Protalix BioTherapeutics, Inc. (PLX) Earnings Call Transcript & Summary

Hello, I am John Vandermosten, senior biotech analyst at Zacks, and welcome, everyone, today to a discussion with Protalix CEO, Dror Bashan; and CFO, Eyal Rubin. We'll have a fireside chat format and some questions for me to start out with. And then we'll open it up to Q&A from the audience. A recording of the event will be available later. [Operator Instructions] And as I said, we'll get to them at the end. So I'll preface our discussion with some background on the company. Protalix is a clinical and commercial biotech company that uses a plant-based expression system that's in contrast to the more commonly used Chinese hamster ovary model. It has one commercialized product, Elelyso. And this is distributed through partners Fiocruz in Brazil and Pfizer globally and is for Gaucher disease. And then there's also one very late-stage development product, pegunigalsidase alfa or PRX-102. And this is indicated for Fabry disease. And then there's a full pipeline of other candidates behind that. Recently, Protalix received a complete response letter from the FDA for PRX-102 related to an on-site inspection. And due to pandemic-related restrictions, the agency has really fallen behind in its efforts to conduct many inspections, not just for new drugs, and they were not able to visit Protalix' sites. So Dror Bashan, CEO; and Eyal Rubin, CFO, are here with me to discuss the state of the company's programs and the road ahead. Welcome to you both.

Protalix has been through a lot in the last months. And the recent interactions with the FDA are probably at the top of most investors' minds. Can you provide the background on the BLA submission for PRX-102? And then also bring us up to date on what's happened since then.

So sure, of course. Let me start. So Protalix developed PRX-102 aiming to treat all Fabry adult patients. PRX-102 showed positive clinical results in the Phase I/II clinical trial conducted in both male and female patients. One of the key endpoints of this Phase I/II study was an analysis of the Gb3 levels in the kidney biopsies. The overall results show the PRX-102 reached the affected tissues and reduced the kidney Gb3 inclusions burden and the lyso Gb3 in the circulation. So PRX-102 showed promising safety profile and an important pharmacokinetic profit. Therefore, Protalix, together with our collaboration partner, Chiesi Global Rare Diseases, we have submitted the BLA in May of 2020 last year under an accelerated approval path. On August 10, 2020, 3 months after, the FDA confirmed the acceptance of this BLA and, in addition, granted us a priority review. And this is despite the fact that we were in the middle of the COVID pandemic, if we can call it middle, and already 2 commercial drugs are approved in the U.S. market. Over the course of the FDA review, since the acceptance letter in August of 2020, we received questions addressing the different aspects of the 5, CMC, preclinical talks, clinical, et cetera and as one would expect the FDA to review as part of a review of a BLA. On March 11, 2021, about 6 weeks ahead of our PDUFA date, which was April 27, 2021, the FDA granted Fabrazyme a full approval. Fabrazyme is a commercial ERT that was approved in 2003 in the U.S. under an accelerated approval pathway. On April 27, the FDA issued the CRL. And we are working together with the agency to agree on future timing for the satisfaction of the preapproval inspection requirement and other requirements related to the resubmission of the BLA to the agency. As part of the resubmission process, we plan to hold a Type A meeting, which is defined as end-of-review meeting, in the third quarter of 2021 with the FDA and then to discuss the CRL and agree on the requirements for the BLA resolution.

Great. Yes. So the Type A meeting, I mean that's obviously very critical for the pathway ahead. And for everyone listening, I mean this is something that can be requested and granted and where they discuss what will need to be done going forward for the resubmission. That's great, third quarter 2021. We'll keep in touch with you after that to see the results and then we'll probably answer a lot of the questions that we don't know about now. One of the questions that I've had posed to me is regarding whether or not there was a virtual inspection. And there seems to be a lot of uncertainty whether or not that happened. It seemed like initially, and I don't think this was publicly stated, maybe just surmised by investors, but that would have been sufficient given the COVID pandemic and some of the rules that the FDA can follow during that time. But did a virtual inspection happen? And also, you mentioned the conversion of Fabrazyme to full approval. Did that play a role at all in what happened with the CRL, inspection requirements and everything? Any clarity on that whole dense topic would be helpful.

Good. So I will answer one by one. First, about the inspection on March of 2021, the Israeli MoH conducted an inspection at Protalix site in Israel and actually declared that the facility complies with the GMP requirements. The outcome of this inspection or the final report was shared with the FDA. And clearly, during the planned type A meeting, we hope to align with the agency and understand better if and when they plan to hold an inspection. It can be an in-person on-site inspection. It can be a record review. It can virtual inspection or anything else or rely on the Israeli inspection or a combination of the above. And with regard to the second topic, indeed, Fabrazyme was converted to a full approval. And indeed, in the CRL, the FDA requested additional data regarding PRX-102 in order to support this decision-making process with respect to the review of the product. So this will be discussed with FDA because what has been done, actually, we are preparing what is defined as a present book ahead of this meeting in order to hold as an effective meeting as possible.

Okay. So yes, type A meeting, very important future event coming up. And then did the full approval of Fabrazyme change? Well, I mean, going forward, does the approval of Fabrazyme change any of your regulatory requirements as you go forward from this point? Or will they remain the same as they were prior?

So the -- right now, we are actually following the CRL, which clearly inclusive of this approval of Fabrazyme fully approved is available therapy, if I may say. And all these topics will be discussed with the FDA in order to make sure that we can -- hopefully, we can resubmit under their direction following this discussion. So we will answer the topics one by one. We will add additional information to the extent we can, of course, and discuss with them to get the right direction.

Okay. For those paying attention to the outcomes of the trials that are ongoing right now, it seems like you can make the case that PRX-102 has a meaningful clinical advantage over existing therapies. Perhaps it's too early for you to mention what your views are on that, but what do you see as the primary advantage of PRX-102 over existing therapies?

So we -- our drug is under investigation or under review process. So what I can say that we believe that, potentially, this drug can be a good alternative of the market for adult Fabry patients, male and female. We have conducted already 3 clinical trials, the Phase I/II with kidney biopsies; the BRIDGE study, where we switched from Replagal, which is the ERT that is approved outside the U.S., to PRX-102; and the third one, which tests additional regimens or regimens under ERT once in 2 weeks, infusion under -- every 2 weeks. And actually, we have added a regimen -- additional regimen, once in 4 weeks. We have conducted this BRIGHT line with 30 patients that were enrolled. All of them were treated either with Fabrazyme or with Replagal. All of them was switched to our drug for 12 months' treatment. So this is the BRIGHT study. And we have actually published already positive outcomes from all these 3 studies. And also, we're actually very close to the end of the 2-year study, which is defined as the BALANCE study. Actually, by October of this year, which is 2.5 months from today, last patient is out. So -- and this is -- in this study, 78 patients were enrolled. So this is the overall clinical program and in light of the data that we see so far. As I mentioned earlier, we believe we could see potentially a good alternative on the market for adult Fabry patients.

There we go. All right. Got muted for a second. Let me just ask about the time line again. We talked about that a bit. Obviously, this is very important for investors to follow. You'll be meeting with the FDA on the type A meeting, discussing the inspection and resubmitting the BLA, among other activities. Walk us through the next year or so and tell us the key activities that we should look out for on the FDA side of the picture.

So once we -- if -- the planned meeting is in Q3, once we meet with the FDA, there will be clearly a discussion. And then I assume there will be minutes of this meeting shared by the FDA. And hopefully by then, we'll have a direction going forward for resubmission in the U.S. And only by then, we will be able to share when we expect to resubmit. We do have to remember that they still have to inspect or to clear, GMP-wise, the 2 facilities: one -- the API one, the one that we have in Israel; and the other one is the [indiscernible].

Okay. And yes, just a side question on that. I think the one in France does not require -- if I'm remembering correctly, it does not require an on-site. Is that correct? I think the FDA was attempting to address that through paperwork.

So the FDA did conduct, I'm sorry, a record review on this [indiscernible]. They gave them a list of comments. And it's the FDA decision how to operate next step [indiscernible] in-person inspection or something else. I understand -- I don't know, but this is what I hear from the media or read on the media that there is a long line in this respect. So I assume there are different alternatives.

Right. Right. And there's -- for investors who are interested in our latest report, we have a link to a report the FDA put out that discusses the backlog. And I think it has actual numbers in there, I think from May 1. But if you're interested in the details on the backlog, I think it's in that -- in our -- a link is in it in our latest research report. So we talked about -- a little bit about the BALANCE, BRIGHT and BRIDGE study. Very important studies, and each is investigating different aspects of PRX-102. Explain the goals of each and a little bit about what they're trying -- each one of those is trying to achieve.

Sure. But just to -- unless you will touch it a bit later, we also have to -- I think, to touch the European angle...

Sure. Yes. Yes, we're going to get -- we'll ask about that. But yes, why don't we get that first then, how...

If [indiscernible] you ask for, if I may say, timetable. So as we mentioned, the planned meeting with the FDA is through Q3. And following that, we will get a direction on action items at the timetable. Also a meeting with the [indiscernible] is planned for late Q3, early Q4, which is part of the process. [indiscernible] is the representative of the EU regulatory authorities as they have nominated. They will sit on the data with us. This is part of the procedure and, again, with directions. Right now, we are preparing ourselves to submit in Q1 or early Q1 of 2022 for the EU authorities.

Okay. Great. Well, yes, thanks for that time line because, obviously, that's very important, too. The EU market is quite large.

Yes. We will have to follow the direction following the meeting with the [indiscernible]. But this is the plan, and this is how we are working towards these timelines.

Okay. And so then we'll turn back to the BALANCE, BRIGHT and BRIDGE studies, which I think were originally intended to support the marketing authorization applications. Provide a little detail on each of those and kind of what each of them is trying to achieve for that application.

So all these 3 studies actually compose the Phase III clinical trial, which came after the Phase I/II. The BALANCE study is a Phase III, 24-month, randomized, double-blind active control study of PRX-102 in Fabry patients with impaired renal function, which is designed to evaluate the safety and efficacy of PRX-102 compared to agalsidase beta, which is Fabrazyme, on renal function of Fabry patients with progressing kidney disease, previously treated with Fabrazyme 1 milligram per each kilogram of the patient every 2 weeks, infusion every 2 weeks. This is the BALANCE study. The BRIDGE study was completed. It was a Phase III, 12 months, open-label study, single-arm switch-over study, evaluating the safety and efficacy of pegunigalsidase alfa, which is PRX-102, 1 milligram per kilogram every 2 weeks in patients previously treated from Replagal, meaning 22 patients that earlier were treated -- that were treated with Replagal were enrolled and switched to our drug for a 1-year treatment. The third study, called the BRIGHT study, actually is a study also completed successfully. It was a Phase III 12-month, open-label, switch-over study designed to evaluate the safety and efficacy and pharmacokinetics of PRX-102 via infusion every 4 weeks of 2 milligram per kilogram administered to the patients to all patients that were treated earlier with Fabrazyme or Replagal. We have enrolled 30 patients to this study for this 12-month duration study. All of them were treated earlier with Fabrazyme or Replagal and was switched to PRX-102 for once in 4 weeks. Earlier, they were treated once in 2 weeks. And this study actually was conducted. And again, we published the results, the top line results. So it was successfully done or completed for these patients. These are the 3 studies. Altogether, just to share, we speak about 130 patients all together which were enrolled to all these 3 studies. With -- in this orphan lysosomal disease or in this rare orphan -- rare lysosomal disease, it's a very robust number.

And for BALANCE in particular, which has not had the final readout, but that's expected coming up, will this help justify PRX-102, assuming it's successful, as clinically superior to Fabrazyme?

So assuming that if I may say -- let's put this way. The BALANCE study primary endpoint was eGFR, okay? And in addition, please note that the interim analysis is a milestone for the review of the European authorities. The FDA is looking into 2 years, meaning the full duration of the study. As I mentioned earlier, last patient out is in coming October. So in -- the plan is that next year, early next year or in half 1 next year, we will publish the final results. So I hope this answers you because this is part of the plan.

Certainly. Certainly.

We will not give the final results as you can understand, just to be clear, of this study at the coming meetings with the FDA and the representative of the European regulatory authorities.

I think a lot of patients were really looking forward to PRX-102 getting approved because there's a substantial portion of the population which is not being adequately -- their needs aren't being adequately met by the current offerings. And along with that, you had offered an expanded access program. Have you seen any changes in enrollment in that program following? Because I think probably a lot of patients were thinking if they just waited, they could probably get the drug prescribed after it was approved in the United States. But since that didn't happen, now the option for patients who are not being properly addressed by the current offerings, they have this option for the expanded access program. Is that -- have you seen enrollment pick up there? And what's -- any observations on that effort?

So I will answer both questions. One with regard to the patient or, if I may say, additional sites. Let's put it this way. Following the receipt of the CRL end of April, additional EAP sites in the U.S., of course, has been opening and these patients are being enrolled. It takes time, of course, but we see more and more patients that are being enrolled. With regard to the unmet need of Fabry. In Fabry, there is an unmet need. This is clear. And the size of the Fabry market today is estimated at $2 billion roughly, planned to be around $2.5 billion by 2025 and, towards the end of the decade, around $3 billion. And as I mentioned earlier, we are planning. And potentially, we will have a good alternative drug on this market for this -- for all adult Fabry patients, male and female.

And you put out some financial numbers there. Can you -- is there any way to identify the potential size of that market that's not being adequately served right now? I think you're providing for the entire market. So there is a subset that even if PRX-102 isn't necessarily superior, there still is an unmet need out there. And maybe you did identify the size of that. But I'm just wondering, based on your -- based on what you've seen, what is the size of that unmet need right now in Fabry?

It's difficult to estimate. I can say there are 2 scenarios, as you mentioned. Superiority is a totally different ball game. And still, even if there is no superiority, we do believe, as I mentioned earlier, and everything I said supports that, that -- we believe that, potentially, we have a good alternative on the market. And we hope it will get -- we'll be positioned well, and we'll get a good market share.

Okay. And then one step back to the FDA. You have these 3 trials that are going on. Do you anticipate that any of that data will be available and be used in -- to make a case for 4-week dosing or any other modifications to your previous submission?

So this is part of our discussion with the FDA. Right now, the BLA was based on the Phase I/II and the clinical and safety data from the BRIDGE study, the switch-over from Replagal to our study and some of -- and clearly, some safety data from the BALANCE study. Just to mention, the once in 4 weeks, the BRIGHT study was not discussed yet with the FDA. So once we will discuss this planned Type A meeting, WE will be much smarter and have much more clarity which studies and, if indeed, all of them will be part of the package for resubmission.

Got it. Got it. Again, accentuating the importance of type A meeting...

Yes. And the same should apply to the European authorities. I'm sorry.

Okay. I wanted to take a turn into the financial sphere and take a look at cash, cash flow needs. There is a $58 million in convertible notes that comes due in November this year. What are your plans to address that? And what are your cash burn estimates beyond that?

So John, as you rightly so mentioned, we have outstanding approximately $58 million of significant notes. As we published as of March 31, 2021, we had approximately $80 million in cash and cash committed by Chiesi. As we published, Protalix obviously has the financial means to pay the debt in full. In addition, we are exploring all possible financial routes to make sure that we have sufficient means to keep the company focused on bringing PRX-102 to the finish line, as Dror elaborated. With regards to your second question about the net cash burn rate. So we are -- our cash burn rate, which is similar to what we had in the past 2 years, is approximately between $5 million to $6 million net cash that we burn every quarter. We don't see a significant change from this ballpark in the coming year.

Okay. Thanks for that clarification. And then still on the financial side of things and looking at the revenues. So sales of Elelyso have been a little bit weak in Brazil. And also maybe they haven't achieved expectations at Pfizer, at least your internal expectations. What's behind this? And then is there an opportunity to modify the commercialization strategy to get more market share?

So let's differentiate between the two. Pfizer, it's ongoing and there is no change. With regard to Brazil, sales in Brazil have been consistent with our expectation for the past year -- excuse me, were consistent until the past year, if I may say, where the COVID pandemic hit Brazil. We have about 25%, 27% market share. And currently, we are working closely with the Brazilian Ministry of Health in order to find a solution and actually to work together. And we hope that despite the pandemic, which severely hit the Brazilian population, we'll be able to, if I may say, be on track. So we are in constant dialogue with them in order to enable supply and keep our supply of the drug, of course, to the patients and, as a consequence, also to be on track with the outcomes, financial outcomes.

All right. Well, we'll keep an eye on that, too. And then also, we'd be remiss if we didn't mention some of the other candidates that you have in the portfolio that are being worked on. Can you talk about some of those, the key ones that are driving the R&D portfolio in coming years after PRX-102 gets approved?

Yes. Sure. And I think it's important. So we do have an early pipeline. The first one is PRX-115, it's Uricase, for the treatment of refractory gout patients. PRX-115 is a recombinant Uricase designed to lower the uric acid levels while having low immunogenicity and increased half-life in the circulation, which, potentially at least, will be translated to improved efficacy. Preliminary data from preclinical studies demonstrate that elongated half-life in the circulation following repeated injections, indicating potentially improved pharmacokinetic profile, compare to the current treatments. Substantially, low antidrug antibodies in animals develop following repeated injection, indicating potential of low monogenic risk affecting in lower uric acid levels in animals. The development plan for PRX-102 is to initiate tox studies in the beginning of 2022 and, following that, to initiate a Phase I study with patients in the early 2023. This is the first drug or the first program, if I may say. The second program is PRX-119, which is under development. And this is a long-acting DNase, potentially customized to the treatment for various medical conditions in which NETs are involved. NETs are the neutrophil extracellular traps. Protalix, if I may say, proprietarily modified this long-acting DNase I is designed to -- for a long presence in patient circulation in the bloodstream, of course, which may potentially enable effective treatment for acute and chronic, by the way, of next related conditions. In different animal models, involving NETs pathologies, including sepsis and cancer metastatic, will be tested in collaboration with leading academic institutes worldwide during this year and for the course of next year. And this is with the aim or target to establish the first indication for our clinical program, which we'll follow. This is the second one. And the third one, we are also considering right now recommencing development of PRX-105, which is a protein-based acetylcholinesterase, which has been developed to treat nerve gas poisoning. PRX-105 has already been tested in Phase I clinical in healthy volunteers a couple of years ago. And recently, a leading defense authority has been interested in collaboration, taking this product forward as part of its, if I may say, organophosphate defense strategy and developing a medical countermeasure. So PRX-105 is actually a recombinant human acetylcholinesterase designed to function as a natural bioscavenger, like a sponge, to bind the organophosphate poisons and deactivate them before they can affect the nervous system and cause neurological death. Today, available treatment options involve repeated doses of a cocktail of 3 different drugs. And clearly, there's an unmet clinical need for optimal and improved treatment for such OP poisoning. So this is in a nutshell. These are the 3 programs. All of them are indeed early stage. And still, we plan to continue and develop them and also to look for additional early-stage collaborations.

Great. And I think for the investors who are interested, we discussed most of these programs in our reports. And we'll try to include a link here to them, so you can get a little bit more detail on our side of what we think of those. Well, great. Thank you, Dror. Thank you, Eyal. This is the end of the formal session with my questions, and we're going to move on to the Q&A section. And we'll request some questions from the group. And I'll go ahead and open the chat box here and see what we can get and post some of these questions to you. All right. So it looks like from [ Olga George ]. We have a question asking about OPRX-106. Can you explain what happened to that program?

So thank you for the question. OPRX-106 is a drug that we put on hold or we put aside right now. There were no interest in the recent 2 years that I'm in the company at least or a serious interest to collaborate. And in order to progress this drug, we need something like a couple of dozens of millions of dollars only for the next clinical stage. We -- I want to add some -- one sentence. The intent is not to have on the presentations anything which is just to -- as a V on the check box, okay? The intent is to have on the presentation the corporate presentations, active projects, okay? So this is why if indeed this specific program, we will find a partner, very nice. Right now, it's on freeze, if I may say.

Okay. Seeking a partner, okay. And then another one from Travis asking about post the Class A meeting with the FDA, what. Is the anticipated time line for approval of PRX-102? I think we touched on that a little bit. But maybe reiterate what we see is going on after the Class A meeting coming up here in third quarter.

So we are also very much interested to know, let's say, the tentative date. I don't want to go into the date not because I am hiding anything. The other way around, we don't want to put information which is not accurate. Therefore, let's all wait for the coming meeting with the FDA. And the intent is indeed to get directions, again, for the action items and timetable. And then we will share with the public, of course.

Okay. And just from our side of things, we do provide a time line based on our experiences with others of these in one of our reports. And again, I'll try to get a link to that. Hopefully, we can make it all clear. And it does not -- it's not company specific. It's just based on kind of the averages that we've seen when one of this happens. That might be helpful to investors to take a look at our report. Okay. Next question, from [ Leon Chu ]. Does it seem like you'll need to include balanced final results before you can resubmit the BLA to the FDA?

So this is part of the discussion with the FDA. It depends on the timetable when we resubmit, okay? It takes a couple of good months, maybe close to 2 quarters at least, before last patient out until you have final, final clinical study results with all the analysis, et cetera. So again, we don't want to put expectations for nothing. And we don't want to, God forbid, mislead anyone. This is why we don't commit to one date or one quarter. We prefer to share what we can. This is what we believe, this is what we think, and this is what we are operating. We will hold the meeting with the FDA. And then we'll get much better direction. And then immediately, we will share with the public, of course, once we have official meeting minutes.

Okay. [Operator Instructions] We do have time for a few more. Here is another question. Does the ITT, the intent to treat, dropout of 2 patients affect the FDA submission or potential approval? I guess they're referring to the BALANCE trial and the interim readout there.

The interim -- I think I said it before, but maybe it was not clear. I'm sorry for that. The interim results are not part of the BLA submission and not part of the requirements of the FDA. It's not that they are not aware of our PRs or any public data, of course. But their direction was to look into 2 years of dosing. So they want to wait until the end of the study in order to look on the overall balance. The BLA currently, as was submitted last year, is based on the Phase I/II and additional safety data from BRIDGE and BALANCE. No clinical efficacy, if I may say.

Okay. Let's see. We have one more right now. [Operator Instructions] They're asking about the plan in November to repay debt. I think we already asked that, that there is sufficient cash available on the balance sheet to address that. Maybe just an extension on that. Is the intent for the company to fully pay down that with cash or perhaps pay down part of it and then maintain some other debt of that $58 million?

So as I mentioned, John, we're exploiting all possible potential financial routes. One could assume that there are various solutions or a combination of alternatives to handle this debt, from a full pay-down of the debt to -- for refinance and all the spectrum in between. Obviously, as Dror mentioned, we don't want to mislead anybody and -- while we're still exploring. We will share with the public as soon as we have something fully baked.

Okay. It looks like we have another question here from [ Chamberlain K. ] to everyone. When can we anticipate initiation of a pediatric trial for PRX-102?

So the pediatric trial is part of Chiesi responsibility. And this is their responsibility, if I may say, vis-à-vis the commitment with FDA.

Okay. So it falls outside your responsibility, it sounds like.

But again, the intent is indeed -- right now, the indication is for all adult male and female patients, the intent to add, if I may say, pediatric labeling. Again, it depends on the time table. I -- probably it's boring, but I repeat myself. We do need to meet with the FDA again to get...

Sure. Right. Yes, exactly. Exactly. Actually, just one other question on the pediatric side of things. What is the current -- based on the current offerings, what is the pediatric availability of the drug? I'm not quite sure what the children are doing now to treat Fabry.

As far as I know, Fabrazyme is approved for all Fabry patients, including these things. So Galafold, I just don't know. Galafold is a chaperone technology. This is the only drug by Amicus. So it treats a certain portion of the well-known mutations. I don't have it in front of my eyes right now. We can check if it is approved also for treatment. Again, it's for a certain portion of the well-known mutation. So I think Fabrazyme is approved for Fabry patients.

Okay. Yes, because since they had that different approval status, I wasn't quite sure if they had run any pediatric...

I don't think there is a connection. I think there was no connection between treatment and effect the way [indiscernible] recently.

Okay. All right. I have another one from [ Olga George ] again. Could you name the most optimistic date for PRX-102 marketing start? Well, I'll just answer that because, I mean, it's a repeat of something that I asked. It's unknown and early, relies on how the Type A meeting turns out and what the requirements are outlined from that meeting. Questions are coming fast and furious here. Let's see. Is it your hope that the upcoming meeting with the FDA will view PRX-102 as potentially superior, based upon monthly dosing? I did ask that question earlier, but I don't know if there's anything else you want to add on that, about PRX-102 as being potentially superior, based on monthly dosing.

I don't think it's -- we can connect between the 2. The once in 4 weeks was not discussed with the FDA as far as I know. As I mentioned, many points or many topics will be discussed at the FDA for the Q3 of this year. And then we will be smart. Just to go out with declaration, I think it's certainly not serious. I want to say something, if it's okay. And I don't want the investors or stakeholders or anyone who is listening to us to think that we are kind of going in circles because we do need to share the information, to share data that we have with the 2 agencies, if I may say, the U.S. and Europe, in order to have better direction. We could have held, if I may say, this call only in a couple of months from today. We thought it's important to speak to our investors now to share what we can and what we know. And following the meeting, we will hold another call and we can share more. We thought it's more responsible to do it this way, not just to stay silent.

Okay. Last question here from [ Ron ]. He's asking about if there's any need to perhaps raise any capital in the near future. Any thoughts on that?

Well, again, we can't comment as a publicly traded company on the considerations. The company is responsible management -- or a responsible management consider various alternatives all the time to maximize the value for the various stakeholders. As I said, with regards to the debt or the upcoming maturity, we are exploring various potential financing alternatives to address it from a full cash redemption to fully refinance. Obviously, it's the only thing that we are exploring. We can't comment on things that are not yet done.

Okay. Well, thank you, Eyal. And I mean I think the answer to that question is always in my mind because, usually, companies will not explicitly state when they're going to raise capital. Just look at the cash that they have, the cash demands, and you can calculate the answer by doing that. And we try to do that in our research as well. Great. Well, thank you guys so much for attending this today with us. It's always a pleasure to speak with you and share what's going on. Obviously, it's been a difficult time with the CRL. And -- but there is a plan going forward, and we're eager to hear the 3Q '21 outcome and the notes from the Type A meeting, which is coming up. So that's obviously going to drive a lot of what's going to go forward from here on out. So we'll check back in with you then and see how it goes. So again, Dror, thank you so much. Eyal, thank you so much for attending with us today. We'll try to follow up with some links to our reports to answer any other questions that come through.

Okay. Thank you, and thank you, everybody that joined the call.

All right. Take care.

Thanks.

Thank you.