MediWound (MDWD) Q3 Earnings call transcript Nov 26, 2024

MediWound, a leading company in advanced wound care, recently held its third quarter 2024 earnings call, providing insight into its ongoing efforts to advance innovative treatments for severe burns and chronic wounds. The call, led by CEO Ofer Gonen, CFO Hani Luxenburg, and EVP of Strategy and Corporate Development Barry Wolfenson, outlined key achievements, financials, and future plans, offering a comprehensive overview of MediWound's strategic direction.

Strategic Milestones and Financial Highlights

MediWound's third quarter was marked by significant strides in its flagship product, NexoBrid. The U.S. Food and Drug Administration (FDA) approved its pediatric use, expanding its label to cover patients from newborn to 18 years old. This approval solidified NexoBrid's status as a treatment option for all age groups in the United States, aligning with its indications in the European Union and Japan. Despite capacity constraints, commercial revenue of NexoBrid has been robust, driven by Vericel's dedicated commercialization efforts.

The company also announced the completion of its state-of-the-art GMP compliant manufacturing facility, with commissioning currently underway. This facility is expected to reach full operational capacity by the end of 2025, increasing MediWound's manufacturing output sixfold. The anticipated revenue for 2024 is $20 million, slightly lower than prior guidance of $24 million, primarily due to the FDA's decision not to require additional post-approval activities for the pediatric indication, eliminating the need for BARDA funding.

EscharEx's Advancements in Chronic Wound Care

MediWound's efforts in chronic wound care, specifically with EscharEx, have been noteworthy. The company is preparing to launch a randomized head-to-head Phase II study of EscharEx versus collagenase in 2025, supporting its BLA submission and further establishing EscharEx's competitive advantages. This study will enroll 45 Velo patients across multiple sites in the United States and Europe, aiming to evaluate key safety endpoints and efficacy measures.

Additionally, MediWound has obtained €16.25 million in funding from the European innovation council to advance the development of EscharEx for diabetic foot ulcers. This accelerates the program timeline by 4 years, with over 1.6 million DFU patients in the United States requiring treatment each year. This funding will enable MediWound to bring a potential new treatment to these underserved patients, reducing the risk of amputations, infections, and deaths from DFU complications.

Key Strategic Partnerships and Future Outlook

MediWound's strategic partnership with Molnlycke Healthcare, a global leader in wound care, has provided critical funding and access to their extensive commercial expertise and regulatory insights. This partnership will help MediWound advance its strategic plans with greater focus and momentum.

The company also announced the successful completion of the Phase III study design for EscharEx in venous leg ulcers, marking a major step forward in addressing an unmet need in the chronic wound debridement market. The upcoming KOL event on January 8, 2025, will provide insights into the trial design, objectives, and anticipated impact of EscharEx on patient outcomes.

Challenges and Future Prospects

Despite these achievements, MediWound faces challenges, including capacity constraints and regulatory approvals for new indications. The company's financials for the third quarter showed a decline in revenue, primarily due to lower revenue from BARDA Development Services. However, MediWound remains optimistic about its future, with a strong financial position and strategic partnerships in place.

Conclusion

MediWound's third quarter earnings call highlighted its significant progress in advancing innovative treatments for severe burns and chronic wounds. With FDA approvals, strategic partnerships, and upcoming clinical trials, MediWound is well-positioned to address critical unmet needs in the wound care market. Despite challenges, the company's focus on innovation and strategic partnerships bodes well for its future growth and impact on patient outcomes. As MediWound moves forward, investors and stakeholders will closely watch its progress in the burn and chronic wound care sectors.