Roivant (Nasdaq: ROIV) today reported its financial results for the
second quarter ended September 30, 2023, and provided an update on
the business.
“In the last few weeks, we announced a historic
deal with Roche for the sale of Telavant for $7.25 billion. While
we intend to be very thoughtful about capital deployment, we expect
that the resulting cash will be sufficient to fund our programs
through profitability, in addition to enabling other opportunities
and investments,” said Matt Gline, CEO of Roivant. “This was also
another significant quarter for our clinical programs with a data
readout from IMVT-1402’s Phase 1 SAD study and 300 mg MAD cohort.
The data represent what we believe is the best-case scenario for
our FcRn franchise and truly broadens the horizon for what is
possible in the landscape of autoimmune therapies and for patients
suffering from autoimmune diseases. We are excited about the recent
progress and look forward to announcing additional clinical results
for 1402 and brepocitinib in the final quarter of the calendar
year. 2023 has continued to deliver on being an incredibly
catalyst-rich year, and certainly Roivant’s biggest year yet.”
Recent Developments
- Telavant: In October 2023, Roivant entered
into a definitive agreement with Roche for the sale of Telavant.
Roche will gain 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. Under
the terms of the agreement, Roche will pay a purchase price of $7.1
billion upfront and a milestone payment of $150 million payable
upon the initiation of a Phase 3 trial in ulcerative colitis.
Roivant owns 75% of the issued and outstanding shares of common
stock and preferred stock of Telavant and Pfizer owns the remaining
25%, in each case on an as-converted basis. Roivant’s net proceeds
from the transaction are expected to be approximately $5.2 billion
plus $110 million from the milestone payment. Regulatory filings in
connection with the transaction have been submitted and the closing
of the transaction remains on track for the fourth quarter of 2023
or the first quarter of 2024.
- Immunovant: In September 2023, Immunovant
announced initial data from the Phase 1 clinical trial evaluating
the safety, tolerability, and pharmacodynamic profiles of IMVT-1402
in healthy adults showed that subcutaneously administered doses of
IMVT-1402 produced dose-dependent reductions in Immunoglobulin G,
with no statistically significant dose-related decrease in serum
albumin or increase in LDL cholesterol, strengthening IMVT-1402 as
a potential best-in-class neonatal fragment crystallizable receptor
(FcRn) inhibitor. In October 2023, Immunovant announced the closing
of an underwritten public offering and concurrent private placement
offering of common stock yielding approximately $467 million in net
proceeds to Immunovant, after deducting underwriting commissions
and estimated offering expenses. Roivant owns approximately 55.2%
of Immunovant as of November 3, 2023.
-
Dermavant: For the second quarter
ended September 30, 2023, Roivant reported VTAMA net product
revenue of $18.4M, representing a 28% gross-to-net yield for the
quarter. As of November 2023, over 250,000 VTAMA prescriptions have
been written by approximately 12,800 unique prescribers for
psoriasis, based on IQVIA data. Coverage has been expanded to 137
million US commercial lives and includes coverage by all three of
the top pharmacy benefit managers.In October 2023, Dermavant
reported that in adult patients, VTAMA showed positive results from
a Phase 4 open-label trial for the treatment of intertriginous
plaque psoriasis - 82.8% achieved an intertriginous Physician
Global Assessment (iPGA) Score of 0 (clear) or 1 (almost clear) and
≥2-grade improvement from baseline at Week 12, demonstrating
compelling efficacy. Additionally, Dermavant reported in adults and
children down to two years of age with atopic dermatitis, VTAMA
showed rapid and significant onset of pruritus (itch) relief as
early as 24 hours after initial application.
- Roivant: In September 2023, Roivant raised
approximately $200 million in a follow-on offering. Roivant
reported cash, cash equivalents and restricted cash of
approximately $1.4 billion at September 30, 2023. Giving effect to
Immunovant’s October 2023 follow-on offering and expected cash
proceeds from the pending sale of Telavant (including one-time
milestone), Roivant’s cash, cash equivalents and restricted cash
would have been approximately $7.0 billion. The acquisition of
Telavant is subject to customary closing conditions and is expected
to close in the fourth quarter of 2023 or the first quarter of
2024.
Major Upcoming Milestones
- Immunovant expects
additional IMVT-1402 data from the 600 mg multiple-ascending dose
cohort in November 2023. Additionally, for batoclimab: Top-line
data from the Phase 3 clinical trial in MG are expected in the
second half of calendar year 2024. For the Phase 3 program in TED,
top-line data are expected in the first half of calendar year 2025.
Immunovant also expects to have initial results from period 1 of
the Phase 2B clinical trial in CIDP in the first half of calendar
year 2024, and initial Phase 2 proof-of-concept data in Graves’
disease by the end of calendar year 2023.
- Priovant plans to
announce topline results from the potentially registrational trial
evaluating brepocitinib for the treatment of patients with systemic
lupus erythematosus (SLE) in the fourth quarter of calendar year
2023. Priovant also 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.
- Hemavant plans to
announce data from the ongoing open-label Phase 1/2 trial
evaluating RVT-2001 for the treatment of transfusion-dependent
anemia in lower-risk myelodysplastic syndromes (MDS) patients 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.
Second Quarter Ended
September 30, 2023 Financial
Summary
Cash Position
As of September 30, 2023, the Company had consolidated
cash, cash equivalents and restricted cash of $1.4 billion.
Research and Development Expenses
Research and development expenses were $132.0 million for each
of the three months ended September 30, 2023, and 2022.
Changes in the components of research and development expenses
included a decrease in personnel-related expenses of $5.4 million
and increases in share-based compensation expense of $1.5 million
and program-specific costs of $1.2 million.
Within program-specific costs, the primary drivers of change
during the three months ended September 30, 2023 as compared
to the three months ended September 30, 2022 were an
additional expense of $18.6 million related to RVT-3101, which was
acquired in November 2022, and a decrease in expenses related to
other development and discovery programs of $18.2 million, which in
part resulted from the deconsolidation of Proteovant in August 2023
along with the reprioritization of certain programs and drug
discovery efforts.
Non-GAAP R&D expenses were $121.9 million for the three
months ended September 30, 2023, compared to $123.3 million
for the three months ended September 30, 2022.
Selling, General and Administrative
Expenses
Selling, general and administrative expenses increased by $6.7
million to $164.4 million for the three months ended
September 30, 2023, compared to $157.7 million for the three
months ended September 30, 2022, primarily due to an increase
in selling, general and administrative expenses of $21.8 million at
Dermavant as a result of the progression of the commercial launch
of VTAMA, partially offset by a decrease of $14.2 million of
share-based compensation expense.
Non-GAAP SG&A expenses were $122.1 million for the three
months ended September 30, 2023, compared to $101.5 million
for the three months ended September 30, 2022. The majority of
non-GAAP SG&A expenses were related to Dermavant’s SG&A and
ongoing VTAMA commercial launch activities.
Net Loss
Net loss was $331.1 million for the three months ended
September 30, 2023, compared to $315.9 million for the three
months ended September 30, 2022. On a per common share basis,
net loss was $0.40 for the three months ended September 30,
2023, and $0.42 for the three months ended September 30, 2022.
Non-GAAP net loss was $225.4 million for the three months ended
September 30, 2023, compared to $226.8 million for the three
months ended September 30, 2022.
ROIVANT SCIENCES
LTD.Selected Balance Sheet
Data(unaudited, in thousands)
| |
September 30, 2023 |
|
March 31, 2023 |
| |
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
1,423,188 |
|
$ |
1,692,115 |
| Total assets |
|
2,065,543 |
|
|
2,389,604 |
| Total liabilities |
|
739,910 |
|
|
782,017 |
| Total shareholders’
equity |
|
1,325,633 |
|
|
1,607,587 |
| Total liabilities and
shareholders’ equity |
|
2,065,543 |
|
|
2,389,604 |
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
| |
|
|
|
|
|
|
|
| Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
18,424 |
|
|
$ |
4,969 |
|
|
$ |
35,083 |
|
|
$ |
5,110 |
|
|
License, milestone and other revenue |
|
18,677 |
|
|
|
7,564 |
|
|
|
23,642 |
|
|
|
11,742 |
|
|
Revenue, net |
|
37,101 |
|
|
|
12,533 |
|
|
|
58,725 |
|
|
|
16,852 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
Cost of revenues |
|
3,266 |
|
|
|
3,641 |
|
|
|
7,480 |
|
|
|
5,367 |
|
|
Research and development (includes $8,877 and $7,417 of share-based
compensation expense for the three months ended September 30, 2023
and 2022 and $16,830 and $19,660 for the six months ended September
30, 2023 and 2022, respectively) |
|
131,984 |
|
|
|
131,995 |
|
|
|
257,117 |
|
|
|
267,825 |
|
|
Acquired in-process research and development |
|
13,950 |
|
|
|
— |
|
|
|
26,450 |
|
|
|
— |
|
|
Selling, general and administrative (includes $40,309 and $54,479
of share-based compensation expense for the three months ended
September 30, 2023 and 2022 and $81,501 and $115,030 for the six
months ended September 30, 2023 and 2022, respectively) |
|
164,355 |
|
|
|
157,663 |
|
|
|
320,545 |
|
|
|
306,735 |
|
|
Total operating expenses |
|
313,555 |
|
|
|
293,299 |
|
|
|
611,592 |
|
|
|
579,927 |
|
| |
|
|
|
|
|
|
|
| Loss from operations |
|
(276,454 |
) |
|
|
(280,766 |
) |
|
|
(552,867 |
) |
|
|
(563,075 |
) |
| |
|
|
|
|
|
|
|
| Change in fair value of
investments |
|
45,849 |
|
|
|
54,678 |
|
|
|
53,413 |
|
|
|
79,225 |
|
| Change in fair value of debt
and liability instruments |
|
21,533 |
|
|
|
(13,541 |
) |
|
|
76,045 |
|
|
|
27,672 |
|
| Gain on deconsolidation of
subsidiaries |
|
(17,354 |
) |
|
|
(16,762 |
) |
|
|
(17,354 |
) |
|
|
(16,762 |
) |
| Interest income |
|
(14,299 |
) |
|
|
(5,670 |
) |
|
|
(31,014 |
) |
|
|
(7,651 |
) |
| Interest expense |
|
9,247 |
|
|
|
8,335 |
|
|
|
18,159 |
|
|
|
10,947 |
|
| Other expense, net |
|
5,931 |
|
|
|
5,950 |
|
|
|
1,338 |
|
|
|
7,035 |
|
| Loss before income taxes |
|
(327,361 |
) |
|
|
(313,756 |
) |
|
|
(653,454 |
) |
|
|
(663,541 |
) |
| Income tax expense |
|
3,757 |
|
|
|
2,165 |
|
|
|
5,509 |
|
|
|
6,164 |
|
| Net loss |
|
(331,118 |
) |
|
|
(315,921 |
) |
|
|
(658,963 |
) |
|
|
(669,705 |
) |
| Net loss attributable to
noncontrolling interests |
|
(26,791 |
) |
|
|
(24,331 |
) |
|
|
(62,820 |
) |
|
|
(46,306 |
) |
| Net loss attributable to
Roivant Sciences Ltd. |
$ |
(304,327 |
) |
|
$ |
(291,590 |
) |
|
$ |
(596,143 |
) |
|
$ |
(623,399 |
) |
| Net loss per common
share—basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.89 |
) |
| Weighted average shares
outstanding—basic and diluted |
|
770,227,849 |
|
|
|
699,888,061 |
|
|
|
764,780,630 |
|
|
|
697,894,414 |
|
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 |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
|
| Net loss |
|
|
$ |
(331,118 |
) |
|
$ |
(315,921 |
) |
|
$ |
(658,963 |
) |
|
$ |
(669,705 |
) |
| Adjustments: |
|
|
|
|
|
|
|
|
|
| Cost of revenues |
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
(1 |
) |
|
|
2,399 |
|
|
|
2,200 |
|
|
|
4,769 |
|
|
|
2,942 |
|
|
Share-based compensation |
(2 |
) |
|
|
60 |
|
|
|
— |
|
|
|
98 |
|
|
|
— |
|
| Research and development: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2 |
) |
|
|
8,877 |
|
|
|
7,417 |
|
|
|
16,830 |
|
|
|
19,660 |
|
|
Depreciation and amortization |
(3 |
) |
|
|
1,205 |
|
|
|
1,230 |
|
|
|
2,694 |
|
|
|
2,300 |
|
| Selling, general and
administrative: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2 |
) |
|
|
40,309 |
|
|
|
54,479 |
|
|
|
81,501 |
|
|
|
115,030 |
|
|
Depreciation and amortization |
(3 |
) |
|
|
1,966 |
|
|
|
1,646 |
|
|
|
3,946 |
|
|
|
2,512 |
|
| Other: |
|
|
|
|
|
|
|
|
|
|
Change in fair value of investments |
(4 |
) |
|
|
45,849 |
|
|
|
54,678 |
|
|
|
53,413 |
|
|
|
79,225 |
|
|
Change in fair value of debt and liability instruments |
(5 |
) |
|
|
21,533 |
|
|
|
(13,541 |
) |
|
|
76,045 |
|
|
|
27,672 |
|
|
Gain on deconsolidation of subsidiaries |
(6 |
) |
|
|
(17,354 |
) |
|
|
(16,762 |
) |
|
|
(17,354 |
) |
|
|
(16,762 |
) |
| Estimated income tax impact
from adjustments |
(7 |
) |
|
|
884 |
|
|
|
(2,219 |
) |
|
|
152 |
|
|
|
(346 |
) |
| |
|
|
|
|
|
|
|
|
|
| Adjusted net loss
(Non-GAAP) |
|
|
$ |
(225,390 |
) |
|
$ |
(226,793 |
) |
|
$ |
(436,869 |
) |
|
$ |
(437,472 |
) |
| |
|
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
| |
Note |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
| |
|
|
|
|
|
|
|
|
|
| Research and
development expenses |
|
|
$ |
131,984 |
|
|
$ |
131,995 |
|
|
$ |
257,117 |
|
|
$ |
267,825 |
|
| Adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2 |
) |
|
|
8,877 |
|
|
|
7,417 |
|
|
|
16,830 |
|
|
|
19,660 |
|
|
Depreciation and amortization |
(3 |
) |
|
|
1,205 |
|
|
|
1,230 |
|
|
|
2,694 |
|
|
|
2,300 |
|
| |
|
|
|
|
|
|
|
|
|
| Adjusted research and
development expenses (Non-GAAP) |
|
|
$ |
121,902 |
|
|
$ |
123,348 |
|
|
$ |
237,593 |
|
|
$ |
245,865 |
|
| |
|
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
| |
Note |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
|
| Selling, general and
administrative expenses |
|
|
$ |
164,355 |
|
|
$ |
157,663 |
|
|
$ |
320,545 |
|
|
$ |
306,735 |
|
| Adjustments: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
(2 |
) |
|
|
40,309 |
|
|
|
54,479 |
|
|
|
81,501 |
|
|
|
115,030 |
|
|
Depreciation and amortization |
(3 |
) |
|
|
1,966 |
|
|
|
1,646 |
|
|
|
3,946 |
|
|
|
2,512 |
|
| |
|
|
|
|
|
|
|
|
|
| Adjusted selling,
general and administrative expenses (Non-GAAP) |
|
|
$ |
122,080 |
|
|
$ |
101,538 |
|
|
$ |
235,098 |
|
|
$ |
189,193 |
|
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 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 one-time gain on deconsolidation of
subsidiaries.
(7) 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, November 13, 2023, to report its financial
results for the second quarter ended September 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.
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, systemic lupus erythematosus, and other
autoimmune conditions; and, additional 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 the pending sale of our subsidiary Telavant to Roche (the
“Telavant Transaction”), 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.
The Telavant Transaction is subject to the expiration or
termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 and other customary closing
conditions. There can be no assurance that the Telavant Transaction
will close on the timelines specified in this presentation or at
all.
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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