Q1 2024 MediWound Ltd Earnings Call
Operator: Good day, and welcome to Mediwound's first quarter 2024 earnings call. Today's conference is being recorded. If you require operator assistance, please press star then zero. At this time, I would like to turn the conference over to Dan Ferry of Lifesci Advisors. Please go ahead.
Good day and welcome to Medi wounds first quarter 'twenty 'twenty four earnings call. Today's conference is being recorded if you require operator assistance. Please press Star then zero at this time I would like to turn the conference over to Dan Ferry of Lifesize Advisors. Please go ahead.
Dan Ferry: Thank you, Operator, and welcome, everyone. Today, before the market opened, Mediwound issued a press release announcing financial results for the first quarter ended March 3, 2024. 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, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A.
Dan Ferry: Thank you operator and welcome everyone.
Speaker Change: Today before the market open medical and issued a press release announcing financial results for the first quarter ended March 31 2024.
Speaker Change: May access that release on the company's website under the investors tab.
Speaker Change: With us today are all forgotten Chief Executive Officer of medical Honey, Luxembourg, Chief Financial Officer, and Barry Wolfensohn, Executive Vice President of strategy and corporate development.
Speaker Change: Following our prepared remarks, we'll open the call for Q&A.
Dan Ferry: 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 the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of MediWound.
Before we begin I would like to remind everyone that statements made during this call, including the Q&A session relating to <unk> 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.
Speaker Change: 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 that could differ materially from those forecasts due to the impact of many factors beyond the control.
Speaker Change: The company assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise.
Speaker Change: Participants are directed to cautionary notes set forth in today's press release as.
Speaker Change: As well as the risk factors set forth in medical it'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.
Dan Ferry: 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 the 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 statement. 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?
Speaker Change: The conference call is property of the Medi wound and then you're recording a rebroadcast is expressly prohibited without the written consent of medical and <unk>.
old Ferghana: Now I would like to turn the call over to old Ferghana, Chief Executive officer of medical it over.
Ofer Gonen: Thank you, Dan. And good morning, everyone. Welcome to Mediwound's first quarter 2024 earnings call. Joining me today are Hani Luxenburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. After a presentation of the financial results and business updates, we will open the call for your questions. During the first quarter, we were laser focused on executing our strategic plan.
Speaker Change: Thank you Dan and good morning, everyone welcome to maybe once first quarter 'twenty 'twenty four earning call.
Speaker Change: Joining me today are Connie Luxemburg, our Chief Financial Officer, and Barry Wolfensohn, Our executive Vice President of strategy and corporate development.
Speaker Change: After a presentation of the financial results and business update we will open the call for your questions.
Speaker Change: During the first quarter, we were laser focused on executing our strategic plan.
Ofer Gonen: At the beginning of the year, we set three major goals. First, to accelerate nexobreed revenue growth. Second, to complete the construction of our new manufacturing facility by mid-year. And third, initiate the SQRX Phase III clinical trial in the second half of 2024, for which we have already established collaborations with the most prominent wound care companies. I am pleased to report that we are on track to achieve all these targets. I am also excited to announce that, according to a pre-millionaire list of additions posted on May 24, we are set to join the Russell 3000 Index as part of the 2024 Russell Indexes Reconstitution. This inclusion will also grant us automatic membership in the Small Cap Russell 2000 Index.
Speaker Change: At the beginning of the year, we set three major goals first to accelerate Nexobrid revenue growth.
Speaker Change: Second to complete the construction of our new manufacturing facility by mid year.
Speaker Change: And third initiate yes, correct phase III clinical trial in the second half of 'twenty 'twenty four for which we already established collaborations with the most prominent one care companies.
Speaker Change: I am pleased to report that we are on track to achieve all of these targets.
Speaker Change: I'm also excited to announce that according to a preliminary list of additions posted on May 24th we have set the joined the Russell 3000 index or spot of the 'twenty 'twenty four Russell indexes reconstitution.
This inclusion will also granted automatic membership in the small cap Russell 2000 index.
Ofer Gonen: Being included in these indexes is a significant milestone enabling our visibility and reach within the investment community. Now let's move for the first quarter highlights and recent developments. Nexobreed Overview This quarter has showcased significant achievements for Nexobreed, aligning with our strategic goals. We have secured orders that meet our annual revenue projection of $24 million, with $5 million realized this quarter.
Speaker Change: Being included in these indexes is a significant milestone, enabling our visibility and rich within the investment community.
Speaker Change: Now, let's move for the first quarter highlights and recent developments.
Speaker Change: Nexobrid overview.
Speaker Change: This quarter has showed case significant achievements for nexobrid.
Speaker Change: Mining with our strategic goals.
Speaker Change: We have secured orders that to meet our annual revenue projection of 24 million with 5 million realized this quarter.
Ofer Gonen: In the United States, our collaborations with VeriCel have been very productive. Over 60 burn centers have submitted applications to their P&T committees. Approximately 40 centers have received approvals, and more than 30 centers have placed initial orders. Barry's team has reported substantial increases in both the number of patients treated with Nexobrid and the number of orders from burn centers and hospitals. Internationally, the adoption of Nexobreed in Europe, Japan, and India through our partnerships with Polymedics, Karken Pharmaceuticals, and BSV continues to show promising growth.
Speaker Change: In the United States, our collaborations with very sale has been very productive over 60 burn centers of submitted applications to their Pnp committees.
Speaker Change: Similarly, 40 have received approval in more than 30 centers are placed initial orders.
Speaker Change: There is still has reported substantial increases in both the number of patients treated with Nexobrid and the number of orders from burn centers and hospitals.
Speaker Change: Internationally, the adoption of Nexobrid in Europe, Japan, and India through our partnerships with fully medics can pharmaceuticals N V. S D.
Speaker Change: Continues to show promising growth.
Ofer Gonen: These markets are instrumental in driving broader interest and use of Nextable. Additionally, we have seen a continued increase in demand for Nexobrid in treating military casualties due to the ongoing war in Israel. Dozens of lives of soldiers and civilians have been saved.
Speaker Change: These markets are instrumental in driving broader interest and use of nexobrid.
Speaker Change: Additionally, we have seen a continued increase in demand for nexobrid in treating military casualties due to the ongoing war in Israel.
Supplies of soldiers and civilians was saved.
Ofer Gonen: The positive outcomes achieved with NexoBrid have generated interest in many governments for future stockpiles. To meet this surging demand, we are actively enhancing our manufacturing infrastructure. Construction of our new GMP-compliant, state-of-the-art facility is progressing on schedule to be completed by mid-2024, with commissioning set to begin in the third quarter of this year. The facility is expected to be fully operational in 2025, increasing our manufacturing capacity sixfold. Regarding additional growth drivers, the FDA has accepted our supplemental BLA for pediatric use, with a decision expected in the second half of this year.
Speaker Change: The positive outcome achieved with Mexico bid have generated interest from many governments for future stockpiling.
Speaker Change: To meet the surging demand we are actively enhancing we're actively enhancing our manufacturing infrastructure construction of a new GMP compliant state there'll be out facility is progressing on schedule to be completed by mid 'twenty 'twenty four with commissioning set at the beginning of this.
Speaker Change: Third quarter of this year.
Speaker Change: The facility is expected to be fully operational in 2025, increasing our manufacturing capacity six fold.
Speaker Change: Regarding additional growth drivers the FDA has accepted our supplemental BLA for pediatric use with a decision expected in the second half of this year.
Ofer Gonen: It is worth noting that Nexobrid is already approved for the pediatric population in Europe and in Japan. Our partnership with the U.S. Army is advancing as planned, focusing on the development of a temperature-stable formulation for next of kin. We anticipate FDA's feedback on the product development path in the second half of this year. This project, bolstered by a $13 million grant from the Department of Defense, underscores the strategic importance of Nexobreed in field care burn treatment. Lastly, we continue to generate further data to support NexoBridge use.
Speaker Change: It is worth noting that Nexobrid is already approved for pediatric population in Europe and in Japan.
Speaker Change: Our partnership with the U S Army is advancing as planned focusing on the development of temperature stable formulation for Nexobrid.
Speaker Change: We anticipate FDA feedback on the product development patch in the second half of this year.
Speaker Change: This project both of those base of $10 million Grant from the department of defense underscores the strategic importance of Nexobrid infield care burn treatment.
Speaker Change: Okay.
Speaker Change: Lastly, we continue to generate further data to support Nexobrid use.
Ofer Gonen: Our Expanded Access Treatment Protocol has successfully treated 239 burn patients across 29 U.S. sites. With enrollment and 12-month follow-up now complete, we are ready to begin data analysis with findings to be published in the second half of 2024. Overall, the increasing global demand and our strategic expansion of the manufacturing capabilities, along with the broadening scope of indications, position Nexobrid to establish a new standard of care for ESCA removal for severe burns. We are very pleased with MeksoBit's performance and the ongoing progress in all those areas.
Speaker Change: Our expanded access treatment protocol has successfully treated 239 burnt patients across 29.
Speaker Change: S sites.
Speaker Change: With enrollment and 12 months follow up now complete we are ready to begin data analysis with findings to be published in the second half of 'twenty 'twenty four.
Speaker Change: Yeah.
Speaker Change: Overall, the increasing global demand and our strategic expansion of the manufacturing capabilities, along with the broadening scope of indications position nexobrid to establish a new standard of care in eschar removal for severe burns.
Speaker Change: We are very pleased with Mexico with performance and the ongoing progress in all those areas.
Speaker Change: Yeah.
Ofer Gonen: Now we'll provide an update on S-Correx, our innovative bioactive therapy for venous leg ulcers and other chronic wounds. We have successfully manufactured the clinical batches and are on schedule to submit the final protocol for our Phase III trial in the first half of 2024. The trial is set to commence in the second half of this year. The Phase III study, mirroring the successful design of our Phase II trials, will be structured as a multicenter, prospective, randomized, and placebo-controlled global trial.
Speaker Change: And that will provide an update on S. Correct, our innovative bioactive therapy for venous leg ulcers.
Speaker Change: Other chronic ones.
Speaker Change: We have successfully manufactured the clinical batches and our scheduled to submit the final protocol for a phase II trial in the first half of 'twenty 'twenty four.
Speaker Change: The trial is set to commence in the second half of this year.
Speaker Change: The phase III study mirroring the successful design of our phase two trials will be structured as a multicenter prospective randomized and placebo controlled global trials.
Ofer Gonen: We aim to enroll 216 patients across 40 sites, focusing on two co-primary endpoints, the incidence of complete debridement and the incidence of wound closure. An interim assessment will be conducted after 67% of the participants complete the trial, providing early insights into the efficacy of escaret.
Speaker Change: We aim to enroll 216 patients across 40 sites focusing on two co primary endpoints the incidence of complete debridement and the incidence of wound closure.
Speaker Change: An interim assessment will be conducted after 67% of the participants completed the trial, providing early insights into the efficacy of S. Correct.
Ofer Gonen: This study has garnered significant interest from prominent companies in the wound care space, resulting in established research collaborations with Solventum, Molniki, and Mimedic, leaders in compression therapy, advanced wound care settings, and dressings, and tissue-based products. SCorEx has also attracted a lot of attention at three major annual wound care conferences. The Wound Healing Society, The Symposium of Advanced Wound Care, and the European Wound Management Association. Strong Phase II data was presented, demonstrating Escarex's superiority over Santil, the current market leader, with more than $360 million in annual US sales.
Speaker Change: This study has garnered significant interest from prominent companies in the wound care space, resulting in established research collaborations with solvent them Malicki and memetics leaders in compression therapy advanced wound care settings, and dressings, I'm sorry, and.
Speaker Change: Tissue based products.
Speaker Change: That's correct. That's also attracted a lot of attention at three major annual wound care conferences.
Speaker Change: The wound healing society.
Speaker Change: Zoom of advanced wound care and the European wound Management Association.
Speaker Change: Strong phase II data was presented demonstrating S. Codexis superiority over something the current market leader with more than $360 million in annual U S sales.
Ofer Gonen: Recently, there has been a significant discussion about the proposed changes in medical reimbursement for cell and tissue-based products. If implemented, these changes will have a major impact on the wound care industry and will greatly benefit SCorex. We are not surprised by these changes.
Speaker Change: Recently, there has been a significant discussion about the proposed changes in Medicare reimbursement for cell and tissue based products.
Speaker Change: If implemented these changes will have major impact on the wound care industry and will greatly benefit S. Correct.
Speaker Change: We are not surprised by these changes we anticipate that the market share will shift from smaller companies without strong clinical evidence to larger established companies.
Ofer Gonen: We anticipate that the market share will shift from smaller companies without strong clinical evidence to larger, established companies. Additionally, one of the key changes is to limit the number of tissue units that can be applied to a wound, requiring more attention to the condition of the wound bed prior to initiating tissue application. SCorex excels in this area.
Speaker Change: Additionally, one of the key changes is to limit the number of tissue units that can be applied to a one requiring more attention to the condition of the wound bed prior to initiating tissue applications.
Speaker Change: That's correct excels in this area.
Ofer Gonen: It's not just debridement, but it also quickly prepares the wounds for the application of tissue. I will continue to say I will, I will. The Phase III study is perfectly aligned with this, as we aim to secure a claim for preparing a wound for active closure. As the market value of tissue therapies decreases, the relative value of biologic drugs with blockbuster potential will increase. SKRx going through a rigorous BLA process, backed by extensive and robust trial data, and entering into a category that has only had stable reimbursement for decades will become an even more valuable asset when these policies become effective.
Speaker Change: It is not just the <unk>, but its also quickly repair the ones for application of tissue.
Speaker Change: Our ongoing phase.
Speaker Change: Hello.
Speaker Change: Phase III study is perfectly aligned with this as we aim to secure claim for preparing award for active closure.
Speaker Change: Generally.
Speaker Change: As the market value of tissue therapies decreases.
Speaker Change: The relative value of biologic drugs with a blockbuster potential will increase.
Speaker Change: That's correct is going through a rigorous BLA process.
Speaker Change: By extensive and robust trial that that and entering into a category that is just stable reimbursement for decades, becoming even more valuable asset when these policies become effective.
Speaker Change: Yeah.
Ofer Gonen: In conclusion, SQRx is poised to become a leader in the biologic sector of the advanced wound care market. Our data to date showcase its superior efficacy in debridement, wound closure preparation, time to wound healing, biofilm removal, and bacteria reduction, highlighting its versatility and utility. The comprehensive clinical and health economic data that we are generating in the Phase 3 study will further solidify SCARECTA's strong position within the industry. Now, I'll hand it over to Hani to briefly review our financials. I'm it. End
Speaker Change: In conclusion as codex is poised to become a leader in the biologic sector of the advanced wound care market.
Speaker Change: Our data to date showcases its superior efficacy in debridement wound closure preparation time to wound healing biofilm removal and bacterial reduction highlighting its versatility and utility.
Speaker Change: The comprehensive clinical and health economic data that we are generating in the phase III study will further solidify S corrected strong position within the industry.
Speaker Change: Now I'll hand, it over to honey to briefly review our financials.
Hani Luxenburg: Thank you, Ofer. Let me begin with our revenue for the first quarter. Revenue for the first quarter of 2024 was $5 million, compared to $3.8 million in the first quarter of 2023. The increase is primarily attributed to revenue from Verisel, a new contract with the U.S. Department of Defense.
Elsa: Thank you Elsa let me begin with our revenue for the first quarter.
Honey: Revenue for the first quarter of 'twenty 'twenty, four 5 million compared to 3.8 million in the first looked at 2023.
Honey: The increase is primarily attributed to revenue from various cell and your contract with the U S Department of defense.
Hani Luxenburg: Gross profit in the first quarter of 2024 was $0.6 million, representing 12.2% of total revenue, compared to $0.8 million, representing 21.7% of total revenue in the same quarter of the previous year. The decrease in gross profit is primarily due to changes in the revenue mix. Turning to our operating expenses, R&D expenses in the first quarter of 2024 were $1.5 million compared to $2.1 million in the first quarter of 2025. This decrease is primarily due to the completion of ESCOREG's Phase II study.
Honey: Gross profit in the first quarter of 'twenty, 'twenty, four or 0.6 million, representing 12, 2% of total revenue compared to 0.8 million representing 21.7% of total revenue in the same quarter in the previous year.
Honey: The decrease in gross profit is primarily due to changes in the revenue mix.
Honey: Turning to our operating expenses.
Honey: R&D expenses in the first worked out of 2024, well, one 5 million compared to 2.1 million in the first booked out of 2023.
Honey: This decrease is primarily due to the completion of S. Correct phase two study.
Hani Luxenburg: SG&A expenses in the first quarter of 2024 were $2.9 million compared to $3.1 million in the first quarter of last year. Operating loss in the first quarter of 2024 was 3.7 million compared to an operating loss of 4.4 million in the first quarter of 2023. The net loss in the first quarter of 2024 was $9.7 million, or $1.05 per share, compared to a net loss of $3.7 million, or $0.44 per share, in the first quarter of 2023.
Honey: SG&A expenses in the first quarter of 2020, full well 259 million compared to $3 1 million in the first quarter over last year.
Honey: Operating loss in the <unk> in the first quarter of 2024 were $3 7 million compared to an operating loss of $4 4 million in the first quarter of 2023.
Honey: Net loss in the first quarter of 2020 full was $9 7 million or $1.05 per share compared to a net loss of $3 7 million or 44 cents per share in the first quarter of 2023.
Hani Luxenburg: The increase in net loss is primarily due to financial expenses from the revaluation of warrants amounting to $6.1 million, driven by a 40% increase in our share price. Non-gap adjusted EBITDA for the first quarter of 2024 was a loss of $2.9 million, compared to a loss of $3.4 million in the first quarter of 2023. Balance Sheet Eyelight, As of March 34, 2024, the company had cash and cash equivalents, restricted cash, and deposit totaling $36 million compared to $42.1 million as of December 31st, 2023.
Honey: The increase in net loss is primarily due to financial expenses from revaluation of warrants and mounting to six 1 million driven by 40% increase in our share price.
non-GAAP adjusted EBITDA for the first quarter of 2024 was a loss of $2 9 million compared to a loss of $3 4 million in the first quarter of 2023.
Honey: Balance sheet highlights as of March 31st 2020 for the company at the cash and cash equivalents restricted cash.
Honey: And deposits totaling 36 million compared to 42.1 million as of the.
Honey: December 31st 2023.
Hani Luxenburg: During the first quarter of 2024, the company received half a million dollars from the exercise of warrants. The company utilized $6.5 million to fund its activities, of which $2.7 million was invested in CAPEX related to facility scaling.
Honey: During the first quarter of 2024, the company received half a million dollar from exercise of warrants.
Honey: The company utilized $6 5 million to fund its activity of which 2.7 million was invested in capex related to facility scaled up.
Hani Luxenburg: This concludes the financial review. I will now turn the call back to Ofer. Ofer?
Speaker Change: This concludes the financial review I will now turn the call back to also wholesale.
Speaker Change: Thank you Jaime.
Ofer Gonen: This past quarter, we demonstrated operational excellence, achieving $5 million in revenues from ExoBrid and progressing towards the completion of our manufacturing facilities. This expansion will enable us to effectively meet both current and anticipated demand for next year for Escarex, which targets a highly lucrative $2 billion market.
Speaker Change: This past quarter, we demonstrated operational excellence, achieving $5 million in revenues from XO bread and progressing towards the completion of our manufacturing facility.
This expansion will enable us to effectively meet both current and anticipated demand for nexobrid.
Regarding gas correct, which targets a highly lucrative 2 billion dollar market.
Ofer Gonen: We remain on track to initiate the phase 3 trial in the second half of this year. We look forward to working closely with Solventum, Molniki, and Mimedics, who are supporting this trial. Their collaboration sets the stage for a successful and reputable phase 3 study, ensuring the best treatment options are available for patients. With these highlights shared, I'd like to turn back to the operator for any questions you may have. Operator?
Speaker Change: We remain on track to initiate the phase II trial in the second half of this year.
Speaker Change: We look forward to working closely with the <unk> molecule memetics, what's supporting this trial they'll collaboration sets the stage for a successful and reputable phase III study, ensuring best treatment options are available for patients.
Speaker Change: With these highlights shared I'd like to turn back to the operator for any questions you may have operator.
Operator: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Josh Jennings with TD Cowan. Please go ahead.
Speaker Change: We will now begin the question and answer session.
Speaker Change: To ask a question you May press Star then one on your telephone keypad.
Speaker Change: If you were using a speaker phone please pick up your handset before pressing the keys.
Speaker Change: Any time your question has been addressed and you would like to withdraw your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.
Speaker Change: The first question comes from Josh Jennings with TD Cowen.
Speaker Change: Please go ahead.
Speaker Change: Yeah.
Joshua Thomas Jennings: Thank you so much for taking the questions and congratulations on the continued progress. Ofer, I was hoping just to ask two manufacturing questions at a relatively high level, maybe you could share some more details. First, on the build out of manufacturing capacity for an Exabrid. What are the remaining steps left to complete that project? And then should we be thinking about that plant, that facility, ramping up and being cleared and ready to go early in 2025? Or could that be sometime closer to mid year?
Joshua Thomas Jennings: Alright, thanks, so much for taking the questions and congratulations on the continued progress.
Joshua Thomas Jennings: I was hoping just to ask two manufacturing questions.
Joshua Thomas Jennings: Relative to the high level maybe.
Speaker Change: He can share some more detail first on.
The build out of manufacturing them.
Speaker Change: Capacity for Nexobrid, So what are the.
Speaker Change: The remaining steps left to complete that project and then should we be thinking about that that plant that facility ramping up and being cleared and ready to go.
Early in 2025 or could that be sometime in the end it closer to mid year.
Ofer Gonen: Thank you for your question, Josh. I would like to address this point, so... As for the facility we guided that we are about to complete manufacturing in mid-2024, it means that all the equipment... [inaudible] After that, it will take a few months, and we are submitting the facility for approval by EMA and FDA. We do not expect both of them to approve the facility at the same time. We expect that the European authorities will be quicker, which means that I don't have an answer when it will be fully operational.
Joshua Thomas Jennings: Thank you for your question, Josh and I would like to address these points. So.
Speaker Change: As for the facility, we guided that we are about to complete the manufacturing in mid 2024.
Speaker Change: That's all the equipment is.
Speaker Change: He is here and it was not a trivial assignments. So all the equipment is here. It is now we are in the final stages of installing it and once it's done and we expect it will be done in the middle of the year, which means through the next few weeks even start the commissioning process, which means all kind of validation.
Speaker Change: Dvds, etc. After that it will take a few months, we are and we are submitting the facility for approval by EMA and F. D. A.
Do not expect both of them to our approve the facility in the same time.
Speaker Change: We expect that the European authorities will be quicker, which means that they don't have an answer when it will be fully operation that it will be at the beginning of 'twenty five or in the mid of 'twenty five or even in the third quarter was 25, I think it will be gradual and it.
Ofer Gonen: If it will be in the beginning of 2025, or in the middle of 2025, or even in the third quarter of 2025, I think it will be gradual, with the European agency approving it much quicker. And when it is done, we have our capacity; our major bottleneck will be resolved, because we can start immediately manufacturing for the European market from the new facility. So in 2025, we will be in a position, definitely towards the end of it, that we have almost no limitations.
Speaker Change: With the European agency proving its much quicker and when it is done.
Speaker Change: Have our capacity.
Speaker Change: Our major bottleneck will be resolved because we can start immediately manufacture to the European market from the new facility. So in 2025, we will be in a position definitely towards the end of it but we have almost no limitations.
Joshua Thomas Jennings: Excellent! That's very helpful.
Speaker Change: Excellent that's helpful. And then just on the last earnings call. You mentioned that there was some initial manufacturing of a burst correct batches for the clinical trial and some stability testing being performed hoping to just get an update on where we're maybe where that stands in terms of S scripts.
Joshua Thomas Jennings: And then, on the last GenX call, you mentioned that there was some initial manufacturing of SQRx batches for the clinical trial and some stability testing being performed. I'm hoping to just get an update on where MediWound stands in terms of SQRx production or manufacturing for the clinical trial. And if you can just remind us about the formulation, any differences in manufacturing between SQRx and ExoBridge, and how everything has progressed. And it sounds like it has because you've given time to start this trial, getting the trial approved and ready to roll by mid-year. Thanks a lot.
Speaker Change: Production or manufacturing.
Speaker Change: The clinical trial and if you can just remind us about the formulation any differences in manufacturing between X correction nexobrid.
Speaker Change: And as everything progressed.
Speaker Change: It sounds like it has because you'd given timelines right.
Speaker Change: This trial getting them up getting the trial proves ready to roll out by mid year. Thanks, a lot.
Ofer Gonen: So, let me elaborate on this aspect. The manufacturing of Escorex and Nexobrid is not being done in the same suites. It's a different process of manufacturing.
Speaker Change: Yeah. So let me elaborate on this aspect.
Speaker Change: The manufacturing of S corrects, and Mexico blade I'm not being done in the same switch it's a different it's a different suite of eh.
Speaker Change: Manufactured right.
Speaker Change: The process of.
Ofer Gonen: The process of getting our clearance from the FDA to start the trial was manufacturing the clinical batches, which was done in Q1. After that, there is a stability time period, which is around 30 days. We do not anticipate any issues with that because we've manufactured many, many Escharic batches for previous trials or for all kinds of preclinical studies. And immediately after that, and as we guide, which means in the middle of this year or in the first half of this year, which is almost the same, we will be able to submit the final protocol to the FDA with all the data regarding the batches that were manufactured. After that, when we get the clearance, it should be something like after 30 days or 60 days; we will be ready to roll.
Speaker Change: Having our clearance from the FDA to.
Speaker Change: The trial is manufacturing of clinical batches, which was done in Q1 after that there is stability.
Joshua Thomas Jennings: Excellent. Thanks for reviewing that. I appreciate it.
Speaker Change: And time period, which is around 30 days.
Speaker Change: We do not anticipate any issues with that because we've been restructured many many.
Speaker Change: Batches for previous trials, all four are all kind of preclinical studies and immediately after that and as we guided which means in the middle of.
Speaker Change: In the middle of this year or in the first half of this year, which is.
Speaker Change: Almost the same.
Speaker Change: We will be able to submit the final protocol to the F D. A.
Speaker Change: All the data regarding the batches that were manufactured after that when we get the clearance it should be something like after 30 days 60 days, we will be ready to roll.
Speaker Change: Excellent thanks for reviewing that I appreciate it.
Francois Brisebois: The next question comes from Francois Brisebois with Oppenheimer. Please go ahead.
Speaker Change: The next question comes from Francois <unk> with Oppenheimer. Please go ahead.
Francois Brisebois: Hi, thanks for the question. Just to follow up on the previous one, in terms of being fully operational in 2025, that six-fold capacity, so that's the part that might be gradual. Is it fair to assume that the six-fold will be, you know, gradual to get there? And can you just elaborate a little bit on where demand is currently versus capacity?
Franois Daniel Brisebois: Hi, Thanks for the question just a follow up on the previous one.
Speaker Change: In terms of being fully operational in 25 debt six fold capacity.
Speaker Change: So that's the part that might be gradual is it fair to assume that the six fold will be.
Speaker Change: Gradual to to get there and can you just elaborate a little bit on where demand is currently versus capacity.
Ofer Gonen: Hi Frank, and thank you for the question. It's an important topic.
Speaker Change: Hi, Frank and and thank you for the question. It's an important topic. So currently the demand is the same as we as we mentioned last quarter. It is the approximately.
Ofer Gonen: So, currently, the demand is the same as we mentioned last quarter. It is approximately three-fold our ability to manufacture. So if you need to anticipate what the step up in our manufacturing capabilities will be, I would currently assume it's a 1x. After we get European approval, it becomes 2x because we can manufacture everything for Europe in the new manufacturing facility. Still, the manufacturing capabilities for the United States and Japan, which are very significant markets, will still be done in the previous manufacturing facility until we get approval from the FDA. But the bottleneck now that makes us a jungle between all kinds of customers and patients that need a solution, we believe the main bottleneck will be removed in the beginning of 2025.
Speaker Change: Three fault in our ability to manufacture so if you need to I anticipate what's the step up in our manufacturing capabilities and I would not currently let's assume at two onex.
Speaker Change: After we get the European approval it becomes two X because we can manufacture everything in every thing for Europe, and the new manufacturing facility still the manufacturing capabilities for the United States, and Japan, which are very significant markets are still will be done in the.
Previous manufacturing facility until we get the approval from the F D. A.
Speaker Change: Bottleneck now that makes us jungle between.
Speaker Change: All kinds of customers and patients, but neither seleucidan action. We believe the main bottleneck will be removed at the beginning of 2025.
Francois Brisebois: In terms of the interim analysis, can you help us understand what that means? Is there a chance that an interim analysis with overwhelming efficacy would just end the trial, or just what are the different scenarios from this interim analysis?
Speaker Change: Understood and then the in terms of the interim analysis can.
Speaker Change: Can you help us understand the implications there what that means is there a chance that the interim analysis would.
Speaker Change: With overwhelming efficacy would just end the trial or just what are the different scenarios from this interim analysis.
Ofer Gonen: Thank you for the question. The interim analysis will not stop the trial. A phase 3 study for such a huge indication, we're speaking about 1 million patients annually in the United States, a phase 3 study with 216 patients is considered very small. I do not anticipate FDA approval of a drug based on a phase 3 study with only 140 patients. The reason that we are doing an interim assessment; it's just an assessment for the sample size.
Speaker Change: Thank you for the question. So so the interim analysis will not stop.
Speaker Change: Stopping the trial.
Speaker Change: Phase III study.
Speaker Change: For such a huge indication with speaking about 1 million patients annually in the United States a phase III study with 216 patients is considered very small.
Speaker Change: I do not anticipate the F D a to approve a drug based on the phase III study with only 140 patients. The reason that we are doing a an interim assessment. It's just an assessment for the sample size.
Speaker Change: If we see currently that the.
Ofer Gonen: As we see currently, the trial is planned for 90% power to succeed in the trial in both primary endpoints. We want to make sure that after 140 patients, we are on track to achieve that. If we need to increase the number by, I don't know, 20 patients, 30 patients, to be sure that we are going to succeed in the trial, it will be done. Most probably, after the interim analysis, we will continue the trial as planned without changing anything.
Speaker Change: Trial is planned it with the 490%.
Speaker Change: Power for succeeding in the trial in all the in the in the both primary endpoints, we want to make sure that after 140 patients. We are on track to achieve that if we need to increase the number but I don't know 20 patients 30 patients to be sure that we are going to succeed in Detroit and it will be done.
Speaker Change: Probably after the interim analysis that we will continue the trial as planned without changing anything.
Speaker Change: Thank you.
R.K.: The next question comes from R.K. at H.C. Wainwright. Please go ahead.
Speaker Change: The next question comes from RK at H C. Wainwright. Please go ahead.
Ofer Gonen: Good morning, Ofer. How are you doing? Thanks for taking my question. In your prepared remarks, you said you secured orders for $24 million from Veracell. Do they have a minimum every year, or how are these all set up?
Good morning, Ofer How're you doing.
Speaker Change: Thanks for taking my questions.
Speaker Change: You know.
Speaker Change: In your prepared remarks, you said you have secured.
Speaker Change: Orders for $24 million from verso.
Speaker Change: Do they have a minimum every year are homeless oh, how about this.
Speaker Change: Rd set up.
Ofer Gonen: Well, I didn't say that we secured $24 million from VeriCell. We said we secured $24 million for the year 2024. VeriCell is only one of our revenue channels. So we have an agreement with VeriCell. They tell us in advance how much they anticipate for the year. We don't disclose the number, and they are getting it as they request. So for 2024, for instance, we already have the binding order for VeriCell. Some of it has already been shipped to them, and some of it is being manufactured.
Speaker Change: What I didn't say that we secure $24 million from various cell. We said, we secured $24 million for the year 2024.
Barry said is only one of the hour.
Speaker Change: And there'll be new channels.
Speaker Change: So we have an agreement with very cell they'll tell us they tell us in advance how much do you anticipate for the year, we didn't disclose the number.
Speaker Change: And they're getting it as they request.
Speaker Change: And for 'twenty 'twenty four for instance, and we already got the binding order for very thin.
Speaker Change: Some of it was already shipped to them and some of it is being manufactured.
R.K.: that and then, in terms of the next data that you're planning to publish So, would we see that... Would we see some of that this year, or do you expect it next year, and how is that going to help? [inaudible]
Speaker Change: Thank you for that.
Speaker Change: Then in terms of the next data that you are planning to publish.
Speaker Change:
Speaker Change: So would we see that.
Speaker Change:
Speaker Change: Cool.
Speaker Change: We see some of that.
Speaker Change: This year or do you expect it next year and how is that going to help.
Speaker Change:
Speaker Change: And in reimbursement and also in your conversations with private payers.
Ofer Gonen: Are you speaking about Nexobrit? Yes.
Speaker Change: I used to thinking about Nexobrid yeah.
Ofer Gonen: Okay, so don't hold your breath. We are going to the 239 patient data that we are about to share in the second half of the year are patients that are being treated in real life. I wouldn't expect anything different than what we saw in the phase three study because the efficacy of Nexobreed is so robust. You saw it in the trial, 93% versus, I don't know, 4%. So it will be very robust.
Speaker Change: Okay. So don't hold your breath, we are going to the 239 patient data that are whereabouts to show the data in the second half of the year are patients that are treated.
Speaker Change: In real life, I wouldn't expect something different than what we saw in the phase three study the efficacy of Nexobrid is so robust you saw it in the trial, 93% versus a I don't know 4% and the.
Speaker Change: So it will be very robust I do not expect anything different than what we saw and I for the impact on the reimbursement very silly is doing a great job in having this treatment approved by P&C committees in hospitals.
Ofer Gonen: I do not expect anything different than what we saw. And as for the impact on reimbursement, VeriCell is doing a great job of having this treatment approved by P&T committees in hospitals at a specific price. And I think it won't make a change at all.
Speaker Change: And the specific price and I think.
Speaker Change: It won't it won't make a change at all.
R.K.: Okay, and then in terms of SGADx, now that you have all your materials ready for the start of the study, is there any other approvals or conversations needed between you and the FDA before you start the study, or is it just IRB approvals that you're waiting for to get the study going?
Speaker Change: Okay, and then Hum in.
Speaker Change: In terms of as Kodak's.
Speaker Change: Now that you have all your material ready for the start of this study is there any other.
Speaker Change: Approvals or conversations needed.
Speaker Change: We knew in the F D. A before you stopped the study or is it just.
Speaker Change: IRB approvals that you're waiting for to get the study going.
Ofer Gonen: So the process is quite clear, since we have manufactured the clinical batches and are waiting for stability, it's only 30 days; let's assume it will be done in the next couple of weeks. After that, we submit a protocol that we have already got guidance and approval from EMA and FDA. We'll submit the protocols, and unless we see something which is very different than what we agreed on, we will get clearance or no objections in the next 30 days following the submission. After that, the IRBs; it's also something technical. I wouldn't expect, and we do not expect any delay in our guidance for initiating the trial in the second half. Thank you very much.
Speaker Change: So the process is quite clear since we manufactured the clinical batches and waiting for is stability, it's only 30 days and.
R.K.: Okay, thank you very much. Thanks for taking all my questions.
Speaker Change: Let's assume it will be done in the next couple of weeks after that we submit the protocol that we already got the guidance and approve of some E. M E and F. D. A will submit the protocols and then they see something which is which is very different than what we agreed on.
Speaker Change: We will get a.
Speaker Change: So no no objections and the next day and the 30 day following falling the submission after that they are busy with something technical I wouldn't expect that we do not expect any delay in our guidance of initiating the trial in the second half of this year.
Speaker Change: Okay. Thank you very much thanks for taking all my questions. Thank you okay.
Michael Okunewitch: The next question comes from Michael Okunewitch from Maxim Group. Please go ahead.
Speaker Change: The next question.
Comes from Michael.
Speaker Change: Michael.
Speaker Change: <unk> with Maxim Group. Please go ahead.
Michael Okunewitch: Hey guys, thank you so much for taking my questions today. Hi Michael. I guess, first off, just to talk about the Medicare changes that you mentioned earlier, in phase three, will you be looking at the difference in the number of required tissue applications just to potentially have data addressing those claims directly?
Michael: Hey, guys. Thank you so much for taking my questions today.
Speaker Change: Hi, Michael.
I guess first off just.
Speaker Change: To talk about the Medicare changes that you mentioned earlier in the phase three will you be looking at the difference in the number of required tissue applications just to potentially have data addressing those claims directly.
Barry J. Wolfenson: Well, it's a great question. Barry, could you please address it?
Speaker Change: Well, it's a it's a great question Barry can you please address it.
Barry J. Wolfenson: Certainly, we will, you know. We're not going to change the protocol of our study in anticipation of any changes that are being made in Medicare, but we will absolutely capture the data.
Barry Wolfensohn: Certainly we will.
Speaker Change: Recapturing, we're not going to change the protocol of our study.
Speaker Change: In anticipation of any changes that are being made in Medicare, but we will absolutely capture the data.
Barry J. Wolfenson: In hopes that it's reflective of, you know, where those changes land. I think, you know, one of the benefits of the study is that we get this head start. And so, as the wounds get to be completely debrided and completely covered with granulation tissue, we get to start with active closure sooner. It stands to reason, given the data that already exists in the published literature, that there's going to be more that close in our arm and close with these limited number of tissues, four, than there would be in the control arm. So either way, we stand.
Speaker Change: And hope that it's reflective of.
Speaker Change: Sure.
Speaker Change: Those changes land I think one of the benefits that obviously in the study is that we get this head start and so on.
Speaker Change: Yes.
Speaker Change: As the wounds get to be completely debride it.
Speaker Change: And completely.
Speaker Change: Covered with granulation tissue, we get to start with active closure sooner.
Speaker Change: And.
Speaker Change: It stands to bear given the data that already exists in the published literature that there's going to be more that closed in our arm and close with these limited number of tissues for.
Then there would be in the control arm, so either way we stand to benefit.
Michael Okunewitch: All right, thank you. And then, with regard to phase three, now that you know you're getting pretty close to getting that started, do you have any updated expectations regarding the enrollment rate and the time to that interim data?
Speaker Change: Alright. Thank you and then with regards to the phase three now that you are getting pretty close to getting that started.
Speaker Change: Do you have any updated expectations regarding the enrollment rate and the times that interim data.
Ofer Gonen: So, with the low number of patients that we anticipate to recruit, the 216 patients, and also we have limited competition; look at clinicaltrials.gov; you will not find clinical trials with VLU patients. We are confident that we will have a very quick patient enrollment. It should take us after 6 months of the start-up period; it will take us an additional 18 months to finish and execute the protocol.
Speaker Change: So.
Speaker Change: What were the low number of patients that we anticipate to a record 216 patients and also we have limited competition look at clinical drive the car if you will not.
Speaker Change: Not find clinical trials with value Ah patients are we have confidence for a very quick Ah Ah patient enrollment it should take us after six months of a startup period. It would take us additional 18 months, two finished and execute and executing the protocol.
Michael Okunewitch: All right. Thank you very much. And then, just one last one from me as a point of clarification. Um... Have you met with the FDA on the temperature stable DOD formulation and are waiting for feedback, or are you still expecting to meet with them in the next couple weeks?
Speaker Change: Alright. Thank you very much and then just one last one.
Speaker Change: As a clarification.
Speaker Change: Hmm.
Speaker Change: Have you met with the FDA on the temperature stable formulation and are waiting for feedback or are you still expecting to meet with them in the next couple of weeks.
Ofer Gonen: Unknown Speaker. Okay. And this is a great question. So, as I said earlier, we got quite significant funding from the DfD to develop this temperature stable formulation. We have already approached the FDA regarding the product development path, and we are anticipating feedback, which will be in the second half of 2024.
Speaker Change: And.
Speaker Change: This is a this this is a great question so oh.
Speaker Change: Told earlier, we got a quite a significant funding from the D to develop this temperature stable formulation. We already are approached the FDA regarding the the product development path and we are anticipating the feedback which will be in the <unk>.
Speaker Change: Half of 'twenty 'twenty four.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Ofer Gonen: This concludes our Q&A session. I would like to turn the call back over to Ofer Gonen for closing remarks.
Speaker Change: This concludes our Q&A session I would like to turn the call back over to bolster our going in for closing remarks.
Ofer Gonen: So thank you everyone for joining us today. We look forward to updating you again on our next quarterly call. The conference has concluded.
Speaker Change: So thank you everyone for joining us today, we look forward to updating you again in our next quarterly call.
Speaker Change: The conference has concluded.
Operator: Thank you for attending today's presentation. You may now disconnect. Unknown Speaker 00.00.00.00, Swayampakula Ramakanth, Mediwound
Speaker Change: Thank you for attending today's presentation you may now disconnect.
Speaker Change: Yeah.
Speaker Change: [music].
Unknown Speaker: BF-WATCH TV 2021