Roivant (Nasdaq: ROIV) today reported its financial results for the
fourth quarter and fiscal year ended March 31, 2024, and provided a
business update.
- Once-daily brepocitinib produced the best Treatment Failure
rates observed to date among studies in active non-infectious
uveitis (NIU), supporting initiation of a pivotal program in NIU in
the second half of calendar year 2024
- Brepocitinib is well positioned to support a potential
multi-blockbuster franchise in rare and orphan autoimmune disease
with an ongoing pivotal study in dermatomyositis on track to read
out in calendar year 2025
- Following a recently completed Type B meeting with the FDA,
Immunovant is on track to initiate 4-5 potentially registrational
studies with IMVT-1402 over the fiscal year ending March 31,
2025
- Immunovant expects to announce detailed results from the study
of batoclimab in Graves’ disease (GD) as well as an overview of the
development plan of IMVT-1402 in GD in the fall of 2024
- VTAMA® sNDA submission for atopic dermatitis was accepted by
the FDA; PDUFA action is expected in the fourth quarter of calendar
year 2024, potentially enabling a four-fold market expansion
- VTAMA, approved for psoriasis, net product revenue was $75.1M
for the fiscal year ended March 31, 2024, with over 385,000
prescriptions written by over 15,300 unique prescribers since
launch
- Roivant renegotiated Dermavant’s debt obligations, reducing
potential cash payments due by over $300M in the aggregate.
Approximately $225M of this reduction is expected to be achieved
over the next three fiscal years
- Roivant has $852M in share repurchase authorization available
following the repurchase of Sumitomo’s entire stake at $9.10 per
share for $648M, which reduced outstanding shares by 9%
- Net cash used in operating activities for the quarter was
$108M
- Roivant reported its consolidated cash, cash equivalents and
restricted cash of $6.6B at March 31, 2024, supporting cash runway
into profitability
“We finished our fiscal year with yet another productive quarter
for the company,” said Matt Gline, CEO of Roivant. “The Priovant
team announced outstanding data for patients with NIU, reaffirming
our view on the blockbuster potential of brepocitinib, which we
expect will continue to deliver benefit to patients with unmet
need. Our board has approved a significant buyback program,
allowing us to return capital to shareholders and to increase
exposure to our most exciting current and future programs. I could
not be more excited for what we’ve accomplished and what I believe
we will deliver in our next chapter ahead.”
Recent Developments
- Priovant: In April
2024, Priovant announced positive results from the Phase 2 study
(NEPTUNE) evaluating brepocitinib in non-anterior non-infectious
uveitis. On the pre-specified primary efficacy endpoint of
Treatment Failure at week 24, 29% of subjects receiving
brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg
met Treatment Failure criteria (lower failure rates reflect greater
treatment benefit). The brepocitinib 45 mg results represent the
best Treatment Failure rates observed to date among studies in
active NIU measuring this registrational endpoint. All secondary
efficacy endpoints were also positive and dose responsive,
including measurements of potential benefit on prevention and
treatment of uveitic macular edema. NEPTUNE represents the seventh
positive Phase 2 study for brepocitinib with over 1,400 subjects
and patients treated with brepocitinib in clinical trials.
Brepocitinib was generally safe and well-tolerated in the study,
with no new safety or tolerability signals identified.
- Immunovant:
Following a recently completed Type B meeting with the FDA, 4-5
potentially registrational programs for IMVT-1402 are on track to
be initiated by March 31, 2025. Immunovant is prioritizing the
development of IMVT-1402 as the lead asset going forward.In March
2024, Immunovant was awarded U.S. Patent No. 11,926,669 covering
composition of matter of IMVT-1402 and its binding sequence to
FcRn, method of use of the antibody for treating autoimmune
disease, and methods for its manufacturing. Not including any
potential patent term extension, the issued composition-of-matter
patent term will extend until June 2043.
-
Dermavant: For the fourth quarter
and fiscal year ended March 31, 2024, Roivant reported VTAMA net
product revenue of $19.3M, and $75.1M, respectively. As of May
2024, over 385,000 VTAMA prescriptions have been written by over
15,300 unique prescribers for psoriasis. VTAMA is covered for over
138M US commercial lives, including coverage by all three of the
top pharmacy benefit managers.In April 2024, Dermavant announced
FDA acceptance of VTAMA’s sNDA submission for the treatment of
atopic dermatitis in adults and children 2 years of age and older.
PDUFA action is expected in the fourth quarter of calendar year
2024.In May 2024, Roivant renegotiated Dermavant’s debt
obligations, reducing potential cash payments due by over $300M in
the aggregate. Approximately $225M of this reduction is expected to
be achieved over the next three fiscal years.
- Genevant: In April 2024, the U.S. District
Court for the District of Delaware issued its claim construction
(Markman) ruling in the lawsuit brought by Genevant and Arbutus
against Moderna. The court agreed with Genevant and Arbutus’
proposed constructions for three of the four disputed terms.
- Kinevant: In April 2024, Kinevant completed
enrollment in RESOLVE-LUNG, a Phase 2 study evaluating namilumab
for chronic pulmonary sarcoidosis.
- Roivant: In April 2024, Roivant announced that
its board of directors had authorized a share repurchase program
for up to $1.5B of the company’s common shares. Pursuant to that
program, the company completed the repurchase of all 71.3M shares
held by Sumitomo Pharma at a purchase price of $9.10 per share. The
aggregate purchase price for Sumitomo Pharma’s stake was
approximately $648.4M, reducing Roivant’s shares outstanding by
approximately 9%.Roivant reported its consolidated cash, cash
equivalents and restricted cash of $6.6B at March 31, 2024. Giving
effect to the Sumitomo share repurchase, Roivant’s cash, cash
equivalents and restricted cash at March 31, 2024 would have been
approximately $5.9B.
Major Upcoming Milestones
- Dermavant expects PDUFA action for VTAMA in
atopic dermatitis in the fourth quarter of calendar year 2024.
- Kinevant plans to report topline data from the
ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis
in the fourth quarter of calendar year 2024.
- Priovant expects
topline results from the ongoing Phase 3 trial of brepocitinib in
dermatomyositis (DM) in calendar year 2025 and to initiate a Phase
3 pivotal trial of brepocitinib in the second half of calendar year
2024.
- Immunovant plans to
have initiated 4-5 potentially registrational programs by March 31,
2025, and plans to have initiated studies in a total of 10
indications by March 31, 2026 for IMVT-1402. Detailed results from
the batoclimab study in Graves’ Disease (GD) and an overview of the
development plan of IMVT-1402 in GD are expected in the fall of
2024. Immunovant expects to report topline data from the study of
batoclimab in MG over this fiscal year with further potentially
registrational development of IMVT-1402 in MG expected to begin in
the same timeframe. Immunovant has decided to run the study of
batoclimab in CIDP longer prior to unblinding period 1 in order to
better ensure that the data from the batoclimab study can be used
to optimize development of IMVT-1402 in CIDP. Top-line data from
the ongoing Phase 3 clinical trial in thyroid eye disease (TED) is
expected in the first half of calendar year 2025.
Fourth Quarter and Fiscal Year Ended March 31, 2024
Financial Summary
Cash Position
As of March 31, 2024, the company had cash, cash
equivalents and restricted cash of approximately $6.6 billion.
Research and Development Expenses
Research and development (R&D) expenses decreased by $11.0
million to $120.9 million for the three months ended March 31,
2024, compared to $131.9 million for the three months ended March
31, 2023, primarily due to a decrease in program-specific costs of
$25.8 million, partially offset by increases in share-based
compensation of $5.9 million, other expenses of $4.6 million, and
personnel-related expenses of $4.3 million.
The decrease of $25.8 million in program-specific costs was
primarily driven by a decrease of $19.8 million in other
development and discovery programs, which in part resulted from the
deconsolidation of Proteovant in August 2023 along with the
reprioritization of certain programs and drug discovery efforts.
The change also included a decrease of $5.9 million relating to
RVT-3101 as a result of the sale of the rights to further develop
and manufacture RVT-3101 to Roche in December 2023.
Non-GAAP R&D expenses were $109.7 million for the three
months ended March 31, 2024, compared to $126.0 million for the
three months ended March 31, 2023.
Research and development expenses decreased by $23.5 million to
$501.7 million for the year ended March 31, 2024, compared to
$525.2 million for the year ended March 31, 2023, primarily
due to a decrease in program-specific costs of $42.4 million,
partially offset by increases in other expenses of $10.7 million,
personnel-related expenses of $4.5 million, and share-based
compensation of $3.7 million.
The decrease of $42.4 million in program-specific costs was
primarily driven by a decrease of $83.1 million in other
development and discovery program expense, which in part resulted
from the deconsolidation of Proteovant in August 2023 along with
the reprioritization of certain programs and drug discovery
efforts. This decrease was partially offset by increases of $32.8
million relating to IMVT-1402 and $27.6 million relating to
RVT-3101, which was acquired in November 2022. The rights to
further develop and manufacture RVT-3101 were sold to Roche in
December 2023.
Non-GAAP R&D expenses were $462.6 million for the year ended
March 31, 2024, compared to $489.2 million for the year ended March
31, 2023.
Acquired In-Process Research and Development
Expenses
There was no acquired in-process research and development
(IPR&D) expense for the three months ended March 31, 2024 and
2023.
Acquired in-process research and development expenses decreased
by $71.3 million to $26.5 million for the year ended March 31,
2024, compared to $97.7 million for the year ended March 31,
2023. The decrease was primarily due to higher consideration for
the purchase of IPR&D during the year ended March 31, 2023
as a result of consideration for the purchase of IPR&D of $87.7
million relating to the acquisition of RVT-3101 in November 2022
and the achievement of a development milestone relating to
batoclimab, which resulted in a one-time milestone expense of $10.0
million. Acquired in-process research and development expenses for
the year ended March 31, 2024 was driven by $14.0 million of
consideration for the purchase of IPR&D relating to an asset
acquisition completed by a newly-formed subsidiary and $12.5
million relating to the achievement of development and regulatory
milestones for batoclimab.
Selling, General and Administrative
Expenses
Selling, general and administrative (SG&A) expenses
increased by $44.1 million to $169.6 million for the three months
ended March 31, 2024, compared to $125.5 million for the three
months ended March 31, 2023. The increase was primarily due to an
increase in share-based compensation of $15.6 million, an increase
in SG&A expenses at Dermavant of $8.5 million due to the
progression of the commercial launch of VTAMA, and an increase of
$8.5 million resulting from a special one-time cash retention bonus
award granted to employees.
Non-GAAP SG&A expenses were $131.3 million for the three
months ended March 31, 2024, compared to $102.6 million for the
three months ended March 31, 2023.
Selling, general and administrative expenses increased by $86.9
million to $687.4 million for the year ended March 31, 2024,
compared to $600.5 million for the year ended March 31, 2023.
The increase was primarily due to an increase in selling, general
and administrative expenses of $55.7 million at Dermavant as a
result of the progression of the commercial launch of VTAMA and an
increase in personnel-related expenses of $25.1 million, primarily
as a result of a special one-time cash retention bonus award
granted to employees.
Non-GAAP SG&A expenses were $514.8 million for the year
ended March 31, 2024, compared to $407.6 million for the year ended
March 31, 2023. A majority of the non-GAAP SG&A expenses of
$514.8 million were related to Dermavant’s SG&A and ongoing
VTAMA commercial launch activities.
Gain on Sale of Telavant Net Assets
Gain on sale of Telavant net assets was approximately $5.3
billion for the year ended March 31, 2024 and resulted from the
sale of our entire equity interest in Telavant to Roche in December
2023. At closing, we received approximately $5.2 billion in cash
for our pro rata portion of the consideration. Additionally, we
derecognized the carrying amount of noncontrolling interest in
Telavant of $87.5 million and transferred net liabilities of $26.5
million. This resulted in a gain of approximately $5.3 billion.
Income (Loss) from Continuing Operations
Loss from continuing operations was $182.5 million for the three
months ended March 31, 2024, compared to $175.4 million for the
three months ended March 31, 2023. On a per common share basis,
loss from continuing operations was $0.19 and $0.20 for the three
months ended March 31, 2024 and 2023, respectively. Non-GAAP loss
from continuing operations was $188.1 million for the three months
ended March 31, 2024, compared to $189.4 million for the three
months ended March 31, 2023.
Income from continuing operations was approximately $4.2 billion
for the year ended March 31, 2024, compared to a loss from
continuing operations of $1.2 billion for the year ended March 31,
2023. On a basic and diluted per common share basis, income from
continuing operations was $5.55 and $5.23, respectively, for the
year ended March 31, 2024. On a per common share basis, loss from
continuing operations was $1.58 for the year ended March 31, 2023.
Non-GAAP loss from continuing operations was $799.9 million for the
year ended March 31, 2024, compared to $924.3 million for the year
ended March 31, 2023.
|
ROIVANT SCIENCES LTD.Selected Balance
Sheet Data(in thousands) |
| |
| |
March 31, 2024 |
|
March 31, 2023 |
| |
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
6,550,450 |
|
$ |
1,692,115 |
| Total assets |
|
7,222,482 |
|
|
2,389,604 |
| Total liabilities |
|
773,953 |
|
|
782,017 |
| Total shareholders’
equity |
|
6,448,529 |
|
|
1,607,587 |
| Total liabilities and
shareholders’ equity |
|
7,222,482 |
|
|
2,389,604 |
| |
|
|
|
|
|
|
ROIVANT SCIENCES LTD.Consolidated
Statements of Operations(in thousands, except share and
per share amounts) |
| |
| |
Three Months Ended March 31, |
|
Years Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
(Unaudited) |
|
(Unaudited) |
|
|
|
|
| Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
19,308 |
|
|
$ |
13,657 |
|
|
$ |
75,057 |
|
|
$ |
28,011 |
|
|
License, milestone and other revenue |
|
9,622 |
|
|
|
13,719 |
|
|
|
49,738 |
|
|
|
33,269 |
|
|
Revenue, net |
|
28,930 |
|
|
|
27,376 |
|
|
|
124,795 |
|
|
|
61,280 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
Cost of revenues |
|
4,412 |
|
|
|
4,175 |
|
|
|
15,560 |
|
|
|
13,128 |
|
|
Research and development (includes $10,290 and $4,366 of
share-based compensation expense for the three months ended March
31, 2024 and 2023, respectively, and $34,595 and $30,914 of
share-based compensation expense for the years ended March 31, 2024
and 2023, respectively) |
|
120,902 |
|
|
|
131,857 |
|
|
|
501,736 |
|
|
|
525,215 |
|
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
26,450 |
|
|
|
97,749 |
|
|
Selling, general and administrative (includes $36,396 and $20,832
of share-based compensation expense for the three months ended
March 31, 2024 and 2023, respectively, and $164,841 and $186,603 of
share-based compensation expense for the years ended March 31, 2024
and 2023, respectively) |
|
169,616 |
|
|
|
125,510 |
|
|
|
687,443 |
|
|
|
600,506 |
|
|
Total operating expenses |
|
294,930 |
|
|
|
261,542 |
|
|
|
1,231,189 |
|
|
|
1,236,598 |
|
| |
|
|
|
|
|
|
|
| Gain on sale of Telavant net
assets |
|
— |
|
|
|
— |
|
|
|
5,348,410 |
|
|
|
— |
|
| |
|
|
|
|
|
|
|
| (Loss) income from
operations |
|
(266,000 |
) |
|
|
(234,166 |
) |
|
|
4,242,016 |
|
|
|
(1,175,318 |
) |
| |
|
|
|
|
|
|
|
| Change in fair value of
investments |
|
(15,907 |
) |
|
|
(32,462 |
) |
|
|
47,973 |
|
|
|
20,815 |
|
| Change in fair value of debt
and liability instruments |
|
(6,433 |
) |
|
|
(12,031 |
) |
|
|
78,943 |
|
|
|
78,001 |
|
| Gain on deconsolidation of
subsidiaries |
|
(15,418 |
) |
|
|
— |
|
|
|
(32,772 |
) |
|
|
(29,276 |
) |
| Interest income |
|
(83,458 |
) |
|
|
(14,284 |
) |
|
|
(146,425 |
) |
|
|
(32,184 |
) |
| Interest expense |
|
7,175 |
|
|
|
8,575 |
|
|
|
34,778 |
|
|
|
27,968 |
|
| Other expense (income),
net |
|
39,494 |
|
|
|
(4,748 |
) |
|
|
6,089 |
|
|
|
(15,808 |
) |
| (Loss) income from continuing
operations before income taxes |
|
(191,453 |
) |
|
|
(179,216 |
) |
|
|
4,253,430 |
|
|
|
(1,224,834 |
) |
| Income tax (benefit)
expense |
|
(8,957 |
) |
|
|
(3,793 |
) |
|
|
22,224 |
|
|
|
5,190 |
|
| (Loss) income from continuing
operations, net of tax |
|
(182,496 |
) |
|
|
(175,423 |
) |
|
|
4,231,206 |
|
|
|
(1,230,024 |
) |
| Income from discontinued
operations, net of tax |
|
— |
|
|
|
114,561 |
|
|
|
— |
|
|
|
114,561 |
|
| Net (loss) income |
|
(182,496 |
) |
|
|
(60,862 |
) |
|
|
4,231,206 |
|
|
|
(1,115,463 |
) |
| Net loss attributable to
noncontrolling interests |
|
(31,381 |
) |
|
|
(27,245 |
) |
|
|
(117,720 |
) |
|
|
(106,433 |
) |
| Net (loss) income attributable
to Roivant Sciences Ltd. |
$ |
(151,115 |
) |
|
$ |
(33,617 |
) |
|
$ |
4,348,926 |
|
|
$ |
(1,009,030 |
) |
| |
|
|
|
|
|
|
|
| Amounts attributable to
Roivant Sciences Ltd.: |
|
|
|
|
|
|
|
| (Loss) income from continuing
operations, net of tax |
$ |
(151,115 |
) |
|
$ |
(148,178 |
) |
|
$ |
4,348,926 |
|
|
$ |
(1,123,591 |
) |
| Income from discontinued
operations, net of tax |
|
— |
|
|
|
114,561 |
|
|
|
— |
|
|
|
114,561 |
|
| Net (loss) income attributable
to Roivant Sciences Ltd. |
$ |
(151,115 |
) |
|
$ |
(33,617 |
) |
|
$ |
4,348,926 |
|
|
$ |
(1,009,030 |
) |
| |
|
|
|
|
|
|
|
| Net (loss) income per common
share, basic: |
|
|
|
|
|
|
|
|
(Loss) income from continuing operations |
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
5.55 |
|
|
$ |
(1.58 |
) |
|
Income from discontinued operations, net of tax |
$ |
— |
|
|
$ |
0.15 |
|
|
$ |
— |
|
|
$ |
0.16 |
|
|
Net (loss) income |
$ |
(0.19 |
) |
|
$ |
(0.05 |
) |
|
$ |
5.55 |
|
|
$ |
(1.42 |
) |
| Net (loss) income per common
share, diluted: |
|
|
|
|
|
|
|
|
(Loss) income from continuing operations |
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
5.23 |
|
|
$ |
(1.58 |
) |
|
Income from discontinued operations, net of tax |
$ |
— |
|
|
$ |
0.15 |
|
|
$ |
— |
|
|
$ |
0.16 |
|
|
Net (loss) income |
$ |
(0.19 |
) |
|
$ |
(0.05 |
) |
|
$ |
5.23 |
|
|
$ |
(1.42 |
) |
| Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
802,859,062 |
|
|
|
742,541,052 |
|
|
|
783,248,906 |
|
|
|
712,791,115 |
|
|
Diluted |
|
802,859,062 |
|
|
|
742,541,052 |
|
|
|
831,049,444 |
|
|
|
712,791,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ROIVANT SCIENCES LTD.Reconciliation of
GAAP to Non-GAAP Financial Measures(unaudited, in
thousands) |
| |
| |
|
|
Three Months Ended March 31, |
|
Years Ended March 31, |
|
|
Note |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
|
|
|
|
|
|
|
|
| (Loss) income from
continuing operations, net of tax |
|
|
$ |
(182,496 |
) |
|
$ |
(175,423 |
) |
|
$ |
4,231,206 |
|
|
$ |
(1,230,024 |
) |
| Adjustments: |
|
|
|
|
|
|
|
|
|
| Cost of revenues: |
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
(1) |
|
|
2,421 |
|
|
|
2,298 |
|
|
|
9,632 |
|
|
|
7,468 |
|
|
Share-based compensation |
(2) |
|
|
38 |
|
|
|
37 |
|
|
|
191 |
|
|
|
95 |
|
| Research and development: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
10,290 |
|
|
|
4,366 |
|
|
|
34,595 |
|
|
|
30,914 |
|
|
Depreciation and amortization |
(3) |
|
|
873 |
|
|
|
1,539 |
|
|
|
4,590 |
|
|
|
5,097 |
|
| Selling, general and
administrative: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
36,396 |
|
|
|
20,832 |
|
|
|
164,841 |
|
|
|
186,603 |
|
|
Depreciation and amortization |
(3) |
|
|
1,912 |
|
|
|
2,116 |
|
|
|
7,814 |
|
|
|
6,292 |
|
| Gain on sale of Telavant net
assets |
(4) |
|
|
— |
|
|
|
— |
|
|
|
(5,348,410 |
) |
|
|
— |
|
| Other: |
|
|
|
|
|
|
|
|
|
|
Change in fair value of investments |
(5) |
|
|
(15,907 |
) |
|
|
(32,462 |
) |
|
|
47,973 |
|
|
|
20,815 |
|
|
Change in fair value of debt and liability instruments |
(6) |
|
|
(6,433 |
) |
|
|
(12,031 |
) |
|
|
78,943 |
|
|
|
78,001 |
|
|
Gain on deconsolidation of subsidiaries |
(7) |
|
|
(15,418 |
) |
|
|
— |
|
|
|
(32,772 |
) |
|
|
(29,276 |
) |
| Estimated income tax impact
from adjustments |
(8) |
|
|
(19,813 |
) |
|
|
(704 |
) |
|
|
1,538 |
|
|
|
(294 |
) |
| |
|
|
|
|
|
|
|
|
|
| Adjusted loss from
continuing operations, net of tax (Non-GAAP) |
|
|
$ |
(188,137 |
) |
|
$ |
(189,432 |
) |
|
$ |
(799,859 |
) |
|
$ |
(924,309 |
) |
| |
| |
|
|
Three Months Ended March 31, |
|
Years Ended March 31, |
|
|
Note |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
$ |
120,902 |
|
|
$ |
131,857 |
|
|
$ |
501,736 |
|
|
$ |
525,215 |
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
10,290 |
|
|
|
4,366 |
|
|
|
34,595 |
|
|
|
30,914 |
|
|
Depreciation and amortization |
(3) |
|
|
873 |
|
|
|
1,539 |
|
|
|
4,590 |
|
|
|
5,097 |
|
| |
|
|
|
|
|
|
|
|
|
|
Adjusted research and development expenses
(Non-GAAP) |
|
|
$ |
109,739 |
|
|
$ |
125,952 |
|
|
$ |
462,551 |
|
|
$ |
489,204 |
|
| |
| |
|
|
Three Months Ended March 31, |
|
Years Ended March 31, |
|
|
Note |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
|
|
|
|
|
|
|
|
| Selling, general and
administrative expenses |
|
|
$ |
169,616 |
|
|
$ |
125,510 |
|
|
$ |
687,443 |
|
|
$ |
600,506 |
|
| Adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
36,396 |
|
|
|
20,832 |
|
|
|
164,841 |
|
|
|
186,603 |
|
|
Depreciation and amortization |
(3) |
|
|
1,912 |
|
|
|
2,116 |
|
|
|
7,814 |
|
|
|
6,292 |
|
| |
|
|
|
|
|
|
|
|
|
| Adjusted selling,
general and administrative expenses (Non-GAAP) |
|
|
$ |
131,308 |
|
|
$ |
102,562 |
|
|
$ |
514,788 |
|
|
$ |
407,611 |
|
| |
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 a one-time gain on the sale of Telavant net
assets to Roche in December 2023.
(5) 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.
(6) 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.
(7) Represents the one-time gain on deconsolidation of
subsidiaries.
(8) Represents the estimated tax effect of the adjustments.
Roivant will also present at two additional upcoming investor
conferences:
- Fireside Chat at Jefferies Global Healthcare Conference in New
York at 11:30 a.m. ET on June 5, 2024
- Fireside Chat at Goldman Sachs 45th Annual Global Healthcare
Conference in Miami at 8:40 a.m. ET on June 10, 2024
Investor Conference Call InformationRoivant
will host a live conference call and webcast at 8:00 a.m. ET on
Thursday, May 30, 2024, to report its financial results for the
fourth quarter and fiscal year ended March 31, 2024, 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.
About Roivant 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 includes VTAMA, a
novel topical approved for the treatment of psoriasis and in
development for the treatment of atopic dermatitis; IMVT-1402 and
batoclimab, fully human monoclonal antibodies targeting the
neonatal Fc receptor (“FcRn”) in development across several
IgG-mediated autoimmune indications; and brepocitinib, a potent
small molecule inhibitor of TYK2 and JAK1 for the treatment of
dermatomyositis and non-infectious uveitis, in addition to other
clinical stage molecules. 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, 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 potential share repurchases, the clinical and therapeutic
potential of our products and product candidates, the availability
and success of topline results from our ongoing clinical trials,
any commercial potential of our products and product candidates and
the benefits expected to be realized from Dermavant’s renegotiation
of its existing debt obligations. 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.
Contacts:InvestorsRoivant Investor
Relationsir@roivant.com
MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com
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