Welcome to MediWound's Second Quarter 2022 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Monique Kosse of LifeSci Advisors. Please go ahead. Thank you, operator, and welcome everyone. Earlier today, MediWound issued a press release announcing financial results for the second quarter ended June 30, 2022. You may access that release on the company's website under the Investors' tab. With us today are Ofer Gonen, Chief Executive Officer of MediWound, and Boaz Gur-Lavie, Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in MediWound's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. The conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Thank you, Monique. Good morning, everyone. Welcome to our Second Quarter 2022 Conference Call to discuss our financial and operational highlights and provide you with our corporate updates. I would like to begin by saying how proud I am of the accomplishment we made this quarter, and note that this is my first earnings call as the new CEO of MediWound. May I add that my transition from being a board member to becoming a CEO has been very smooth. This quarter, we had positive news across all of our programs, and the company is on a strong trajectory. Before I begin my update, I would like to welcome Mr. Nachum "Homi" Shamir as our new Chairman of the Board, Dr. Rob Snyder as our Chief Medical Officer, and Mr. Tzvi Palash as our Chief Operating Officer. Many of you already know Homi from his years as a CEO of Luminex and Given Imaging. He led both companies to M&A transactions valued at billions of dollars. We are honored to have him lead our board and look forward to benefiting from his valuable insights and extensive experience. Dr. Rob Snyder, a top-notch industry leader in wound care, is an outstanding addition to our team. He joined us at the optimal time as EscharEx becomes our primary focus. Dr. Snyder is the past president of the Association for the Advancement of Wound Care and the past president of the American Board of Wound Management. He published over 165 papers in peer-reviewed journals and served as principal investigator on over 65 randomized controlled trials for innovative wound healing products. He has been instrumental in the development of EscharEx, and as of January 1st, 2023, he will assume full responsibility from Professor Lior Rosenberg, who will continue to support MediWound as its Medical Director. Lastly on that, Tzvi Palash has over 35 years of proven experience in commercial operation in the healthcare industry. His notable record of seamless execution makes him the right COO for MediWound. Moving now to our performance. It was an excellent quarter for MediWound as we met all of our objectives we set for ourselves. We were successful in both EscharEx phase II clinical trials. We received FDA's acceptance of the NexoBrid BLA resubmission, and we had positive preliminary results in the MW005 U.S. phase I/ II study. On top of that, MediWound significantly enhanced the board and its leadership team, and now we are ready to advance forward, maximizing our strategic alternatives. Let's discuss the EscharEx program. Last month, we hosted a KOL Investor Day with four industry leaders highlighting the current treatment practices, the unmet medical need, and the potential commercial opportunity for EscharEx. We believe EscharEx has the potential to be a blockbuster. The phase II data from both clinical studies were robust and demonstrated that EscharEx is safe, well-tolerated, and effective. Primary and secondary endpoints were achieved with statistical significance. EscharEx is superior to gel vehicle and to non-surgical standard of care in all the relevant parameters. It is better in the incidence of complete debridement, better in number of application needed, and much better in the time to achieve complete debridement. On average, less than four applications are required to achieve a complete debridement with EscharEx compared to nearly 13 with non-surgical standard of care. Median time to complete debridement is nine days for patients treated with EscharEx, compared to 59 days for patients treated with non-surgical standard of care. These are huge differences. Additionally, its strong effect on the reduction of biofilm and bacterial burden further demonstrates EscharEx's superiority over the other debridement modalities. Our market research, which was conducted by a third party, suggests that based on those results, it is anticipated that EscharEx will draw market share from all other debridement modalities. Not just from the enzymatic and the autolytic debridement, but also from sharp debridement, which is currently considered the most effective standard of care and comprise approximately 60% of this market. As we look at the sales of the current commercial enzymatic debridement agent and drawing additional market share from other modalities, we are optimistic about the commercial opportunity. We believe that we can become a significant player in this $2 billion total debridement market. We aim to be the first choice for the millions of patients suffering from chronic wounds. I strongly encourage you to view the webinar of our KOL event, which is available on our website, for an in-depth review of EscharEx's capabilities and its potential market. Since announcing our phase II data, we seek growing interest from potential strategic players, and we are pleased to have several options to continue advancing this therapy. We are evaluating all possibilities, including collaboration with a potential partner or developing it independently. No matter the pathway, we are moving forward. We will develop EscharEx for both VLUs and DFUs. The development cost for additional territories is marginal. Therefore, we will be developing it for the United States, for Europe, and for other international markets. We believe that global approach will also speed up our time to market. Our next step is to meet with the FDA in the second half of this year to discuss the phase III protocol. We will have more to say about this once we gain clarity on the trial design and the regulatory pathway going forward. We believe that EscharEx clinical development program is de-risked, not only because of the robust data generated to date, but given the fact that it has the same API as NexoBrid, which is a commercial product with more than 10,000 patients successfully treated worldwide. Moving to our NexoBrid program. We announced last week that the FDA accepted our resubmission filing and has given a PDUFA date of January 1st, 2023. We continue to have strong partnerships with BARDA and Vericel, and together, we are committed to NexoBrid becoming a commercial success in the United States. We continue to enroll new patients in the next expanded access program at 24 leading U.S. burn centers with over 165 burn patients who have already been treated successfully with NexoBrid to date. We are on track with our collaboration with the United States Department of Defense for the development of NexoBrid as a non-surgical solution for field care burn treatment for the U.S. Army. The success of this program would open the gate for armies all over the world. It is also expected to simplify our supply chain costs and administration. In Europe, we continue to see burn centers embrace NexoBrid as their standard of care and have seen consistent revenue growth. We are progressing with the pediatrics label extension and expecting approval in the first half of 2023. Internationally, we continue to execute on our commercial strategy of global expansion, and currently, NexoBrid is already approved in 41 countries. Later this year, we anticipate additional marketing approvals in the larger markets, including Japan and India. Lastly, we were pleased with the positive initial data from our U.S. phase I/II study of MW005 for the treatment of Basal Cell Carcinoma, BCC. The data shows MW005 to be safe and well-tolerated, with a majority of patients who completed the study achieved complete histological clearance of their target lesions. These encouraging results suggest that we are on the right path to offer a topical treatment for patients with BCC that would be an alternative to a surgery. The market is definitely ready for a safe, effective, and patient-friendly topical solution for BCC. This is another validation for our technology platform. To conclude, we are fundamentally in a very strong position. We believe we have a winner with EscharEx, with multiple options moving forward. We have a potential approval in the United States for NexoBrid with an excellent commercial partner, and we have a pipeline of follow-on therapies with MW005 in BCC with very encouraging initial data. Let me now turn the call over to Boaz for a brief review of our financials. Boaz? Thank you, Ofer, and good morning, everyone. Total revenues for the second quarter of 2022 were $4.7 million compared to $6.1 million for the second quarter of 2021. This was primarily due to decrease in revenues from products and licenses of $1.9 million compared to $3 million in the second quarter of 2021. This resulted from $0.7 million decrease in emergency stockpile procurement by BARDA and $0.6 million shift in revenue due to the temporary shortage in the supply chain of gel jars. We have managed to address this issue and expect to regain some of those revenues in the third quarter of 2022. Gross profit was $1.1 million, or 24% of net revenues, compared to a gross profit of $2.4 million, or 39% of net revenues for the second quarter of 2021, resulting from the decrease in revenues from products and licensing. Operating expenses were $4.8 million compared to $5.3 million in the second quarter of 2021. The decrease in expenses was primarily driven by the completion of the company's U.S. phase II EscharEx trials. Operating loss was $3.7 million compared to $2.9 million in the second quarter of 2021. Net loss was $4.4 million, or $0.13 per share, compared to a net loss of $3.2 million, or $0.12 per share for the second quarter of 2021. Adjusted EBITDA was a loss of $2.8 million compared to a loss of $2 million for the second quarter of 2021. Moving to year-to-date 2022 financial results. Total revenues for the first half of 2022 were $9.1 million compared to $11.9 million in the first half of 2021. Revenues from product and licenses in the first half of 2022 were $3.2 million compared to $5.9 million for the first half of 2021. This was primarily caused by decrease in emergency stockpile procurement by BARDA. Also, as stated before, it also included $0.6 million revenue shift due to the temporary supply chain shortage, and we expect to regain some of the revenue in the third quarter of 2022. Operating loss was $7 million, compared with an operating loss of $4.8 million in the first half of 2021. Net loss was $7.9 million, or $0.26 per share, compared to a net loss of $6 million or $0.22 per share for the first half of 2021. Adjusted EBITDA was a loss of $5.4 million, compared to a loss of $3.3 million for the first half of 2021. Moving now to balance sheet highlights. As of June 30th, 2022, MediWound had $10.4 million in cash and short-term investments, compared with $11 million as of December 31st, 2021, and no debt. MediWound utilized $6.4 million in the second quarter of 2022 for its operational activities, which was affected by $1.8 million delay in collection from customers subsequently received in July, $0.6 million shift in revenue to the third quarter due to the temporary shortage in supply chain. In addition, cash used for the quarter included $0.6 million in commissions related to the equity raise during the first quarter. The company is updating its cash use for 2022 to be between $13 million-$15 million from the $11 million-$13 million due to the impact of management changes and projected revenue shifting to 2023. With that, I have concluded my financial overview and will now turn the call back over to Ofer. Ofer? Thank you, Boaz. I'm very proud of our accomplishment this quarter. We have made significant strides across our pipeline of game-changing therapies. While we believe NexoBrid's potential FDA approval is a meaningful step forward for burn care in the United States, EscharEx remains our primary focus. We believe it has the potential to be a transformative treatment option for millions of patients suffering from chronic wounds and become a best-in-class debridement preference throughout the medical community. With EscharEx, we hope to capture a significant part of the billion-dollar chronic wound debridement market in the United States. I look forward to sharing continued progress throughout the second half of this year. Our anticipated milestones include meeting with the FDA in the second half of this year regarding the EscharEx phase III study. A PDUFA date of January 1st, 2023, with the potential U.S. approval of NexoBrid. MW005 phase I/II clinical results for Basal Cell Carcinoma in the second half of 2022. With that, it is now my pleasure to open the call for your questions. Operator? At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the question and answer roster. Your first question comes from the line of Josh Jennings from Cowen. Your line is open. Hi, this is Brian here for Josh. Thank you for taking my questions. I want to start on NexoBrid. Just on the pre-launch activity, can you provide an update on the Nexo protocol and whether that will be expanded ahead of the formal launch next year? Also for the BLA itself, have the two needed facility inspections been scheduled? Or perhaps more broadly, how are you thinking about the completion of those in the context of the FDA's current review times? Okay. Hi, Brian. Thank you for those questions. As we said, we continue to enroll patients for the next expanded access program at 24 leading U.S. burn centers. More than 165 patients have been already enrolled. Our plan is to increase the size of the next expanded access program at least until the approval of NexoBrid. We are working with BARDA and Vericel on that, and we will update you as soon as we have additional information about it. This is for the first question. As for the second one, interesting you ask because we just had a discussion about it. As for the pre-approval inspection, we assume that the FDA will conduct a pre-approval inspection in both facilities, in Israel and in Taiwan. As far as we know, FDA schedules a few facility inspections in Israel for the next couple of months, so we don't see an issue about it, and we think it will be as planned. Great. Thank you. I also want to follow up on your comments regarding possible partnerships or strategic options and specific to EscharEx. When should investors expect a clearer indication of the decision to either independently fund the phase III program versus looking for a partner? I guess my very specific question is: Will that decision be settled by the end of the phase II meeting with the FDA and prior to the start of the phase III program, or is this an ongoing process that could extend into phase III development itself? Thank you for taking the questions. Thank you for that question. As I said earlier, since announcing the phase II data, we see growing interest from potential strategic players. We have several options. We have many inbound approaches. We are evaluating all the possibilities. As you can imagine, when we meet with the FDA in the fourth quarter, we will know better about how the phase III looks like, how many patients are required, and then we will know how much money is required in order to fund this trial. We can either sign a deal prior or after that. We don't have a decision, we need to take such a decision soon. Brian? Hello? Thank you. Okay, good. Your next question comes from the line of Ryan Zimmerman from BTIG. Your line is open. Thank you for taking the questions. Good to connect with everyone this morning. Maybe just to follow up on a couple other topics. One, the supply chain dynamics that impacted product revenues in the third quarter, it sounds like they're fully resolved, Boaz, but can you just give us a little more color there? You know, is this something that you think it shouldn't come up again in terms of you know, just getting the appropriate products for the international sales? First of all, good morning, Ryan, and thank you for the question. This temporary shortage in supply chain relates to gel jars, which is part of the kit of NexoBrid and gel. That, as we indicated, affected us with approximately $0.6 million, which most of that will be regained in Q3. Last week we got 20,000 gel jars, so we have enough now inventory for the next year and a half. We believe that we've resolved it and currently working on replenishment of all the orders that were pending. We believe that's something we've overcome already and of course look forward to continue to support our customers. That's helpful. Twenty thousand sounds like it's certainly enough. What the second question I have, Ofer, is if you could just talk a little bit about BARDA's plans to support a pediatric study and just where BARDA stands in terms of continued support for NexoBrid and just how to think about, you know, the potential for BARDA revenue over the next, you know, few quarters and into 2023. Okay. It's a good question. Thank you. I will answer, but something that I cannot answer. I'm not allowed to. As you can im- The speaker's line has just been disconnected. One moment while we can reconnect the line. Ofer, do you hear me? Y-yeah. Okay. Let me tell you where I have you. Okay. Ofer, you may go ahead. Okay. Ryan, I'm sorry about that. I don't know if you heard my, if you Yeah. Heard my answer, but okay. We kinda lost you at the start there, Ofer. Okay, I'm sorry about that. As for that BARDA, as you can imagine, we have a very good relationship with them. NexoBrid is considered a strategic program for BARDA. They supported it quite substantially in the past. We have a few programs going forward. We are speaking about replenishment, we are speaking about pediatric, a pediatric label extension. We have many plans going forward, and we don't see any. We just see positive with that specific collaboration in the future. Okay. That's helpful. Then if I could just ask one more and then hop back in queue. You know, just following up from the previous question, you've talked about this, Ofer, since you've joined the company in terms of interest, in terms of partnering or, you know, striking some sort of deal on EscharEx and- Yeah. It'd just be helpful to know kind of, you know, what you consider an ideal partner. Mm-hmm. You know, as we think about potential partners for you guys, you know, be it a comprehensive advanced wound care player or a pharmaceutical company. Yeah. I mean, what do you think about in terms of the things you're looking for in a partner? You know, the financial terms aside, you know, what is it that you- Mm-hmm. believe can bring the best value for EscharEx? Okay. Thank you for that question. As you saw from my background in my previous career, I made many transactions, many M&A transactions, many collaborations with Big Pharma, and made many strategic agreements with all kind of pharmaceutical companies. In MediWound, there is a high probability that we have an option to do here something like that as well. The answer for your question is yes, we have an option to do deals with pharmaceutical companies, with biotech companies, and with wound care companies. The reason is that the market is huge, and if you look at the number of approved biotech drugs in the wound care space, you see that the number is somewhere between zero to two. Therefore, this asset is considered very unique and there you cannot find a significant player in the field that is indifferent to the results that we had in the phase II study of EscharEx. Having said that, I want to be very clear, we are not looking for a partner to license EscharEx in the United States. We think that the way to have approval is not that long, and it's not that expensive, and we don't want to let go percentage of the drug at this stage. We can look at other avenues, such as other territories or all kind of collaborations around that. The ideal transaction, and I want to make it clear, is not to license the deal, the EscharEx in North America, as we did with NexoBrid. Very helpful. Thank you for answering the questions. Thank you. Your next question comes from the line of François Brisebois from Oppenheimer. Your line is open. Hi, this is Daniel on for Frank. Congrats on the quarter, and congrats, Ofer, on your transition to CEO. Thanks for taking our questions. Thank you. Firstly, if I could start with the market research for EscharEx. You know, based on these efficacy signals you have seen so far, be it speed of complete debridement and improvements in biomarkers, are these sufficient to shift the standard of care where a non-surgical debridement option like EscharEx is used as first-line therapy as a replacement for surgical options? I think that they definitely touch upon the most important aspect, Daniel, because when we did the market research, and we approached dozens of physicians, and when they saw the capabilities or the characteristics of product X, they claimed, all of them said, or not all of them, but the majority of them, said, "We need that product," which means that we anticipate that EscharEx will draw market share from all the other debridement modalities. We are not speaking only on the enzymatic and autolytic, which is very natural, which is currently something between 20%- 29% of the market. We are speaking about taking pieces from the sharp debridement, which is currently considered the most effective standard of care, and it comprises something like 50% of the market. If you look at those numbers, you see that the numbers that you're getting are quite huge. We're speaking about something like 30% of a $2 billion market. When we did that specific market analysis, we spoke only about the United States. We haven't shared information about the European potential. We are working on that as we speak with a third party, but our internal analysis suggests that there is a significant potential in Europe as well. I hope I answered the question. Yep. Thanks for that added color. If I could slip in one more to follow up. In case you were sharing anything on this, on the upcoming FDA meeting, you know, could you add some color on what you expect to gain clarity on? Would you know, talking about sharp debridement, is there non-inferiority for wound closure? Is that something that is on the table for discussion, anything on that? Yeah. I can share with you something like that. As you can imagine when you're working on a pivotal program for EscharEx, we are trying the trial to be as close as it can to the very robust phase II study that we did. Actually, we did three phase II studies. In all of them, we saw the same results. Our motivation is that the phase III will look almost the same as the robust, the largest phase II that we did. Of course, with the FDA, when we approach them, we need to speak about the indications, we need to speak about the sample size, and we need to speak about the study design, which we expect will be very close to the study design that we had in the phase II. Which means we're speaking about incidence of complete debridement as a primary endpoint because we know that we can. The FDA already approved that we can use that endpoint as a primary endpoint. We saw all kind of clinical benefits. When we disclosed the full data of EscharEx, you saw all the other benefits that EscharEx shows. We are going to repeat those, hopefully, we're going to repeat those results in the phase III study, and then hopefully the product will be approved. Great. Thanks for taking my I hope it was helpful. Yes. Thanks for taking our questions, and congrats again on the quarter. Thank you. Again, if you would like to ask a question, press star then the number one on your telephone keypad. Your next question comes from the line of Arthur Yu He from H.C. Wainwright. Your line is open. Hey, everyone. Thanks for taking my question. This is Arthur on for RK. Most of my question has been asked, and I just want to quickly touch on the MW005 program. Could you remind us what's the difference between the first cohort and the second cohort? And also regarding the dosing regimen, what's the rationale behind to choose seven topical applications every other week as the dosing regimen? Would that dosing regimen be adjusted when we go for the later clinical study? Thank you. Thank you for the question about MW005. We believe that the market is definitely ready for a safe, effective, patient-friendly topical solution for BCC. If you look at the market, you see that like in burns, like in wounds, the most common modality is surgery. If you look at superficial BCCs, topical treatments are quite common. The two available treatments for BCC are fairly they have some safety issues. Not some safety issues, they have safety issues, and their efficacy is very limited. What we wanted to prove in our BCC study with those two cohorts is that the product is safe, well tolerated, friendly to the patient, and efficient. What we did is we took the phase first cohort of patients, and we try to see if it is as effective as we saw in a previous study that was a kind of a case series study. If we see that the efficacy and safety, we have no issues or there are issues, we'll take a decision regarding the second cohort. In the second cohort, the amount of material or the amount of the number of application is higher. We may be in a situation that we do not need that according to the result that we are going to publish next quarter. Oh, thank you. I hope it was helpful. Yep. It is. Thank you. At this time, there are no further questions in the queue. I would now like to turn the call back over to Ofer Gonen, Chief Executive Officer, for closing remarks. Okay. Thank you everyone for joining us today. We look forward to updating you again in our next call. Thank you. This concludes today's conference call. You may now disconnect.