Roivant Sciences Reports Financial Results for the Quarter Ended December 31, 2021 and Provides Business Update
BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, today reported its financial results for the third fiscal quarter ended December 31, 2021 and provided an update on the Company’s operations.
Roivant’s Chief Executive Officer, Matt Gline, noted: “We are looking forward to the upcoming launch of tapinarof this year and to the impact we believe it can have for psoriasis patients. We are also pleased with the continued enrollment in Dermavant’s registrational studies in atopic dermatitis. We remain on track this year to initiate multiple Phase 2 and Phase 3 clinical trials, including at Immunovant and Kinevant, and to expand the ongoing Phase 1/2 trial in MDS patients at newly launched Hemavant. RVT-2001, the lead product candidate at Hemavant, is a great example of our plans for pipeline expansion, which will come from both in-licensing and from our internal computational discovery efforts.”
Recent Developments
- Hemavant: Roivant has launched a new Vant, Hemavant, which entered into a licensing agreement with Eisai Co., Ltd. for exclusive global rights to the investigational agent RVT-2001, a potential first-in-class small molecule SF3B1 modulator. RVT-2001 has achieved a red blood cell transfusion independence rate of over 30% in 19 patients with lower-risk, transfusion-dependent MDS, 15 of whom had documented prior treatment with lenalidomide and/or hypomethylating agents. Hemavant plans to develop RVT-2001 as an oral therapy for transfusion-dependent anemia in patients with lower-risk MDS, with a robust open-label expansion of the ongoing Phase 1/2 clinical trial for RVT-2001 in the first half of calendar year 2022.
- Genevant: The Federal Circuit Court of Appeals rejected Moderna’s appeal of the prior Patent Trial and Appeal Board decision holding all claims of U.S. Patent 8,058,069 patentable. The court also dismissed Moderna’s appeal challenging a similar finding of patentability of certain claims of U.S. Patent 9,364,435 for lack of standing. Together, the decisions confirm the strength of Genevant’s nucleic acid delivery-related patent portfolio.
- Dermavant: Dermavant’s NDA submission for tapinarof remains on track, with no expectation of an FDA advisory committee and an assigned PDUFA date in Q2 2022. Dermavant continues to build out its organization, with key commercial leadership in place, and manufacturing remains on track for launch upon FDA approval. In December 2021, results from the PSOARING 1 and PSOARING 2 pivotal trials of tapinarof in plaque psoriasis were published in The New England Journal of Medicine. In January 2022, Dermavant presented patient satisfaction data demonstrating consistently high rates of satisfaction and positive perception of treatment with tapinarof, with 81.1% preferring tapinarof to topical drugs used in the past and 67.8% preferring tapinarof to systemic drugs used in the past.
- Aruvant: 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, presented data highlighting the clinically meaningful reduction in vaso-occlusive events for participants in the ongoing ARU-1801 Phase 1/2 trial and the unique attributes that contribute to the potency of ARU-1801 at the American Society of Hematology (ASH) Annual Meeting on December 13, 2021.
- Immunovant: In December 2021, Immunovant announced it had achieved alignment with the FDA Division of Neurology 1 to move forward in myasthenia gravis. The Phase 3 trial will include an induction (primary efficacy) period during which Immunovant plans to study doses of 680mg and 340mg of batoclimab delivered weekly by subcutaneous injection, followed by alternative dosing regimens (including potential lower maintenance and higher rescue doses) in subsequent study periods. The trial is designed to address unmet patient needs by leveraging batoclimab’s broad therapeutic window and simple subcutaneous delivery device to provide a differentiated treatment option.
- Kinevant: In December 2021, the FDA cleared the IND submitted by Kinevant for a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis.
- Lysovant: In January 2022, the FDA cleared the IND submitted by Lysovant for a multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis.
Major Upcoming Milestones
- Dermavant: Dermavant expects 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. Dermavant also expects to report topline data from the Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
- Immunovant: Immunovant plans to initiate a pivotal trial evaluating batoclimab for the treatment of myasthenia gravis in 1H 2022, with topline results expected in 2024. Immunovant also plans to re-initiate its programs in thyroid eye disease and warm autoimmune hemolytic anemia in 2022, and to announce at least two new indications by August 2022. Immunovant expects to initiate pivotal trials for two of these four indications in 2022, with a total of three pivotal trials initiating in 2022.
- Aruvant: Aruvant expects to announce ongoing new patient and follow up data through 2022 and to initiate its Phase 3 trial for ARU-1801 for the treatment of sickle cell disease in 2023.
- Kinevant: Kinevant remains on track to initiate its Phase 2 trial evaluating namilumab for the treatment of sarcoidosis in the first half of calendar year 2022.
- Hemavant: Hemavant plans to amend its ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the first half of calendar year 2022, with initial data expected in 2023.
- 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 December 31, 2021 Financial Summary
Cash Position
As of December 31, 2021, we had cash and cash equivalents of approximately $2.2 billion.
On February 14, 2022, Roivant entered into a committed equity facility with an affiliate of Cantor Fitzgerald & Co. (“Cantor”). Under the terms of the facility, Cantor has committed to purchase up to an aggregate of $250.0 million in the Company’s common shares from time to time at the request of the Company. This at-the-market-style facility will provide Roivant with the ability to raise additional capital opportunistically in the future.
Research and Development Expenses
Research and development (R&D) expenses were $153.5 million for the three months ended December 31, 2021 compared to $202.3 million for the three months ended December 31, 2020. The decrease was primarily due to reduced consideration for the purchase of in-process research and development through asset acquisitions and license agreements as compared to the comparable prior year period, partially offset by increases in program-specific costs relating to our product candidates, personnel-related expenses, and share-based compensation expense. Non-GAAP R&D expenses were $118.9 million for the three months ended December 31, 2021 compared to $50.8 million for the three months ended December 31, 2020.
General and Administrative Expenses
General and administrative (G&A) expenses were $115.5 million for the three months ended December 31, 2021 compared to $61.9 million for the three months ended December 31, 2020. The increase was largely due to higher share-based compensation expense as compared to the comparable prior year period, primarily as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended December 31, 2020 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP G&A expenses were $61.4 million for the three months ended December 31, 2021 compared to $47.7 million for the three months ended December 31, 2020.
Net Loss
Net loss for the three months ended December 31, 2021 was $306.1 million compared to $275.6 million for the three months ended December 31, 2020. On a per common share basis, net loss was $0.41 for both the three months ended December 31, 2021 and 2020. Non-GAAP net loss was $157.0 million for the three months ended December 31, 2021 compared to $87.6 million for the three months ended December 31, 2020.
ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)
| December 31, 2021 | March 31, 2021 | |||||||
| Cash, cash equivalents and restricted cash | $ | 2,226,135 | $ | 2,141,676 | ||||
| Total assets | 2,799,375 | 2,589,692 | ||||||
| Total liabilities | 529,622 | 527,687 | ||||||
| Total shareholders’ equity | 2,247,262 | 2,039,514 | ||||||
| Total liabilities, redeemable noncontrolling interest and shareholders’ equity | 2,799,375 | 2,589,692 | ||||||
ROIVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)
| Three Months Ended December 31, | Nine Months Ended December 31, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Revenue, net | $ | 24,341 | $ | 5,750 | $ | 46,063 | $ | 8,649 | |||||||
| Operating expenses: | |||||||||||||||
| Cost of revenues | 1,384 | 684 | 8,507 | 1,579 | |||||||||||
| Research and development | 153,450 | 202,261 | 486,335 | 358,404 | |||||||||||
| General and administrative | 115,530 | 61,875 | 636,060 | 178,730 | |||||||||||
| Total operating expenses | 270,364 | 264,820 | 1,130,902 | 538,713 | |||||||||||
| Loss from operations | (246,023 | ) | (259,070 | ) | (1,084,839 | ) | (530,064 | ) | |||||||
| Change in fair value of investments | 38,036 | 18,235 | 14,382 | (107,210 | ) | ||||||||||
| Gain on sale of investment | — | — | (443,754 | ) | — | ||||||||||
| Change in fair value of debt and liability instruments | 23,017 | 4,304 | 40,747 | 31,577 | |||||||||||
| Gain on termination of Sumitomo Options | — | — | (66,472 | ) | — | ||||||||||
| Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity | — | — | — | (115,364 | ) | ||||||||||
| Other (income) expense, net | (1,029 | ) | (5,788 | ) | 2,529 | (3,703 | ) | ||||||||
| Loss before income taxes | (306,047 | ) | (275,821 | ) | (632,271 | ) | (335,364 | ) | |||||||
| Income tax expense (benefit) | 38 | (224 | ) | 532 | 1,708 | ||||||||||
| Net loss | (306,085 | ) | (275,597 | ) | (632,803 | ) | (337,072 | ) | |||||||
| Net loss attributable to noncontrolling interests | (21,549 | ) | (14,568 | ) | (57,603 | ) | (37,402 | ) | |||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (284,536 | ) | $ | (261,029 | ) | $ | (575,200 | ) | $ | (299,670 | ) | |||
| Net loss per common share—basic and diluted | $ | (0.41 | ) | $ | (0.41 | ) | $ | (0.87 | ) | $ | (0.48 | ) | |||
| Weighted average shares outstanding—basic and diluted | 686,589,478 | 629,668,846 | 662,268,788 | 629,076,726 | |||||||||||
ROIVANT SCIENCES LTD.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited, in thousands)
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Net loss | $ | (306,085 | ) | $ | (275,597 | ) | $ | (632,803 | ) | $ | (337,072 | ) | ||||||
| Adjustments: | ||||||||||||||||||
| Research and development: | ||||||||||||||||||
| Share-based compensation | (1 | ) | 17,669 | 3,754 | 47,441 | 6,760 | ||||||||||||
| Milestone payments | (2 | ) | 2,000 | 1,000 | 42,165 | 4,216 | ||||||||||||
| In-process research and development | (3 | ) | 14,105 | 146,452 | 96,212 | 191,791 | ||||||||||||
| Depreciation and amortization | (4 | ) | 778 | 207 | 2,301 | 331 | ||||||||||||
| General and administrative: | ||||||||||||||||||
| Share-based compensation | (1 | ) | 53,547 | 13,570 | 440,356 | 38,756 | ||||||||||||
| Depreciation and amortization | (4 | ) | 592 | 583 | 1,925 | 2,565 | ||||||||||||
| Other: | ||||||||||||||||||
| Change in fair value of investments | (5 | ) | 38,036 | 18,235 | 14,382 | (107,210 | ) | |||||||||||
| Gain on sale of investment | (6 | ) | — | — | (443,754 | ) | — | |||||||||||
| Change in fair value of debt and liability instruments | (7 | ) | 23,017 | 4,304 | 40,747 | 31,577 | ||||||||||||
| Gain on termination of Sumitomo Options | (8 | ) | — | — | (66,472 | ) | — | |||||||||||
| Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity | (9 | ) | — | — | — | (115,364 | ) | |||||||||||
| Estimated income tax impact from adjustments | (10 | ) | (689 | ) | (119 | ) | (629 | ) | 1,392 | |||||||||
| Adjusted net loss (Non-GAAP) | $ | (157,030 | ) | $ | (87,611 | ) | $ | (458,129 | ) | $ | (282,258 | ) | ||||||
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||
| Research and development expenses | $ | 153,450 | $ | 202,261 | $ | 486,335 | $ | 358,404 | ||||||
| Adjustments: | ||||||||||||||
| Share-based compensation | (1 | ) | 17,669 | 3,754 | 47,441 | 6,760 | ||||||||
| Milestone payments | (2 | ) | 2,000 | 1,000 | 42,165 | 4,216 | ||||||||
| In-process research and development | (3 | ) | 14,105 | 146,452 | 96,212 | 191,791 | ||||||||
| Depreciation and amortization | (4 | ) | 778 | 207 | 2,301 | 331 | ||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 118,898 | $ | 50,848 | $ | 298,216 | $ | 155,306 | ||||||
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||
| General and administrative expenses | $ | 115,530 | $ | 61,875 | $ | 636,060 | ||||||||
