Company Performance - MediWound reported a quarterly loss of $0.98 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.48, marking an earnings surprise of -104.17% [1] - The company's revenues for the quarter ended September 2024 were $4.36 million, missing the Zacks Consensus Estimate by 27.48%, and down from $4.78 million a year ago [2] - Over the last four quarters, MediWound has surpassed consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Movement and Outlook - MediWound shares have increased approximately 70.4% since the beginning of the year, outperforming the S&P 500's gain of 25.5% [3] - The future performance of the stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.58 on revenues of $7.82 million, and for the current fiscal year, it is -$2.69 on revenues of $23.85 million [7] Industry Context - The Medical - Drugs industry, to which MediWound belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total revenue for Q3 2024 was $4.4 million, a decrease from $4.8 million in Q3 2023, primarily due to lower BARDA development services revenue[13] - Gross profit for Q3 2024 was $0.7 million, representing 16% of total revenue, down from 19% in Q3 2023, reflecting a shift in revenue mix[13] - The company anticipates total revenue of $20 million for 2024, revised down from prior guidance of $24 million due to strong demand exceeding current manufacturing capacity[8] - Operating loss for Q3 2024 was $5.1 million, compared to a loss of $3.0 million in Q3 2023[15] - Net loss for Q3 2024 was $10.3 million, or $0.98 per share, compared to a net loss of $2.2 million, or $0.24 per share, in Q3 2023[15] - Total revenues for the nine months ended September 2024 increased to $14,382 thousand, up from $13,348 thousand for the same period in 2023, representing an increase of 7.7%[39] - Gross profit for the nine months ended September 2024 was $1,731 thousand, a decrease of 39.4% compared to $2,859 thousand for the same period in 2023[39] - Operating loss for the nine months ended September 2024 was $(13,299) thousand, compared to $(11,396) thousand for the same period in 2023, reflecting a deterioration of 16.7%[39] - Net loss for the nine months ended September 2024 was $(26,316) thousand, significantly higher than $(4,973) thousand for the same period in 2023, indicating a year-over-year increase of 429.5%[39] - The company reported a basic and diluted loss per share of $(2.72) for the nine months ended September 30, 2024, compared to $(0.56) for the same period in 2023[39] - The company reported a net loss of $(10,282) million for the quarter ending September 2024, compared to $(2,196) million for the same quarter in the previous year[45] - The total net loss for December 31, 2023, was $(6,716) million, showing a consistent trend of losses[45] Cash and Assets - As of September 30, 2024, cash and cash equivalents totaled $46.0 million, up from $42.1 million at the end of 2023[21] - Total current assets as of September 30, 2024, were $53,888 thousand, an increase from $53,250 thousand as of September 30, 2023[37] - Total non-current assets increased to $20,846 thousand as of September 30, 2024, compared to $13,767 thousand as of September 30, 2023, marking a growth of 51.4%[37] - Total liabilities and shareholders' equity as of September 30, 2024, were $74,734 thousand, up from $67,017 thousand as of September 30, 2023, reflecting an increase of 11.5%[37] - Cash and cash equivalents at the end of the period were $6,475 thousand, down from $9,279 thousand at the end of September 30, 2023, a decrease of 30.2%[43] Research and Development - R&D expenses for Q3 2024 were $2.5 million, an increase from $1.5 million in Q3 2023, mainly due to costs associated with the EscharEx Phase 3 clinical trial[14] - Research and development expenses for the nine months ended September 30, 2024, were $5,892 thousand, slightly up from $5,659 thousand for the same period in 2023[39] - The Phase 3 study of EscharEx for venous leg ulcers is set to commence, with FDA IND submission planned by year-end[9] Strategic Investments - The company raised $25 million through a strategic private investment in public equity (PIPE) to strengthen its cash runway[12] Adjusted Financial Metrics - Adjusted EBITDA for September 2024 was $(9,897) million, slightly worse than $(9,021) million in the same period last year[45] - Total adjustments amounted to $(16,419) million in September 2024, compared to $4,048 million in September 2023, reflecting a substantial negative shift[45] - Financial income (expenses), net for September 2024 was $(12,974) million, a decline from $6,488 million in September 2023[45] - Share-based compensation expenses increased to $(2,316) million in September 2024 from $(1,642) million in September 2023, indicating rising costs in this area[45] - Depreciation and amortization expenses rose to $(1,086) million in September 2024, compared to $(957) million in the same quarter last year[45] - Taxes on income were $(43) million in September 2024, slightly improved from $(65) million in September 2023[45] - Other income, net remained stable at $224 million in both September 2023 and December 31, 2023[45]

EscharEx IND Submission by Year-End; Phase 3 Study to Begin Shortly Thereafter; KOL Event Set for January 8, 2025 FDA Approves NexoBrid for Pediatric Use $25 Million Financing and €16.25 Million EIC Funding Strengthen Cash Runway to Profitability NexoBrid Product Revenue Meets Expectations; Demand Exceeds Capacity as New Manufacturing Facility Commissioning Underway Conference Call Today, November 26 at 8:30 a.m. Eastern Time YAVNE, Israel, Nov. 26, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a ...

MediWound Ltd. (NASDAQ: MDWD ) is a low-risk but long-term stock buy opportunity, perhaps extending over the next two years. Retail value investors with cash to set aside and patience canI write for retail value investors who cannot afford to lose money but sometimes like to take a risk. I speak for free to community and school groups. I was teaching business, social/political activism, and Middle East politics to international university students in Tel Aviv b4 the pandemic hit. A college in Jerusalem hire ...

YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age g ...

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 ...