Isavuconazonium Sulfate

Total revenue increases by 14% to CHF 119 million Operating profit increases by 32% to CHF 32 million and net profit by 77% to CHF 28 million Fosmanogepix phase 3 program on track for data readout and regulatory submission in 2028 Raising full-year 2026 guidance: operating profit growth of 40%, driven by increase in total revenues Conference call and webcast today at 4 p.m. (CEST) Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 18, 2026 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharma company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today its results for the first half year 2026. David Veitch, Chief Executive Officer, stated: “Our half-year results demonstrate the successful execution of our strategy across both our commercial and R&D portfolio. We have continued to focus on our key value drivers, with Cresemba maintaining its market leadership position in invasive fungal infections and the progress of the phase 3 program for our key asset fosmanogepix. We also continue to prepare for the initiation of the phase 3 program for our antibiotic ceftibuten-ledaborbactam. Our operational progress is underscored by the continued support from the Biomedical Advanced Research and Development Authority, BARDA, which has awarded additional non-dilutive funding for these two clinical programs this year.” He continued: “Beyond these late-stage programs, we are focusing on creating future value by advancing our earlier-stage pipeline. A highlight was the award of additional non-dilutive funding from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, CARB-X, for BAL2420, as we initiated the first phase 1 study. Our research collaborations with Prokaryotics and Phare Bio are progressing too, advancing innovative approaches to developing the next generation of antifungal and antibacterial therapies. With a growing portfolio that spans commercial products, late- and early-stage development programs and promising research projects, we remain firmly on track to achieve our goal of being a leading anti-infectives company with four commercial assets by 2030 and strong long-term growth prospects.” Adesh Kaul, Chief Financial Officer, said: “We delivered a strong financial performance in the first half-year. Global in-market sales of Cresemba by our partners increased by 27% year-on-year to USD 782 million for the twelve months from April 2025 to March 2026. Following the launch of Zevtera in the US in July of last year, and with market access enabled, we are now seeing increasing numbers of hospitals ordering across the US. In addition, our commercial partner Innoviva Specialty Therapeutics recently expanded its commercial infrastructure to further broaden hospital coverage, which will also benefit Zevtera. Our strong operational execution allows us to significantly increase our operating profit guidance for full-year 2026, and gives us confidence that we are fully on track to deliver on our cash flow targets under Basilea’s Agenda 2030.” He added: “We continue to invest in the future of Basilea. R&D expenditure increased in line with the progress of the phase 3 fosmanogepix program, the preparations for the phase 3 development of ceftibuten-ledaborbactam and the start of the phase 1 clinical study of BAL2420. We made these investments while improving profitability, reducing financial debt and further expanding our net cash position. This combination of strong cash flows from our commercial business and a strong balance sheet provides us with the financial flexibility to advance our phase 3 pipeline, progress our earlier stage programs and pursue additional external growth opportunities, in order to remain one step ahead as outlined in our Agenda 2030.” Financial summary In the first half year (H1) 2026, Basilea reported total revenue of CHF 119.0 million (H1 2025: CHF 104.0 million), an increase of 14.4% year-on-year. Royalty income rose to CHF 57.8 million (H1 2025: CHF 52.1 million), up 10.9% year-on-year, mainly driven by continued strong market demand for Cresemba. Product revenue amounted to CHF 29.9 million (H1 2025: CHF 31.5 million). Milestone and upfront payments totaled CHF 4.7 million (H1 2025: CHF 6.9 million). Other revenue increased to CHF 26.7 million (H1 2025: CHF 13.5 million). This included CHF 22.3 million revenue related to the contracts with BARDA [ 1 ] (H1 2025: CHF 11.1 million) and CHF 1.7 million revenue related to the contract with CARB-X [ 2 ] (H1 2025: CHF 1.9 million). BARDA revenue is based on activities related to the fosmanogepix phase 3 program, the antifungal BAL2062, the close-out of the ceftobiprole phase 3 program, and ceftibuten-ledaborbactam, while CARB-X revenue is based on activities related to the antibiotic BAL2420. In H1 2026, Basilea invested CHF 54.0 million (H1 2025: CHF 38.3 million) in R&D, mainly related to the two ongoing phase 3 clinical studies of fosmanogepix in invasive yeast and mold infections. It also includes expenses related to preparations for the upcoming phase 3 program of ceftibuten-ledaborbactam in complicated urinary tract infections, which is planned to start mid next year. Additionally, it includes expenses for the phase 2 preparation for BAL2062, the phase 1 study for BAL2420, and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 18.0 million (H1 2025: CHF 17.4 million) and cost of products sold amounted to CHF 15.4 million (H1 2025: CHF 24.2 million). Basilea recorded an operating profit of CHF 31.6 million (H1 2025: CHF 24.0 million), an increase of 31.7% year-on-year. The net profit increased by 76.6% year-on-year to CHF 27.9 million (H1 2025: CHF 15.8 million), resulting in basic and diluted earnings per share of CHF 2.26 and CHF 2.13, respectively (H1 2025: basic and diluted earnings per share CHF 1.29 and CHF 1.26, respectively). In H1 2026, Basilea presented a positive operating cash flow of CHF 19.0 million (H1 2025: CHF 23.1 million). The decrease compared to the previous year’s period was mainly driven by a temporary increase in receivables and inventory because of the growing commercial business and strong operational execution. The Company repurchased senior unsecured convertible bonds, due July 2027, in the amount of CHF 5.0 million nominal value in the first half of 2026, further reducing its debt to CHF 71.0 million nominal value as of June 30, 2026. Since the beginning of 2022, Basilea has reduced its total financial debt by approximately CHF 150 million. Cash, cash equivalents and restricted cash increased by 32.6% to CHF 176.0 million as of June 30, 2026 (June 30, 2025: CHF 132.7 million). Furthermore, Basilea increased its net cash position to CHF 105.3 million as of June 30, 2026 (June 30, 2025: CHF 50.7 million). Key financial figures (in CHF million, except per share data) H1 2026 H1 2025 Product revenue 29.9 31.5 Contract revenue 62.4 59.0 Other revenue 26.7 13.5 Total revenue 119.0 104.0 Cost of products sold (15.4) (24.2) Research & development expenses (54.0) (38.3) Selling, general & administrative expenses (18.0) (17.4) Total cost and operating expenses (87.4) (79.9) Operating profit 31.6 24.0 Profit before taxes 32.1 19.3 Income taxes (4.2) (3.5) Net profit 27.9 15.8 Net cash provided by operating activities 19.0 23.1 Basic earnings per share, in CHF 2.26 1.29 Diluted earnings per share, in CHF 2.13 1.26 (in CHF million) June 30, 2026 June 30, 2025 Cash and cash equivalents and restricted cash 176.0 132.7 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2026 can be found on the Company’s website at . Raised 2026 financial guidance: increase in total revenue driving 40% increase in operating profit Basilea provides the following updated guidance for the full year (FY) 2026 versus FY 2025: (in CHF million / percent) FY 2026 updated guidance FY 2026 previous guidance FY 2025 actuals Total revenue ~15% increase ~10% increase 232.4 Research & development expenses ~20% increase ~20% increase 105.9 Operating profit ~40% increase ~20% increase 51.5 Cresemba and Zevtera-related revenue is now expected to increase to CHF ~210 million (versus CHF ~200 million previous guidance) with a continued shift towards higher margin contract revenue, which results in an expected increase of cash contribution to CHF ~180 million from the commercial business. While maintaining investment levels in R&D as planned, Basilea expects the operating profit to increase by ~40% (versus ~20% increase in previous guidance). Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 18, 2026, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: . Please note that there is no function to ask questions via webcast. For asking questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 50 00 (Switzerland, Europe and RoW) +1 (1) 631 570 56 13 (USA) +44 (0) 203 059 58 63 (UK) Replay The webcast, along with the presentation, will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. Save the date – Basilea Capital Markets Day on October 28, 2026, in Zurich The event will provide the audience with a comprehensive update on the company’s strategic direction and value drivers and will include presentations from senior management and external experts. Further details on the agenda and registration will follow. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com . Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This ad hoc announcement can be downloaded from . References The U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), provided partial funding with federal funds for Basilea’s ceftobiprole phase 3 program under contract number HHSO100201600002C. This funding covered approximately USD 111 million, or about 75% of the costs for the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities, and non-clinical work. BARDA is also supporting Basilea’s fosmanogepix and BAL2062 programs under OTA number 75A50124C00033, and the ceftibuten-ledaborbactam program under contract number 75A50123C00050. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. Attachment Press release (PDF)

精彩内容 今年以来，科伦药业动态频频：拿下4个重磅首仿、14个产品中选第12批国采、35个产品新纳入基药等。科伦药业坚持“三发驱动，创新增长”的发展战略，目前有40余款新药（30款1类新药）在研，60余个新品瞄准百亿市场。 拿下4个首仿！60余个新品瞄准百亿市场 8月6日，国家药监局官网显示，科伦药业3款仿制药同日获批生产并视同过评。其中，丙戊酸钠缓释片(Ⅰ)2025年在中国三大终端六大市场（统计范围详见本文末）销售额超过10亿元。 米内网数据显示，今年以来，科伦药业（含联营公司，下同）有29个品种首次在国内获批生产并视同过评，以神经系统药物为主。其中，西尼莫德片、甲磺酸沙非胺片、注射用阿立哌唑、枸橼酸西地那非口溶膜等为国内首仿+首家过评。 今年以来科伦药业首次获批上市的仿制药 来源：米内网中国申报进度（MED）数据库 据不完全统计，2023年至今，科伦药业已有19个首仿（含剂型首仿，含并列获批）在国内首次获批，集中在全身用抗感染药物（以粉液双室袋为主）、血液和造血系统药物（以肠外营养产品为主）两个治疗大类。 2023年以来科伦药业获批上市的部分首仿 注：标*为独家品种 来源：米内网中国上市药品（MID）数据库 目前科伦药业还有60余个品种以新注册分类申报在审（不含已有批文、主动撤回品种），2025年在中国三大终端六大市场合计销售额超过100亿元，不乏依达拉奉右莰醇注射用浓溶液、非奈利酮片、艾普拉唑肠溶片等多个超10亿大品种。 其中，20余个品种暂无首仿（含剂型首仿）获批上市，包括注射用头孢米诺钠/氯化钠注射液、注射用哌拉西林钠/氯化钠注射液等9款粉液双室袋产品；此外，注射用甲苯磺酸奥马环素、苹果酸奈诺沙星氯化钠注射液等均为国产1类新药。 科伦药业新分类报产在审且暂无首仿获批的部分品种 来源：米内网中国申报进度（MED）数据库 领跑过评榜！喜提第12批国采“中标王” 截至8月14日，科伦药业已有240余个品种通过/视同通过一致性评价，在过评品种数集团排名中名列前茅。公司过评品种集中在全身用抗感染药物、血液和造血系统药物、消化系统及代谢药、神经系统药物等领域，占比均超过10%。 科伦药业过评品种大类分布情况 来源：米内网一致性评价进度数据库 凭借丰富的过评产品群，科伦药业已成为国采头部供应商之一。在已落地执行的十批十一轮化药国采中，公司分别有1个、5个、4个、4个、11个、11个、7个、4个、12个、12个品种成功中选，合计71个品种。 日前，第十二批国采中选结果正式公布，科伦药业有14个品种在列，为此次集采中标品种数最多的企业；14个品种中，包括9个注射剂、5个口服常释剂型，治疗大类上以消化系统及代谢药为主。 第十二批国采科伦药业中选情况 来源：公司公告、米内网数据库等 从中选品种销售情况看，科伦药业的恩扎卢胺软胶囊、盐酸曲唑酮片（2026年1月获批）、复合磷酸氢钾注射液、注射用硫酸艾沙康唑（2026年4月获批）、门冬氨酸钾注射液、氯化钙注射液、艾拉莫德片（2026年3月获批）、盐酸戊乙奎醚注射液、屈螺酮炔雌醇片(II)（2026年6月获批）等品种2025年暂未销售。 科伦药业表示，在采购周期中，医疗机构将优先使用本次集采中选药品。若公司后续签订采购合同并实施，将进一步扩大相关产品的销售，提高市场占有率，提升公司品牌影响力。 猛攻ADC！化药1类新药上市可期 近年来，科伦药业坚持“三发驱动，创新增长”的发展战略，不断加大研发力度与强度。2025年公司研发投入22.05亿元，同比增长1.57%，占营收比重超过10%；2026年第一季度研发费用5.86亿元，同比增长约13.76%，占营收比重进一步提升至13.76%。 目前科伦药业已有3款1类创新药获批上市，包括注射用博度曲妥珠单抗、注射用芦康沙妥珠单抗2款ADC，以及PD-L1单抗塔戈利单抗注射液。 除去已获批品种，目前科伦药业还有40余款新药（30款1类新药）在国内处于申请临床及以上阶段（不含终止开发品种），聚焦肿瘤、精神神经、心血管、肝病、呼吸等疾病领域，其中抗肿瘤药独占“半壁江山”。 科伦药业国内处于II期（含I+II期）临床及以上阶段的1类新药 来源：米内网综合数据库 富马酸仑博替尼胶囊（KL590586）进展最快，其上市申请已于2025年9月获受理，适应症为晚期RET+非小细胞肺癌（NSCLC）。这是一款新型第二代小分子选择性RET抑制剂，具有克服第一代SRI耐药的潜力。 从药物形式看，ADC是科伦药业重点布局的赛道。据不完全统计，除去已获批品种，公司还有10余款ADC新药在国内处于获批临床及以上阶段，其中，SKB518（潜在FIC靶点ADC）、SKB571（新型双抗ADC）、SKB500（B7-H3 ADC）、SKB315（CLDN18.2 ADC）等已处于II期临床。 创新药BD方面，目前科伦药业已先后与默沙东、Crescent、Windward Bio等多家企业达成合作，涉及SKB264（TROP2 ADC）、SKB315（CLDN18.2 ADC）、SKB410（Nectin-4 ADC）、SKB105（ITGB6 ADC）、SKB378/HBM9378（TSLP单抗）等多款创新药，最高潜在总金额超过140亿美元。 资料来源：米内网数据库、公司公告等 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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8月14日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。 本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。