to announce at least two new indications and submit INDs with their trial designs to the FDA by August 2022.
Aruvant: We expect Aruvant to report additional clinical data from its ongoing Phase 1/2 trial of ARU-1801 in sickle cell disease patients at ASH (Free ASH Whitepaper), including data that demonstrates how the potent anti-sickling effect of ARU-1801 can translate into robust clinical outcomes.
Kinevant: Kinevant remains on track to initiate its Phase 2 trial evaluating namilumab for the treatment of pulmonary sarcoidosis in the first half of calendar year 2022.
Lysovant: Lysovant remains on track to initiate its multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis in the first half of calendar year 2022.
Fiscal Quarter Ended September 30, 2021 Financial Summary
Cash Position
As of September 30, 2021, we had cash and cash equivalents of approximately $2.5 billion. The increase from cash and cash equivalents of approximately $2.0 billion as of June 30, 2021 reflects net cash proceeds of $213.4 million received at the closing of the business combination with MAAC and concurrent PIPE financing, approximately $320 million in cash proceeds from Datavant’s merger with Ciox Health (the "Datavant Merger") and funding of the second $100.0 million payment to Proteovant Sciences under a subscription agreement entered into with SK, Inc. in December 2020.
Research and Development Expenses
Research and development (R&D) expenses were $254.3 million for the three months ended September 30, 2021 compared to $97.4 million for the three months ended September 30, 2020. The increase was primarily due to an increase in program-specific costs relating to our product candidates, one-time consideration for the purchase of in-process R&D related to an asset acquisition, and an increase in share-based compensation expense due to the achievement of the liquidity event vesting condition for restricted stock units, performance options and capped value appreciation rights upon the closing of the business combination with MAAC, resulting in the recognition of a one-time catch-up expense of $22.9 million. Non-GAAP R&D expenses were $103.9 million for the three months ended September 30, 2021 compared to $50.2 million for the three months ended September 30, 2020.
General and Administrative Expenses
General and administrative (G&A) expenses were $437.8 million for the three months ended September 30, 2021 compared to $59.7 million for the three months ended September 30, 2020. The increase was largely due to an increase in share-based compensation expense, primarily as a result of the achievement of the liquidity event vesting condition for restricted stock units, performance options and capped value appreciation rights upon the closing of the business combination with MAAC, resulting in the recognition of a one-time catch-up expense of $350.0 million. Non-GAAP G&A expenses were $68.6 million for the three months ended September 30, 2021 compared to $47.7 million for the three months ended September 30, 2020.
Gain on Sale of Investment
Gain on sale of investment resulted from the Datavant Merger in July 2021. At closing of the Datavant Merger, we received approximately $320 million in cash and a minority equity interest in the combined company, which resulted in a gain of $443.8 million.
Net Loss
Net loss for the three months ended September 30, 2021 was $225.6 million compared to $53.5 million for three months ended September 30, 2020. On a per common share basis, net loss was $0.32 and $0.06 for the three months ended September 30, 2021 and 2020, respectively. Non-GAAP net loss was $169.2 million for the three months ended September 30, 2021 compared to $96.9 million for the three months ended September 30, 2020.
(1) Represents non-cash share-based compensation expense.
(2) Represents one-time development milestone payments.
(3) Represents one-time in-process research and development expense.
(4) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.
(5) 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. This is a non-cash loss (gain) that has no direct correlation to the operation of Roivant’s business.
(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized loss (gain) 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 one-time gain on deconsolidation of a subsidiary and the remeasurement of a previously held interest in an unconsolidated entity upon its consolidation.
(9) Represents the estimated tax effect of the adjustments.
The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Roivant believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. Management uses certain non-GAAP information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Roivant’s operating results as reported under GAAP. Non-GAAP financial information generally excludes (i) non-cash items, including share-based compensation expense and the change in fair value of debt and liability instruments, (ii) consideration for the purchase of in-process research and development through asset acquisitions and license agreements, including upfront cash payments, the fair value of equity liability instruments issued, and the fair value of certain future contingent consideration payments, and (iii) other items that are considered unusual or not representative of underlying trends of Roivant’s business. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the tables above.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 15, 2021 to report its second quarter 2021 financial results, and provide a corporate update.
To access the live conference call, please dial +1-844-224-1923 (domestic) or +1-214-989-7105 (international) and use conference ID 3545615. 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.
Upcoming Investor Events
Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 12:20 p.m. GMT
Evercore ISI HealthCONx Conference on Tuesday, November 30, 2021 at 2:15 p.m. ET