Buprenorphine Hydrochloride

– Generated Record Quarterly Net Revenue of $188.0 Million, Up 29% Year-over-Year – – Generated Record Quarterly Jornay PM® Net Revenue of $32.6 Million and Grew Prescriptions by 23% Year-over-Year – – Generated Net Revenue of $155.4 Million from the Pain Portfolio, Up 7% Year-over-Year with All Three Core Products Recording Revenue Growth in the Quarter – – Raised Full-Year 2025 Net Revenue Guidance to be in the Range of $745 to $760 Million and Adjusted EBITDA Guidance in the Range of $440 to $455 Million – – Ended Q2’25 with Cash, Cash Equivalents and Marketable Securities of $222.2 Million – – Board of Directors Authorized $150 Million Share Repurchase Program – – Conference Call Scheduled for Today at 8:00 a.m. ET – STOUGHTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today reported its financial results for the quarter ended June 30, 2025, and provided a business update. “We continued to generate strong momentum in the second quarter, driven by sustained execution across our three strategic priorities, including record revenue from Jornay PM, maximizing our pain portfolio, and strategically deploying capital to enhance shareholder value,” said Vikram Karnani, President and Chief Executive Officer. “Following encouraging performance in the first half of the year, we anticipate a strong back-to-school season and second half of the year for Jornay PM and have raised our full-year revenue guidance accordingly. Additionally, our pain portfolio generated solid revenue growth in the quarter, reinforcing the durability of our differentiated medicines to treat chronic pain. Looking ahead, we are focused on driving additional top- and bottom-line growth as we continue to serve patients living with serious medical conditions.” “We delivered another impressive quarter characterized by record quarterly revenue, robust adjusted EBITDA, and significant cash flow generation, leading us to increase our 2025 financial guidance,” said Colleen Tupper, Chief Financial Officer. “We now expect to grow full-year revenue by 19%, with Jornay PM net revenue expected between $140 to 145 million, and adjusted EBITDA to grow by 12%, compared to 2024. We will continue to evaluate external opportunities to expand our portfolio through business development and generate shareholder value through our capital deployment strategies, as demonstrated by the recent completion of a $25 million accelerated share repurchase program and the announcement of a new $150 million share repurchase program authorized through the end of 2026.” ADHD Business Highlights Grew Jornay PM prescriptions 23% year-over-year in the quarter ended June 30, 2025 (the 2025 Quarter).Generated $32.6 million in Jornay PM net revenue in the 2025 Quarter. Full-year 2025 Jornay PM net revenue is expected to be in the range of $140 to $145 million, up from the previous guidance of at least $135 million.Jornay PM prescribers reached an all-time high in the 2025 Quarter with over 26,000 healthcare providers writing Jornay PM prescriptions, up 23% year-over-year. Pain Portfolio Highlights Grew net revenues from pain portfolio to a record $155.4 million in the 2025 Quarter, up 7% year-over-year.Generated Belbuca® net revenue of $52.6 million in the 2025 Quarter, up 1% year-over-year.Generated Xtampza® ER net revenue of $52.6 million, up 18% year-over-year.Generated Nucynta® Franchise net revenue of $46.4 million, up 4% year-over-year. Corporate Updates In July, the Board of Directors authorized a new share repurchase program to repurchase up to $150 million of common stock through December 31, 2026.In July, completed an accelerated share repurchase program returning $25 million of value to shareholders through the repurchase of 0.8 million shares at an average share price of $30.41.In May, appointed Gino Santini as Chairman of the Board of Directors and added Dr. Carlos Paya as a director. Upcoming Events The Company will participate in the following upcoming investor conferences: Piper Sandler CNS Symposium – Virtual; August 14, 20252025 Wells Fargo Healthcare Conference – Boston, MA; September 4, 2025Morgan Stanley 23rd Annual Global Healthcare Conference – New York, NY; September 8, 2025H.C. Wainwright 26th Annual Global Investment Conference – New York, NY; September 9, 2025 Financial Guidance for 2025 The Company updates its full-year 2025 guidance for Product Revenues, Net, Adjusted Operating Expenses, and Adjusted EBITDA: PriorUpdated Product Revenues, Net$735 - $750 million$745 - $760 million Adjusted Operating Expenses(Excluding Stock-Based Compensation)$220 - $230 million$225 - $235 million Adjusted EBITDA(Excluding Stock-Based Compensation)$435 - $450 million$440 - $455 million Financial Results for Quarter Ended June 30, 2025 Product revenues, net were $188.0 million for the 2025 Quarter, compared to $145.3 million for the quarter ended June 30, 2024 (the 2024 Quarter), representing a 29% increase year-over-year.GAAP operating expenses were $73.3 million for the 2025 Quarter, compared to $43.3 million for the 2024 Quarter, representing a 69% increase year-over-year. Adjusted operating expenses, which exclude stock-based compensation expense and other adjustments to reflect changes that occur in our business but do not represent ongoing operations, were $61.9 million for the 2025 Quarter, compared to $30.3 million for the 2024 Quarter, representing a 104% increase year-over-year.GAAP net income for the 2025 Quarter was $12.0 million, with $0.38 GAAP earnings per share (basic) and $0.34 GAAP earnings per share (diluted), compared to GAAP net income for the 2024 Quarter of $19.6 million, with $0.60 GAAP earnings per share (basic) and $0.52 GAAP earnings per share (diluted). Non-GAAP adjusted net income for the 2025 Quarter was $64.3 million, with $1.68 adjusted earnings per share, compared to non-GAAP adjusted net income for the 2024 Quarter of $64.0 million, with $1.62 adjusted earnings per share.Adjusted EBITDA for the 2025 Quarter was $105.1 million, compared to $96.0 million for the 2024 Quarter, representing a 9% increase year-over-year. The Company generated $72.4 million in cash from operations, and exited the 2025 Quarter with cash, cash equivalents and marketable securities of $222.2 million. Conference Call Information The Company will host a conference call and live audio webcast on Thursday, August 7, 2025, at 8:00 a.m. ET. To access the conference call, please dial (877) 407-8037 (U.S.) or (201) 689-8037 (International) and reference the “Collegium Pharmaceutical Second Quarter 2025 Earnings Call.” An audio webcast will be accessible from the Investors section of the Company’s website: www.collegiumpharma.com. The webcast will be available for replay on the Company’s website approximately two hours after the event. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and a rapidly growing neuropsychiatry business driven by Jornay PM®, a differentiated treatment for ADHD. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. Non-GAAP Financial Measures To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In addition, certain non-GAAP financial measures, primarily adjusted EBITDA, are used to measure performance when determining components of annual compensation for substantially all non-sales force employees, including senior management. We may discuss the following financial measures that are not calculated in accordance with GAAP in our quarterly and annual reports, earnings press releases, and conference calls. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset(s) being impaired may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business;we exclude litigation settlements from adjusted EBITDA, as well as any applicable income items or credit adjustments due to subsequent changes in estimates. This does not include our legal fees to defend claims, which are expensed as incurred;we exclude acquisition related expenses as the amount and/or frequency of these expenses are not part of our underlying business. Acquisition related expenses include transaction costs, which primarily consisted of financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the acquisition, and miscellaneous other acquisition related expenses incurred;we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense associated with sale of our products as part of our underlying business;we exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis;we exclude executive transition expenses from adjusted EBITDA as the amount and/or frequency of these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis; andwe exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. Adjusted Operating Expenses Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted Net Income and Adjusted Earnings Per Share Adjusted net income is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of the tax effect of the adjustments. Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net income per share. Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security. Reconciliations of adjusted EBITDA, adjusted operating expenses, adjusted net income, and adjusted earnings per share to the most directly comparable GAAP financial measures are included in this press release. The Company has not provided a reconciliation of its full-year 2025 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company’s control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. A reconciliation of adjusted EBITDA or adjusted operating expenses would imply a degree of precision and certainty as to these future items that does not exist and could be confusing to investors. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our 2025 financial guidance, including projected product revenues, adjusted operating expenses and adjusted EBITDA, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contacts:Ian KarpHead of Investor Relationsir@collegiumpharma.com Danielle JesseDirector, Investor Relationsir@collegiumpharma.com Media Contact:Cheryl WheelerHead of Corporate Communicationscommunications@collegiumpharma.com Collegium Pharmaceutical, Inc.Unaudited Selected Consolidated Balance Sheet Information(in thousands) June 30, December 31, 2025 2024Cash and cash equivalents $117,348 $70,565Marketable securities 104,805 92,198Accounts receivable, net 213,023 228,540Inventory 38,148 35,560Prepaid expenses and other current assets 56,037 30,394Property and equipment, net 12,903 14,329Operating lease assets 5,263 5,822Intangible assets, net 780,456 891,402Restricted cash 20,900 26,047Deferred tax assets 91,967 98,033Other noncurrent assets 3,845 8,368Goodwill 147,936 162,333Total assets $1,592,631 $1,663,591 Accounts payable and accrued liabilities 70,326 76,058Accrued rebates, returns and discounts 310,758 338,642Business combination consideration payable 17,566 28,956Term notes payable 585,231 615,316Convertible senior notes 237,688 237,172Operating lease liabilities 6,191 6,810Deferred royalty obligation 122,627 120,613Deferred revenue 10,000 10,000Contingent consideration 38 1,182Shareholders’ equity 232,206 228,842Total liabilities and shareholders’ equity $1,592,631 $1,663,591 Collegium Pharmaceutical, Inc.Unaudited Condensed Statements of Operations(in thousands, except share and per share amounts) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024Product revenues, net$188,000 $145,276 $365,757 $290,199 Cost of product revenues Cost of product revenues (excluding intangible asset amortization) 24,143 19,955 49,103 38,905 Intangible asset amortization and impairment 55,473 34,515 110,946 69,032 Total cost of product revenues 79,616 54,470 160,049 107,937 Gross profit 108,384 90,806 205,708 182,262 Operating expenses Selling, general and administrative 73,637 43,335 150,060 85,317 Gain on fair value remeasurement of contingent consideration (358) — (1,144) — Total operating expenses 73,279 43,335 148,916 85,317 Income from operations 35,105 47,471 56,792 96,945 Interest expense (20,463) (15,587) (41,253) (32,926)Interest income 2,383 4,397 4,608 8,884 Loss on extinguishment of debt — (7,184) — (7,184)Income before income taxes 17,025 29,097 20,147 65,719 Provision for income taxes 5,042 9,491 5,747 18,400 Net income$11,983 $19,606 $14,400 $47,319 Earnings per share — basic$0.38 $0.60 $0.45 $1.46 Weighted-average shares — basic 31,810,612 32,433,025 31,802,222 32,379,807 Earnings per share — diluted$0.34 $0.52 $0.44 $1.24 Weighted-average shares — diluted 39,075,703 40,383,694 39,283,297 40,510,943 Collegium Pharmaceutical, Inc.Reconciliation of GAAP Net Income to Adjusted EBITDA(in thousands)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024GAAP net income$11,983 $19,606 $14,400 $47,319 Adjustments: Interest expense 20,463 15,587 41,253 32,926 Interest income (2,383) (4,397) (4,608) (8,884)Loss on extinguishment of debt — 7,184 — 7,184 Provision for income taxes 5,042 9,491 5,747 18,400 Depreciation 1,135 952 2,226 1,869 Amortization 55,473 34,515 110,946 69,032 Stock-based compensation 10,818 10,012 22,342 17,487 Recognition of step-up basis in inventory 1,954 — 5,431 — Executive transition expense — 3,051 1,397 3,051 Acquisition related expenses 935 — 2,224 — Gain on fair value remeasurement of contingent consideration (358) — (1,144) — Total adjustments$93,079 $76,395 $185,814 $141,065 Adjusted EBITDA$105,062 $96,001 $200,214 $188,384 Collegium Pharmaceutical, Inc.Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses(in thousands)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024GAAP operating expenses$73,279 $43,335 $148,916 $85,317Adjustments: Stock-based compensation 10,818 10,012 22,342 17,487Executive transition expense — 3,051 1,397 3,051Acquisition related expenses 935 — 2,224 —Gain on fair value remeasurement of contingent consideration (358) — (1,144) —Total adjustments$11,395 $13,063 $24,819 $20,538Adjusted operating expenses$61,884 $30,272 $124,097 $64,779 Collegium Pharmaceutical, Inc.Reconciliation of GAAP Net Income to Adjusted Net Income and Adjusted Earnings Per Share(in thousands, except share and per share amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024GAAP net income$11,983 $19,606 $14,400 $47,319 Adjustments: Non-cash interest expense 1,355 1,604 2,722 3,384 Loss on extinguishment of debt — 7,184 — 7,184 Amortization 55,473 34,515 110,946 69,032 Stock-based compensation 10,818 10,012 22,342 17,487 Recognition of step-up basis in inventory 1,954 — 5,431 — Executive transition expense — 3,051 1,397 3,051 Acquisition related expenses 935 — 2,224 — Gain on fair value remeasurement of contingent consideration (358) — (1,144) — Income tax effect of above adjustments(1) (17,871) (12,008) (36,608) (24,661)Total adjustments$52,306 $44,358 $107,310 $75,477 Non-GAAP adjusted net income$64,289 $63,964 $121,710 $122,796 Adjusted weighted-average shares — diluted(2) 39,075,703 40,383,695 39,283,297 40,510,943 Adjusted earnings per share(2)$1.68 $1.62 $3.16 $3.09 (1)The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the items that have a tax effect. The blended federal and state statutory rate for the three months ended June 30, 2025 and 2024 were 25.7% and 25.9%, respectively; and the blended federal and state statutory rate for the six months ended June 30, 2025 and 2024 were 25.8% and 26.2%, respectively. As such, the non-GAAP effective tax rates for the three months ended June 30, 2025 and 2024 were 25.5% and 21.3%, respectively; and the non-GAAP effective tax rates for the six months ended June 30, 2025 and 2024 were 25.4% and 24.6%, respectively.(2)Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for our convertible notes in accordance with ASC 260, Earnings per Share. As such, adjusted weighted-average shares – diluted includes shares related to the assumed conversion of our convertible notes and the associated cash interest expense is added-back to non-GAAP adjusted net income. For the three and six months ended June 30, 2025 and 2024, adjusted weighted-average shares – diluted includes 6,606,305 shares, attributable to our convertible notes. In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive.

Q2'25 Total Net Revenue of $302m; Q2'25 SUBLOCADE® Net Revenue of $209m, up 9% Year-over-Year Indivior Action Agenda Underway to Strengthen Business and Generate Operational Momentum Conference Call Scheduled for Today at 8:00 A.M. EDT RICHMOND, Va., July 31, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today reported its financial results for the second quarter ended June 30, 2025, and provided a business update. "SUBLOCADE® net revenue and pricing stability in SUBOXONE® Film in the U.S. drove solid results in the second quarter, leading us to raise our 2025 financial guidance," said Joe Ciaffoni, Chief Executive Officer. "In the second half of 2025, we are focused on implementing Phase 1 of the Indivior Action Agenda, Generate Momentum, which includes growing U.S. SUBLOCADE net revenue and simplifying the organization to generate operational momentum. We are committed to achieving our financial guidance for the year, investing in U.S. SUBLOCADE growth and implementing organizational changes that will strongly position us to advance to Phase 2 of the Indivior Action Agenda, Accelerate, at the start of 2026 and immediately realize bottom line accretion." "We are increasing our 2025 financial guidance to reflect better-than-expected net revenue performance in the first half of the year," said Ryan Preblick, Chief Financial Officer. "Our expectations for total net revenue and adjusted EBITDA are increasing by $65 million and $48 million, respectively, at the mid-points from our original guidance." Business Highlights Grew total SUBLOCADE Q2'25 net revenue to $209m, up 9% year-over-year and 19% versus Q1'25. Q2'25 U.S. SUBLOCADE net revenue increased 9% to $195m versus Q2'24 and 20% versus Q1'25. Growth was primarily volume driven. Initiated the Indivior Action Agenda with workstreams focused on U.S. SUBLOCADE growth and reducing organizational complexity. These efforts are expected to support long-term growth with significant operating leverage and durable cash generation. Strengthened Executive Team and Board of Directors with the addition of Patrick Barry, Chief Commercial Officer, Vanessa Procter, Executive Vice President of Corporate Affairs and Tony Kingsley, Independent Director. Completed London Stock Exchange (LSE) cancellation effective July 24, 2025. INDV now trades exclusively on Nasdaq, which aligns to the Company's capital markets footprint and a stronger focus on SUBLOCADE growth in the U.S. Announced inclusion in Russell Equity Indexes. Effective June 30, 2025, Indivior became a member of the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index. Presented new SUBLOCADE data at the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting demonstrating higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use. Published study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in The American Journal on Addictions, illustrating monthly SUBLOCADE use as a potential treatment option for opioid use disorder during and after pregnancy. Published real-world study in Drug and Alcohol Dependence Reports that found that opioid use disorder patients treated with extended-release buprenorphine (SUBLOCADE / SUBUTEX® Prolonged Release) had 57% lower odds of all cause emergency department (ED) visits compared to those who received no medications for opioid use disorder. Introduced Adjusted EBITDA (replacing Non-GAAP Operating Income) as a new key profitability measure and financial guidance metric because management believes it to be a better measure of operating results and cash generation. See page 11 and the accompanying Q2 2025 Financial Results Presentation. Raising Financial Guidance for 2025 Raised its full-year 2025 financial guidance. Guidance assumes no material change in exchange rates for key currencies compared with 2024 average rates, notably USD/GBP and USD/EUR. Financial Results for Second Quarter Ended June 30, 2025 Total net revenue in Q2 increased 1% to $302m (Q2'24: $299m) at actual exchange rates (1% increase at constant exchange rates). Total SUBLOCADE Q2 net revenue was $209m, up 9% year-over-year and 19% versus Q1'25. U.S. net revenue in Q2 of $256m increased slightly over Q2'24. U.S. SUBLOCADE net revenue increased 9% to $195m versus Q2'24. The slight increase in U.S. net revenue was primarily driven by volume growth of SUBLOCADE offsetting the decline in SUBOXONE Film due to generic competition and the discontinuation of PERSERIS in July 2024. Rest of World net revenue in Q2 increased 5% at actual exchange rates to $46m (3% increase at constant exchange rates). Growth in SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film more than offset ongoing generic erosion of the legacy SUBUTEX (buprenorphine) tablet business. Rest of World Q2 SUBLOCADE net revenue was $14m at actual exchange rates, an increase of 4% versus Q2'24. Gross margin in Q2 was 83% (Q2'24: 74%). Non-GAAP gross margin in Q2 was 84% (Q2'24: 84%). SG&A expense in Q2 was $158m (Q2'24: $152m). Non-GAAP SG&A expense in Q2 increased 6% to $146m (non-GAAP Q2'24: $137m) and primarily reflects an expected increase in marketing for U.S. SUBLOCADE. R&D expense in Q2 was $21m (Q2'24: $26m), a decrease of 20%, reflecting the refocusing of the pipeline on existing Phase 2 OUD assets (INDV-2000 and INDV-6001). Net income in Q2 was $18m and diluted EPS was $0.14 (Q2'24 net loss $97m; diluted loss per share: $(0.72)). Non-GAAP net income in Q2 was $64m and non-GAAP diluted EPS was $0.51 (Q2'24 non-GAAP net income: $66m; non-GAAP diluted EPS $0.48). The increase in non-GAAP diluted EPS reflects a lower diluted share count of approximately 8%. Adjusted EBITDA in Q2 was $88m ($93m Q2'24). The decrease primarily reflects increased marketing for U.S. SUBLOCADE. Cash and investments totaled $538m at the end of Q2'25, an increase of $191m compared to $347m at the end of 2024. Conference Call and Webcast Details A live conference call and webcast presentation will be held on July 31, 2025, at 8:00 A.M. EDT (13:00 GMT). The details to access the conference call and webcast are below. Materials will be available on the Company's website prior to the event at . The webcast link is: Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser): (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) 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  to learn more. Connect with Indivior on LinkedIn by visiting . Non-GAAP Financial Measures This announcement includes financial measures that are not measures defined by US GAAP, such as non-GAAP gross margin, non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, and adjusted EBITDA, 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. 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 share-based compensation expense, 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. Beginning with this Q2 2025 financial release, adjusted EBITDA will replace adjusted operating income as a non-GAAP measure. The Company believes adjusted EBITDA may be useful to investors to understand the Company's performance. In addition, the Company uses "Adjusted EBITDA" in its annual incentive plan in which all executive officers participate. Supplemental historical reconciliations of net income to adjusted EBITDA for Q1 2024 to Q1 2025 are included on page 10. Share-based compensation has been excluded from non-GAAP selling, general and administrative expenses, non-GAAP net income, non-GAAP diluted earnings per share and adjusted EBITDA for the current period and prior period comparatives presented. 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 net revenue, gross margin, non-GAAP gross margin, non-GAAP SG&A, non-GAAP R&D expense, and Adjusted EBITDA, 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; 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; 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; company actions expected to improve or support execution, reduce organizational complexity, support long-term growth with significant operating leverage, drive durable cash generation and create value for the patients we serve and our shareholders; our belief that higher doses of SUBLOCADE may offer better outcomes for individuals with high levels of fentanyl use; 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, our Form 10-Q filed May 1, 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. We define adjusted gross margin % as adjusted gross profit divided by net revenue. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) The 2025 YTD effective tax rate was 46% (2024 YTD: 25%). On a non-GAAP basis, the 2025 YTD effective tax rate was 18% (2024 YTD: 17%). We define Non-GAAP effective tax rate as Non-GAAP tax expense divided by Non-GAAP income before taxation. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) 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. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, income tax expense or benefit, depreciation and amortization, as well as share-based compensation and other adjustments reflecting changes in our business that do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. Indivior PLC (Amounts in millions, except per share data and percentages) (Unaudited) FY 2025 Original Guidance (April 24, 2025) FY 2025 Guidance now reflects the adoption of Adjusted EBITDA as a key profit measure, replacing non-GAAP Operating Income. SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED