Mediwound Ltd (MDWD)

[midastouch017]

MediWound Reports Fourth Quarter and Full Year 2021 Financial Results

https://finance.yahoo.com/news/mediwound-reports-fourth-quarter-full-110000871.html

Full-Year 2021 Total Revenues of $23.8 Million; Product Revenues Up 46%

Positive Top-Line Data for EscharEx Phase 2 Clinical Trial, with Full Data Set Anticipated in Second Quarter 2022

Raised Gross Proceeds of $10 Million through Public Equity Offering

Conference Call Begins Today at 8:30 am ET

YAVNE, Israel, March 17, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.

Fourth Quarter, Full-Year 2021 and Recent Weeks Financial Highlights:

Total revenues for 2021 were $23.8 million; compared to $21.8 million in 2020

Product revenues in 2021 increased by 46% over 2020 to $11.4 million

Total revenues for the fourth quarter of 2021 were $5.5 million, compared to $6.7 million in the fourth quarter of 2020

Achieved profitability with commercial operations for NexoBrid for 2021

The Company had $11.0 million in cash and short-term investments as of December 31, 2021

In March 2022, the Company raised an additional $10 million in total gross proceeds through an equity offering

Business Highlights and Updates:

Positive topline results from the U.S. Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel vehicle

Gained clarity from the U.S. Food and Drug Administration (FDA) on a path forward for resubmission of the NexoBrid Biologics License Application (BLA), which is now anticipated in mid-2022

The Biomedical Advanced Research and Development Authority (BARDA) expanded its awarded contract by providing supplemental funding of $9 million to support the NexoBrid BLA resubmission with the FDA and the ongoing expanded access treatment protocol (NEXT)

Positive data from the U.S. Phase 2 pharmacology study of EscharEx showing effective and rapid debridement in chronic and hard-to-heal wounds and demonstrating EscharEx reduced biofilm and bacterial load

Following the robust results from the Phase 3 pediatric study, gained regulatory path clarity towards a pediatric label extension for NexoBrid from the European Medicines Agency (EMA) through scientific advice

Awarded a U.S. Department of Defense research grant for the development of NexoBrid for the U.S. Army

"The Company continued to execute well across all operating areas of the business in 2021, setting up 2022 to be a transformational year for us," said Sharon Malka, Chief Executive Officer of MediWound. "Meeting the primary endpoint with superior efficacy data from our U.S. Phase 2 EscharEx trial recently announced reinforces our belief that EscharEx has the potential to become a best-in-class debridement option for the millions of patients suffering from hard-to-heal wounds. We expect the full data set for the EscharEx trial in the second quarter, which we will use to guide and develop our Phase 3 program. With NexoBrid, we are on track for resubmitting the BLA to the FDA in mid-year. We have strengthened our balance sheet, improving our liquidity and we believe we are now well-positioned as we approach several important upcoming milestones throughout the year."

Fourth Quarter 2021 Financial Results

Revenues for the fourth quarter of 2021 were $5.5 million, a decrease of 18% compared to $6.7 million for the fourth quarter of 2020. The decrease in revenues was primarily due to reduced BARDA emergency stockpile procurement in the fourth quarter of 2021 and decrease in revenues from services to BARDA, resulting from the completion of DETECT and CIDS clinical studies.

Gross profit for the fourth quarter of 2021 was $1.5 million with gross margins of 28%, compared to gross profit of $2.3 million and gross margins of 35% for the fourth quarter of 2020.

Research and development expenses for the fourth quarter of 2021 were $2.5 million, compared to $2.2 million for the fourth quarter of 2020. The increase was primarily due to clinical development program of EscharEx.

Selling, general and administrative expenses for the fourth quarter of 2021 were $2.6 million, compared to $2.5 million in the fourth quarter of 2020.

Operating loss for the fourth quarter of 2021 was $3.5 million, compared to an operating loss of $2.4 million in the fourth quarter of 2020.

The Company posted a net loss of $4.2 million, or $0.15 per share, for the fourth quarter of 2021 compared to a net loss of $1.7 million, or $0.06 per share, for the fourth quarter of 2020.

Adjusted EBITDA, as defined below, for the fourth quarter of 2021 was a loss of $2.9 million, compared to a loss of $1.8 million for the fourth quarter of 2020.

Full-Year 2021 Financial Results

Revenues for the year ended December 31, 2021 were $23.8 million compared to $21.8 million for the year ended December 31, 2020, an increase of 9%. Product revenues (sales of product and license fee) in 2021 were $11.4 million, an increase of 46% compared to $7.8 million in 2020, primarily driven by BARDA emergency stockpile procurement and increased sales in Europe.

Gross profit for the year ended December 31, 2021 was $8.8 million with gross margin of 37%, compared with a gross profit of $7.5 million with gross margin of 35% in the prior year period.

Research and development expenses for the year ended December 31, 2021, were $10.3 million, compared to $7.7 million in the prior year. The increase was primarily due to clinical development for EscharEx.

Selling, general and administrative expenses for the year ended December 31, 2021 were $9.7 million compared to $8.7 million in the prior year. The increase was primarily as a result of one-time legal expenses and lease and maintenance classification costs.

Operating loss for the year ended December 31, 2021 was $11.2 million, compared to an operating loss of $8.8 million for the year ended December 31, 2020, primarily due to increase in research and development expenses.

The Company’s net loss for the year ended December 31, 2021 was $13.6 million or $0.50 per share, compared to a net loss of $9.2 million or $0.34 per share for the year ended December 31, 2020.

Adjusted EBITDA, for the year ended December 31, 2021, was a loss of $8.3 million, compared to a loss of $6.4 million for the year ended December 31, 2020.

Balance Sheet Highlights

As of December 31, 2021, MediWound had $11.0 million in cash and short-term investments, compared to $21.6 million as of December 31, 2020. The Company utilized $10.6 million to fund its operating activities in 2021.

On March 7, 2022, the Company completed a public offering, which provided the Company with an additional $10 million in gross proceeds. The Company expects cash use for 2022 to be in the range of $11 to $13 million. Based on our current operating plan, we believe that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses for at least the next 24 months.

Conference Call

MediWound management will host a conference call for investors today, Thursday, March 17, 2022, beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.) or 678-894-3057 (outside the U.S. & Israel) and entering passcode 2281543. The call also will be webcast live on the Company’s website at http://ir.mediwound.com/events-and-presentations.