MediWound(MDWD) - 2023 Q3 - Quarterly Report

MediWound Third Quarter 2023 Financial Results and Company Update Company Overview and CEO Remarks In Q3 2023, MediWound achieved significant milestones, including the successful commercial launch of NexoBrid® in the U.S. and Japan, while maintaining a strong cash position of $46 million - Successfully launched NexoBrid® in two key markets, the U.S. and Japan, enhancing the company's global footprint[3] - Global conflicts have escalated demand for NexoBrid®, leading the company to prioritize resources to meet this increase, with the U.S. Department of Defense funding a field-care burn treatment[4] - Preparations for the EscharEx® Phase III study are advancing, with protocol submission to the FDA expected in Q1 2024 and enrollment to begin in H2 2024, alongside a new collaboration with 3M Healthcare[5] - The company reported a cash position of $46 million, with an operating cash runway expected to last through profitability[1] Third Quarter 2023 Highlights and Recent Developments This section details specific operational achievements for NexoBrid® and EscharEx®, alongside corporate management updates, including commercial launches and progress on clinical trials NexoBrid® NexoBrid® saw major commercial launches in the U.S. and Japan, expanded its European presence, and received increased demand and funding due to global conflicts and military needs - Announced commercial availability of NexoBrid® in the U.S. with partner Vericel Corporation and in Japan with partner Kaken Pharmaceutical Co[8] - Deployed all available non-U.S. inventory to treat mass burn casualties from the war in Israel and is reallocating resources to scale up manufacturing to meet surging global demand[8] - Secured a $6.5 million R&D budget from the U.S. Department of Defense to develop a new, temperature-stable formulation of NexoBrid® for the U.S. Army[8] - Expanded European market presence through a collaboration with PolyMedics Innovations (PMI) for promotion in Germany, Austria, and the Benelux countries[8] EscharEx® Preparations for the global Phase III trial are advancing, with protocol submission to the FDA expected in Q1 2024 and patient enrollment in H2 2024, supported by a new R&D partnership with 3M Healthcare - An updated Phase III protocol will be submitted in Q1 2024, with patient enrollment expected to commence in H2 2024[8] - The global Phase III trial will enroll approximately 216 patients, with co-primary endpoints of complete debridement and wound closure, and an interim assessment planned after 67% of participants complete the trial[8] - Established a research and development partnership with 3M Healthcare to support the EscharEx Phase III clinical study[8] Corporate Development MediWound appointed Dr. Shmulik Hess as the new Chief Operating Officer and Chief Commercial Officer, effective December 1, 2023, to strengthen its operational and commercial capabilities - Appointed Shmulik Hess, Ph.D. as Chief Operating Officer and Chief Commercial Officer, effective December 1, 2023, to fortify the company's global operations and commercial activities[11] Financial Performance The company reported Q3 2023 revenues of $4.8 million, a decrease from the prior year, but a significantly narrowed net loss of $2.2 million, supported by a strong cash position of $46 million Third Quarter 2023 Financial Highlights Q3 2023 revenues were $4.8 million, down from $5.8 million in Q3 2022, primarily due to the absence of nonrecurring BARDA income, while net loss improved to $2.2 million Q3 2023 Financial Results (in millions of USD, except per share data) | Metric | Q3 2023 | Q3 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $4.8 | $5.8 | -17.2% | | Gross Profit | $0.9 | $2.4 | -62.5% | | Operating Loss | ($3.0) | ($3.5) | Improved | | Net Loss | ($2.2) | ($4.2) | Improved | | Net Loss Per Share | ($0.24) | ($0.88) | Improved | | Adjusted EBITDA | ($2.6) | ($2.5) | Widened | Year-to-Date 2023 Financial Highlights For the first nine months of 2023, revenues were $13.3 million, a decrease from $14.9 million in the prior year, with the net loss significantly decreasing to $5.0 million from $12.1 million Nine Months Ended Sep 30, 2023 Financial Results (in millions of USD, except per share data) | Metric | YTD 2023 | YTD 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $13.3 | $14.9 | -10.7% | | Operating Loss | ($11.4) | ($10.5) | Widened | | Net Loss | ($5.0) | ($12.1) | Improved | | Net Loss Per Share | ($0.56) | ($2.67) | Improved | | Adjusted EBITDA | ($9.0) | ($7.9) | Widened | Balance Sheet Overview As of September 30, 2023, the company held $46 million in cash, restricted cash, and investments, an increase from $34.1 million at year-end 2022, bolstered by a $27.5 million offering - Cash, restricted cash, and investments totaled $46 million as of September 30, 2023, compared to $34.1 million as of December 31, 2022[13] - The company raised a gross amount of $27.5 million in Q1 2023 through a registered direct offering[13] - Existing cash and cash equivalents are expected to provide sufficient funds for the company's current operating plan through profitability[13] Financial Statements This section provides the detailed, unaudited condensed interim consolidated financial statements for the period ended September 30, 2023, including the Balance Sheet, Income Statement, Cash Flows, and Adjusted EBITDA reconciliation Consolidated Statements of Financial Position The balance sheet as of September 30, 2023, shows total assets of $67.0 million, primarily driven by $45.5 million in cash and short-term deposits, with total shareholders' equity of $33.1 million Key Balance Sheet Items (in thousands of USD) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,279 | $33,895 | | Short-term bank deposits | $36,244 | - | | Total Assets | $67,017 | $50,016 | | Total Liabilities | $33,967 | $39,102 | | Total Shareholders' Equity | $33,050 | $10,914 | Consolidated Statements of Profit or Loss The income statement for Q3 2023 details revenues of $4.8 million and a net loss of $2.2 million, with year-to-date revenues of $13.3 million and a net loss of $5.0 million Key Income Statement Items (in thousands of USD) | Metric | Q3 2023 | Q3 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $4,776 | $5,803 | $13,348 | $14,878 | | Gross Profit | $896 | $2,434 | $2,859 | $5,007 | | Operating Loss | ($3,025) | ($3,510) | ($11,396) | ($10,468) | | Net Loss | ($2,196) | ($4,199) | ($4,973) | ($12,142) | Consolidated Statements of Cash Flows For the nine months ended September 30, 2023, net cash used in operating activities was $7.9 million, with $39.3 million used in investing activities and $23.1 million provided by financing activities Cash Flow Summary - Nine Months Ended Sep 30, 2023 (in thousands of USD) | Activity | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,850) | ($13,885) | | Net cash used in investing activities | ($39,349) | ($2,877) | | Net cash provided by financing activities | $23,121 | $21,126 | Adjusted EBITDA Reconciliation The company reported a non-IFRS Adjusted EBITDA loss of $2.6 million for Q3 2023, a slight increase from the $2.5 million loss in Q3 2022, with a year-to-date loss of $9.0 million Adjusted EBITDA (in thousands of USD) | Period | Net Loss | Adjustments | Adjusted EBITDA | | :--- | :--- | :--- | :--- | | Q3 2023 | ($2,196) | $403 | ($2,599) | | Q3 2022 | ($4,199) | ($1,734) | ($2,465) | | YTD 2023 | ($4,973) | $4,048 | ($9,021) | | YTD 2022 | ($12,142) | ($4,275) | ($7,867) | Additional Information This section contains details about the investor conference call, a description of the company's business and product pipeline, and the standard cautionary note regarding forward-looking statements Conference Call Information MediWound management hosted an investor conference call on Tuesday, November 21, 2023, at 8:30 a.m. Eastern Time to discuss financial results and provide a corporate update - A conference call for investors was scheduled for Tuesday, November 21, 2023, at 8:30 a.m. Eastern Time[14] About MediWound MediWound is a global leader in enzymatic therapeutics for non-surgical tissue repair, with key products including NexoBrid® for severe burns and EscharEx® (Phase III) for chronic wounds - MediWound focuses on non-surgical tissue repair using enzymatic therapeutics[20] - Key products include NexoBrid® for severe burns, EscharEx® (Phase III) for chronic wounds, and MW005 for basal cell carcinoma (Phase I/II completed)[21] Forward-Looking Statements This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements concerning product development, timelines, and commercial potential - The press release contains forward-looking statements regarding the progress, timelines, and commercial potential of products like EscharEx® and NexoBrid®[23][24] - Actual results may differ due to inherent uncertainties in product development, regulatory approvals, market acceptance, and other factors detailed in SEC filings[24][25]