MediWound(MDWD)

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MediWound(MDWD) - 2024 Q2 - Quarterly Report
2024-08-14 11:07
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]
MediWound (MDWD) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release
ZACKS· 2024-08-07 15:06
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 ...
MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT)
GlobeNewswire News Room· 2024-08-05 11:30
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 ...
MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT)
Newsfilter· 2024-08-05 11:30
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 ...
MediWound to Report Second Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-08-02 12:00
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 ...
MediWound Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg Ulcers
GlobeNewswire News Room· 2024-07-29 12:00
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 ...
MediWound Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg Ulcers
Newsfilter· 2024-07-29 12:00
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 ...
MediWound Announces €16.25 Million Funding from the European Innovation Council Accelerator Program
GlobeNewswire News Room· 2024-07-16 11:30
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 ...
MediWound Announces €16.25 Million Funding from the European Innovation Council Accelerator Program
Newsfilter· 2024-07-16 11:30
Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs) Award advances MediWound's DFU program and its future revenues four years ahead of original schedule YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. Th ...
Mölnlycke® Health Care announces US $15m investment in next-generation enzymatic therapeutics company MediWound Ltd
Prnewswire· 2024-07-15 11:32
GOTHENBURG, Sweden, July 15, 2024 /PRNewswire/ -- Mölnlycke Health Care, a world-leading MedTech company specialising in solutions for wound care and surgical procedures, announced today an investment of US $15m in MediWound Ltd. (Nasdaq: MDWD) (MediWound) through a definitive share purchase agreement in a private investment in public equity (PIPE). MediWound, a global leader in next-generation enzymatic therapeutics focused on non-surgical wound debridement, has a vision to improve the existing standards o ...