Q2 2022 Mediwound Ltd Earnings Call
[music].
Good day and welcome to meta one second quarter 2022 earnings call.
<unk> conference is being courted.
At this time I would like to turn the conference over to Monique coffee of lifestyle advisors. Please go ahead.
Today's conference is being recorded.
At this time, I would like to turn the conference over to Monique Cossie of LifeSite Advisors. Please go ahead.
Yeah.
Thank you operator and welcome everyone.
Earlier today met alone issued a press release announcing financial results for the second quarter ended June 32022.
Thank you, operator, and welcome everyone.
Earlier today, Medawun issued a press release announcing financial results for the second quarter ended June 30, 2022. You may access that release on the company's website under the investors tab. With us today are Ofar Gonin, Chief Executive Officer of Medawun and Boaz Gerlevi, Chief Financial Officer.
You may access that release on the company's website under the investors tab with US today are Ofer <unk>, Chief Executive officer of medical and Boaz Gur Lavie Chief Financial Officer.
Following our prepared remarks, we will open the call for Q&A.
Before we begin I would like to remind everyone that statements made during this call, including the Q&A session relating to metal ones 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 19 900.
Following our prepared remarks, we will open the call for Q&A.
Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to Meadowland'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.
Hi.
Although the company believes that expectations reflected in such forward looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors beyond the control of metals.
Although the company believes that expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of meta wounds.
The company assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise.
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 <unk> annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in MetaWOOOM's annual report filed with the FCC 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 matter wound and any recording or rebroadcast is expressly prohibited without the written consent of metalworking now I would like to turn the call over to Ofer <unk> Chief Executive officer of <unk>.
The conference call is the property of metal wound and any recording or rebroadcast is expressly prohibited without the written consent of metal. Now, I would like to turn the call over to offer go nan. Chief executive officer of metal wound. Hello.
Sure.
Thank you Monique.
Morning, everyone welcome to our second quarter 2022 conference call to discuss our financial and operational highlights and provide you with our corporate updates.
Thank you, Monique. Good morning, everyone. Welcome to our second quarter 2022 conference call to discuss our financial and operational highlights and provide you with our corporate updates.
I would like to begin by saying how proud I am of the accomplishments. We've made this quarter and note that this is my first earnings call as the new CEO of maybe ones.
I would like to begin by saying how proud I am of the accomplishment we made this quarter and note that this is my first earning call as the new CEO of Mediwound.
Mary Anne.
Transition from being a board member to becoming CEO has been very smooth.
May I add that my transition from being a board member to becoming a CEO has been very smooth.
This quarter, we had positive news across all of our programs and the company is on a strong trajectory before I begin my update I would like to welcome Mr. Malcolm will niche Amir as our new chairman of the board Dr. Rob Schneider, our Chief Medical Officer and Mr.
This quarter, we had positive news across all of our programs, and the company is on a strong trajectory.
Before I begin my update, I would like to welcome Mr. Mahum Humi Shamir as our new Chairman of the Board, Dr. Rob Snyder as our Chief Medical Officer and Mr. Tzvi Palasz as our Chief Operating Officer.
The potash as our Chief operating officer.
Many of you already know from his years as a CEO of leumi mix and given imaging.
Many of you already know Homi from his years as a CEO of Fluminix and Given Imaging.
The led both companies two M&A transactions.
Billions of dollars, we are honored to have been lido aboard and look forward to benefiting from his valuable insights and extensive experience.
He led both companies to emanate transactions valued at billions of dollars.
We are honored to have him lead our board and look forward to benefiting from his valuable insights and extensive experience.
Dr. Robert Snyder, our top notch industry leader in wound care is an outstanding addition to our team.
Dr. Rob Snyder, a top-notch industry leader in wound care, is an outstanding addition to our team.
He joined US at the optimal time as correct becomes our primary focus.
He joined us at the optimal time as S-QureX becomes our primary focus.
Snyder is the past president of the U S with aviation advancement of wound care and the past President of the American Board of wound management.
Dr. Snyder is the past president of the U.S. Association of Advancement of Wound Care and the past president of the American Board of Wound Management.
We published over 165 papers in peer reviewed journals and served as principal investigator on over 65 randomized controlled trials for innovative wound healing products.
He published over 165 papers in peer-reviewed journals and served as principal investigator on over 65 randomized controlled trials for innovative wound healing products.
He has been instrumental in the development of first correct and as of January 1st 2023.
He has been instrumental in the development of S.R.X. and as of January 1, 2023, he will assume full responsibility from Professor Leo Rosenberg, who will continue to supportfield's Medi electronesville as its medical director.
Assume full responsibility from professor Rosenberg, who will continue to support <unk> as its medical director will.
Lastly on that the palace has over 35 years of proven experience in commercial operation in the healthcare industry.
Lastly on that, Today's Palasz has over 35 years of proven experience in commercial operation in the healthcare industry.
These notable record of seamless execution makes him the right CEO .
Or maybe ones.
His notable record of seamless execution makes him the right COO for many ones.
Moving now to our performance.
It was an excellent quarter for <unk> as we met all of our objectives, we set for ourselves.
Moving now to our performance.
It was an excellent quarter for MeriWound as we met all of our objectives we set for ourselves.
We were successful in both S correct phase II clinical trials.
Fda's acceptance of the Nexobrid BLA Resubmission and we had positive preliminary results in the MW or five U S phase one two study.
We were successful in both S-QRX Phase II clinical trials. We received FDA's acceptance of the NexoBrid BLA resubmission, and we had positive preliminary results in the MW005 US Phase I-II study.
On top of that maybe one significantly enhanced the board and its leadership team.
On top of that, MediOne significantly enhanced the board and its leadership team. And now...
And now.
And now we are ready to advance forward maximizing our strategic alternatives.
Now we are ready to advance forward, maximizing our strategic alternatives.
Let's discuss the <unk> program.
Last month, we hosted the Kols Investor day with for industry leaders, highlighting the current treatment practices, the unmet medical need and the potential commercial opportunity for S. Correct.
Let's discuss the S-QA-REX program.
Last month, we hosted a KOL investor day with four industry leaders highlighting the current treatment practices, the unmet medical need, and the potential commercial opportunity for S- employers.
We believe <unk> has the potential to be a blockbuster.
The phase two data from both clinical studies were robust and demonstrated that <unk> is safe well tolerated and effective.
We believe SqRX has the potential to be a blockbuster.
The phase 2 data from both clinical studies were robust and demonstrated that SqRx is safe, well tolerated and effective.
Primary and secondary endpoints.
With statistical significance.
Primary and secondary endpoints were achieved with statistical significance.
Curt is superior to gel vehicle and two surgical standard of care in all the relevant parameters.
Escort is superior to gel vehicle and to non-surgical standard of care in all the relevant parameters.
Better in the incidence of complete debridement.
Better in number of application needed.
It is better in the incidence of complete debridement.
And much better in the time to achieve complete debridement.
better in number of applications needed, and much better in the time to achieve complete engagement.
On average less than four applications are required to achieve a completed <unk> with S correct compared to nearly 13 with nonsurgical standard of care.
On average, less than four applications are required to achieve a complete debridement with S. corrix, compared to nearly 13 with non-surgical standard of care.
Median time to complete debridement is nine days for patients treated with <unk> correct.
Median time to complete the bryman is nine days for patients treated with S-Curex, compared to 59 days for patients treated with non-surgical standard of care.
<unk> to 59 days for patients treated with nonsurgical standard of care.
These are huge differences.
Additionally, strong effect on the reduction of biofilm and bacteria and burden further demonstrates <unk> superiority over the other debridement modalities.
These are huge differences.
Additionally, its strong effect on the reduction of biofilm and bacteria burden further demonstrates S-Curex superiority over the other debridement modalities.
Our market research, which was conducted by a third party suggests that based on those results. It is anticipated that <unk> will drove market share from all other debridement modalities.
Our market research, which was conducted by a third party, suggests that based on those results, it is anticipated that S-Courette's will draw market share from all other Debright men modalities.
Not just from the enzymatic and the autolytic debridement, but also from sharp debridement, which is currently considered the most effective standard of care and comprised approximately 50% of this market.
not just from the enzymatic and the autolytic debridement, but also from sharp debridement, which is currently considered the most effective stand-up of care and comprise approximately 60% of this market.
As we look at the sales of the current commercial enzymatic debridement agent in drawing additional market share from other modalities, we are optimistic about the commercial opportunity.
As we look at the sales of the current commercial enzymatic debride agent and drawing additional market share from other modalities, we are optimistic about the commercial opportunity.
We believe that we can become a significant player in this $2 billion total broadband markets.
We believe that we can become a significant player in this $2 billion total debridement market.
We aim to be the first choice for the millions of patients suffering from chronic wounds.
We aim to be the first choice for the millions of patients suffering from chronic wounds.
I strongly encourage you to view the will be now of our Kols event, which is available on our website for an in depth review of S corrections capabilities and its potential markets.
I strongly encourage you to view the webinar of our KOL event, which is available on our website for an in-depth review of S-COREx's capabilities and its potential markets.
Since announcing our phase II data, we see growing interest from potential strategic players and we are pleased to have several options to continue advancing this therapy.
Since announcing our Phase 2 data, we see growing interest from potential strategic players and we are pleased to have several options to continue advancing this therapy.
We are evaluating all possibilities, including collaboration with a potential partner or developing it independently.
We are evaluating all possibilities, including collaboration with a potential partner or developing it independently.
No matter the pathway, we are moving forward.
We will develop S correct for both <unk> and <unk> with.
No matter the pathway, we are moving forward.
The development cost for additional territories is marginal.
We will develop S-Correction for both VLUs and DFUs.
Therefore, we will be developing it for the United States for Europe .
The development cost for additional territories is marginal.
For other international markets will.
Therefore, we will be developing it for the United States, for Europe , and for other international markets.
We believe that global approach will also speed up.
Our time to market.
We believe that global approach will also speed up our time to market.
Our next step is to meet with the FDA in the second half of this year to discuss the phase III protocol.
Our next step is to meet with the FDA in the second half of this year to discuss the Phase III protocol. The next step is to meet with the FDA in the second half of the year to discuss the Phase III protocol.
We'll have more to say about this once we gain clarity on the trial design and the regulatory pathway going forwards.
We will have more to say about this once we gain clarity on the trial design and the regulatory pathway going forward.
We believe that S. Correct clinical development program is derisked.
Not only because of the robust data generated to date.
We believe that SCCORP's clinical development program is de-risked not only because of the robust data generated to date.
But given the fact that it has the same API as Nexobrid, which is a commercial product with more than 10000 patients successfully treated worldwide moving to our Mexico breed program, we announced last week that the <unk>.
but given the fact that it has the same API as NexoBrid, which is a commercial product with more than 10,000 patients successfully treated worldwide.
The accepted our Resubmission filing and is given at the due date of January 1st 2023.
Moving to our next subgroup program.
We announced last week that the FDA accepted our resubmission filing and has given a PDUFA date of January 1, 2023.
We continue to have strong partnerships with BARDA and <unk> and together, we are committed to nexobrid, becoming a commercial success in the United States.
We continue to have strong partnerships with BADA and Verisil, and together we are committed to NexoBritt becoming a commercial success in the United States.
We continue to enroll new patients in the next expanded access program at 24, leading U S burn centers with over 165 burn patients who have already been treated successfully with nexobrid to date.
We continue to enroll new patients in the next Expanded Access Program at 24 leading US Bend Centers with over 165 burn patients who have already been treated successfully with NexoRib to date.
We are on track with our collaboration with the United States Department of Defense.
We are on track with our collaboration with the United States Department of Defense.
For the development of Nexobrid as a non surgical solution fulfilled.
Current treatment for the U S Army.
for the development of Nexobrid as a non-surgical solution for field care burn treatment for the US Army.
The success of this program with open the gate for armies all over the world.
The success of this program would open the gates for armies all over the world.
It is also expected to simplify our supply chain costs and administration.
It is also expected to simplify our supply chain costs and administration.
In Europe , we continue to see burn centers embraced nexobrid as the standard of care and our Sim consistent revenue growth we.
In Europe , we continue to see burn centers embrace Nexobrid as their standard of care and have seen consistent revenue growth.
We are progressing with the pediatric label extension and expecting approval in the first half of 2023.
We are progressing with the pediatric level extension and expecting approval in the first half of 2023.
Internationally, we continue to execute on our commercial strategy of global expansion.
Internationally, we continue to execute on our commercial strategy of global expansion. And currently, Nextop breed is already approved in 41 countries.
And currently Nexobrid is already approved in 41 countries.
Later this year, we anticipate additional marketing approvals in the larger markets, including Japan and India.
Later this year, we anticipate additional marketing approvals in the larger markets, including Japan and India.
Lastly, we were pleased with the positive initial data from our U S. Phase one two study of MW of five for the treatment of basal cell carcinoma.
Lastly, we were pleased with the positive initial data from our US Phase 1-2 study of MW005 for the treatment of basal cell carcinoma, BCC.
<unk>.
The data shows MW or five to be safe and well tolerated with a majority of patients who completed the study achieved complete histological clearance of their target lesions.
The data shows MW005 to be safe and well tolerated with a majority of patients who completed the study achieved complete histological clearance of their target lesions.
These encouraging results suggest that we are on the right path to offer a topical treatment for patients with BCC that would be an alternative to surgery.
These encouraging results suggest that we are on the right path to offer a topical treatment for patients with BCC that would be an alternative to a surgery.
The market is definitely ready for a safe effective and patient friendly topical solution for BCC.
The market is definitely ready for a safe, effective, and patient-friendly topical solution for BCC.
This is another validation for our technology platform.
To conclude we are fundamentally in a very strong position.
This is another validation for our technology platform.
To conclude, we are fundamentally in a very strong position.
We believe we have a winner with S correct with multiple option moving forward.
We believe we have a winner with S-T-A-R-X with multiple options moving forward.
We have a potential approval in the United States for Nexobrid with an excellent commercial partner and.
We have a potential approval in the United States for NexoBrid with an excellent commercial partner. And we have a pipeline of follow-on therapies with MW005 in BCC with very encouraging initial data.
And we have a pipeline of follow on therapies with MW of fires in BCC with very encouraging initial data.
Let me now turn the call over to <unk> for a brief review of our financial.
Let me now turn the call over to Boaz for a brief review of our financials.
Sure.
over to Boaz for a brief review of our financial. Boaz?
Thank you Ofer and good morning, everyone.
Total revenues for the second quarter of 2022 were $4 7 million compared to $6 1 million for the second quarter of 2021.
Thank you Ofer and good morning everyone.
Total revenues for the second quarter of 2022 were $4.7 million compared to $6.1 million for the second quarter of 2021.
This was primarily due to decrease in revenues from products in licenses $1 9 million compared to $3 million in the second quarter of 2021.
This was primarily due to decrease in revenues from products and licenses of $1.9 million compared to $3 million in the second quarter of 2021.
This result is <unk> 7 million decrease in emergency stockpile procurements.
This resulted from 0.7 million decrease in emergency stockpile procurement by Varda and 0.6 million shifting revenues due to the temporary shortage in the supply chain of GLDRs.
In Europe 60 million shifting revenue due to the temporary shortage in the supply chain.
<unk> jaws.
Yes.
This issue and expect to regain some of those revenues in the third quarter of 2022.
We have managed to address this issue and expect to regain some of the revenue in the third quarter of 2022.
Gross profit was $1 1 million or 24%, while net revenues from <unk>.
Gross profit was 1.1 million or 24% on net revenue.
<unk> to gross profit of $2 4 million or 39% of net revenues for the second quarter of 2021.
Compared to gross profit of 2.4 million or 39% of net revenues for the second quarter of 2021.
Resulting from the decrease in revenues from products and licensees.
Operating expenses were $4 8 million compared to $5 3 million in the second quarter of 2021.
resulting from decreasing revenues from products and licenses.
Operating expenses were $4.8 million compared to $5.3 million in the second quarter of 2021. The decrease in expenses was primarily driven by the completion of the company's US phase 2 S-QRS trial.
Decrease in expenses was primarily driven by the completion of the company's U S phase III registration trials.
Operating loss was $3 7 million compared to $2 9 million in the second quarter of 2021.
Operating loss was 3.7 million compared to 2.9 million in the second quarter of 2021.
Net loss was $4 4 million or <unk> 13 per share compared to a net loss of $3 2 million or <unk> 12 per share for the second quarter of 2021.
Net loss was 4.4 million or 13 cents per share compared to a net loss of 3.2 million or 12 cents per share for the second quarter of 2021.
Adjusted EBITDA was a loss of $2 8 million compared to a loss of $2 million for the second quarter of 2021.
Adjusted Edita was a loss of 2.8 million compared to a loss of 2 million for the second quarter of 2021.
Moving to year to date 2022 financial results.
Total revenues for the first half of 2022 nine.
Moving to year-to-date 2022 financial results.
$1 million compared to $11 9 million in the first half of 2021.
Total revenues for the first half of 2022 were 9.1 million compared to 11.9 million in the first half of 2021.
Revenues from products and license fees in the first half of 2022 were $3 2 million compared to $5 9 million for the first half of 2021.
Revenues from products and licenses in the first half of 2022 were $3.2 million compared to $5.9 million for the first half of 2021.
This was primarily caused by decreasing emergency stockpile procurement by BARDA.
This was primarily caused by decrease in emergency stop by procurement by BIDAM.
Also as stated before it also included <unk> 6 million revenue shift due to the temporary supply chain shortage.
Also, as stated before, it also included 0.6 million revenue shifts due to the temporary supply chain shortage and we expect to regain some of the revenue in the third quarter of 2022.
Specter regain some of the revenue in the third quarter of 2022.
Operating loss was $7 million compared to an operating loss of $4 8 million in the first half of 2021.
Operating loss was 7 million compared with an operating loss of 4.8 million in the first half of 2021.
Net loss was $7 9 million or <unk> 26 per share.
<unk> to a net loss of $6 million or 22 per share for the <unk>.
Net loss was $7.9 million or $0.26 per share compared to a net loss of $6 million or $0.22 per share for the first half of 2021.
First half of 2021.
Adjusted EBITDA was a loss of $5 4 million.
Turning to the loss of $3 3 million towards the first half of 2021.
Adjusted EBITDA was a loss of 5.4 million compared to a loss of 3.3 million for the first half of 2021.
Moving now to balance sheet highlights.
As of June 32020 to maybe $110 4 million in cash and short term investments compared with $11 million as of December 31, 2021.
Moving now to balance sheet highlights.
As of June 30th, 2022, MEDI won hot 10.4 million in cash and short-term investments.
Dennis.
compared with 11 million as of December 31, 2021 in low-depth.
Maybe one utilized $6 4 million in the second quarter of 2022 for its operational activities, which was affected by $1 8 million delay in collection from customers. Subsequently received in July <unk> 60 million shifts in revenue through the third quarter due to the temporary.
Medi-One utilized $6.4 million in the second quarter of 2022 for its operational activities, which was affected by $1.8 million delay in collection from customers, subsequently received in July $0.6 million shift in revenue to the third quarter due to the temporary shortage in supply chain.
Our army shortage in supply chain.
In addition.
Cash used for the quarter included <unk> 6 million in commission related to the equity raise during the first quarter.
In addition, cash used for the quarter included $0.6 million in commissions related to the equity raised during the first quarter.
The company is updating its cash use for 2022 to be between $13 million to $15 million from the 11% to $13 million due to the impact of management changes and projected revenue shifting to 2023.
The company is updating its cash yield for 2022 to be between $13 to $15 million from the $11 to $13 million due to the impact of management changes and projected revenue shifting to 2023.
With that I have.
Concluding my financial overview.
Ill turn the call back over to Austin also.
With that, I have concluded my financial overview and will now turn the call back over to Austin.
Thank you Bob.
I'm very proud of our accomplishment this quarter.
Awesome.
Thank you, Boaz.
We have made significant strides across our pipeline of game changing therapies.
I'm very proud of our accomplishment this quarter.
We have made significant strides across our pipeline of game-changing therapies.
While we believe Mexico grids potential FDA approval is a meaningful step forward for China and United States.
While we believe NexoBrid's potential FDA approval is a meaningful step forward for volunteer in the United States.
Correct.
Our primary focus will.
We believe it has the potential to be a transformative treatment option for millions of patients suffering from chronic wounds and become a best in class debridement preference throughout the medical community.
S-Qurex remains our primary focus.
We believe it has the potential to be a transformative treatment option for millions of patients suffering from chronic wounds and become a best-in-class debridement preference throughout the medical community.
With S correct.
We hope to capture a significant part of the $1 billion chronic wound broadening market in the United States.
With S-Curex, we hope to capture a significant part of the billion dollar chronic wound and frightening market in the United States.
I look forward to sharing continued progress throughout the second half of this year.
I look forward to sharing continued progress throughout the second half of this year.
Our anticipated milestones include.
The meeting with the FDA in the second half of this year regarding the <unk> phase III study.
Our anticipated milestones include
meeting with the FDA in the second half of this year regarding the SqRx phase 3 study.
If the due date of January one 2023, with a potential U S approval of Nexobrid.
at the DUSA date of January 1, 2023, with the potential US approval of NexoBrid.
MW of five phase one two clinical results for basal cell carcinoma in the second half of 2022.
and MW005 Phase 1-2 clinical results of basal cell carcinoma in the second half of 2022.
With that it is now my pleasure to open the call for your questions.
Operator.
With that, it is now my pleasure to open the call for your questions.
operator
At this time I would like to remind everyone in order to ask a question.
Press Star then the number one on your telephone keypad.
At this time, I would like to remind everyone in order to ask a question.
We'll pause for just a moment to compile the question and answer roster.
Press star then the number one on your telephone keypad.
We'll pause for just a moment to compile the question and answer roster.
Yeah.
Your first question comes from the line of Josh Jennings from Cowen Your line is open.
Your first question comes from the line of Josh Jennings from Cowen. Your line is open.
Hi, This is Brian here for Josh. Thank you for taking my questions.
I wanted to start on Nexobrid just on our prelaunch activity can you provide an update on the next protocol and whether that will be expanded ahead of the formal launch next year and also for the BLA itself have the two needed facility inspection has been scheduled or perhaps more broadly how are you thinking about.
Hi, this is Brian here for Josh. Thank you for taking my questions.
I want to start on Nexabrid. Just on the pre-launch activity, can you provide an update on the next protocol and whether that will be expanded ahead of the formal launch next year? And also for the BLA itself, have the two needed facility inspections been scheduled or perhaps more broadly? How are you thinking about the completion of those in the context of the FDA's current review times?
The completion of those in the context of the Fda's current review times.
Okay, Hi, Bryan. Thank you. Thank you for.
The question. So as we said we continue to enroll patients for the next extended access.
Okay. Hi, Brian . Thank you. Thank you for all those questions. So, as we said, we continue to enroll patients for the next Extended Access Program at 24 leading U.S. VIN centers. More than 165 patients have been already enrolled. Our plan is to increase the size of the next child into fort
Program.
At 24, leading U S burn centers.
More than 165 patients have been already intervals.
Our plan is to increase the size of the Nic expanded access program.
At least until the approval.
extended access program at least until the approval of the of next operator
Mexico, we're working with BARDA and various settlement that.
Update you.
As soon as we have additional information about.
We are working with Varda and very seldom that and we will update you as soon as we have additional information about it.
We're working with Varda and Verisil on that, and we will update you as soon as we have additional information about it. This is for the first question.
Is it for the questions first question.
As for the second one.
Interesting, you're asking because we just had a discussion about it.
As for the second one, interesting you asked because we just had the discussion about it. As for the pre-approval inspection, we assume that the FDA will conduct a pre-approval inspection in both facilities. We are not sure if the FDA will conduct a pre-approval inspection in both facilities.
The preapproval.
Infection, we assume that the FDA will conduct.
The approval inspection in both facilities in Israel and in Taiwan as far as we know Fda's hedges a few facility inspections in Israel for the next couple of months. So we don't see an issue about this and we think it would be.
in Israel and in Taiwan. As far as we know, FDA schedules a few facility inspections in Israel for the next couple of months, so we don't see an issue about it and we think it will be advanced.
Great. Thank you and I also wanted to follow up on your comments regarding possible partnerships or strategic options and specific to <unk>.
Great. Thank you. And I also want to follow up on your comments regarding possible partnerships or strategic options and specific to SGRX, when should investors expect a clearer indication of the decision to either independently fund the Phase 3 program versus looking for a partner? And I guess my very specific question is, will that decision be settled by the end of
When should investors expect a clearer indication of the decision to either independently fund the phase III program versus looking for a partner and I guess my very specific question is will that decision be settled by the end of phase II meeting with the FDA and prior.
To the start of the Phase III program or is this an ongoing process that could extend into phase III development itself. So thank you for taking the questions.
the phase two meeting with the FDA and prior to the start of the phase three program or is this an ongoing process that could extend into
Thank you for that question so.
phase three development itself. So thank you for taking the questions.
I said earlier since announcing the phase two data, we see growing interest from potential strategic players.
So thank you for that question. So as I said earlier, since announcing the phase 2 data, we see growing interest from potential strategic players. We have several options. We have many inbound approaches. We are evaluating all the possibilities, as you can imagine, when we meet with the FDA in the fourth quarter.
We have several options we have many inbound approaches.
We are evaluating all the possibilities as you can imagine when we meet with the FDA in the fourth quarter.
We will know better about how the phase II looks like how many patients are required and then we will know how much money easily flat in order to fund. This trial. So we can either financing prior or after that we don't have a decision and we make we need to take that.
we will know better about how the phase three looks like, how many patients are required, and then we will know how much money is required in order to fund this trial. So we can either sign a deal prior or after that. We don't have a decision, and we need to take such decisions.
Decision support.
Okay.
Brian .
Hello.
Thank you.
Brian ?
Okay.
Hello?
Your next question comes from the line of Ryan Zimmerman from <unk>. Your line is open.
Thank you.
Okay, good.
Your next question comes from the line of Ron Zimmerman from BTIG. Your line is open. Your line is open.
Thank you for taking the questions. Good day connect with everyone. This morning.
Maybe just a follow up on a couple of other topics.
Thank you for taking the questions. Good to connect with everyone this morning. Maybe just to follow up on a couple other topics. One, the supply chain dynamics that impacted product revenues in the third quarter, it sounds like they're fully resolved, Boaz, but can you just give us a little more color there and is this something that you think shouldn't come up again in terms of just getting the appropriate products for?
One.
The supply chain dynamics that impacted product revenues in the third quarter.
It sounds like they are fully resolved faas, but can you just.
Give us a little more color there.
Is this something that you think shouldnt come up again in <unk>.
Terms of.
Getting the appropriate products for.
For international sales.
First of all good morning, Ryan. Thank you for the question.
for the international sales. First of all, good morning Ryan and thank you for the question.
Hey.
It implies shortage in supply chain relates to Zhejiang.
This temporary short-eating supply chain relates to GLJARL.
Which is part of the key for Nexobrid and Jill.
That as we indicated.
which is part of the keep of NexoBreathe and gel.
Thank you Jos is approximately 0.6 million, which most of that would be regaining TSV.
That, as we indicated, affected us with approximately 0.6 million, which most of that will be regained in Q3.
Last.
Week, we got plenty Joe John .
a lot
So we had enough now inventory for the next year.
We got 20,000 gel jars.
Year and a half.
So we believe that we have resolved and currently working on.
So we had enough now inventory for the next
year and a half. So we believe that we've resolved it and currently working on
We finished moving all the ore.
So we believe that something we've overcome already of course look forward to.
with the refinishment of all the orders that were pending.
The new support our customers.
So we believe that's something we've overcome already and of course look forward to continue support our customers.
No. That's helpful and 20000 is it sounds like it's certainly enough.
That's helpful and 20,000 is sounds like it's certainly enough. The second question I have Ofer is if you just talk a little bit about BARDA's plans to support a pediatric study and just where BARDA stands in terms of continued support for NexoBrid and just how to think about the next few quarters and into
The second question I have ofer as if you guys talk a little bit about BARDA has plans to support.
Pediatric study in Gist, where BARDA stands in terms of.
Continued support for Nexobrid.
And just how to think about.
<unk> for BARDA revenue over the next.
A few quarters and into 2003.
Okay. That's a good question. Thank you.
I will.
Okay, it's a good question. Thank you.
That's something that I cannot answer and not allowed to.
As you can imagine.
I will answer something that I cannot answer. I'm not allowed to but as you can
Hello.
Hello?
The speaker's line has just been disconnected one moment, while we can reconnect your line.
The speaker's line has just been disconnected. One moment while we reconnect the line.
Yeah.
Do you hear me.
Yeah.
Okay, Let me tell her I have you.
Ofer, do you hear me? Yeah.
Okay.
Okay.
Okay.
Okay, let me tell her I have you.
Hi.
Yes.
Okay.
Thank you.
Bye.
And yet the tabular sequel.
Ofer you May go ahead.
Okay, I'm, Brian I'm, sorry about that about that I don't know if you heard my.
when you take Insulin alcohol
Ofer, you may go ahead.
Jim heard my I'm sorry.
Okay, Ryan, I'm sorry about that. I don't know if you heard my...
Okay.
Laura Ofer.
I'm sorry, but okay.
Sorry, Okay, I'm, sorry about I'm, sorry about that so as for BARDA.
As you can imagine we have a very good.
As for BARDA, as you can imagine, we have a very good relationship with them. Next to BRID is considered a strategic program for BARDA. They supported it quite substantially in the past. We have a few programs going forward.
Relationship with them Nexobrid is considered.
Strategic program for BARDA, they supported it quite subtypes substantially in the past we have.
A few programs going forward.
We are speaking about replenishment, we're speaking about the pediatric.
A pediatric label extension, we have many plans going forward and we don't see any.
We are speaking about replenishment, we are speaking about pediatric label extension. We have many plans going forward and we just see positive with that specific collaboration in the future.
We just see.
Positive.
Specific collaboration in the future.
Okay. That's helpful. And then if I could just ask one more and then hop back in queue, but.
Okay, that's helpful. And then if I could just ask one more and then hop back in queue. But just following up from the previous question, and you've talked about this, Ofer, since n1.
Just following up on the previous question and you've talked about this over cents.
You've joined the company in terms of interest in terms of partnering or.
Striking some sort of deal on eschar action, yes, it'd just be helpful to know kind of what you consider an ideal partner.
you've joined the company in terms of interest, in terms of partnering or striking some sort of deal on SGRX and it'd just be helpful to know kind of what you consider an ideal partner as we think
As we think about potential.
Partners for you guys be it a comprehensive advanced wound care player or a pharmaceutical company.
partners for you guys, you know, be it a comprehensive advanced wound care player or a pharmaceutical company. I mean, what do you think about in terms of the things you're looking for in a partner and you know the financial terms aside, you know, what is it that you believe can bring the best value for S.R.X.?
<unk>.
What do you think about in terms of the things you're looking for.
And our partner in <unk>.
The financial terms aside what is it that you believe can bring the best value for eschar acts.
Okay. Thank you for that question and.
As you saw from my background in my previous career I have made many transactions many M&A transactions, mainly collaborations with big pharma and.
Okay, thank you for that question.
As you saw from my background in my previous career, I made many transactions, many M&A transactions, many collaborations with big pharma and made many strategic agreements with all kinds of pharmaceutical companies. In Mediwound, there is a high probability that we have an option to do here something like that as well. Sh facilities should also Customsith severeound in that order due to low critical pair volume,II, and the apparatus. 367 are more protective offices, but they work very closely with the broadcast service networks, as well as the MSA, the Medical Center, here at the University of California,habitat as opposed to our office.Holy Tigers, usually. The changes are also slow 29 cats are operated around the
Made many strategic agreements with all kind of pharmaceutical companies in Med D. One there is a high probability that we will that we have an option to do hear something like that as well. So the answer for your question is yes. We are we have an option to do deals with.
So, the answer for your question is yes, we have an option to do this with pharmaceutical companies, with biotech companies and with wound care companies. The reason is that the market is huge and if you look at the number of approved biotech drugs in the wound care space, you see that the number is somewhere between zero to two. Therefore, this asset is considered very unique.
Pharmaceutical companies with biotech companies and with wound care companies. The reason is that the market is huge and if you look at the number of approved approved biotech drugs.
And the wound care space, you will see that the number is somewhere between zero to two therefore this asset is considered very unique and that you cannot find a significant player in the field that is indifferent to the result that we had in the phase two study of S. Correct, having said that.
and you cannot find a significant player in the field that is indifferent to the result that we had in the phase 2 study of S-QaRX.
I want to be very clear, we're not looking for a pilot there.
Having said that, I want to be very clear. We are not looking for a partner to license S-Qerex in the United States.
License.
That's correct.
In the United States.
We think that the.
The way to have approval is not that long and its not that expensive and we don't want to let go percentage of the drug at this stage, but we can look at other avenues, such as other territories all kinds of collaborations around that but.
We think that the way to have approval is not that long and it's not that expensive and we don't want to let go percentage of the drug at this stage. But we can look at other avenues such as other territories or all kind of collaborations around that. But the ideal transaction, and I want to make it clear, is not to license the deal, the escalates in North America.
Ideal transaction and I want to make it clear is not to license the data.
That's correct in North America, as we did with Nexobrid.
Very helpful. Thank you for answering the questions.
as we did with NexoBrid.
with NexoBrid. Very helpful. Thank you for answering the questions.
Thank you.
Your next question comes from the line of Vince Swab replace from Oppenheimer. Your line is open.
Thank you.
Your next question comes from the line of Francois Breedboys from Oppenheimer. Your line is open.
Hi, This is Daniel on for Frank Congrats on the corner and congrats elsewhere on your transition to CEO . Thanks for taking my questions.
Hi, this is Daniel Onfer Frank. Congrats on the quarter and congrats on your transition to CEL. Thanks for taking our questions.
Firstly, if I can start with the market research.
For Eschar acts.
Based on these efficacy signals, we have seen so far.
Firstly, if I could start with the market research for S-Core X. Based on these efficacy signals you have seen so far, the speed of complete debridement and improvements in biomarkers, are these sufficient to shift the standard of care where a non-surgical debridement option like S-Core X is used as first-line therapy as a replacement for surgical options?
Speed of complete debridement and implemented Biomarkers.
Is it sufficient to rb's fashion to ship the standard of care, where a non surgical debridement option like S. Coax is used as first line therapy as a replacement for surgical options.
I think that they definitely touched upon the most important aspect daimyo because when we did the market research and we approached.
I think that they definitely touched upon the most important aspect, Daniel, because when we did the market research and we approached dozens of physicians and when they saw the capabilities or the characteristics of product X.
Dozens of physicians.
And when they saw the capabilities or the characteristics of product X. They claim all of them said that not all of them, but the majority of them said, we need does that product, which means that the that we anticipate that <unk> will grow market share from all the other debridement modelo.
They claim all of them said, not all of them, but the majority of them said we need that product, which means that we anticipate that S.C.A.R.X. will draw market share from all the other debridement modalities. They're not speaking only on the thematic and autolytic, which is very natural, which is currently something between 20-29% of the market. We're speaking about taking pieces from the S.C.A.R.X. debridement.
It is we're not speaking only on the thematic monopolistic, which is very natural and which is currently something between 20 and 29% of the market. We're speaking of both taking pieces from the sharp debridement, which is currently considered the most effective standard of care and mid.
This comprises something like 50% of the market and if you look at those numbers you see that the numbers that you are getting a quite huge we're speaking about something like 30% of the $2 billion market.
which is currently considered the most effective standard of care and it comprises something like 50% of the market. And if you look at those numbers, you see that the numbers that you're getting are quite huge. We're speaking about something like 30% of a $2 billion market.
And we are speaking when we when we did that specific market analysis.
Only about the United States, we have ensured information about the European potential.
We are speaking when we did that specific market analysis, we spoke only about the United States. We haven't shared information about the European potential. We are working on that as we speak with the third party, but our internal analysis suggests that there is a significant potential in Europe as well.
And we are working on that as we speak with a third party, but our internal analysis suggests that there.
There is a significant potential in Europe as well.
I hope I answered your question yes.
Thanks for that added color and just if I could just slip in one more just a follow up in case you are sharing anything on this on the upcoming FDA meeting.
I hope I answered the question.
Yep, thanks for that added color. And just if I could just slip in one more just to follow up. In case you were sharing anything on the upcoming FDA meeting, could you add some color on what you expect to gain clarity on? Talking about sharp debridement, is there non-inferiority for wound closures? Is that something that is on the table for discussion? Anything on that?
Could you add some color on what you expect to gain clarity on what you know.
I'm talking about sharp debridement is there non inferiority or wound closure is that something that is on the table for discussion on.
On that.
Yeah.
Yeah, I can share with us something like that as you can as you can imagine when you're when you're working on that piece.
Yes, I can share with you something like that. As you can imagine, when you are working on a pivotal program for S-Qurex, we are trying the trial to be as close as it can to the very robust phase 2 study that we did. Actually, we did three phase 2 studies. In all of them, we saw the same results.
People.
Program 444.
For S. Correct, we're trying the the trial to be as close as it can to the very robust phase two study that we did actually we did three phase two studies in all of them. We sold the same results, but we but our motivation is that the phase III, we'd look at.
Almost the same as the robust the largest phase II did so of course with the FDA. When we approach them, we need to speak about indications, we need to speak about the sample size and we need to speak about the study design, which we expect will be very close to the study design that we have.
but our motivation is that the Phase 3 will look almost the same as the robust, the largest Phase 2 that we did. So of course with the FDA when we approach them we need to speak about indications, we need to speak about the sample size and we need to speak about the study design which we expect will be very close to the study design that we had in the Phase 2 which means we are speaking about incidence of complete debridement as a primary.
In the phase two which means we're speaking about the incidence of complete debridement as a primary endpoint because we know that we can the FDA already approved that we can use that debt that endpoint as a primary endpoint and we saw all kinds of clinical benefits in Australia and in our when we.
The full debt, though first correct you saw all the other benefits that shows we're going to we're going to repeat those.
And hopefully we're going to repeat those results in the end.
Phase III study and then hopefully the product could be approved.
those results in the Phase 3 study and then hopefully the product will be approved.
Great. Thanks Hope it was helpful.
Yes, thanks for taking my questions and congrats again on the quarter.
I hope it was helpful.
Thank you.
Yes, thanks for taking our questions and congrats again on the quarter.
Again, if you would like to ask a question Press Star then the number one on your telephone keypad.
Thank you.
Again, if you would like to ask a question, press star, then the number 1 on your telephone keypad.
Your next question comes from the line of.
Arthur <unk> from H C. Wainwright your line is open.
Your next question comes from the line of Arthur He from HC Wainwright. Your line is open.
Hey, Adam.
Thanks for taking my question Arthur on for RJ.
Hey everyone, thanks for taking my question. This is Arthur on 4RK. Most of my question has been asked, and I just want to quickly touch on the MW005 program. Could you remind us what's the difference between the first cohort and the second cohort, and also regarding the dosing regimen.
Most of my question has been asked and I just wanted to quickly touch on the.
And they were they were five program.
Could you remind us what's the difference between the first cohort the second cohort.
And.
Also regarding the dosing regimens.
What's the rationale behind to choose seven Tom.
Topic applications every other week as the dosing regimen would.
What's the rationale behind to choose seven topic applications every other week as the dosing regimen? Would be that a dosing regimen is adjusted when we go for the later clinical study? Thank you.
It would be that dosing regimen adjuster away we go for the later.
Clinical study thank you.
Yeah.
Thank you for the question about about zero.
005 mm mm.
Thank you for the question about 0.05. We believe that the market is definitely ready for a safe, effective patient friendly a topic of solution for BCC. If you look at the markets, you see that like in burns, like in wounds. If you look at the market, you see that in wounds. It does not really exist. in warmth.
We believe that the market is definitely ready for a safe effective patient friendly.
Topical solution for BCC, if you look at the markets you see that like in Burns.
<unk> warns the.
The most common modality is.
Surgery, but if you look at superficial BCC.
The most common modality is
Topical treatments quite common, but those but the two available treatments for BCC or fair.
surgery. But if you look at superficial diseases, topical treatments are quite common.
But the two available treatments for BCC are fairly, they have some safety issues.
Fairly they have some safety issues.
Not some safety issues they have safety issues and their efficacy is very limited. So what we wanted to prove in our BCC study we dose two cohorts is that the product is safe well.
not some safety issues, they have safety issues and their efficacy is very limited. So what we wanted to prove in our BCC study with those two cohorts is that the product is safe.
Well tolerated friendly to the patient and officious. So the first cohort is.
Well, tolerated, friendly to the patient and efficacious. So the first cohort is what we are going to do, what we did is we took the first cohort of patients and we try to see if it is as effective as we saw in a previous study, that was a kind of case serious study. And if we see that efficacy is...
What we're going to do what we did is we took the faced first cohort of patients and we and we try to see if it is as effective as we saw in the previous study that was a kind of a case series study.
If we see that the.
Because the efficacy is the efficacy and safety, we have no issues or there are issues will take a decision regarding the second cohort in the second cohort the aim.
efficacy and safety, we have no issues or there are issues, we will take a decision regarding the second cohort and the second cohort, the amount of material or the amount of the number of application is higher. But we may be in a situation that we do not need that according to the result that we are going to publish next quarter.
The amount.
Amount of material or the amount of the number of application is higher.
We may be in the solution that we win situation that we do not need that according to the reserve that we're going to publish next quarter.
Yeah.
Yeah.
Thank you.
Helpful.
Yes.
I hope it wasn't helpful.
Thank you.
Yes, it is. Thank you.
At this time there are no further questions in the queue.
I would now like to turn the call back over to you.
At this time, there are no further questions in the queue. I would now like to turn the call back over to...
Ofer.
Keith Executive officer for closing remarks.
Ofer Gohman, Chief Executive Officer for closing remarks.
Okay. So thank you everyone for joining us today, we look forward to updating you again anywhere in Mexico. Thank you.
Okay, so thank you everyone for joining us today. We look forward to updating you again in our next call. Thank you.
Okay.
This concludes today's conference call you may now disconnect.
This concludes today's conference call. You may now disconnect. This concludes today's conference call.
[music].
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