Full Press Release Details
Roivant Reports Financial Results for the First Quarter Ended June 30, 2023, and Provides Business Update
BASEL, LONDON, and NEW YORK, August 14, 2023 - Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2023, and provided an update on the business.
"This was an incredibly busy quarter with multiple clinical readouts and trial
initiations. We reported positive data from the chronic period of the Phase 2b study of RVT-3101 in ulcerative colitis, in addition to positive data from the ADORING 1 trial evaluating VTAMA in patients as young as 2 years old with
moderate-to-severe atopic dermatitis. We also initiated two separate trials, the TAHOE Phase 2 study of RVT-3101 in Crohn's disease and the
Phase 1 study of IMVT-1402 in healthy volunteers. We're incredibly excited about the progress we've made in this quarter alone and look forward to announcing additional clinical results in the upcoming months," said Matt Gline, CEO of Roivant.
"On the commercial side, we saw another three months of continued product revenue growth for the company from VTAMA sales."
Major Upcoming Milestones
First Quarter Ended June 30, 2023, Financial Summary
As of June 30, 2023, the company had consolidated cash, cash equivalents and restricted cash of $1.4
Research and Development Expenses
Research and development (R&D) expenses decreased by $10.7 million to $125.1 million for the three months ended June 30, 2023, compared to $135.8 million for the three months ended June 30, 2022, primarily due to
decreases in program-specific costs of $7.8 million and share-based compensation of $4.3 million, partially offset by an increase in other
expenses of $2.2 million.
The decrease of $7.8 million in program-specific costs largely reflects the discontinued
development of several programs, including ARU-1801, LSVT-1701 and CVT-TCR-01, as well as our reprioritization of drug discovery efforts. These decreases were partially offset by increases reflecting the progression of our programs, including
Immunovant's anti-FcRn franchise, RVT-3101, and namilumab. The asset acquisition of RVT-3101 was completed in November 2022.
Non-GAAP R&D expenses were $115.7 million for the three months ended June 30, 2023,
compared to $122.5 million for the three months ended June 30, 2022.
Acquired In-Process Research and Development Expenses
Acquired in-process research and development was $12.5 million for the three months ended June
30, 2023, relating to the achievement of development and regulatory milestones for batoclimab.
Selling, General and Administrative Expenses
Selling, general and administrative expenses (SG&A) increased by $7.1 million to $156.2 million for the three months ended June 30, 2023, compared to $149.1 million for the three months ended June 30, 2022, primarily due to a
decrease of $19.4 million of share-based compensation expense partially offset by an increase in selling, general and administrative expenses of $27.1 million at Dermavant as a result of the commercial launch of VTAMA.
Non-GAAP SG&A expenses were $113.0 million for the three months ended June 30, 2023,
compared to $87.7 million for the three months ended June 30, 2022. The majority of non-GAAP SG&A expenses were related to Dermavant's SG&A and ongoing VTAMA commercial launch
Net loss was $327.8 million for the three months ended June 30, 2023, compared to $353.8 million for the three months ended June 30, 2022. On a per common share basis, net loss was $0.38 for the three months ended June 30,
2023, and $0.48 for the three months ended June 30, 2022. Non-GAAP net loss was $211.5 million for the three months ended June 30, 2023,
compared to $210.7 million for the three months ended June 30, 2022.
ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)
| June 30, 2023 | March 31, 2023 | |||||||
| Cash, cash equivalents and restricted cash | $ | 1,449,648 | $ | 1,692,115 | ||||
| Total assets | 2,136,646 | 2,389,604 | ||||||
| Total liabilities | 802,507 | 782,017 | ||||||
| Total shareholders' equity | 1,334,139 | 1,607,587 | ||||||
| Total liabilities, redeemable noncontrolling interest and shareholders' equity | 2,136,646 | 2,389,604 |
ROIVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)
| Three Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 16,659 | $ | 141 | ||||
| License, milestone and other revenue | 4,965 | 4,178 | ||||||
| Revenue, net | $ | 21,624 | $ | 4,319 | ||||
| Operating expenses: | ||||||||
| Cost of revenues | 4,214 | 1,726 | ||||||
| Research and development (includes $7,953 and $12,243 of share-based compensation expense for the three months ended June 30, 2023 and 2022, respectively) | 125,133 | 135,830 | ||||||
| Acquired in-process research and development | 12,500 | - | ||||||
| Selling, general and administrative (includes $41,192 and $60,551 of share-based compensation expense for the three months ended June 30, 2023 and 2022, respectively) | 156,190 | 149,072 | ||||||
| Total operating expenses | 298,037 | 286,628 | ||||||
| Loss from operations | (276,413 | ) | (282,309 | ) | ||||
| Change in fair value of investments | 7,564 | 24,547 | ||||||
| Change in fair value of debt and liability instruments | 54,512 | 41,213 | ||||||
| Interest income | (16,715 | ) | (1,981 | ) | ||||
| Interest expense | 8,912 | 2,612 | ||||||
| Other (income) expense, net | (4,593 | ) | 1,085 | |||||
| Loss before income taxes | (326,093 | ) | (349,785 | ) | ||||
| Income tax expense | 1,752 | 3,999 | ||||||
| Net loss | (327,845 | ) | (353,784 | ) | ||||
| Net loss attributable to noncontrolling interests | (36,029 | ) | (21,975 | ) | ||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (291,816 | ) | $ | (331,809 | ) | ||
| Net loss per common share-basic and diluted | $ | (0.38 | ) | $ | (0.48 | ) | ||
| Weighted average shares outstanding-basic and diluted | 759,273,550 | 695,878,859 |
ROIVANT SCIENCES LTD.
Reconciliation of GAAP to Non-GAAP Financial Measures
(unaudited, in thousands)
| Three Months Ended June 30, | |||||||||||
| Note | 2023 | 2022 | |||||||||
| Net loss | $ | (327,845 | ) | $ | (353,784 | ) | |||||
| Adjustments: | |||||||||||
| Cost of revenues | |||||||||||
| Amortization of intangible assets | (1) | 2,370 | 742 | ||||||||
| Share-based compensation | (2) | 38 | - | ||||||||
| Research and development: | |||||||||||
| Share-based compensation | (2) | 7,953 | 12,243 | ||||||||
| Depreciation and amortization | (3) | 1,489 | 1,070 | ||||||||
| Selling, general and administrative: | |||||||||||
| Share-based compensation | (2) | 41,192 | 60,551 | ||||||||
| Depreciation and amortization | (3) | 1,980 | 866 | ||||||||
| Other: | |||||||||||
| Change in fair value of investments | (4) | 7,564 | 24,547 | ||||||||
| Change in fair value of debt and liability instruments | (5) | 54,512 | 41,213 | ||||||||
| Estimated income tax impact from adjustments | (6) | (732 | ) | 1,873 | |||||||
| Adjusted net loss (Non-GAAP) | $ | (211,479 | ) | $ | (210,679 | ) |
| Three Months Ended June 30, | |||||||||||
| Note | 2023 | 2022 | |||||||||
| Research and development expenses | $ | 125,133 | $ | 135,830 | |||||||
| Adjustments: | |||||||||||
| Share-based compensation | (2) | 7,953 | 12,243 | ||||||||
| Depreciation and amortization | (3) | 1,489 | 1,070 | ||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 115,691 | $ | 122,517 |
| Three Months Ended June 30, | |||||||||||
| Note | 2023 | 2022 | |||||||||
| Selling, general and administrative expenses | $ | 156,190 | $ | 149,072 | |||||||
| Adjustments: | |||||||||||
| Share-based compensation | (2) | 41,192 | 60,551 | ||||||||
| Depreciation and amortization | (3) | 1,980 | 866 | ||||||||
| Adjusted selling, general and administrative expenses (Non-GAAP) | $ | 113,018 | $ | 87,655 |
Notes to non-GAAP financial measures:
(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory
(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 (gain) loss on equity investments in unconsolidated entities that are accounted for at fair value
with changes in value reported in earnings.
(5) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized
loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.
(6) Represents the estimated tax effect of the adjustments.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 14, 2023, to report its financial results for the first
quarter ended June 30, 2023, and provide a corporate update.
To access the conference call by phone, please register online using this
registration link. The presentation and webcast details 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.
Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and
commercialization of medicines that matter. Today, Roivant's pipeline is concentrated in inflammation and immunology and includes VTAMA , a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic
dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor ("FcRn") in development across several IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody in development for
ulcerative colitis and Crohn's disease, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or "Vants" to develop and commercialize our medicines and
technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.com.
Roivant 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 our products and product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of our products and product candidates. 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