UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549


FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): February 10, 2025


Roivant Sciences Ltd.
(Exact Name of Registrant as Specified in Charter)


Bermuda
001-40782
98-1173944
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

7th Floor
50 Broadway
London SW1H 0DB
United Kingdom
(Address of Principal Executive Offices, and Zip Code)

+44 207 400-3347
Registrant’s Telephone Number, Including Area Code

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

  ☐
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

  ☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

  ☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

  ☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Common Shares, $0.0000000341740141 par value per share
   ROIV
   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 2.02.
Results of Operations and Financial Condition.

On February 10, 2025, Roivant Sciences Ltd. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended December 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth under this “Item 2.02. Results of Operations and Financial Condition” (including the exhibit thereto) shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended, other than to the extent that such filing incorporates by reference any or all of such information by express reference thereto.

Item 9.01.
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit No.
  
Description of Exhibit
     
 
Roivant Sciences Ltd. Press Release, dated February 10, 2025
104
  
Cover Page Interactive Data File (embedded with Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ROIVANT SCIENCES LTD.
  
   
By:
/s/ Keyur Parekh
  
Name:
Keyur Parekh
  
Title:
Authorized Signatory
  

 
Dated: February 10, 2025
  


Exhibit 99.1


Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update

BASEL, LONDON and NEW YORK, February 10, 2025 – Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2024, and provided a business update.


 •
Brepocitinib to be developed in third indication, cutaneous sarcoidosis (CS), an orphan indication with high unmet need; Phase 2 study initiation expected in second quarter of calendar year with topline data in second half of calendar year 2026

•
IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiated

•
Batoclimab topline results from pivotal trial in myasthenia gravis (MG) and initial results from period 1 of trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025

•
Progress in ongoing LNP litigation, with the summary judgment phase in the Moderna case taking place across the second and third quarters of calendar year 2025 and a jury trial scheduled for September 2025

•
Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement

“Roivant has broadened our clinical pipeline with the newly announced trial of brepocitinib in cutaneous sarcoidosis. As with dermatomyositis and non-infectious uveitis, brepocitinib has the potential to be a first-in-class agent for CS and expands the treatment options for patients suffering from an indication with high unmet need,” said Matt Gline, CEO of Roivant. “We also look forward to announcing multiple significant study outcomes this year including for batoclimab in MG, CIDP and TED, and for brepocitinib in dermatomyositis. 2025 is a year of harvest for Roivant.”

Recent Developments

 •
Immunovant:
In January 2025, Immunovant announced a $450 million private placement with participation from a U.S.-based healthcare focused investor, a large mutual fund complex, and Roivant, bringing Roivant’s basic ownership up to approximately 57%.

Endocrinology Program
Immunovant recently initiated the first potentially registrational trial of IMVT-1402 in adult participants with GD who are hyperthyroid despite antithyroid drug (ATD) treatment. This study builds on the batoclimab proof-of-concept data presented in 2024, which suggest the potential for deep IgG reduction in the treatment of GD for patients who are not well controlled on ATDs.

Rheumatology Program
Immunovant recently initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive difficult-to-treat rheumatoid arthritis. The trial includes IMVT-1402’s higher dose (600 mg) as recent in-class data suggest that deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor.


 •
Priovant: In February 2025, Priovant announced a Phase 2 study of the safety and efficacy of brepocitinib in adults with cutaneous sarcoidosis. Cutaneous sarcoidosis marks the third indication for brepocitinib and continues the strategy to develop the drug in orphan indications with high unmet need. There are 30,000 to 50,000 patients in the US affected by cutaneous sarcoidosis with no approved therapies. The trial is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026.


•
Genevant: The Pfizer / BioNTech Markman hearing was held in December 2024.


•
Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement.

In December 2024, Roivant announced Kinevant’s Phase 2 study of namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. Kinevant is discontinuing further development of namilumab for the treatment of sarcoidosis.

Major Upcoming Milestones

 •
Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026.

Neurology Program
Immunovant intends to report topline results from the pivotal trial of batoclimab in MG by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and inform the design of a potentially registrational program for IMVT-1402 in MG, which Immunovant expects to initiate following the disclosure of the batoclimab data in MG.
 
Results from period one of the trial evaluating batoclimab in CIDP continue to be expected by March 31, 2025. Those results, as well as observations drawn from public disclosures of other studies in CIDP, are expected to inform a potentially registrational program for IMVT-1402 in CIDP, which Immunovant expects to initiate following the disclosure of the batoclimab CIDP data.

Endocrinology Program
Immunovant plans to announce additional data from the batoclimab proof-of-concept study in GD including 6-month, treatment-free remission data designed to further articulate potential for IMVT-1402 in GD. These data are expected in the summer of 2025.
 
Topline results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025, along with a decision whether to pursue marketing authorization for batoclimab in TED. Data from this trial may also inform the IMVT-1402 program in GD.


 •
Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027.

Priovant’s Phase 2 trial of brepocitinib in cutaneous sarcoidosis is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026.


 •
Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026.


•
Genevant litigation against Moderna continues to progress with summary judgment phase scheduled for second and third quarter of calendar year 2025; Moderna jury trial scheduled for September 2025.

Third Quarter Ended December 31, 2024 Financial Summary

Cash Position and Marketable Securities

As of December 31, 2024, the Company had consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $5.2 billion.

Research and Development Expenses

Research and development (R&D) expenses increased by $33.4 million to $141.6 million for the three months ended December 31, 2024, compared to $108.1 million for the three months ended December 31, 2023. This increase was primarily driven by increases in program-specific costs of $26.2 million, personnel-related expenses of $3.9 million, and share-based compensation of $2.8 million.

Within program-specific costs, the increase of $26.2 million was primarily driven by an increase in expense of $29.1 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $5.7 million related to RVT-3101, which was sold to Roche in December 2023.
 
Non-GAAP R&D expenses were $131.2 million for the three months ended December 31, 2024, compared to $100.2 million for the three months ended December 31, 2023.

General and Administrative Expenses

General and administrative (G&A) expenses increased by $13.4 million to $141.5 million for the three months ended December 31, 2024, compared to $128.2 million for the three months ended December 31, 2023. This increase largely resulted from an increase in share-based compensation expense of $25.0 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. This increase was partially offset by a decrease in personnel-related expenses of $15.9 million, primarily due to higher expense in the three months ended December 31, 2023 related to a special one-time cash retention bonus award granted to employees, following approval in December 2023.

Non-GAAP G&A expenses were $71.1 million for the three months ended December 31, 2024, compared to $82.6 million for the three months ended December 31, 2023.

Income (loss) from discontinued operations, net of tax

Income from discontinued operations, net of tax was $327.0 million for the three months ended December 31, 2024 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $58.5 million for the three months ended December 31, 2023, representing the financial results of Dermavant during this period.

(Loss) income from continuing operations, net of tax

Loss from continuing operations, net of tax was $208.9 million for the three months ended December 31, 2024, compared to income from continuing operations, net of tax of approximately $5.1 billion for the three months ended December 31, 2023. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.22 for the three months ended December 31, 2024. On a basic and diluted per common share basis, income from continuing operations, net of tax was $6.44 and $6.10, respectively, for the three months ended December 31, 2023. Non-GAAP loss from continuing operations, net of tax was $143.7 million for the three months ended December 31, 2024, compared to $138.0 million for the three months ended December 31, 2023.

ROIVANT SCIENCES LTD.
Selected Balance Sheet Data
(unaudited, in thousands)

   
December 31, 2024
    
March 31, 2024
  
             
Cash, cash equivalents and restricted cash
  
$
2,001,674
    
$
6,506,189
  
Marketable securities
    
3,155,825
      
—
  
Total assets
    
5,792,345
      
7,222,482
  
Total liabilities
    
256,375
      
773,953
  
Total shareholders’ equity
    
5,535,970
      
6,448,529
  
Total liabilities and shareholders’ equity
    
5,792,345
      
7,222,482
  

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,
  
   
2024
    
2023
    
2024
    
2023
  
                         
Revenue, net
  
$
9,018
    
$
15,562
    
$
21,483
    
$
23,693
  
Operating expenses:
                                
Cost of revenues
    
259
      
197
      
706
      
1,403
  
Research and development (includes $9,685 and $6,913 of share-based compensation expense for the three months ended December 31, 2024 and 2023 and $30,128 and $22,639 for the nine months ended December 31, 2024 and 2023, respectively)
    
141,595
      
108,148
      
405,175
      
332,354
  
Acquired in-process research and development
    
—
      
—
      
—
      
26,450
  
General and administrative (includes $69,386 and $44,419 of share-based compensation expense for the three months ended December 31, 2024 and 2023 and $165,670 and $120,891 for the nine months ended December 31, 2024 and 2023, respectively)
    
141,545
      
128,172
      
444,318
      
308,030
  
Total operating expenses
    
283,399
      
236,517
      
850,199
      
668,237
  
                                 
Gain on sale of Telavant net assets
    
—
      
5,348,410
      
110,387
      
5,348,410
  
                                 
(Loss) income from operations
    
(274,381
)
    
5,127,455
      
(718,329
)
    
4,703,866
  
                                 
Change in fair value of investments
    
21,314
      
10,467
      
(42,287
)
    
63,880
  
Change in fair value of liability instruments
    
(2,147
)
    
(2,492
)
    
(1,632
)
    
49,475
  
Gain on deconsolidation of subsidiaries
    
—
      
—
      
—
      
(17,354
)
Interest income
    
(61,851
)
    
(31,953
)
    
(203,751
)
    
(62,967
)
Other expense (income), net
    
2,816
      
(2,112
)
    
7,877
      
2,245
  
(Loss) income from continuing operations before income taxes
    
(234,513
)
    
5,153,545
      
(478,536
)
    
4,668,587
  
Income tax (benefit) expense
    
(25,568
)
    
22,365
      
(1,147
)
    
27,276
  
(Loss) income from continuing operations, net of tax
    
(208,945
)
    
5,131,180
      
(477,389
)
    
4,641,311
  
Income (loss) from discontinued operations, net of tax
    
327,020
      
(58,515
)
    
373,030
      
(227,609
)
Net income (loss)
    
118,075
      
5,072,665
      
(104,359
)
    
4,413,702
  
Net loss attributable to noncontrolling interests
    
(51,306
)
    
(23,519
)
    
(138,853
)
    
(86,339
)
Net income attributable to Roivant Sciences Ltd.
  
$
169,381
    
$
5,096,184
    
$
34,494
    
$
4,500,041
  
                                 
Amounts attributable to Roivant Sciences Ltd.:
                                
(Loss) income from continuing operations, net of tax
  
$
(157,639
)
  
$
5,154,466
    
$
(338,691
)
  
$
4,726,682
  
Income (loss) from discontinued operations, net of tax
    
327,020
      
(58,282
)
    
373,185
      
(226,641
)
Net income attributable to Roivant Sciences Ltd.
  
$
169,381
    
$
5,096,184
    
$
34,494
    
$
4,500,041
  
                                 
Net income per common share, basic:
  
(Loss) income from continuing operations, net of tax
  
$
(0.22
)
  
$
6.44
    
$
(0.46
)
  
$
6.09
  
Income (loss) from discontinued operations, net of tax
  
$
0.45
    
$
(0.07
)
  
$
0.51
    
$
(0.29
)
Net income per common share
  
$
0.23
    
$
6.37
    
$
0.05
    
$
5.79
  
                                 
Net income per common share, diluted:
  
(Loss) income from continuing operations, net of tax
  
$
(0.22
)
  
$
6.10
    
$
(0.46
)
  
$
5.73
  
Income (loss) from discontinued operations, net of tax
  
$
0.45
    
$
(0.07
)
  
$
0.51
    
$
(0.27
)
Net income per common share
  
$
0.23
    
$
6.03
    
$
0.05
    
$
5.46
  
                                 
Weighted average shares outstanding:
                                
Basic
    
722,716,168
      
800,587,716
      
731,318,202
      
776,759,728
  
Diluted
    
722,716,168
      
844,461,685
      
731,318,202
      
824,310,013
  
 
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
    
2024
    
2023
    
2024
    
2023
  
                               
(Loss) income from continuing operations, net of tax
        
$
(208,945
)
  
$
5,131,180
    
$
(477,389
)
  
$
4,641,311
  
Adjustments:
                                      
Research and development:
                                      
Share-based compensation
  
(1)

   
9,685
      
6,913
      
30,128
      
22,639
  
Depreciation and amortization
  
(2)

   
728
      
1,023
      
2,147
      
3,717
  
General and administrative:
                                      
Share-based compensation
  
(1)

   
69,386
      
44,419
      
165,670
      
120,891
  
Depreciation and amortization
  
(2)

   
1,083
      
1,199
      
3,267
      
3,684
  
Gain on sale of Telavant net assets
  
(3)

   
—
      
(5,348,410
)
    
(110,387
)
    
(5,348,410
)
Other:
                                      
Change in fair value of investments
  
(4)

   
21,314
      
10,467
      
(42,287
)
    
63,880
  
Change in fair value of liability instruments
  
(5)

   
(2,147
)
    
(2,492
)
    
(1,632
)
    
49,475
  
Gain on deconsolidation of subsidiaries
  
(6)

   
—
      
—
      
—
      
(17,354
)
Estimated income tax impact from adjustments
  
(7)

   
(34,786
)
    
17,666
      
(38,976
)
    
18,035
  
                                       
Adjusted loss from continuing operations, net of tax (Non-GAAP)
        
$
(143,682
)
  
$
(138,035
)
  
$
(469,459
)
  
$
(442,132
)
 

         
Three Months Ended
December 31,
    
Nine Months Ended
December 31,
  
   
Note
    
2024
    
2023
    
2024
    
2023
  
                               
Research and development expenses
        
$
141,595
    
$
108,148
    
$
405,175
    
$
332,354
  
Adjustments:
                                      
Share-based compensation
  
(1)

   
9,685
      
6,913
      
30,128
      
22,639
  
Depreciation and amortization
  
(2)

   
728
      
1,023
      
2,147
      
3,717
  
Adjusted research and development expenses (Non-GAAP)
        
$
131,182
    
$
100,212
    
$
372,900
    
$
305,998
  

         
Three Months Ended
December 31,
    
Nine Months Ended
December 31,
  
   
Note
    
2024
    
2023
    
2024
    
2023
  
                               
General and administrative expenses
        
$
141,545
    
$
128,172
    
$
444,318
    
$
308,030
  
Adjustments:
                                      
Share-based compensation
  
(1)

   
69,386
      
44,419
      
165,670
      
120,891
  
Depreciation and amortization
  
(2)

   
1,083
      
1,199
      
3,267
      
3,684
  
Adjusted general and administrative expenses (Non-GAAP)
        
$
71,076
    
$
82,554
    
$
275,381
    
$
183,455
  

Notes to non-GAAP financial measures:
 
(1) Represents non-cash share-based compensation expense.
 
(2) Represents non-cash depreciation and amortization expense.
 
(3) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023 and a gain on the achievement of a one-time milestone in June 2024.
 
(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 earnings.
 
(5) Represents the change in fair value of 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.
 
(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, February 10, 2025, to report its financial results for the third quarter ended December 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 biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. 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 clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

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:

Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com