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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.

 

 

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): April 24, 2025

 

 

INDIVIOR PLC

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales   001-37835   98-1204773

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

10710 Midlothian Turnpike Suite 125

North Chesterfield, VA

    23235
(Address of principal executive offices)     (Zip Code)

Registrant’s telephone number, including area code: 804-379-1040

 

(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 communications 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

Ordinary shares, $0.50 nominal value per share   INDV   The Nasdaq Stock Market LLC
    Indicate by check
  INDV   London Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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 April 24, 2025, Indivior PLC (“Indivior”) issued a press release reporting its first quarter 2025 results and posted on its website the press release and related presentation materials. The press release and related presentation materials are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit

No.

   Description
99.1    Press release issued by Indivior PLC dated April 24, 2025.
99.2    Presentation materials dated April 24, 2025.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

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

 

      Indivior PLC

 Date: April 24, 2025

    By:  

/s/ Kathryn Hudson

    Name:   Kathryn Hudson
    Title:   Company Secretary
EX-99.1 2 d926381dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

April 24, 2025

Indivior Announces Results for the First Quarter Ended March 31, 2025; FY 2025 Guidance Unchanged

 

   

Total Net Revenue (NR) of $266m in Line with Expectations

 

   

SUBLOCADE® NR of $176m is Consistent with FY 2025 Guidance of $725m to $765m

 

   

On Track to Deliver Gross Annual Operating Expense Savings of Over $100m in FY 2025

 

Unaudited, $m

   Q1 2025      Q1 2024      %
Change2
 

Net Revenue

     266        284        (6 )% 

Operating Income

     66        75        (12 )% 

Net Income

     47        61        (23 )% 

Diluted EPS2 ($)

   $ 0.38      $ 0.45        (15 )% 

Non-GAAP Measures

        

Non-GAAP Operating Income1

     69        76        (10 )% 

Non-GAAP Net Income1

     51        57        (11 )% 

Non-GAAP Diluted EPS1,2 ($)

   $ 0.41      $ 0.42        (2 )% 

 

1

Non-GAAP measures exclude the impact of non-recurring items and other adjustments. Refer to “Reconciliation of GAAP to non-GAAP financial information” on page 11. Non-GAAP measures are not a substitute for, or superior to, results presented in accordance with US GAAP.

Percentages and per share data have been calculated using actual, non-rounded figures.

The “Company” refers to Indivior PLC and its consolidated subsidiaries.

“Our first quarter results were in line with our planning assumptions and consistent with our FY 2025 outlook,” said Mark Crossley, Chief Executive Officer. “Net revenue performance was primarily impacted by intensified generic competition for SUBOXONE Film in the U.S. and the discontinuation of PERSERIS in the prior year. SUBLOCADE continued to grow solidly year-over-year in organized health systems (OHS), but as expected, net revenue declined modestly due to near-term impacts from funding gaps among certain justice system customers. We expect to generate SUBLOCADE growth again in the second half of FY 2025 from our increased marketing investments and the important FDA-approved label changes that further improve the patient and physician experience.”

“As previously announced, I will be stepping down as CEO of Indivior next month. It has been an honor to lead the Company over the past five years and I would like to add a personal note of thanks to all my colleagues for tirelessly pursuing our goal of making meaningful recovery from addiction humanly possible. The opioid epidemic remains one of the greatest health challenges of our time and our mission and vision are as relevant as ever. I believe that our team, under Joe Ciaffoni’s leadership, will deliver the next chapter of growth and value creation for Indivior.”

Q1 2025 Product Highlights

 

   

SUBLOCADE (buprenorphine extended-release) Injection: Overall Q1 2025 NR of $176m (2)% vs. Q1 2024. As expected, the modest year-over-year decline in SUBLOCADE NR in Q1 2025 reflected solid dispense volume growth in the organized health system (OHS) channel, more than offset by an expected dispense volume decline in the justice system channel due to near-term funding gaps among certain customers as well as unfavorable pricing/channel mix. Total U.S. patients on a 12-month rolling basis at the end of Q1 2025 were approximately 170,700 (+14% vs. Q1 2024 and unchanged vs. Q4 2024). Q1 2025 U.S. units dispensed were approximately 151,900 (+2% vs. Q1 2024 and (6)% vs. Q4 2024).

 

1


   

OPVEE® (nalmefene) nasal spray: Q1 2025 NR was immaterial. Near-term launch focus is on supporting policy changes to enable broader access to nalmefene opioid rescue treatments and on increasing product trial among targeted users.

 

   

SUBOXONE® (buprenorphine/naloxone) Film: U.S. SUBOXONE Film net revenue declined in Q1 2025 due to intensified competitive activity from generic film providers. U.S. SUBOXONE Film share of oral buprenorphine medication assisted treatment (BMAT) was 14.8% in Q1 2025 (Q1 2024: 17.5%), in-line with the Company’s expectations.

SUBLOCADE Label Update

On February 24, 2025, the FDA approved label changes for SUBLOCADE, including a rapid initiation protocol and alternative injection sites, which further improve the patient and physician experience and mark an advancement in the treatment of moderate to severe opioid use disorder (OUD). Key SUBLOCADE label changes include:

 

   

Rapid Initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. In addition, the second injection of SUBLOCADE may be administered as early as one week after the first injection to rapidly achieve and maintain target plasma buprenorphine levels (>2–3 ng/mL) to control symptoms of craving and withdrawal, particularly in synthetic opioid users.

 

   

Alternative Injection Sites: SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.

Pipeline Update

 

   

INDV-2000 (Selective OREXIN-1 Receptor Antagonist): Phase 2 proof of concept study. First subject first visit achieved June 10, 2024. Estimated last subject last visit is now expected in H1 2026 (previously Q4 2025). The delay is due to a lower than expected conversion rate from subject screening to study enrollment.

 

   

INDV-6001 (3-Month Buprenorphine Long-acting Injectable): Multiple dose clinical Phase 2 Pharmacokinetics (PK) study. First subject first visit achieved September 17, 2024. Estimated last subject last visit is Q4 2025.

Share Repurchase Program

Indivior’s fourth $100m share repurchase program was completed on January 31, 2025. Under this program, the Company repurchased and canceled 9,415,726 Indivior ordinary shares at a weighted average purchase price of $10.62.

FY 2025 Guidance Unchanged

The Company’s guidance for FY 2025 under U.S. GAAP is unchanged.

Guidance assumes no material change in exchange rates for key currencies compared with FY 2024 average rates, notably USD/GBP and USD/EUR. Guidance also assumes no material change to Medicaid eligibility policy and/or other changes to Federal funding levels due to executive actions. Guidance also does not include any potential impacts from tariffs imposed by the U.S. government or any retaliatory tariffs that may be imposed by other countries.

 

2


     FY 2025

Net Revenue (NR)

   $955m to $1,025m

(-17% at the mid-point vs. FY 2024)

SUBLOCADE NR

   $725m to $765m

(-1% at the mid-point vs. FY 2024)

OPVEE NR

   $10m to $15m

SUBOXONE Film Market Share

   Accelerated NR decline in FY 2025 reflecting increased
generic competitive activity and the potential impact
from a fifth buprenorphine/naloxone sublingual film
generic in the U.S. market

Non-GAAP Gross Margin

   Low to mid-80s % range

Non-GAAP SG&A

   ($525m) to ($535m)

Non-GAAP R&D

   ($85m) to ($90m)

Non-GAAP Operating Income

   $185m to $225m

 

3


U.S. OUD Market Update

In Q1 2025, U.S. BMAT grew mid-single digits in volume terms. The Company continues to expect long-term U.S. growth to be sustained in the mid- to high-single digit percentage range due to increased overall awareness of the opioid epidemic and approved treatments and ongoing destigmatization efforts. Regulatory and legislative actions are also expected to increase access to BMAT treatments.

Financial Performance in Q1 2025

Total NR in Q1 2025 decreased 6% to $266m (Q1 2024: $284m) at actual exchange rates (5% decrease at constant exchange rates1).

U.S. NR decreased 8% in Q1 2025 to $222m (Q1 2024: $241m). In Q1 2025, U.S. SUBLOCADE NR decreased 3% to $163m (Q1 2024: $168m). The decrease in U.S. NR was primarily driven by the decline in SUBOXONE Film due to intensified generic competition that resulted in lower oral BMAT market share and lower pricing. The decline in PERSERIS (risperidone) extended release injection NR also contributed to the decline in U.S. NR due to discontinuation of promotion for the treatment in July 2024. SUBLOCADE NR was modestly lower year-over-year as described above.

Rest of the World NR increased 3% at actual exchange rates in Q1 2025 to $44m (Q1 2024: $42m; +1% at constant exchange rates1). In both periods, positive contributions from new products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) were partially offset by ongoing generic erosion of the legacy SUBUTEX (buprenorphine) tablet business. In Q1 2025, SUBLOCADE / SUBUTEX Prolonged Release NR increased $1m to $13m (Q1 2024: $12m) at actual exchange rates.

Gross margin in Q1 2025 was 83% (Q1 2024: 87%). The year-over-year decline primarily reflects favorable manufacturing variances for SUBLOCADE inventory sold in the same year-ago quarter.

SG&A expense in Q1 2025 was $132m (Q1 2024: $143m). Non-GAAP SG&A expense in Q1 2025 decreased 8% to $130m (non-GAAP Q1 2024: $142m) and primarily reflects benefits from streamlining actions taken in 2024, including narrowing the Company’s commercial focus on OUD treatments and discontinuing PERSERIS in July 2024. Q1 2025 SG&A expense also benefited from a low to mid-single digit $ million change in estimate related to Indivior’s share of the Branded Fee.

R&D expense in Q1 2025 was $22m (Q1 2024: $28m) and decreased 19% reflecting the Company’s actions to refocus its development pipeline on its Phase 2 OUD assets (INDV-2000 and INDV-6001).

Operating income was $66m in Q1 2025 (Q1 2024: $75m). The change reflects lower NR and higher cost of sales, partially offset by decreased operating expenses (SG&A and R&D combined).

After excluding non-GAAP adjustments of $3m and $2m in Q1 2025 and Q1 2024, respectively, Q1 2025 non-GAAP operating income decreased 10% to $69m (Q1 2024: $76m). The decrease primarily reflects the drivers discussed above.

Net interest expense was $7m in Q1 2025 (Q1 2024: $2m) reflecting the Company’s new borrowing secured in Q4 2024.

Tax expense was $11m in Q1 2025, resulting in an effective tax rate of 19% (Q1 2024: $11m, effective rate 16%). Both periods benefited from U.K. innovation deductions and intragroup financing transactions. In Q1 2025, this benefit was partially offset by a U.K. global minimum top-up tax. In Q1 2024, the Company recognized a share-compensation excess tax benefit. This excess tax benefit is excluded from the Company’s non-GAAP results.

Net income in Q1 2025 was $47m and non-GAAP net income was $51m (Q1 2024 net income: $61m, non-GAAP net income: $57m). The decline in net income primarily reflects lower NR and higher net interest expense, partly offset by lower operating expenses (SG&A and R&D combined).

 

Net revenue at constant exchange rates is an alternative performance measure used by management to evaluate underlying performance of the business and is calculated by applying the prior year exchange rate to current year net revenue in the currencies of the non-U.S. entities.

 

4


Diluted earnings per share in Q1 2025 were $0.38 and non-GAAP diluted earnings per share were $0.41 (Q1 2024: $0.45 diluted earnings per share and non-GAAP diluted earnings per share of $0.42). The modest decrease in non-GAAP diluted earnings per share in Q1 2025 includes the impact of the lower number of ordinary shares outstanding as a result of the Company’s share repurchase programs.

Balance Sheet & Cash Flow

Cash and investments totaled $400m at the end of Q1 2025, an increase of $53m versus $347m at the end of 2024. The increase was due to a combination of cash generated by operations and reduced net working capital due to the late receipt of government rebate invoices totaling approximately $100m, as reflected in the increase in Accrued Rebates and Product Returns on the balance sheet. These benefits were partially offset by litigation settlement payments of $65m.

Cash provided by operating activities in Q1 2025 was $75m (Q1 2024 cash used in operating activities: $37m), reflecting cash from operations and the late receipt of government rebate invoices, partly offset by litigation settlement payments. Cash used in operations in Q1 2024 reflected litigation settlement payments, partly offset by cash from operations.

Cash used in investing activities in Q1 2025 was $5m (Q1 2024 cash provided by investing activities: $25m) primarily reflecting capital expenditures in Q1 2025. Cash provided by investing activities in 2024 was driven by maturities of investment securities.

Cash used in financing activities in Q1 2025 was $17m (Q1 2024: $56m) reflecting lower cash outflows in Q1 2025 for share repurchases and net settlement of equity awards partially offset by higher repayments under the new debt facility.

Revision to Previously Issued Financial Statements

Indivior has revised its previously issued financial statements to correct the methodology used to accrue for the Company’s share of the annual U.S. fee imposed on drug manufacturers (the ‘Branded Fee’). This resulted from an immaterial overstatement of SG&A of $6m in 2024, $4m in 2023, $4m in 2022, and $2m before 2022. The adjustments increase operating income and impact the quarters evenly over the respective year. The cumulative impact to Accounts Payable and Accrued Expenses at December 31, 2024 was $16m.

The discussion of financial performance and the financial statements included in this announcement reflect the revised results for Q1 2024. The revised financial statements for the impacted periods noted will be included in the Company’s Form 10-Q as of March 31, 2025.

Webcast Details

A live webcast presentation will be held on April 24, 2025, at 13:00 GMT (8:00 am EDT). The details are below. Materials will be available on the Company’s website prior to the event at www.indivior.com. Please copy and paste the below web links into your browser.

The webcast link is: https://edge.media-server.com/mmc/p/yn37cxqk

Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser):

https://register-conf.media-server.com/register/BI4482694d7c294502b6a4dedd62e88c5b

(Registrants will have an option to be called back directly immediately prior to the call or be provided a call-in # with a unique pin code following their registration)

 

5


For Further Information

 

Investor Inquiries    Jason Thompson   

VP, Investor Relations

Indivior PLC

  

+1 804 402 7123

jason.thompson@indivior.com

   Tim Owens    Director, Investor Relations Indivior PLC   

+1 804 263 3978

timothy.owens@indivior.com

Media Inquiries    Jonathan Sibun   

Teneo

 

U.S. Media Inquiries

  

+44 (0)20 7353 4200

 

+1 804 594 0836

Indiviormediacontacts@indivior.com

 

Corporate Website    www.indivior.com

This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

 

6


About Indivior

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

Non-GAAP Financial Measures

This announcement includes financial measures that are not measures defined by US GAAP, such as non-GAAP selling, general and administrative expenses, non-GAAP operating income, non-GAAP net income and non-GAAP diluted earnings per share. These non-GAAP financial measures are not a substitute for, or superior to, results presented in accordance with US GAAP. Non-GAAP results as presented by the Company are not necessarily comparable to similarly titled measures used by other companies. As a result, these performance measures should not be considered in isolation from, or as a substitute analysis for, the Company’s results as reported in accordance with US GAAP. Management performs a quantitative and qualitative assessment to determine if an item should be considered for adjustment.

Management may use the Company’s non-GAAP financial measures to better understand trends in the business and these non-GAAP financial measures may be useful to investors. Non-GAAP financial measures adjust for non-recurring items and other items representing significant expenses or income that we believe do not reflect the Company’s ongoing operations or the adjustment of which may help with the comparison to prior periods. Non-recurring items and other adjustments are excluded from non-GAAP financial measures consistent with the internal reporting provided to management and the Directors. Examples of such items could include income or restructuring and related expenses from the reconfiguration of the Company’s activities and/or capital structure, impairment of current and non-current assets, gains and losses from the sale of intangible assets, certain costs arising as a result of significant and non-recurring regulatory and litigation matters, and certain tax related matters.

We have not provided the forward-looking U.S. GAAP equivalents for certain forward-looking non-U.S. GAAP metrics as a result of the uncertainty and potential variability of reconciling items. Accordingly, the Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-U.S. GAAP guidance metrics to their corresponding U.S. GAAP equivalents are not available without unreasonable effort.

Columns and rows within financial tables may not foot due to rounding. Percentages and per share data have been calculated using actual, non-rounded figures.

Important Cautionary Note Regarding Forward-Looking Statements

This announcement contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: the Company’s financial guidance including revenue, operating, and gross margins for 2025 and its medium- and long-term growth outlook; expected future growth and expectations for sales levels for particular products, and expectations regarding the future impact of factors that have affected sales in the past; expected operational savings and expected benefits from our reinvestment efforts; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; expected timing of our previously-announced CEO transition; our expectations that we can reach a final settlement related to the provision we recorded regarding opioid litigation (including the MDL) brought by certain municipalities and tribal nations and the material terms and conditions of the final settlement agreement, including the ultimate timing and structure of payments and product distribution, injunctive relief, and scope of releases; expected growth in the number of BMAT treatments administered in the U.S., growing normalization of medically assisted treatment for opioid use disorder, and expanded access to treatment; our product development pipeline and potential future products, including the timing of clinical trials, expectations regarding regulatory approval of such product candidates, the timing of such approvals, and the timing of potential commercial launch of such products or product candidates, and eventual annual revenues of such future products; and other statements containing the words “believe,” “anticipate,”

 

7


“plan,” “expect,” “intend,” “estimate,” “forecast,” “strategy,” “target,” “guidance,” “outlook,” “potential,” “project,” “priority,” “may,” “will,” “should,” “would,” “could,” “can,” “outlook,” the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.

Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including: lower than expected future sales of our products; greater than expected impacts from competition; failure to achieve market acceptance of OPVEE; unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs; whether we are able to identify efficiencies and fund additional investments that we expect to generate increased revenues, and the timing of such actions; and litigants with whom we are otherwise unable or unwilling to agree to final terms, or who choose to “opt out” of proposed settlements. For additional information about some of the risks and important factors that could affect our future results and financial condition, see “Risk Factors” in Indivior’s Annual Report on Form 10-K filed March 3, 2025 and our other filings with the U.S. Securities and Exchange Commission.

We have based the forward-looking statements in this report on our current expectations and beliefs concerning future events. Forward-looking statements contained in this report speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, future developments or otherwise.

 

8


Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

 

Consolidated statements of operations

 

Three Months Ended March 31,

   Q1 2025     Q1 2024  

Net revenue

   $ 266     $ 284  

Cost of sales

     44       38  
  

 

 

   

 

 

 

Gross profit

     221       246  
  

 

 

   

 

 

 

Selling, general and administrative

     132       143  

Research and development

     22       28  

Litigation settlement

     1       —   
  

 

 

   

 

 

 

Operating income

     66       75  
  

 

 

   

 

 

 

Interest income

     4       7  

Interest expense

     (12     (9
  

 

 

   

 

 

 

Income before income taxes

     59       73  
  

 

 

   

 

 

 

Income tax expense

     (11     (11
  

 

 

   

 

 

 

Net income

   $ 47     $ 61  
  

 

 

   

 

 

 

Earnings per share

    

Basic

   $ 0.38     $ 0.45  

Diluted

   $ 0.38     $ 0.45  

 

9


Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

 

Consolidated balance sheets

 

     Mar 31, 2025     Dec 31, 2024  

Assets

    

Current assets

    

Cash and cash equivalents

   $ 372     $ 319  

Short-term investments

     1       1  

Accounts receivable, net of allowances of $2 (2025) and $3 (2024)

     243       254  

Inventories

     163       167  

Prepaid expenses

     56       31  

Current tax receivable

     29       33  

Other current assets

     20       21  
  

 

 

   

 

 

 

Total current assets

     883       827  
  

 

 

   

 

 

 

Long-term investments

     27       27  

Property, plant and equipment, net

     104       100  

Operating lease right of use assets, net

     37       39  

Goodwill and other intangible assets, net

     7       6  

Deferred tax assets

     279       277  

Other non-current assets

     39       39  
  

 

 

   

 

 

 

Total assets

   $ 1,375     $ 1,316  
  

 

 

   

 

 

 

Liabilities and shareholders’ deficit

    

Current liabilities

    

Accrued rebates and product returns

   $ 675     $ 562  

Accounts payable and accrued expenses

     183       216  

Accrued litigation settlement expenses, current

     105       99  

Current portion of long-term debt

     18       18  

Operating lease liabilities, current

     11       10  

Income taxes payable

     12       7  

Other current liabilities

     3       11  
  

 

 

   

 

 

 

Total current liabilities

     1,005       924  
  

 

 

   

 

 

 

Long-term debt, less current portion

     311       315  

Accrued litigation settlement expenses, non-current

     297       365  

Operating lease liabilities, non-current

     30       32  

Other non-current liabilities

     17       18  
  

 

 

   

 

 

 

Total liabilities

     1,660       1,652  
  

 

 

   

 

 

 

Shareholders’ deficit

    

Common stock, par value $0.50 per share
Issued shares: 125 (2025) and 125 (2024)

     62       62  

Additional paid-in capital

     93       90  

Share repurchase commitment

     —        (10

Accumulated other comprehensive loss

     (35     (36

Accumulated deficit

     (406     (443
  

 

 

   

 

 

 

Total shareholders’ deficit

     (285     (337
  

 

 

   

 

 

 

Total liabilities and shareholders’ deficit

   $ 1,375     $ 1,316  
  

 

 

   

 

 

 

 

 

10


Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

 

Consolidated statements of cash flows

 

Three Months Ended March 31,

   Q1 2025     Q1 2024  

Cash flows from operating activities:

    

Net income

   $ 47     $ 61  

Adjustments to reconcile net income to net cash from operating activities:

    

Depreciation and amortization

     5       5  

Share-based compensation expense

     6       6  

Impairment of tangible and intangible assets

     0       1  

Deferred income taxes

     (2     3  

Impact from foreign exchange movements

     (1     (1

Other adjustments, net

     1       1  

Change in operating assets and liabilities

     18       (113
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     75       (37

Cash flows from investing activities:

    

Purchases of property and equipment

     (5     (2

Purchases of in-process research and development and intangible assets

           (1

Purchases of investments in debt securities

     (5     (4

Sales and maturities of debt securities

     6       31  
  

 

 

   

 

 

 

Net cash (used in) provided by investing activities

     (5     25  

Cash flows from financing activities:

    

Proceeds from the issuance of common stock

     1       1  

Cash paid for repurchases of common stock

     (11     (36

Repayments of debt

     (4     (1

Settlement of tax on equity awards

     (3     (20
  

 

 

   

 

 

 

Net cash used in financing activities

     (17     (56
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     53       (68

Cash and cash equivalents at beginning of period

     319       316  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 372     $ 248  
  

 

 

   

 

 

 

 

11


Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

 

Selected revenue and expense information

 

Three Months Ended March 31,

   Q1 2025      Q1 2024  

US:

     

SUBLOCADE

   $ 163      $ 168  

Sublingual & other

     54        63  

PERSERIS1

     4        11  
  

 

 

    

 

 

 

Total U.S.

     222        241  

Rest of World

     44        42  
  

 

 

    

 

 

 

Net revenue

   $ 266      $ 284  
  

 

 

    

 

 

 

*Total SUBLOCADE net revenue

   $ 176      $ 179  

Selling, general and administrative expenses:

     

Selling and marketing

   $ 67      $ 67  

Administrative and general

     65        77  

Total selling, general and administrative expenses

   $ 132      $ 143  
  

 

 

    

 

 

 

 

Marketing and promotion activities for PERSERIS were discontinued in July 2024.

 

12


Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

 

Reconciliation of GAAP to non-GAAP financial information

 

Three Months Ended March 31,

   Q1 2025      Q1 2024  

GAAP selling, general and administrative expenses

   $ 132      $ 143  

Adjustments within SG&A

     

Corporate Initiative Transition1

     2        0  

Acquisition-related costs2

     —         2  
  

 

 

    

 

 

 

Less: Adjustments in selling, general and administrative expenses

     2        2  
  

 

 

    

 

 

 

Non-GAAP selling, general and administrative expenses

   $ 130      $ 142  
  

 

 

    

 

 

 

 

1.

Includes expenses related to severance and share-based compensation.

2.

Non-recurring costs related to the acquisition and integration of the aseptic manufacturing site acquired in November 2023.

 

Three Months Ended March 31,

   Q1 2025      Q1 2024  

GAAP operating income

   $ 66      $ 75  

Adjustments in selling, general and administrative expenses

     2        2  

Litigation settlement expenses

     1        —   
  

 

 

    

 

 

 

Non-GAAP operating income

   $ 69      $ 76  
  

 

 

    

 

 

 

 

Three Months Ended March 31,

   Q1 2025     Q1 2024  

GAAP tax expense

   $ (11   $ (11
  

 

 

   

 

 

 

Tax on non-GAAP adjustments

     (1     (1

Tax non-GAAP adjustments

     1       (5
  

 

 

   

 

 

 

Less: Adjustments in tax expenses

     —        (6
  

 

 

   

 

 

 

Non-GAAP tax expense

   $ (11   $ (17
  

 

 

   

 

 

 

We define Non-GAAP effective tax rate as Non-GAAP tax expense divided by Non-GAAP income before taxation.

 

Three Months Ended March 31,

   Q1 2025      Q1 2024  

GAAP net income

   $ 47      $ 61  

Adjustments in selling, general and administrative expenses

     2        2  

Litigation settlement expenses

     1        —   

Adjustments in tax expenses

     —         (6
  

 

 

    

 

 

 

Non-GAAP net income

   $ 51      $ 57  
  

 

 

    

 

 

 

Non-GAAP earnings per share

     

Non-GAAP diluted earnings per share

   $ 0.41      $ 0.42  

Shares used in computing non-GAAP earnings per share

     

Diluted

     125        137  
  

 

 

    

 

 

 

Non-GAAP diluted earnings/(loss) per share

Management believes that Non-GAAP diluted earnings/(loss) per share, adjusted for the impact of non-recurring items and other adjustments after the appropriate tax amount, may provide meaningful information on underlying trends to shareholders in respect of earnings per ordinary share. Weighted average shares used in computing non-GAAP diluted earnings per share are included in the table above. A reconciliation of GAAP net income to non-GAAP net income is included above.

 

13

EX-99.2 3 d926381dex992.htm EX-99.2 EX-99.2

Slide 1

Q1 2025 Results April 24, 2025 Exhibit 99.2


Slide 2

Q1 2025 Results | april 24, 2025 Important Cautionary Statement Regarding Forward-looking Statements This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: the Company’s financial guidance including revenue, operating, and profit margins for 2025, and its medium- and long-term growth outlook; expected expense savings; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; expected future growth and expectations for sales levels for particular products, and expectations regarding the future impact of factors that have affected sales in the past; our product development pipeline and potential future products, the timing of clinical trials, expectations regarding regulatory approval of such product candidates, the timing of such approvals, and the timing of commercial launch of such products or product candidates, and eventual annual revenues of such future products; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate," "forecast," “strategy,” “target,” “guidance,” “outlook,” “potential,” "project," "priority," "may," "will," "should," "would," "could," "can," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including: lower than expected future sales of our products; greater than expected impacts from competition; failure to achieve market acceptance of OPVEE; unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs; whether we are able to identify efficiencies and fund additional investments that we expect to generate increased revenues, and the timing of such actions; and litigants with whom we are otherwise unable or unwilling to agree to final terms, or who choose to "opt out" of proposed settlements. For additional information about some of the risks and important factors that could affect our future results and financial condition, see "Risk Factors" in Indivior's Annual Report on Form 10-K filed March 3, 2025 and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.


Slide 3

Mark Crossley Chief Executive Officer


Slide 4

Q1 2025 Results | April 24, 2025 Q1 2025 Overview1 %-comparisons versus revised Q1 2024 See Non-GAAP Financial Measures in the Appendix for reconciliation NM = Not Meaningful; OHS = Organized Health Systems Overall results in line with planning assumptions and FY 2025 outlook SUBLOCADE NR as expected – solid growth in the OHS channel was more than offset by a decline in the justice system channel due to near-term funding gaps On track to deliver annual gross operating expense savings of over $100m FY 2025 guidance unchanged TOTAL NET REVENUE (NR) (6)% $266m SUBLOCADE® NR (2)% $176m OPERATING PROFIT / (LOSS) (12)% $66m Non-GAAP OPERATING PROFIT2 (10)% $69m EARNINGS PER SHARE $0.38 (15)% Non-GAAP EARNINGS PER SHARE2 (2)% $0.41


Slide 5

Ryan Preblick Chief Financial Officer


Slide 6

$ mil Q1 2025  Q1 2024  Change Net Revenue (NR):   U.S. NR   ROW2 NR $266 222 44 $284 241 42 (6)% (8)% 3% Gross Profit: Gross Margin $221 83% $246 87% (10)% (400) Bps Operating Expenses:   SG&A    R&D Litigation Settlement ($155) (132) (22) (1) ($171) (143) (28) - (9)% (8)% (19)% NM Operating Expenses – Non-GAAP:   SG&A    R&D Litigation Settlement ($152) (130) (22) - ($170) (142) (28) - (11)% (8)% (19)% -                                       Op. Profit / (Loss)  - Reported: $66 $75 (12)%                                    - Non-GAAP: $69 $76 (10)% Earnings Per Share  - Reported: $0.38 $0.45 (15)%                                    - Non-GAAP: $0.41 $0.42 (2)% Q1 2025 Results | April 24, 2025 Q1 2025 Financial Highlights OPERATING RESULTS: (Reported and Non-GAAP1) KEY TAKEAWAYS: (vs Q1 2024 unless otherwise indicated) 1. See Non-GAAP Financial Measures in the Appendix for reconciliation; %s reflect unrounded #s which may not tie; Q1 2024 numbers revised 2. At actual foreign exchange rates 3. NM = Not Meaningful; OHS = Organized Health Systems; JS = Justice Systems; BMAT = buprenorphine medication-assisted treatments Total NR decline of 6% (5% at constant FX): U.S. NR down 8%; lower SUBOXONE Film and PERSERIS discontinuation were main drivers ROW NR up 3% (1% at constant FX); growth in new products (SUBLOCADE and SUBOXONE Film) more than offset legacy tablet products (SUBUTEX) SUBLOCADE NR of $176m (2)% YOY reflecting solid volume dispense growth in the OHS channel that was more than offset by volume dispense decline in the justice channel as well as by unfavorable price/channel mix U.S. Film NR reflects increased generic competitive activity resulting in lower U.S. oral BMAT share (within expectations) and lower pricing Gross margin lower reflecting Q1 2024 favorable manufacturing variances Non-GAAP SG&A1 expenses down 8% primarily reflecting previously announced streamlining actions and branded fee estimate change partially offset by increased commercial investments behind U.S. SUBLOCADE R&D expenses decreased 19% reflecting focused pipeline activities on Phase 2 OUD assets (INDV-2000 and INDV-6001) Non-GAAP operating profit1 down 10% driven by lower NR; Diluted EPS down 2% driven by Non-GAAP operating profit partially offset with lower share count


Slide 7

Q1 2025 Results | April 24, 2025 Cash and Borrowing Position Cash and Borrowings: KEY TAKEAWAYS: (vs. December 31, 2024, unless otherwise indicated) 1. See discussion of obligations in Note 12 in SEC filed form 10-K on March 3, 2025 Cash & Investments of $400m1 Cash generated by operations and reduced net working capital partially due to the timing of receipt of government rebate invoices (~$100m) partially offset by $65m in legal settlement payments Fourth $100m buyback completed January 31, 2025, with total share repurchases of 9.4m at a weighted average price of $10.62 ($ in mil.) March 31, 2025 December 31, 2024 Cash & Cash Equivalents 372 319 ST & LT Investments 28 28 Total Cash & Investments1 $400 $347 Current Borrowings (18) (18) Long-term Borrowings (311) (315)


Slide 8

Q1 2025 Results | April 24, 2025 FY 2025 Guidance1 TOP-LINE ASSUMPTIONS: Gross MARGIN & EXPENSE CONSIDERATIONS: As of April 24, 2025, before exceptional items and assuming no material change in key FX rates vs. FY 2024 average rates Assumes no material change to Medicaid eligibility policy and/or other changes to Federal funding levels due to executive actions. Guidance also does not include ay potential impacts from tariffs imposed by the U.S. government or any retaliatory tariffs that may be imposed by other countries LAI = Long-Acting Injectable Buprenorphine/naloxone. Buprenorphine prolonged release (SUBLOCADE). Guidance Items: Total Net Revenue Key Products SUBLOCADE NR2 (Total)  OPVEE NR $955m to $1,025m $725m to $765m $10m to $15m Non-GAAP Gross Margin % Low to mid 80% range  Non-GAAP OPEX (SG&A + R&D) SG&A R&D  $610m to $625m $525m to $535m $85m to $90m Non-GAAP Op. Profit $185m to $225m Total NR decline of 17% at the mid-point reflects U.S. SUBOXONE Film (11pp of the decline) and PERSERIS discontinuation (3pp of the decline) SUBLOCADE NR2 down 1% at the mid-point Strong underlying LAI3 category growth offset by continued share gains by competitor toward steady-state U.S. LAI share split expectations Solid growth in the base OHS business offset by transitory headwinds in the Justice channel due to ongoing funding constraints at certain Justice accounts resulting in materially lower NR from this sub-channel OPVEE NR assumes fulfillment of one BARDA order (~$8m) and increased commercial adoption  U.S. SUBOXONE4 Film NR down approximately 55% from FY 2024: NR decline assumes continued share erosion and higher rebating due to intensified generic competition (including the potential of a 5th generic entrant) ROW NR: Flat growth as newer products (SUBUTEX PR®5, SUBOXONE Film) NR offset by continued pressure on legacy tablet products Non-GAAP Gross Margin: Low to mid 80% range Non-GAAP OPEX: Total OPEX reduced over $50m at the midpoint SG&A –Significant cost reductions more than offsetting SUBLOCADE reallocated commercial investments R&D - Pipeline progression of INDV-2000 (OX-1 receptor antagonist for OUD) and INDV-6001 (3-month LAI buprenorphine for OUD); Last patient last visit planned Q4 2025 Non-GAAP Op. Profit: Lower, primarily reflecting expected reset in SUBOXONE Film NR and SUBLOCADE reallocated commercial investments For Non-GAAP guidance items, the Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-GAAP guidance metrics to their corresponding GAAP equivalents are not available without unreasonable effort.


Slide 9

Q&A


Slide 10

Appendix


Slide 11

Trial Population Patients Design Primary Endpoints Status Estimated Completion INDV-6001 3-month long- acting buprenorphine Phase II NCT06576843 Moderate to severe Opioid Use Disorder (OUD) 122 Multiple dose Phase II PK study Evaluate PK, safety and tolerability of INDV-6001 following multiple doses in participants with OUD. Recruiting1 Last Patient Last Visit Q4 2025 INDV-2000 Selective Orexin-1 receptor antagonist Phase II NCT06384157 Moderate to severe Opioid Use Disorder (OUD) 300 Placebo or 3 dosing regimes of INDV-2000 Efficacy – Proportion (probability) of patients without treatment failure2 by the end of week 12 Recruiting1 Last Patient Last Visit H1 2026 (previously Q4 2025) 1. Recruitment status as per ct.gov, March 2025 2. Treatment failure defined as either one of two criteria: 1. Urine Drug Screen positive for opioids, or fentanyl on 4 consecutive assessments while participants are on INDV-2000 or placebo alone, 2. Discontinued INDV-2000 or placebo prematurely Q1 2025 Results | April 24, 2025 Key Ongoing Clinical Trials


Slide 12

1. We have not provided the forward-looking GAAP equivalents for certain forward-looking non-GAAP metrics, including Non-GAAP Operating Profit, Non-GAAP Gross Margin, Non-GAAP SG&A, and Non-GAAP Operating Expense, or GAAP reconciliations of any of the aforementioned, as a result of the uncertainty regarding, and the potential variability of, reconciling items such as extraordinary litigation settlement expense. The Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-GAAP guidance metrics to their corresponding GAAP equivalents are not available without unreasonable effort. Q1 2025 Results | April 24, 2025 Financial Reconciliations1


Slide 13