MediWound Q2 2024 Financial Results and Company Update

MediWound Ltd., a leader in next-generation enzymatic therapeutics, has released its financial results for the second quarter ending June 30, 2024, along with a corporate update. CEO Ofer Gonen highlighted the company's accomplishments, including the completion of a new manufacturing facility for NexoBrid® and significant milestones for EscharEx®.

The new state-of-the-art, GMP-compliant manufacturing facility for NexoBrid® has been completed, addressing the increasing global demand for the product. This facility is expected to reach full operational capacity by 2025, increasing manufacturing capability sixfold. Vericel's U.S. launch of NexoBrid® is gaining momentum, with 70 burn centers having submitted to Pharmacy and Therapeutics (P&T) committees, 40 of which have already received approval and placed initial orders. This has contributed to a 76% growth in revenue over the previous quarter. Additionally, the U.S. NexoBrid Expanded Access Protocol (NEXT) has shown positive results consistent with Phase III studies, reinforcing the product's safety and efficacy. FDA approval for pediatric use is anticipated in the third quarter of 2024.

For EscharEx®, a Phase III study for venous leg ulcers is set to commence in the second half of 2024. The European Innovation Council (EIC) has provided €16.25 million in funding to expedite the development of EscharEx® for diabetic foot ulcers, expanding the product’s market potential. This funding accelerates the program by four years, targeting a significant portion of the market needing debridement. Preparations are underway for a Phase II/III study, and Phase II results have been published in THE LANCET’s eClinicalMedicine journal, demonstrating EscharEx's superiority over non-surgical standard of care in debridement and healthy tissue promotion.

Corporate developments include a $25 million strategic investment led by Mölnlycke Health Care, a leader in wound care solutions. This investment strengthens MediWound’s financial position and is accompanied by a collaboration agreement with Mölnlycke. The company has also been included in the Russell 3000® Index as part of the 2024 Russell indexes annual reconstitution.

Financial highlights for the second quarter of 2024 show revenue of $5.1 million, up from $4.8 million in the same period of 2023. Gross profit decreased from $1.1 million to $0.4 million, primarily due to changes in the revenue mix and nonrecurring production costs. Research and development expenses were $1.9 million, consistent with the previous year, while selling, general, and administrative expenses remained stable at $3.0 million. The operating loss was $4.5 million, compared to $4.0 million in the same quarter of 2023. Net loss increased to $6.3 million, or $0.68 per share, primarily due to financial expenses related to the revaluation of warrants.

For the first half of 2024, total revenues reached $10.0 million, up from $8.6 million in the first half of 2023. This increase is attributed to revenue from Vericel and new contracts with the U.S. Department of Defense. Gross profit for the first half was $1.1 million, down from $2.0 million the previous year. Research and development expenses decreased to $3.4 million, while selling, general, and administrative expenses dropped to $5.9 million. The operating loss for the first half of 2024 was $8.2 million, slightly better than the $8.4 million loss in the same period of 2023. Net loss for the first half of 2024 was $16.0 million, or $1.73 per share, significantly impacted by financial expenses from warrant revaluation.

As of June 30, 2024, MediWound had cash and cash equivalents totaling $29.7 million, down from $42.1 million at the end of 2023. This reduction reflects the company's funding activities, including a $25 million PIPE offering completed on July 15, 2024.

MediWound Ltd. continues to advance its strategic goals and strengthen its market position through innovative enzymatic therapeutics, securing significant funding, and achieving key clinical milestones.