Full Press Release Details
Roivant Sciences Reports Financial Results for the Second Quarter Ended September 30, 2022 and Provides Business Update
BASEL, Switzerland, LONDON, NEW YORK and BOSTON, November 14, 2022 - Roivant Sciences Ltd. (Nasdaq: ROIV) today reported its financial results for the second quarter
ended September 30, 2022 and provided an update on the Company's operations.
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
Major Upcoming Milestones
Second Quarter Ended September 30, 2022 Financial Summary
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 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.
ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)
| September 30, 2022 | March 31, 2022 | |||||||
| Cash, cash equivalents and restricted cash | $ | 1,612,646 | $ | 2,074,034 | ||||
| Total assets | 2,215,534 | 2,585,129 | ||||||
| Total liabilities | 701,385 | 523,695 | ||||||
| Total shareholders' equity | 1,514,149 | 2,038,943 | ||||||
| Total liabilities, redeemable noncontrolling interest and shareholders' equity | 2,215,534 | 2,585,129 |
ROIVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue, net | $ | 12,533 | $ | 13,987 | $ | 16,852 | $ | 21,722 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues | 3,641 | 6,381 | 5,367 | 7,123 | ||||||||||||
| Research and development (includes $7,417 and $28,157 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $19,660 and $29,772 for the six months ended September 30, 2022 and 2021, respectively) | 131,995 | 132,098 | 267,825 | 210,613 | ||||||||||||
| Acquired in-process research and development | - | 122,161 | - | 122,272 | ||||||||||||
| Selling, general and administrative (includes $54,479 and $369,155 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $115,030 and $386,809 for the six months ended September 30, 2022 and 2021, respectively) | 157,663 | 437,776 | 306,735 | 520,530 | ||||||||||||
| Total operating expenses | 293,299 | 698,416 | 579,927 | 860,538 | ||||||||||||
| Loss from operations | (280,766 | ) | (684,429 | ) | (563,075 | ) | (838,816 | ) | ||||||||
| Change in fair value of investments | 54,678 | (32,273 | ) | 79,225 | (23,654 | ) | ||||||||||
| Gain on sale of investment | - | (443,754 | ) | - | (443,754 | ) | ||||||||||
| Change in fair value of debt and liability instruments | (13,541 | ) | 13,145 | 27,672 | 17,730 | |||||||||||
| Gain on termination of Sumitomo Options | - | - | - | (66,472 | ) | |||||||||||
| Gain on deconsolidation of subsidiary | (16,762 | ) | - | (16,762 | ) | - | ||||||||||
| Other expense, net | 8,615 | 3,692 | 10,331 | 3,558 | ||||||||||||
| Loss before income taxes | (313,756 | ) | (225,239 | ) | (663,541 | ) | (326,224 | ) | ||||||||
| Income tax expense | 2,165 | 401 | 6,164 | 494 | ||||||||||||
| Net loss | (315,921 | ) | (225,640 | ) | (669,705 | ) | (326,718 | ) | ||||||||
| Net loss attributable to noncontrolling interests | (24,331 | ) | (17,159 | ) | (46,306 | ) | (36,054 | ) | ||||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (291,590 | ) | $ | (208,481 | ) | $ | (623,399 | ) | $ | (290,664 | ) | ||||
| Net loss per common share-basic and diluted | $ | (0.42 | ) | $ | (0.32 | ) | $ | (0.89 | ) | $ | (0.45 | ) | ||||
| Weighted average shares outstanding-basic and diluted | 699,888,061 | 650,225,764 | 697,894,414 | 650,041,993 |
ROIVANT SCIENCES LTD.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited, in thousands)
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | |||||||||||||||
| Net loss | $ | (315,921 | ) | $ | (225,640 | ) | $ | (669,705 | ) | $ | (326,718 | ) | |||||||
| Adjustments: | |||||||||||||||||||
| Cost of revenues | |||||||||||||||||||
| Amortization of intangible assets | (1) | 2,200 | - | 2,942 | - | ||||||||||||||
| Research and development: | |||||||||||||||||||
| Share-based compensation | (2) | 7,417 | 28,157 | 19,660 | 29,772 | ||||||||||||||
| Depreciation and amortization | (3) | 1,230 | 780 | 2,300 | 1,523 | ||||||||||||||
| General and administrative: | |||||||||||||||||||
| Share-based compensation | (2) | 54,479 | 369,155 | 115,030 | 386,809 | ||||||||||||||
| Depreciation and amortization | (3) | 1,646 | 589 | 2,512 | 1,333 | ||||||||||||||
| Other: | |||||||||||||||||||
| Change in fair value of investments | (4) | 54,678 | (32,273 | ) | 79,225 | (23,654 | ) | ||||||||||||
| Gain on sale of investment | (5) | - | (443,754 | ) | - | (443,754 | ) | ||||||||||||
| Change in fair value of debt and liability instruments | (6) | (13,541 | ) | 13,145 | 27,672 | 17,730 | |||||||||||||
| Gain on termination of Sumitomo Options | (7) | - | - | - | (66,472 | ) | |||||||||||||
| Gain on deconsolidation of subsidiary | (8) | (16,762 | ) | - | (16,762 | ) | - | ||||||||||||
| Estimated income tax impact from adjustments | (9) | (2,219 | ) | (156 | ) | (346 | ) | 60 | |||||||||||
| Adjusted net loss (Non-GAAP) | $ | (226,793 | ) | $ | (289,997 | ) | $ | (437,472 | ) | $ | (423,371 | ) |
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | |||||||||||||||
| Research and development expenses | $ | 131,995 | $ | 132,098 | $ | 267,825 | $ | 210,613 | |||||||||||
| Adjustments: | |||||||||||||||||||
| Share-based compensation | (2) | 7,417 | 28,157 | 19,660 | 29,772 | ||||||||||||||
| Depreciation and amortization | (3) | 1,230 | 780 | 2,300 | 1,523 | ||||||||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 123,348 | $ | 103,161 | $ | 245,865 | $ | 179,318 |
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | |||||||||||||||
| Selling, general and administrative expenses | $ | 157,663 | $ | 437,776 | $ | 306,735 | $ | 520,530 | |||||||||||
| Adjustments: | |||||||||||||||||||
| Share-based compensation | (2) | 54,479 | 369,155 | 115,030 | 386,809 | ||||||||||||||
| Depreciation and amortization | (3) | 1,646 | 589 | 2,512 | 1,333 | ||||||||||||||
| Adjusted selling, general and administrative expenses (Non-GAAP) | $ | 101,538 | $ | 68,032 | $ | 189,193 | $ | 132,388 |
Notes to non-GAAP financial measures:
(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
(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:
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.
About Roivant Sciences
Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster
by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch "Vants" - nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com.
Roivant Sciences Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered
forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of
words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may
identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements
contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies
regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of VTAMA and our other existing and future product candidates, the timing and expectations of potential regulatory
submissions, the availability and success of topline results from our ongoing clinical trials, any commercial potential of VTAMA and our other product candidates, including but not limited to the anticipated timeline of commercial coverage of
VTAMA, the receipt of proceeds from the expected sale of the Myovant top-up shares to Sumitomo Pharma, any pending or potential litigation, including but not
limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation, and our business strategies, financial condition, and trends, competitive position, potential growth opportunities, and
expectations or probabilities for success. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give
no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks,
uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing
environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
Roivant Investor Relations