Regulatory Compliance - The company is subject to scrutiny by regulatory authorities regarding compliance with healthcare laws, which could lead to significant civil, criminal, and administrative penalties [97]. - Violations of the federal Anti-Kickback Statute can result in civil monetary penalties for each violation, plus up to three times the remuneration involved [100]. - The federal False Claims Act allows for treble damages and penalties for each false claim submitted, impacting pharmaceutical and healthcare companies significantly [101]. - The company may face substantial costs to ensure compliance with healthcare laws and regulations, which could adversely affect its operations [107]. - The company is subject to the U.S. Foreign Corrupt Practices Act, which prohibits improper payments to officials for business purposes, potentially affecting operations in regions with governmental corruption [108]. - Compliance with evolving data protection laws, such as GDPR, may impose additional costs and liabilities on the company, with fines for noncompliance reaching up to €20 million or 4% of annual global revenues [114]. - The company must navigate complex compliance issues related to state and federal privacy laws, which may conflict and complicate operations [111]. - The company is required to report payments and transfers of value to healthcare professionals, with significant penalties for failure to comply [104]. - The company expects ongoing scrutiny regarding international personal data transfers, particularly under the new EU-US Data Privacy Framework [114]. - The company may face additional costs and regulatory investigations due to guidance on personal data export mechanisms, potentially affecting service provision and financial results [116]. - The UK GDPR allows for fines up to £17.5 million or 4% of global turnover, which could impact the company's operations as it expands internationally [117]. - Non-compliance with the PPL and its regulations could lead to significant administrative fines and civil claims, with potential sanctions reaching millions of NIS after Amendment 13 takes effect in August 2025 [118]. Intellectual Property - As of December 31, 2024, the company had been granted a total of 88 patents, with 50 currently in force and 17 pending patent applications [133]. - The patent family covering NexoBrid includes 13 granted patents that are in force worldwide, while EscharEx is covered by 13 patents in force [133]. - Eleven of the currently issued NexoBrid patents are set to expire in November 2025, with one U.S. patent expected to receive a 5-year extension, expiring in 2030 [140]. - The international PCT patent applications for EscharEx were filed on January 30, 2017, with the 13 patents issued set to expire on January 30, 2037 [140]. - The company may face challenges in protecting its intellectual property rights in jurisdictions with limited legal protections, potentially allowing competitors to develop similar products [139]. - The company relies on a combination of patents, trademarks, and trade secrets to protect its intellectual property, but may face difficulties in enforcement and protection [132]. - The biotechnology patent landscape is highly uncertain, and changes in patent laws could diminish the value of the company's intellectual property [135]. - The company may incur significant costs and management distraction from potential lawsuits to enforce its intellectual property rights [136]. - Unauthorized use of the company's intellectual property could adversely affect its business and reputation, leading to reduced demand for its products [141]. - The company may be subject to claims of infringement from third parties, which could result in substantial litigation costs and potential damages [146]. Financial Performance and Market Conditions - The company anticipates that sales in the Asia Pacific region will be denominated in dollars, which may affect competitiveness if the dollar strengthens against other currencies [96]. - Changes in tax legislation, such as the Inflation Reduction Act of 2022, could adversely affect the company's effective income tax rate and overall financial condition [129]. - The OECD's BEPS initiative may lead to significant changes in international tax obligations, impacting the company's plans for international expansion and financial results [130]. - The company's ordinary shares were first offered publicly in March 2014 at a price of $98.00 per share, with a trading range between $7.10 and $127.12 through December 31, 2024 [153]. - The market price of the company's ordinary shares may fluctuate due to various factors, including operational results, market acceptance of products, and regulatory developments [155]. Operational Risks - The company is increasingly dependent on information technology systems, and failures or cyberattacks could disrupt operations and lead to material financial losses [119]. - Cybersecurity risks are heightened due to geopolitical tensions, with increased frequency and sophistication of attacks targeting Israeli companies [120]. - Compliance with environmental, health, and safety regulations may incur substantial costs, including potential liabilities from chemical use and accidents [128]. - The company faces risks related to climate change, which could disrupt operations and lead to increased operational expenses, adversely impacting profitability [172]. - Increased scrutiny regarding environmental, social, and governance (ESG) factors may result in higher costs and risks of litigation, affecting the company's financial condition [173]. - The ongoing conflict in Israel has not materially impacted the company's operations as of the report date, but escalation could negatively affect business and financial results [178]. - The company’s workforce availability has been affected by the war, which may impact product development and sales if the situation escalates [179]. - Recent downgrades of Israel's credit rating by Fitch and Moody's could negatively affect the company's operations and ability to conduct business [180]. - The company may face challenges in mergers or acquisitions due to Israeli corporate law, which imposes strict requirements for such transactions [184]. - Israeli tax considerations may deter potential transactions, as tax laws differ significantly from those in the U.S., affecting shareholder appeal [185]. Shareholder and Employee Relations - As of March 15, 2025, there were 1,428,691 ordinary shares subject to outstanding option and RSU awards under share incentive plans, including 700,189 shares issuable under currently exercisable options and RSUs [158]. - The company has made significant offerings of ordinary shares, including a shelf registration statement on Form F-3 for 1,605,732 shares effective April 22, 2019, and additional registrations for 1,819,780 shares on June 3, 2022, and 1,453,488 shares on September 9, 2024 [157]. - The 2024 Share Incentive Plan was adopted with 280,375 ordinary shares initially available for issuance, rolled over from the 2014 Plan [160]. - The company may face claims for remuneration or royalties for assigned service invention rights by employees, which could result in litigation and adversely affect its business [151]. - Proposed U.S. federal restrictions on non-compete agreements could adversely impact the company's ability to protect its investment in key employees [150]. - The company has entered into assignment-of-invention agreements with employees, but may still face claims for additional remuneration for service inventions [151]. - Shareholder rights and responsibilities are governed by Israeli law, which differs from U.S. corporate governance standards [191]. Grants and Financial Obligations - The total gross amount of grants received from the Israeli Innovation Authority (IIA) is approximately $14.1 million as of December 31, 2024 [186]. - The amortized cost of the liability related to IIA grants as of December 31, 2024, is approximately $8.3 million [186]. - Net royalties paid to the IIA as of December 31, 2024, amount to $2.2 million [186]. - Since 2020, the company has not submitted applications for IIA grants and does not plan to submit in 2025 [186]. - The obligation to pay royalties is contingent on actual sales of products developed with IIA grants, with no payment required in the absence of such sales [187]. - Increased royalties may be required if products are manufactured outside of Israel, depending on the manufacturing volume [188]. - The transfer of IIA-supported technology outside of Israel may involve significant penalties and conditions imposed by the IIA [188]. - The company determined in 2018 that it will no longer be supported by the IIA [186]. - The company must comply with the Innovation Law even after full repayment of IIA grants [187].

Exhibit 99.1 MediWound Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update Initiated VALUE, a global Phase III pivotal trial of EscharEx® for venous leg ulcers Expanded strategic research collaborations with industry leaders, now including Kerecis $20 million in revenue for 2024; $24 million projected for 2025; $44 million in cash as of Year-End 2024 Conference call today, March 19 at 8:30am Eastern Time YAVNE, Israel, March 19, 2025 -- MediWound Ltd. (Nasdaq: MDWD), a ...

Core Insights - MediWound Ltd. has initiated the VALUE Phase III pivotal trial for EscharEx® targeting venous leg ulcers, marking a significant milestone in its clinical development [1][3][6] - The company reported a revenue of $20.2 million for the full year 2024, an increase from $18.7 million in 2023, driven by new contracts and increased sales [10][13] - MediWound has expanded strategic collaborations with industry leaders, including Kerecis, to enhance its research capabilities and improve patient outcomes [1][3][6] Financial Performance - Fourth quarter revenue was $5.8 million, compared to $5.3 million in the same quarter of 2023, reflecting a growth of approximately 9.4% [13] - The gross profit for the fourth quarter was $0.9 million, with a gross margin of 15.5%, up from $0.7 million and a 13.5% gross margin in the prior year [13] - The net loss for 2024 was $30.2 million, or $3.03 per share, compared to a net loss of $6.7 million, or $0.75 per share in 2023, primarily due to financial expenses related to warrant revaluation [10][13] Clinical Developments - The VALUE Phase III trial will enroll 216 patients across 40 sites in the U.S. and Europe, with an interim analysis expected in mid-2026 [6] - A Phase II study protocol has been submitted to the FDA for a head-to-head trial comparing EscharEx to collagenase in VLU patients, aimed at supporting a future Biologics License Application [6] - NexoBrid, another product from MediWound, has seen a 42% increase in hospital orders in the fourth quarter compared to the previous quarter, indicating strong market adoption [6][10] Strategic Collaborations - MediWound has secured €16.5 million in funding from the European Innovation Council to accelerate EscharEx's development for diabetic foot ulcers, with a Phase II/III trial expected to start in 2026 [6] - The company has completed a comparative analysis of EscharEx against SANTYL®, demonstrating superior clinical outcomes for EscharEx [6] - The collaboration with Mölnlycke Health Care, which led a $25 million private investment, further strengthens MediWound's position in the wound care market [8] Market Potential - The total addressable market for EscharEx in the U.S. is estimated at $2.5 billion, with a projected market share of 22% upon approval, leading to peak sales expectations of approximately $725 million [6] - The company is advancing its manufacturing capabilities with a new GMP-compliant facility expected to increase output sixfold by the end of 2025 [6] Cash Position - As of December 31, 2024, MediWound had cash and cash equivalents totaling $43.6 million, an increase from $42.1 million in 2023 [11] - The company raised $25 million through a PIPE offering and received additional funding from various sources, including grants and warrant exercises [11][13]

Core Viewpoint - MediWound Ltd. is set to release its financial results for Q4 and the full year ended December 31, 2024, on March 19, 2025, followed by a conference call to discuss these results and provide corporate updates [1][2]. Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development, production, and commercialization of innovative biologics that enhance care standards and improve patient experiences while reducing healthcare costs [3]. Product Information - The company's first drug, NexoBrid®, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions [4]. - MediWound is advancing EscharEx, a promising candidate currently in Phase III development for chronic wound debridement, which has shown distinct advantages over existing treatments in Phase II trials, presenting a unique opportunity for significant market growth in a $375+ million market [4].

Core Insights - The publication of the Phase III Children Innovative Debridement Study (CIDS) confirms NexoBrid's superiority over standard of care in treating pediatric patients with deep thermal burns [1][2][4] Group 1: Study Findings - NexoBrid achieved complete eschar removal in a median time of one day compared to six days with standard of care (p < 0.001) [7] - The mean percentage of wound area surgically excised was significantly lower in the NexoBrid arm (1.5%) compared to standard of care (48.1%) (p < 0.001) [7] - Only 8.3% of patients treated with NexoBrid required surgical excision, while 64.4% of those treated with standard of care did [7] - At 12 months, NexoBrid demonstrated comparable cosmesis and functional outcomes to standard of care, with lower MVSS scores of 3.8 in the NexoBrid arm versus 4.9 in the standard of care (p < 0.001) [5] Group 2: Clinical Significance - NexoBrid is recognized as a rapid, effective, and non-surgical alternative for eschar removal in pediatric burn patients, addressing the unique challenges of treating this demographic [2][3] - The study involved 145 pediatric patients across 36 burn centers in the US, EU, Israel, and India, highlighting its multinational scope [4] Group 3: Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, with NexoBrid being its first FDA- and EMA-approved orphan biologic for eschar removal [9][10] - The company is advancing EscharEx®, a promising candidate currently in Phase III development for chronic wound debridement, which presents a unique opportunity for significant market growth [10]

Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair [3] - The company specializes in the development, production, and commercialization of innovative biologics that enhance existing standards of care, improve patient experiences, and reduce healthcare costs [3] Product Pipeline - MediWound's first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions [4] - The company is advancing EscharEx, a promising candidate currently in Phase III development for the debridement of chronic wounds, which has shown distinct advantages over the currently available $375+ million drug for wound debridement in Phase II clinical trials [4] Upcoming Events - CEO Ofer Gonen will present a corporate overview at the 45th Annual TD Cowen Health Care Conference on March 5, 2025, at 11:50 AM ET [1] - The management team will host one-on-one meetings during the conference, encouraging interested investors to contact their TD Cowen representative to schedule a meeting [2]

Core Viewpoint - MediWound Ltd. has initiated a pivotal Phase III trial named VALUE to evaluate the efficacy and safety of EscharEx for treating venous leg ulcers (VLUs), aiming to redefine the standard of care in chronic wound debridement [1][2][10] Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development and commercialization of innovative biologics [9] - The company’s first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in burns, significantly reducing the need for surgical interventions [10] Clinical Trial Details - The VALUE study is a global, multicenter, randomized, double-blind, placebo-controlled trial involving 216 patients across 40 sites in the U.S. and Europe [2][3] - Patients will be randomized 1:1 to receive either EscharEx or placebo, with up to eight daily applications over two weeks, followed by ten weeks of standardized wound management [2] - The primary endpoints include the incidence of complete debridement and complete wound closure, with secondary endpoints assessing granulation tissue, time to debridement, and changes in wound area [3] Strategic Collaborations - To support the VALUE trial, MediWound has established strategic research collaborations with industry leaders Solventum, Mölnlycke, and MIMEDX to ensure consistent wound management across study sites [4] Future Studies - In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025 comparing EscharEx to collagenase in VLU patients [5] - The company is also preparing for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), expected to begin in 2026 [5] Market Context - Venous leg ulcers affect approximately 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S., highlighting the urgent need for effective treatment options [6] - The current market leader in wound debridement, SANTYL, has a market size exceeding $375 million, indicating significant potential for EscharEx to capture market share [2][10]

Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development, production, and commercialization of innovative biologics that enhance existing standards of care while reducing healthcare costs and unnecessary surgeries [3][4]. Upcoming Events - The CEO of MediWound, Ofer Gonen, will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 8:00 AM ET [1]. - A webcast link for the fireside chat will be available on MediWound's website, and the management team will also host one-on-one meetings during the conference [2]. Product Development - MediWound's first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions [4]. - The company is advancing EscharEx, a promising candidate currently in Phase III development for the debridement of chronic wounds, which has shown distinct advantages over existing treatments in Phase II clinical trials [4].

Core Viewpoint - MediWound (MDWD) shares experienced an 8.5% increase, attributed to positive investor sentiment regarding the company's product pipeline and upcoming sales expectations [1][2]. Company Overview - MediWound is developing EscharEx, currently in mid to late-stage studies for treating various ulcer indications, with a regulatory filing for venous leg ulcers expected in 2025 [2]. - Another candidate, MW005, is in mid-stage development for non-melanoma skin cancer [2]. - The company markets NexoBrid, approved for eschar removal in patients with thermal burns, and is expected to see year-over-year sales growth in the upcoming quarterly release [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.61 per share, reflecting a year-over-year change of -221.1% [3]. - Revenues are anticipated to be $5.8 million, representing an 8.6% increase from the same quarter last year [3]. - The consensus EPS estimate has been revised 0.6% lower over the last 30 days, indicating a negative trend in earnings estimate revisions [4]. Industry Context - MediWound is part of the Zacks Medical - Drugs industry, which includes other companies like Nektar Therapeutics (NKTR) [4]. - Nektar's consensus EPS estimate has changed by +0.2% over the past month, with a year-over-year change of +40.9% [5].

Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development, production, and commercialization of innovative biologics that enhance existing standards of care while reducing healthcare costs [8][9]. Product Development - MediWound is advancing EscharEx, a bioactive, multimodal debridement therapy for chronic and hard-to-heal wounds, currently in late-stage clinical development. EscharEx has shown safety and efficacy in previous Phase II trials and is set to initiate a Phase III study for venous leg ulcers (VLUs) imminently [7][9]. - The upcoming Phase III VALUE study will focus on EscharEx's application in VLUs, addressing a substantial unmet need in the treatment landscape for VLUs and diabetic foot ulcers (DFUs) [2][7]. Clinical Expertise - The virtual Key Opinion Leader (KOL) event will feature distinguished clinical experts, including Dr. John C. Lantis II, Dr. Vickie R. Driver, and Dr. Robert J. Snyder, who will discuss compelling results from Phase II studies, the upcoming Phase III study, and EscharEx's competitive advantages [2][3][4][5]. Market Opportunity - EscharEx presents a unique opportunity for significant market growth, with distinct advantages over the current market leader in the $360+ million chronic wound care market [9]. The event will highlight EscharEx's unique commercial potential and its role in addressing the unmet needs in wound care [2][7].