Roivant (Nasdaq: ROIV) today reported its financial results for the
third quarter ended December 31, 2023, and provided a business
update.
- Roivant completed the sale of
Telavant to Roche for $7.1B with an additional $150M in cash
payable upon the completion of a near-term milestone
- Batoclimab produced positive
results in Graves’ disease with response rates meaningfully
exceeding 50% in the initial cohort of an ongoing 24-week Phase 2
trial
- VTAMA® (tapinarof) cream, 1% net product revenue was $20.7M for
the quarter ended December 31, 2023, with over 300,000
prescriptions written by approximately 14,000 unique prescribers
since launch
- New VTAMA positive long-term efficacy and safety data announced
from analyses of the ADORING Phase 3 program in atopic dermatitis.
Data from these analyses will be included in sNDA submission
expected this quarter
- Brepocitinib topline data from the Phase 2 trial in patients
with non-infectious uveitis (NIU) is expected this quarter
- Roivant reported its consolidated cash, cash equivalents and
restricted cash of $6.7B at December 31, 2023, supporting cash
runway into profitability
“This was another productive quarter across the
company - we were pleased to announce the closing of the Telavant
transaction with Roche in December. I am proud of our continued
progress in clinical development, with another positive result
generated by the Immunovant team in Graves’ disease. The positive
initial data continues to support our view of the broad
applicability of FcRn and the potentially meaningful clinical
benefits associated with deeper IgG suppression,” said Matt Gline,
CEO of Roivant. “Looking ahead, we are excited about multiple
upcoming clinical data readouts and other catalysts expected this
year, as well as the prospect of expanding our clinical pipeline.
2024 will be a year of growth for Roivant.”
Recent Developments
- Roivant: In
December 2023, Roivant announced the completion of the sale of
Telavant to Roche for an upfront payment of approximately $7.1
billion with an additional $150 million in cash payable upon the
completion of a near-term milestone. Under the terms of the
agreement, Roche gained the rights to develop, manufacture and
commercialize RVT-3101 in the US and Japan for the treatment of
inflammatory bowel disease and potentially other diseases. Prior to
the closing of the transaction, Roivant owned 75% of the issued and
outstanding shares of common stock and preferred stock of Telavant
and Pfizer owned the remaining 25%, in each case on an as-converted
basis. Roivant’s net cash proceeds from the transaction are
approximately $5.2 billion. Approximately $110 million of the
additional milestone payment will be payable to Roivant.Roivant
reported its consolidated cash, cash equivalents and restricted
cash of $6.7 billion at December 31, 2023.
- Immunovant: In November 2023, Immunovant
reported IMVT-1402, a second-generation antibody targeting the
neonatal fragment crystallizable receptor (FcRn), continued to show
potentially best-in-class profile in a Phase 1 clinical trial in
healthy adults. Initial data from the 600 mg MAD cohort showed that
four subcutaneously administered doses of 600 mg IMVT-1402 reduced
total immunoglobulin G (IgG) levels by a mean of 74%, very similar
to the 76% IgG reduction after four weekly injections of 680 mg
batoclimab, but with no or minimal changes in serum albumin and LDL
cholesterol, consistent with observations in placebo.In December
2023, Immunovant reported in an open-label Phase 2 proof-of-concept
clinical trial of batoclimab in Graves’ disease, response rates
from an initial cohort of patients who were hyperthyroid despite
treatment with an anti-thyroid medication for more than 12 weeks
were meaningfully higher than 50 percent, after receiving
once-weekly subcutaneous injections of 680 mg batoclimab for 12
weeks. This trial is ongoing.
-
Dermavant: For the third quarter
ended December 31, 2023, Roivant reported VTAMA net product revenue
of $20.7M, representing a 28.5% gross-to-net yield for the quarter.
As of February 2024, over 300,000 VTAMA prescriptions1 have been
written by approximately 14,000 unique prescribers for psoriasis2,
based on IQVIA data. VTAMA is covered for 137 million US commercial
lives, including coverage by all three of the top pharmacy benefit
managers.In January 2024, Dermavant announced new positive efficacy
and safety data from analyses of ADORING 3, an ongoing open-label,
long-term extension Phase 3 trial being conducted to evaluate the
safety and efficacy of VTAMA cream, 1% in patients with AD for up
to 48 weeks of total treatment. The integrated analysis across the
ADORING development program showed that efficacy continued to
improve beyond the 8-week double blind treatment period in ADORING
1 and ADORING 2 across multiple endpoints including:
- vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a
2-grade improvement from baseline was observed in 73% (519/711) of
patients included
- 80.7% (574/711) of patients achieved at least a 75% improvement
in the Eczema Area and Severity Index (EASI75)
- 77.9% (218/280) of patients ≥12 years old with a baseline Peak
Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point
reduction in PP-NRS
- 92.3% (656/711) of patients achieved at least a 1-grade
improvement in vIGA-AD scoreThe interim analysis of the ADORING 3
open-label, long-term extension Phase 3 trial demonstrated that
51.2% (373/728) of patients achieved complete disease clearance
(vIGA-AD score of 0). No new safety signals were observed with up
to 56 weeks of treatment. Data from these analyses will be included
in sNDA submission expected this quarter.
- Hemavant: We have discontinued the development
of RVT-2001 after an interim data analysis from the Phase 1/2
study.
Major Upcoming Milestones
- Immunovant expects
initial results from period 1 of the Phase 2b clinical trial of
batoclimab in CIDP in the second or third quarter of calendar year
2024, while top-line data from the Phase 3 clinical trials of
batoclimab in MG and TED are on track and expected in the second
half of calendar year 2024 and the first half of calendar year
2025, respectively. For IMVT-1402, Immunovant plans to initiate 4-5
potentially registrational programs by March 31, 2025 and plans to
initiate trials in 10 indications by March 31, 2026 (inclusive of
the 4-5 potentially registrational programs).
- Priovant expects to
announce topline results from the Phase 2 POC study in
non-infectious uveitis (NIU) in the first quarter of calendar year
2024 and topline results from the Phase 3 trial in dermatomyositis
(DM) in calendar year 2025.
- Dermavant plans to submit its sNDA for VTAMA
in atopic dermatitis to the FDA in the first 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 second half of calendar year 2024.
Third Quarter
Ended December 31, 2023 Financial
SummaryCash PositionAs of
December 31, 2023, the Company had consolidated cash, cash
equivalents and restricted cash of $6.7 billion.
Research and Development
ExpensesResearch and development expenses decreased by
$1.8 million to $123.7 million for the three months ended
December 31, 2023, compared to $125.5 million for the three
months ended December 31, 2022. Changes in the components of
research and development expenses included a decrease in
program-specific costs of $10.0 million offset by increases in
personnel-related expenses of $6.5 million and other expenses of
$1.1 million.
Within program-specific costs, the decrease of
$10.0 million was primarily driven by a decrease of $9.5 million
related to other development and discovery programs due to the
deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in
August 2023, along with the reprioritization of certain programs
and drug discovery efforts, and decreases of $3.1 million each
related to RVT-2001 and batoclimab. These decreases were partially
offset by an increase in expense of $4.0 million related to
RVT-3101, which was acquired in November 2022, and an increase of
$3.5 million related to IMVT-1402. The rights to further develop
and manufacture RVT-3101 were sold to Roche in December 2023.
The increase of $6.5 million in
personnel-related expenses was primarily driven by a special
one-time cash retention bonus award granted to employees during the
three months ended December 31, 2023.
Non-GAAP R&D expenses were $115.2 million
for the three months ended December 31, 2023, compared to
$117.4 million for the three months ended December 31,
2022.
Selling, General and Administrative
ExpensesSelling, general and administrative expenses
increased by $29.0 million to $197.3 million for the three months
ended December 31, 2023, compared to $168.3 million for the
three months ended December 31, 2022, primarily due to an
increase in personnel-related expenses of $27.0 million as a result
of a special one-time cash retention bonus award granted to
employees.
Non-GAAP SG&A expenses were $148.4 million
for the three months ended December 31, 2023, compared to
$115.9 million for the three months ended December 31,
2022.
Gain on Sale of Telavant Net
AssetsGain on sale of Telavant net assets 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.
Net Income (Loss)Net income was
approximately $5.1 billion for the three months ended
December 31, 2023, compared to a net loss of $384.9 million
for the three months ended December 31, 2022. On a basic and
diluted per common share basis, net income was $6.37 and $6.03,
respectively, for the three months ended December 31, 2023.
Basic and diluted net loss per common share was $0.49 for the three
months ended December 31, 2022. Non-GAAP net loss was $174.9
million for the three months ended December 31, 2023, compared
to $297.5 million for the three months ended December 31,
2022.
ROIVANT SCIENCES LTD. |
Selected Balance Sheet Data |
(unaudited, in thousands) |
|
|
December 31, 2023 |
|
March 31, 2023 |
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
6,685,458 |
|
$ |
1,692,115 |
Total assets |
|
7,312,679 |
|
|
2,389,604 |
Total liabilities |
|
728,097 |
|
|
782,017 |
Total shareholders’
equity |
|
6,584,582 |
|
|
1,607,587 |
Total liabilities and
shareholders’ equity |
|
7,312,679 |
|
|
2,389,604 |
|
|
|
|
|
|
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, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
20,666 |
|
|
$ |
9,244 |
|
|
$ |
55,749 |
|
|
$ |
14,354 |
|
License, milestone and other revenue |
|
16,474 |
|
|
|
7,808 |
|
|
|
40,116 |
|
|
|
19,550 |
|
Revenue, net |
|
37,140 |
|
|
|
17,052 |
|
|
|
95,865 |
|
|
|
33,904 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of revenues |
|
3,668 |
|
|
|
3,586 |
|
|
|
11,148 |
|
|
|
8,953 |
|
Research and development (includes $7,475 and $6,888 of share-based
compensation expense for the three months ended December 31, 2023
and 2022 and $24,305 and $26,548 for the nine months ended December
31, 2023 and 2022, respectively) |
|
123,717 |
|
|
|
125,533 |
|
|
|
380,834 |
|
|
|
393,358 |
|
Acquired in-process research and development |
|
— |
|
|
|
97,749 |
|
|
|
26,450 |
|
|
|
97,749 |
|
Selling, general and administrative (includes $46,944 and $50,741
of share-based compensation expense for the three months ended
December 31, 2023 and 2022 and $128,445 and $165,771 for the nine
months ended December 31, 2023 and 2022, respectively) |
|
197,282 |
|
|
|
168,261 |
|
|
|
517,827 |
|
|
|
474,996 |
|
Total operating expenses |
|
324,667 |
|
|
|
395,129 |
|
|
|
936,259 |
|
|
|
975,056 |
|
|
|
|
|
|
|
|
|
Gain on sale of Telavant net
assets |
|
5,348,410 |
|
|
|
— |
|
|
|
5,348,410 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Income (loss) from
operations |
|
5,060,883 |
|
|
|
(378,077 |
) |
|
|
4,508,016 |
|
|
|
(941,152 |
) |
|
|
|
|
|
|
|
|
Change in fair value of
investments |
|
10,467 |
|
|
|
(25,948 |
) |
|
|
63,880 |
|
|
|
53,277 |
|
Change in fair value of debt
and liability instruments |
|
9,331 |
|
|
|
62,360 |
|
|
|
85,376 |
|
|
|
90,032 |
|
Gain on deconsolidation of
subsidiaries |
|
— |
|
|
|
(12,514 |
) |
|
|
(17,354 |
) |
|
|
(29,276 |
) |
Interest income |
|
(31,953 |
) |
|
|
(10,249 |
) |
|
|
(62,967 |
) |
|
|
(17,900 |
) |
Interest expense |
|
9,444 |
|
|
|
8,446 |
|
|
|
27,603 |
|
|
|
19,393 |
|
Other income, net |
|
(34,743 |
) |
|
|
(18,095 |
) |
|
|
(33,405 |
) |
|
|
(11,060 |
) |
Net income (loss) before
income taxes |
|
5,098,337 |
|
|
|
(382,077 |
) |
|
|
4,444,883 |
|
|
|
(1,045,618 |
) |
Income tax expense |
|
25,672 |
|
|
|
2,819 |
|
|
|
31,181 |
|
|
|
8,983 |
|
Net income (loss) |
|
5,072,665 |
|
|
|
(384,896 |
) |
|
|
4,413,702 |
|
|
|
(1,054,601 |
) |
Net loss attributable to
noncontrolling interests |
|
(23,519 |
) |
|
|
(32,882 |
) |
|
|
(86,339 |
) |
|
|
(79,188 |
) |
Net income (loss) attributable
to Roivant Sciences Ltd. |
$ |
5,096,184 |
|
|
$ |
(352,014 |
) |
|
$ |
4,500,041 |
|
|
$ |
(975,413 |
) |
|
|
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
|
|
Basic |
$ |
6.37 |
|
|
$ |
(0.49 |
) |
|
$ |
5.79 |
|
|
$ |
(1.39 |
) |
Diluted |
$ |
6.03 |
|
|
$ |
(0.49 |
) |
|
$ |
5.46 |
|
|
$ |
(1.39 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
800,587,716 |
|
|
|
713,319,399 |
|
|
|
776,759,728 |
|
|
|
703,054,773 |
|
Diluted |
|
844,461,685 |
|
|
|
713,319,399 |
|
|
|
824,310,013 |
|
|
|
703,054,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
$ |
5,072,665 |
|
|
$ |
(384,896 |
) |
|
$ |
4,413,702 |
|
|
$ |
(1,054,601 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
(1) |
|
|
2,442 |
|
|
|
2,228 |
|
|
|
7,211 |
|
|
|
5,170 |
|
Share-based compensation |
(2) |
|
|
55 |
|
|
|
— |
|
|
|
153 |
|
|
|
— |
|
Research and development: |
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
7,475 |
|
|
|
6,888 |
|
|
|
24,305 |
|
|
|
26,548 |
|
Depreciation and amortization |
(3) |
|
|
1,023 |
|
|
|
1,258 |
|
|
|
3,717 |
|
|
|
3,558 |
|
Selling, general and
administrative: |
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
46,944 |
|
|
|
50,741 |
|
|
|
128,445 |
|
|
|
165,771 |
|
Depreciation and amortization |
(3) |
|
|
1,956 |
|
|
|
1,664 |
|
|
|
5,902 |
|
|
|
4,176 |
|
Gain on sale of Telavant net
assets |
(4) |
|
|
(5,348,410 |
) |
|
|
— |
|
|
|
(5,348,410 |
) |
|
|
— |
|
Other: |
|
|
|
|
|
|
|
|
|
Change in fair value of investments |
(5) |
|
|
10,467 |
|
|
|
(25,948 |
) |
|
|
63,880 |
|
|
|
53,277 |
|
Change in fair value of debt and liability instruments |
(6) |
|
|
9,331 |
|
|
|
62,360 |
|
|
|
85,376 |
|
|
|
90,032 |
|
Gain on deconsolidation of subsidiaries |
(7) |
|
|
— |
|
|
|
(12,514 |
) |
|
|
(17,354 |
) |
|
|
(29,276 |
) |
Estimated income tax impact
from adjustments |
(8) |
|
|
21,199 |
|
|
|
756 |
|
|
|
21,351 |
|
|
|
410 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted net loss
(Non-GAAP) |
|
|
$ |
(174,853 |
) |
|
$ |
(297,463 |
) |
|
$ |
(611,722 |
) |
|
$ |
(734,935 |
) |
|
|
|
|
Three Months Ended December 31, |
|
Nine Months Ended December 31, |
|
Note |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
$ |
123,717 |
|
|
$ |
125,533 |
|
|
$ |
380,834 |
|
|
$ |
393,358 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
7,475 |
|
|
|
6,888 |
|
|
|
24,305 |
|
|
|
26,548 |
|
Depreciation and amortization |
(3) |
|
|
1,023 |
|
|
|
1,258 |
|
|
|
3,717 |
|
|
|
3,558 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted research and
development expenses (Non-GAAP) |
|
|
$ |
115,219 |
|
|
$ |
117,387 |
|
|
$ |
352,812 |
|
|
$ |
363,252 |
|
|
|
|
|
Three Months Ended December 31, |
|
Nine Months Ended December 31, |
|
Note |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
|
$ |
197,282 |
|
|
$ |
168,261 |
|
|
$ |
517,827 |
|
|
$ |
474,996 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2) |
|
|
46,944 |
|
|
|
50,741 |
|
|
|
128,445 |
|
|
|
165,771 |
|
Depreciation and amortization |
(3) |
|
|
1,956 |
|
|
|
1,664 |
|
|
|
5,902 |
|
|
|
4,176 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted selling,
general and administrative expenses (Non-GAAP) |
|
|
$ |
148,382 |
|
|
$ |
115,856 |
|
|
$ |
383,480 |
|
|
$ |
305,049 |
|
|
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 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.
Investor Conference Call
InformationRoivant will host a live conference call and
webcast at 8:00 a.m. ET on Tuesday, February 13, 2024, to report
its financial results for the third quarter ended December 31,
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.
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; batoclimab and IMVT-1402, fully human monoclonal
antibodies targeting the neonatal Fc receptor (“FcRn”) in
development across several IgG-mediated autoimmune indications;
brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development
for dermatomyositis and other autoimmune conditions, 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,” “suggest,” “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, plans to develop our product
candidates for particular indications, the availability and success
of topline results from our ongoing clinical trials, cash runway
and profitability 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.
Contacts:InvestorsRoivant Investor
Relationsir@roivant.com
MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com
1 IQVIA National Prescription Audit (NPA) for the 3-month period
ending 1/26/2024, reflecting estimates of real-world activity. All
rights reserved.2 NPA for the period 5/20/22 to 1/19/2024,
reflecting estimates of real-world activity. All rights
reserved.
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