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| Statement |
|---|
| government remains solid |
| I'm excited to share that we had a remarkable year |
| So as you can all figure out the strength of this data of EscharEx versus SANTYL were extremely robust |
| EscharEx has demonstrated superior results over the dominant product in this over $2 billion potential market |
| Utilizing the same proven active pharmaceutical ingredient as NexoBrid, EscharEx has demonstrated superiority over the current market leader in Phase II studies |
| NexoBrid had an exciting year on a number of fronts |
| Moreover, NexoBrid continues to benefit from federal funding in the United States, supporting both emergency preparedness and ongoing research and development activities |
| This expansion will enhance our production capabilities six-fold, enabling us to fulfil the increasing global demand for NexoBrid |
| Vericel already reported that by the end of last year, they were approached already 50, they got 50 committee engagements, 25 of them already approved, so I think that we have, they're doing a very good job with that |
| Most notably, the clinical outcomes and the feedback from burn surgeons regarding the initial patient treated with NexoBrid have been extremely positive |
| To conclude, the company achieved significant milestones in the past quarter and in 2023 overall, and we are confident about 2024 and our future growth |
| NexoBrid has also successfully launched in two major markets, Japan through our partnership with Kaken Pharmaceuticals and in India through BSV |
| Our promising drug candidate, EscharEx is gaining recognition for its potential in revolutionizing chronic wound care with validation from leading global wound care entities |
| In our Phase II study, EscharEx demonstrated superior results |
| Looking ahead, we anticipate significant revenue growth exceeding 40% in the coming years with revenue projection of $30 million for 2025 and $39 million for 2026 |
| Overall, we are very pleased with the tremendous progress we have made with NexoBrid this year and the strong global demand we have experienced |
| We continue to prioritize increasing our manufacturing capabilities to fulfill both current and future orders and meet the rising demand for NexoBrid and thereby grow our revenue by greater than 40% |
| We have all kind of very successful or encouraging results and we are hoping to see the U.S |
| Our unwavering commitment to executing our commercial strategy of NexoBrid, coupled with our substantial operational excellence, has yielded revenue of $19 million |
| So, the product was accepted there extremely well |
| So, to summarize, MediWound has made an outstanding progress in 2023 |
| They position in EscharEx to become the market leader in enzymatic agents for the treatment of chronic wounds |
| EscharEx is a potential blockbuster and the company is focused and committed to the successful execution of the clinical development program and to diligently performing all the pre-commercial activities required to ensure an optimal launch |
| This is a strong indicator of NexoBrid potential to change the standard-of-care in Eschar removal for patients with severe burns |
| Vericel is focused on building a strong foundation for NexoBrid by supporting P&T committee approvals |
| I'm excited about what the future holds for us as we stay committed to redefining the standard of care with NexoBrid and EscharEx |
| This successful development has sparked increased interest from various global governments in stockpiling NexoBrid for future emergencies |
| The results of the head-to-head analysis are compelling and were achieved with robust statistical significance |
| All of these have driven an increased global demand, which we are on track to meet with the scale up of our manufacturing facility |
| Therefore, this label extension should significantly increase the addressable markets |
| Statement |
|---|
| In the first quarter of 2023, the company reported revenue of $5.3 million, a decrease from $11.6 million in the first quarter of 2022 |
| For the year ended December 31, 2023, the company's revenue totaled $18.7 million, a decrease from $26.5 million for the year ended 2022 |
| The operating loss of the quarter was $3.9 million compared to an operating profit of $2.1 million in the first quarter of 2022 |
| Ofer Gonen I believe that if you look at how the standard-of-care in the United States was until a quarter ago, it is even painful to watch, very aggressive, a lot of pain and blood and associated |
| The non-GAAP adjusted EBITDA for the quarter was a loss of $3.2 million compared to a profit of $3.4 million in the first quarter of 2022 |
| The non-GAAP adjusted EBITDA showed a loss of $12.3 million compared to a loss of $4.4 million reported in the previous year |
| Gross profit for the year was $3.6 million or 19.1% of total revenue, a decrease from $13.2 million or 49.7% of total revenue in prior year |
| The decrease in gross profit is largely attributed to the BLA approval milestone payment from Vericel in prior year |
| The demand for NexoBrid currently exceeds our production capabilities |
| The net loss was reported at $1.7 million or $0.19 per share, which is a decrease from a net loss of $7.5 million or $1.18 per share in the first quarter of the previous year |
| The operating loss for the year was $15.3 million compared to an $8.3 million loss in previous year |
| Research and development expenses for the year were $7.5 million, a decrease from $10.2 million in the previous year |
| We didn't plan on a very significant growth of demand |
| The decrease in gross profit percentage reflects the absence of the significant one-time payment received in 2022 |
| The company's research and development expenses amounted to $1.8 million, a decrease from $2.7 million in the first quarter of 2022 |
| The net loss for the year was $6.7 million or $0.75 per share compared to a net loss of $19.6 million or $3.93 per share for the year ended December 31, 2022 |
| So, as for 2026, the $39 million, we do not include all kinds of growth and unexpected positive surprises |
| Ofer, just hoping to do a two-part question on NexoBrid first, but just seems like the demand is surging globally |
| Selling, general and administrative expenses were reported at $2.8 million, slightly less than the $3 million in the same quarter of the previous year |
| Our expectations and guidance is only limited by our ability to manufacture |
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