The conference must not be recorded for publication or broadcast. This conference call may contain certain forward-looking statements based on current assumptions and forecasts made by Santhera Pharmaceuticals. Such statements involve certain risks, uncertainties, and other factors which could cause the actual results, financial condition, performance, or achievements of Santhera Pharmaceuticals to be materially different from those expressed or implied by such statements. These factors include those discussed in the comprehensive risk factor disclosure on the company's website at www.santhera.com. Santhera disclaims any obligation to update any forward-looking statements. The conference may be downloaded on Santhera's website during the two weeks following the call. At this time, it's my pleasure to hand over to Mr. Dario Eklund, CEO. Please go ahead, sir.
Thank you, Moira. Good afternoon and good morning to those that are based in the U.S. listening in. Thanks for joining today's call on the occasion of the annual results of 2021 publication. I'm joined today by Andrew Smith, who's our CFO, as well as by Dr. Shabir Hasham, who's our Chief Medical Officer. We will briefly review last year's performance and then give you an outlook across various milestones and into 2023. I'd like to start by saying how pleased I am with the recent developments at Santhera and the prospects it has today. For a long time, we've weathered through many difficult times, and it seems that for the first time in many years, our path forward is clearly lined out. Over the past year and a half, we made progress on numerous fronts.
We initiated the NDA submission with vamorolone and DMD to the U.S. FDA. We realigned our organization and started expanding its U.S. operations in view of near-term launch. We entered into the partnering agreements in China and implemented various measures to secure funding. Thanks to financing arrangements concluded just last week, which Andrew will highlight in more detail, the team can now devote its efforts towards advancing vamorolone towards market entry without the uncertainty of not knowing whether our cash would be sufficient to take us to the expected FDA approval. The next milestone will be the completion of the rolling NDA submission by the end of this month. Subject to being granted priority review, vamorolone could be brought to patients with DMD in the U.S. as early as in the first quarter of next year. For vamorolone, we anticipate to present compelling new data at forthcoming conferences.
This data, which will be presented by academic collaborators, will highlight characteristics of vamorolone, such as, for example, its bone-sparing properties, which will differentiate vamorolone compared to standard of care on the basis of safety and tolerability. This may potentially also apply to other indications which will still have to be developed, in which chronic use of steroids is standard practice, and where our benefits on height and bone health can make a remarkable difference. These exciting presentations will hopefully shed more light on this most promising compound. As we are nearing the potential launch time, we are gearing up efforts to enhance the awareness of and interest in the vamorolone story, which we are convinced is a compelling proposition. I look forward to answering any of your questions in the Q&A session, and I'll hand over to Andrew now for an overview on the finances.
Thank you, Dario, and hello, everyone. A brief highlight of the financial results. Total revenue for the year was - CHF 1.5 million, a reduction of CHF 16 million, which reflected an CHF 11 million adjustment due to uncertainties around pricing and reimbursement for Raxone in France, together with the impact of supply of free goods to patients while negotiations are ongoing. We expect the recently announced positive results from the post-marketing study, LEROS, to significantly support these discussions, which adds further support to the use of Raxone in treating LHON. Operating expenses decreased by 11% year-on-year to CHF 52 million. These included a CHF 6 million provision related to France reimbursement, in addition to the amount recorded in revenue mentioned earlier.
Also expenses reflect the refocus during the year onto vamorolone, continued development on lonodelestat, as well as starting to establish a U.S.-based commercial team in anticipation of vamorolone launch in early 2023. Bottom line, the company recorded a net loss of CHF 55.5 million for the year, compared to CHF 67.6 million in the same period last year. This also includes a total non-current provision of CHF 16.8 million related to the France pricing and reimbursement discussed earlier. We reported cash and cash equivalents of CHF 21.2 million as of the end of December 2021, compared to CHF 12.4 million as of the end of December 2020. The balance included CHF 14 million reserved to settle the convertible bond 2017/22, which matured in February 2022.
Recent financing has provided much needed short-term liquidity, expected to extend reach up to approval through an up to CHF 40 million facility. Given current challenging capital market conditions, it was important that such a facility was put in place to ensure funding available if other more attractive sources remained unavailable during the period to anticipated approval. In addition, we've negotiated a reduction in approval milestones of CHF 20 million by extending these to a sales-based milestone, which again helps the near-term liquidity situation. Combined, this provides approximately half the previously communicated cash requirement through to breakeven expected in late 2024. The full year report for 2021 with operational highlights and further details is now available on the company's website. I pass back to Dario.
Thanks, Andrew. With this, we'll close the summary remarks, and we'll hand over to the operator for the Q&A session. Thank you.
We will now begin the question- and- answer session. Anyone who wishes to ask a question may press star and one on their touch-tone telephone. You will hear a tone to confirm that you've entered a queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking a question. Anyone who has a question may press star and one at this time. The first question is from Bob Pooler from valuationLAB. Please go ahead.
Thank you. Good afternoon, gentlemen. First of all, congratulations on the progress you made since last year. If I may, a few questions, starting with vamorolone. First of all, could you explain a little bit the differentiation of vamorolone versus existing steroids? What is the major benefit of this versus the current standard of care? Then maybe also differentiate in short-term, because I think you're seeing an impact already on short-term versus also long-term effects. I believe also the long-term effects, that's where you're gonna have upcoming news in the scientific community. Is that correct?
Yeah, Bob. Hi, good afternoon, and thanks for the call, or for the question on the call. I think the question that you're asking is probably best placed with Shabbir, who we have online here. Shabbir, do you wanna take a shot at it?
Sure. Bob, thanks for the question. Bob, yeah, we've completed the analysis now, and of course, we've indicated there's new data to be presented, but what we're seeing now is a very clear picture of our differentiation. Vamorolone, from the data we have, indicates that actually we're bone sparing, right? We know that-
Mm.
growth stunting isn't impacted. We've looked at that in the short-term and long-term now, up to 2.5 years, we're not seeing any indication of growth stunting. But actually a little bit more exciting is that we're seeing the trend that we didn't have a negative impact on bone biomarkers holding out now to 2.5 years. Next week at PPMD, we'll be actually presenting some new data looking at the prevalence of fracture and severity versus current standard-
Mm.
of care. I don't wanna preempt that, but actually it's very exciting.
Mm.
We're seeing a very clear signal that with vamorolone, we're bone sparing, which results in fewer and less severe fractures than the current standard of care to the medium and long-term, again, analysis. In terms of some of the other areas of differentiation, generally, we're seeing that our side effect profile is less severe than prednisone, and that's from our internal comparisons.
Mm.
We're also seeing that weight gain behavior is dose-dependent, which again gives us the ability for physicians to tailor treatment. We're hoping that, of course, that we've shown with two doses, effective at 2 and 6, physicians will then have the ability to really tailor treatment to the individual.
Mm.
If you take it collectively, vamorolone is unique in terms of it doesn't cause growth stunting. It seems to be bone sparing, and I'll allow you to judge the data next week. On top of that, because we have two doses threefold apart, the 2 and 6, physicians really-
Mm.
will have the ability to tailor treatment to the response of the individual.
Mm-hmm.
There are some other data, of course.
So ba-
Go ahead, please, Bob.
No, no. Basically just on the dosing, they would start potentially then with the lower dosing, and then if there's no side effects, go up to the higher dosing. Would that be the sort of treatment paradigm?
No. What we're recommending is just starting at the 6, a majority-
Okay, starting at the 6.
of our individuals. Right. 6 we've shown clearly to be comparable to standard of care. The dosing recommendation
Mm-hmm.
Will be to start at the 6. If you need to down titrate. You know, our data from the
Yeah.
The open-label long-term study shows that we're talking about maybe 20% of individuals needed down-titration. Either dose gives you the benefit in terms of no growth stunting, and less impact-
Mm.
on bone health, but that dose range gives you the advantage of trying to manage weight gain, cushingoid, which is again common with most steroid treatment.
You announced the announcement this morning that you have the completion of the NDA submissions expected by the end of June. When do you expect to receive the important NDA acceptance of filing?
That, Bob, would be typically 60 days after you complete your submission. If we take two months from the end of June-
Mm-hmm.
we would expect that somewhere, at the end of August.
Okay. On the EU MAA filing, that's planned for Q3, when do you expect roughly approval in the EU?
In the EU it will be. In the U.S., as you probably know, we have a six-month review period if we have a priority review starting,-
Mm-hmm.
with the acceptance of filing, and if it's a standard review, it'll be 10 months. In Europe, the review is typically 12 months, and there may be potential clock stops on the way,
Mm-hmm.
what we've guided towards is a second half of next year approval.
Okay. Just, you also mentioned that you're gonna expand the commercial organization in the U.S. and E.U. this year. What are those plans?
We've already started with that. We've hired the leadership team in the U.S. and are starting activities on all the items that have long lead times, mainly medical education, key opinion leader development, but also value and access work that is ongoing already. We're staging the hiring in a way that makes where we make sure that with the cash that we have, we have the critical functions manned early on, and then as we get closer to approval and launch, we will hire the remaining team. The last of the team will obviously be the field-based salespeople who will be identified and have basically contracts in hand, but they will be triggered by the approval itself.
After approval, we will bring them in-house for training and then launch, you know, a few weeks later, properly. We're not gonna be having the full team on board until we have approval.
Mm-hmm.
That's how we're staging it. I think once we have the acceptance of filing from the FDA, we will have de-risked the submission yet another step. I think after that, end of August or maybe first days of September time point, we will then start scaling up more aggressively in the U.S. towards launch. In Europe, we will stage it also. In Europe, we're not gonna be launching in all the countries at the same time. As you can imagine,
Mm-hmm.
we're quite dependent on the reimbursement status in the country to really put proper resources behind it. The first market to launch will be Germany, second will be U.K. and France, and then Italy and Spain will probably come a bit later. The hiring will focus first on all the more general functions that will be shared between the European affiliates, you know, central medical functions, market access functions and so on, which we will start hiring soon. Then, you know, the country organizations we'll start hiring later in the year, starting with Germany.
Okay. Just with the acceptance of filing probably end of August, do you expect with the product then more de-risk that you would have also other regional license agreements which come around soon?
It's potential. I mean, we don't wanna give you an update on every call, or not you specifically, but in general, update on every call where we stand on these licensing arrangements or regional partnership arrangements. What I have said in the past is that we are having active negotiations with potential partners in Japan. Japan is much slower than China when it comes to doing deals like this. They also want to see the full filing and the acceptance of filing before they move on. I don't think that we're gonna have a deal in Japan until maybe the last quarter of this year at the earliest.
We're also now starting negotiations with partners with the smaller European markets, so the Nordics, Austria, Switzerland, and you know, former Eastern European countries, et cetera, where we don't intend to you know, commercialize ourselves, but we'll be commercializing through partners.
Mm-hmm.
That's starting now as well.
Okay. Just a final on Raxone. What is actually the main issue with the ongoing price reimbursement in France, and particularly in light of the positive LEROS and PHAROS results supporting the long-term use of the drug?
Yeah. I'll pass the last question on. I'll give you a little bit of background and to the other listeners as well on the whole Raxone story in France, because it's gone back a long time.
Mm-hmm.
Back in 2016, you know, Santhera was denied the regular reimbursement for Raxone in France. We resubmitted the Raxone pricing and reimbursement file with the newly obtained supportive data from the studies that you just mentioned, LEROS, which was a study for efficacy and-
Mm-hmm.
PHAROS, which was a study for safety. Both of those studies had excellent results and confirmed the clinical profile that we had seen in earlier studies. During this entire period and until August 2021, from 2016 to 2021, Raxone was reimbursed under a temporary access scheme in France. It's called an ATU or post ATU, which granted the French LHON patients access to the treatment. Since Raxone was delisted from that ATU program in August 2021, for ethical reasons, we continued to provide Raxone free of charge to patients in France so that they could continue getting their treatment. In January this year, we received a positive reimbursement recommendation from the French authorities, which actually rated Raxone as a first-line therapy.
I mean, for those that are really into French reimbursement.
Mm-hmm.
We got a moderate SMR and a category of four ASMR from them. Subsequent to that, the reimbursement file was then transferred to the CEPS, which is the pricing committee in France for final pricing negotiations. Now we are in those negotiations, and they will result in two things. One, we will get a reimbursed price for future sales of Raxone from these negotiations, but we will also get a reference price, which will be required for the calculation of any eventual clawback over the temporary access period. Any clawback for Raxone calculation is based on the difference between the price charged during the temporary access period, so during that ATU period, and the reference price that is finally then established.
It's the delta between the old price and the new price-
Mm-hmm.
which will then define the clawback. Based on input from our French counsel, these negotiations may take up to 15 rounds and they may last for several months to over a year. Right now, as we speak, we're in round 3 with the CEPS, but we're making good progress with them, and the discussions are in good spirits, so I'm not so worried about it. The CEPS, they understand our financial situation, and they've shown a willingness to come to a mutually satisfactory solution on any eventual clawback, and also in the way the restitution payments could be made.
You know, these could be in kind, so we could provide any potential clawback in free goods, or we could provide that from, you know, paid back from revenues that are generated under the new reimbursement price that we will get in France. To your, I think, second last question, when do we expect to settle this? I hope that we will settle it this year despite the fact that, you know, worst case scenario could be 50, up to 15 rounds.
Mm.
It could take longer, but I think we'll have it done by the end of this year. As you can see from the annual results, we've taken quite a conservative position on the potential accounting impact of any-
Mm-hmm.
potential clawback, just so we have this, you know, in the books and kind of taken care of already. Andrew, do you wanna answer this last question here?
Yeah. I mean, on revenue later this year, it depends on what the final outcome is. I mean, if there is a reference price set and we continue to supply product, then yes, there would be some revenue, or potentially release of the provision that we have. Additionally, it could be that France is also transferred to Chiesi in line with the Chiesi licensing agreement, which again, future revenue would support the.
Somewhere on what that reference price or new reference price ends up being and any clawback and how it might be settled. As Dario says, we've taken a position which we think is a fairly conservative one right now, to provide on a non-current basis, that is.
Okay. This revenue, potential revenue that might flow in, that's not in your guidance for the-
No, it's not.
the funding period.
It's not, no.
Okay. Thanks for answering my question.
Thanks, Bob.
Keep on boxing in the next round.
Thank you very much, Bob.
For any further questions, please press star and one on your telephone. The next question is from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.
This is Swayampakula Ramakanth. Can you hear me okay?
Yes, Ramakanth, we can hear you fine. Hi.
Yeah. Awesome, great. Just to start, a few questions from our end. Just to start off, you're planning to complete the rolling submission this month. I'm just curious, what are the pending elements in the package that still needs to be done or it should be completed by end of this month?
We've already submitted two proverbial trucks, if you will. The first truck of data was the preclinical package, which kicked off the rolling submission at the end of March. A few weeks back, we completed the CMC truck submission. The remaining piece is now the clinical package, the CSR and the clinical package, which will go in by the end of the month, or maybe the first day of July. In the next two weeks.
Great. Secondly, you highlighted some of the commercial launch prep activities. Just curious, what's the size of full team you had in mind, assuming vamorolone is approved by FDA?
The full team that we will have in place by the time we launch is in the magnitude of about 70 people. Of that team, about half of them are gonna be field-based, either patient advocacy facing, reimbursement facing, medical facing or sales facing team members. The remainder will then be office based.
Okay. Got it. In terms of driving vamorolone adoption, what kind of messaging is very important to drive uptake?
I think the differentiation in the shoes of a DMD parent or patient where they have so many issues that they have to deal with. One of the issues that they're dealing with is that even without steroids, these patients develop osteoporosis over time. The bone gets weaker because in order for the bone to remain strong, it needs mechanical stimulation. With the weaker muscles that these patients have, the mechanical stimulation isn't there anymore, so they become more prone to fractures. Now, the steroids that they're given to for the anti-inflammatory properties on the muscles, they make that situation much worse. You know, no pun intended, but they put that osteoporosis on steroids.
Many of the patients are not, first of all, willing to start on steroids because of the fears around the fractures over time or because of the stunting of growth, which and the two are obviously interrelated. If you don't have healthy bone growth in a vertical direction, it's probably not healthy either in its architecture, which makes sense. Many patients then who are on steroids are taken off steroids when they start having these issues, or, and/or I should say, during the period of when they're getting these steroids, they're given all kinds of other drugs to counteract the effects of steroids as it relates to bone health. They're given testosterone, they're given vitamin D, they're given bisphosphonates.
All those drugs come with their own set of side effects. Bisphosphonates, for instance, these boys, many dentists refuse to treat them because they have osteonecrosis of the jaw as a side effect of the bisphosphonates that are given to them in order to counteract the osteoporosis that comes from the drug that is given to them in the form of a steroid. If you can introduce a steroid into this market that has the same efficacy as the standard of care steroids today, but doesn't have any of the nasty side effects on bone health and also doesn't stunt the growth plus, you know, other more benign side effects.
For instance, when you look at mood and behavior, we have a lower frequency of mood and behavior issues, and we have a lower intensity of mood and behavior issues seen in our clinical trial as well as compared to natural history. It's a more benign profile, but the real differentiator is gonna be the bone health component of this. That's where I'm really excited about the profile that is emerging. Does that answer your question, Swayampakula Ramakanth?
Switching gears a little bit, with respect to lonodelestat, which is going to be your next focus. Can you share some preliminary thoughts maybe with respect to trial design or the number of patients you need to demonstrate proof of concept and how quickly you can show the proof of concept data in phase II trials?
We have not yet disclosed the indication in which we have two indications which we're pursuing. One of them is the chronic indication of cystic fibrosis, and another indication is acute, which we have not disclosed yet. We also haven't disclosed the exact trial size of those patients. It's a phase IIa study. It's gonna be a study where we will have clinical proof of concept before the summer of next year.
Got it. That's it from me. Thank you so much for taking my questions.
Thanks, Ramakanth.
The next question is from Ruben Boyajian from Finanz und Wirtschaft. Please go ahead.
Hello. Thanks for taking my questions. It's also about lonodelestat and these two studies that shall start. How do you finance those studies? Is it possible that you are looking for partners to start them and/or, yeah, how should we think of that?
Both of these studies are still relatively small studies, phase IIa studies, which we intend currently to finance ourselves and take forward to a clinical proof of concept. We've seen in discussions with multiple potential pharma partners, where we have had discussions with lonodelestat, which have been facilitated by people who have good connections in that space, that these pharma companies do wanna see more clinical data than what we have right now. Respectively, they would take it on, but then there would be really not very attractive financials for us to do so.
It makes a lot of sense for us to take it to the next level, show the clinical proof of concept in these two indications and then potentially partner them after that. I think for a company like Santhera, the size of Santhera, it would potentially make more sense to partner the chronic indications because the chronic indications require a much larger footprint to commercialize successfully. The acute indications, which are mostly in ICUs, are something that requires a footprint much smaller and is much more affordable to launch ourselves. The lonodelestat asset in itself with the devices that go with it would allow for a separation of these two markets, if you will.
You wouldn't have cannibalization if you partnered in the chronic indication with a pharma company and then commercialized the acute indication yourself because the devices that are used for the acute care is very different from that used in chronic care. There is a potential down the line that we may partner both acute and chronic or just chronic. For now, to answer your specific question, we wanna take it forward ourselves to the next stage.
Can you give some sort of a price tag to those studies?
I don't think we have provided any guidance on that.
No. It depends on, again, partly the indications and the study design, but we'll come back to you with that as those are finalized.
Mm-hmm. Okay. Thanks a lot.
Thanks, Ruben.
As a reminder, for any further questions, please press star and one. We have a follow-up question from Bob Pooler from valuationLAB. Please go ahead.
Hello, just two follow-ups. First of all, I think you mentioned just on the key message for vamorolone that currently patients now on steroids, they start late or they don't start on steroids because of the development of osteoporosis, but also then because of osteoporosis, they end earlier the treatment there. Do you expect actually to have a larger market share than the current steroids because you could potentially start earlier with vamorolone and then if you don't have the fractures also continue the treatment also longer than the current standard therapies?
It's a good question, Bob. We, in our forecasting that we've done, at peak sales, which would be towards the end of the decade, we're looking to have about a 40% share of patients on steroids, so patients on drug.
We expect about 60% of patients to be on the other two drugs that are in the market, one of which is already generic, which is prednisone. In terms of the market size, I believe that the market will grow due to the vamorolone introduction, not so much in terms of the patients, because that's relatively stable, but because the fact that the tolerability profile of vamorolone is so much better than the existing drugs that we believe that not only will you be able to start patients earlier at a younger age over time, but patients will also typically we expect them to be taking the drug longer than today because of the tolerability.
In a typical case today, when the patient loses the ability to walk independently and ends up in the wheelchair, the benefit risk of continuing to take steroids is seen as negative at that point. Many of the patients, because they can't tolerate the side effects, stop taking steroids when they end up in the wheelchair. That's typically at the age of 11, 12 or 13. Everybody knows that they would continue to benefit from taking steroids because it would still support the muscle strength in the upper limbs and the arms.
Mm-hmm.
It would slow down the respiratory decline. It would slow down the decline in heart muscle. They should be on steroids for as long as they possibly can. We believe that with the vamorolone profile that we have, that we see today, many of these patients would continue taking steroids also after they end up in the wheelchair. By doing so, we would expand the total market size of steroids, patients on steroids in Duchenne.
Very clear. Just one final.
Maybe
Could you provide some?
I'm sorry, Bob.
Yeah.
Maybe I'll ask.
It's okay.
See if Shabir has anything to add to that.
Sure.
The medic at the table here.
Thanks. That being said. You know, one of the key efforts right now is to start treatment earlier, right? There's a recognition that obviously this is an inflammatory-based disease, especially in the early stages. You want to really start steroids sooner than they currently are. Average age of diagnosis around three to five. Peak utilization at about 8. It's telling you that there's some hesitancy.
Mm-hmm.
In the market. Now, in speaking to physicians, you know, one of the key concerns they have about starting children on steroids earlier is that you start to arrest growth, right? Growth stunting.
Mm-hmm.
Right now, at the moment, you know, you've got teenagers, adolescents who look like they're 10, 11, 12 in terms of stature. You can imagine if you're starting a two-year-old child on a steroid.
Mm.
Very early, it's gonna become a bigger problem. You're starting them earlier, osteoporosis becomes an issue, right? At the moment, it's already a problem, but it'll become a more amplified problem the sooner you start. That's one area where-
Mm-hmm.
certainly there is a value proposition for vamorolone in terms of newly diagnosed. The other area that we're seeing a lot of interest from the patient advocacy groups, but also from physicians, are those who've discontinued, right? They already have exposure to long-term steroids. They already have certain issues, and there's a hesitancy to restart because of safety concerns. That's another area where we feel-
Mm-hmm.
vamorolone may be of value, bringing back patients who have discontinued or are considering to discontinue because for them the benefit risk is different. In the older non-ambulant patient population, of course, you know, osteoporosis is a key factor. These young men have been on steroids for such a long time, so anything that has less of a detrimental impact on skeletal health, bone, may encourage them to restart or may encourage them to continue for longer. Then of course, you have those who are currently being treated and we know that this is a dynamic market. You know, after about three, four years, there's those down titration.
Mm.
Trying to come off steroids because of concerns around safety. One of the predominant features in this age group, again, is they're starting to have bone problems.
Mm-hmm.
We're seeing a very clear value proposition communicated to us by, you know, decision makers, but also really importantly by parents and then those who are concerned about the current toxicity with steroids. Overall-
Mm.
You know, we feel there is a very clear value proposition for vamorolone.
Mm-hmm.
Yeah. It sounds like, yeah, you'll have, in that respect, quite a replacement, and additionally, new patients as well, in that respect. Just one final question, if I may. It's just, could you provide guidance on your operating expenses for this year?
Yes, Bob. You know, as Dario mentioned earlier, partly dependent on the,
Mm-hmm.
The priority review or the process for the acceptance of filing is how aggressively we go about building the commercial organization in the US preparing for launch. In the region of CHF 50 million-CHF 60 million is where we'd expect.
Okay. Thank you very much.
Thanks, Bob.
Any further questions, please press star and one. There are no more questions at this time.
Well, if there's no more questions, then I'll just say a few words before we wrap up this Q&A session. First of all, thanks to all of you for joining today and for your interest in Santhera. We believe that vamorolone will have an... With vamorolone we have a really attractive anti-inflammatory drug with a unique bone-sparing profile, as you've heard. It has the potential to becoming a paradigm shift, you know, changing the lives of boys with Duchenne, but also down the line in potentially other pediatric indications, rare and orphan disease indications. Our ambition is to make it available to patients as soon as possible.
In addition to that, the financing that we have now will take us into the early next year and allows us to advance lonodelestat into phase II. I'd like to take this moment now to say a few words of thanks also to the investors who have believed in us. I would also like to thank our employees for their passion and persistence throughout the past two years. It hasn't been easy. They've done a phenomenal job with a very small team. We've been advancing on many fronts and always been delivering on our promises since a couple of years back. I hope that's recognized. Please stay tuned for updates on our progress on this exciting journey. Thanks again for everybody for joining today, and have a nice weekend.