| 展示稿99.1 |
protalix biotherapeutics报告
2024年第三季度财务和业务结果
公司将于今天东部时间上午8:30举行电话会议和网络直播
CARMIEL, Israel, November 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the quarter ended September 30, 2024, and provided a business and clinical update.
“We are pleased to report that all eight cohorts of our phase I first-in-human study of PRX-115, our recombinant uricase candidate being developed for the treatment of uncontrolled gout, are now complete,” said Dror Bashan, Protalix’s President and Chief Executive Officer. “Preliminary results from this study, being presented today and this week in a late-breaking poster at ACR Convergence 2024, are encouraging and demonstrate the potential of PRX-115 to be a promising uric-acid lowering treatment option for individuals with gout. We are actively planning a phase II clinical trial of PRX-115 in gout patients and expect to initiate the study in the second half of 2025.”
2024年第三季度和近期业务亮点
管道发展
The Company’s PRX-115 trial is a double blind, placebo-controlled, single ascending dose (SAD), First-in-Human phase I clinical trial evaluating PRX-115 for the potential treatment of gout. The study is designed to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD; reduction of uric acid) following a single dose of PRX-115 in subjects with elevated uric acid levels. In the study, 64 randomized subjects were enrolled across eight cohorts, each composed of eight subjects (six active and two placebo). All of the subjects completed the study. At this time, the data is locked and is currently being analyzed.
Preliminary results from the full study are as follows:
| ● | 暴露于PRX-115会呈剂量依赖性增加。在第6、7和8队的受试者中，可观察到PRX-115在血浆中的水平长达12周。 |
| ● | 在所有测试剂量下，单剂PRX-115迅速降低血浆尿酸水平。反应的效应和持续时间被发现与剂量有关。在单次剂量后，平均血浆尿酸水平在最高剂量水平下长达12周保持在6.0 mg/dl以下。 |
| ● | PRX-115耐受性良好，仅有25%的受试者在研究中接受PRX-115治疗（12/48）报告了与研究药物相关的不良事件，其中大多数为轻度至中度，并具有短暂性质。一名受试者在开始输注后立即经历了过敏反应，但完全恢复了。研究中没有报告其他严重不良事件。 |
| 在研究中发现PRX-115能够以仅有25%的主体（12/48）报告了与研究药物相关的不良事件。其中大多数为轻度至中度，且具有短暂性质。其中一位受试者在输注开始后立即出现了过敏反应，但完全恢复了。研究中没有报告其他严重不良事件。 |
初步结果表明，PRX-115可能提供一种有效的降尿酸治疗方法，同时还具有潜在的宽容量间隔优势，这可能提高患者的依从性和治疗灵活性。需要进一步研究以确认PRX-115在痛风患者群体中的长期安全性和有效性。
这些初步结果将在2024年11月举行的美国风湿病学学院（ACR）2024年度大会上作为晚期海报展示。 2024年11月14日至19日，在华盛顿特区的沃尔特·华盛顿会议中心举行的ACR Convergence 2024会议上展示。已接受的摘要可在ACR Convergence 2024网站上获取。https://acrabstracts.org/abstract/prolonged-plasma-urate-lowering-after-a-single-intravenous-administration-of-prx-115-a-novel-pegylated-uricase-in-participants-with-elevated-urate-levels/。海报副本将在Protalix网站上提供。
企业发展
| ● | 2024年9月，公司全额偿还了到期的7.50%优先担保可转换应债券的所有本金和利息。债券到期时的偿还完全由可用现金融资。 |
2024年第三季度财务亮点
| ● | The Company recorded revenues from selling goods of $1780万 during the three months ended September 30, 2024, an increase of $7.6 million, or 75%, compared to revenues of $10.2 million for the three months ended September 30, 2023. The increase resulted primarily from an increase of $6.8 million in sales to Chiesi Farmaceutici S.p.A. (“Chiesi”), and an increase of $1.1 million in sales to Pfizer Inc. (“Pfizer”), partially offset by a decrease of $30万 in sales to Brazil. |
| ● | Cost of goods sold was $8.4 million for the three months ended September 30, 2024, an increase of $350万, or 71%, from cost of goods sold of $4.9 million for the three months ended September 30, 2023. The increase in cost of goods sold was primarily the result of an increase in sales to Chiesi and Pfizer. |
| ● | 截至2024年9月30日的三个月，我们的总研发费用约为300万美元，其中约60万美元为分包商相关费用，约160万美元为工资和相关费用，约20万美元为材料相关费用，约 60万美元为其他费用。 |
| 其他费用约60万美元。截至2023年9月30日的三个月，我们的总研发费用约为370万美元，其中约100万美元为分包商相关费用，约190万美元为工资和相关费用，约20万美元为材料相关费用，约60万美元为其他费用。 |
截至2024年9月30日的三个月，研发费用总减少了70万美元，或19%，相较于截至2023年9月30日的三个月。研发费用的减少主要是由于我们Fabry临床项目的完成以及美国和欧洲联盟的Elfabrio生物制品许可申请（BLA）和营销授权申请（MAA）的审查相关监管流程完成。
| ● | 2024年9月30日的三个月，销售、一般和管理费用为260万美元，较2023年9月30日的三个月的370万美元减少了110万美元，或30%。这一减少主要是由于工资和相关费用减少了50万美元，专业费用减少了40万美元。 |
| ● | 截至2024年9月30日三个月的财务费用净额为0.1百万元，相比于截至2023年9月30日三个月的0.2百万元的财务收入净额。主要原因是银行存款利息收入较低，汇率成本较高，部分抵销了2024年9月全部偿还的2024年票据的全部应付本金和利息的降低利息支出。 |
| ● | 2024年9月30日结束的三个月，我们记录的所得税约为0.6百万元，相比于2023年9月30日结束的0.1百万元所得税。记录的所得税主要是基于2017年12月颁布的《美国减税和就业法》第174条的税费。 |
| ● | 2024年9月30日，现金及现金等价物约为2740万美元。 |
| ● | 2024年9月30日结束的三个月净利润约为 320百万元，每股基本为0.04美元，每股稀释为0.03美元，相比于2023年同期每股基本0.03美元，每股稀释0.04美元的净损失190百万元。. |
| ● | 从2024年9月30日结束的季度结束至今，公司从向赛诗公司销售中收取了约390万美元。 |
电话会议和网络直播信息
公司将于2024年11月14日上午8:30（美东时间）举行电话会议，审查财务业绩并提供业务更新。参加电话会议，请在会议开始前拨打以下电话号码：
电话会议详情：
日期:2024年11月14日，星期四
时间：上午8点30分美国东部时间（EST）
免费电话：1-877-423-9813
国际：1-201-689-8573
以色列免费电话：1-809-406-247
会议ID：13749493
Call me™： https://tinyurl.com/2n9fhumh
Call me™ 功能允许您避免等待运营商；您在平台上输入您的电话号码，系统将立即给您打电话。
网络研讨会详情：
公司链接： https://ir.protalix.com/news-events/events
网络链接：https://tinyurl.com/3be68pkw
会议ID： 13749493
参与者被要求至少提前15分钟访问网站以注册、下载并安装任何必要的音频软件。在公司网站的投资者板块的事件日历上，以上链接将提供两周的通话回放。
关于Protalix BioTherapeutics, Inc.
Protalix是一家专注于通过其专有植物电芯表达系统ProCellEx表达的重组治疗蛋白质的生物制药公司。它是第一家获得美国粮食和药物管理局（FDA）批准通过悬浮表达系统生产植物细胞制造的蛋白质的公司。这种独特的表达系统代表了一种工业化规模开发重组蛋白质的新方法。Protalix已授权辉瑞公司全球开发和商业化塔利格酶阿尔法的权利，用于治疗高雪氏病，Protalix通过ProCellEx制造的首个产品，除了在巴西，Protalix保留全部权利。 Protalix的第二个产品，Elfabrio®，该药品于2023年5月获得了美国食品和药物管理局以及欧洲药品管理局的批准。
Protalix与Chiesi Farmaceutici S.p.A.合作全球开发和商业化Elfabrio。Protalix的开发管线包括瞄准成熟药品市场的专有重组治疗蛋白的产品候选药物，包括以下产品候选药物：PRX–115，一种植物细胞表达的重组聚乙二醇尿酸酶
用于治疗失控痛风的PRX–119，一种植物细胞表达的长效DNase I，以及其他药物。
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. The terms “expect,” “anticipate,” “believe,” “estimate,” “project,” “may,” “plan,” “will,” “would,” “should” and “intend,” 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 for 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; the possible disruption of our operations due to the war declared by Israel’s security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, 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 a greater regional conflict; 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 potential commercial value 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; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA 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 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 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; the risk that the results of our clinical trials 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; risks relating to our ability to
管理与我们的合作者、分销商或合作伙伴的关系，包括但不限于辉瑞公司、辉瑞和Chiesi Farmaceutici S.p.A.；与我们的现金及现金等价物金额和充足性有关的风险；与我们宣布或发布的临时、前期或初步临床试验数据的变化相关的风险；致力于巴西卫生部分支Fundação Oswaldo Cruz根据我们的供应和技术转让协议承担购买义务的遵从性相关风险，这可能对我们产生重大不利影响，并可能导致协议的终止；重大诉讼风险，包括在生命科学领域常见的股东诉讼；我们依赖第三方服务供应商的履行，包括但不限于临床试验服务；在开发我们正在开发的药品平台和产品过程中固有的风险和不确定性；其他公司开发竞争性疗法和/或技术的影响；与向辉瑞供应药物产品相关的风险；潜在产品责任风险，以及获得足够额度的相关保险覆盖的风险；有可能侵犯第三方的专利或其他知识产权，以及获得覆盖我们产品和流程的专利和成功向第三方执行我们知识产权权利的不确定性；以及与美国或其他地方卫生法律、规则和法规变化相关的风险; 以及在我们提交给美国证券交易委员会的文件中描述的其他因素. 本新闻稿中的声明仅在此日期之日起生效，我们声明除非法律要求，否则不承担更新此信息的任何义务。
投资者联系人
Mike Moyer，董事总经理
LifeSci顾问
+1-617-308-4306
mmoyer@lifesciadvisors.com
protalix biotherapeutics
(以千美元计)
（未经审计）
|
| 2024年9月30日 |
| 2023年12月31日 | | ||
| | | | | | | |
资产 | | | | | | | |
| | | | | | | |
流动资产： | | | | | | | |
现金及现金等价物 | | $ | 27,409 | | $ | 23,634 | |
开空期银行存款 | | | | | | 20,926 | |
Accounts receivable – Trade | |
| 2,195 | |
| 5,272 | |
其他资产 | |
| 1,050 | |
| 1,055 | |
库存 | |
| 17,199 | |
| 19,045 | |
总流动资产 | | $ | 47,853 | | $ | 69,932 | |
| | | | | | | |
非流动资产: | | | | | | | |
养老时员工权益的基金 | | $ | 561 | | $ | 528 | |
房地产和设备，净额 | |
| 4,648 | |
| 4,973 | |
递延所得税资产 | | | 2,856 | | | 3,092 | |
资产：租赁资产 | |
| 5,645 | |
| 5,909 | |
资产总额 | | $ | 61,563 | | $ | 84,434 | |
| | | | | | | |
负债和股东权益 | |
| | |
|
| |
| | | | | | | |
流动负债： | |
| | |
|
| |
应付账款及预计费用： | |
| | |
|
| |
交易 | | $ | 3,135 | | $ | 4,320 | |
其他 | |
| 19,577 | |
| 19,550 | |
经营租赁负债 | |
| 1,508 | |
| 1,409 | |
转换票据 | | | - | | | 20,251 | |
流动负债合计 | | $ | 24,220 | | $ | 45,530 | |
| | | | | | | |
长期负债： | |
| | |
|
| |
养老时员工权益的负债 | | $ | 730 | | $ | 714 | |
营业租赁负债 | |
| 4,176 | |
| 4,621 | |
总长期负债 | | $ | 4,906 | | $ | 5,335 | |
总负债 | | $ | 29,126 | | $ | 50,865 | |
| | | | | | | |
承诺 | | | | | | | |
| | | | | | | |
股东权益 | | | 32,437 | | | 33,569 | |
负债和股东权益总额 | | $ | 61,563 | | $ | 84,434 | |
protalix biotherapeutics
(以千美元计，除每股和每股数据外)
（未经审计）
| | 截至九个月 | | 截至三个月 | ||||||||||
|
| 2024年9月30日 |
| 2023年9月30日 |
| 2024年9月30日 |
| 2023年9月30日 | ||||||
销售商品收入 | | $ | 34,820 | | $ | 30,309 | | $ | 17,839 | | $ | 10,168 | ||
许可和研发服务收入 | |
| 361 | |
| 24,699 | |
| 120 | |
| 177 | ||
营业收入合计 | | | 35,181 | | | 55,008 | | | 17,959 | | | 10,345 | ||
营业成本 | |
| (20,433) | |
| (14,126) | |
| (8,375) | |
| (4,893) | ||
研发费用 | |
| (8,846) | |
| (13,991) | |
| (2,998) | |
| (3,669) | ||
销售、一般和管理支出 | |
| (9,194) | |
| (10,816) | |
| (2,595) | |
| (3,670) | ||
营业额（亏损） | |
| (3,292) | |
| 16,075 | |
| 3,991 | |
| (1,887) | ||
财务费用 | |
| (1,056) | |
| (2,406) | |
| (299) | |
| (460) | ||
财务收入 | |
| 1,186 | |
| 1,323 | |
| 151 | |
| 628 | ||
净财务收入（费用） | |
| 130 | |
| (1,083) | |
| (148) | |
| 168 | ||
税前税前利润（损失） | | | (3,162) | | | 14,992 | | | 3,843 | | | (1,719) | ||
所得税 | | | (400) | | | (636) | | | (607) | | | (133) | ||
净利润（亏损） | | $ | (3,562) | | $ | 14,356 | | $ | 3,236 | | $ | (1,852) | ||
普通股每股盈利（亏损）: | | | | | | | | | | | | | ||
BASIC | | $ | (0.05) | | $ | 0.22 | | $ | 0.04 | | $ | (0.03) | ||
DILUTED | | $ | (0.05) | | $ | 0.16 | | $ | 0.03 | | $ | (0.04) | ||
普通股加权平均股份 | | | | | | | | | | | | | ||
用于计算每股盈利（亏损）： | | | | | | | | | | | | | ||
BASIC | |
| 73,301,091 | |
| 65,811,506 | |
| 73,549,745 | |
| 72,281,681 | ||
稀释的 | |
| 73,301,091 | |
| 81,040,281 | |
| 81,217,068 | |
| 83,782,679 | ||