MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update
MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update
$19 million revenue in 2023; $24 million projected revenue in 2024
NexoBrid commercially launched in U.S., Japan, India
Potential blockbuster EscharEx to begin Phase III in the second half of 2024
$42 million cash runway through profitability
2023 年收入为 1900 万美元;2024 年预计收入为 2,400 万美元
nexoBrid在美国、日本、印度商业推出
潜在的大片 eSchareX 将在2024年下半年开始第三阶段
通过盈利实现4200万美元的现金流
Conference call today, March 21 at 8:30am Eastern Time
会议 c所有 t今天,美国东部时间 3 月 21 日上午 8:30
YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
以色列亚夫内,2024年3月21日(环球新闻专线)——下一代组织修复酶疗法的全球领导者MediWound Ltd.(纳斯达克股票代码:MDWD)今天公布了截至2023年12月31日的第四季度和全年财务业绩,并提供了公司最新情况。
"2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass casualty incidents (BMCI) during the war in Israel. Furthermore, the full capacity of our new manufacturing facility in 2025 will enable us to meet the soaring demand of NexoBrid," said Ofer Gonen, CEO of MediWound. "Recent clinical data further validates our pipeline product, EscharEx, demonstrating that it significantly outperformed SANTYL in a head-to-head comparative analysis. The product has attracted research collaborations with industry leaders 3M, Mölnlycke and MIMEDX and the Phase III study is set to begin in the second half of 2024. We strongly believe in the exciting future ahead for MediWound."
“2023年对NexoBrid来说是非同寻常的一年,这得益于新的市场推出、扩大的适应症、大量的新政府拨款以及全球需求的增加。此外,这种救生疗法在以色列战争期间在现实生活中的烧伤大规模伤亡事件(BMCI)中成功进行了实战测试。此外,我们在2025年新制造工厂的满负荷产能将使我们能够满足NexoBrid不断增长的需求。” MediWound首席执行官奥弗·戈南说。“最近的临床数据进一步证实了我们的管道产品eSchareX,表明其表现明显优于SANTYL 在正面对比分析中。该产品吸引了行业领导者3M、Molnlycke和MIMEDX的研究合作,三期研究定于2024年下半年开始。我们坚信MediWound未来将迎来令人兴奋的未来。”
2023 Highlights and Recent Developments:
2023 年亮点和近期动态:
NexoBrid
nexoBrid
- Expanded commercial availability to U.S., Japan, and India, leading to $19 million revenue in 2023, and a surge of orders for 2024, with $24 million projected revenue.
- Construction of a new GMP-compliant state-of-the-art manufacturing facility is on track for mid-2024 completion. It is projected to achieve a 6-fold manufacturing capacity increase in 2025.
- Commercial Activities:
- Launched in the U.S. by Vericel Corp, with more than 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and more than 25 already approved. Furthermore, the Centers for Medicare & Medicaid Services (CMS) awarded NexoBrid a permanent J code and granted it transitional pass-through payment status, enhancing its accessibility and reimbursement potential.
- Launched in Japan through Kaken Pharmaceuticals, and in India through Bharat Serums and Vaccines (BSV).
- Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands, and Luxembourg.
- Successfully fulfilled emergency demand in Israel to treat mass burn casualties resulting from the war, consuming all available non-U.S. inventory.
- Government Funding:
- Awarded $13.0 million R&D funding by U.S. Department of Defense (DoD) to develop and produce a new NexoBrid temperature stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army.
- Awarded $10.1 million in additional funding from the Biomedical Advanced Research and Development Authority (BARDA) for emergency preparedness product replenishment and R&D activities.
- Pediatric label expansion:
- Gained European Commission approval for the removal of eschar in deep partial- and full-thickness thermal burns for all ages.
- Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.
- 将商业供应扩大到美国、日本和印度,从而在2023年实现1900万美元的收入,2024年的订单激增,预计收入为2400万美元。
- 一座符合GMP标准的先进制造工厂的建设有望在2024年中期完工。预计到2025年,其制造能力将增长6倍。
- 商业活动:
- 由Vericel Corp在美国推出,有50多个烧伤中心向药房和治疗委员会(P&T)提交包裹,超过25个已经获得批准。此外,医疗保险和医疗补助服务中心(CMS)授予了NexoBrid永久的J码,并授予其过渡性直通支付地位,从而增强了其可获得性和报销潜力。
- 通过Kaken制药在日本推出,通过巴拉特血清和疫苗(BSV)在印度推出。
- 通过与PolyMedics Innovations(PMI)建立合作关系,在德国、奥地利、比利时、荷兰和卢森堡推广NexoBRID,从而扩大了欧洲市场占有率。
- 成功满足了以色列治疗战争造成的大规模烧伤伤亡的紧急需求,消耗了所有可用的非美国库存。
- 政府资助:
- 获得美国国防部(DoD)1,300万美元的研发资金,用于开发和生产一种新的NexoBrid温度稳定配方,用作美国陆军野战烧伤治疗的非手术解决方案。
- 从生物医学高级研究与发展局(BARDA)获得了1,010万加元的额外资金,用于应急准备产品补充和研发活动。
- 儿科标签扩展:
- 获得欧盟委员会批准,可去除所有年龄段的深度局部和全厚度热烧伤中的焦炭。
- 儿科适应症的补充 BLA 已获美国食品药品监督管理局 (FDA) 接受审查。预计将在2024年下半年做出决定。
EscharEx
eSchareX
- Aligned the Phase III study protocol with the European Medicine Agency (EMA) and the FDA, and expected to submit a final protocol in the first half of 2024. 216 patients will be treated globally across 40 sites with either EscharEx or a gel vehicle placebo, with an interim assessment to be performed once 67% of participants complete the study. Study initiation is expected in the second half of 2024.
- Established research collaborations with 3M, Mölnlycke and MIMEDX to support the EscharEx Phase III clinical study.
- Conducted head-to-head comparative analysis of EscharEx vs SANTYL. Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures: incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. The data is scheduled for oral presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).
- 与欧洲医学管理局(EMA)和美国食品药品管理局调整了三期研究方案,预计将在2024年上半年提交最终方案。全球40个地点的216名患者将使用eSchareX或凝胶载体安慰剂接受治疗,67%的参与者完成研究后将进行中期评估。研究预计将于2024年下半年启动。
- 与3M、Molnlycke和MIMEDX建立了研究合作,以支持Escharex III期临床研究。
- 对 eschareX 与 SANTYL 进行了正面比较分析。一项II期随机对照研究的数据表明,在多种临床结果指标上,eSchareX比SANTYL具有显著优势:完全清创发生率;实现完全清创的中位时间;实现伤口床准备的发生率(WBP);实现WBP的中位时间;以及伤口闭合时间。这个 数据 计划于2024年5月在三个致力于高级伤口护理的主要年度大会上进行口头演讲:伤口愈合协会(WHS)、高级伤口护理研讨会(SAWC)和欧洲伤口管理协会(EWMA)。
MW005
MW005
- Reported positive results of the Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data showed MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.
- 报告了评估 MW005 治疗低风险基底细胞癌 (BCC) 安全性和有效性的 I/II 期研究的积极结果。数据显示,MW005 安全且耐受性良好,患者目标病变的临床和组织学完全清除。
Fourth Quarter 2023 Financial Highlights
2023 年第四季度财务摘要
- Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
- Gross Profit: Gross profit in the fourth quarter 2023 was $0.7 million, representing 13.5% of the total revenue in the fourth quarter of 2023, compared to $8.2 million, representing 70.2% of total revenue in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel in the fourth quarter of 2022.
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Expenditures:
- Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.
- Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
- Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.
- Net Loss: Net loss in the fourth quarter of 2023 was $1.7 million or $0.19 per share, compared to the net loss of $7.5 million, or $1.18 per share in the fourth quarter of 2022. The decrease is primarily attributed to a favorable adjustment from the revaluation of warrants.
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Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the fourth quarter of 2023 was a loss of $3.2 million, compared to a profit of $3.4 million in the fourth quarter of 2022.
- 收入:2023年第四季度的收入为530万美元,而2022年第四季度为1160万美元。下降主要归因于Vericel支付的BLA批准里程碑款项。
- 毛利:2023年第四季度的毛利为70万美元,占2023年第四季度总收入的13.5%,而2023年第四季度为820万美元,占2022年第四季度总收入的70.2%。下降的主要原因是Vericel在2022年第四季度支付了BLA批准里程碑式的款项。
- 支出:
- 2023年第四季度的研发费用为180万美元,而2022年第四季度为270万美元。这种变化主要归因于EschareX二期研究于2022年完成。
- 2023年第四季度的销售、一般和管理费用为280万美元,而2022年第四季度为300万美元。
- 经营业绩:2023年第四季度的营业亏损为390万美元,而2022年第四季度的营业利润为210万美元。
- 净亏损:2023年第四季度的净亏损为170万美元,合每股亏损0.19美元,而2022年第四季度的净亏损为750万美元,合每股亏损1.18美元。下降的主要原因是认股权证重估后的有利调整。
- 非公认会计准则调整后息税折旧摊销前利润:2023年第四季度调整后的息税折旧摊销前利润为320万美元,而2022年第四季度的利润为340万美元。
Full Year 2023 Financial Highlights
2023 年全年财务摘要
- Revenue: Revenue for the year ended December 31, 2023, was $18.7 million, compared to $26.5 million for the year ended December 31, 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
- Gross Profit: Gross profit for the year ended December 31, 2023, was $3.6 million with a gross margin of 19.1%, compared to $13.2 million with a gross margin of 49.7% in the prior year period. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
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Expenditures:
- Research and development expenses for the year ended December 31, 2023, were $7.5 million compared to $10.2 million in the prior year.
- Selling, general, and administrative expenses for the year ended December 31, 2023, were $11.6 million, compared to $10.6 million in the prior year.
- Operating Results: Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in the year ended December 31, 2022.
- Net Loss: Net loss in the year ended December 31, 2023 was $6.7 million or $0.75 per share, compared to the net loss of $19.6 million, or $3.93 per share for the year ended December 31, 2022.
- Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2023 was a loss of $12.3 million, compared to a loss of $4.4 million for the year ended December 31, 2022.
- 收入:截至2023年12月31日止年度的收入为1,870万美元,而截至2022年12月31日的年度收入为2650万美元。下降主要归因于Vericel支付的BLA批准里程碑款项。
- 毛利:截至2023年12月31日止年度的毛利为360万美元,毛利率为19.1%,而去年同期为1,320万美元,毛利率为49.7%。下降主要归因于Vericel支付的BLA批准里程碑款项。
- 支出:
- 截至2023年12月31日止年度的研发费用为750万美元,而去年同期为1,020万美元。
- 截至2023年12月31日止年度的销售、一般和管理费用为1160万美元,而去年同期为1,060万美元。
- 经营业绩:截至2023年12月31日止年度的营业亏损为1,530万美元,而截至2022年12月31日的年度亏损为830万美元。
- 净亏损:截至2023年12月31日止年度的净亏损为670万美元,合每股亏损0.75美元,而截至2022年12月31日止年度的净亏损为1,960万美元,合每股亏损3.93美元。
- 非公认会计准则调整后息税折旧摊销前利润:截至2023年12月31日止年度的调整后息税折旧摊销前利润为亏损1,230万美元,而截至2022年12月31日止年度的亏损为440万美元。
Balance Sheet Highlights
资产负债表亮点
As of December 31, 2023, the Company's cash, restricted cash, and investments were $42.1 million, compared to $34.1 million reported on December 31, 2022. In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering. The company used $17.1 million to fund its activities. The existing cash and restricted cash, and investments will provide sufficient funds through profitability.
截至2023年12月31日,该公司的现金、限制性现金和投资为4,210万美元,而2022年12月31日公布的为3,410万美元。2023年第一季度,公司通过注册直接发行筹集了总额为2750万澳元的资金。该公司使用1710万美元为其活动提供资金。现有现金和限制性现金以及投资将通过盈利提供足够的资金。
Conference Call
电话会议
MediWound management will host a conference call for investors on Thursday, March 21, 2024, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company's website.
A replay of the call will be available on the Company's website at www.mediwound.com.
电话会议的重播将在公司的网站上公布,网址为 www.mediwond.com。
Non-IFRS Financial Measures
非国际财务报告准则财务指标
To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.
为了补充根据国际财务报告准则编制和列报的合并财务报表,公司提供了一项补充的非国际财务报告准则衡量标准,供评估公司业绩时考虑。管理层使用调整后的息税折旧摊销前利润,其定义为扣除利息、税项、折旧和摊销、减值、一次性支出、重组和基于股份的薪酬支出前的收益。
Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.
尽管调整后的息税折旧摊销前利润不是根据国际财务报告准则计算的业绩或流动性的衡量标准,但我们认为,我们提出的非国际财务报告准则财务指标提供了有关我们经营业绩的有意义的补充信息,主要是因为它们排除了某些非现金费用或在预算、计划和预测、确定薪酬以及与高级管理层评估业务业绩时我们认为无法反映我们持续经营业绩的项目。
However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.
但是,投资者不应孤立地考虑这些指标,也不得将其作为营业收入、经营活动现金流或根据国际财务报告准则计算的确定公司经营业绩或流动性的任何其他衡量标准的替代品。此外,由于调整后的息税折旧摊销前利润不是根据国际财务报告准则计算的,因此不一定可以与其他公司采用的类似标题的指标进行比较。本新闻稿中包含的非国际财务报告准则指标已与下表中的国际财务报告准则结果进行了核对。
About MediWound
关于 MediWond
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of solutions that seek to improve existing standards of care. MediWound is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound 有限公司(纳斯达克股票代码:MDWD)是专注于非手术组织修复的下一代酶疗法的全球领导者。该公司专门从事旨在改善现有护理标准的解决方案的开发、生产和商业化。MediWound 致力于提供快速有效的生物制剂,改善患者体验和疗效,同时降低成本和不必要的手术。
MediWound's first drug, NexoBrid, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company's lead drug under development, EscharEx. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages over the $360 million dominant product and an opportunity to expand the market. MediWound's pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.
MediWound 的第一种药物 NexoBrid,是一种经美国食品药品管理局批准的孤儿生物制剂,用于在严重烧伤中去除皮屑,可以取代手术干预措施并最大限度地降低相关费用和并发症。MediWound利用相同的核心生物治疗酶平台技术,开发了强大的研发渠道,包括该公司在开发的主要药物eScharex。Escharex是一种可用于慢性伤口清创的III期生物制剂,与3.6亿美元的主导产品相比,具有显著的潜在优势,也是扩大市场的机会。MediWound 的产品线还包括 MW005,这是一种治疗基底细胞癌的局部疗法,在 I/II 期研究中已显示出积极的结果。
For more information visit www.mediwound.com and follow the Company on LinkedIn and X.
欲了解更多信息,请访问 www.mediwond.com 然后关注该公司 领英 和 X。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性陈述的警示说明
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx and NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
MediWound 提醒您,本新闻稿中包含的除历史事实陈述以外的所有陈述均为前瞻性陈述,这些陈述涉及我们预期、认为或预计未来将或可能发生的活动、事件或发展。尽管我们认为此处包含的前瞻性陈述有合理的依据,但这些陈述是基于当前对影响我们的未来事件的预期,并受风险、假设、不确定性和因素的影响,所有这些都难以预测,其中许多是我们无法控制的。实际结果可能与本新闻稿中前瞻性陈述所表达或暗示的结果存在重大差异。这些陈述通常但并非总是通过使用诸如 “预期”、“打算”、“估计”、“计划”、“期望”、“继续”、“相信”、“指导”、“展望”、“目标”、“未来”、“潜力”、“目标” 和类似的词语或短语或短语或未来或条件动词(例如 “将”、“将”、“将”、“将”、“将”、“” 应该”、“可以”、“可以” 或类似的表达。
具体而言,本新闻稿包含前瞻性陈述,涉及我们的产品和候选产品(包括eSchareX)的预期进展、开发、研究设计、预期数据时机、目标、预期时间表、预期和商业潜力 还有 nexoBrid。可能导致结果与本文所述结果存在重大差异的因素包括与产品开发过程的不确定、漫长和昂贵的性质相关的固有不确定性;我们对产品和候选产品研究的时间和进行,包括当前和未来临床研究的时间、进展和结果,以及我们的研发计划;美国食品药品管理局、欧洲药品管理局或任何其他监管机构对监管申请的批准,我们获得的能力我们的产品和候选产品在美国或其他市场的上市批准;我们的产品和产品的临床效用、潜在优势以及监管机构申报和批准的时机或可能性;我们对未来增长的预期,包括我们开发新产品的能力;与我们与BARDA签订的合同相关的风险;我们的产品和候选产品的市场接受度;我们对知识产权的充分保护的能力;竞争风险;额外融资的需求;政府法律的影响以及法规以及当前的全球宏观经济环境对我们为业务采购供应的能力或我们未来制造、销售和支持使用我们的产品和候选产品的能力的影响。
These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission ("SEC") on March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound截至12月31日止年度的20-F表年度报告中详细讨论了这些因素和其他重要因素, 2023,于3月向美国证券交易委员会(“SEC”)提交 21, 2024 以及关于6-K表格的季度报告以及不时向美国证券交易委员会提交的其他文件。这些前瞻性陈述反映了MediWound截至本文发布之日的当前观点,除非法律要求,否则MediWound承诺,特别不承担更新任何前瞻性陈述以反映本新闻稿发布之日之后发生的各自观点或事件或情况的变化的任何义务。
Contacts: | |
Hani Luxenburg | Daniel Ferry |
Chief Financial Officer | Managing Director, LifeSci Advisors |
MediWound Ltd. | 617-430-7576 |
ir@mediwound.com | daniel@lifesciadvisors.com |
Media Contact: | |
Ellie Hanson | |
FINN Partners for MediWound | |
ellie.hanson@finnpartners.com | |
929-588-2008 |
联系人: | |
哈尼·卢森堡 | 丹尼尔·费里 |
首席财务官 | LifeSci Advisors董事总经理 |
MediWond Ltd | 617-430-7576 |
ir@mediwound.com | daniel@lifesciadvisors.com |
媒体联系人: | |
艾莉·汉森 | |
MediWound 的芬兰合作伙伴 | |
ellie.hanson@finnpartners.com | |
929-588-2008 |
MediWound, Ltd. | |||
Audited Condensed Consolidated Statements of Financial Position | |||
U.S. dollars in thousands | |||
Dec 31, | |||
2023 | 2022 | ||
CURRENT ASSTS: | |||
Cash and cash equivalents and short-term deposits | 41,708 | 33,895 | |
Trade and other receivable | 5,141 | 9,982 | |
Inventories | 2,846 | 1,963 | |
Total current assets | 49,695 | 45,840 | |
Non-current assets | |||
Other receivables | 673 | 364 | |
Property, plant and equipment, net | 9,228 | 2,366 | |
Right of use assets, net | 6,698 | 1,215 | |
Intangible assets, net | 165 | 231 | |
Total non-current assets | 16,764 | 4,176 | |
Total assets | 66,459 | 50,016 | |
CURRENT LIABILITIES: | |||
Current maturities of long-term liabilities | 1,410 | 2,242 | |
Trade payables and accrued expenses | 5,528 | 5,656 | |
Other payables | 3,891 | 4,159 | |
Total current liabilities | 10,829 | 12,057 | |
Warrants, net | 7,296 | 15,606 | |
Liabilities in respect of IIA grants | 7,677 | 7,445 | |
Liability in respect of TEVA | 2,256 | 2,788 | |
Lease liabilities | 6,350 | 846 | |
Severance pay liability, net | 456 | 360 | |
Total non-current liabilities | 24,035 | 27,045 | |
Shareholders' equity | 31,595 | 10,914 | |
Total liabilities & equity | 66,459 | 50,016 |
MediWound, Ltd. | |||
经审计的简明合并财务状况表 | |||
以千美元计 | |||
十二月 31, | |||
2023 | 2022 | ||
流动资产: | |||
现金和现金等价物以及短期存款 | 41,708 | 33,895 | |
贸易和其他应收账款 | 5,141 | 9,982 | |
库存 | 2,846 | 1,963 | |
流动资产总额 | 49,695 | 45,840 | |
非流动资产 | |||
其他应收账款 | 673 | 364 | |
财产、厂房和设备,净额 | 9,228 | 2,366 | |
使用权资产,净额 | 6,698 | 1,215 | |
无形资产,净额 | 165 | 231 | |
非流动资产总额 | 16,764 | 4,176 | |
总资产 | 66,459 | 50,016 | |
流动负债: | |||
长期负债的当前到期日 | 1,410 | 2,242 | |
贸易应付账款和应计费用 | 5,528 | 5,656 | |
其他应付账款 | 3,891 | 4,159 | |
流动负债总额 | 10,829 | 12,057 | |
认股权证,净额 | 7,296 | 15,606 | |
与国际投资协定补助金有关的负债 | 7,677 | 7,445 | |
与 TEVA 有关的责任 | 2,256 | 2,788 | |
租赁负债 | 6,350 | 846 | |
遣散费负债,净额 | 456 | 360 | |
非流动负债总额 | 24,035 | 27,045 | |
股东权益 | 31,595 | 10,914 | |
负债和权益总额 | 66,459 | 50,016 |
MediWound, Ltd. | |||||||
Audited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss | |||||||
U.S. dollars in thousands (except of share and per share data) | |||||||
Twelve months ended | Three months ended | ||||||
Dec 31, | Dec 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Total Revenues | 18,686 | 26,496 | 5,338 | 11,618 | |||
Cost of revenues | 15,108 | 13,331 | 4,619 | 3,460 | |||
Gross profit | 3,578 | 13,165 | 719 | 8,158 | |||
Research and development | 7,467 | 10,181 | 1,808 | 2,699 | |||
Selling and Marketing | 4,844 | 3,725 | 1,209 | 692 | |||
General and administrative | 6,768 | 6,920 | 1,583 | 2,269 | |||
Other (Income) expenses | (211) | 684 | 13 | 375 | |||
Operating loss | (15,290) | (8,345) | (3,894) | 2,123 | |||
Financial income (expenses), net | 8,759 | (11,176) | 2,271 | (9,515) | |||
Taxes on income | (185) | (78) | (120) | (65) | |||
Net loss | (6,716) | (19,599) | (1,743) | (7,457) | |||
Foreign currency translation adjustments | (13) | 14 | (11) | (20) | |||
Total comprehensive loss | (6,729) | (19,585) | (1,754) | (7,477) | |||
Basic and diluted loss per share: | |||||||
Net loss per share | (0.75) | (3.93) | (0.19) | (1.18) | |||
Weighted average number of ordinary shares | 9,013,144 | 4,987,069 | 9,219,923 | 6,332,981 |
MediWound, Ltd. | |||||||
经审计的简明合并损益表和其他综合收益或亏损表 | |||||||
千美元(股票和每股数据除外) | |||||||
十二个月已结束 | 三个月已结束 | ||||||
十二月 31, | 十二月 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
总收入 | 18,686 | 26,496 | 5,338 | 11,618 | |||
收入成本 | 15,108 | 13,331 | 4,619 | 3,460 | |||
毛利 | 3,578 | 13,165 | 719 | 8,158 | |||
研究和开发 | 7,467 | 10,181 | 1,808 | 2,699 | |||
销售和营销 | 4,844 | 3,725 | 1,209 | 692 | |||
一般和行政 | 6,768 | 6,920 | 1,583 | 2,269 | |||
其他(收入)支出 | (211) | 684 | 13 | 375 | |||
营业亏损 | (15,290) | (8,345) | (3,894) | 2,123 | |||
财务收入(支出),净额 | 8,759 | (11,176) | 2,271 | (9,515) | |||
所得税 | (185) | (78) | (120) | (65) | |||
净亏损 | (6,716) | (19,599) | (1,743) | (7,457) | |||
外币折算调整 | (13) | 14 | (11) | (20) | |||
综合损失总额 | (6,729) | (19,585) | (1,754) | (7,477) | |||
每股基本亏损和摊薄后亏损: | |||||||
每股净亏损 | (0.75) | (3.93) | (0.19) | (1.18) | |||
普通股的加权平均数 | 9,013,144 | 4,987,069 | 9,219,923 | 6,332,981 |
MediWound, Ltd. | |||||||
Audited Condensed Consolidated Statements of Cash Flows | |||||||
U.S. dollars in thousands | |||||||
Twelve months ended | Three months ended | ||||||
Dec 31, | Dec 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Audited | Unaudited | ||||||
Cash Flows from Operating Activities: | |||||||
Net Loss | (6,716) | (19,599) | (1,743) | (7,457) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Adjustments to profit and loss items: | |||||||
Depreciation and amortization | 1,303 | 1,272 | 346 | 284 | |||
Share-based compensation | 1,940 | 1,946 | 298 | 642 | |||
Revaluation of warrants accounted at fair value | (8,310) | 8,977 | (1,603) | 8,977 | |||
Issuance expenses of warrants through profit and loss | - | 1,911 | - | 1,523 | |||
Revaluation of liabilities in respect of IIA grants | 427 | (132) | (282) | (944) | |||
Revaluation of liabilities in respect of TEVA | 468 | 533 | 111 | 129 | |||
Financing income and exchange differences of lease liability | 257 | (109) | 463 | 37 | |||
Increase in severance liability, net | 83 | 109 | 3 | 45 | |||
Other income | (211) | - | 13 | - | |||
Financial income, net | (2,231) | (74) | (836) | (408) | |||
Un-realized foreign currency loss (gain) | 189 | 525 | (347) | 60 | |||
(6,085) | 14,958 | (1,834) | 10,345 | ||||
Changes in asset and liability items: | |||||||
Decrease (increase) in trade receivables | 5,658 | (7,582) | (528) | (5,137) | |||
Decrease (increase) in inventories | (906) | (721) | 782 | (113) | |||
Decrease (increase) in other receivables | (894) | 364 | (696) | 221 | |||
Increase (decrease) in trade payables and accrued expenses | (594) | 414 | 1,093 | 784 | |||
Increase (decrease) in other payables | (928) | 281 | 311 | 2,107 | |||
2,336 | (7,244) | 962 | (2,138) | ||||
Net cash used in operating activities | (10,465) | (11,885) | (2,615) | 750 |
MediWound, Ltd. | |||||||
经审计的简明合并现金流量表 | |||||||
以千美元计 | |||||||
十二个月已结束 | 三个月已结束 | ||||||
十二月 31, | 十二月 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
已审计 | 未经审计 | ||||||
来自经营活动的现金流: | |||||||
净亏损 | (6,716) | (19,599) | (1,743) | (7,457) | |||
为使净亏损与经营活动中使用的净现金相一致而进行的调整: | |||||||
损益项目的调整: | |||||||
折旧和摊销 | 1,303 | 1,272 | 346 | 284 | |||
基于股份的薪酬 | 1,940 | 1,946 | 298 | 642 | |||
按公允价值核算的认股权证的重估 | (8,310) | 8,977 | (1,603) | 8,977 | |||
通过损益计算认股权证的发行费用 | - | 1,911 | - | 1,523 | |||
对与国际投资协定补助金有关的负债的重新估值 | 427 | (132) | (282) | (944) | |||
对TEVA的负债进行重估 | 468 | 533 | 111 | 129 | |||
融资收入和租赁负债的汇兑差额 | 257 | (109) | 463 | 37 | |||
遣散费责任增加,净额 | 83 | 109 | 3 | 45 | |||
其他收入 | (211) | - | 13 | - | |||
财务收入,净额 | (2,231) | (74) | (836) | (408) | |||
未实现的外币损失(收益) | 189 | 525 | (347) | 60 | |||
(6,085) | 14,958 | (1,834) | 10,345 | ||||
资产和负债项目的变化: | |||||||
贸易应收账款减少(增加) | 5,658 | (7,582) | (528) | (5,137) | |||
库存减少(增加) | (906) | (721) | 782 | (113) | |||
其他应收账款减少(增加) | (894) | 364 | (696) | 221 | |||
贸易应付账款和应计费用的增加(减少) | (594) | 414 | 1,093 | 784 | |||
其他应付账款增加(减少) | (928) | 281 | 311 | 2,107 | |||
2,336 | (7,244) | 962 | (2,138) | ||||
用于经营活动的净现金 | (10,465) | (11,885) | (2,615) | 750 |
MediWound, Ltd. | |||||||
Audited Condensed Consolidated Statements of Cash Flows | |||||||
U.S. dollars in thousands | |||||||
Cash Flows from Investing Activities: | |||||||
Purchase of property and equipment | (6,464) | (555) | (2,209) | (174) | |||
Interest received | 1,947 | 74 | 722 | 71 | |||
Proceeds from (Investment in) short term bank deposits, net | (29,804) | - | 6,515 | 2,499 | |||
Net cash used in investing activities | (34,321) | (481) | 5,028 | 2,396 | |||
Cash Flows from Financing Activities: | |||||||
Repayment of lease liabilities | (778) | (701) | (204) | (170) | |||
Proceeds from issuance of shares and warrants, net | 24,909 | 38,390 | - | 16,475 | |||
Repayments of IIA grants, net | (380) | (258) | - | - | |||
Repayment of liabilities in respect of TEVA | (834) | (1,667) | - | (417) | |||
Net cash provided by (used in) financing activities | 22,917 | 35,764 | (204) | 15,588 | |||
Exchange rate differences on cash and cash equivalent balances | (160) | (549) | 378 | (44) | |||
Increase (decrease) in cash and cash equivalents | (22,029) | 22,849 | 2,587 | 18,990 | |||
Balance of cash and cash equivalents at the beginning of the period | 33,895 | 11,046 | 9,279 | 14,905 | |||
Balance of cash and cash equivalents at the end of the period | 11,866 | 33,895 | 11,866 | 33,895 |
MediWound, Ltd. | |||||||
经审计的简明合并现金流量表 | |||||||
以千美元计 | |||||||
来自投资活动的现金流: | |||||||
购买财产和设备 | (6,464) | (555) | (2,209) | (174) | |||
收到的利息 | 1,947 | 74 | 722 | 71 | |||
(投资)短期银行存款的收益,净额 | (29,804) | - | 6,515 | 2,499 | |||
用于投资活动的净现金 | (34,321) | (481) | 5,028 | 2,396 | |||
来自融资活动的现金流: | |||||||
偿还租赁负债 | (778) | (701) | (204) | (170) | |||
发行股票和认股权证的收益,净额 | 24,909 | 38,390 | - | 16,475 | |||
国际投资协定补助金的还款额,净额 | (380) | (258) | - | - | |||
偿还与TEVA有关的负债 | (834) | (1,667) | - | (417) | |||
由(用于)融资活动提供的净现金 | 22,917 | 35,764 | (204) | 15,588 | |||
现金和现金等价物余额的汇率差异 | (160) | (549) | 378 | (44) | |||
现金和现金等价物的增加(减少) | (22,029) | 22,849 | 2,587 | 18,990 | |||
期初的现金和现金等价物余额 | 33,895 | 11,046 | 9,279 | 14,905 | |||
期末现金和现金等价物的余额 | 11,866 | 33,895 | 11,866 | 33,895 |
MediWound, Ltd. | |||||||
Adjusted EBITDA | |||||||
U.S. dollars in thousands | |||||||
Twelve months ended | Three months ended | ||||||
Dec 31, | Dec 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Net loss | (6,716) | (19,599) | (1,743) | (7,457) | |||
Adjustments: | |||||||
Financial income (expenses), net | 8,759 | (11,176) | 2,271 | (9,515) | |||
Other (Income) expenses, net | 211 | (684) | (13) | (375) | |||
Taxes on income | (185) | (78) | (120) | (65) | |||
Depreciation and amortization | (1,303) | (1,272) | (346) | (284) | |||
Share-based compensation expenses | (1,940) | (1,946) | (298) | (642) | |||
Total adjustments | 5,542 | (15,156) | 1,494 | (10,881) | |||
Adjusted EBITDA | (12,258) | (4,443) | (3,237) | 3,424 |
MediWound, Ltd. | |||||||
调整后 EBITDA | |||||||
以千美元计 | |||||||
十二个月已结束 | 三个月已结束 | ||||||
十二月 31, | 十二月 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
净亏损 | (6,716) | (19,599) | (1,743) | (7,457) | |||
调整: | |||||||
财务收入(支出),净额 | 8,759 | (11,176) | 2,271 | (9,515) | |||
其他(收入)支出,净额 | 211 | (684) | (13) | (375) | |||
所得税 | (185) | (78) | (120) | (65) | |||
折旧和摊销 | (1,303) | (1,272) | (346) | (284) | |||
基于股份的薪酬支出 | (1,940) | (1,946) | (298) | (642) | |||
调整总额 | 5,542 | (15,156) | 1,494 | (10,881) | |||
调整后 EBITDA | (12,258) | (4,443) | (3,237) | 3,424 |