Mediwound Ltd (MDWD)

[midastouch017]

MediWound Reports First Quarter 2022 Financial Results

https://finance.yahoo.com/news/mediwound-reports-first-quarter-2022-110000235.html

Positive Results from Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds

On track for NexoBrid BLA resubmission by mid-year

Conference Call Begins Today at 8:30 am ET

YAVNE, Israel, May 17, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced Financial results for the first quarter ended March 31, 2022.

First Quarter and Recent Weeks Financial Highlights

Total revenues for the first quarter of 2022 were $4.4 million compared to $5.8 million in the first quarter of 2021

Raised an additional $10 million of total net proceeds through an equity offering


Cash and short-term investments of $16.8 million as of March 31, 2022

Business Highlights and Updates:

Positive results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs): (i) the study met its primary and its key secondary endpoints with statistically significant results compared to control arms; (ii) significant improvement over the current standard-of-care; and (iii) no deleterious effects on wound closure and no observed safety issues.

EscharEx clinical data from phase 2 clinical trials was highlighted in poster and oral presentation at the symposium of advance wound care (SAWC)

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)

Awarded a U.S. Department of Defense (DoD) research grant for the development of NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army

“EscharEx is demonstrating to be a true game changer, and we believe the robust results position it at the forefront of enzymatic debridement solutions for chronic and hard to heal wounds,” said Sharon Malka, Chief Executive Officer of MediWound. “We believe we have a clear path forward to advance EscharEx clinical program into pivotal Phase 3 clinical trials and current next step is to meet with the U.S. FDA in the second half of this year to discuss the clinical program. Additionally, we are looking forward to resubmitting the BLA for NexoBrid by mid-year, with an anticipated approval by year-end. As the potential for having two approved products on the market in the U.S. draws closer, we are fully committed to realizing the potential of our assets, while remaining focused on continuing to execute across our global platform.”

First Quarter Financial Results

Revenues for the first quarter of 2022 were $4.4 million, compared with $5.8 million for the first quarter of 2021. Revenue from products in the first quarter of 2022 were $1.1 million, a decrease of 56% compared to the first quarter of 2021. The decrease in revenues was primarily as a result of a $1.2 million decrease in emergency stockpile procurement by BARDA.

Gross profit for the first quarter of 2022 was $1.5 million, or 33% of net revenues, compared to a gross profit of $2.4 million, or 41% of net revenues for the first quarter of 2021.

Research and development expenses for the first quarter of 2022 were $2.4 million compared with $2.2 million, in the first quarter of 2021.

Selling, general and administrative expenses for the first quarter of 2022 were $2.3 million, compared with $2.1 million in the first quarter of 2021.

Operating loss for the first quarter of 2022 was $3.3 million, compared with $1.9 million in the first quarter of 2021. This resulted primarily from a decrease in revenues from BARDA.

The Company posted a net loss of $3.6 million, or $0.12 per share, for the first quarter of 2022 compared with a net loss of $2.9 million, or $0.10 per share, for the first quarter of 2021.

Adjusted EBITDA, as defined below, for the first quarter of 2022 was a loss of $2.6 million, compared with a loss of $1.3 million for the first quarter of 2021.

Balance Sheet Highlights

As of March 31, 2022, MediWound had $16.8 million in cash and short-term investments, compared with $11.0 million as of December 31, 2021. MediWound remained on budget, utilizing $4.0 million in the first quarter of 2022 for its operational activities. The Company expects cash use for 2022 to be in the range of $11 to $13 million.

Conference Call

MediWound management will host a conference call for investors today, Tuesday, May 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.), 1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 1297705. The call will be webcast live on the Events & Presentations page of Company’s website at: https://ir.mediwound.com/events-and-presentations

A replay of the call will be available on the Company’s website for 90 days at www.mediwound.com.