Core Insights - MediWound Ltd. is presenting 10 scientific abstracts at the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, focusing on EscharEx's mechanism of action and its advantages over SANTYL in treating chronic wounds [1][2][4] Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid for thermal burns [6][7] Product Information - EscharEx is a bromelain-based enzymatic therapy designed for the debridement of chronic wounds, showing a favorable safety profile and effective wound bed preparation in multiple Phase II trials [5][6] - The therapy has demonstrated the ability to remove non-viable tissue, promote granulation, and reduce bioburden and biofilm, targeting a substantial global market opportunity [5][7] Clinical Development - The ongoing VALUE Phase III study is enrolling patients with venous leg ulcers (VLUs), building on positive results from three completed Phase II studies that confirmed EscharEx's efficacy and safety [4][5] - A Phase II/III study in diabetic foot ulcers (DFUs) is in preparation, with new data supporting the planned clinical trial strategy [2][5] Conference Highlights - Key presentations at WHS and SAWC will include new in vitro data on EscharEx's multitargeted proteolytic activity, case studies in advanced DFUs and VLUs, and updates on the VALUE Phase III study design and enrollment progress [6][8]

MediWound Ltd. (NASDAQ:MDWD) Q4 2024 Results Conference Call March 19, 2025 8:30 AM ET Company Participants Dan Ferry - IR, LifeSci Advisors Ofer Gonen - Chief Executive Officer Hani Luxenburg - Chief Financial Officer Barry Wolfenson - Executive Vice President, Strategy & Corporate Development Conference Call Participants Josh Jennings - Cowen Francois Brisebois - Oppenheimer RK - H.C. Wainwright Chase Knickerbocker - Craig Hallum Michael Okunewitch - Maxim Group Operator Good day, and welcome to MediWound ...

Financial Performance - MediWound reported a quarterly loss of $0.36 per share, better than the Zacks Consensus Estimate of a loss of $0.59, and compared to a loss of $0.19 per share a year ago, indicating an earnings surprise of 38.98% [1] - The company posted revenues of $5.84 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 1.53% and showing an increase from year-ago revenues of $5.34 million [2] - Over the last four quarters, MediWound has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - MediWound shares have increased approximately 8.3% since the beginning of the year, contrasting with the S&P 500's decline of 4.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.56 on revenues of $5.25 million, and for the current fiscal year, it is -$2.39 on revenues of $24.98 million [7] Industry Outlook - The Medical - Drugs industry, to which MediWound belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5][6]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported revenue of $5.8 million, an increase from $5.3 million in the same period last year [17] - Gross profit for Q4 was $900,000 with a gross margin of 15.5%, up from $700,000 and 13.5% margin in Q4 2023 [17] - The full year revenue was $20.2 million compared to $18.7 million in 2023, driven by higher revenue from Vericel and a new contract with the U.S. Department of Defense [19] - The net loss for the year was $30.2 million or $3.03 per share, compared to $6.7 million or $0.75 per share in the prior year [20] Business Line Data and Key Metrics Changes - EscharEx, the next-generation asthmatic debridement therapy, is positioned for significant market potential with peak sales estimated at $725 million [7] - NexoBrid generated annual revenue of $20.2 million in 2024, with projected revenue of $24 million in 2025 [12][13] - R&D expenses for the year were $8.9 million, up from $7.5 million in 2023, primarily due to costs related to the EscharEx Value Phase III trial [20] Market Data and Key Metrics Changes - NexoBrid is now available in over 90 burn centers in Europe and has been adopted by over 400 medical facilities in Japan [13] - The new Medicare LCD policy, effective April 13, 2025, will require full wound debridement before covering cellular and tissue-based products, which benefits EscharEx [44] Company Strategy and Development Direction - The company aims to strengthen its position through strategic partnerships and collaborations in advanced wound care [10] - Plans for a Phase II/III study for diabetic foot ulcers (DFU) are underway, with a focus on obtaining regulatory approval from both FDA and EMA [32] - The company is expanding its manufacturing capabilities with a new GMP facility expected to reach full operational capacity by late 2025 [15] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2024 as a transformative year with significant clinical, commercial, and strategic achievements [23] - The company anticipates continued strong growth driven by expanding sales in key markets and new product approvals [12][13] - Management expressed confidence in the clinical trial designs and the strategic derisking of their programs [46] Other Important Information - The company secured EUR 16.5 million in funding from the European Innovation Council to accelerate the development of EscharEx for diabetic foot ulcers [10] - A strategic $25 million PIPE financing round was completed, reflecting industry confidence in the company's strategy [15] Q&A Session Summary Question: Can you elaborate on the role of MiMedix in the study? - The company confirmed that MiMedix will provide standardized products and training to minimize variability in the study [28] Question: Will the DFU study be global and what is the FDA approval process? - The DFU study will closely follow the VLU study design, with plans to approach FDA and EMA for protocol approval in the second half of the year [32] Question: What is the expected timeline for regulatory approvals for NexoBrid? - The company expects European approval in early 2026 and FDA approval by mid-2026, contingent on successful manufacturing validation [35][36] Question: How does the new Medicare LCD impact EscharEx? - The new policy emphasizes the need for complete debridement before tissue substitute application, positioning EscharEx favorably due to its efficacy in wound preparation [44] Question: What are the expected R&D costs for 2025? - R&D costs are expected to increase substantially in 2025, with an estimated cost of around $100,000 per patient enrolled in the VLU trial [71]

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]