Q4 2022 Mediwound Ltd Earnings Call
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Speaker 2: Good day and welcome to Mattie Wurm's fourth quarter in year-end 2022 earnings call.
Speaker 2: Today's conference is being recorded.
Speaker 2: At this time, I would like to turn the conference over to Monique Cause of LifeSci Advisors.
Speaker 2: Monique, please go ahead.
Speaker 2: Thank you, operator, and welcome everyone. Earlier today, Medawoon issued a press release announcing financial results for the fourth quarter and year ended December 31, 2022.
Speaker 2: You may access that release on the company's website under the investors tab.
Speaker 2: With us today are Ofer Gonin, Chief Executive Officer of Medawoo, and Boaz Gerlidi, Chief Financial Officer. As always, I'm Ofer Gonin, Chief Executive Officer, Medawoo, and Boaz Gerlidi.
Speaker 2: Following our prepared remarks, we will open the call for Q&A.
Speaker 2: Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MetaWoon'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.
Speaker 2: of many factors beyond the control of metawound.
Speaker 2: 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 2: Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in Meadowland's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward booking statements.
Speaker 2: The conference call is the property of Medawoon and any recording or rebroadcast is expressly prohibited without the written consent of Medawoon.
Speaker 2: Now I'd like to turn the call over to Ofer Gonin, Chief Executive Officer of MetaWound. Ofer. I'm Ofer Gonin, Chief Executive Officer of MetaWound.
Speaker 3: Thank you, Muneeq. Good morning, everyone. It is my pleasure to welcome you to our conference call.
Speaker 3: I'm excited to be here today to discuss the remarkable company achievements in the fourth quarter and throughout 2022.
Speaker 3: We have made important achievements in all of our programs, positioning ourselves to become a global biopharmaceutical company.
Speaker 3: During my eight months tenure as CEO , our progress has been significant.
Speaker 3: including the FDA approval of NexoBrid, which is now ready for a commercial launch in the United States with our partner, Verveisil.
Speaker 3: This innovative therapy has the potential to transform treatment of severe burns and become the standard of care in the United States as it is already in Europe .
Speaker 3: Additionally, we are moving S-TREX into phase three study in venous leg ulcers.
Speaker 3: demonstrating our commitment to advancing treatments for patients in need.
Speaker 3: Our success is due in part to our strong financial position.
Speaker 3: fueled by fundraising efforts that have brought in $70 million over the past year from top quality institutional investors.
Speaker 3: Looking ahead, we are well positioned to take advantage of what we believe will be another excellent year.
Speaker 3: Our team is fully dedicated to realizing the mission of improving patient outcomes and bringing innovative therapies to the global healthcare market.
Speaker 3: Now let me discuss the next oblique in more detail.
Speaker 3: We were proud to see next complete approved by the FDA in December .
Speaker 3: This achievement is a testament to the hard work and dedication of our team who left no stone unturned in developing the science, conducting the trials, analyzing the data, completing the BLA, and of course putting manufacturing protocols in place.
Speaker 3: We are confident that NexoBrid has the potential to change the standard of care for burn patients in the United States and around the world, and we are proud to be at the forefront of this revolution.
Speaker 3: We also know that the data in the rigorous review that supported NexoBreathe approval validates our technology platform and will support the regulatory pathway for our pipeline product. To keep our team friendly and
Speaker 3: We look forward to partnering with Vericel for the U.S. commercial launch of NexoBrids, which has a market potential of $300 million.
Speaker 3: VeriCell is actively preparing for the launch in the second quarter with their sales teams, medical training, and educational sessions. And we have seen widespread interest and enthusiasm for Nectibrin, from burn centers and other healthcare professionals.
Speaker 3: We are confident in Verisil's ability to successfully launch NexoBrid and provide access to burn patients in the United States. Our ongoing NexoBrid expanded access program has allowed physicians at leading burn centers in the United States.
Speaker 3: to gain important first-hand experience using NexoBrid. We have successfully treated 206 patients at 26 leading burn centers in the United States. And based on their feedback, we are confident that NexoBrid will be an important part of the community.
Speaker 3: of the standard of care practice. We are also pleased to collaborate with the U.S. Department of Defense for the development of NexoBrig as a non-surgical solution.
Speaker 3: for the treatment of burns in the field. And we look forward to continue promoting this project and will provide additional updates this year.
Speaker 3: Globally, Nextup would gain marketing approvals in Japan, India and Switzerland and we anticipate commercial launches in these large markets later this year.
Speaker 3: We also anticipate an approval of the pediatric label expansion in Europe by mid-2023, which will further broaden the market and accelerate Nextup with revenue growth worldwide. Nextup we generated $26.5 million in revenue last year. Nextup we generated $26.5 million in
Speaker 3: and it will be cash flow positive this year.
Speaker 3: We expect revenue growth to exceed 50% in 2023 due to the product launches, the global demand, and the periodic label extension in Europe .
Speaker 3: To meet the growing demand, we are expanding our manufacturing capabilities by scaling up our facility and adding an additional manufacturing line.
Speaker 3: We are on track to complete this process.
Speaker 3: Also, in preparation for our expanding needs, we have made some important additions to our team that include several talented executives who have experience in building world-class facilities, and a number of other organizations that have been working on the development of the new
Speaker 3: developing innovative wound care products, and executing on commercial operation.
Speaker 3: This includes Dr. Rob Snyder, our Chief Medical Officer.
Speaker 3: Barry Wolfensohn, our Executive Vice President of Strategy and Corporate Development. Barry Wolfensohn, our Executive Vice President of Strategy and Corporate Development.
Speaker 3: and Alisa Kurenova, our Vice President of European Operations. These talents will be essential for expanding our global presence, supporting the increased demand of ex-computers. We will accelerate our blockbuster opportunity as correct. Now let me turn to the next speaker.
Speaker 3: to our progress with S-Correct, our next generation enzymatic therapy for chronic and hard to heal wounds. MediWound is focused on realizing this billion dollar market opportunity.
Speaker 3: Our phase two results clearly demonstrated that SREX outperformed the non-surgical standard of care in the deployment of venous leg ulcers.
Speaker 3: With only eight applications over 14 day period, the study method started the primary endpoint with a high degree of statistical significance.
Speaker 3: The median time to achieve complete debridement was nine days in patient research with SDRX.
Speaker 3: compared to 59 days in the non-surgical standard of care arm.
Speaker 3: on average.
Speaker 4: 3.6 treatment applications were needed to achieve complete debridement with S-QRX, compared to 12.8 applications of the non-surgical standard of care. Results were highly statistically significant.
Speaker 5: Thank you..
Speaker 6: The study also demonstrated a reduction in biofilm and bio-burden.
Speaker 7: We submitted the protocol design of the phase three study to the FDA for review.
Speaker 8: The final trial design will be announced when the discussions with the FDA are completed.
Speaker 9: to anticipate initiating the study in the second half of 2023. We plan also to submit a request to Emma for the scientific advice on our phase three protocol and on the clinical development plan of S-TORiC.
Speaker 10: This global approach should not have an impact on our timeline. XRX has gained the attraction of volunteer specialists and many important strategic players in the market. Cognitive Development agents can euros and millimeters.
Speaker 11: with the competitive advantages of SRX would be a significant step forward for patients and caregivers.
Speaker 12: We are thrilled to have the funding to advance this program as quickly as possible and are confident that FRX has its credible potential to unlock significant shareholder value.
Speaker 13: Finally, turning to MW005, where I'm excited to update you on our promising biological drug candidates for treating non-melanoma skin cancers. Q4 2022, we released positive data from our Phase 1-2 study on low-risk basal cell carcinoma.
Speaker 14: demonstrating that MW005 is safe and well tolerated.
Speaker 15: Patients in the study achieved complete clinical and histological clearance of their target vision. We are currently enrolling additional patients.
Speaker 16: in this specific study to optimize dosing and application and expect results in Q3 2023.
Speaker 17: It is worth noting that MW005 shares the same active pharmaceutical ingredients as NexoGrid and Esporin.
Speaker 18: This platform technology reduces many of the clinical development risks associated with MW005 as it has already been proven to be safe and effective.
Speaker 19: In conclusion, we are very well positioned for a strong 2023.
Speaker 20: In conclusion, we are very well positioned for a strong 2023. There are several promising milestones in the future.
Speaker 21: Next, the BRID is set to launch in the United States in the second quarter of this year.
Speaker 22: Additionally, we anticipate further key global market launches and are preparing for potential periodic label expansion in Europe .
Speaker 23: To support this growth, we are scaling up our manufacturing facilities. Furthermore, we plan to initiate a phase three study with S-CAREQ and Venus-LED altars in the second half of 2023 and anticipate additional data for MW-005. For more information, visit www.s-careq.gov.
Speaker 24: With a strong balance sheet and nearly $66 million in cash, we are well positioned to support our development and strategic plan through 2026.
Speaker 25: I'm very optimistic about medical future and believe that we have established a solid foundation for a continued success.
Speaker 26: Before I turn the call over to Boaz for review of our financials, I want to take a moment to address the news of his departure that was announced today.
Speaker 27: Boaz has been invaluable asset to the company and has provided strong financial and commercial leadership during his tenure.
Speaker 28: I am grateful for his support during my transition to CEO and appreciate all that he has done for us.
Speaker 29: I'm excited to welcome Hani Luxembourg as our new Chief Financial Officer. With a proven track record of 20 years delivering business growth and profitability, I'm confident that Hani will help us continue to achieve our goals and drive our success forward.
Speaker 30: The boss will remain with the company through July 31st to ensure a smooth and orderly transition.
Speaker 31: I want to thank him for his dedication and hard work over those years. With that said, I will now hand it over to Goa for a brief overview of our financial.
Speaker 32: Good morning everyone and thank you for your kind words.
I would also like to express my gratitude to all of you, our investors and analysts, for your support and collaboration throughout my time as CFO at Mediwood.
As offer mentioned, I will be stepping down for my role at the end of July .
It has been an honor and a pleasure to lead such a talented team of individuals and to spearhead the financial and commercial accomplishments that we have achieved together.
I'm proud to have played a key role in driving our growth and success and I'm confident that the company is in a strong financial position to continue executing its clinical and commercial programs under the new leadership of Ofar SCO.
It was important for me to assist with offer transition at COET Marywood.
and to contribute to the recent fundraising round, as well as to develop and execute in our European operation and our global expansion strategy.
With these efforts, I'm confident that Medi-1 is well positioned for continued success.
Not less, it was fun working together. Once again
Thank you for the great communication and collaboration over the years.
It has been a wonderful journey and it's time for me to move on. Moving to the financial statement.
Total revenues for the full year were 26.5 million compared to 23.8 million for the year ending December 31, 2021, an increase of 12% year over year.
Licensed revenues were $8.2 million, driven by the $7.5 million of BLA approval milestone from Verisound.
Revenues from products were $5.3 million, a decrease of 44% compared to the $9.6 million in 2021 due to the largest recruitment completion for emergency stoplights. Total revenues for the fourth quarter of 2022 were $11.6 million.
compared to 5.5 million in the parallel period, primarily driven by the BLE approval milestone of 7.5 million from the rest.
Revenues from products were 1.2 million compared to 1.9 million in the fourth quarter of 2021 due to 1 million decrease in emergency stockpiles determined by BARDA, partially offset by European international sales increase.
Gross profit for the year was 13.2 million or 50% of net revenues compared to a gross profit of 8.8 million or 37% of net revenues for the same period in 2021.
The gross profit for the quarter was $8.2 million or 70% of net revenue compared to a gross profit of $1.5 million or 28% of net revenue for the first quarter of 2021.
Both for the full year and the quarter, gross margin improvements were driven by the $7.5 million milestone payments from Verisela from the DLA approval.
Total operating expenses for the full year of 2022 were 21.5 million versus 20 million in 2021. Total operating expenses for the fourth quarter were 6 million compared to 5.1 million in the first quarter of 2021.
Both for the full year and the fourth quarter of 2022, the increase in total expenses was primarily driven by one-time expense related to the BLE approval and management change. Operating loss for the full year was $8.3 million compared to an operating loss of $11.3 million.
for the year ended December 31st 2021. Operating profit for the quarter was 2.1 million compared to a loss of 3.5 million in the fourth quarter of 2021.
The improvement was primarily driven by the $7.5 million milestone payment from VeriCell upon the B&A approach.
Net loss for the full year was $19.6 million or $3.93 per share compared to a net loss of $13.6 million or $3.5 million.
dollars per share for the year ending December 31st 2021.
Net loss for the quarter was $7.5 million or 1.18 cents per share compared to a net loss of $4.2 million or $1.07 per share for the fourth quarter of 2021.
The increase in loss for the full year and the quarter was due to non-cash financial expenses derived from the September and October fundraising warrant evaluation.
The active debit after the full year was a loss of 4.4 million compared to a loss of 8.3 million for the year ending December 31st 2021.
The active debit for the first quarter was a profit of 3.4 million compared to a loss of 2.9 million for the first quarter of 2021.
Moving now to the balance sheet highlight.
As of December 31, 2022, Mediwin has $34.1 million in cash and short-term investment, compared with $11 million as of December 31, 2021.
Medi-Wound utilized $11.9 million to fund its operating activities and $3.1 million for continuous liabilities and capital expenditure.
during 2022. In February 2020, the company received a 7.5 million mass payment from its partner Verisil for US FDA approval of NexoBrid in December 2022.
On February 7, 2023, the company completed the public offering which provided the company with additional 27.5 million in gross proceeds.
The company expects cash used for 2020 speed to be in the range of $16 to $18 million.
Based on the company's current operating plan, it believes that existing cash and cash equivalents will support its operation through 2020.
With that I have concluded my financial overview and will now turn the call back to Ocsel.
With that, I have concluded my financial overview. We will now turn the call back to Orsz. Orsz. Thank you, Boaz.
Our positive momentum continues and we expect 2023 to be driven by several significant catalysts.
Strong growth and meaningful revenue for Nexo grid fueled by commercial launches in key markets such as the United States, India and Japan.
scaling up our manufacturing facility to ensure we can meet the growing global demand for our product.
Initiating a Phase III pivotal trial for S, correct? Targeting a billion dollar market opportunity.
And finally, we look forward to sharing more about our MW-005 Development Plan for BCC.
With that, we would now like to open the call for any questions you may have.
We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please speak up your handset before pressing the keys.
If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.
At this time, we will pause momentarily to assemble our roster. And our first question comes from Josh Jennings from TD Colwin.
At this time, we will pause momentarily to assemble our roster. And our first question comes from Josh Jennings from TD Colwyn. Josh, please go ahead.
Hi, good morning. Thanks for taking the questions and congratulations on all the progress in 2022. Boaz, good luck in your next chapter. I was hoping to just start with asking a couple on S-QURX and first just on the back and forth with the FDA and finalizing the...
the clinical development program from here, clinical trial design. Anything you can share just in terms of.
incremental color or are there any sticking points or any other details you can provide would be helpful to understand. I know that you said the timelines for when you expect the finalization of the design, but I was wondering if there's anything more you could share on that.
Hi, Josh. Thank you for the question. So, as I said, we submitted the protocol design for the FDA for their review.
The final trial design will be announced once the discussions are done. We don't anticipate any issues. I think we got very good answers from the FDA. And I think that we are in the last stages of having their understanding in how the Phase 3 will look like.
As I said, in parallel, we plan to submit a request to Emma for scientific advice and also to understand how the clinical development plan of S-QaRX looks in Europe . This global approach should not have an impact on the timeline, so we still estimate that the trial will start. www. discreet shortly.co.uk
in 2023. As for how the trial will look like, I reiterate what I said in the previous call. We will try to make it as close as possible to the phase 2 study in order for all the investors and strategic players understand that we are going to meet the end point with no issues. Thanks for reviewing that again. I appreciate it.
It's a very good question. As you can imagine, we discussed it internally. It's good to gain the attention of all the wound care specialists and many of the important strategic care players in the market.
Everyone is looking these days for topical de-breathing agents with the advantages of S-Curex being able to provide a wound in one week. We are very lucky to have the funding and flexibility to be very, uh, RodHistory Music
to discuss a deal that will be very favorable for Marywound. Having said that, we're not speaking about North America licensing, because this is the big market and it's going to stay with us. Having said that, we are in discussion with several potential partners.
regarding a collaboration in the phase three study, our cash position and our track record in succeeding in trials, I will remind you that we succeeded in 14 out of 14 clinical trials in a few indications. The cash position that the track record enabled us to have stability in those discussions.
2005 has the same qualities as Nexo Breed has with burns and S-KREX for chronic wounds
If the results remain positive, I believe we have a strong collaboration for that. Excellent, appreciate that. And then last question is on Mexico grid. It sounds like Barra sells expecting somewhere between four to eight million in Mexico grid revenues once they launch that.
product in the U.S. in the second quarter of 23. Can you just remind us of kind of the royalty flow-through and how that could impact the revenue line for many women in 2023? Thanks for taking all the questions.
Thank you for your comments in the beginning. It was a real pleasure working with you and your team.
So regarding the question for very sales, so the economics going forward.
After the 7.5 million was achieved in February , is three kind of streamlines for the revenue. One is the transfer pricing of the product when the cost is too massive.
second stream of revenue is royalties which is a high single digit
Well, yeah, for sale of very self-designed customers.
And the third would be the two sales milestones. If the foreign region is searching threshold of revenue, then they get a certain percentage. And I think to that you can take around 20, 25% of the economic from very service would be in our CME.
Thanks, Pohaz. It's been a pleasure working with you as well. Any additional questions, Ros? We have... needs...
Yes, we have a question now from Francois Bizoubois from Oppenheimer. Francois, please go ahead.
Thanks for taking the questions and best of luck on the next venture here. On my side, I just wanted to touch on, in terms of SGRX, you talked about keeping it to yourself in the US just based on its massive opportunity. Can you just maybe help us understand how many physicians are out there and how many
What kind of sales force would be necessary, what kind of numbers wise, to be able to target the position? So thank you for the question, Frank. So first of all, the reason for us is...
the North American right and the reason that it is our top priority to have it approved is first of all that we target a market of $2 billion. I think we made that very clear in our previous presentation. Our first priority is to have it approved.
Currently we look at the different sales, sales are between $300 and $400 million annually. According to market research that was done by an external policy, we saw that not only that we draw a significant share from the current enzymatic de-briting agent, but also that we saw that the market was not as good as it was in the past.
but also we draw a significant share from the other modalities, mainly the sharp debridement, which is used by 50% of the physicians.
It's a very big market and maybe one should will be will get ready for that commercially in the next few years. I think I see the interest from the big players. I don't believe that in the end of the story, maybe one will be the one that will approach the final user.
Having said that, we are preparing for that.
Thank you very much for that. In terms of FSCAR-X, you talked about approaching the EMA. Any reason here in terms of maybe historically in this space that EMA and FDA would require different things for trial design or...
Is there any weight from the US maybe on to see what the EMA does or are these completely independent and shouldn't be much impacted? So it's a very interesting question since I tackled that basically in the first couple of months that I became a CEO . So maybe one has them.
a history of developing a drug for severe burns. It was approved by EMA. Only a few years later it was approved by the FDA. The requirements were quite different. Even the endpoints were different. Having said that, when a pediatric label extension was discussed, both agencies, EMA and FDA, agreed that the company will do a
the same trial for both agencies. We are following EMA guidelines and we are looking closely at the FDA guidelines and we also, of course, as we communicated, we also spoke with the FDA a couple of times. So we know what is required from the FDA.
We think we know how to adjust it to EMA's requirement as well, but these are not identical requirements for a phase three study. Having said that, the bar for the FDA is considered higher. Therefore, I think that we're in a good position to address the issue of the FDA's
shape and this is the reason that we estimated that approaching Emma regarding our phase three study will not change the timeline. Understood okay and then lastly the pediatric label expansion hopefully in the middle of this year in Europe you just maybe help us understand
how big the pediatric footprint in the market commercially, and then just maybe any thoughts about label expansion into pediatrics in the US. Thank you.
Okay, so let's start with the first question. Pediatric patients represent about 25 to 30% of the total burn population. Having said that, the market is a little bit smaller than 25 to 30% because the people, the children are smaller than adult patients.
Pediatric population often face painful surgery.
and it can be very traumatic for the young patients and their families, so we believe that approval will allow the pediatric patients and their family a much better experience.
So we think that it will have a big impact on the demand of an extra breathe in Europe once it is approved as for the United States We have also a plan to submit for the pediatric label expansion It's the same clinical trial. We do the same clinical trial for Emma MBA
Thank you.
Thank you.
We now have a question from Swayampakkula Ramakath from HC Wayrise. Thank you for your question.
Soy un pácola. Please go ahead. Thank you. This is RK from Hit See When Road.
Please go ahead. Thank you. This is our case. I'm receiving it. Boaz. Hi, everyone. I'm Dr. Boaz.
It's been a great pleasure working with you. Certainly will miss you. Good luck. Thank you, Akshay. As you move and progress. So, offer a couple of questions from me. On the Nexa Grid Expanded Access Program, you stated that
About 200 patients have been treated so far. I'm just trying to understand what your learnings are from that and how are you and where is utilizing that information as you prepare for the commercial launch.
So, hi, Alkay. Good to hear from you. So, as I said, we have successfully treated the 206 patients at 26 leading birth centers in the United States.
At some point we will need some data from those treatments, but what I can share is that they are very consistent with the clinical trial. When we said that the patients were treated successfully, we mean successfully. palace obviously that x-ray is mentally reinstChuck
95, 96% of the applications are success in four hours. So we just see it as a kind of an education for the US burn centers and specialists. This, we know what each more nearly.
Expanded-access trial will support very self-launch because, I don't know, something like 20% of the centers in the United States are treating patients with that drug regularly. Having said that, don't forget that the approval currently is only for that.
And in the Expanded Access Program, we are also treating pediatric populations. So I think it will support, if I go back to the question that Frank asked me earlier, it will also support the pediatric indication expansion.
because we will keep on recruiting patients in this study, although the Nexobrid will be approved in the United States, will be available in the United States commercially very soon.
Fantastic. Then regarding your obligation to BARDA, if there's any, can you kind of tell us our highlight for 23?
Can you repeat the question? You said obligation to BARDA? Do you have any obligation to BARDA in 2013? Yes, we have, as you know, BARDA has a kind of replenishment program, $16.5 million.
done in the previous two years. We are currently negotiating 2023 and 2024. BARDA also supports our SULFR master program. As you know after NEXO bridge was approved we started pushing the 43 million dollar
a grant that we got from them in order to have a deriding agent also for sauce for Master's Gals injury.
So if we look at 2023, I would expect for additional stockpile commitment, a little bit more fundraising of financing of R&D staff and especially the full-time master's day program.
Okay, my last question is on the manufacturing facility. You said that it's progressing well, but can you give us a little bit on the timeline for commissioning it? And also, is that a needed step?
For a successful launch of next ADE there. These are independent event. First of it'is an independent event. We are going- we are working in order to meet the timelines that we communicated- to the market of Q2? U us a launch.
But you are right. Hello, I lost you. I'm sorry. I think we lost... I'm sorry.
Let me check back with the presenters. Please hold on.
Hello operator. Yes, we have the speakers back. Sorry for that delay. Yeah, please go ahead. Let me let me put
Yes, we have the speakers back. Sorry for that glitch. Yeah, please go ahead. Let me put... I think we're good.
The questioner back as well. Okay, everybody is live now. Go ahead, please. Okay, I'm sorry about that. I think it's both.
I'm going back to speak about the manufacturing. As I said, our current sales are limited by our production capacity. Having said that, we are going to meet the launch requirement, a very important partner for us.
This year is going to be a special one because on top of the demand that we have from the market we also need to manufacture S-QRX for our Phase V tribe.
So we have initiated the scale up of the manufacturing facility Immediately after we raised the capital in September 2022 The total cost is something like 10 to 12 million dollars But we expect 30% to be covered by all kinds of grants
Since it's a sterile manufacturing facility, the process of scaling up will take approximately 24 months. It's not something that you can do in five months because there are a lot of regulatory affairs that are involved. We are working very hard in order to execute and make sure that we are doing it on time.
star and one.
The question now comes from Michael Okunowicz from Maxine Group.
Michael, please go ahead. Michael Michael, please go ahead. Hey there. Thank you for taking my question, and congrats on the great progress over the last couple of months. And also, Boaz, I'd like to wish you luck with the next steps in your career.
please go ahead. Hey there, thank you for taking my question and congrats on the great progress over the last couple of months. And also Boaz, I'd like to wish you luck with the next steps in your career. Thank you.
You guys have done a lot to shore up your balance sheet. You have three years, three to four years of cash at this point. Can you talk a bit about how you plan to leverage that balance sheet? Is there anything in your portfolio that would benefit from increased funds to accelerate programs? Are you looking at any potential benefits from increased funds to increase your balance sheet?
M&A targets or is this best used to just keep your balance sheets strong and provide funding through that phase three for s corrects? Thank you for your question. Maybe I'll start and Boaz will add if needed. So if you ask me
Two months ago, I would have told you that we have enough cash to do the phase three study and enough cash for the scale-up manufacturing facility because these were our requirements and we communicated that we have cash to go through 2025.
Having said that, we got a reverse inquiry from a very strong investor for an additional investment, making sure that we are able to accelerate the S-Qa-Rex effort. And the reason for accelerating it, because if we are aiming a very significant market for many hundreds of millions of dollars in capital gains, we are going to be able to
We feel very comfortable these days in these markets to have a cushion of a few tens of millions of dollars. We will not run for adventures buying assets now because we think that we have a very strong product which is S.C.A.R.X. which will generate a significant value for our shareholders.
and the next sub-grid is profitable and we will make sure that we increase the revenues quite substantially. I think if we focus on those two efforts, the value of maybe one will increase substantially. Of course, if something opportunistic will arise, we can discuss it.
And maybe just to add, Mark, from a numbers perspective, on top of the 34 million that we had at the end of 2022, we already received the 7.5 and then we have the recent fundraising, we're talking about 66 million, which should suffice us to 2026.
stress in our balance sheet. And just to maybe to summarize on top of that once you have the facility scale up we will be able to meet the growing demand and of course that I think would take us hopefully to profitability in the future years. All right, thank you for that.
I'd like to follow up on the SGRX development plans. Obviously, VLUs are the immediate opportunity. We've discussed why that's a particularly attractive market, but how are you looking at the potential use in DFUs? Is that something where you think about a parallel Phase III program?
Again, it's a very good question. As I mentioned, I think, early in this Q&A session, our top priority is to get an approval of S-Q-A-R-X. We look at the current enzymatic agent.
We see how our superiority compared to it, and we want to get an approval ASAP. Unfortunately, the FDA is already
says that a heart-willed wound or a chronic wound is not an indication. The indication of VLUs, DFUs, pressure ulcers, et cetera. We know, we chose venous leg ulcers because the unmet need there is much bigger.
Some of the discussions that we are doing with strategic players is trying to broaden our efforts around additional wound types. We are looking into it. I don't think that we will need to do another face-free study. Maybe we will need to do another bridging study or something like that.
But our top priority currently is to get an approval, being able to, making sure that we collect data that justifies a very high pricing for our drug. And after we are there, we think we can broaden the indication for additional type of forms. All right, thank you very much. And then just one final one for me and I'll hop back in the queue.
I'd like to ask a little bit about the opportunities for Nexo-Bred in Japan and India. Obviously, Japan is a major market and doesn't need much introduction, but in India, we might expect lower pricing. Is that offset by the massive population? Just give a bit more color on how those markets look for burned abridement.
Yeah, thank you for the question. So, Japanese market definitely, you know, one of the biggest health markets in the world. Probably, if you want to look at the numbers, so we see that probably around one and a half million. We see it as a first year and then definitely...
We're very excited with the enthusiasm of Kachem, which is a global pharmaceutical company and our distributor in Japan, from the launch. The launch is expected by mid-year. And of course, we expect it to grow in 2024 and 2025. Regarding India, this is a partnership that we have...
So we're still kind of learning this market. It's the biggest market, by the way, by the number of severe bone patients.
by far and I think we're still learning. I would expect it around half a million in the first year and then I think we'll be able to provide more details about this market. I will just add one trivia information. India is the only market in the world in which Nexobut didn't get the often indicated indication. The number of burn patients there are...
So this year we do not plan to sell more to India, more than half a million dollars.
All right, thank you very much. Thank you. Michael, we will take another question from you if you so desire.
I was because I got bumped off the call before so you might have to in the queue for me.
because I got bumped off the call before so you might have two in the queue for me.
All right, at this time we have no further questions then, and I would like to turn the call back over to management for some closing remarks. Thank you. Okay, so thank you everyone for joining us today. We look forward to updating you again in our next call.
or sticking to you offline. Bye-bye. Thank you everyone for joining us today. We look forward to updating you again. You may now disconnect.
That.
I.
Good day and welcome to Mattiwone's fourth quarter in year-end 2022 earnings call. Today's conference is being recorded.
At this time, I would like to turn the conference over to Monique Cause of LifeSci Advisors.
Monique, please go ahead. Thank you, operator, and welcome everyone. Earlier today, Medawoon issued a press release announcing financial results for the fourth quarter and year ended December 31, 2022.
You may access that release on the company's website under the investors tab. With us today are Ofer Gounen, Chief Executive Officer of MetaWoo and Boaz Gerlidi, 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 MetaWoon'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.
those forecasts due to the impact of many factors beyond the control of MetaWound. 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 Meadowoon's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward booking statements. The conference called this the property of Meadowoon.
and any recording or rebroadcast is expressly prohibited without the written consent of MetaWound. Now I'd like to turn the call over to Ofer Gounen, Chief Executive Officer of MetaWound. Ofer. Thank you, Monique. Good morning, everyone. It is my pleasure to welcome you to our conference call. I'm excited to be here today to discuss the remarkable company achievements in the fourth quarter and throughout 2022.
We have made important achievements in all of our programs, positioning ourselves to become a global biopharmaceutical company. During my eight months tenure as CEO , our progress has been significant.
including the FDA approval of NexoBrid, which is now raging for a commercial launch in the United States, with our partner, Verysel.
This innovative therapy has the potential to transform treatment of severe burns and become the standard of care in the United States as it is already in Europe . Additionally, we are moving S-T-A-R-X into phase three study in venous leg ulcers, demonstrating our commitment to advancing treatments for patients in need.
are well positioned to take advantage of what we believe will be another excellent year. Our team is fully dedicated to realizing the mission of improving patient outcomes and bringing innovative therapies to the global healthcare market. Now let me discuss the next of breed in more detail.
We were proud to see Nexcom grid approved by the FDA in December . This achievement is a testament to the hard work and dedication of our team who left no stone unturned in developing the science, conducting the trials, analyzing the data, completing the BLA, and of course putting manufacturing protocols in place. For more information, visit www.nexcomgrid.org
We are confident that NexoBrid has the potential to change the standard of care for burn patients in the United States and around the world, and we are proud to be at the forefront of this revolution.
We also know that the data in the rigorous review that supported NexoBreathe approval validates our technology platform and will support the regulatory pathway for our pipeline product. For more information on NexoBreathe review, go to NexoBreathe.com
We look forward to partnering with VeriCell for the U.S. commercial launch of NexoBrids, which has a market potential of $300 million. VeriCell is actively preparing for the launch in the second quarter with their sales teams, medical training and educational sessions.
and we have seen widespread interest and enthusiasm for Nexobreeds from burn centers and other healthcare professionals. We are confident in Verisil's ability to successfully launch Nexobreeds and provide access to burn patients in the United States. We are ongoing Nexobreeds.
in the United States, and based on their feedback, we are confident that Nexobrig will be an important part of the standard of care practice. We are also pleased to collaborate with the U.S. Department of Defense for the development of Nexobrig as a non-surgical solution for the treatment of burns in the field.
And we look forward to continue promoting this project and will provide additional updates this year. Globally, Nextup.net gained marketing approvals in Japan, India and Switzerland and we anticipate commercial launches in these large markets later this year. We also anticipate an approval of the pediatric label expansion in Europe .
by mid-2023, which will further broaden the market and accelerate NexoBrid's revenue growth worldwide. NexoBrid generated $26.5 million in revenue last year and it will be cash flow positive this year.
We expect revenue growth to exceed 50% in 2023 due to the product launches, the global demand and the pediatric label extension in Europe .
To meet the growing demand, we are expanding our manufacturing capabilities by scaling up our facility and adding an additional manufacturing line.
We are on track to complete this process. Also, in preparation for our expanding needs, we have made some important additions to our team that includes several talented executives who have experience in building world-class facilities, developing innovative volunteer products, and
and executing on commercial operations. This includes Dr. Rob Snyder, our Chief Medical Officer, Steve Palas, our Chief Operating Officer,
Barry Wolfensohn, our Executive Vice President of Strategy and Corporate Development and Alista Turenova, our Vice President of European Operations
These talents will be essential for expanding our global presence, supporting the increased demand of exporters.
accelerate our blockbuster opportunity, S-CoureX. Now let me turn to our progress with S-CoureX, our next generation enzymatic therapy for chronic and hard to heal wounds.
Mediwound is focused on realizing this billion dollar market opportunity. Our phase two results clearly demonstrated that SREX outperformed the non-surgical standard of care in the deployment of venous leg ulcers.
With only eight applications over 14 day period, the study method started the primary endpoint with a high degree of statistical significance.
The median time to achieve complete debridement was nine days in patient research with S-T-A-R-X.
compared to 59 days in the non-surgical standard of care arm. On average, 3.6 treatment applications were needed to achieve complete debridement with S-Curex compared to 12.8 applications of the non-surgical standard of care.
results were highly statistically significant. Additionally, our phase two pharmacology study showed robust results with an average of 3.9 applications.
to achieve debridement. The study also demonstrated a reduction in biofilm and bio-burden. We submitted the protocol design of the phase 3 study to the FDA for review. The final trial design will be announced.
when the discussions with the FDA are completed, to anticipate initiating the study in the second half of 2023. We plan also to submit a request to Emma for the scientific advice on our Phase III protocol and on the clinical development plan of S-TORP.
This global approach should not have an impact on our timeline. SRECS has gained the attraction of wound care specialists and many important strategic players in the market. Topical Debridement Agents with the competitive advantages of SRECS have been
would be a significant step forward for patients and caregivers. We are thrilled to have the funding to advance this program as quickly as possible.
and are confident that FRX has its credible potential to unlock significant shareholder value. Finally, turning to MW005.
where I'm excited to update you on our promising biological drug candidates for treating non-melanoma skin cancers. In Q4 2022, we released positive data from our Phase 1-2 study on low-risk basal cell carcinoma. In Q4, we released positive data from our Phase 1-2 study on low-risk basal cell carcinoma.
demonstrating that MW-005 is safe and well tolerated. Patients in this study achieved complete clinical and histological clearance of their target vision. We are currently enrolling additional patients in this specific study to optimize dosing and application.
and expect results in Q3 2023. It is worth noting that MW005 shares the same active pharmaceutical ingredients as Nexovid and S-T This platform technology reduces many of the clinical development associated with MW005.
as it has already been proven to be safe and effective. In conclusion, we are very well positioned for a strong 2023. There are several promising milestones in the future.
Next, the bridge is set to launch in the United States in the second quarter of this year.
Additionally, we anticipate further key global market launches and are preparing for potential periodic label expansion in Europe .
support this growth, we are scaling up our manufacturing facility. Furthermore, we plan to initiate a phase three study with S-CAREQ and Venus Legals in the second half of 2023 and anticipate additional data for MW-005. That concludes today's webinar. Thank you for joining us.
With a strong balance sheet and nearly $66 million in cash, we are well positioned to support our development and strategic plan through 2026.
I'm very optimistic about medical future and believe that we have established a solid foundation for a continued success. Before I turn the call over to Boaz for review of our financials, I want to take a moment to address the news of his departure that was announced today.
Boaz has been invaluable asset to the company and has provided strong financial and commercial leadership during his tenure. I'm grateful for his support during my transition to CEO and appreciate all that he has done for us. I'm excited to welcome Hani Luxembourg as our new Chief Financial Officer.
With a proven track record of 20 years delivering business growth and profitability, I'm confident that Hani will help us continue to achieve our goals and drive our success forward.
Boaz will remain with the company through July 31st to ensure a smooth and orderly transition. I want to thank him for his dedication and hard work over those years.
With that said, I will now hand it over to Boaz for a brief overview of our financial. Boaz? What?
Good morning everyone and thank you for your kind words. I would also like to express my gratitude to all of you, our investors and analysts, for your support and collaboration throughout my time as CFO at Mediwood. As offer mentioned, I will be stepping down from my role at the end of July .
It has been an honor and a pleasure to lead such a talented team of individuals and to spearhead the financial and commercial accomplishments that we have achieved together. I'm proud to have played a key role in driving our growth and success and I'm confident that the company is in a strong financial position.
to continue executing clinical and commercial programs under the new leadership of Ofer as CEO . It was important for me to assist with Ofer's transition as CEO at Mediwool and to contribute to the recent fundraising round as well as to develop and execute in our European operation and our global expansion strategy.
With these efforts, I'm confident that MediWound is well positioned for continued success. Not less, it was fun working together. Once again, thank you for the great communication and collaboration over the years.
It has been a wonderful journey and it's time for me to move on. Moving to the financial statement. Total revenues for the full year were $26.5 million compared to $23.8 million for the year ending December 31, 2021, an increase of 12% year over year.
Isense revenues were $8.2 million driven by the $7.5 million of daily approval milestone from VerasSay.
Revenues from products were $5.3 million, a decrease of 44% compared to the $9.6 million in 2021 due to broader procurement completion for emergency stop-fire. Total revenues for the first quarter of 2022 were $11.6 million compared to $5.5 million in the parallel period. For more information, visit www.fema.gov
primarily driven by the DLA approval milestone of 7.5 million from the recent. Revenues from products were 1.2 million compared to 1.9 million in the fourth quarter of 2021 due to 1 million decrease in emergency stockpiles determined by BARDA partially offset by our European international sales increase.
Gross profit for the year was $13.2 million or 50% of net revenue compared to a gross profit of $8.8 million or 37% of net revenues for the same period in 2021.
gross profit for the quarter was 8.2 million or 70% of net revenues compared to a gross profit of 1.5 million or 28% of net revenues for the first quarter of 2021. Both for the full year and the quarter
The gross margin improvements were driven by the $7.5 million milestone payment from VeriSell upon the VLA approval. Total operating expenses for the full year of 2022 were $21.5 million versus $20 million in 2021. Total operating expenses for the fourth quarter were $6 million.
compared to $5.1 million in the fourth quarter of 2021. Both for the full year and the fourth quarter of 2022, the increase in total expenses was primarily driven by one-time expense related to the BLE approval and the management change. Operating loss for the full year was 8.3 million.
The improvement was primarily driven by the $7.5 million milestone payment from VeriSell upon the BLE approval. Net loss for the full year was $19.6 million or $3.93 per share compared to a net loss of $13.6 million or $3.5 per share for the year ending December 31, 2021.
Net loss for the quarter was $7.5 million or 1.18 cents per share compared to a net loss of $4.2 million or $1.07 per share for the fourth quarter of 2021.
The increasing loss for the full year and the quarter was due to non-cash financial expenses derived from the September and October fundraising warrants evaluation.
The active debut of the full year was a loss of $4.4 million compared to a loss of $8.3 million for the year ending December 31, 2021.
Jaffa De Bitta for the first quarter was a profit of 3.4 million compared to a loss of 2.9 million for the fourth quarter of 2021. Moving now to the balance sheet highlights. As of December 31st 2022, Medi-One has 34.1 million in cash and short-term investment compared with 11 million as of December 31st 2021. Medi-One utilized 11.9 million
to fund its operating activities and 3.1 million for continuous liabilities and capital expenditure during 2022.
In February 2020, the company received a $7.5 million mass repayment from its partner Verisil for USFDA approval of Nexabrid in December 2022.
On February 7, 2023, the company completed the public offering which provided the company with additional $27.5 million in gross proceeds.
The company expects cash use for 2023 to be in the range of $16 to $18 million. Based on the company's current operating plan, it believes that existing cash and cash equivalents will support its operations through 2023. With that, I have concluded my financial overview and will now turn the call back to Orson.
Thank you, Boaz. Our positive momentum continues and we expect 2023 to be driven by several significant catalysts. Strong growth and meaningful revenue for NexoBrid, fueled by commercial launches in key markets such as the United States, India and Japan. Scaling up our manufacturing facilities to ensure we can meet the growing global demand for our product.
Initiating a Phase III pivotal trial for S-CoureX, targeting a billion dollar market opportunity, and finally, we look forward to sharing more about our MW-005 development plan for BCC. With that, we would now like to open the call for any questions you may have. Operator.
We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please speak up your handset before pressing the keys.
If at 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. And our first question comes from...
just start with asking a couple on S-QURX. And first, just on the back and forth with the FDA and finalizing the clinical development program from here, clinical trial design. Anything you can share just in terms of
incremental color or are there any sticking points or any other details you can provide would be helpful to understand. I know that you set the timelines for when you expect the finalization of the design, but I was wondering if there's anything more you could share on that. Hi Josh, thank you for the question.
So as I said, we submitted the protocol design for the FDA for their review. The final trial design will be announced once the discussions are done. We don't anticipate any issues. I think we got very good answers from the FDA. And I think that we are in the last stages of having their understanding of how the Phase 3 will look like.
As I said that in parallel, we plan to submit a request to Emma for scientific advice and also to understand how the clinical development plan of S-CorX looks in Europe . This global approach should not have an impact on the timeline, so we still estimate that the trial will start in 2023. As for how the trial will look like,
I reiterate what I said in the previous call. We will try to make it as close as possible to the place to study in order for all the investors and strategic players understand that we are going to meet the end point with no issues. Actually, no, thanks for reviewing that again. I appreciate it. And wanted to ask just about partnership opportunities for S-QRX and W-005. How should investors be thinking about future partnership opportunities? It sounds like you're moving forward with S-QRX independently, but should we think of that down the line that could still be partnership opportunities?
It's a very good question. As you can imagine, we discuss it internally. S-CAREX has gained the attention of all the wound care specialists and many of important strategic care players in the market. Everyone is looking these days for topical de-breathing agents with the advantages of S-CAREX being able to provide a wound in one week. We are very lucky.
to have the funding and flexibility to be very, to discuss a deal that will be very favorable for Meriwound. Having said that, we're not speaking about North America licensing, because this is the big market that is going to stay with us. Having said that, we are in discussion with several potential partners regarding a collaboration in the phase three study.
our cash position and our track record is exceeding in size. I will remind you that we succeeded in 14 out of 14 clinical trials in a few indications. The cash position that the track record enables us to have the stability in those discussions. But I can tell you that there is a lot of interest. As for MW005, the pharma company is interested in that.
We are waiting patiently to Q3 2023, and we are going to see if MW005 has the same qualities as Nexobrid has with burns and S-Carex for chronic wounds. If the results remain positive, I believe we will have a strong collaboration for that. Excellent. Appreciate that. Thank you.
for many wounds in 2023. Thanks for taking all the questions.
So, first of all, Joe, thank you for your comment in the beginning. Definitely, it was a real pleasure working with you and your team.
Regarding the question for very sales, the economics going forward, after the 7.5 million was received in February , is three kind of streamlines for the revenue. One is one
The transfer pricing, you know the product when it costs us basis Second stream of revenue is royalties. This is a high single digital loyalty upon sales of very self-designed customers.
And the third would be the two sales milestones. If upon reaching a certain threshold of revenue, then they get a certain percentage. And I think to that you can take around 20, 25% of the economic, from very sales would be in our PMM. Thanks, Pohaz. And it's been a pleasure working with you as well.
Any additional questions, Ros? Yes, we have a question now from Francois from Oppenheimer. Francois, please go ahead. Thanks for taking the questions and best of luck on the next venture.
to be able to target the physician. So thank you for the question, Frank. So first of all, the reason for us to keep S. cor. X. the North American right, and the reason that it is our top priority to have it approved.
is first of all that we target a market of $2 billion. I think we made that very clear in our previous presentation. Our first priority is to have it approved. Currently we look at the sand-fill sales. Sand-fill sales are between $300 and $400 million annually. According to market research that was done by an external policy.
we saw that not only that we draw a significant share from the talent enzymatic debriding agents, but also we draw a significant share from the other modalities, mainly the sharp debridement, which is used by 50% of the physicians. It's a very big market. Maybe one should, will get ready for that commercially in the next few years.
Since I see the interest from the big players, I don't believe that in the end of the story, maybe we will be the one that will approach the final user. Having said that, we are preparing for that.
Thank you very much for that. In terms of SGRX, you talked about approaching the EMA. Any reason here in terms of maybe historically in this space that EMA and FDA would require different things for trial design? Or is there any weight from the U.S.
maybe on to see what the EMA does or are these completely independent and they shouldn't be much much effective? So it's a very interesting question since I tackled that basically in the first couple of months that I became a CEO . So MediWound has a history of developing a drug for severe burns. It was approved by EMA only a few years later it was approved by the FDA. The requirements were quite different even the endpoints were different.
Having said that, when a pediatric label extension was discussed, both agencies, EMA and FDA, agreed that the company will do the same trial for both agencies. We are following EMA guidelines, and we are looking closely at the FDA guidelines, and we also, of course, as we communicated, we also spoke with the FDA a couple of times.
So we know what is required from the FDA. We think we know how to adjust it to Emma's requirement as well, but these are not identical requirements for a phase three study.
Having said that, the bar for the FDA is considered higher. Therefore, I think that we're in a good shape and this is the reason that we estimated that approaching EMA regarding our phase three study will not change the timeline. I understand, okay. And then lastly, the pediatric.
hopefully in the middle of this year in Europe . Can you just maybe help us understand how big the pediatric footprint in the market commercially? And then just maybe any thoughts about label expansion into pediatrics in the US.
Thank you. Okay, so let's start with the first question. Pediatric patients represents about 20 to 25 to 30 percent of the total burn population.
Having said that, the market is a little bit smaller, the 25 to 33%, because the people, the children are smaller than adult patients. Pediatric population often face painful surgery, and it can be very traumatic for the young patients and their families, so we believe that approval...
will allow the pediatric patients and their family a much better experience.
So we think that it will have a big impact on the demand of an extra breathe in Europe once it is approved as for the United States We have also a plan to submit for the pediatric label expansion It's the same clinical trial. We did the same clinical trial for Emma and the FDA Therefore we don't think that we don't see any issues with approval Having said that the timeline will be a little bit shifted because we started with you
But.
It's been a great pleasure working with you. Certainly will miss you. Good luck. Thank you, Asim. As you move and progress. So offer a couple of questions from me. On the next upgrade expanded access program, you stated that about 200 odd patients have been treated so far.
I'm just trying to understand what your learnings are from that and how are you and where is also utilizing that information as you prepare for the commercial launch.
So, hi RK, good to hear from you. So, as I said, we have successfully treated 2,206 patients at 26 leading burn centers in the United States. At some point, we will release some data from those treatments, but what I can share is that they are very consistent with the clinical supply.
burn centers and specialists. I think this expanded access trial will support very self-launch because I don't know, something like 20% of the centers in the United States are treating patients with that drug regularly. Having said that, don't forget that...
The approval currently is only for adults. And in the Expanded Access Program, we are also treating pediatric population. So I think it will support, if I go back to the question that Frank asked me earlier, it will also support the pediatric indication expansion.
because we will keep on recruiting patients in this study although the Nexoboid will be approved in the United States, will be available in the United States commercially very soon. Fantastic. Then regarding your obligation to BARDA, if there's any, can you kind of tell us our highlight for 23?
Can you repeat the question? You said obligation to BARDA? Do you have any obligation to BARDA in 23?
Yes, we have, as you know, BARDA has a kind of replenishment program, $16.5 million done in the previous two years. We are currently negotiating 2023 and 2024. BARDA also supports the
our Solsthor Master's program. As you know, after Nexobrig was approved, we started pushing the $43 million grant that we got from them in order to have a debriding agent also for Solsthor Master's gas injuries. So if we look at 2023, I would...
I would expect for additional stockpile commitment, a little bit more fundraising of financing of R&D staff and especially the full form after the program. Okay, my last question is on the manufacturing facility. You said that it's progressing well.
But, you know, can you give us a little bit on the timeline for commissioning it? And also, is that a needed step for a successful launch of Next
we are working in order to meet the timelines that we communicated to the market of the Q2 US launch. But you are right. Hello, I lost you. I'm sorry, I think we lost...
a line here. Let me check back with the presenters. Please hold on. Okay.
That.
move.
Hello, operator.
Yes, we have the speakers back. Sorry for that glitch. Yeah, sorry about that. Yeah, please go ahead. Let me put...
the questioner back as well. Okay, everybody is live now. Go ahead, please. Okay, I'm sorry about that. I think it's Boaz's fault. So I'm going back to speak about the manufacturing. So as I said, our current sales are limited by our production capacity.
Having said that, we are going to meet the launch requirement. Veritell is a very important partner for us. This year is going to be a special one because on top of the demand that we have from the market, we also need to manufacture S-QRX for our phase III tribe.
So, we have initiated the scale up of the manufacturing facility immediately after we raised the capital in September 2022. The total cost is something like $10 to $12 million, but we expect 30% to be covered by all kinds of grants. Since it's a sterile manufacturing facility, the process of scaling up will take approximately 24 months. It's not something that you can do.
remind everyone that if you would like to pose a question, press star and one. The question now comes from Michael Okunowich from Maxine Group. Michael, please go ahead. Thank you for taking my question and congrats on the great progress over the last couple of months. And also, Boaz, I would like to wish you luck with the next steps in your career.
You guys have done a lot to shore up your balance sheet. Three to four years of cash at this point. You talk a bit about how you plan to leverage that balance sheet. Is there anything in your portfolio that would benefit from increased funds to accelerate programs? Are you looking at any potential M&A targets or is this best used to keep your balance sheet strong and provide funding through that phase three for SREX?
from a very strong investor for an additional investment, making sure that we are able to accelerate the S-QA-REX effort and the reason for accelerating it.
Because if we are aiming a very significant market for many hundreds of millions of dollars in sales Let's make sure that we get there quicker. So if you look at the numbers 66 million dollars
reduced from that to 25 for a phase three trial, ballpark, and another $10 million for the scale-upping efforts, you will see that we have enough capital to do whatever is required. We feel very comfortable these days in these markets to have a cushion of a few tens of millions of dollars. We will not run for adventures buying assets now.
because we think that we have a very strong product which is S-Q-X which will generate a significant value for our shareholders. Next to it, it is profitable and we will make sure that we increase the revenues quite substantially. I think if we focus on those two efforts, we will make sure that we increase the revenues quite substantially.
the value of maybe one would increase substantially. Of course, if something opportunistic will arise, we can discuss it. And maybe just to add more, you know, from a numbers perspective, you know, on top of 34 million that we had in the end of 2022, we already received the 7.5 and then we have the recent fundraising. So we're talking about 66 in one.
which should suffice us through 2026. And also on top of that, we have the commercial set of NexoBid, definitely given the recent marketing approvals in India and Japan and in the US now, we believe that they're going to be increasing 50% in the product revenues, which of course would strengthen our balance sheet. And just to maybe to summarize on top of that, once you have the facility scale up, you will be able to meet the...
the growing demand and of course that I think would take us all to profitability in the future years. Right, thank you for that. Then I'd like to follow up on the SGRX development plans. Obviously VLUs are the immediate opportunity. We've discussed why that's a particularly attractive market, but how are you looking at the potential use in DFPs? Is that something where you think about a pattern?
I'm typically FDA.
says that a hard-willed wound or a chronic wound is not an indication. The indication of VLUs, DFUs, pressure ulcers, et cetera. We know, we chose venous leg ulcers because the unmet need there is much bigger.
Some of the discussions that we are doing with strategic players is trying to broaden our efforts around additional wound types. We are looking into it. I don't think that we will need to do another face-free study. Maybe we will need to do another bridging study or something like that. But our top priority currently is to get an approval, being able to to
making sure that we collect data that justifies a very high pricing for our drug. And after we are there, we think we can go to the indication for additional type of forms. All right, thank you very much. And then just one final one for me and I'll hop back in the queue. I'd like to ask a little bit about the opportunities for Nexo-Brid in Japan and India. Obviously, Japan's a major market and doesn't need much introduction, but in India, we might expect lower pricing.
Is that offset by the mass of population? Can you just give a bit more color on how those markets look for burned abridement? Yeah, thank you for the question. So the Japanese market definitely is one of the biggest health care markets in the world. Probably, if you want to look at the numbers, we see probably around one and a half million. We see it as the first year and then definitely we're very excited with the enthusiasm of Keikin, which is a global pharmaceutical company and our distributor in Japan, from the launch. The launch is expected by mid-year and of course we expect it to grow in 2024 and 2025.
around half a million in the first year and then I think we'll be able to provide more details about this market.
I will just add one trivia information. India is the only market in the world in which Nexobut didn't get the orphan indication. The number of burn patients there are extremely unproportional to the size of the population, which is higher regardless. But as Boaz said, half a million dollars this year and we're learning the market and we'll be able to give some more guidance later this year. And again,
We are limited by our capacity to manufacture. So this year we do not plan to sell more to India more than what happened with the others. All right, thank you very much. Thank you. Michael, we will take another question from you if you so desire. That was because I got bumped off the call before, so you might have two in the queue for me.
Okay. All right. At this time, we have no further questions then, and I would like to turn the call back over to management for some closing remarks. Thank you. Okay. So, thank you, everyone, for joining us today. We look forward to updating you again in our next call or speaking to you offline. Bye-bye. Thank you, everyone, for joining us today. We look forward to seeing you again soon.