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spk01: Good day and thank you for standing by. Welcome to the Q2 MediWound 2021 conference call. At this time, all participants are in a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jeremy Pfeffer, please go ahead.
spk15: Thank you, Dawn, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results for the second quarter of 2021. You may access that release on the company's website under the Investors tab. With us today are Sharon Malka, Chief Executive Officer of MediWound, and Boaz Gorlevi, Chief Financial Officer. Following management's 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 Meadowood'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 the 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 forecast due to the impact of many factors beyond the control of Meadowood. 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 following 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 Sharon Malka, Chief Executive Officer of Network. Sharon? Thank you, Jeremy.
spk14: Good morning to our U.S. listeners, and good afternoon to our listeners in Israel. Welcome to our second quarter 2021 conference call to discuss our financial results and business highlights. The second quarter of 2021 and the subsequent weeks have been eventful from a clinical and commercial standpoint, with a positive interim assessment for SCAR-X Phase II study, FDA feedback on NexoBridge VLA, and the robust results of NexoBridge Phase III pediatric study. Commercially, we continued to generate product revenue growth compared with the prior year, driven by the procurement of NexoBridge by BARDA and the revenue's continued growth out of U.S. On the clinical front, we are pleased with the progress we gained across each of our ongoing clinical programs and are encouraged by the positive clinical data for both SCRx and Nexobrit. Let me begin first with a review of our SCRx clinical development program, where we most recently announced the best possible outcome of the interim assessment for its U.S. Phase II adaptive design study. Recall that this study aims to assess the safety and efficacy of escarex for the debridement of venous leak ulcers as compared to gel vehicle and non-surgical standard of care, while the interim assessment served to determine whether a sample size adjustment is required to maintain conditional power for this study. The interim assessment had three potential outcomes. continuation of the trial at its current sample size, an increase in the sample size to power the trial, or a sudden end of the trial due to futility. The interim assessment conducted after about 80 patients, approximately two-thirds of the original enrollment target of 120 patients, completed the debridement treatment. Based on the independence, data monitoring committee's recommendation, the interim assessment yielded two positive takeaways. First, no enrollment sample size changes are necessary to maintain the pre-specified statistical power of 80% or greater for the study's primary endpoint of incidence of complete debridement compared to the gel vehicle. This positive outcome means that the study is appropriately sized at the planned enrollment of 120 patients and can continue without the need to add more patients. As a reminder, we had previously reduced the enrollment target from 174 patients to 120 patients, so we were happy with the independent data monitoring committee's recommendation confirming that change. no safety concerns were identified in the study population, which is another positive result. This successful interim assessment suggests that SCRx is safe and tolerable and provides positive signals that increase our confidence that SCRx may prove to be an effective non-surgical therapy for debridement of chronic wounds. We anticipate completing full enrollment in this study by end of 2021 with data readout anticipated in the first half of 22. Also in our SKX program, we have enrolled our first patients in our phase two pharmacology study and anticipate data from that study later this year. As a reminder, this is a phase two open label single arm study designed to evaluate the clinical performance, safety, and pharmacology effects of escarex in the debridement of lower leg ulcers, i.e., venous leg ulcers and diabetic foot ulcers, in up to 15 patients. The data generated to date for escarex have been very encouraging. We published a peer-reviewed paper summarizing the results of a successful Phase II assessor-blinded study of our first generation Escarex, which achieved its efficacy and safety endpoints. Escarex was well tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other out-wield wounds within a few daily applications. Earlier this year, we completed successfully a comparator in vivo study designed to evaluate the debridement efficacy of Escarex and the commercial collagenous enzymatic debridement agent in a post-in-heart-to-heal model. The study concluded that Escarex treatment was clinically superior to the commercially available collagenous agent in removing Escar in this model. The data from these trials, together with a positive interim assessment, give us confidence in both of our current ongoing Phase II trials of second-generation SKRx, and we look forward to data from both of these trials. With a clear unmet medical need for a non-surgical, rapid and effective debridement agent in the outpatient setting, SKRx has the potential to improve on the current standard of care and have a meaningful impact on chronic wounds management. Turning to NexoBREED, On the commercial front, BARDA's procurement for emergency stockpile continues to drive product revenue growth, and we are expecting to recognize most of the remaining revenues related to BARDA procurement in 2021. In addition, we continue to execute on our global expansion strategy, which sustained revenues growth and expecting additional marketing approvals in lucrative markets during the next 18 months. We continue to enroll new patients to the next expanded access program at leading U.S. burn centers with over 100 burn victims who were already treated with Nexobrid to date. The expanded access program runs through approval. We believe that the continued burn centers training on the use of Nexobrid through the next expanded access protocol will support NexoBridge launch upon approval in the U.S. Turning to the NexoBridge BLA, though we were disappointed with the receipt of the CRL, we believe the FDA comments and concerns are manageable and can be addressed. We will continue to partner with BARDA and VeriCell to leverage their vast experience and track record in regulatory domain, to meet with the FDA as soon as possible, and provide the FDA with a detailed response to the CRL. While it's premature to provide a specific timeline for the BLA resubmission, we are actively preparing for a Type A meeting with the FDA and will provide a further update at the appropriate time. We remain optimistic about the prospects and long-term potential for NexoBREAD and committed to bringing NexoBREAD to the U.S. market as expeditiously as possible. Regarding our pediatric investigational plan, we were thrilled to announce positive top-line results from our Phase III study of NexoBREAD in children with severe thermal burns, which met all of its primary endpoints with high degree of statistical significance, reinforcing the stronger clinical safety and efficacy profile of the product. The data for NexoBit is clear, and we strongly believe it will become an important treatment option for the pediatric burn patients. Following those results, we are planning to submit the data for label expansion in Europe and other international markets during 2022, and believe it would further enhance growth and global expansion of Nexroid. Turning to our newest clinical development program for non-melanoma skin cancers, we initiated an open-label Phase I-II study of 005 product in basal cell carcinoma designed to evaluate the safety and tolerability of the product using different schedules of administration. This study will provide us with a preliminary evaluation of 005 efficacy, and this could be a very exciting program for us. In tandem, the first patients were enrolled in an investigator-initiated phase two trial conducted at the Soroka Medical Center in Israel, designed to evaluate the safety and efficacy of 005 in removing normal melanoma skin cancers. We expect that data from both studies will be generated by the end of 2021. Lastly, we were pleased to have the case series data of passive cell carcinoma destruction by a concentrate of portalitic enzymes enriching bromelain, which is actually 005, published in a peer-reviewed paper. provide a preliminary proof of concept that 005 may be a safe and effective destructive treatment for basal cell carcinomas, and more importantly, establish the foundation for our non-melanoma skin cancer clinical development. Now, I would like to turn the call over to Boaz for a summary of our financials.
spk13: Boaz? Thank you, Sharon, and good morning to our U.S. listeners and good afternoon to the Israeli ones. First, I'd like to reiterate our continued product revenue growth from both the U.S. market and the ex-U.S. market as NexaBrit continues to support our balance sheet. We're looking to enhance our global expansion and expecting to have additional marketing approvals in new territories this year and throughout 2022. I would like now to provide you with an update of our financial results for the second quarter and first half of 2021. Revenues for the second quarter of 2021 increased 50% to 6.1 million compared to 4 million for the second quarter of 2020. Product revenue for the quarter was 3 million, an increase of 175% compared to 2020 second quarter product revenue of 1.1 million primarily driven by buy-up recruitment of Nexrobit for emergency stockpile and sales increase outside of the U.S. Gross profit for the quarter was $2.4 million, or 39% of net revenue, compared to a gross profit of $1.2 million, or 30% of net revenue, for the parallel quarter. Gross profit from product revenue was 57% of net revenue versus 48% in the second quarter of 2020, driven by increase in product revenue versus the fixed nature of our manufacturing costs. Research and development expenses for the quarter were 2.7 million, compared with 1.6 million for the second quarter of 2020. The increase was primarily due to SCOREx Clinical Development Program. Selling general administrative expenses for the quarter were 2.6 million, compared with 2.3 million in the second quarter of 2020. As a percentage of revenue, SG&A expenses decreased 1400 basis points from 57% in the second quarter of last year to 43% for the second quarter of 2021. Operating loss for the quarter was 2.9 million compared with an operating loss of 2.7 million in the second quarter of 2020. The company posted a net loss of $3.2 million or $0.12 per share for the quarter, compared with a net loss of $3.1 million or $0.11 per share for the second quarter of 2020. Adjusted EBITDA for the quarter was a loss of $2 million, compared with a loss of $2.1 million for the second quarter of 2020. Moving now to the first half of 2021 financial results. Revenue for the first half of 2021 increased 41% to $11.9 million compared to $8.5 million in the first half of 2020. Product revenue for the half were $5.9 million, an increase of 224% compared to the $1.8 million in the first half of 2020. Operating loss for the half was $4.8 million compared with an operating loss of $4.9 million in the first half of 2020. The company's net loss for the half was 6 million or 22 cents per share, compared with a net loss of 5.6 million or 20 cents per share for the first half of 2020. Adjusted EBITDA for the half was a loss of 3.3 million, compared with a loss of 3.9 million for the first half of 2020, an improvement of 14%. This was driven by our product revenue growth and continued budget discipline, allowing us to advance our clinical development program of S-Corrects while yielding this improvement. Now, moving to the balance sheet headlines. As of June 30th this year, MediWin had $17.2 million in cash and short-term investments, compared with $21.6 million as of December 31st, 2020, and no debt. MediWon remained on budget, utilizing $4.4 million in the first half of 2021 for its operational activities. Throughout the remainder of 2021, the company will continue to invest primarily in research and development efforts for SKRX, while the planned Nextorbit BLA resubmission and its related ongoing development programs will be funded by BARDA. We now expect cash use for 2021 to be in the range of $9 to $11 million. Our financial guidance also assumes that the COVID-19 dynamics do not worsen, including the impact of the Delta variant in the second half of the year. With that, I've concluded my financial overview and will now turn the call back to Sharon. Sharon? Thank you, Boaz.
spk14: We are excited by our prospects as a company. We have a diversified pipeline with meaningful early and late-stage products to support our continual growth for years to come, as we have several tremendous opportunities ahead of us. With that, it is my pleasure to open the call for your questions. Operator?
spk01: At this time, if you would like to ask a question, please press star 1 on your telephone keypad. Again, if you have a question... please press star one on your telephone keypad. We'll pause for just a moment. Your first question comes from the line of Kevin DeGeneres with Oppenheimer.
spk02: Hey, guys. Thanks for taking our questions. Maybe first off, congratulations on the pediatric data for Nexabrid. Can you provide us an update on how to think about, you know, regulatory measures process in the U.S. We believe that it's a separate regulatory filing from the adult population. Do you need any additional clinical data or other supporting information apart from resolution of the CRL for the adult population before filing?
spk14: Thank you for the question, Kevin. As we communicated earlier when we got the CRL and mentioned in our prepared remark, we believe that we can address the FDA concerns without additional study, and we do have sufficient data. Given the robust clinical data package, we believe that NexoBridge remains well-positioned to become a standard of care and ready for approval. We are actively preparing together with our partners Vericel and BARDA for a type A meeting with the FDA. This meeting can be requested within three months after the FDA regulatory action and typically scheduled within 30 days from application. That's the timeframe we are looking for. So obviously we are looking to do so as soon as possible. and beyond that, we are not going to comment on when the meeting is scheduled and so on, but we plan and we certainly update investors and analysts at the appropriate time when we have more clarity after this meeting.
spk02: That's where you actually answered my second question, but my first one was actually in context of the pediatric population, which I believe is not included in the filing for which you received a CRL. Can you provide an update on the regulatory strategy in the U.S. for the pediatric population?
spk14: Yeah, correct. Regarding the pediatric population, any label expression in the U.S. will be only after we'll get the approval for the adult BLA or the adult indication. This is a label extension. Currently, we are leveraging the pediatric data in the safety updates we will provide the FDA as part of the resubmission and leverage the pediatric data where we have already approval for Nexobrit, i.e. in EMA and other international markets for label extension. As a reminder, in the U.S., we are waived from pediatric investigation and plan, so based on our data, prior discussion with the FDA, we plan to submit this data of the pediatric kid study after we will finalize the adult review of the file.
spk02: Thank you for that. And then maybe just lastly, on the next study, I think you called out that you've dosed about 100 patients or treated about 100 patients on compassionate use. How many centers roughly have used UNEXABRID under the Expanded Access Protocol, and has that changed meaningfully over the last quarter or two?
spk14: Yeah, so currently we have 21 active sites in the U.S., and we have about three to five additional sites and process of initiation in the U.S. I would like to reiterate that the Expanded Access Program runs through approval and and we will continue to enroll patients to this study and treat patients with Nexobrid until the review of the PLA will finalize. And as you said, we already treated over 100 parent victims to date, and according to the protocol, we are able to extend to up to 30 sites and treat at least 200 patients under the current protocol. Thank you for that.
spk01: Your next question comes from the line of Josh Jennings with Cowan.
spk05: Hi, good morning, Sharon and Boaz. Thanks for taking the questions. Can you hear me okay?
spk12: Yeah. Good morning.
spk05: Good morning. So first, it's on next year break. Last week on their call, Veracel talked about how their team was taking a leadership role in the BLA resubmissions. of NexoBridge, just to help us understand how the MediWood's role and how VeriCell's role has changed since the CRL and what exactly they mean by leadership role.
spk14: Thank you for your question. So in general, bringing NexoBridge to the U.S. market is a joint collaboration or joint project, as you know, of VeriCell as the U.S. commercial partner who owns the rights in North America, BARDA, as the ones that provide support and funding, and of course many ones are on the IP and the extensive experience of NexoBREAD. We have vast experience with NexoBREAD, given the 20 years of history with the development of NexoBREAD. VeriCell have a clinical regulatory and operation team with great deal of experience and success on the regulatory front. So we are in a great position to leverage to lead the regulatory front with our years of experience with NexoBREAD and Barda's special matter consultants who bring their personal experience. And this joint collaboration providing us with the confidence that we have the best team to achieve the BLA approval. So we feel good about the path going forward. And we have a great deal of confidence with NexoBREAD robust clinical data And we look forward to bringing this product into the U.S. market.
spk04: Understood. Thanks.
spk05: And on escorex, I believe you mentioned historically that the possibility of starting a second U.S. pivotal trial for escorex after you've seen the results of the interim analysis of the first trial, now that we have favorable interim results, any updated thoughts on timing of starting the second trial or Accelerating approval timelines on that stretch.
spk14: As I mentioned in the prepared remark, we plan to complete the enrollment of the ongoing Phase II study by year-end and to generate data from the pharmacology study by year-end. And if we meet this goal, we will have data readout from the ongoing Phase II study anticipated in the first half of 2022. that will be generated from those two ongoing trials together with the data generated to date, which is the prior phase two study. And the preclinical studies will be gathered and incorporated for a discussion with the FDA before we move forward to the next study in the U.S. in order to align and get FDA concurrence for the next stage of development in the U.S.
spk05: Got it, got it. So just in terms of the pharmacology study, you have EscherX, and when you have those data later this year, how will those data inform the next steps in the pivotal program? What will the pharmacology study show you, and how will that be incorporated into the development pathway? Thank you.
spk14: As a reminder, this pharmacology study is an open-label study assessing the pharmacological effect of SCRX in up to 15% both VLUs and DFUs. We already enrolled several patients to this study, and this study will provide us with a better understanding of what is happening in the wound bed during and after the debridement with SCRX, and most specifically, it will enable us to assess effect on reduction of biofilm burden, reduction of inflammation, and initiation of healing process. All of those data points or measurements provide us with additional clinical benefits of SKRx, and we would like to have this data as part of the discussion with the FDA because we would like to incorporate the best results of this study or some of the results of this study also as measurement in the next clinical study in the U.S.
spk03: Understood. Thanks for watching.
spk01: And once again, if you'd like to ask a question, please press star 1 on your telephone keypad. Again, a star, then the number 1 on your telephone keypad. Your next question comes from the line of Siyam Pakula Ramakant with H.C. Wainwright.
spk06: Thank you. This is RK from . Good morning, Sharon and . Good morning. One of the concerns of, one of the issues which are brought up in the CRL was the inspection of your plants at both Israel and Taiwan. So what's the situation there? You know, how is FDA resolving the travel stuff? Any updates there?
spk14: So in terms of the inspections, that's not a discussion that we have been engaged with the FDA at this point. We can resubmit the package, and the inspections just need to occur prior to the approval. And since the situation is dynamic worldwide, and also the instructions in the FDA are changing on a monthly basis, we will have to monitor carefully and see the vehicles or the tools that the FDA is implementing in order to get the backlog they have with inspections domestically and foreign inspections going forward.
spk06: Thank you for that. And then on the 005 molecule, when should we expect data from that study?
spk14: As communicated previously, we plan to have data from both studies, the Phase I-II study in the U.S. and the IIT study conducted in Israel by IREN 2021. Okay. Thank you.
spk06: Thanks for taking my questions.
spk14: Thank you.
spk01: And there are no further questions in queue. I will now turn the call back over to CEO Sharon. Please go ahead.
spk14: Thank you very much. Thank you, everyone, for joining us today and for your continued interest in MediWound. We look to continue executing on our strategy and bringing new therapies to the market and to update you again on our next update call. Thank you very much and have a great day. Thank you.
spk01: Thank you for participating in today's conference call. You may now disconnect. The Lone Ranger Thank you. Thank you. Hello. Bye. Thank you. Good day and thank you for standing by. Welcome to the Q2 MediWound 2021 conference call. At this time, all participants are in a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jeremy Pfeffer, please go ahead.
spk15: Thank you, Dawn, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results for the second quarter of 2021. You may access that release on the company's website under the Investors tab. With us today are Sharon Malka, Chief Executive Officer of MediWound, and Boaz Gorlevi, Chief Financial Officer. Following management's 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 Meadowood'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 the 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 forecast due to the impact of many factors beyond the control of Meadowood. 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 Meadowood'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 Meadowood, and any recording or rebroadcast is expressly prohibited without the written consent of Meadowood. Now, I would like to turn the call over to Sharon Malka, Chief Executive Officer of Network. Sharon?
spk14: Thank you, Jeremy. Good morning to our U.S. listeners and good afternoon to our listeners in Israel. Welcome to our second quarter 2021 conference call to discuss our financial results and business highlights. The second quarter of 2021 and the subsequent weeks have been eventful from a clinical and commercial standpoint, with a positive interim assessment for SCAR-X Phase II study, FDA feedback on Nexobrid BLA, and the robust results of Nexobrid Phase III pediatric study. Commercially, we continued to generate product revenue growth compared with the prior year, driven by the procurement of Nexobrid by BARDA and the revenue's continued growth out of U.S. On the clinical front, we are pleased with the progress we gained across each of our ongoing clinical programs and are encouraged by the positive clinical data for both SCRx and Nexobrit. Let me begin first with a review of our SCRx clinical development program, where we most recently announced the best possible outcome of the interim assessment for its U.S. Phase II adaptive design study. Recall that this study aims to assess the safety and efficacy of escarex for the debridement of venous leak ulcers as compared to gel vehicle and non-surgical standard of care, while the interim assessment served to determine whether a sample size adjustment is required to maintain conditional power for this study. The interim assessment had three potential outcomes. continuation of the trial at its current sample size, an increase in the sample size to power the trial, or a sudden end of the trial due to futility. The interim assessment conducted after about 80 patients, approximately two-thirds of the original enrollment target of 120 patients, completed the debridement treatment. Based on the independence, Data Monitoring Committee's recommendation, the interim assessment yielded two positive takeaways. First, no enrollment sample size changes are necessary to maintain the pre-specified statistical power of 80% or greater for the study's primary endpoint of incidence of complete debridement compared to the gel vehicle. This positive outcome means that the study is appropriately sized at the planned enrollment of 120 patients and can continue without the need to add more patients. As a reminder, we had previously reduced the enrollment target from 174 patients to 120 patients, so we were happy with the independent data monitoring committee's recommendation confirming that change. no safety concerns were identified in the study population, which is another positive result. This successful interim assessment suggests that SCRx is safe and tolerable and provides positive signals that increase our confidence that SCRx may prove to be an effective non-surgical therapy for debridement of chronic wounds. We anticipate completing full enrollment in this study by end of 2021 with data readout anticipated in the first half of 22. Also in our S-CREX program, we have enrolled our first patients in our Phase II pharmacology study and anticipate data from that study later this year. As a reminder, this is a Phase II open-label single-arm study designed to evaluate the clinical performance, safety, and pharmacology effects of S-CAREX in the debridement of lower leg ulcers, i.e., venous leg ulcers and diabetic foot ulcers, in up to 15 patients. The data generated to date for S-CAREX have been very encouraging. We published a peer-reviewed paper summarizing the results of a successful Phase II assessor-blinded study of our first-generation Escarex, which achieved its efficacy and safety endpoints. Escarex was well tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other out-wield wounds within a few daily applications. Earlier this year, we completed successfully a comparator in vivo study designed to evaluate the debridement efficacy of escarex and the commercial collagenous enzymatic debridement agent in a post-in-heart-to-heal model. The study concluded that escarex treatment was clinically superior to the commercially available collagenous agent in removing escar in this model. The data from these trials, together with a positive interim assessment, give us confidence in both of our current ongoing Phase II trials of second-generation SKRx, and we look forward to data from both of these trials. With a clear unmet medical need for a non-surgical, rapid and effective debridement agent in the outpatient setting, SKRx has the potential to improve on the current standard of care and have a meaningful impact on chronic wounds management. Turning to NexoBREED, On the commercial front, BARDA's procurement for emergency stockpile continues to drive product revenue growth, and we are expecting to recognize most of the remaining revenues related to BARDA procurement in 2021. In addition, we continue to execute on our global expansion strategy, which sustained revenues growth and expecting additional marketing approvals in lucrative markets during the next 18 months. We continue to enroll new patients to the next expanded access program at leading U.S. burn centers with over 100 burn victims who were already treated with NexoBRED to date. The expanded access program runs through approval. We believe that the continued burn centers training on the use of NexoBRED through the Next Expanded Access Protocol will support NexoBrit launch upon approval in the U.S. Turning to the NexoBrit BLA, though we were disappointed with the receipt of the CRL, we believe the FDA comments and concerns are manageable and can be addressed. We will continue to partner with BARDA and VeriCell to leverage their vast experience and threat record in regulatory domain, to meet with the FDA as soon as possible, and provide the FDA with a detailed response to the CRL. While it's premature to provide a specific timeline for the BLA resubmission, we are actively preparing for a Type A meeting with the FDA and will provide a further update at the appropriate time. We remain optimistic about the prospects and long-term potential for NexoBREAD and committed to bringing NexoBREAD to the U.S. market as expeditiously as possible. Regarding our pediatric investigational plan, we were thrilled to announce positive top-line results from our Phase III study of NexoBREAD in children with severe thermal burns, which met all of its primary endpoints with high degree of statistical significance, reinforcing the stronger clinical safety and efficacy profile of the product. The data for NexoVid is clear, and we strongly believe it will become an important treatment option for the pediatric burn patients. Following those results, we are planning to submit the data for label expansion in Europe and other international markets during 2022 and believe it would further enhance growth and global expansion of Nexroid. Turning to our newest clinical development program for non-melanoma skin cancers, we initiated an open-label Phase I-II study of 005 product in basal cell carcinoma designed to evaluate the safety and tolerability of the product using different schedules of administration. This study will provide us with a preliminary evaluation of 005 efficacy, and this could be a very exciting program for us. In tandem, the first patients were enrolled in an investigator-initiated Phase II trial conducted at the Soroka Medical Center in Israel, designed to evaluate the safety and efficacy of 005 in removing non-menanoma skin cancers. We expect that data from both studies will be generated by the end of 2021. Lastly, we were pleased to have the case series data of passive cell carcinoma destruction by a concentrate of proteolytic enzymes enriching bromelain, which is actually 005, published in a peer-reviewed paper. provide a preliminary proof of concept that 005 may be a safe and effective destructive treatment for basal cell carcinomas, and more importantly, establish the foundation for our non-melanoma skin cancer clinical development. Now, I would like to turn the call over to Boaz for a summary of our financials.
spk13: Boaz? Thank you, Sharon, and good morning to our U.S. listeners and good afternoon to the Israeli ones. First, I'd like to reiterate our continued product revenue growth from both the U.S. market and the ex-U.S. market as NexoBrit continues to support our balance sheet. We're looking to enhance our global expansion and expecting to have additional marketing approvals in new territories this year and throughout 2022. I would like now to provide you with an update of our financial results for the second quarter and first half of 2021. Revenues for the second quarter of 2021 increased 50% to $6.1 million compared to $4 million for the second quarter of 2020. Product revenue for the quarter was $3 million, an increase of 175% compared to 2020 second quarter product revenue of $1.1 million primarily driven by buy-up recruitment of Nexrobit for emergency stockpile and sales increase outside of the U.S. Gross profit for the quarter was $2.4 million, or 39% of net revenue, compared to a gross profit of $1.2 million, or 30% of net revenue, for the parallel quarter. Gross profit from product revenue was 57% of net revenue versus 48% in the second quarter of 2020, driven by increase in product revenue versus a fixed nature of our manufacturing costs. Research and development expenses for the quarter were 2.7 million compared with 1.6 million for the second quarter of 2020. The increase was primarily due to S-Correct's clinical development program. Selling general administrative expenses for the quarter were 2.6 million compared with 2.3 million in the second quarter of 2020. As a percentage of revenue, SG&A expenses decreased 1400 basis points from 57% in the second quarter of last year to 43% for the second quarter of 2021. Operating loss for the quarter was 2.9 million compared with an operating loss of 2.7 million in the second quarter of 2020. The company posted a net loss of $3.2 million or $0.12 per share for the quarter, compared with a net loss of $3.1 million or $0.11 per share for the second quarter of 2020. Adjusted EBITDA for the quarter was a loss of $2 million, compared with a loss of $2.1 million for the second quarter of 2020. Moving now to the first half of 2021 financial results. Revenue for the first half of 2021 increased 41% to $11.9 million compared to $8.5 million in the first half of 2020. Product revenue for the half were $5.9 million, an increase of 224% compared to the $1.8 million in the first half of 2020. Operating loss for the half was $4.8 million compared with an operating loss of $4.9 million in the first half of 2020. The company's net loss for the half was $6 million or $0.22 per share, compared with a net loss of $5.6 million or $0.20 per share for the first half of 2020. Adjusted EBITDA for the half was a loss of $3.3 million, compared with a loss of $3.9 million for the first half of 2020, an improvement of 14%. This was driven by our product revenue growth and continued budget discipline, allowing us to advance our clinical development program of S-Corrects while yielding this improvement. Now, moving to the balance sheet highlights. As of June 30th this year, MediWin had $17.2 million in cash and short-term investments, compared with $21.6 million as of December 31st, 2020, and no debt. MediWon remained on budget, utilizing $4.4 million in the first half of 2021 for its operational activities. Throughout the remainder of 2021, the company will continue to invest primarily in research and development efforts for SKRX, while its planned Nextorbit VLA resubmission and its related ongoing development programs will be funded by BARDA. We now expect cash use for 2021 to be in the range of $9 to $11 million. Our financial guidance also assumes that the COVID-19 dynamics do not worsen, including the impact of the Delta variant in the second half of the year. With that, I've concluded my financial overview and will now turn the call back to Sharon. Sharon? Thank you, Boaz.
spk14: We are excited by our prospects as a company. We have a diversified pipeline with meaningful early and late-stage products to support our continual growth for years to come, as we have several tremendous opportunities ahead of us. With that, it is my pleasure to open the call for your questions. Operator?
spk01: At this time, if you would like to ask a question, please press star 1 on your telephone keypad. Again, if you have a question... please press star one on your telephone keypad. We'll pause for just a moment. Your first question comes from the line of Kevin DeGeneres with Oppenheimer.
spk02: Hey, guys. Thanks for taking our questions. Maybe first off, congratulations on the pediatric data for next year. Can you provide us an update on how to think about, you know, regulatory changes process in the U.S. who believe that it's a separate regulatory filing from the adult population. Do you need any additional clinical data or other supporting information apart from resolution of the CRL for the adult population before filing?
spk14: Thank you for the question, Kevin. As we communicated earlier when we got the CRL and mentioned in our prepared remark, we believe that we can address the FDA concerns without additional study, and we do have sufficient data. Given the robust clinical data package, we believe that NexoBridge remains well-positioned to become a standard of care and ready for approval. We are actively preparing, together with our partners Vericel and BARDA, for a Type A meeting with the FDA. This meeting can be requested within three months after the FDA regulatory action, and typically scheduled within 30 days from application. That's the timeframe we are looking for. So, obviously, we are looking to do so as soon as possible. and beyond that, we are not going to comment on when the meeting is scheduled and so on, but we plan and we certainly update investors and analysts at the appropriate time when we have more clarity after this meeting.
spk02: That's where you actually answered my second question, but my first one was actually in context of the pediatric population, which I believe is not included in the filing before which you received a CRL, you provide an update on the regulatory strategy in the US for the pediatric population.
spk14: Yeah, correct. So regarding the pediatric population, any label expression in the US will be only after we'll get the approval for the adult BLA or the adult indication. This is a label extension. Currently, we are leveraging the pediatric data in the safety update we will provide the FDA as part of the resubmission and leverage the pediatric data where we have already approval for Nexobrit, i.e. in EMA and other international markets for label extension. As a reminder, in the U.S., we are waived from pediatric investigation and plan, so based on our data, prior discussion with the FDA, we plan to submit this data of the pediatric kid study after we will finalize the adult review of the file.
spk02: Thank you for that. And then maybe just lastly, on the next study, I think you called out that you've dosed about 100 patients or treated about 100 patients on compassionate use. How many centers, roughly, have used UNEXABRID under the Expanded Access Protocol, and has that changed meaningfully over the last quarter or two?
spk14: Yes, so currently we have 21 active sites in the U.S., and we have about three to five additional sites and process of initiation in the U.S. I would like to reiterate that the Expanded Access Program runs through approval. and we will continue to enroll patients to this study and treat patients with Nexobrid until the review of the BLA will finalize. And as you said, we already treated over 100 parent victims to date, and according to the protocol, we are able to extend to up to 30 sites and treat at least 200 patients under the current protocol. Thank you for that.
spk01: Our next question comes from the line of Josh Jennings with Cowan.
spk05: Hi, good morning. Thanks for taking the questions. Can you hear me okay?
spk12: Yeah. Good morning.
spk05: Good morning. First, it's on next year break. Last week on the audience call, Veracel talked about how their team was taking a leadership role in the BLA resubmissions. of NexoBridge. Just to help us understand how the MediWood's role and how VeriCell's role has changed since the CRL and what exactly they mean by leadership role.
spk14: Thank you for your question. In general, bringing NexoBridge to the U.S. market is a joint collaboration or joint project, as you know, of VeriCell as the U.S. commercial partner who owns the rights in North America, Parda, as the ones that provide support and funding, and of course many ones who are on the IP and the extensive experience of NexoBREAD. We have vast experience with NexoBREAD given the 20 years of history with the development of NexoBREAD. VeriCell have a clinical regulatory and operation team with great deal of experience and success on the regulatory front. So we are in a great position to leverage to lead the regulatory front with our years of experience with NexoBREAD and Barda's special matter consultants who bring their personal experience. And this joint collaboration providing us with the confidence that we have the best team to achieve the BLA approval. So we feel good about the path going forward. And we have a great deal of confidence with NexoBREAD robust clinical data And we look forward to bringing this product into the U.S. market.
spk04: Understood. Thanks.
spk05: And on escorex, I believe you mentioned historically that the possibility of starting a second U.S. pivotal trial for escorex after you've seen the results of the interim analysis of the first trial, now that we have favorable interim results, any updated thoughts on timing of starting the second trial or Accelerating approval timelines on that stretch.
spk14: As I mentioned in the prepared remark, we plan to complete the enrollment of the ongoing Phase II study by year-end and to generate data from the pharmacology study by year-end. And if we meet this goal, we will have data readout from the ongoing Phase II study anticipated in the first half of 2022. that will be generated from those two ongoing trials together with the data generated to date, which is the prior phase two study. And the preclinical studies will be gathered and incorporated for a discussion with the FDA before we move forward to the next study in the U.S. in order to align and get FDA concurrence for the next stage of development in the U.S.
spk05: Got it, got it. So just in terms of the pharmacology study, you have escorex, and when you have those data later this year, how will those data inform the next steps in the pivotal program? What will the pharmacology study show you, and how will that be incorporated into the development pathway? Thank you.
spk14: As a reminder, this pharmacology study is an open-label study assessing the pharmacological effect of SCRX in up to 15% both VLUs and DFUs. We already enrolled several patients to this study, and this study will provide us with a better understanding of what is happening in the wound bed during and after the debridement with SCRX, and most specifically, it will enable us to assess effect on reduction of biofilm burden, reduction of inflammation, and initiation of healing process. All of those data points or measurements provide us with additional clinical benefits of SKRx, and we would like to have this data as part of the discussion with the FDA because we would like to incorporate the best results of this study or some of the results of this study also as measurement in the next a clinical study in the U.S.
spk03: Understood. Thanks for watching.
spk01: And once again, if you'd like to ask a question, please press star 1 on your telephone keypad. Again, a star, then the number 1 on your telephone keypad. Your next question comes from the line of Siyam Pakula Ramakant with H.C. Wainwright.
spk06: Thank you. This is RK from . Good morning, Sharon and Boris. Good morning. One of the issues which are brought up in the CRL was the inspection of your plants at both Israel and Taiwan. So what's the situation there? How is FDA resolving the travel stuff? Any updates there?
spk14: So in terms of the inspections, that's not a discussion that we have been engaged with the FDA at this point. We can resubmit the package, and the inspections just need to occur prior to the approval. And since the situation is dynamic worldwide, and also the instructions in the FDA are changing on a monthly basis, we will have to monitor carefully and see the vehicles or the tools that the FDA is implementing in order to get the backlog they have with inspections domestically and foreign inspections going forward. Thank you for that.
spk06: And then on the 005 molecule, when should we expect data from that study?
spk14: As communicated previously, we plan to have data from both studies, the Phase I-II study in the U.S. and the IIT study conducted in Israel by IREN 2021. Okay.
spk06: Thank you. Thanks for taking my questions.
spk14: Thank you.
spk01: And there are no further questions in queue. I will now turn the call back over to CEO Sharon. Please go ahead.
spk14: Thank you very much. Thank you, everyone, for joining us today and for your continued interest in MediWound. We look to continue executing on our strategy and bringing new therapies to the market and to update you again on our next update call. Thank you very much and have a great day. Thank you.
spk01: Thank you for participating in today's conference call. You may now disconnect.
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