Mediwound Ltd (MDWD)

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MediWound Reports Third Quarter 2022 Financial Results and Provides Company Update

https://finance.yahoo.com/news/mediwound-reports-third-quarter-2022-120000346.html

$30.5 million in gross proceeds raised; operating cash runway through 2025

NexoBrid PDUFA date of January 1, 2023; Upon approval, NexoBrid expected to generate meaningful revenues

Company focused on the billion-dollar market opportunity with EscharEx Phase 3 clinical study to begin in first-half 2023

Conference call begins today at 8:30 a.m. Eastern Time

YAVNE, Israel, Nov. 15, 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 third quarter ended September 30, 2022 and provided a corporate update.

“We are approaching several significant inflection points for the Company,” said Ofer Gonen, Chief Executive Officer of MediWound. “We believe, once approved, NexoBrid® is poised to generate meaningful revenues in 2023 and exponential growth going forward. Following the launch of NexoBrid, we will focus on the billion-dollar market opportunity presented to us with EscharEx®, where we plan to initiate a Phase III study next year. We have all the essential elements aligned for success: a mature pipeline, favorable data, large addressable markets, an experienced operational team, tier-1 partners, and a strong balance sheet. We are strategically positioned to unlock additional opportunities that will improve patient lives and add value to our shareholders.”

Third Quarter Highlights and Recent Developments:

Raised $30.5 million in gross proceeds in a concurrent Registered Direct and Private Placement offering with participation from current and new shareholders including Israel Biotech Fund, New Era Capital Partners, Discount Capital and Deep Insight, as well as members of the management team and board of directors. The Company intends to use the net proceeds primarily for the development of EscharEx®, scale up of the manufacturing facility, and general corporate purposes.

EscharEx’s promising results from the completed Phase 2 trials featured in oral and poster presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022, in Las Vegas, Nevada. Pivotal Phase 3 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs) is currently expected to start in the first-half of 2023.

FDA’s review of NexoBrid BLA is progressing; inspections of manufacturing facilities in Taiwan and Israel are underway.

The European Medicines Agency (EMA) validated for review the Company’s Type II Variation to expand NexoBrid’s currently approved indication for the pediatric population. The company anticipates a decision from the EMA during the first quarter of calendar year 2023.

NexoBrid was highlighted in 45 posters and presentations at the 19th European Burns Association Congress in Turin, Italy. Leading European burn specialists and thought leaders from around the world shared their positive experiences and patient outcomes using NexoBrid in a wide range of settings.

Positive initial data from the Company’s U.S. Phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) was announced. The initial data showed MW005 to be safe and well-tolerated, and target lesions clearance data provided clinical efficacy proof-of-concept. Additional study data expected later this year.

Strategic Advisory Board (SAB) of esteemed industry leaders was established to add significant expertise and insight to MediWound’s strategic and operational activities.

Total revenues for the third quarter of 2022 were $5.8 million compared to $6.4 million in the third quarter of 2021, and $4.7 million in the second quarter of 2022.

Cash and short-term investments of $17.6 million as of September 30, 2022. An additional $17.2 million in gross proceeds ($16.6 million net proceeds) was received from the Private Placement Offering closed on October 6, 2022. The Company has sufficient cash to fund its expected operations through 2025.

Third Quarter Financial Highlights

Total revenues for the third quarter of 2022 were $5.8 million, compared to $6.4 million for the third quarter of 2021. Revenues from products in the third quarter of 2022 were $1.4 million compared to $2.6million in the third quarter of 2021. This was primarily due to decrease in emergency stockpile procurement by BARDA.

Gross profit for the third quarter of 2022 was $2.4 million, or 42% of net revenues, compared to a gross profit of $2.5 million, or 39% of net revenues, for the third quarter of 2021.

Research and development expenses for the third quarter of 2022 were $2.9 million same as in the third quarter of 2021.

Selling, general and administrative expenses for the third quarter of 2022 were $3.1million, compared to $2.4 million in the third quarter of 2021. The increasewas primarily a result of approximately $0.2 million of share-based compensation costs and $0.3 million of one-time marketing expenses.

Operating loss for the third quarter of 2022 was $3.5 million compared to $2.9 million in the third quarter of 2021.

The Company posted a net loss for the third quarter of 2022 of $4.2 million, or $0.13 per share, compared to a net loss of $3.3 million, or $0.12 per share, for the third quarter of 2021.

Adjusted EBITDA, as defined below, for the third quarter of 2022 was a loss of $2.4 million, compared to a loss of $2.2 million for the third quarter of 2021.

Year-to-Date 2022 Financial Results

Total revenues for the first nine months of 2022were $14.9 million, compared to $18.3 million in the first nine months of 2021.Revenues from products in the first nine months of 2022were $4.2millioncompared to $7.7million for the first nine monthsof 2021. This was primarily the result of a decrease in emergency stockpile procurement by BARDA.

Operating loss for the first nine months of 2022 was $10.5 million, compared to an operating loss of $7.7 million in the first nine months of 2021.

Net loss for the first nine months of 2022was $12.1 million, or $0.38 per share compared to a net loss of $9.4 million or $0.34per share for the first nine months of 2021.

Adjusted EBITDA, as defined below, for the first nine months of 2022, was a loss of $7.8 million, compared to a loss of $5.5 million for the first nine months of 2021.

Balance Sheet Highlights

As of September 30, 2022, MediWound had $17.6 million in cash and short-term investments, compared with $11.0 million as of December 31, 2021, and no debt. MediWound utilized $4.6 million in the third quarter of 2022 for its operational activities. The Company reiterates its cash use for 2022 to be in the range of $13 to $15 million. In addition, $17.2 million in gross proceeds ($16.6 million in net proceeds were received in October from the $30.5 equity offering), to support the Company’s expected operations through 2025.

Conference Call

MediWound management will host a conference call for investors today, Tuesday, November 15, 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 833-630-1956 (in the U.S.), 80-921-2373 (Israel), or 412-317-1837 (outside the U.S. & Israel) and entering passcode 4399134. 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 at www.mediwound.com.