Buprenorphine Hydrochloride

Q1’26 Total Net Revenue of $317 Million, Up 19% YoY Q1’26 Total SUBLOCADE® Net Revenue of $232 Million, Up 32% YoY Q1'26 GAAP Net Income of $89 Million and Q1'26 Non-GAAP Net Income of $123 Million Record Quarterly Adjusted EBITDA of $164 Million in Q1'26, Up 112% YoY Repurchased Approximately Four Million Shares in Q1'26 for $125 Million Conference Call at 8:00 A.M. EDT Today RICHMOND, Va., April 30, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals, Inc. (Nasdaq: INDV) today reported its financial results for the first quarter ended March 31, 2026, and raised its full-year 2026 financial guidance. “We are encouraged by our first quarter results, which reflect the progress we are making against Phase II of the Indivior Action Agenda – Accelerate," said Joe Ciaffoni, Chief Executive Officer. "Year-over-year we accelerated SUBLOCADE net revenue and dispense unit growth and grew adjusted EBITDA and cash at an even faster rate while executing on our capital deployment strategy. We remain focused on accelerating SUBLOCADE dispense unit growth, growing our bottom line at a significantly faster rate, and strategically deploying capital as we earn our way to Phase III of the Indivior Action Agenda – Breakout – which we are on track to enter in the second half of 2026.” “Strong SUBLOCADE performance in the first quarter led us to raise our 2026 financial guidance," said Ryan Preblick, Chief Financial Officer. "We now expect 2026 total SUBLOCADE net revenue growth of 13% year-over-year and adjusted EBITDA growth of 50% year-over-year at the midpoint of our guidance ranges. We strengthened our financial position with the completion of a $500 million convertible senior notes offering and returned capital to our shareholders through the opportunistic repurchase of $125 million in shares during the quarter. We are committed to creating long-term shareholder value as we advance the Indivior Action Agenda.” Q1 2026 Business Highlights : As of March 31, 2026, over 500,000 patients in the U.S. have been prescribed SUBLOCADE since launch. Grew total SUBLOCADE net revenue 32% year-over-year to $232 million. U.S. SUBLOCADE net revenue increased 33% year-over-year to $218 million versus the prior year, driven by 20% dispense unit volume growth. New patient starts of approximately 31,800 were a record. Net revenue also benefited from more favorable price/mix and gross-to-net adjustments. In February 2026, announced a share repurchase program of up to $400 million with a term of up to 18 months. To date, 3,974,153 shares were repurchased at an average price of $31.45 for a total of $125 million. Indivior has $275 million remaining under the program. Successfully completed a $500 million offering of 0.625% convertible senior notes due in 2031. The majority of the proceeds were used to repay in full the $333 million balance of Indivior's previous term loan. Announced three publications highlighting the importance of SUBLOCADE as a treatment option for opioid use disorder across various healthcare settings, including: New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder , National Survey Finds Only 58% of U.S. Correctional Facilities Offer Medications for Opioid Use Disorder and New Cost Impact Model Highlights Potential for Monthly Injectable Buprenorphine to Reduce Staffing Burdens in Correctional Facilities . Pipeline Update : INDV-6001 (Buprenorphine Caproate): Indivior does not intend to pursue Phase 3 development of INDV-6001 and has amended its license agreement with Alar Pharmaceuticals. Pursuant to the amendment, Alar will regain development rights to the asset and will have commercialization rights outside the U.S. Indivior will maintain exclusive commercial rights in the U.S. should Alar receive FDA approval for a commercially viable product in the future. INDV-2000 (Rocavorexant): Announced today that following a thorough evaluation of the Phase 2 proof-of-concept study, Indivior will not be advancing INDV-2000 internally as a treatment for opioid use disorder. INDV-2000 did not meet the primary endpoint of "no treatment failure." The Company will seek external business development opportunities for the asset as supportive findings included directional effects on abstinence-related measures, exploratory anxiety outcomes, fMRI evidence consistent with modulation of relapse-related neural circuitry, and a favorable safety and tolerability profile. Raising Full-Year 2026 Financial Guidance: Full-year financial guidance assumes no material change in exchange rates for key currencies compared with 2025 average rates, notably USD/GBP and USD/EUR. Prior FY 2026 Guidance (2/26/2026) Revised FY 2026 Guidance Net Revenue $1,125 million to $1,195 million $1,215 million to $1,285 million Total SUBLOCADE Net Revenue $905 million to $945 million $950 million to $990 million Non-GAAP Operating Expenses* $430 million to $450 million $430 million to $450 million Adjusted EBITDA* $535 million to $575 million $620 million to $660 million *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. Financial Results for Quarter Ended March 31, 2026 : Total net revenue was $317 million for the quarter ended March 31, 2026 (the 2026 quarter), compared to $266 million for the quarter ended March 31, 2025 (the 2025 quarter), representing a 19% increase year-over-year. Total SUBLOCADE net revenue was $232 million for the 2026 quarter, compared to $176 million for the 2025 quarter, representing a 32% increase year-over-year. GAAP operating expenses were $139 million for the 2026 quarter, compared to $156 million for the 2025 quarter, representing a 10% decrease year-over-year. Non-GAAP 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 $116 million for the 2026 quarter, compared to $147 million for the 2025 quarter, representing a 21% decrease year-over-year. GAAP net income for the 2026 quarter was $89 million ($0.69 diluted earnings per share), compared to GAAP net income for the 2025 quarter of $47 million ($0.38 diluted earnings per share). Non-GAAP net income for the 2026 quarter was $123 million ($0.96 diluted earnings per share), compared to non-GAAP net income for the 2025 quarter of $56 million ($0.45 diluted earnings per share). Adjusted EBITDA for the 2026 quarter was $164 million, compared to $78 million for the 2025 quarter, representing a 112% increase year-over-year. The Company ended the 2026 quarter with cash and investments of $201 million. Conference Call and Webcast Details: A live conference call and webcast presentation will be held on April 30, 2026, at 8:00 A.M. EDT. 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 number with a unique pin code following their registration) About Indivior As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine — developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities, we are powering recovery and renewing hope. Visit to learn more. Connect with Indivior on LinkedIn by visiting . Columns and rows within financial tables may not foot due to rounding. Percentages and per share data in the financial tables have been calculated using actual, non-rounded figures. Non-GAAP Financial Measures : Non-GAAP financial measures adjust for non-recurring items and other items representing 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. The Company believes its non-GAAP financial measures 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. Important Cautionary Note Regarding Forward-Looking Statements : This announcement contains certain statements that are forward-looking statements. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements include, among other things, express and implied statements regarding: expected acceleration in SUBLOCADE net revenue and dispense unit growth; expected future investments and capital deployments; expected growth in adjusted EBITDA, cash flow, and our bottom line, and expected acceleration of such growth; expected creation of shareholder value; our 2026 financial guidance including with respect to net revenue, total SUBLOCADE net revenue, non-GAAP operating expenses, and Adjusted EBITDA; 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. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and only express management’s beliefs regarding future results or events which, by their nature, are inherently uncertain and outside of management’s control or ability to predict. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including but not limited to: lower than expected future sales of our products; greater than expected impacts from competition; and unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs. For additional information about some of the risks and important factors that could affect our future results and financial condition, see “Important Cautionary Note Regarding Forward-looking Statements” and "Risk Factors" in Indivior's Annual Report on Form 10-K filed February 26, 2026 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, or to reflect events or developments that occur after the date the statement was made. For Further Information Investors Jason Thompson VP, Investor Relations +1 804 402 7123 jason.thompson@indivior.com Media Cassie France-Kelly VP, Communications +1 804 594 0836 Indiviormediacontacts@indivior.com Indivior Pharmaceuticals, Inc. (Amounts in millions, except per share data and percentages) (Unaudited) Condensed consolidated statements of operations Three Months Ended March 31, 2026 2025 Net revenue $ 317 $ 266 Cost of sales 40 44 Gross profit 277 221 Selling, general and administrative 124 133 Research and development 16 22 Total operating expenses 139 156 Operating income 137 66 Interest (income) (3) (4) Interest expense 7 12 Loss on debt extinguishment 18 — Income before income taxes 115 59 Income tax expense 26 11 Net income $ 89 $ 47 Earnings per share Basic $0.71 $0.38 Diluted $0.69 $0.38 Indivior Pharmaceuticals, Inc. (Amounts in millions, except per share data and percentages) (Unaudited) Condensed consolidated balance sheets March 31, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents $ 175 $ 195 Accounts receivable, net of allowances of $3 (2026) and $4 (2025) 273 253 Inventories 152 153 Prepaid expenses 15 34 Current tax receivable 12 2 Other current assets 40 16 Total current assets 667 652 Long-term investments 27 28 Property, plant and equipment, net 157 144 Operating lease right of use assets, net 22 26 Goodwill and other intangible assets, net 2 2 Deferred tax assets 296 323 Other noncurrent assets 26 27 Total assets $ 1,197 $ 1,201 Liabilities and stockholders' deficit Current liabilities Accrued rebates and product returns $ 551 $ 582 Accounts payable and accrued expenses 178 250 Accrued litigation settlement expenses, current 14 42 Current portion of long-term debt — 29 Operating lease liabilities, current 9 10 Income taxes payable 26 2 Total current liabilities 779 914 Long-term debt, less current portion 486 290 Accrued litigation settlement expenses, noncurrent 41 52 Operating lease liabilities, noncurrent 14 22 Other noncurrent liabilities 21 21 Total liabilities 1,341 1,300 Stockholders' deficit Common stock, par value $0.001 per share Issued shares: 121 (2026) and 125 (2025) — 62 Additional paid-in capital 165 112 Accumulated other comprehensive loss (29) (30) Accumulated deficit (280) (243) Total stockholders' deficit (144) (98) Total liabilities and stockholders' deficit $ 1,197 $ 1,201 Indivior Pharmaceuticals, Inc. (Amounts in millions, except per share data and percentages) (Unaudited) Condensed consolidated statements of cash flows Three Months Ended March 31, 2026 2025 Cash flows from operating activities: Net income $ 89 $ 47 Adjustments to reconcile net income to net cash from operating activities: Depreciation and amortization 2 3 Amortization of right-of-use assets 2 2 Stock-based compensation expense 9 6 Impairment of tangible and intangible assets 6 — Loss on debt extinguishment 18 — Deferred income taxes 27 (2) Impact from foreign exchange movements — (1) Other adjustments, net — 1 Change in operating assets and liabilities (163) 18 Net cash (used in) provided by operating activities (9) 75 Cash flows from investing activities: Purchases of property and equipment (20) (5) Purchases of investments in debt securities (5) (5) Sales and maturities of debt securities 6 6 Net cash used in investing activities (19) (5) Cash flows from financing activities: Proceeds from the issuance of common stock — 1 Cash paid for repurchases of common stock (126) (11) Proceeds from debt, net 489 — Repayments of debt (333) (4) Transaction costs related to debt refinancing (5) — Settlement of equity awards (21) (3) Other 3 — Net cash provided by (used in) financing activities 7 (17) Net (decrease) increase in cash and cash equivalents (20) 53 Exchange differences — — Cash and cash equivalents at beginning of period 195 319 Cash and cash equivalents at end of period $ 175 $ 372 Indivior Pharmaceuticals, Inc. (Amounts in millions, except per share data and percentages) (Unaudited) Selected revenue information Three Months Ended March 31, 2026 2025 US: SUBLOCADE* $ 218 $ 163 Sublingual & other 50 54 PERSERIS 1 5 4 Total U.S. 272 222 Rest of World 45 44 Net revenue $ 317 $ 266 *Total SUBLOCADE net revenue $ 232 $ 176 1 Marketing and promotion activities for PERSERIS were discontinued in 2024. Reconciliation of GAAP to non-GAAP financial information Three Months Ended March 31, 2026 2025 GAAP operating expenses $ 139 $ 156 Share-based compensation 9 6 Corporate initiative transition 1 14 1 Litigation settlement expense — 1 Less: Adjustments in operating expenses 23 9 Non-GAAP operating expenses $ 116 $ 147 1 Includes severance, consulting, impairment, and costs related to planned facility closures. Non-GAAP diluted earnings per share Management believes that non-GAAP diluted earnings 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 below. A reconciliation of GAAP net income to non-GAAP net income is included below. Three Months Ended March 31, 2026 2025 GAAP net income $ 89 $ 47 Adjustments in cost of sales 1 2 — Adjustments in operating expenses 23 9 Loss on debt extinguishment 18 — Adjustments in tax expenses (9) — Non-GAAP net income $ 123 $ 56 Shares used in computing diluted non-GAAP earnings per share 129 125 Non-GAAP diluted earnings per share $ 0.96 $ 0.45 1 Includes manufacturing transition and other costs Indivior Pharmaceuticals, Inc. (Amounts in millions, except per share data and percentages) (Unaudited) Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income adjusted to exclude interest expense, interest income, income tax expense or benefit, depreciation and amortization, as well as stock-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. Three Months Ended March 31, 2026 2025 Net income $ 89 $ 47 Interest (income) (3) (4) Interest expense 7 12 Income tax expense 26 11 Depreciation and amortization 2 3 Stock-based compensation expense 9 6 Corporate initiative transition 14 1 Manufacturing transition 1 — Loss on debt extinguishment 18 — Litigation settlement expense — 1 Adjusted EBITDA $ 164 $ 78

欧洲监管碎片化正通过多重机制侵蚀制药创新根基，其核心症结在于27国分散的审批体系、定价冲突与政策内耗，导致研发投资外流、新药上市延迟，最终动摇欧洲在全球医药创新中的领导地位。 一、监管碎片化的核心表现 割裂的审批体系 欧洲药品管理局（EMA）仅负责欧盟层面审批，但成员国保留独立监管权，药企需面对27套不同的临床试验标准、定价规则和医保报销政策。例如，同一款新药在德国获批后，仍需在法国重新提交材料，平均审批耗时430天，比美国（356天）和中国（390天）更长。 定价冲突与医保压价 各国医保系统相互参考定价，形成"低价螺旋"：丹麦一旦降低某抗癌药价格，意大利、西班牙迅速跟进压价，导致药企在欧洲的收益仅为美国的1/3-1/2。部分药企被迫退出市场，如安进的降胆固醇药Repatha因价格压力撤出丹麦。 二、对创新链条的系统性拖累 研发投资大规模外流 资本转移：欧盟生物科技企业获得的风投仅为美国的1/5-1/10，2025年欧洲研发支出占全球份额从1990年的50%暴跌至26%，而美国升至55%。 产业迁移：32家药企联名警告，若欧盟不改革，2029年前将有1130亿欧元投资转向美国；辉瑞、诺华等已缩减欧洲研发中心，转向中美建立基地。 新药上市策略性延迟 受美国"最惠国定价"政策影响（要求美国药价对标全球最低价），药企为避免欧洲低价拉低美国利润，主动推迟新药在欧洲上市。2025年欧盟新药上市量同比暴跌35%，90%的新药选择先在美国上市。典型案例包括抗炎药Brunspli在德国延迟上市，戒毒药Subutex退出瑞典市场。 临床资源与数据割裂 成员国临床试验标准不统一，导致跨国多中心研究效率低下。例如，同一试验在波兰需额外伦理审查，而在荷兰可直接启动，拖累研发进度。欧盟在首创新药（First-in-class） 数量上已被中国反超。 三、深层影响：创新生态恶性循环 企业生存空间压缩 欧洲药品支出仅占GDP的1%（美国2%、中国1.8%），且二十年来未增长。价格管制下，中小企业难以回收研发成本，如微污染物污水处理费导致行业新增38亿欧元成本。 人才与技术双重流失 顶尖科研人员流向中美：剑桥大学团队被中国药企高薪招募，瑞士罗氏实验室迁至波士顿。欧洲在基因治疗、ADC药物等前沿领域专利占比不足全球10%，而中国达33%。 全球竞争地位滑落 过去十年，欧盟新活性药物成分（API）获批量下降20%，中国增长470%；欧洲仅占全球TOP50药企中的4家，中国已有7家跻身榜单。罗氏CEO施内克直言："欧洲在创新药竞赛中已彻底落后。" 四、改革困境与未来挑战 欧盟虽推出《生物技术法案》和"地平线欧洲计划"，但成员国利益难以协调： - 法国支持统一采购，但德国反对权力让渡，担心丧失定价主导权； - 定价改革受阻：延长数据保护期至12年的提案遭北欧国家反对，认为将推高医保支出； - 监管简化停滞：EMA提议的"欧盟临床试验统一门户"因预算分歧搁置。 关键警示：若欧盟无法在2027年前建立统一监管框架，欧洲可能彻底沦为中美企业的"销售办事处"，丧失源头创新能力。 (以上内容均由AI生成)