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MediWound Reports Fourth Quarter and Full Year 2021 Financial Results

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 -- 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.

Business Highlights and Updates:

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"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, reinforce 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.

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.

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.

About MediWound Ltd.

 

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; risks related to our contracts with BARDA; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

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MediWound, Ltd.

MediWound, Ltd.

MediWound, Ltd.

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MediWound, Ltd.

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