Pegunigalsidase alfa

Company to host conference call and webcast today at 8:00 a.m. EDT 公司将于东部时间今天上午8:00举办电话会议和网络直播。The European Commission (EC) approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio 欧盟委员会（EC）批准了Elfabrio每4周2mg/kg的给药方案。® ®in adults living with Fabry disease providing a meaningful reduction in treatment burden without compromising efficacy 在患有法布里病的成人中，显著减轻了治疗负担，同时没有降低疗效。The EC approval triggered the Company's entitlement to a $25.0 million milestone payment from Chiesi, strengthening the Company's cash position and supporting an expected cash balance of approximately $50.0 million by April 2026 欧盟的批准触发了公司从凯西获得2500万美元里程碑付款的权利，增强了公司的现金状况，并支持公司在2026年4月前预计约5000万美元的现金余额。Based on current estimates, management expects total revenues in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million payment referenced above 基于当前的估计，管理层预计2026年的总收入将在约7800万美元至8300万美元之间，其中包括上述提到的2500万美元付款。The Phase 2 clinical trial of PRX–115 is actively enrolling; the Company believes PRX-115 has the potential to be a best-in-class therapy, improving uncontrolled gout patients' compliance and outcomes PRX-115 的 2 期临床试验正在积极招募中；公司认为 PRX-115 有潜力成为同类最佳疗法，改善难治性痛风患者的依从性和治疗效果。Continued strategic focus on rare renal diseases to build a pipeline through innovation and partnerships 持续专注于罕见肾脏疾病的战略，通过创新和合作建立产品管线CARMIEL, Israel 以色列卡米埃尔, ，March 18, 2026 2026年3月18日/PRNewswire/ --Protalix BioTherapeutics, Inc. (NYSEAmerican: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the fiscal year endedDecember31, 2025, and provided a business and clinical update.. /PRNewswire/ -- Protalix BioTherapeutics, Inc.（纽约证券交易所代码：PLX）是一家专注于发现、开发、生产和商业化针对存在显著未满足需求的罕见病创新疗法的生物制药公司，今天公布了截至2025年12月31日的财政年度财务业绩，并提供了业务和临床更新。'2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline,' said Dror Bashan, President and Chief Executive Officer, Protalix BioTherapeutics. 'The EC approval of the E4W dosing regimen for Elfabrio in the European Union represents an advancement for patients by reducing treatment burden without compromising efficacy. “2025年对普罗塔利克斯来说是取得有意义进展的一年，我们与合作伙伴的商业执行强劲，并且在临床和临床前管线中取得了重要进展并明确了战略方向，”普罗塔利克斯生物治疗公司总裁兼首席执行官德罗尔·巴桑表示。“欧盟委员会批准Elfabrio在欧洲联盟的E4W剂量方案，这通过减轻治疗负担而不会影响疗效，为患者带来了进步。”This milestone strengthens the long–term value of our Fabry franchise. In parallel, we believe the ongoing development of PRX–115 positions us to address the substantial unmet need in uncontrolled gout with a potential best–in–class therapy. We are also sharpening our focus on rare renal diseases with PRX–119 and our RNA–based discovery collaboration with Secarna, leveraging the capabilities of our ProCellEx. 这一里程碑增强了我们Fabry专营权的长期价值。同时，我们相信PRX-115的持续开发将使我们能够通过潜在的最佳疗法来满足未被控制的痛风领域的重大未满足需求。我们还通过PRX-119和与Secarna基于RNA的发现合作，进一步聚焦于罕见肾病领域，充分利用我们的ProCellEx平台能力。® ®platform. As we enter 2026, we remain committed to driving profitable growth, expanding opportunities across our portfolio, and delivering innovative therapies that meaningfully improve the lives of patients with rare diseases.' 平台。随着我们进入2026年，我们仍然致力于推动盈利增长，扩大我们产品组合中的机会，并提供创新疗法，为罕见病患者的生活带来有意义的改善。Recent Business Highlights 近期业务亮点Elfabrio for Fabry Disease - E4W regimen provides meaningful reduction in treatment burden in EU Elfabrio用于法布里病——E4W方案在欧盟显著减轻了治疗负担。In March 2026, the European Commission (EC) approved a novel 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in adults with Fabry disease who are stable on an enzyme replacement therapy (ERT). 2026年3月，欧洲委员会（EC）批准了一种新的每4周2mg/kg剂量方案，用于那些在酶替代疗法（ERT）中病情稳定的成人法布里病患者使用Elfabrio。This decision followed the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending this additional dosing regimen. 这一决定遵循了人用药品委员会 (CHMP) 的积极意见，该意见推荐了这一额外的给药方案。The E4W regimen provides a potentially meaningful reduction in treatment burden without comprising efficacy, one of the more common unmet needs inFabry disease, and the 50% infusion frequency reduction represents a quality of life improvement for Fabry patients in the EU. E4W 方案在不降低疗效的情况下显著减轻了治疗负担，这是法布里病患者最常见的未满足需求之一，而 50% 的输注频率减少则代表了欧盟地区法布里病患者生活质量的提升。This approval was supported by the BRIGHT study and long-–term extension data, which demonstrated that the E4W dosing regimen maintained clinical and renal outcomes in stable patients. 该批准得到了BRIGHT研究和长期扩展数据的支持，这些数据表明E4W剂量方案在稳定的患者中保持了临床和肾脏结果。Further support came from an updated Population Pharmacokinetics (PopPK) model and exposure–response analysis, which leveraged data from multiple clinical studies. 进一步的支持来自于更新的群体药代动力学（PopPK）模型和暴露-反应分析，这些分析利用了来自多个临床研究的数据。 Elfabrio is now the only ERT approved for E4W dosing to treat Fabry in the EU – strengthening its competitive positioning and potential market share expansion. Elfabrio 现在是欧盟批准的唯一用于 E4W 剂量治疗法布里病的酶替代疗法（ERT）——这增强了其竞争地位和潜在的市场份额扩展。The FDA-approved dosing regimen for Elfabrio in the United States remains 1mg/kg every 2 weeks. 美国食品药品监督管理局（FDA）批准的Elfabrio给药方案仍为每2周1mg/kg。PRX-115 for Uncontrolled Gout – Phase 2 trial actively enrolling PRX-115用于难治性痛风——第二阶段试验正在积极招募中Actively enrolling, and the first patients have been randomized, in the RELEASE Phase 2 clinical trial of PRX–115 ( 积极招募中，并且首批患者已经随机分组，参与PRX-115的RELEASE二期临床试验（NCT07280156 NCT07280156), a recombinant PEGylated uricase. )，一种重组PEG化尿酸酶。The RELEASE study builds on favorable Phase 1 clinical trial results, where PRX–115 was generally well–tolerated and demonstrated rapid, durable serum urate reduction below target levels across all cohorts. RELEASE 研究基于有利的 1 期临床试验结果，其中 PRX-115 通常耐受性良好，并在所有队列中显示出快速、持久的血清尿酸降至目标水平以下。PRX–115 is designed as a potential best–in–class, long–acting therapy, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout. PRX-115被设计为潜在的最佳同类长效疗法，可能采用E4W剂量计划，无论是否联合免疫调节剂使用，或者在使用免疫调节剂的情况下减少给药频率，旨在提高难治性痛风患者的依从性和治疗反应的持久性。By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX–115 is well-positioned to capture a meaningful share in the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity. 通过解决免疫原性挑战并实现更灵活的给药间隔，公司相信 PRX-115 有望在不受控制的痛风领域中占据重要份额，即使适度的渗透率也代表着显著的商业机会。The Company anticipates top-line results in the second half of 2027. 公司预计将在2027年下半年取得初步成果。The Company recently received an allowance from the US Intellectual Property Office (USPTO) for Patent Application No. 18/035,149 entitled 'MODIFIED URICASE AND USES THEREOF' protecting the PEGylateduricase. 公司近期收到美国知识产权局 (USPTO) 关于专利申请号 18/035,149 的授权，该专利标题为“修饰的尿酸酶及其用途”，保护了聚乙二醇化的尿酸酶。Focus on Rare Renal Indications (Preclinical Programs) 专注于罕见肾脏疾病的指示（临床前项目）The Company is deepening its focus on rare renal diseases by advancing PRX–119, its long–acting DNase I program. 公司正在通过推进其长效DNase I项目PRX-119，深化对罕见肾病的关注。The Company is also collaborating with Secarna to discover RNA–based therapeutic candidates that may complement its ProCellEx platform. 公司还与Secarna合作，发现可能与其ProCellEx平台互补的基于RNA的治疗候选药物。Financial Outlook: Building Durable Growth and Long–Term Value 财务展望：打造持久增长与长期价值Protalixenters 2026 with a profitable commercial business through its partnerships and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale.. 普罗塔利克斯通过其合作伙伴关系，在2026年将迎来一个盈利的商业业务，并拥有专注于高度未满足需求领域的研发管线。公司资产负债表强劲，无未偿债务或认股权证。公司认为，其当前的商业模式在推进临床项目、扩大商业版图以及寻求战略合作伙伴以加速影响和规模的过程中，既降低了下行风险，又保留了显著的上升潜力。Priorities remain consistent: 优先事项保持一致：Support our commercial partnerships 支持我们的商业合作伙伴关系AdvancePRX–115 as a potential best–in–class therapy for uncontrolled gout 推进PRX-115作为潜在的同类最佳疗法用于治疗不受控制的痛风Advance rare renal programs leveraging the Company's R&D strengths 利用公司的研发优势，推进罕见肾病项目。Based on current estimates, management expects: 基于当前的估计，管理层预计：Total revenue in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million milestone which the Company is entitled to from Chiesi. 2026年的总收入预计在约7800万美元至8300万美元之间，其中包括公司从Chiesi获得的2500万美元里程碑款项。Full–year 2026 revenues from sales of Elfabrio without milestones to range from approximately $33.0 million to $35.0 million. 2026年全年Elfabrio销售不含里程碑的收入预计在约3300万美元至3500万美元之间。Full–year 2026 revenues from sales of Elelyso to range from approximately $20.0 million to $23.0 million. 2026年全年Elelyso的销售收入预计在约2000万美元至2300万美元之间。This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See 'Forward-Looking Statements' for additional information.. 该展望并非未来业绩的保证，股东不应依赖此类前瞻性陈述。这些估计基于管理层当前的估计，可能会有所变动，并会相应更新。更多信息请参见“前瞻性陈述”。Fiscal Year 2025 Financial Highlights 2025财年财务亮点 Revenues from selling goods 销售收入were $51.8 million for the year ended December 31, 2025, a decrease of $1.2 million (2%) versus $53.0 million in 2024, driven primarily by a $6.8 million decline in sales to Chiesi to $22.5 million, partially offset by an increase in sales to Pfizer Inc., or Pfizer (up $5.6 million to $18.2 million), and to Fundação Oswaldo Cruz, or Fiocruz (Brazil) (up $0.03 million to $11.1 million). 2025年截至12月31日的年度收入为5,180万美元，相比2024年的5,300万美元减少了120万美元（下降2%），主要原因是向Chiesi的销售额下降了680万美元至2,250万美元，部分被向辉瑞公司（Pfizer Inc.，或Pfizer）的销售额增加所抵消（增加了560万美元至1,820万美元），以及向奥斯瓦尔多·克鲁兹基金会（Fundação Oswaldo Cruz，或Fiocruz，巴西）的销售额小幅增长（增加了3万美元至1,110万美元）。. 。The decrease in revenues recorded from sales to Chiesi in 2025 resulted primarily from a change in the average net selling price of drug product in the applicable territory as well as changes in the quantities the Company sold to Chiesi's inventory. The increase in revenues recorded from sales to Pfizer resulted primarily from increased purchases of Elelyso by Pfizer to address unexpected manufacturing issues on their end. 2025年，公司对Chiesi的销售收入减少，主要原因是适用区域内药品的平均净销售价格发生变化，以及公司向Chiesi库存销售的数量有所变化。而公司对辉瑞的销售收入增加，主要是由于辉瑞为应对自身出现的意外生产问题而增加了对Elelyso的采购量。. 。Revenues from license and R&D services 许可和研发服务收入were $0.9 million in 2025, up $0.5 million (125%) from $0.4 million in 2024. Revenues from license and R&D services are comprised primarily of revenues recognized in connection with the Company's agreements with Chiesi. Other than potential regulatory milestone payments that may become payable, the Company expects to generate minimal revenues from license and R&D services.. 2025年为90万美元，比2024年的40万美元增加了50万美元（增长125%）。许可和研发服务收入主要由与凯西公司协议相关的收入构成。除可能支付的潜在监管里程碑款项外，公司预计许可和研发服务产生的收入将很少。Cost of goods sold 销售成本were $27.0 million in 2025, an increase of $2.7 million (11%) versus $24.3 million in 2024. The increase in cost of goods sold was primarily the result of increase in sales to Pfizer and Fiocruz (Brazil) partially offset by a decrease in sales to Chiesi. 2025年为2700万美元，比2024年的2430万美元增加了270万美元（11%）。销售成本的增加主要是由于对辉瑞和Fiocruz（巴西）的销售增长，部分被对Chiesi的销售下降所抵消。Research & development (R&D) expenses 研发费用totaled $19.6 million in 2025 (vs. $13.0 million in 2024) up $6.6 million (51%). The increase in research and development expenses resulted primarily from preparations for the RELEASE Phase 2 study of PRX-115. The Company expects to continue to incur significant and increasing research and development expenses as it progresses with the RELEASE study and commences more advanced stages of preclinical and clinical trials for certain of its other product candidates.. 总计为 1960 万美元（相较于 2024 年的 1300 万美元）增加了 660 万美元（51%）。研发费用的增加主要源于 PRX-115 的 RELEASE 第二阶段研究的准备工作。公司预计，随着 RELEASE 研究的推进以及针对其他某些产品候选物展开更高级别的临床前和临床试验，其将继续承担显著且不断增加的研发费用。Selling, general and administrative (SG&A) expenses 销售、一般和管理（SG&A）费用were $11.7 million in 2025, a decrease of $0.5 million (4%) from $12.2 million in 2024. The decrease resulted primarily from a decrease in share-based compensation. 2025年为1,170万美元，较2024年的1,220万美元减少了50万美元（4%）。减少的主要原因是基于股份的薪酬减少。Financial income (expenses) 财务收入（费用）, ，net 网was an expense of $0.1 million in 2025 versus income of $0.2 million in 2024, resulting primarily from approximately $1.3 million in exchange rate expense effects, partially offset by approximately $1.0 million in reduced interest expense following the full repayment of the then outstanding senior secured convertible promissory notes, including all outstanding principal and interest, in September 2024. 2025年的支出为10万美元，而2024年为20万美元收入，主要原因是由约130万美元的汇率支出影响，部分被约100万美元的利息支出减少所抵消，这是由于在2024年9月全额偿还了当时未偿还的高级担保可转换期票，包括所有未偿还本金和利息。. 。Taxes on income 所得税were $1.0 million in 2025, a decrease of $0.2 million (18%) compared to $1.2 million in 2024, the tax expenses resulted primarily from taxes on income mainly derived from global intangible low-taxed income (GILTI) resulting primarily from limitations under U.S. Internal Revenue Code Section 174 (the U.S. 2025年为100万美元，相比2024年的120万美元减少了20万美元（18%），税收支出主要源于与全球无形资产低税收入（GILTI）相关的所得税，而这些收入主要受美国《国内税收法》第174条规定的限制影响。Tax Cuts and Jobs Act). . 《减税与就业法案》。Cash, cash equivalents, and short–term bank deposits 现金、现金等价物和短期银行存款were $30.3 million on December 31, 2025. 2025年12月31日为3030万美元。Net loss 净亏损for the year ended December 31, 2025, was approximately $6.6 million, or $(0.08) per share, basic and diluted, compared to net income of $2.9 million or $0.04 per share, basic and diluted, for the same period in 2024. 截至2025年12月31日的年度，净亏损约为660万美元，或每股（基本和稀释）0.08美元，而2024年同期的净收入为290万美元，或每股（基本和稀释）0.04美元。Conference Call and Webcast Information 电话会议和网络直播信息 The Company will host a conference call today, March 18, 2026, at 8:00 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call: 公司将于2026年3月18日东部时间上午8:00举办电话会议，以回顾财务业绩并提供业务更新。如需参与电话会议，请在会议开始前拨打以下号码：Conference Call Details: 电话会议详情： Date: 日期：March 18, 2026 2026年3月18日Time: 时间：8:00 a.m. Eastern Daylight Time (EDT) 东部夏令时间（EDT）上午8:00Toll Free: 免费电话：1-877-423-9813 1-877-423-9813International: 国际：1-201-689-8573 1-201-689-8573Israeli Toll Free: 以色列免费电话： 1-809-406-247 1-809-406-247Conference ID: 会议 ID： 13758983 13758983Call me™: 叫我™：http://bit.ly/4aOQNnE http://bit.ly/4aOQNnEThe Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away. “Call me™”功能让您无需等待接线员；您只需在平台上输入您的电话号码，系统就会立即给您打电话。Webcast Details: 网络直播详情：The conference will be webcast live from the Protalix website and will be available via the following links: 会议将通过Protalix网站进行现场直播，并可通过以下链接获取：Company Link: 公司链接：https://ir.protalix.com/news-events/events https://ir.protalix.com/news-events/eventsWebcast Link: 网络直播链接：https://tinyurl.com/4jxzchdh https://tinyurl.com/4jxzchdhConference ID: 13758983 会议 ID：13758983Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software. 参与者需在会议开始前至少15分钟访问网站，进行注册，并下载和安装任何必要的音频软件。A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link. 电话会议的重播将在普罗塔利克斯网站投资者部分的活动日历中提供两周时间，可通过上述链接访问。About Protalix BioTherapeutics, Inc. 关于Protalix生物治疗公司Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. Protalix是一家生物制药公司，专注于罕见病创新疗法的发现、开发、生产和商业化。Protalix已经研究、开发并目前生产两种酶替代疗法，这些疗法已在多个市场上市。These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx. 这些疗法是通过Protalix专有的植物细胞表达系统ProCellEx表达的重组治疗蛋白。® ®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. ProCellEx 是一种独特的基于植物细胞的系统，使 Protalix 能够以工业化规模生产重组蛋白，且无需接触哺乳动物细胞。Protalix 是首家获得美国食品药品监督管理局 (FDA) 批准通过植物细胞悬浮表达系统生产的蛋白质的公司。Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso. Protalix已将taliglucerase alfa（Elelyso）的全球开发和商业化权利授权给辉瑞公司。® ®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. ，用于治疗戈谢病，但在巴西除外，因为Protalix在巴西保留全部权利。Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio 普罗塔利克斯已与凯西制药公司合作，共同进行Elfabrio的全球开发和商业化。® ®which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNaseI for the treatment of NETs-related diseases. 该协议于 2023 年 5 月获得美国食品药品监督管理局 (FDA) 和欧洲药品管理局 (EMA) 的批准。Protalix 的研发管线包括两个针对已确立医药市场的重组治疗蛋白的专利版本：PRX-115，一种用于治疗不受控制的痛风的植物细胞表达重组 PEG 化尿酸酶；以及 PRX-119，一种用于治疗 NET 相关疾病的植物细胞表达长效 DNase I。To learn more, please visit . 要了解更多信息，请访问 。www.protalix.com www.protalix.com. 。Forward-Looking Statements 前瞻性声明To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. 本新闻稿中的声明在非严格历史性的范围内，均为前瞻性声明，是根据1995年《私人证券诉讼改革法案》的安全港条款作出的。这些声明通常涉及未来事件或公司的未来财务或运营表现，包括上述2026年的财务展望。Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. The terms 'anticipate,' 'believe,' 'estimate,' 'expect,' 'can,' 'continue,' 'could,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and other words or phrases of similar import are intended to identify forward-looking statements. 实际结果可能与这些前瞻性陈述中表达或预测的内容有重大差异。术语“预期”、“相信”、“估计”、“预计”、“能够”、“继续”、“可能”、“打算”、“也许”、“计划”、“潜在”、“预测”、“预计”、“应该”、“将”、“会”以及其他类似含义的词语或短语旨在识别前瞻性陈述。These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings of the clinical trial. 这些前瞻性陈述受到已知和未知的风险和不确定性的影响，实际的未来经历和结果可能与所作的陈述有重大差异。这些陈述是基于我们对这种未来结果的当前信念和期望。药物发现和开发涉及高度风险，临床试验的最终结果可能与临床试验的初步结果不同。Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio. 可能导致重大差异的因素包括但不限于：与Elfabrio商业化相关的风险。® ®(pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers. (pegunigalsidase alfa-iwxj)，我们获批用于治疗成人法布里病患者的产品；与Elfabrio市场接受度、竞争、报销和监管行动相关的风险，包括因FDA批准该产品时包含的黑框警告而产生的风险；与我们其他产品及候选产品的监管审批和商业成功相关的风险（如获批准）；与我们对产品及候选产品预计市场规模预期相关的风险；我们的临床前研究和临床试验开始或完成失败或延迟的风险，这可能是由多种因素造成的，包括：患者招募速度低于预期；未能预见的安全问题；剂量问题的确定；临床试验期间缺乏有效性；无法充分证明非劣效性于已批准疗法；医学研究人员和机构审查委员会不愿或无法遵循我们的临床方案；和/或在治疗期间或之后无法充分监测患者；我们的候选产品临床试验结果不支持其安全性或有效性的相关声明的风险，以及我们的候选产品不会产生预期效果或可能伴随不良副作用或其他意外特性的风险；由于伊朗地区冲突、以色列与伊朗之间的军事行动、加沙地带的哈马斯恐怖组织、真主党、控制也门部分地区胡塞武装恐怖组织等所导致的对我们运营可能造成的干扰风险，包括某些监管机构和部分供应商运营中断所带来的影响。Investor Contact 投资者联系Mike Moyer, Managing Director 迈克·莫耶，董事总经理LifeSci Advisors 生命科学顾问+1-617-308-4306 +1-617-308-4306[emailprotected] 电子邮件地址PROTALIX BIOTHERAPEUTICS,INC. 普罗塔利克斯生物治疗公司CONSOLIDATED BALANCE SHEETS 合并资产负债表 (U.S. dollars in thousands) （美元单位：千）December31, 12月31日，2024 20242025 2025ASSETS 资产CURRENT ASSETS: 流动资产： Cash and cash equivalents 现金及现金等价物$ $19,760 19,760$ $14,680 14,680Short-term bank deposits 短期银行存款15,070 15,07015,593 15,593Restricted deposit 受限存款- -702 702Accounts receivable 应收账款2,909 29098,840 8,840Other assets 其他资产1,096 1,0961,129 1,129Inventories 库存21,243 21,24325,729 25,729Total current assets 总流动资产$ $60,078 60,078$ $66,673 66,673NON-CURRENT ASSETS: 非流动资产：Funds in respect of employee rights upon retirement 退休时关于员工权利的资金$ $462 462$ $578 578Property and equipment, net 物业和设备，净值 4,591 4,5914,879 4,879Deferred income tax asset 递延所得税资产2,856 28562,516 2,516Operating lease right of use assets 经营租赁使用权资产5,430 5,4307,700 7,700Total assets 总资产$ $73,417 73,417$ $82,346 82,346LIABILITIES AND STOCKHOLDERS' EQUITY 负债和股东权益 CURRENT LIABILITIES: 流动负债： Accounts payable and accruals: 应付账款和应计项目： Trade 贸易$ $4,533 4,533$ $5,259 5,259Other 其他19,588 19,58819,875 19,875Operating lease liabilities 经营租赁负债1,500 15001,384 1,384Total current liabilities 流动负债总计$ $25,621 25,621$ $26,518 26,518LONG TERM LIABILITIES: 长期负债：Liability for employee rights upon retirement 员工退休时的权利责任$ $559 559$ $661 661Operating lease liabilities 经营租赁负债4,026 4,0266,937 6,937Total long term liabilities 长期负债总计$ $4,585 4,585$ $7,598 7,598Total liabilities 总负债$ $30,206 30,206$ $34,116 34,116COMMITMENTS 承诺STOCKHOLDERS' EQUITY 股东权益 Common Stock, $0.001 par value: Authorized - as of December 31, 2024 普通股，面值0.001美元：授权 - 截至2024年12月31日and 2025, 185,000,000 shares; issued and outstanding - as of December 31, 截至 2025 年 12 月 31 日，已发行并流通股数为 185,000,000 股；2024 and 2025, 75,850,275 and 80,425,981 shares, respectively 2024年和2025年，分别为75,850,275股和80,425,981股。76 7680 80Additional paid-in capital 额外实收资本 421,528 421,528433,147 433,147Accumulated deficit 累积赤字(378,393) (378,393)(384,997) (384,997)Total stockholders' equity 股东权益总额 43,211 43,21148,230 48,230Total liabilities and stockholders' equity 总资产和股东权益$ $73,417 73,417$ $82,346 82,346PROTALIX BIOTHERAPEUTICS,INC. 普罗塔利克斯生物治疗公司CONSOLIDATED STATEMENTS OF OPERATIONS 合并经营报表 (U.S. dollars in thousands, except share and per share amounts) （美元单位：千美元，股份和每股金额除外）Year Ended December31, 截至12月31日的年度，2023 20232024 20242025 2025REVENUES FROM SELLING GOODS 销售收入$ $40,418 40,418$ $52,981 52,981$ $51,802 51,802REVENUES FROM LICENSE AND R&D SERVICES 许可证和研发服务收入25,076 25,076418 418942 942TOTAL REVENUE 总收入65,494 65,49453,399 53,39952,744 52,744COST OF GOODS SOLD 销货成本 (22,982) （22,982）(24,319) (24,319)(26,993) （26,993）RESEARCH AND DEVELOPMENT EXPENSES 研发费用(17,093) （17,093）(12,970) （12,970）(19,569) （19,569）SELLING, GENERAL AND ADMINISTRATIVE EXPENSES 销售、一般和管理费用(14,959) （14,959）(12,193) (12,193)(11,682) （11,682）OPERATING INCOME (LOSS) 营业利润（亏损）10,460 10,4603,917 3,917(5,500) （5,500）FINANCIAL EXPENSES 财务费用(3,180) (3,180)(1,062) (1,062)(1,191) (1,191)FINANCIAL INCOME 财务收入 1,286 1,2861,299 1,2991,083 1,083FINANCIAL INCOME (EXPENSES), NET 财务收入（费用），净额(1,894) (1,894)237 237(108) (108)INCOME (LOSS) BEFORE TAXES ON INCOME 税前收入（损失）8,566 8,5664,154 4,154(5,608) （5,608）TAXES ON INCOME 所得税(254) (254)(1,222) (1,222)(996) （996）NET INCOME (LOSS) 净收入（损失）$ $8,312 8,312$ $2,932 2,932$ $(6,604) (6,604)EARNINGS (LOSS) PER SHARE OF COMMON STOCK: 每股普通股收益（亏损）：BASIC 基础的$ $0.12 0.12$ $0.04 0.04$ $(0.08) (0.08)DILUTED 稀释的$ $0.09 0.09$ $0.04 0.04$ $(0.08) (0.08)WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK 加权平均普通股股份数USED IN COMPUTING EARNINGS (LOSS) PER SHARE: 用于计算每股收益（亏损）：BASIC 基础67,512,527 67,512,52772,530,698 72,530,69878,546,234 78,546,234DILUTED 稀释的82,424,016 82,424,01681,057,176 81,057,17678,546,234 78,546,234Logo: 标志：https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpgSOURCE Protalix BioTherapeutics, Inc. 来源：Protalix BioTherapeutics, Inc.21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示

Company to host conference call and webcast today at 8:00 a.m. EDT The European Commission (EC) approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in adults living with Fabry disease providing a meaningful reduction in treatment burden without compromising efficacy The EC approval triggered the Company's entitlement to a $25.0 million milestone payment from Chiesi, strengthening the Company's cash position and supporting an expected cash balance of approximately $50.0 million by April 2026 Based on current estimates, management expects total revenues in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million payment referenced above The Phase 2 clinical trial of PRX–115 is actively enrolling; the Company believes PRX-115 has the potential to be a best-in-class therapy, improving uncontrolled gout patients' compliance and outcomes Continued strategic focus on rare renal diseases to build a pipeline through innovation and partnerships CARMIEL, Israel, March 18, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the fiscal year ended December 31, 2025, and provided a business and clinical update. "2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline," said Dror Bashan, President and Chief Executive Officer, Protalix BioTherapeutics. "The EC approval of the E4W dosing regimen for Elfabrio in the European Union represents an advancement for patients by reducing treatment burden without compromising efficacy. This milestone strengthens the long–term value of our Fabry franchise. In parallel, we believe the ongoing development of PRX–115 positions us to address the substantial unmet need in uncontrolled gout with a potential best–in–class therapy. We are also sharpening our focus on rare renal diseases with PRX–119 and our RNA–based discovery collaboration with Secarna, leveraging the capabilities of our ProCellEx® platform. As we enter 2026, we remain committed to driving profitable growth, expanding opportunities across our portfolio, and delivering innovative therapies that meaningfully improve the lives of patients with rare diseases." Recent Business Highlights Elfabrio for Fabry Disease - E4W regimen provides meaningful reduction in treatment burden in EU In March 2026, the European Commission (EC) approved a novel 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in adults with Fabry disease who are stable on an enzyme replacement therapy (ERT). This decision followed the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending this additional dosing regimen. The E4W regimen provides a potentially meaningful reduction in treatment burden without comprising efficacy, one of the more common unmet needs in Fabry disease, and the 50% infusion frequency reduction represents a quality of life improvement for Fabry patients in the EU. This approval was supported by the BRIGHT study and long-–term extension data, which demonstrated that the E4W dosing regimen maintained clinical and renal outcomes in stable patients. Further support came from an updated Population Pharmacokinetics (PopPK) model and exposure–response analysis, which leveraged data from multiple clinical studies. Elfabrio is now the only ERT approved for E4W dosing to treat Fabry in the EU – strengthening its competitive positioning and potential market share expansion. The FDA-approved dosing regimen for Elfabrio in the United States remains 1mg/kg every 2 weeks. PRX-115 for Uncontrolled Gout – Phase 2 trial actively enrolling Actively enrolling, and the first patients have been randomized, in the RELEASE Phase 2 clinical trial of PRX–115 (NCT07280156), a recombinant PEGylated uricase. The RELEASE study builds on favorable Phase 1 clinical trial results, where PRX–115 was generally well–tolerated and demonstrated rapid, durable serum urate reduction below target levels across all cohorts. PRX–115 is designed as a potential best–in–class, long–acting therapy, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout. By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX–115 is well-positioned to capture a meaningful share in the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity. The Company anticipates top-line results in the second half of 2027. The Company recently received an allowance from the US Intellectual Property Office (USPTO) for Patent Application No. 18/035,149 entitled "MODIFIED URICASE AND USES THEREOF" protecting the PEGylated uricase. Focus on Rare Renal Indications (Preclinical Programs) The Company is deepening its focus on rare renal diseases by advancing PRX–119, its long–acting DNase I program. The Company is also collaborating with Secarna to discover RNA–based therapeutic candidates that may complement its ProCellEx platform. Financial Outlook: Building Durable Growth and Long–Term Value Protalix enters 2026 with a profitable commercial business through its partnerships and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale. Priorities remain consistent: Support our commercial partnerships Advance PRX–115 as a potential best–in–class therapy for uncontrolled gout Advance rare renal programs leveraging the Company's R&D strengths Based on current estimates, management expects: Total revenue in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million milestone which the Company is entitled to from Chiesi. Full–year 2026 revenues from sales of Elfabrio without milestones to range from approximately $33.0 million to $35.0 million. Full–year 2026 revenues from sales of Elelyso to range from approximately $20.0 million to $23.0 million. This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See 'Forward-Looking Statements' for additional information. Fiscal Year 2025 Financial Highlights Revenues from selling goods were $51.8 million for the year ended December 31, 2025, a decrease of $1.2 million (2%) versus $53.0 million in 2024, driven primarily by a $6.8 million decline in sales to Chiesi to $22.5 million, partially offset by an increase in sales to Pfizer Inc., or Pfizer (up $5.6 million to $18.2 million), and to Fundação Oswaldo Cruz, or Fiocruz (Brazil) (up $0.03 million to $11.1 million). The decrease in revenues recorded from sales to Chiesi in 2025 resulted primarily from a change in the average net selling price of drug product in the applicable territory as well as changes in the quantities the Company sold to Chiesi's inventory. The increase in revenues recorded from sales to Pfizer resulted primarily from increased purchases of Elelyso by Pfizer to address unexpected manufacturing issues on their end. Revenues from license and R&D services were $0.9 million in 2025, up $0.5 million (125%) from $0.4 million in 2024. Revenues from license and R&D services are comprised primarily of revenues recognized in connection with the Company's agreements with Chiesi. Other than potential regulatory milestone payments that may become payable, the Company expects to generate minimal revenues from license and R&D services. Cost of goods sold were $27.0 million in 2025, an increase of $2.7 million (11%) versus $24.3 million in 2024. The increase in cost of goods sold was primarily the result of increase in sales to Pfizer and Fiocruz (Brazil) partially offset by a decrease in sales to Chiesi. Research & development (R&D) expenses totaled $19.6 million in 2025 (vs. $13.0 million in 2024) up $6.6 million (51%). The increase in research and development expenses resulted primarily from preparations for the RELEASE Phase 2 study of PRX-115. The Company expects to continue to incur significant and increasing research and development expenses as it progresses with the RELEASE study and commences more advanced stages of preclinical and clinical trials for certain of its other product candidates. Selling, general and administrative (SG&A) expenses were $11.7 million in 2025, a decrease of $0.5 million (4%) from $12.2 million in 2024. The decrease resulted primarily from a decrease in share-based compensation. Financial income (expenses), net was an expense of $0.1 million in 2025 versus income of $0.2 million in 2024, resulting primarily from approximately $1.3 million in exchange rate expense effects, partially offset by approximately $1.0 million in reduced interest expense following the full repayment of the then outstanding senior secured convertible promissory notes, including all outstanding principal and interest, in September 2024. Taxes on income were $1.0 million in 2025, a decrease of $0.2 million (18%) compared to $1.2 million in 2024, the tax expenses resulted primarily from taxes on income mainly derived from global intangible low-taxed income (GILTI) resulting primarily from limitations under U.S. Internal Revenue Code Section 174 (the U.S. Tax Cuts and Jobs Act). Cash, cash equivalents, and short–term bank deposits were $30.3 million on December 31, 2025. Net loss for the year ended December 31, 2025, was approximately $6.6 million, or $(0.08) per share, basic and diluted, compared to net income of $2.9 million or $0.04 per share, basic and diluted, for the same period in 2024. Conference Call and Webcast Information The Company will host a conference call today, March 18, 2026, at 8:00 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call: Conference Call Details: Date: March 18, 2026 Time: 8:00 a.m. Eastern Daylight Time (EDT) Toll Free: 1-877-423-9813 International: 1-201-689-8573 Israeli Toll Free: 1-809-406-247 Conference ID: 13758983 Call me™: The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away. Webcast Details: The conference will be webcast live from the Protalix website and will be available via the following links: Company Link: Webcast Link: Conference ID: 13758983 Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software. A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link. About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit . Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings of the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors, and customers, and the risk that the current hostilities will result in increased regional conflict; delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency or other health regulatory authorities for our other product candidates and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity or debt markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc. and Chiesi Farmaceutici S.p.A.; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; risks relating to changes to interim, top-line or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, or Fiocruz, an arm of the Brazilian Ministry of Health with its purchase obligations under our supply and technology transfer agreement that we entered into with Fiocruz in June 2013, which may have a material adverse effect on us and may result in our terminating such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law. You are cautioned not to place undue reliance on these forward-looking statements. Investor Contact Mike Moyer, Managing Director LifeSci Advisors +1-617-308-4306 [email protected] Logo: SOURCE Protalix BioTherapeutics, Inc. 21% more press release views with Request a Demo