Buprenorphine

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

药械追踪No.1 / BMS双免疗法欧狄沃联合逸沃在华获批肺癌一线适应证2025年7月28日，百时美施贵宝（简称“BMS”，NYSE：BMY）宣布，旗下PD-1抑制剂欧狄沃（纳武利尤单抗）和CTLA-4抑制剂逸沃（伊匹木单抗）“双免”联合疗法获中国国家药监局（NMPA）批准新适应证，适用于由NMPA批准的检测评估为PD-L1肿瘤比例分数（TPS）>1%的表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非小细胞肺癌一线治疗，成为中国首个获批的肺癌双免疫联合疗法。此次新适应证获批基于CheckMate-227研究，这是非小细胞肺癌免疫治疗领域迄今随访时间最长的III期研究之一。研究数据证实，欧狄沃联合逸沃方案可带来长期、持续的生存获益，使22%的PD-L1>1%患者实现6年长生存（化疗组仅13%），同时避免了化疗毒性。->点击文末阅读原文，解锁完整双语新闻No.2 / GSK玛贝兰妥单抗获欧盟批准复发/难治性多发性骨髓瘤2025年7月27日，葛兰素史克（LSE/NYSE：GSK）宣布，Blenrep已获得欧盟（EU）批准，用于以下适应证：联合硼替佐米和地塞米松（BVd），用于既往接受过至少一线治疗的复发或难治多发性骨髓瘤成人患者；或联合泊马度胺和地塞米松（BPd），用于既往接受过至少一线治疗（包括含来那度胺的治疗）的复发或难治多发性骨髓瘤成人患者。Blenrep是一种抗体偶联药物，由人源化B细胞成熟抗原单克隆抗体通过不可裂解的连接子与细胞毒药物auristatin F偶联而成。药物连接子技术由Seagen Inc.授权；单克隆抗体使用BioWa Inc.（Kyowa Kirin集团子公司）授权的POTELLIGENT技术生产。DREAMM-7和DREAMM-8研究证实，Blenrep相关的眼部副作用可通过适当的剂量调整和随访进行有效管理和逆转，从而使患者维持获益：在两项试验中，因眼部副作用导致的停药率均较低（≤9%）。在含Blenrep的联合治疗方案组中，最常报告的非眼部不良事件（发生率>30%）在DREAMM-7中为血小板减少症（87%）和腹泻（32%），在DREAMM-8中为中性粒细胞减少症（63%）、血小板减少症（55%）和COVID-19感染（37%）。含Blenrep的联合治疗方案目前也已获英国、日本以及其他市场，包括加拿大和瑞士（基于DREAMM-8的结果）批准用于复发或难治多发性骨髓瘤治疗。该方案目前正在全球所有主要市场接受审评，包括美国和中国（基于DREAMM-7的结果，该联合疗法获得了突破性疗法认定，其上市申请也获得了优先审评资格）。->点击文末阅读原文，解锁完整双语新闻No.3 / 赛诺菲赛可益获欧盟批准用于新诊多发性骨髓瘤移植适应人群2025年7月25日，赛诺菲（EURONEXT: SAN; NASDAQ: SNY）宣布，其抗CD38单克隆抗体赛可益（赛可益，通用名：艾沙妥昔单抗）获得欧盟委员会批准，联合硼替佐米、来那度胺和地塞米松（VRd方案）用于自体造血干细胞移植适应的初治多发性骨髓瘤（NDMM）成人患者诱导治疗。此次批准使赛可益成为欧盟首个获批用于该人群的抗体类治疗药物，进一步拓展了其适应证范围，实现涵盖无论是否符合移植资格患者的全线治疗。该批准基于GMMG-HD7 Ⅲ期临床研究第一部分的数据。研究显示，赛可益联合VRd方案显著提高了18周诱导期结束时的微小残留病灶（MRD）阴性率（主要终点），同时延长了无进展生存期（PFS）。MRD持续阴性率方面，赛可益-VRd组达53.1%，对照组为38%。整体生存数据尚不成熟，安全性结果与以往一致。赛可益目前已在包括美国、欧盟、日本和中国在内的 50 多个国家/地区获批，用于治疗多种多发性骨髓瘤 (MM)。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 恒瑞医药与GSK达成许可合作协议，最高金额或达120亿美元2025年7月28日，恒瑞医药（600276.SH）公告称，公司与葛兰素史克（GSK）旗下两家知识产权公司签署许可、合作与选择权协议。恒瑞将其PDE3/4抑制剂HRS-9821的全球独家权益（不含中国大陆、港澳台）授予GSK，同时赋予其对最多11个处于临床前阶段的创新项目的独家选择权（不含中国大陆、港澳台）。根据协议，恒瑞将获得5亿美元首付款。如GSK行使全部选择权并成功开发、注册及销售里程碑事件，恒瑞有望获得总额最高达120亿美元的潜在付款。此外，恒瑞将有权向GSK收取相应的分梯度的销售提成。HRS-9821是一款处于临床开发阶段的潜在同类最优PDE3/4双重抑制剂，拟用于慢性阻塞性肺疾病（COPD）维持治疗，无需参考既往治疗历史。其早期研究显示出显著支气管扩张与抗炎作用，具备开发干粉吸入剂的潜力。->点击文末阅读原文，解锁完整双语新闻No.2 / Matchpoint与诺华达成高达10.6亿美元的炎症疾病创新药合作协议2025年7月24日，Matchpoint Therapeutics宣布与诺华（NYSE: NVS）达成一项专属选择权及许可协议，双方将合作开发针对多种炎症性疾病的口服共价抑制剂。该项目靶向一类与炎症疾病密切相关、传统方法难以成药的转录因子。Matchpoint是一家专注于共价口服药物研发的私营生物技术公司。根据协议条款，Matchpoint将利用其先进的共价探索(ACE)平台推进该项目至候选药物阶段，并负责所有前期研究工作。诺华将提供高达6000万美元的首付款和研究经费；若其选择行使许可选项，将获得该项目的全球开发和商业化权利。Matchpoint有资格获得总计高达10亿美元的里程碑付款，以及基于未来产品销售的分成。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 三部委发布2025年版药用类麻醉药品和精神药品目录2025年7月28日，国家药监局、公安部、国家卫生健康委制定了药用类麻醉药品目录（2025年版）和药用类精神药品目录（2025年版），共纳入32款麻醉药品和96款精神药品（一类18款，二类78款）。药品大部分都在2023年增补后的麻精药品目录内，药用类精神药品中与麻精药品目录相比，额外有哌甲酯、卡立普多、西博帕多、依替唑仑、瑞马唑仑、丝右哌甲酯、韦利西贝、舒拉诺龙、丁丙诺啡、纳洛酮复方口服固体制剂和含可待因复方口服液体制剂。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻