MediWound (MDWD) Q1 2025 Earnings Call May 21, 2025 08:30 AM ET Company Participants Dan Ferry - Managing DirectorOfer Gonen - Chief Executive OfficerHani Luxenburg - Chief Financial OfficerRamakanth Swayampakula - Managing DirectorBarry Wolfenson - Executive Vice President of Strategy & Corporate Development Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareMichael Okunewitch - Senior Biotechnology AnalystScott Henry - Managing Director & Senior Research Analyst ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [17] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [17] - R&D expenses totaled $2.9 million, up from $1.5 million in Q1 2024, reflecting continued investment in the EscharEx VALUE Phase III trial [17] - SG&A expenses were $3.1 million, compared to $2.9 million in the prior year [17] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [17] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share last year [17] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [17] - Cash, cash equivalents, and deposits as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [19] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid's U.S. adoption continues to expand, with a 207% year-over-year increase and a 31% sequential increase in revenue during Q1 2025 [12] - Demand for NexoBrid in Japan and Europe continues to exceed manufacturing capacity, with a new manufacturing facility expected to be operational by year-end 2025 [12][13] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support the clinical and regulatory advancement of EscharEx for diabetic foot ulcers [9] - The U.S. government has expressed interest in establishing a domestic backup manufacturing site for NexoBrid, supported by BARDA [15][25] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [21] - EscharEx is positioned to become a global leader in enzymatic wound debridement, with strong clinical advantages over competitors [11] - The company is advancing complementary studies to support market access and future commercial success [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates achieving operational capacity for the new manufacturing facility by the end of 2025, with regulatory inspections expected thereafter [25] - Management remains optimistic about the VALUE Phase III trial and expects interim data by mid-2026 [31] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The pediatric Phase III study results for NexoBrid were published, reinforcing its efficacy and safety [13] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [25] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [28] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [31] Question: How is the stockpiling of NexoBrid being planned? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [37] Question: What is the structure of the EscharEx trial sites? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [39] Question: Will the results of the head-to-head study and phase three study come around the same time? - The head-to-head study is expected to finish ahead of the phase three study due to its shorter duration [43] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider treatment costs, health economics, and potential savings from faster debridement [51] Question: How should investors think about BARDA and DoD funding? - The company anticipates no material impact on revenue outlook for 2025, with programs back on track [61]

Group 1 - MediWound reported a quarterly loss of $0.07 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.65, representing an earnings surprise of 89.23% [1] - The company posted revenues of $3.96 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 22.39%, and down from $4.96 million a year ago [2] - MediWound shares have increased approximately 17.3% since the beginning of the year, outperforming the S&P 500's gain of 1% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.67 on revenues of $5.74 million, and for the current fiscal year, it is -$2.84 on revenues of $24.36 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 21% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

"We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum established in 2024," said Ofer Gonen, Chief Executive Officer of MediWound. "The VALUE Phase III study for EscharEx remains on schedule, and our additional collaboration with Kerecis marks a significant milestone—bringing nearly all leading global wound care companies into our clinical research programs. Meanwhile, NexoBrid continues to gain global traction, as we advance strategic m ...

YAVNE, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company’s Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx® compared with collagenase ointment (SANTYL®), the only FDA-cleared enzymatic debridement agent commercial ...

Wound Healing Society (WHS) Symposium on Advanced Wound Care (SAWC) "These new data further validate EscharEx's unique mechanism of action and its potential to redefine the standard of care for chronic wound management," said Dr. Robert Snyder, Chief Medical Officer at MediWound. "We remain committed to advancing EscharEx through rigorous clinical development, with the goal of offering a meaningful, non-surgical solution for patients suffering from chronic wounds." Presentations at WHS and SAWC to highlight ...

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].