MediWound Ltd. (NASDAQ:MDWD) Q3 2023 Earnings Call Transcript November 21, 2023 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors Ofer Gonen - Chief Executive Officer Barry Wolfenson - Executive Vice President of Strategy & Corporate Development Hani Luxenburg - Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer Michael Okunewitch - Maxim Group Operator Good day, and welcome to MediWound Third Quarter 2023 Earnings Call. [Operator Instructions]. Please note, ...

Exhibit 99.1 MediWound Reports Third Quarter 2023 Financial Results and Provides Company Update NexoBrid® commercially launched in U.S. and Japan; Company prioritizes operational resources to meet increased global demand EscharEx® Phase III study preparations progressing; Protocol submission to FDA expected in first quarter 2024 Cash of $46 million; Operating cash runway through profitability Conference call on Tuesday, November 21 at 8:30 a.m. Eastern Time YAVNE, Israel, November 21, 2023 -- MediWound Ltd. ...

财务数据和关键指标变化 - 第二季度收入为4.8百万美元,较去年同期的4.7百万美元略有增长 [34] - 毛利润保持在1.1百万美元,占总收入的24% [34] - 研发费用为2百万美元,较去年同期的2.2百万美元略有下降 [35] - 销售、一般及管理费用增加至3.1百万美元,主要由于增加了支持未来增长的全职员工,以及股份支付费用的增加 [35] - 第二季度经营亏损为4百万美元,较去年同期的3.7百万美元略有增加 [36] - 第二季度净利润为0.9百万美元或每股0.10美元,较去年同期的4.4百万美元净亏损或每股0.29美元有显著改善 [36] - 第二季度经调整EBITDA亏损为3百万美元,较去年同期的2.8百万美元略有增加 [36] - 上半年收入为8.6百万美元,较去年同期的9.1百万美元有所下降,主要由于2022年BARDA的紧急储备订单 [37] - 上半年经营亏损为8.4百万美元,高于去年同期的7百万美元 [37] - 上半年净亏损为2.8百万美元或每股0.32美元,较去年同期的7.9百万美元或每股1.79美元有所改善 [37] - 上半年经调整EBITDA亏损为6.4百万美元,高于去年同期的5.4百万美元 [37] 各条业务线数据和关键指标变化 - NexoBrid在美国获批后,公司正专注于制造和向合作伙伴Vericel交付产品以支持美国商业发售 [13] - 由于第三方检测实验室在制造过程中出现偏差,Vericel目前无法释放NexoBrid进行商业销售,但公司正与FDA积极沟通,希望尽快解决此问题 [13][14] - 公司正在制造下一批NexoBrid供货给Vericel,这些批次不会受到此偏差的影响 [14] - 在日本,合作伙伴Kaken Pharmaceutical已成功商业发售NexoBrid,日本市场每年有6,000多名重度烧伤患者接受治疗,其中大部分需要进行溃疡清除 [17] - 日本是NexoBrid首个获批用于成人和儿童患者的市场 [17] - 在欧洲,NexoBrid和EscharEx的需求持续增长,正被更广泛地采用 [18] - 公司正在扩大NexoBrid和EscharEx的生产能力,预计到2024年中期完成新厂房建设,2025年达到满产 [19] 各个市场数据和关键指标变化 - 日本是NexoBrid最大的市场之一,公司预计2024年日本市场将为公司贡献重要收入 [69][70] - 公司正集中资源优先满足美国、日本和欧洲5大国家的NexoBrid需求,暂时无法满足其他小国的需求 [92][93] 公司战略和发展方向及行业竞争 - 公司正积极推进商业产品组合的发展、管线的拓展、战略合作的加强、新联盟的建立以及制造能力的扩张 [11][12] - 公司正准备启动EscharEx的III期临床试验,这是过去10年来最大规模的静脉性溃疡临床试验 [20][21] - 公司与MIMEDX和Molnlycke等行业领先企业达成合作,为EscharEx III期试验提供最佳级别的压缩疗法、敷料和细胞产品 [25][26][27] - 公司正与更多行业内知名企业就EscharEx展开合作洽谈,充分体现了EscharEx的巨大潜力 [22][51][52] - 公司正积极推进MW005的临床开发,并寻求战略合作伙伴 [29][30] - 公司新任命Milky Rubinstein为独立董事,增强董事会实力 [31] 管理层对经营环境和未来前景的评论 - 公司有信心通过EscharEx III期试验,并在获批后在美国市场成功推出 [40][52][53] - 公司预计NexoBrid收入将持续增长,并将受益于美国上市和儿童适应症的扩展 [41] - 公司正在扩大NexoBrid的生产能力,以满足不断增长的全球需求 [19][41] - 公司有充足的现金储备,可支持业务持续发展直至实现盈利 [38] 问答环节重要的提问和回答 问题1 **Josh Jennings 提问** 询问EscharEx III期试验启动前的准备工作 [45][46][47] **Ofer Gonen 回答** 公司正在与各方合作伙伴进行复杂的协调,以确保试验顺利进行并达到预期目标,不会过于急于招募患者而影响结果 [46][47][48] 问题2 **Francois Brisebois 提问** 询问NexoBrid供应问题对公司收入的影响 [62][63] **Ofer Gonen 回答** 公司有足够的备货可以销售给其他客户,不会对2023-2024年收入产生影响,且下一批产品制造过程不会受到影响 [62][63] 问题3 **Swayampakula Ramakanth 提问** 询问公司与FDA就NexoBrid的沟通进展 [66][67] **Ofer Gonen 回答** 公司正在与FDA积极沟通,但出于保密原因无法透露更多细节,但仍然对尽快解决问题保持乐观 [67]

Exhibit 99.2 MEDIWOUND LTD. AND ITS SUBSIDIARIES CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023 IN U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX Page Unaudited Condensed Interim Consolidated Statements of Financial Position F-2 Unaudited Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income F-3 or Loss Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity (Deficit) F-4 – F-5 Unaudited Condensed Interim Consolidated St ...

MediWound Ltd. (NASDAQ:MDWD) Q1 2023 Earnings Conference Call May 30, 2023 8:30 AM ET Company Participants Monique Kosse - LifeSci Advisors, IR Ofer Gonen - Chief Executive Officer Hani Luxenburg - Chief Financial Officer Barry Wolfenson - Executive Vice President of Strategy & Corporate Development Conference Call Participants Josh Jennings - TD Cowen Francois Brisebois - Oppenheimer Michael Okunewitch - Maxim Group Swayampakula Ramakanth - H.C. Wainwright Operator Good day everyone and welcome to MediWoun ...

MediWound Ltd. (NASDAQ:MDWD) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Monique Kosse - LifeSci Advisors, IR Ofer Gonen - Chief Executive Officer Boaz Gur-Lavie - Chief Financial Officer Conference Call Participants Josh Jennings - TD Cowen Francois Brisebois - Oppenheimer Swayampakula Ramakanth - H.C. Wainwright Michael Okunewitch - Maxim Group Operator Good day. And welcome to MediWound???s Fourth Quarter and Year End 2022 Earnings Call. Today???s conference is being r ...

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Exhibit 99.1 MediWound Reports Fourth Quarter and Full Year 2022 Financial Results and Company Update 2022 total revenues of $26.5 million FDA approval of NexoBrid® in December 2022; U.S. commercial availability expected in the second quarter of 2023 EscharEx® Phase III protocol design is under review by the FDA; study to be initiated in the second half of 2023 Cash position of $66 million, including cash received for the NexoBrid approval milestone and recent equity financing Conference call begins today a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________________ to ____________________ OR ☐ SHELL COMPANY REPORT P ...