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Strong CSL Behring portfolio growth especially Ig FINANCIAL HIGHLIGHTS 4 Revenue $8.05 billion, up 11% at CC3 NPAT $1.90 billion1, up 17% NPAT $1.94 billion1 at CC3, up 20% NPATA $2.02 billion1,2 , up 11% NPATA $2.06 billion1,2 at CC3, up 13% NPATA1,2 earnings per share $4.182, up 11% NPATA1,2 earnings per share $4.26 at CC3 up 13% Interim dividend 5 of US$1.19 per share Converted to Australian currency, the interim dividend is approximately A$1.81 per share, up 12% Guidance reaffirmed – FY24 NPATA2,4 anticipated to be in the range of approximately $2.9 billion to $3.0 billion2 at CC3 MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3. Dr. Paul McKenzie, CSL's Chief Executive Officer and Managing Director said, "Our strong first-half result for the 2024 financial year was driven by CSL Behring's exceptional performance across its portfolio, especially immunoglobulins. The plasma initiatives we have implemented are starting to drive gross margin recovery. "CSL Seqirus achieved solid growth in a challenging season. Its portfolio of differentiated products outperformed the market. "For CSL Vifor we are well prepared for the transitioning iron market." PERFORMANCE CSL Behring Total revenue was $5,238 million, up 14%3 when compared to the prior comparable period. Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand. PRIVIGEN® / INTRAGRAM® (Immune Globulin Intravenous (Human), 10% Liquid) sales grew 27%3 as the momentum from the prior year continued in improving product availability and patient diagnosis rates. HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by patient diagnosis rates. HIZENTRA® continues to be the clear market leader for subcutaneous immunoglobulin. Underlying demand for Ig continues to be strong due to significant patient needs in core indications – namely Primary Immune Deficiency, Secondary Immune Deficiency and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Albumin sales of $613 million, were up 8%3. Sales were strong in emerging markets with solid growth in the US and Europe. Growth in China was modest, tempered by competitive pressure. Haemophilia product sales of $662 million increased 8%3. IDELVION®, CSL Behring's novel long-acting recombinant factor IX product achieved growth of 7%3 and continues to be the market leader in key markets. HEMGENIX®, the first and only gene therapy for haemophilia B was successfully launched in the US in FY23 and patient referrals have been accelerating. The haemophilia A market continued to be competitive resulting in a modest decline in sales for AFSTYLA®, a novel recombinant factor VIII product. Plasma-derived haemophilia products, however, achieved growth of 8% driven by HUMATE® / HAEMATE®, therapies for the treatment of patients with von Willebrand disease. Specialty products sales of $976 million, were up 6%3 led predominately by demand for KCENTRA® and HAEGARDA®. KCENTRA® (4 factor prothrombin complex concentrate) recorded sales growth of 12%3, as it continues to further penetrate the warfarin reversal market in the US. HAEGARDA®, our therapy for patients with Hereditary Angioedema, increased 9%, driven by the continued shift from on-demand to prophylaxis treatment and a strong performance in the UK and Europe. Garadacimab (Anti-FXIIa) for HAE, was filed for regulatory approval in the US and EU. Plasma Collections Plasma collections remain strong. The cost of collections, which includes donor compensation and labour, continued to trend down. A new roll out plan for the RIKA plasmapheresis devices was developed. Deployment across the US fleet is expected over the next 18 months. In addition, results from an individualised nomogram trial conducted by our supplier have been submitted for regulatory approval. CSL Seqirus Total revenue of $1,804 million, was up 2%3 driven by the adjuvanted influenza vaccine FLUAD®, which increased by 14%3. This growth was achieved against a backdrop of reduced rates of immunisation and highlights the strength of CSL Seqirus' differentiated product portfolio. During the period: Self-amplifying mRNA vaccine for COVID was approved by Japan's Ministry of Health, Labour and Welfare aQIVc, a next generation influenza vaccine combining adjuvant technology with cell-based manufacturing, enrolled its last patient in the Phase III clinical study in January 2024. CSL Vifor Total revenue was $1,011 million. The prior comparable period included only 5 months revenue following the acquisition of Vifor Pharma in August 2022. During the period: Preparations were made for the transitioning iron market There was strong performance from the long-acting erythropoiesis-stimulating agent, MIRCERA® TAVNEOS® was successfully launched in multiple European countries While the strategic potential of the business remains strong, we have dampened our near-term growth aspirations for CSL Vifor. Expense Performance Research and development (R&D) expenses were $669 million8 , up 11%3 when compared to the prior comparable period. The increase in expenses reflects higher costs associated with the progression of the R&D portfolio and investment in R&D infrastructure. Selling and marketing expenses (S&M) were $707 million8, up 2%3 in comparison to the prior comparable period. An additional month of CSL Vifor and an increase in labour costs accounts for the increase in S&M expenses while other S&M expenses were held in line with the prior comparable period. General and administrative (G&A) expenses were $323 million8, down 7%3 due to favourable foreign exchange differences and efficiencies generated from the centralisation of the group's Enabling Functions. Depreciation and amortisation (D&A) expense (excluding acquired intellectual property) was $297 million, up 1%3. Net finance costs were $234 million9, up 32%3. The increase in net finance costs was due to the debt associated with the acquisition of Vifor Pharma and higher interest rates. Financial position Cashflow from operations was $1,069 million, up 9%. The increase was driven by higher profitability and overall growth in sales. This was partly offset by higher payments for income tax and interest. Cash outflow from investing was $702 million, down significantly when compared to the prior comparable period as payment for the acquisition of Vifor Pharma was made in the prior period. CSL's balance sheet remains in a strong position with net assets of $19,162 million. Current assets increased by 10% to $10,146 million. The main driver was an increase in receivables due to the increase in sales and the seasonality of CSL Seqirus. Non-current assets increased by 1% to $27,158 million in comparison to the previous year. Current liabilities increased by 2% to $4,718 million. The increase in interest-bearing liabilities and borrowings (bank debt) was offset by the decrease in trade and other payables and current tax liabilities. Non-current liabilities decreased by 3% to $13,424 million. The decrease was due to the reclassification of certain bank borrowings as current, coupled with repayment across the Group's debt portfolio including the private placement senior notes. Outlook (at FY23 exchange rates) Commenting on CSL's outlook, Dr. McKenzie said, "For FY24, I am pleased to reaffirm our previous guidance. CSL's underlying profit, NPATA is expected be in the range of approximately $2.9 billion to $3.0 billion at constant currency3, representing growth over FY23 of approximately 13-17%[6]" "CSL is in a strong position to deliver annualised double-digit earnings growth over the medium term. "The strong growth in our immunoglobulins franchise is expected to continue as patient demand remains strong. "We have a number of initiatives underway in plasma collections that are improving efficiencies and processing times, supporting continued expansion in CSL Behring's gross margin. "Our transformational gene therapy product for haemophilia B patients, HEMGENIX®, is attracting significant interest from patients and health care professionals and patient referrals have accelerated. We expect more patients dosed in the second half of this financial year. "CSL Seqirus has performed well in a challenging season. However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year. "For CSL Vifor, we are operating within an evolving iron market. While there are challenges for near-term growth, we are well positioned for iron competition in the EU and further geographic expansion. Our focus remains on unlocking value by leveraging capabilities across the CSL group", Dr. McKenzie concluded. In compiling the company's financial forecasts for FY24, a number of key variables that may have a significant impact on guidance have been identified and these have been included in the endnote[7]. FURTHER INFORMATION Additional details about CSL's results are included in the company's 4D statement, investor presentation slides and webcast, all of which can be found on CSL's website A glossary of medical terms can also be found on the website. 1 Attributable to CSL shareholders 2 Statutory net profit after tax (NPAT) before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and the unwind of the inventory fair value uplift. 3 Constant currency (CC) removes the impact of exchange rate movements, facilitating the comparability of operational performance. For further detail refer to CSL's Financial Statements for the Half Year ended December 2023 (Directors Report). 4 All figures are expressed in US dollars unless otherwise stated. 5 For shareholders with an Australian registered address, the interim dividend of US$1.19 per share (approximately A$1.81) is expected to be paid on 3 April 2024. For shareholders with a New Zealand registered address the interim dividend of US$1.19 per share (approximately NZ$1.94) is expected to be paid on 3 April 2024. The exchange rates will be fixed at the record date of 12 March 2024. All other shareholders will be paid in US$. CSL also offers shareholders the opportunity to receive dividend payments in US$ by direct credit to a US bank account. 6 % growth rates excludes the one-off gain from the sale of property in FY23 (NPATA $44m). 7 Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; ability to collect plasma; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and CSL's ability to protect its patents and other intellectual property. 8 Underlying results are adjusted to exclude amortisation of acquired intellectual property ($132 million), business acquisition and integrations costs and the unwind of the inventory fair value uplift. 9 At reported currency For further information, please contact: Investors: Bernard Ronchi Director, Investor Relations CSL Limited P: +61 3 9389 3470 E: [email protected] Stephen McKeon Director, Investor Relations CSL Limited P: +61 402 231 696 E: [email protected] Media: Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected] SOURCE CSL Limited

精彩内容近日，天津牵头的京津冀“3+N”药品带量联动采购即将完成产品报价。经统计，此次联采拟纳入200个品种，涉及多款化学药、生物药及中成药。其中，不乏他克莫司口服常释剂、亮丙瑞林注射剂等2022年在公立医疗机构终端销售额均超30亿元的大品种；中成药以独家品种（含剂型独家，下同）为主，生物药包含5款常用血液制品。据悉，山西、湖南、江西等省市已发文明确跟进此次京津冀“3+N”联采，业内预测，后续或有10个以上省市跟标，覆盖面相当广阔。双向选择，联动全国最低价带量联动采购（下文简称“联采”）是近两年引入的省采新模式，即对其他省已实施集中带量采购的药品，以本省/省级联盟的量联动其他省集采的中选价格，真正做到以量换价。2022年11月，天津曾就《京津冀“3+N”联盟部分西药和中成药带量联动采购和使用工作方案》公开征求意见。时隔近一年，天津市先后于8月底及9月初发布多份京津冀“3+N”药品带量联动采购（下文简称“京津冀‘3+N’联采”）工作通知。经梳理，已公布的三批药品目录中，共计200个品种拟纳入此次联采，其中第一批40个、第二批98个、第三批62个，涉及138个化学药、15个生物药和47个中成药。来源：天津医药采购中心根据规则，本次联采采用“带量联动、双向选择”的方式，即申报企业依据采购主体（医疗机构）采购需求量，参照市场总体价格水平、综合质量等因素，联动全国最低带量采购价，进行供应意向确认。其中，对于申报企业拒绝供应以及谈判不成功的产品，对应采购需求量作为待分配量，由采购主体重新分配给其他符合条件同品种名称的申报产品，如分配给既往轮次确认供应的申报产品，原则上企业不可拒绝供应，即选择成功；如分配给既往轮次未分配采购需求量的申报产品，申报企业继续进行供应意向确认。可见，该规则在一定程度上给予了双方自主权，充分调动医疗机构动力，将市场选择权交予医疗机构，总体而言，对提高双方的自主参与度都有一定的积极影响。关于采购主体，联盟地区有采购相应药品需求的公立医疗机构（含军队医疗机构）均应参加，社会办医药机构按所在联盟地区相关规定自愿参加，支持京津冀“3+N”医药采购联盟其他省（自治区、直辖市）医疗机构按照所在地医疗保障部门要求参加。采购周期方面，去年发布的征求意见稿中表示“联采周期为2年”，而在正式文件中联采周期变为1年，体现出药价联动调整的灵活性。第一、二批：5个超30亿重磅来袭，石四药、石药......优势十足前两批京津冀“3+N”联采目录共计拟纳入138个品种，清一色为化学药。按治疗大类统计，消化系统及代谢药占据36个席位，遥遥领先；呼吸系统用药（17个）、心脑血管系统药物（16个）、血液和造血系统药物（16个）、杂类（13个）、抗肿瘤和免疫调节剂（11个）分别位居其后。第一批目录拟纳入40个品种，以临床用量大、医疗机构覆盖率广的药品为主，包括他克莫司口服常释剂、亮丙瑞林注射剂、多柔比星注射剂、倍他司汀注射剂、碳酸钙D3口服常释剂等2022年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端销售额均超30亿元的大品种。拟纳入京津冀“3+N”联采品种目录（第一批）注：带*为独家品种，非基药用“-”表示他克莫司口服常释剂、亮丙瑞林注射剂及多柔比星注射剂同属抗肿瘤和免疫调节剂，其2022年在中国公立医疗机构终端销售规模分别超52、51、47亿元。其中，他克莫司为免疫抑制剂TOP1品种，也是肝、肾移植术后抗排斥的一线用药；亮丙瑞林（微球）、多柔比星（脂质体）均属高壁垒制剂，前者仅有日本武田制药、丽珠制药、北京博恩特药业3家企业的产品获批上市，而后者也仅有石药集团、常州金远药业、浙江智达药业3家企业通过/视同一致性评价。他克莫司口服常释剂、亮丙瑞林注射剂及多柔比星注射剂销售趋势（单位：万元）来源：米内网中国公立医疗机药品终端竞争格局倍他司汀注射剂是神经科常用药物之一，近年来该药国内市场呈高速增长态势，2022年在中国公立医疗机构终端销售额超过38亿元，同比增长48.76%；市场份额方面，石家庄四药、国药国瑞药业、亚宝药业三者合计占比超70%。2022年中国公立医疗机构终端倍他司汀注射剂品牌格局来源：米内网中国公立医疗机药品终端竞争格局而第二批目录拟纳入98个品种，其对入围产品剂型进行更细化的划分。像丙戊酸钠分为缓释剂和口服溶液剂（合剂）、美沙拉秦分为灌肠剂、缓释颗粒和栓剂、乙酰半胱氨酸分为口服常释剂和注射剂等进行报价，能进一步激发企业参与的积极性。拟纳入京津冀“3+N”联采品种目录（第二批）注：带*为独家品种，非医保药、非基药均用“-”表示值得一提的是，拟纳入第一、二批联采目录的品种大多为国家医保药物，其中甲类品种13个，乙类品种114个，非医保品种11个；还涉及环孢素口服溶液剂、昂丹司琼口服常释剂、奥卡西平口服常释剂等22个基药品种。第三批：中成药独家品种占比高，生物药以血液制品为主第三批京津冀“3+N”联采目录拟纳入62个品种，包括47个中成药和15个生物药。从治疗大类看，心脑血管疾病用药为主力，占据18个席位；呼吸系统疾病用药、泌尿系统疾病用药、血液和造血系统药物分别占9、5、5个。拟纳入京津冀“3+N”联采品种目录（第三批）注：带*为独家品种，非医保药、非基药均用“-”表示其中，中成药以独家品种为主，不乏麝香保心丸剂、苏黄止咳胶囊剂、尿毒清颗粒剂等2022年在中国公立医疗机构终端销售额超15亿元的大品种。此外，多个品种与此前已开始执行的中成药集采目录品种重叠。根据此次联采要求，曾中选企业报价将不得高于曾中选产品全国中选最低价和联盟地区近一年实际采购的最低价。这意味着，参与联采产品的价格或再被压低，而独家品种的企业在报价上更有优势。部分京津冀“3+N”联采与已执标中成药集采项目重叠的品种注：执行中的集采项目用“√”表示来源：各省（市）医药采购中心生物药方面，血液制品为本批联采目录的主力军，有5个产品入围，包括人血白蛋白注射剂、人凝血因子Ⅷ注射剂、人纤维蛋白原注射剂、重组人凝血因子Ⅷ注射剂及重组人凝血因子Ⅸ注射剂。其中，人血白蛋白注射剂用于低蛋白血症、创伤烧伤等引起的休克、肝硬化或肾病引起的水肿和腹水、脑水肿、新生儿高胆红素血症等，是临床急救的一种特殊药品。目前，本品已上市的制剂有3种，分别是人血白蛋白、冻干人血白蛋白以及人血白蛋白注射液，其2022年中国公立医疗机构终端合计销售规模超过280亿元，市场体量十分庞大。米内网招投标数据显示，以杰特贝林的人血白蛋白（50ml:10g）为例，今年以来在全国不同省市的最新平均中标单价在369.5元至498元不等，价差超过100元。通过此次京津冀“3+N”联采（陆续有更多省市跟标），能让药品中标价回归至更加合理的价格区间。杰特贝林的人血白蛋白（50ml:10g）最新中标单价（单位：元）来源：米内网招投标数据库此外，重组人凝血因子Ⅷ注射剂、人纤维蛋白原注射剂等品种2022年中国公立医疗机构终端销售收入均超过10亿元，且获批企业数均在8家及以上，竞争条件比较充分。若最终执行联采，其市场格局有望迎来大洗牌。多省市迅速响应，山西、湖南......陆续跟标在京津冀“3+N”联采品种目录陆续发布的同时，全国多个省市已迅速响应，包括山西、湖南、重庆、江西、陕西等相继发文明确跟标，参与联采的药品数均达百余款。9月14日，山西省药械集中采购网发布“关于报送京津冀‘3+N’联采品种范围相关采购数据的通知”，据其报量清单显示，山西在此次联采中有200个品种参与带量联动，全部跟标。来源：山西省药械集中采购网9月12日，江西省医保局也发文启动京津冀“3+N”联采数据的填报工作。据统计，该省合计117个跟标品种，包括第一批18个，第二批59个，以及第三批40个。医疗机构报量时间为9月12日至9月18日。9月4日，湖南省医保局发布通知称，将明确跟进京津冀“3+N”联采。从具体品种来看，除拉氧头孢注射剂、胰激肽原酶口服常释剂、苯唑西林注射剂等7个与此前多批集采重叠的品种外，其余193个品种湖南都将在此次联采中跟标。来源：湖南省医保局官网8月29日，陕西省医保局发布《关于报送京津冀“3+N”联盟部分药品带量联动品种范围相关采购数据的通知》，陕西省跟进了这一联盟带量联动，目前已完成二批共107个品种的数据填报工作。......根据业内人士披露的信息，此前参与跟标京津冀的省份大概率会跟进本批联采（不排除个别省市的品种重叠及其他因素暂不考虑），后续或许有10个以上省市跟标，可见其覆盖面相当广阔。不难发现，带量联动采购逐渐成为未来省采的新趋势。随着后续京津冀“3+N”带量联动采购的落地执行，全国范围内的药品价格有望进一步趋近。来源：米内网数据库、天津医药采购中心等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月15日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092●温馨提示●因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦