Mediwound Ltd (MDWD)

[midastouch017]

MediWound Reports Third Quarter 2021 Financial Results

https://finance.yahoo.com/news/mediwound-reports-third-quarter-2021-120000781.html

Third Quarter Revenues of $6.4 Million; Year-to-Date 2021 Revenues Increased 21%

Clarity on Regulatory Pathway for Resubmission of NexoBrid BLA, Anticipated in Mid- 2022

EscharEx Phase 2 Program Top-Line Results Accelerated, Currently Expected in the First Quarter of 2022

Conference call begins today at 8:30 am ET

YAVNE, Israel, Nov. 16, 2021 (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 third quarter ended September 30, 2021.

Third Quarter and Recent Corporate and Financial Highlights:

Total revenues for the third quarter of 2021 were $6.4 million, compared to $6.6 million in the third quarter of 2020


Total revenues for the first nine months of 2021 were $18.3 million, an increase of 21% compared to $15.1 million in the same period 2020


The Company had $13.9 million in cash and short-term investments as of September 30, 2021


Following a productive Type A meeting with the U.S. Food and Drug Administration (FDA), the Company gained clarity on a path forward for resubmission of its NexoBrid® Biologics License Application (BLA), which is now anticipated in mid-2022


Positive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns


Completion of study enrollment in the EscharEx® U.S. phase II study for the treatment of venous leg ulcers (VLUs) expected by year-end with top-line data now expected in the first quarter of 2022


Positive outcome of interim assessment for EscharEx U.S. phase II adaptive design study with no changes to study sample size of 120 patients and no safety concerns identified


Announced peer-reviewed publication of EscharEx in-vivo head-to-head comparator study in the Journal of Wound Care, which showed EscharEx to be more effective than the commercially available collagenase product


Initiated a U.S. phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC); phase II investigator-initiated trial in non-melanoma skin cancers running in parallel with data from both expected in the first half of 2022.

“We are pleased with the progress we have made this quarter across our portfolio. We gained regulatory clarity on the pathway for resubmission of NexoBrid BLA, and we continue to advance significantly the clinical development programs of EscharEx, where we remain on track to complete patient enrollment of the U.S. phase 2 study for the treatment of VLUs and generate data from the phase 2 pharmacology study by year-end,” said Sharon Malka, Chief Executive Officer of MediWound. “As we approach the end of the year and look into 2022, we remain optimistic about our programs and believe 2022 will be a very meaningful year, as we are moving towards important milestones in the coming quarters. We look forward to continuing to build on the momentum as we execute on our strategic goals.”

Third Quarter Financial Results

Revenues for the third quarter of 2021 were $6.4 million, a decrease of 4% compared to $6.6 million for the third quarter of 2020 primarily due to decrease in revenues from development services provided to BARDA, and up 5% sequentially.

Gross profit for the third quarter of 2021was $2.5 million with gross margins of 39%, compared to gross profit of $2.8 million and gross margins of 42% for the third quarter of 2020.

Research and development expenses for the third quarter of 2021 were $2.9 million, compared to $2.1 million for the third quarter of 2020. The increase in expenses was primarily due to clinical development for EscharEx.

Selling, general and administrative expenses for the third quarter of 2021 were $2.4 million, compared to $2.2 million in the third quarter of 2020.

Operating loss for the third quarter of 2021 was $2.9 million, compared to an operating loss of $1.5 million in the third quarter of 2020.

The Company posted a net loss of $3.3 million, or $0.12 per share, for the third quarter of 2021 compared to a net loss of $1.9 million, or $0.07 per share, for the third quarter of 2020.

Adjusted EBITDA, as defined below, for the third quarter of 2021 was a loss of $2.2 million, compared to a loss of $0.8 million for the third quarter of 2020.

Year-to-Date 2021 Financial Results

Revenues for the first nine months of 2021 were $18.3 million compared to $15.1 million in the first nine months of 2020, an increase of 21%. Product revenues in the first nine months of 2021 were $9.0 million, an increase of 81% compared to product revenues of $5.0 million for first nine months of 2020.

Operating loss for the first nine months of 2021 was $7.7 million, compared to an operating loss of $6.5 million in the first nine months of 2020, primarily due to increase in research and development expenses.

The Company’s net loss for the first nine months of 2021 was $9.4 million or $0.34 per share compared to a net loss of $7.5 million or $0.27 per share for the first nine months of 2020.

Adjusted EBITDA, for the first nine months of 2021, was a loss of $5.5 million, compared to a loss of $4.7 million for the first nine months of 2020.

Balance Sheet Highlights

As of September 30, 2021, MediWound had $13.9 million in cash and short-term investments, compared to $21.6 million as of December 31, 2020. MediWound remained on budget, utilizing $7.7 million in the first nine months of 2021 for its operational activities. The Company reiterates its cash use for 2021 to be in the range of $9.0 to $11.0 million.

Conference Call

MediWound management will host a conference call for investors today, Tuesday, November 16, 2021 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 7771457. The call also will be webcast live on the Company’s website at http://ir.mediwound.com/events-and-presentations.