MediWound Reports Third Quarter 2021 Financial Results
MediWound Ltd. (Nasdaq: MDWD) reported Q3 2021 revenues of $6.4 million, a 4% decline from Q3 2020. Year-to-date revenues rose by 21% to $18.3 million. The company maintains $13.9 million in cash and short-term investments as of September 30, 2021. A regulatory path for the resubmission of NexoBrid's Biologics License Application (BLA) is established, targeted for mid-2022. The EscharEx Phase 2 program's top-line results are now expected in Q1 2022. Notably, net loss for Q3 2021 was $3.3 million, or $0.12 per share.
- Year-to-date revenue increased by 21% to $18.3 million.
- Product revenues surged 81% to $9.0 million year-to-date.
- Establishment of a clear regulatory path for NexoBrid BLA resubmission.
- Q3 revenue declined by 4% compared to Q3 2020.
- Operating loss increased to $2.9 million in Q3 2021 from $1.5 million in Q3 2020.
- Net loss of $3.3 million in Q3 2021, up from $1.9 million in Q3 2020.
Third Quarter Revenues of
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 of21% 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
Gross profit for the third quarter of 2021was
Research and development expenses for the third quarter of 2021 were
Selling, general and administrative expenses for the third quarter of 2021 were
Operating loss for the third quarter of 2021 was
The Company posted a net loss of
Adjusted EBITDA, as defined below, for the third quarter of 2021 was a loss of
Year-to-Date 2021 Financial Results
Revenues for the first nine months of 2021 were
Operating loss for the first nine months of 2021 was
The Company’s net loss for the first nine months of 2021 was
Adjusted EBITDA, for the first nine months of 2021, was a loss of
Balance Sheet Highlights
As of September 30, 2021, MediWound had
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.
A replay of the call will be available on the Company website for 90 days at www.mediwound.com.
About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, biotherapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx is our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
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; 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; risks related to our contracts with BARDA; 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, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021, 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.
| Contacts: | Monique Kosse |
MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| September 30, | December 31, | ||||
| 2021 | 2020 | 2020 | |||
| Unaudited | Audited | ||||
| Cash, cash equivalents and short term deposits | 13,866 | 25,023 | 21,584 | ||
| Accounts and other receivable | 3,553 | 3,495 | 3,229 | ||
| Inventories | 1,252 | 1,805 | 1,380 | ||
| Total current assets | 18,671 | 30,323 | 26,193 | ||
|
| |||||
| Property, plant and equipment, net | 2,531 | 2,448 | 2,630 | ||
| Right of use assets, net | 1,650 | 2,170 | 1,884 | ||
| Intangible assets, net | 314 | 380 | 363 | ||
| Total long-term assets | 4,495 | 4,998 | 4,877 | ||
|
| |||||
| Total assets | 23,166 | 35,321 | 31,070 | ||
| Current maturities of long-term liabilities | 1,867 | 1,081 | 1,750 | ||
| Trade payables and accrued expenses | 3,710 | 3,155 | 2,992 | ||
| Other payables | 4,384 | 7,394 | 3,524 | ||
| Total current liabilities | 9,961 | 11,630 | 8,266 | ||
| Deferred revenues | 352 | 1,283 | 1,234 | ||
| Liability in respect of Israeli Innovation Authority grants net of current maturity | 7,715 | 7,157 |
7,267 | ||
| Contingent consideration for the purchase of shares net of current maturity | 4,195 | 4,408 |
4,998 | ||
| Lease liability, net of current maturity | 1,483 | 1,942 | 1,741 | ||
| Severance pay liability, net | 281 | 284 | 292 | ||
| Total long-term liabilities | 14,026 | 15,074 | 15,532 | ||
|
| |||||
| Shareholders' equity (deficit) | (821) | 8,617 | 7,272 | ||
| Total liabilities & shareholder equity | 23,166 | 35,321 | 31,070 | ||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) (UNAUDITED)
U.S. dollars in thousands
| Nine months ended | Three months ended | ||||||||
| September 30, | September 30, | ||||||||
| 2021 | 2020 | 2021 |
| 2020 | |||||
| Revenues | 18,276 | 15,090 | 6,372 | 6,625 | |||||
| Cost of revenues | 11,044 | 9,873 | 3,917 | 3,855 | |||||
| Gross profit | 7,232 | 5,217 | 2,455 | 2,770 | |||||
| Operating expenses: |
|
| |||||||
| Research and development, net | 7,795 | 5,473 | 2,897 | 2,142 | |||||
| Selling, general & administrative | 7,137 | 6,198 | 2,442 | 2,170 | |||||
| Operating loss | (7,700) | (6,454) | (2,884) | (1,542) | | ||||
| Financial expenses, net | (1,668) | (1,093) | (457) | (448) | | ||||
| Loss from continuing operations | (9,368) | (7,547) | (3,341) | (1,990) | | ||||
| Profit from discontinued operation | - | 83 | - | 83 | |||||
| Loss before Taxes on Income | (9,368) | (7,464) | (3,341) | (1,907) | |||||
| Taxes on Income | (23) | - | (4) | - | |||||
| Net Loss | (9,391) | (7,464) | (3,345) | (1,907) | |||||
| Foreign currency translation adjustments | 15 | (11) | 7 | (12) | |||||
| Total comprehensive loss | (9,376) | (7,475) | (3,338) | (1,919) | |||||
| Net loss per share | (0.34) | (0.27) | (0.12) | (0.07) | |||||
| Weighted average number of ordinary shares used in the computation of basic and diluted loss per share: | 27,243 | 27,206 | 27,179 | 27,179 | |||||
MediWound, Ltd.
ADJUSTED EBITDA
U.S. dollars in thousands
| Nine months ended | Three months ended | ||||||
| September 30, | September 30, | ||||||
| 2021 | 2020 | 2021 | 2020 | ||||
| Loss for the period | (9,391) | (7,464) | (3,345) | (1,907) | |||
| Adjustments: |
|
| |||||
| Financial expenses, net | (1,668) | (1,093) | (457) | (448) | |||
| Profit from discontinued operation | - | 83 | - | 83 | |||
| Tax Expenses | (23) | - | (4) | - | |||
| Depreciation and amortization | (962) | (866) | (335) | (327) | |||
| Share-based compensation expenses | (1,283) | (923) | (399) | (404) | |||
| Total adjustments | (3,936) | (2,799) | (1,195) | (1,096) | |||
| Adjusted EBITDA | (5,455) | (4,665) | (2,150) | (811) | |||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
(UNAUDITED)
U.S. dollars in thousands
| Nine months ended | Three months ended | |||||||||
| September 30, | September 30, | |||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||
| Cash Flows from Operating Activities: | ||||||||||
| Net loss | (9,391) | (7,464) | (3,345) | (1,907) | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
| Adjustments to profit and loss items: Profit from discontinued operations | - | (83) | - | (83) | ||||||
| Depreciation and amortization | 962 | 866 | 335 | 327 | ||||||
| Share-based compensation | 1,283 | 923 | 399 | 404 | ||||||
| Revaluation of liabilities in respect of IIA grants | 808 | 692 | 311 | 268 | ||||||
| Revaluation of liabilities in respect of purchase of shares | 446 | 558 | 147 | 210 | ||||||
| Revaluation of lease liabilities | 84 | 127 | 49 | 63 | ||||||
| Increase (decrease) in severance liability, net | 3 | 35 | 8 | (5) | ||||||
| Financing income, net | (11) | (244) | - | (53) | ||||||
| Unrealized foreign currency (gain) loss | (238) | (8) | (12) | (36) | ||||||
| 3,337 | 2,866 | 1,237 | 1,095 | |||||||
| Changes in asset and liability items: | ||||||||||
| Decrease in trade receivables | 697 | 1,477 | 17 | 136 | ||||||
| Decrease (increase) in inventories | 188 | (231) | 171 | 95 | ||||||
| Increase in other receivables | (1,078) | (397) | (646) | (113) | ||||||
| Increase (decrease) in trade payables and prepaid expenses | 733 | (925) | (342) | 724 | ||||||
| Increase (decrease) in other payables & deferred revenues | (1,167) | 1,288 | 90 | 1,202 | ||||||
| (627) | 1,212 | (710) | 2,044 | |||||||
| Net cash used in continuing operating activities | (6,681) | (3,386) | (2,818) | 1,232 | ||||||
| Net cash used in discontinued operating activities | - | (192) | - | (192) | ||||||
| Net cash used in operating activities | (6,681) | (3,578) | (2,818) | 1,040 | ||||||
| Nine months ended | Three months ended | |||||||||
| September 30, | September 30, | |||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||
| Cash Flows from Investment Activities: | ||||||||||
| Purchase of property and equipment | (373) | (480) | (129) | (236) | ||||||
| Interest received | 35 | 43 | - | 1 | ||||||
| Proceeds from short term bank deposits, net of investments | 4,002 | 8,136 | - | (2,459) | ||||||
| Net cash provided by (used in) investing activities | 3,664 | 7,699 | (129) | (2,694) | ||||||
| Cash Flows from Financing Activities: | ||||||||||
| Repayment of lease liabilities | (513) | (533) | (176) | (220) | ||||||
| Proceeds from IIA grants, net of repayments | (360) | (121) | (180) | (55) | ||||||
| Net cash used in financing activities | (873) | (654) | (356) | (275) | ||||||
| Exchange rate differences on cash and cash equivalent balances | 197 | 32 | (7) | 58 | ||||||
| Increase (decrease) in cash and cash equivalents from continuing activities | (3,693) | 3,691 | (3,310) | (1,679) | ||||||
| Decrease in cash and cash equivalents from discontinued activities | - | (192) | - | (192) | ||||||
| Balance of cash and cash equivalents at the beginning of the period | 17,376 | 7,242 | 16,993 | 12,612 | ||||||
| Balance of cash and cash equivalents at the end of the period | 13,683 | 10,741 | 13,683 | 10,741 | ||||||
FAQ
What were MediWound's Q3 2021 revenues?
How much did MediWound's revenues increase in the first nine months of 2021?
What is the expected timeline for the NexoBrid BLA resubmission?
What was MediWound's net loss for Q3 2021?
When are the top-line results for the EscharEx Phase 2 program expected?
