Denosumab-dssb

注意-更正并替换：Samsung Epis Holdings公布2026年第一季度财务业绩• Samsung Bioepis 2026年第一季度营收达4549亿韩元，营业利润为1440亿韩元专注于生物制药和生物技术创新的投资公司Samsung Epis Holdings (KRX: 0126Z0)今日公布了其2026财年第一季度的财务业绩。Samsung Epis Holdings总裁兼首席执行官Kyung-Ah Kim表示：“依托生物类似药产品组合的持续增长动力，Samsung Bioepis本季度实现稳健增长。我们正通过新的全球合作和持续的产品组合扩张，进一步巩固市场地位。值此公司首款生物类似药在欧洲上市十周年之际，我们将在既有基础上再接再厉，同时开展战略性投资以支持长期发展。我们将持续致力于为股东创造可持续价值。”2026年第一季度业绩按单独基准计算，2026年第一季度，Samsung Bioepis实现营收4549亿韩元，营业利润1440亿韩元。第一季度营收和营业利润分别同比增长14%（543亿韩元）和13%（161亿韩元）。第一季度整体增速较2025年1月发布的业绩指引高出10%以上，反映出各项业务表现优于预期。Samsung Epis Holdings实现合并营收4539亿韩元，营业利润905亿韩元。合并营收和营业利润包含收购价格分摊(PPA)相关研发成本的摊销等非现金会计调整项目；2025年11月至12月，公司合并营收为2517亿韩元，营业亏损为636亿韩元。[Samsung Bioepis收益数据，单位：十亿韩元]2024年第一季度2025年第一季度2026年第一季度同比变化营收280.1400.6454.9+54.3 (+14%)营业利润38.1127.9144.0+16.1 (+13%)业务近况2025年10月，Samsung Bioepis与Cordavis就Prolia1生物类似药OSPOMYV™ (denosumab-dssb)达成自有品牌合作。BENEPALI™ (etanercept)是Samsung Bioepis的首款登陆欧洲的生物类似药，今年迎来欧洲上市十周年，持续稳固市场领先地位。今年3月，Samsung Bioepis扩大与Sandoz的研发和商业化合作关系，双方将在多个市场合作开发和推广至多五款生物类似药候选产品，包括参考Entyvio (vedolizumab)的生物类似药候选药物SB36。同样在3月，Samsung Bioepis首款新型抗体药物偶联物(ADC)候选药物SBE303正式启动一期首次人体临床试验。在此次宣布之后，公司于4月20日在2026年美国癌症研究协会(AACR)年会上以海报形式展示了该药物的临床前数据，这些数据显示其疗效、安全性和耐受性表现良好，具备与现有肿瘤免疫疗法联合用药的良好前景。Samsung Bioepis的第二款新型ADC候选药物SBE313目前正与Phrontline Biopharma合作开展临床前研发工作。免责声明本文包含关于未来预期、预测、计划和展望的“前瞻性陈述”。“前瞻性陈述”涉及与公司未来业务和财务表现相关的事项，会受到诸如国内外金融市场趋势等各类不确定因素影响，包括但不限于汇率和/或利率波动。“前瞻性陈述”本质上涉及可能存在不确定性的事项；实际业绩可能与本文所述存在重大差异。关于Samsung Epis Holdings Co., Ltd.Samsung Epis Holdings是一家专注于生物制药及生物技术领域的投资控股公司，致力于通过积极的研发投入与投资活动，实现公司与股东价值最大化，并为旗下子公司Samsung Bioepis和Epis NexLab优化业务战略。Samsung Epis Holdings始终积极应对未来挑战，通过发掘新的增长动力、强化全球合作平台来驱动创新发展，从而为子公司的持续成长奠定坚实基础。关于Samsung Bioepis Co., Ltd.Samsung Bioepis成立于2012年，是一家致力于实现普惠医疗保健的生物制药公司。通过产品开发领域的创新和对质量的坚定承诺，Samsung Bioepis旨在成为全球领先的生物制药企业。Samsung Bioepis持续推进涵盖广泛治疗领域的生物类似药候选药物管线，包括免疫学、肿瘤学、眼科学、血液学、肾病学、神经病学和内分泌学。关于Epis NexLab Co., Ltd.Epis NexLab成立于2025年，是Samsung Epis Holdings的全资子公司，致力于通过新一代生物技术平台的研发驱动创新发展。Epis NexLab将具备高度可扩展性的肽类相关技术转化为药物研发平台，专注于探索创新治疗模式，针对多种疾病开发多款候选治疗药物。 转载请注明出处。

Basel, 29 April 2026 – Sandoz (SIX: SDZ/OTCQX: SDZNY), the global leader in affordable medicines, today presents its net-sales performance for the first quarter of 2026. Q1 2026 % Q1 2025 Change USD m Net sales USD m USD % CC %1,2,3 Net sales 2,756 100% 2,480 11% 3% Biosimilars 853 31% 671 27% 18% Generics 1,903 69% 1,809 5% -3% Europe 1,556 57% 1,372 13% 2% International 609 22% 590 3% -2% North America 591 21% 518 14% 12% Performance in line with Company expectations. Overall net sales up by 3% at CC, and by 5% when excluding effect of adverse dynamics in anti-infective B2B business4. Impact of dynamics in year concentrated in first quarter, with remaining effects dissipating thereafter Biosimilar net sales up by 18% at CC, with generics net sales declining by 3% at CC. Underlying generics net sales declined by 1% at CC when excluding aforementioned anti-infective B2B impact North America net sales up by 12% at CC, reflecting exceptional biosimilars performance. Europe net sales up by 2% at CC with biosimilars net sales up by double digit. Excluding anti-infective B2B impact, Europe net sales up by 4% at CC. Exceptional International biosimilar net sales, with region’s generics result impacted by active portfolio rationalisation and phasing of sales, as well as anti-infective B2B effect Announcement of strategic partnership with Samsung Bioepis, covering up to five biosimilar assets Full-year 2026 guidance confirmed Richard Saynor, Chief Executive Officer of Sandoz, commented: “The performance in the first quarter illustrates the underlying strengths of Sandoz. I was delighted by the exceptional growth in North America and International across biosimilars, supported by new launches and excellence in execution. We produced sales growth in line with our expectations, and the fundamentals of the 2026 roadmap are strong. We are happy to confirm our full-year guidance today. “As we look further out, I’m excited by the overwhelming scale of the opportunities ahead. We’ll complete the construction of our biosimilar hub soon; we’re rapidly expanding the biosimilar pipeline; regulatory streamlining is an important tailwind, and a very significant number of losses of exclusivity are approaching. More than 20,000 Sandoz colleagues are ready to capitalise on these opportunities and deliver even more for patients and shareholders.” BUSINESS HIGHLIGHTS In March 2026, Sandoz and Samsung Bioepis entered a strategic partnership covering up to five biosimilar assets, with the first being a proposed vedolizumab biosimilar. The agreement expands the Sandoz biosimilar pipeline to up to 32 assets In the period, the Company focused its biosimilar development, manufacturing and supply activities under newly appointed Armin Metzger. This will drive faster decision making, greater vertical integration and improved launch readiness across the expanding biosimilars pipeline. There are no changes to the Company’s financial-reporting structure The European Medicines Agency (EMA) recently confirmed that, for well‑characterised biological medicines, a robust analytical comparability package, combined with comparative pharmacokinetic data, may be sufficient to demonstrate biosimilarity, and comparative clinical efficacy and safety studies are not necessarily required. The EMA commented, “this tailored clinical approach is expected to be applicable for the majority of biosimilar candidates” In March 2026, the US FDA expanded the label for Enzeevu® (aflibercept) to include macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema, along with the previously approved indication of neovascular (wet) age-related macular degeneration. This significantly broadened the treatable patient population and supports a planned Q4 2026 US launch In the period, the European Commission granted marketing authorisation for Ranluspec® (ranibizumab) across all reference indications, reinforcing the Company’s ophthalmology franchise and paving the way for an expected H2 2026 European launch In April2026, following a Commerce Department investigation, the US government confirmed that generic and biosimilar medicines “should not be subject to section 232 tariffs at this time” During the period, the Company announced the issuance of a CHF 275 million bond with a six-year maturity and a CHF 275 million bond with a 10-year maturity, for the refinancing of maturing debt and other general corporate purposes. Sandoz is on track to extend its average debt maturity to six to seven years FULL-YEAR 2026 GUIDANCEThe Company continues to anticipate strong net-sales growth and further core EBITDA-margin expansion this year. As a result, the Company confirms its guidance for 2026: Net sales to grow at CC by a mid-to-high single-digit percentage Core EBITDA-margin expansion of around 100 basis points No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low-to-mid single-digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this Media Release covers the three-month period ended 31 March 2026 (Q1 2026), compared to the three-month period ended 31 March 2025 (Q1 2025). In this Media Release, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales. CALENDARThe Company intends to publish its half-year results on 5 August 2026.DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialise or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES1 Constant currencies. 2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025. 3 For Q1 2026, all growth at constant currencies is the same as the comparable growth rate. Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. 4 As part of its vertically integrated penicillin production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) on a business-to-business (B2B) basis. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6 Aminopenicillanic acid (6 APA), the foundational compound for all penicillin. This price decline coincided with an increase in global market supply. Penicillin API represented a significant part of anti-infective B2B net sales in FY 2025. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alexis Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Chris Lewis +49 174 244 9501 Tamara Hackl +41 79 790 5217 Gregor Rodehueser +49 170 574 3200 Silvia Siegfried +41 79 795 9061 FIRST-QUARTER NET SALES Net sales of USD 2,756 million in the quarter represented growth of 3% at CC. Volumes grew by 7%, partly offset by price erosion of 4%. Net-sales growth was primarily driven by the performance of biosimilars, which continue to benefit from an extensive launch programme. When excluding the impact of adverse dynamics in the anti-infective B2B business, the growth in net sales amounted to 5% at CC. By business Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Biosimilars 853 31% 671 27% 18% 18% Generics 1,903 69% 1,809 5% -3% -3% Biosimilars overview Net sales of biosimilars of USD 853 million reflected a strong growth of 18% at CC. Biosimilars represented 31% of total net sales (Q1 2025: 27%). The Europe biosimilars performance benefited from the launch of Afqlir® (aflibercept) and good performances from Hyrimoz® (adalimumab) and Binocrit® (epoetin alfa). Exceptional North America biosimilar net-sales growth reflected the strong launch of Wyost® & Jubbonti® (denosumab), while an exceptional International biosimilar result was driven by the performances of Hyrimoz, Rixathon® (rituximab) and the recent launches of Wyost & Jubbonti. Generics overview Net sales of generics of USD 1,903 million reflected a decline of 3% at CC and, when excluding the impact of adverse dynamics in the anti-infective B2B business, this translated to a decrease of 1% at CC. Generics represented 69% of net sales (Q1 2025: 73%). The decline in net sales was mainly driven by the performance in the International business which was significantly impacted by active portfolio rationalisation and the phasing of sales, as well as the aforementioned anti-infective B2B effect. By region Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Europe 1,556 57% 1,372 13% 2% 2% International 609 22% 590 3% -2% -2% North America 591 21% 518 14% 12% 12% Europe overview Net sales in Europe were USD 1,556 million, reflecting growth of 2% at CC, with a double-digit biosimilars performance at CC outweighed by a decline in generics net sales, with the latter impacted by the effect of adverse dynamics in the anti-infective B2B business. This performance was also driven by unfavourable seasonal effects on the sale of antibiotics and over-the-counter cold & cough medicines, alongside the impacts of market dynamics in Germany, price erosion and healthcare-policy changes in France. International overview Net sales in International were USD 609 million, a decline of 2% at CC. Biosimilars delivered an exceptional performance, driven by Hyrimoz, Rixathonand the recent launches of Wyost & Jubbonti. Generics net sales decreased at CC, primarily due to active portfolio rationalisation and the phasing of sales, as well as the impact of adverse dynamics in the anti-infective B2B business. North America overview Net sales in North America were USD 591 million, representing growth of 12% at CC. An exceptional biosimilar result was driven by the strong launches of Wyost & Jubbonti. Generics net-sales growth was driven by recent US launch of lisdexamfetamine and the performance of estradiol. The Company provides the net-sales performance by region by business at each half-year and full-year results. APPENDIX QUARTERLY 2025 NET SALES BY BUSINESS Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Biosimilars 671 8% 11% 825 15% 12% 862 16% 13% 934 21% 16% Generics 1,809 -3% 0% 1,927 5% 2% 1,963 6% 3% 2,095 8% 2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% BY REGION Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,372 3% 7% 1,460 12% 6% 1,530 12% 6% 1,574 15% 6% International 590 -8% -2% 694 11% 11% 659 4% 4% 770 18% 14% North America 518 -1% 1% 598 -4% -3% 636 6% 7% 685 -1% -2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek