Follitropin Alfa (Merck)

Financial results of fiscal 2023 Net sales decrease organically by 1.6% to € 21.0 billion EBITDA pre down organically by 9.0% to € 5.9 billion “Transitional year” 2023 characterized by demanding market conditions in Life Science and Semiconductor Materials Strong sales and earnings performance of Healthcare demonstrates benefits of diversified business model of the Group Stable dividend proposal: € 2.20 per share Forecast for fiscal 2024 Return to organic growth expected in 2024 Sales and EBITDA pre: slight to moderate organic growth Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported financial results for 2023 in line with its guidance published in August despite a challenging market environment, thus demonstrating the robustness of its business model. The strong development of the Healthcare business sector partly compensated for the market-related declines in sales and earnings in Life Science and Electronics. The company expects to gradually return to organic growth in the course of fiscal 2024. Fiscal 2023 was characterized by difficult market conditions: the significant decline in Covid-19-related demand as expected persistent inventory destocking by key customers in Process Solutions and the cyclical slowdown in demand for semiconductor materials. Overall, Group net sales decreased by 5.6% (organically: ‑1.6%) to € 20,993 million. EBITDA pre declined by 14.2% (organically: ‑9.0%) to € 5,879 million. “We delivered solid results in a transitional year 2023 despite difficult market conditions, demonstrating the robustness of our businesses. Our diversified business will continue to benefit from the attractive market growth opportunities also in the medium term,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “Now, we are fully focusing on gradually returning to growth during fiscal 2024, while defining our strategic roadmap to ensure long term profitable and sustainable growth for our company.” Negative foreign exchange effects weigh on sales and earnings In fiscal 2023, Group net sales decreased organically by 1.6% in comparison with the previous year. Foreign exchange effects, primarily from the development of the U.S. dollar and the Chinese renminbi, had an adverse impact of 4.1% on sales. EBITDA pre declined organically by 9.0%. Foreign exchange had an additional negative impact on earnings of 4.9%. The EBITDA pre margin was 28.0%. Earnings per share pre were € 8.49. On this basis, the Executive Board and Supervisory Board will propose to the Annual General Meeting on April 26, 2024, a dividend of € 2.20 per share. This corresponds to the dividend of the previous year. Life Science: Market environment affected by decline in Covid-19-related demand and inventory destocking among key customers In fiscal 2023, the sales and earnings performance of the Life Science business sector was mainly impacted by two market factors. As expected, Covid-19-related sales declined significantly from around € 800 million in the previous year to around € 250 million. In addition, the core business of Process Solutions slowed down considerably due to inventory destocking by key customers, who consequently placed fewer new orders. This led to an overall organic sales decline in the core business (excluding Covid-19-related sales) of Life Science of around 2%. Overall, sales of the business sector decreased by 10.6% to € 9,281 million. Organically, the decline amounted to 7.9%. Foreign exchange had a negative impact of 2.7% on sales. As a result of the aforementioned market factors, the Process Solutions (‑14.4%) and Life Science Services (‑14.6%) business units recorded organic sales declines. Science & Lab Solutions, which generated around half of the net sales of Life Science in fiscal 2023, saw an organic sales decline of 0.6%. The business unit offers products and services to support research, diagnostics and testing activities. In fiscal 2023, EBITDA pre of Life Science decreased organically by 21.4% to € 2,820 million. Foreign exchange had a negative impact of 3.3% on earnings. The EBITDA pre margin was 30.4%. Healthcare: Wave 1 launches remain major growth drivers, supported by resilient growth of the established product portfolio Net sales of the Healthcare business sector increased organically by 8.5% in fiscal 2023. Amid negative foreign exchange effects of 5.8%, sales rose overall by 2.7% to € 8,053 million. The key growth drivers were once again the so-called Wave 1 launches. The oncology medicine Bavencio grew organically by 23.4%. Sales of Mavenclad for the treatment of relapsing multiple sclerosis increased organically by 15.9%. Mavenclad exceeded the equivalent of US$ 1 billion in sales per year for the first time since its market launch, thus achieving blockbuster status. The same applied for the second year to the oncology drug Erbitux with sales of € 1,025 million. The Fertility (organically: +14.9%) and Cardiovascular, Metabolism & Endocrinology (organically: +4.0 %) franchises also generated organic sales increases. In Fertility, this was further supported by stock-outs of competitor products. EBITDA pre of Healthcare rose organically by 17.1% to € 2,543 million. Foreign exchange had a negative impact of 14.4% on earnings. The EBITDA pre margin was 31.6%. Electronics: Cyclical slowdown in demand for semiconductor materials impacts business performance In the Electronics business sector, fiscal 2023 was mainly characterized by the ongoing cyclical slowdown in the semiconductor industry. Overall, sales decreased by 8.8% to € 3,659 million. In addition to the organic decline of 5.1%, foreign exchange had an adverse impact of 4.1% on the sales development. In the Semiconductor Solutions business unit, sales decreased organically by 3.9%, outperforming the market. The decline was mainly the result of weaker demand for semiconductor materials. This was partly offset by the project and equipment business within Delivery Systems & Services, which benefited from continued investments by key customers in long-term capacity expansion. Persistent price pressure and low-capacity utilization by customers in the liquid crystals field, especially in the first half of 2023, were the main reasons for the organic sales decline of 9.2% in the Display Solutions business unit. EBITDA pre of Electronics amounted to € 913 million. Apart from the organic decline of 17.1%, foreign exchange had an adverse impact of 5.6% on the earnings development. The EBITDA pre margin was 25.0%. Outlook for fiscal 2024: Return to growth Merck KGaA, Darmstadt, Germany, expects a gradual return to organic growth during 2024. The year is expected to be characterized by the following developments: In the Life Science business sector, order intake in Process Solutions will gradually improve. The company expects the inflection point during the first half of 2024. Sales will subsequently recover in the second half of 2024. In fiscal 2024, the Group expects the remaining Covid-19-related sales to phase out. Sales of the Healthcare business sector are forecast to grow in line with medium-term expectations as tailwinds from competitor stock-outs fade out. The semiconductor materials market in the Electronics business sector is expected to recover gradually in 2024 compared with 2023, with the turning point occurring early in the second half of the year. Overall, the company assumes the following qualitative development. As in previous years, the company will announce a quantitative forecast with the publication of Q1 financial results on May 15, 2024. The Group expects slight to moderate organic sales growth in fiscal 2024, with Healthcare as the main driver. Foreign exchange is expected to impact sales development by ‑3% to 0%. For EBITDA pre, the company also expects slight to moderate organic growth. Earnings growth will be mainly driven by the Healthcare business sector in fiscal 2024. Foreign exchange will likely have an impact of ‑4% to ‑1% on the earnings development. Overview of the key figures for fiscal 2023 Group Key figures Change € million 2023 2022 € million % Net sales 20,993 22,232 -1,239 -5.6% Operating result (EBIT) 1 3,609 4,474 -865 -19.3% Margin (% of net sales) 1 17.2% 20.1% EBITDA 2 5,489 6,504 -1,015 -15.6% Margin (% of net sales) 1 26.1% 29.3% EBITDA pre 1 5,879 6,849 -970 -14.2% Margin (% of net sales) 1 28.0% 30.8% Profit after tax 2,834 3,339 -505 -15.1% Earnings per share (€) 6.49 7.65 -1.16 -15.2% Earnings per share pre (€) 1 8.49 10.05 -1.56 -15.5% Operating cash flow 3,784 4,259 -475 -11.2% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Life Science Net sales by business unit € million 2023 Share Organic growth 1 Exchange rate effects Acquisitions / divestments Total change 2022 2 Share Science & Lab Solutions 4,706 51% -0.6% -3.3% – -3.9% 4,898 47% Process Solutions 3,782 41% -14.4% -2.3% – -16.7% 4,540 44% Life Science Services 792 8% -14.6% -2.0% 0.6 % -15.9% 943 9% Life Science 9,281 100% -7.9% -2.7% 0.1 % -10.6 % 10,380 100% 1 Not defined by International Financial Accounting Standards (IFRS). 2 Prior-year figures have been adjusted due to internal realignment. Healthcare Net sales by major product lines/products € million 2023 Share Organic growth 1 Exchange rate effects Total change 2022 Share Oncology 1,819 22% 17.3% -9.2% 8.1% 1,683 22% thereof: Erbitux ® 1,025 13% 10.9% -10.6% 0.3% 1,023 13% thereof: Bavencio ® 713 9% 23.4% -6.8% 16.6% 611 8% Neurology & Immunology 1,665 21% -0.9% -3.5% -4.5% 1,743 22% thereof: Mavenclad ® 956 12% 15.9% -4.3% 11.7% 856 11% thereof: Rebif ® 709 9% -17.2% -2.9% -20.1% 887 11% Fertility 1,547 19% 14.9% -7.8% 7.0% 1,446 18% thereof: Gonal-f ® 847 11% 10.5% -7.8% 2.7% 825 11% Cardiovascular, Metabolism and Endocrinology 2,786 35% 4.0% -4.6% -0.7% 2,805 36% thereof: Glucophage ® 882 11% -0.5% -4.6% -5.1% 930 12% thereof: Concor ® 571 7% 1.6% -4.9% -3.3% 590 8% thereof: Euthyrox ® 565 7% 5.4% -3.2% 2.2% 553 7% thereof: Saizen ® 332 4% 35.7% -10.6% 25.1% 266 3% Other 235 3% 161 2% Healthcare 8,053 100% 8.5% -5.8% 2.7% 7,839 100% 1 Not defined by International Financial Reporting Standards (IFRS). Electronics Net sales by business unit € million 2023 Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2022 Share Semiconductor Solutions 2,479 68% -3.9% -3.9% 0.5% -7.3% 2,674 67% Display Solutions 770 21% -9.2% -5.3% – -14.5% 900 22% Surface Solutions 411 11% -3.6% -2.9% – -6.5% 439 11% Electronics 3,659 100% -5.1% -4.1% 0.3% -8.8% 4,013 100% ¹ Not defined by International Financial Accounting Standards (IFRS). Notes to editors: The press conference for media representatives will take place at 10:00 a.m. (CET). The respective presentation and further information for journalists, including a digital press kit , can be found here The annual report 2023 can be found here Merck KGaA, Darmstadt, Germany, on LinkedIn Photos and videos can be found here Stock symbols Reuters: MRCG, Bloomberg : MRK GY, Dow Jones : MRK.DE Frankfurt Stock Exchange : ISIN : DE 000 659 9905 – WKN : 659 990 All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

「  本文共：16条资讯，阅读时长约：3分钟 」今日头条晟济促排卵药rhFSH-CTP报产。晟济药业的重组人卵泡刺激素-CTP融合蛋白注射液（rhFSH-CTP注射液）上市申请获CDE受理，应用于妇女接受人工辅助生殖技术（ART）计划时，与性腺刺激素释放激素拮抗剂（GnRH antagonist）并用，用于控制下刺激卵巢，以诱导多个滤泡发育。目前，国内促卵泡激素药物市场达30-40亿，其中默克的短效rhFSH水针（果纳芬，每天1-2次注射）占据60%的市场份额。国内药讯1.卫材URAT1抑制剂在华报痛风NDA。卫材与富士药品开发的5.1类化药多替诺雷片（Dotinurad）的上市申请获CDE受理，推测适应症为“痛风”。Dotinurad通过选择性抑制与肾脏中尿酸重吸收有关的尿酸盐转运蛋白（URAT1），抑制尿酸重吸收并降低血液中尿酸水平。2020年，该新药已在日本获批上市，用于治疗伴或不伴痛风的高尿酸血症。2.明慧JAK抑制剂启动白癜风II期临床。明慧医药JAK抑制剂MH004乳膏登记启动一项II期临床（CTR20240183），评估用于治疗非节段型白癜风患者的初步疗效、安全性、耐受性及药代动力学特征。此前，该产品已在治疗特应性皮炎的II期临床中获得积极结果，与安慰剂相比，1.0% MH004乳膏显著降低患者的湿疹面积和严重程度指数（EASI）评分（-78.7%vs-46.7%；P=0.0003）。3.加科思KRAS G12C抑制剂胰腺癌临床积极。加科思药业KRAS G12C抑制剂戈来雷塞在2024 ASCO GI年会上公布用于治疗胰腺癌和其他实体瘤患者临床数据。在50例可评估实体瘤患者中，确认客观缓解率（ORR）为48%，疾病控制率（DCR）为90%；在二线及以上的KRAS G12C突变胰腺癌患者中，确认ORR为41.9%，DCR为93.5%，中位无进展生存期（mPFS）为5.6个月，中位总生存期（mOS）为10.7个月。4.科济Claudin18.2靶向CAR-T早期临床积极。科济药业靶向Claudin18.2自体CAR-T产品CT041在2024 ASCO GI年会上公布用于治疗胃癌/食管胃结合部腺癌（GC/GEJ）或胰腺癌（PC）的Ⅰb期临床（ELIMYN18.2）积极结果。中位随访为8.9个月时，CT041（250-600×106个细胞）在GC/GEJ患者的确认ORR为42.9%，CBR为57.1%，中位无进展生存期（mPFS）和中位缓解持续时间（mDOR）分别为5.7个月和6.9个月。Ⅱ期推荐剂量（RP2D）确定为DL3 （600×106个细胞）。药物总体安全性良好。5.正大天晴TIM-3单抗启动肝癌Ⅰb期临床。正大天晴TIM-3单抗TQB2618注射液登记启动一项Ⅰb期临床，拟评估TQB2618联合派安普利单抗与盐酸安罗替尼一线治疗晚期肝细胞癌的有效性和安全性。该项试验将由上海交通大学医学院附属仁济医院医学博士夏强牵头开展。目前，TQB2618正在多项临床中评估治疗急性髓系白血病、骨髓增生异常综合征、晚期实体瘤、广泛期小细胞肺癌、结直肠癌和鼻咽癌等潜力。6.三迭纪3D打印胃滞留抗凝药获批临床。三迭纪公司宣布其3D打印胃滞留药物产品「阿哌沙班胃滞留缓释胶囊（T20G）」获国家药监局临床许可，拟开发用于降低非瓣膜性心房颤动患者卒中和全身性栓塞的风险。T20G是一款改良型新型口服抗凝药（NOAC）产品。在临床前动物研究中，T20G一天一次给药和对照制剂一天两次给药，在比格犬体内获得可比的药代动力学参数（AUC、Cmax和Cmin）。国际药讯1.强生膀胱癌靶向药获FDA完全批准。强生FGFR激酶抑制剂Balversa（erdafitinib）获FDA完全批准，用于治疗FGFR3遗传变异、局部晚期或转移性尿路上皮癌（mUC）经治患者。2019年4月，Balversa已获得FDA加速批准上市，成为获批用于治疗带有FGFR变异mUC患者的首款靶向药物。在Ⅲ期临床(THOR)中，与化疗相比，Balversa显著提高患者的总生存期，将死亡风险降低36%。2.阿斯利康PD-L1单抗肝癌III期临床积极。阿斯利康PD-L1抑制剂Imfinzi（durvalumab）与动脉化疗栓塞（TACE）和贝伐珠单抗联合治疗适合栓塞治疗的肝细胞癌（HCC）患者的Ⅲ期临床EMERALD-1达到主要终点。与TACE治疗相比，Imfinzi联合治疗将患者疾病进展或死亡风险降低23%（HR=0.77，95% CI：0.61-0.98，p=0.032），两组中位PFS分别为15个月和8.2个月；关键次要终点总生存期（OS）的数据正在评估当中。3.诺华放射性配体联合用药Ⅲ期临床积极。诺华放射性配体药物Lutathera一线治疗生长抑素受体（SSTR）阳性、晚期胃肠胰神经内分泌瘤（GEP-NETs）的Ⅲ期临床NETTER-2达到主要终点。与单用大剂量奥曲肽LAR相比，Lutathera联合奥曲肽LAR显著改善患者的无进展生存期（中位PFS：22.8个月vs8.5个月），将疾病进展或死亡风险降低72%；联合用药未观察到新的安全性问题。详细结果公布于ASCO-GI会议上。4.BAFFR靶向CAR T最新临床数据积极。PeproMene Bio公司公布其靶向B细胞活化因子受体（BAFFR）的CAR-T细胞疗法PMB-CT01在治疗复发/难治性急性B淋巴细胞白血病（r/r B-ALL）的Ⅰ期临床积极结果。首例患者在治疗一个月后达到完全缓解，还达到微小残余病（MRD）阴性的标准；该患者耐受性良好，仅出现低水平治疗所致的急性毒性，包括1级细胞因子释放综合征（CRS）。5.CRISPR基因编辑猪肝脏用于肝脏灌注研究积极。eGenesis公司经基因编辑改造的猪肝脏与OrganOx公司的体外灌注（extracorporeal perfusion）系统相结合，在体外评价用于支持肝衰竭患者进行肝脏灌注的临床前研究结果积极。试验结果显示，这一肝脏灌注系统上的猪肝脏，能够成功完成患者（脑死亡患者）血液流过猪肝脏并循环回患者体内。72小时期间患者血压和血液pH值均保持稳定，猪肝脏表现出强力的胆汁分泌。研究中无任何免疫排斥的现象。6.放射性药物公司Ratio完成B轮融资。Ratio Therapeutics宣布完成5000万美元的B轮融资，以用于扩大其专有药代动力学调控平台Trillium和Actinium-225螯合剂Macropa的应用范围，以开发新型精准放射性药物，用于治疗实体瘤。此轮融资还将推动该公司针对成纤维细胞活化蛋白-α的靶向放射性药物疗法的临床开发。目前，该公司已与拜耳、Lantheus和默沙东等药企建立了合作关系。医药热点1.2024美国癌症报告发布。1月18日，2024美国癌症报告发布，预计2024年美国将新增癌症患者超200万例，死亡61万例。在全人群中，致死率最高的分别是肺癌、结直肠癌和胰腺癌。总体来看，美国癌症死亡率呈逐年下降趋势，自1991年以来，死亡人数预估减少了400万。然而，癌症发病率仍在上升，在10种主要癌症中，有6种癌症的患病率仍在不断上升。2.冠心病合并抑郁焦虑的认知临床诊疗指南发布。近日，由首都医科大学附属北京安贞医院、中国计量大学等40多家单位共同参与的《冠心病合并抑郁焦虑的认知临床诊疗指南》正式发布。这是我国双心医学领域的首个标准，为临床工作提供了冠心病合并抑郁焦虑患者的抑郁焦虑、精神压力诱发心肌缺血、认知功能与谵妄的评估方法及其临床诊断与治疗的指导，适用于冠心病合并抑郁焦虑患者的认知障碍及谵妄临床诊断及治疗。3.广东省医保信用管理办法出台。1月16日，广东省医保局发布的《广东省医疗保障信用管理办法(试行)》明确，将医保定点医疗机构、零售药店等机构类主体和医师、药师、医保参保人等个人类主体纳入医保信用管理，按积分分为ABCDE共5个等级，对A级个人类信用主体提供信用就医等便利。被医保部门认定为严重失信或一般失信的主体，将由医保部门按失信惩戒措施清单实施惩戒。评审动态  1. CDE新药受理情况（01月22日) 2. FDA新药获批情况（北美01月19日）股市资讯上个交易日 A 股医药板块 -4.40%涨幅前三     跌幅前三锦波生物+6.00%  绿康生化-10.00%康乐卫士+5.68%  益盛药业 -6.73%峆一药业+5.42%  龙津药业 -5.26%【奥赛康】旗下子公司于近日收到国家药监局核发的《药品注册证书》，产品为枸橼酸托瑞米芬片，可与雌激素竞争性的与雌激素受体结合从而阻止癌细胞的增殖。【福安药业】庆余堂于近日收到国家药监局签发的药品补充申请批准通知书，产品为门冬氨酸鸟氨酸注射液，适应症为因急、慢性肝病引发的血氨升高及治疗肝性脑病。 【普蕊斯】普蕊斯发布业绩预告，预计 2023 年年度实现归母净利润为1.23亿元-1.46亿元， 比上年同期增长69.86%至101.63%；扣非归母净利润为 1.04亿元-1.24亿元，比上年同期增长55.41%至85.30%。 - The End -戳“阅读原文”，了解更多医药研发及股市资讯。