Calliditas Therapeutics AB (CALT) 2021 Q1 法說會逐字稿

Ladies and gentlemen, welcome to the Calliditas Therapeutics Q1 2021 Conference. (Operator Instructions)

I'll now hand the floor to CEO, Renee Lucander. Please begin your meeting.

Thank you, and welcome to this Q1 2021 report from Calliditas. If you turn to Page 2, and before we begin, giving our listing on NASDAQ Global Select, I would just like to draw your attention to the forward-looking statements.

So turning to Page 3. In Q1, the company reached a major milestone with a filing for approval in IgA nephropathy with the FDA. This is the first-ever submission for proven IgAN, and it provides for thousands of patients living every day with this progressive disease. We subsequently received priority review from the FDA, and we're also granted accelerated assessment by EMA in April.

We continue to deliver on our plan, and we will submit our dossier to EMA this quarter, as previously announced, and we're very excited to engage with the regulatory agencies. We believe that we have a very robust data package as we didn't just show significant reduction in proteinuria, but a clear impact on the actual treatment goal itself, namely stabilization of the kidney function by way of an interruption at the very top of the disease cascade using a local disease-specific and targeted approach.

And with that, just to remind everybody very briefly about the data, I'm going to hand over to our Chief Medical Officer, Richard Philipson.

Thank you, Renee. So now moving on to Slide 4, I'll provide a brief summary of the analysis of Part A of the pivotal Phase III clinical trial of Nefecon. This analysis was performed on the first 199 patients enrolled into the trial who completed 9 months of treatment. It is a randomized double-blind placebo-controlled study, and the study is ongoing.

In terms of the primary endpoint reduction in proteinuria, we saw a 31% reduction in proteinuria as measured by UPCR, urine protein to creatinine ratio, in patients who receive Nefecon 16 milligrams at the 9-month time point versus a 5% reduction in patients who received placebo. So overall, that was a 27% reduction in UPCR in patients who received Nefecon compared to placebo at 9 months, and that outcome was highly statistically significant.

And in terms of the key secondary endpoint, we saw stabilization of eGFR at 9 months in patients who received Nefecon 16 milligrams versus a 7% reduction in eGFR in patients who received placebo. That; equates to approximately a loss of 4 milligrams per minute in eGFR over the 9-month treatment period. And again, that comparison between Nefecon and placebo was highly statistically significance, and that is also noteworthy that we continue -- we need to see a decline in proteinuria at the 12-month time point when patients have been off treatment for 3 months.

In terms of tolerability, the treatment is generally well tolerated the safety profiles in keeping with Phase IIb. A particular note of no severe infections in contrast to off-label use of systemic corticosteroid. And there's a no adverse clinical effects on the cardiovascular or metabolic system.

Moving on to Slide 5. I'd like to just briefly summarize the outcome of some biomarker analysis that have been performed based on samples taken from the Phase IIb Nefecon trial. And taken together, these important analyses show modification to the circulating biomarkers relevant to the pathogenesis of IgA nephropathy. So specifically, we saw, in association with Nefecon treatment, reductions in galactose-deficient IgA I levels and in IgA immune complexes. And we also showed reductions in vast B-cell activating factor, which is a potent activating B-cell. So overall, we saw a clearly relevant impact on circulating pathogenic biomarkers in IgAN.

So moving to Slide 6. In summary then, in terms of the Phase III clinical trial, we saw robust demonstration of efficacy in terms of reduction in proteinuria and stabilization of eGFR in patients who received Nefecon with a tolerability and safety profile in line with the active ingredient as expected with the high first-pass metabolism and, therefore, low systemic availability.

Overall, in the clinical development program, we've seen high consistency of efficacy data across the Phase IIb and Phase III clinical trials, enrolling a broad range of patients with IgA nephropathy. And the eGFR stabilization that we've seen across these 2 large randomized placebo-controlled study provides clear support for the disease-modifying effects of Nefecon.

I'll now hand back to Renee.

Thank you. So if we turn the page -- to Slide #7. So in addition to the defining event of our regulatory filing, other events in the quarter included the full enrollment into the NefIgArd trial, which took place in early January. We're very proud as an organization to achieve this enrollment goal during the pandemic, and we look forward to the full readout in early 2023.

The quarter also saw the first patient enrolled in the OLE study, so this is the extension study at which patients can enroll in once they have completed the 2 years in the NefIgArd trial. And we are excited about being able to offer Nefecon to all qualifying participants in the NefIgArd study in this fashion.

We recently decided not to pursue the NefXtend study in the second half of this year due to a combination of the significant delay of the study start due to this ongoing pandemic and recent interactions supporting alternative formats for achieving [insighted] treatment paradigms post a potential approval. This was not a regulatory study, so there's no bearing from a regulatory perspective.

Finally, in Q1, we saw the successful readout of the setanaxib Phase I study, which supports higher dosing going forward, and Richard will shortly give you some more details around the pivotal trial, which we plan to start in the second half of this year.

We continue to build out in the U.S., and as part of that, Andrew Udell was recently promoted to President of North America. And he's been with us for almost 3 years and has strong ties across the entire European organization, which I believe is a key component of building a successful transatlantic business.

I will turn over to Andy, with no further ado, who will take you through some of our recent progress in the U.S.

Thanks, Renee. We're on Page 8 now. Over the last quarter, we've continued to grow our team, bringing on key members of our U.S. leadership team, which included a Head of Marketing, Head of U.S. Sales and a VP of Medical Affairs. Our team will continue to grow significantly over the next several quarters as we prepare for commercialization in the fourth quarter of this year. With this growth comes the need to expand our office space, and we are in the process of finalizing our lease in a substantially larger office space in New York City.

Next page, please. As the slide shows, we have continued to meet our time lines, and with an FDA action date of September 15, we are preparing for commercialization in the fourth quarter of this year.

Next, Page 10, please. In our preparations, we continue to conduct market research and get further entrenched in the IgA nephropathy market, and the trends continue to be encouraging. Over the next few slides, I'd like to highlight some recently completed syndicated research conducted by Spherix Global Insights. This research includes 188 nephrologists and chart audits of 468 IgA nephropathy patients.

Slide 11, please. It's clear this is an unsatisfied market. 46% of the nephrologists rate IgA nephropathy as extremely challenging to manage in non-dialysis patients. 52% believe there are few or no effective treatment options currently available. The nephrologists anticipate that 65% of their current patients will progress to dialysis and end-stage renal disease. 53% of the nephrologists would like to replace the systemic steroids high doses as they're using for treatment option, and 80% believe that early intervention is critical to successful outcomes, and this number has been growing.

If you go to Slide 12, please. When asked about Nefecon -- when asked about the pipeline, Nefecon had the greatest unaided awareness by nephrologists, with almost half of them rating themselves as very familiar with Nefecon in the Phase III results. This awareness has continued to increase from the last reporting period. And of these that rated themselves as very familiar, they indicated they are extremely likely to prescribe Nefecon for 70% of their current patients.

Next slide. We continue to work -- to entrench ourselves in this market and educate and work on a disease awareness campaign, as you can see here, which launched earlier this quarter. And it can be found at iganephropathyculprit. com.

And with that, I think we'll go to the next slide and pass to Richard to review the clinical activities.

Thank you very much, Andrew. So I'm on Slide 14. I'll summarize the clinical activities that are ongoing at present. So in terms of Nefecon, the NefIgArd study, the Phase III clinical trial is fully enrolled as of January of this year, and we anticipate that the last patient will complete 2 years of follow-up in early 2023.

In terms of setanaxib, we remain on track to start the Phase III -- Phase IIb/III clinical trial in primary biliary cholangitis in the second half of this year. And similarly, we remain on track to start the Phase II proof-of-concept study in squamous cell carcinoma of the head and neck in the second half of this year. We have ongoing setanaxib investigator-sponsored studies in interstitial pulmonary fibrosis and diabetic kidney disease. And the Nefecon open-label extension is open, active and enrolling patients.

Moving on to Slide 15. Just to give some background about primary biliary cholangitis, the target of our setanaxib Phase IIb/III clinical trial, this is a rare autoimmune disease with the high female preponderance, so the female to male ratio is 9:1. And it's a rare disease, and it affects around 1 in 3,000 to 4,000 people. It's characterized pathologically by gradual destruction of small intrahepatic bile ducts with clinical features, which include debilitating fatigue and itching of the skin. And eventually, the condition progresses to cirrhosis, with all of the attendant complications. But interestingly, in many patients, their initial diagnosis is made when they're asymptomatic based on incidental liver enzyme abnormalities.

Moving on to Slide 16. There is and remains a clear unmet need in PBC, despite existing therapies, in particular, with respect to the clinical features that I mentioned, such as fatigue and itching, both of which can be highly debilitating. 45% of patients showed inadequate response or are intolerant to UDCA, the first-line therapy. In terms of second-line therapy, obeticholic acid can, in fact, worsen the pruritus.

So setanaxib is well positioned as a potential treatment in PBC. It has a unique mechanism of action with antiinflammatory and antifibrotic property. It has demonstrated benefits in the Phase IIa clinical trial, in particular with respect to effects on fatigue and liver stiffness. It's clearly pharmacologic reactive, but with also an unremarkable safety profile.

In terms of the clinical trial that we have planned on July 17, this will be a study in early PBC. It's a 52-week randomized, placebo-controlled, double-blind adaptive Phase IIb/III clinical trial. The primary endpoint is based on reduction in alkaline phosphatase, and we will be studying 2 doses of setanaxib, daily doses of 1,200 and 1,600 milligrams per day, administered as add-on therapy in patients with early PBC, an elevated liver stiffness and intolerant or inadequate response to UDCA. We will enroll approximately 318 patients in up to 150 investigational centers in North America, Europe, Israel, Australia and New Zealand.

We will be performing an interim analysis comprising approximately 30% of the planned sample size once the 99th randomized patient has completed the week 24 visit. This is expected in the first half of 2023, with the final data readout in late 2024, early 2025, or the current time lines predicated on the FDA feedback on the protocol, which is expected.

I'll now hand over to Fredrik.

Thank you, Richard, and good afternoon, everyone. I will present to you the financial overview for the first quarter of 2021, and all numbers presented to you are in million SEK, as always.

To start with, as expected, we reported no revenues for the period. Our total operating expenses for the period amounted to SEK 160.8 million compared to SEK 72.8 million for the same period last year.

After the total operating expenses, the cost for research and development increased by SEK 36 million to SEK 90.1 million compared with SEK 64.1 million for the same period previous year. Increase in R&D expenses originates mainly from the increased number of patients participating in the NefIgArd trial, as the NefIgArd trial was fully enrolled in general this year.

During the quarter, we also started having expenses related to preparations and product development for setanaxib trial, which, Richard was mentioning, our plan to start in the second half of this year.

The sales and administration expenses amounted to SEK 58.8 million for the period to be compared with SEK 18 million for the same period last year. The increase of SEK 40.8 million between the periods is primarily related to the intensified preparations for commercial and [internal] affair activities in the U.S., as we continue to invest and prepare to be ready to commercialize Nefecon in the U.S., once this therapy is approved.

This leaves us with an operating loss of SEK 150.8 million for this period compared to an operating loss of SEK 72.3 million for the same quarter last year.

The cash flow used in operating activities for the period amounted to SEK 134.2 million compared to SEK 18.8 million for the previous year, where we can see that channeling milestone payment from Everest amounting to $5 million.

Our cash flow used in financing activities was SEK 9.6 million since we continued to purchase minority share in -- from CALTX. And during the quarter, we reached about 90% in ownership and moving to reach 100% as soon as possible.

For the quarter, we had a financial income of SEK 14.6 million due to unrealized foreign currency gains on cash accounts. We've seen growth slightly stronger against the SEK as of end of March.

Finally, our cash position remains solid as we had a cash position of SEK 867.4 million at the end of March.

And that was all for me. And now back to you, Renee.

Thank you, Fredrik. So in summary, we're positioned to be the first approved treatment for IgA nephropathy. We've been granted priority review and accelerated assessment. We've shown significant impact on the underlying kidney function in IgA nephropathy, with the potential for disease modification. We are progressing on plan across all key aspects of our business and look forward to engaging with regulators, continue to develop our pipeline as well as continue building our U.S. capability.

And with that, I hand over to the operator for questions.

(Operator Instructions) And we have a few questions lined up so far. The first is from the line of Yigal Nochomovitz of Citigroup.

Could you comment at all on the ideal label language that you believe will be in the label? What is -- what claims do you believe you will see in the label? And I have a separate question on setanaxib, but I'll wait on that one.

Well, I mean, why don't I start, and maybe Richard will tell you more detail as well, and maybe Andy also as a comment. But I guess, obviously, I mean, we are not in label negotiations as of yet. And obviously, I think that our view is obviously that we would like to have a broader label as possible, which I think that the data in the trials that we've carried out will support.

But Richard, maybe you want to...

Right. I agree. I mean, I think we would expect to be negotiating a label where the base of the indication would be for the treatment of IgA nephropathy, with a clear description of the clinical trial outcomes and the relevant section of the product information.

I would add one thing because I think that's very important and is very encouraging to us is that the nephrologists are telling us in research that they -- when we showed them a profile that has no claims, just as the actual data from Phase IIb or Phase III top line data, they understand the product. They understand, these are the endpoints and the measurements that they are comfortable with and that they routinely assess on these patients. So they understand the clinical results, and these don't contain claims in these product profiles that we use in research.

Okay. And then I just had a question about the mechanism of action for setanaxib. Could you just help us understand how setanaxib could simultaneously be playing a role in treating autoimmune condition, like PBC and, at the same time, potentially having a role to treat cancer, such as head and neck cancer?

Yes. Interesting. But it really lies not one and not all lies at the sense of a critical pathway involving reactive oxygen specie. And the conversion of the transition of fibroblast to an activated myofibroblast, and that activated myofibroblast has important role in many different fibrosing conditions, hence the potential application in primary biliary cholangitis.

But it's also important in oncology because an important cell involving the phenotype of many tumors is the cancer associated by the blood, which typically is very similar to the myofibroblast. So essentially, they're very similar in terms of their phenotype.

Therefore, there's a clear rationale, and there's some very nice published data supporting the potential application of setanaxib in tumors with high cancer associated fibroblast density within the tumor.

And our next question comes from the line of Maury Raycroft at Jefferies.

You mentioned that you decided not to pursue the NefXtend study to assess continuous dosing in the treatment paradigm. Just wondering if you can comment more on reasons why not to pursue and what alternative options might be.

Sure. No, I think that it's really a combination of the fact that, obviously, we -- the study start has been very significantly delayed due to the pandemic. I mean, this is something that we had originally really planned to start -- really start enrolling patients in Q2 of last year. So obviously, it's quite a delay.

And secondly, I think, obviously, things have moved on since, but I also think that in terms of interactions, both with market research, payers, nephrologists, et cetera, a lot of the kind of interactions that we've had, I think that it's clear that based on where we are now in our development, there are a lot of other kind of options, which probably are more appropriate at this point in time in terms of just looking at treatment paradigms because this is never a regulatory study. This was really just more kind of on health economic support, et cetera. And I think based on where we are now, there are other options, which I think would serve us and the patients better.

Got it. That's helpful. And then I was just wondering if you think a partner update in the EU could be made this quarter or next quarter. And if you can provide any more perspective into what the partnership could look like and what the goals are for the partnership.

Sure. So yes, so we have initiated a kind of an organized process in terms of finding a good partner in Europe for commercial partnership. I think we're very encouraged by the activity that we've seen in this process. And so I think that there's -- it's progressing very well. And it's always a little bit difficult to give kind of an exact timing because there's obviously other parties on the other side.

The timing is always really kind of a function of when we're all going to get to kind of the best outcome for everybody. But I think that it's all developing very well, and we're very confident that we will find a good commercial partner for our product in Europe.

And our next question comes from the line of Edwin Zhang of H.C. Wainwright.

Congrats on the very successful quarter. First, a regulatory question. We know Nefecon is under priority review. Between now and the PDUFA date, when and how often are you going to meet with the FDA in this review process? In particular, when is the mid-cycle review set? And what is your current thinking on the possible outcome for Nefecon?

And I have a second question on the Nefecon commercialization. I know you have made some key appointments in the U.S., and the team has been doing a great work to prepare for the U.S. commercialization. I wonder if you could share with us your current U.S. strategy, including sales and marketing. Also importantly, any new thoughts and feedback on the U.S. pricing?

Right. So let me -- let's hope I got all of these things down. I will try to address the regulatory side. And Richard, please, feel free to add.

So obviously, so in terms of -- I believe that in terms of the -- obviously the PDUFA date or the target date for the PDUFA is the 15th of September. And we were informed at the end of April, obviously, that we've been granted priority review.

And actually, I'm so -- I can't -- I don't remember off the top of my head in terms of the mid-cycle date, but obviously, it's a fairly short review period in total from kind of from May to September. And obviously, there also needs to be label negotiation in there somewhere.

And with regards to an AdCom , obviously, if we have been informed that there was a plan for AdCom, we would obviously have communicated that. So obviously, there was no such communication from the FDA at the time of the granting of the priority review. And I guess, considering the very short time period that we're talking about here, between kind of May and September, I guess that, in our view, it's not particularly likely that there would be -- that there suddenly would be an AdCom announced.

I think the FDA generally tends to announce that well in advance in order to allow the company also to be prepared for such an AdCom. And obviously, the FDA has some work in order to organize these AdComs as well. So not to say that it's impossible, but I guess, in our view, it would be highly unlikely at this stage based on the communications that we have had so far from the regulators.

In terms of the -- I think that was on the regulatory side. I think in terms of the U.S. preparations, as I said, I'll hand over to Andy to answer those questions.

Sure. I think your first question was on the sales force, and as we've indicated, we continue to build to about a sales force of 40. We brought on Head of U.S. Sales to bring on sales management. Right now, we're in the process of looking for those folks. And as I said, we're building to a sales force of about 40.

As far as pricing, you asked, we continue to do our work on the market access area. As the Spherix research that I've discussed earlier indicated, a large percentage of these patients in the chart audits of 63% to 73% of the IgA nephropathy patients have commercial insurance, which is encouraging. And we continue to hear from the payers that they recognize the product, and they're pinning it towards the high cost of end-stage renal disease and dialysis of the 50% of patients that progressed to end-stage renal disease.

In 2019, we conducted some work with IQVIA using our Phase IIb data. And as we've previously indicated, we tested price ranges that exceeded SEK 100,000 there, but price range between SEK 55,000 and SEK 85,000 for a course of therapy seem to be appropriate -- managed appropriately without any barriers to access for patients, meaning it would be required to be written by a nephrologist, and the patient would have to have an IgA nephropathy confirmed indications or a kidney biopsy.

We continue to be encouraged, continue to do our work to develop a value-based pricing strategy and recent launches also in this area in the space. There was a product that was recently launched or product targeting nephritis provided good clinical value that has a price of about $12,000 per month. So we continue to be encouraged at the opportunities and as we work to do our work here to finalize this.

And our next question comes from the line of Annabel Samimy of Stifel.

This is Nick Rubino on for Annabel. First off, will we see the 12-month per scenario data basically just to better extrapolate progression in the future?

And then on setanaxib, in the PBC trial, it looks like the primary endpoint is just going to be an ALP rather than GGT and ALP levels we've seen before. Why was the GGT dropped? In head and neck, can you give us a sense of how that clinical trial is going to be designed?

Okay. So in terms of the -- so in terms of kind of the GGT, I guess that was something that was the endpoint that was used in kind of the Phase IIa trial, which Genkyotex designed and ran earlier. Obviously, the kind of the approvable endpoint in PBC is not GGT. It's actually ALP. So that's obviously the endpoint that we have chosen is the -- it's kind of the approvable endpoint in PBC, as this is a pivotal trial, hopefully registrational, and that's why that endpoint has been chosen.

In terms of the head and neck cancer, I guess that's something that we are still working on, and there's quite a lot of preparations going on there. I think it's something that we would hope to share with you in much more detail at our next kind of quarterly call release, and which I'm happy for Richard to you to kind of give you an outline of kind of what we're thinking about there if you want to before we address the 12 month.

Sure. As I've already mentioned, I mean, the hypothesis is based on some very strong preclinical data relating to cancer-associated fibroblast and tumors. And head and neck cancer is a significant population of patients with that tumor that have -- sorry, with head and neck cancer, that tumor is with high numbers of CAFs.

So clearly, we want to focus on a population of patients with head and neck cancer with high CAF levels. And again, from preclinical data, we know there are some interesting effects relating to the benefits of immunotherapy in head and neck cancer and potentially how modulating CAF can improve responses to immunotherapy.

So I think those are the kind of areas we're looking at in greater detail now. And as Renee said, hopefully, we can share further details on our next update.

So in terms of any kind of data beyond and above what's been publicly released, we are very constrained since this is an ongoing trial, which just continues to be blinded. And I think that it's very clear that the regulators are very keen that limited data is shared externally at this point in time.

So I think that we're actually -- we have provided earlier, I believe, in our R&D Day, that, obviously, we do not have the 12-month data for the entire population since, obviously, there was only a subset of patients who had reached 12 months at the time of the database lock.

But what we have been saying, in terms of proteinuria, obviously, is that based on the trends that we saw from that group of patients who had reached that time, that we would expect the cohort to basically have a result, in terms of overall treatment effect, be somewhere in the kind of mid-40s, so somewhere between 42% to 48% as a kind of treatment effect at 12 months. But obviously, this is just an estimate based on a trend seen in a partial population.

But I think that's really kind of all that we can disclose at this point in time. And I think it's been very clear that any further disclosure of any other information is not something that we're going to be able to do.

And our next question comes from the line of Rami Katkhuda of LifeSci Capital.

Congrats on the update. Whilst it's early, are there any key learnings to the launch of the product Andy was mentioning that may apply to Nefecon?

I'm sorry, can you repeat that? Are there any...

Key learnings from kind of the launch that Andy was talking about that may also apply to Nefecon.

All right. Andy, do you want to take that?

I think it's kind of early to really project or make any conclusions. Sorry.

Andy, you're disappearing. We can't hear you. You must -- for some reason, you're going in and out. We can't hear you.

I think it's difficult to make any conclusions at this early time in their launch for us. The only thing we continue to monitor the whole market and how things are going on in this interesting time of the pandemic and the marketing mix, those are the kind of things that we are looking at right now. But it's hard to draw any conclusions from this recent launch.

Got it. And then quickly, can you remind us where you stand in terms of manufacturing capacity for a potential launch at the end of the year?

Yes. So in terms of the -- so I guess, I mean, in terms of the kind of manufacturing situation, we do have -- it's the same kind of formulation in the commercial -- kind of commercially that we're going to use as we used for the Phase III. So we're not kind of expecting any moves or changes or other kind of complications.

And -- but otherwise, I mean, we're kind of just working as normal in order to kind of try to, again, execute on the plans that we've had in place for a while that we will be in a position to launch in Q4, which is the earliest possible time that, that could happen. So...

And our next question comes from the line of [Hampus Axton], who's a private investor.

And congratulations on the priority review designation. I was wondering if somebody could elaborate on the risk for Calliditas that other modified-release budesonide medicines already approved for other indications, such as Budenofalk corticosteroid could then -- could be off-label for IgA nephropathy, pending an approval of Nefecon in either the U.S. or the EU.

Sure. So obviously, this is an orphan indication to start with. Obviously, in an orphan indication, you do have market exclusivity and -- which obviously is relevant relative to this in terms of not being able to have any kind of competition from other potential parties with a similar substance -- or same substance mode of action. And so that gives a 7-year market exclusivity in the U.S. and 10-year market exclusivity in Europe, subject to approval.

Secondly, obviously, these kind of formulations have been formulated to target completely different diseases. This is a Crohn's disease, so Crohn's disease actually exists in your entire gut. And so these formulations are different in terms of how they've been -- kind of why they have been kind of formulated the way that they are, and they are basically approved for 9 milligrams for use for 3 months. And so I think there also has never really been any clinical data ever at the time we had produced this.

And finally, it is not something that we hear or see about or see anyone actually trying to -- we don't hear that from the market or from nephrologists that it has been used. And obviously, if you were trying to experiment with some of these formulations, which are formulated for completely different diseases and at much lower concentrations, you will most likely end up having to give those type of doses at a multiples of what they have been approved for.

And this obviously then will give -- most likely will give you significant and severe side effects, depending on how much higher than the approved dose you are forced to go in order to see any clinical effect since the formulation of Nefecon is so highly targeted and focused really on the kind of area of payers' patches.

And so I think it would be -- I'm not sure what the purpose would be to kind of again go backwards and start kind of exposing patients to exploratory off-label drugs, which, up until now, have clearly kind of not been proven in terms of efficacy or safety.

Okay. Can I just have a quick follow-up on that? This 7-year market exclusivity in the U.S. and 10-year in the EU, is that also for -- that's for the indication? So even if somebody has an approved agent that could be used, they would not be able to do it for that particular label.

That's correct. So it is for that indication that you have a market exclusivity for that indication for that period of time. And this is why no one actually can promote or market that and also, therefore, cannot be reimbursed for that indication.

We currently have one further question in the queue. (Operator Instructions) And next question comes from the line of Johan (inaudible) of Redeye.

And congratulations again. Sorry if this is partly repeated. I actually missed the call briefly. Anyway, as I understand it earlier, you seem to be as advanced in securing your paying partner. Is that correct? That would be the first question.

Yes. I mean, we are running a process in order to kind of select someone to be our commercial partner. So yes, we are in the middle of running that process now.

And also you are stepping back from the plan to initiate the NefXtend. Can you explore -- give a bit more color on that decision, please?

Sure. And also I think in terms of the -- again, that study was meant to be initiated quite some time ago. But obviously, due to the pandemic, there's been kind of continuous delays. And obviously, where we are now in terms of the priority review, with accelerated assessment, we are positioned to be the first-ever approved drug to be on the market.

We have obviously been in quite a lot of interactions in a variety of forums. And I think it's become quite clear that there are other alternatives, which probably will be better for the patients, maybe significantly faster, might be a better way of kind of achieving some insight into the treatment paradigms, which really was the purpose of NefXtend, as it was not a regulatory study.

So we believe that there are other options, which would be preferable and, again, better alternatives to achieve the same outcome rather than kind of the NefXtend trial.

So we can expect more information on that side, perhaps when you get more feedback and experience from the clinics next year.

Yes. We will -- I'm sure we're going to be providing additional information later on in the year in terms of some of the kind of complementary activities that we may be undertaking.

Yes. And also you -- your premarket -- or market study that you presented earlier, some 63% to 75% or thereabout seems to be -- of the future existing patients seems to be commercially insured. How should we -- how much of that segment is in play before actually securing reimbursement?

I'm not sure what you mean by are they in play? I mean, they're -- everybody is in play, both commercial and governments subsidized. It's just a matter of they determine on their formularies and the out-of-pocket costs and those things for the patients.

So we're not segmenting or moving anybody from our market. It just indicated the commercial -- the large commercial population is favorable when you're looking to commercialize.

And what base -- how should we frame it for reimbursement? And how will you approach a large part of that segment?

We're going to approach all the largest PBMs, and we have people that are going to begin calling on payers in that market as early as this summer.

Yes. And how many will you be able to approach, say, 1 or 2 months into post formal approval?

Well, they -- most of them don't provide an approval on the first -- right off the bat. So they'll cover you until they make a decision, and that could take 3 months, 6 months. It really is plan dependent, and we'll be calling on all of them as much as we can and often as we can. But they have their own pace on certain things that's typical for any product in the market.

As there are no further questions coming through at this time, I'll hand back to our speakers for the closing comments.

Thank you very much for participating. Thank you for the questions, and we look forward to catching up with you again at the next quarterly report. Thank you.