Financial Data and Key Metrics Changes - Revenue for Q2 2024 was $5.1 million, an increase from $4.8 million in Q2 2023, primarily attributed to revenue from Vericel [14] - Gross profit for Q2 2024 was $0.4 million, representing 9% of total revenue, compared to $1.1 million or 24% in Q2 2023, with the decrease in gross margin due to changes in revenue mix and nonrecurring production costs [14] - Net loss for Q2 2024 was $6.3 million or $0.68 per share, compared to a net profit of $0.9 million or $0.10 per share in Q2 2023, primarily due to financial expenses from the revaluation of warrants [15] - Total revenue for the first half of 2024 was $10 million, up from $8.6 million in the first half of 2023 [16] - Net loss for the first half of 2024 was $16 million or $1.73 per share, compared to a net loss of $2.8 million or $0.32 per share in the first half of 2023 [16] Business Line Data and Key Metrics Changes - NexoBrid's revenue growth was driven by a 76% increase in hospital orders and the number of patients treated in the U.S. [6] - The new manufacturing facility for NexoBrid will increase manufacturing capacity sixfold, with full operational capacity expected in 2025 [6] - EscharEx received EUR 16.5 million in funding to expand its indications to include diabetic foot ulcers, significantly increasing its total addressable market [9] Market Data and Key Metrics Changes - Approximately 70 burn centers in the U.S. have submitted to P&T committees, with over 40 centers obtaining approval and placing initial product orders for NexoBrid [6] - Among the 38 million diabetic patients in the U.S., approximately 30% will develop diabetic foot ulcers, with 1.6 million patients requiring debridement annually [10] Company Strategy and Development Direction - The company aims to become a global leader in tissue repair, focusing on completing the construction of a new manufacturing facility, accelerating NexoBrid revenue growth, and initiating the Phase III clinical trial of EscharEx [4] - A strategic collaboration agreement with Molnlycke Healthcare aims to enhance the company's strategic plans and create long-term value for stakeholders [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for NexoBrid escalating rapidly due to major market launches and growing governmental interest [20] - The company is well-positioned with resources to achieve its goals and looks forward to an exciting second half of the year [18] Other Important Information - The company raised $25 million in financing led by Molnlycke, reflecting strong confidence in its technology and significantly enhancing its financial position [5] - The company received additional funding from the U.S. Department of Defense to support ongoing research and development activities [9] Q&A Session Summary Question: What are the next steps to increasing NexoBrid capacity? - Management indicated that commissioning the new facility will take about a year, including six months of stability testing [20] Question: How will the EIC funding for the DFU trial be structured? - The funding will be reimbursed quarterly based on expenses, and the trial is expected to start after regulatory negotiations [21] Question: What is the timeline for the Phase III study for venous leg ulcers? - The Phase III study is on track to start in the second half of 2024, with an interim assessment planned after 67% of participants have completed the trial [23] Question: How will the EIC data be utilized for regulatory pathways? - The EIC data will support a Phase III trial similar to the venous leg ulcer study, with recruitment expected to begin one year later [29] Question: What is the expected coverage of the EIC funding for the DFU study? - The study is anticipated to be at zero cost for the company, as it will utilize existing infrastructure [31] Question: Is there interest from large players in collaborating on EscharEx? - There is significant interest from global wound care players in collaborating on EscharEx, although specific details cannot be disclosed [34]

MediWound (MDWD) came out with a quarterly loss of $0.68 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to earnings of $0.10 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -61.90%. A quarter ago, it was expected that this developer of treatments for burns and hard-to-heal wounds would post a loss of $0.40 per share when it actually produced a loss of $0.39, delivering a surprise of 2.50%. Over ...

Financial Performance - Total revenues for the six months ended June 30, 2024, increased to $10,027 thousand, up 17% from $8,572 thousand for the same period in 2023[3] - Revenues from product sales reached $3,202 thousand for the six months ended June 30, 2024, compared to $2,358 thousand in the same period last year, representing a 36% increase[3] - Gross profit for the six months ended June 30, 2024, was $1,054 thousand, down 46% from $1,963 thousand for the same period in 2023[3] - Operating loss for the six months ended June 30, 2024, was $(8,218) thousand, slightly improved from $(8,371) thousand in the same period last year[3] - Net loss for the six months ended June 30, 2024, was $(16,034) thousand, compared to $(2,777) thousand for the same period in 2023[3] - The company reported a total comprehensive loss of $(6,303) for the period ending June 30, 2024[28] Assets and Liabilities - Total current assets decreased to $37,313 thousand as of June 30, 2024, down 36% from $58,053 thousand as of June 30, 2023[2] - Total liabilities increased to $39,427 thousand as of June 30, 2024, up 34% from $29,437 thousand as of June 30, 2023[2] - Cash and cash equivalents decreased to $3,790 thousand as of June 30, 2024, down 80% from $19,166 thousand as of June 30, 2023[2] - Total equity decreased to $17,869 thousand as of June 30, 2024, down 49% from $34,929 thousand as of June 30, 2023[2] - The company’s accumulated deficit increased to $(190,856) as of June 30, 2024, from $(170,883) as of June 30, 2023[28] Research and Development - Research and development expenses for the six months ended June 30, 2024, were $3,368 thousand, down 18% from $4,126 thousand for the same period in 2023[3] - The second investigational product, EscharEx, is being developed for chronic wound debridement, with a Phase III clinical trial planned[13] - The company signed new agreements for services totaling $3,300 for the Phase III clinical trial of EscharEx, covering a two-year period[18] - The company signed new agreements with suppliers totaling $6,086 thousand for the Phase III clinical trial of EscharEx, covering a period of two years[54] - The company expects to initiate the Phase III study for Nexobrid in the second half of 2024[66] Funding and Contracts - The total funding received from BARDA amounts to approximately $92,065, with an additional $16,500 for Nexobrid procurement, netting around $10,500 after profit sharing[16] - The company has secured $14,591 in funding from the DoD and MTEC to advance the development of a new temperature-stable formulation of Nexobrid[17] - The company has a BARDA contract valued at up to $175 million, extended until September 2025[45] - The company was selected to receive €16,250 in blended funding from the European Innovation Council, including €2,500 as a grant and €13,750 as an investment, with terms currently being negotiated[77] Cash Flow - For the six months ended June 30, 2024, the net cash used in operating activities was $(8,231) thousand, compared to $(4,599) thousand for the same period in 2023, representing an increase of 79%[38] - The company reported a net cash provided by investing activities of $1,061 thousand for the six months ended June 30, 2024, compared to $(33,521) thousand in the same period of 2023[62] - The company reported a net cash used in financing activities of $(802) thousand for the six months ended June 30, 2024, compared to $23,848 thousand in the same period of 2023[62] Shareholder Activity - A definitive share purchase agreement was entered into on July 15, 2024, for the sale and purchase of 1,453,488 ordinary shares at a price of $17.20 per share, resulting in gross proceeds of $25,000[76] - During the first half of 2024, 46,456 Series A warrants were exercised at an exercise price of $13.475 per ordinary share[78] - An additional 44,573 Series A warrants were exercised on July 16, 2024, at the same exercise price of $13.475 per ordinary share[79] Product Approvals and Distribution - The company’s first product, Nexobrid, has received multiple international approvals, including from the FDA and EMA, for treating deep partial and full-thickness thermal burns[11] - As of June 30, 2024, the company has established local distribution channels in Asia Pacific, EMEA, CEE, and LATAM markets[12] Other Expenses - The company reported a depreciation and amortization expense of $725 thousand for the six months ended June 30, 2024, up from $618 thousand in the same period of 2023[38] - The company recorded financial expenses of $550 thousand related to the settlement agreement with Teva Pharmaceutical Industries Ltd.[53]

Wall Street expects a year-over-year decline in earnings on higher revenues when MediWound (MDWD) reports results for the quarter ended June 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 14, 2024, might help the stock move higher if these key numbers are better than expecta ...

YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated t ...

YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated t ...

YAVNE, Israel, Aug. 02, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the second quarter ended June 30, 2024 on Wednesday, August 14, 2024. Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions. Dial-in and call details ...

Research Published in THE LANCET's eClinicalMedicine EscharEx® Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eCl ...

Cautionary Note Regarding Forward-Looking Statements EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reductio ...

Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs) The EIC Accelerator offers grants and equity investments to support innovative, game-changing products. In addition to financial support, selected projects benefit from a range of business acceleration services that provide access to global experts, businesses, investors and ecosystem players. The funding package includes a €2.5 million grant and an investment, with terms to be finalized between the Company and the E ...