Full Year 2023 Calliditas Therapeutics AB (publ) Earnings Call

Okay.

Okay.

Welcome to the <unk> Therapeutics Q4, 2023 report.

For the first part of the conference call the participants will be in listen only mode.

During the questions and answer session participants are able to ask questions by Dialling pound key five on the telephone keypad now I will hand, the conference over to the speakers C. O Renee Agri all candour CFO Fredrik Johansson Maria Thompson, President North America, and Richard Phillips Some CMO.

Please go ahead.

Thank you very much and welcome to the Q4, 2020 three presentation.

I'd like to draw your attention first of all so the disclaimer notice as usual.

Which covers our forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, as amended and I refer you to a public filings, including those.

Painting risk factors.

Page six.

Operator: So with regard to Q4, I'd like to start just with some highlights. Obviously, the key event for this quarter was that on December 20th, the FDA granted us full approval of TARPAO based on the submission of the full phase three data set, which we filed in June of 2023. The phase three trial showed a highly statistically significant outcome on the primary endpoint of EGFR with a p-value of less than 0.0001.

So with regards to Q4 I'd like to start just with some highlights.

So obviously the key event for this quarter was on December 20th the FDA granted us full approval of our payout.

Based on the submission of the full phase III dataset, which we filed in June 2023.

The phase III trial showed a highly statistically significant outcome on the primary endpoint of Egfr or the P value of less than their appoints are 001.

Rene Aguiar-Lucanda: Additional supportive data, obviously, it's been presented at conferences and in other places in terms of slope analysis, three mils per minute per year in favor of Tarpeio versus placebo, and statistically significant impact on microhematuria and biomarkers such as IgA1. The new indication that we have received reflects reduction of loss of kidney function and is now also indicated for the entire IgAN population at risk of disease progression. Other things that occurred in the quarter were obviously, we also received conditional approval of Nefacon in China, which was granted in November. And this approval, we believe, provides access to a very large market opportunity as Igan is not a rare disease in China but actually fairly common with estimates of up to 5 million patients, and we're very excited about being able to launch commercially this year with our partner Ivers Medicines.

Additional supportive data, obviously is being presented on conferences.

In another and other places in terms of slope analysis, three miles per minute per year in favor of her payout versus placebo.

A statistically significant impact of micro hematuria and biomarkers such as Iga one.

The new indication that we have received reflect reduction of loss of kidney function.

And it's not won't be indicated for the entire ICANN population at risk of disease progression.

Other things that occurred in the quarter. Although obviously, we also received conditional approval I've never gone in China, which was granted in November.

And this approval, we believe provides us access to a very large market opportunity and I guess, it's not a rare disease in China, but actually fairly common but estimates of up to 5 million patients.

And we're very excited about being able cheap for a part drivers medicines to launch commercially.

Rene Aguiar-Lucanda: In the quarter, there was also the initiation of a phase two trial in Alport syndrome, and this is being done with Cetamaxib. This is the lead compound from our pipeline platform consisting of NOX inhibitors, a novel platform with Cetamaxib being the first ever candidate in clinical trials. Alport syndrome is a rare kidney disease, and today there are no approved medications.

This year.

In the quarter. There was also initiation of a phase II trial in all Port syndrome, and this is being done with symptomatic said. This is the lead compound from our pipeline platform consisting of Nox inhibitors are a novel platform. It sits on actually being the first ever candidate in clinical trials.

So all toward syndrome is a rare kidney disease and today there are no approved medications.

Rene Aguiar-Lucanda: And so we're very excited about being able to hopefully repeat our success in the Igam space of being the first company to hopefully bring an approved medication to those patients suffering from this rare disease. Also, in the quarter, the USPTO issued a notice of allowance for a new patent covering tarpaulins in the US, and that provides a run rate until 2043, and this was issued in December of last year. We also, towards the end of the year, refinanced an existing credit line that we had with Ethereum Capital, and we added a small amount of additional capital to our balance sheet in terms of just under $20 million. This allowed us to continue to have an interest rate only, interest payment only kind of period for another several years.

And so we're very excited about being able to hopefully repeat our success in the eye against space of being the first company to hopefully bring an approved medication.

To those patients suffering.

From this rare disease.

And also in the quarter the U S. P. T O we shouldn't notice of allowance for a new patent covering for a payout in the U S. A and that provides the run rate until 2043.

And this was a this was issued in December.

Of last year.

We also towards the end of the refinanced our existing credit line that we had with a theory of capital.

And Oh, we added a small amount of additional capital to our balance sheet in terms of just under $20 million and actually this allowed us to continue to have a interest rate only interest payment only kind of period for another several years.

Rene Aguiar-Lucanda: So if we can turn the page, please. So talking a little bit more about the commercial highlights. And this obviously on the commercial side, we saw a very strong quarter from Parpeo reflected by strong growth both in terms of enrollments and new prescribers. So actually, we saw a 51% increase in enrollments over Q3, and new prescribers also grew by over 50%. And we believe that this is reflecting growing familiarity with the phase three data, especially the convincing EGFR data, Q4 saw total revenues of $42.4 million, or 452 million Swedish crowns, out of which Tarpaio represented $32.6 million, which is a 22% growth over Q3, and more than 100% growth over Q4 2020.

So if we can turn the page please.

So talking a little bit more about the commercial highlights.

And this obviously on the commercial side, we saw a very strong quarter from propane to our payout.

Reflected by strong growth both in terms of enrollment and named prescribers.

So actually we saw a 51% increase in enrollments over Q3.

New prescribers also grew by over 50%.

And we believe that this is reflecting of the growing family already with the phase III data, especially the convincing egfr data as well as good results in positive patient experiences from Nephrologist using the product are in real life.

Our Q4 total revenues of $42 $4 million or 450 to millions of Swedish cramps, and auto which chart payer represented 32.6 million.

Which is a 22% growth over Q3 and more than 100% growth over Q4, 2022.

We also achieved positive cash flow from operations in Q4, and this was a target we had set for ourselves earlier in the year and we are indeed very excited to have successfully achieved that in the year of 2023.

Rene Aguiar-Lucanda: We also achieved positive cash flow from operations in Q4, and this was a target we had set for ourselves earlier in the year, and we are indeed very excited to have successfully achieved that in the year of 2023. So looking forward a little bit into the first half of 2024, we do expect that there might be some initial disconnect between the new label language and the existing payor rules, which obviously are based on the old label. As I'm sure you understand, this is a new label. This would have to go through the same kind of process in the P&T committees as when we originally launched the product a couple of years ago. And so until those P&T committees have taken place, and the rules have been amended following the new label, we are just seeing that they might take a longer period of time to actually convert enrolments into revenues as there might be some market access friction during that period of time.

Yeah.

So looking forward a little bit into the first half of 'twenty 'twenty four we do expect that there might be some initial disconnect between a new label language and the existing payer rules, which obviously are based on the old label.

As I'm sure you understand this is a new label. This would have to go through the same kind of process in a pnp committees as when we originally launched the product a couple of years ago.

And so until those PMT committee has taken place and the rules have been amended a.

Following the new label and that we are just saying that they might take a longer period of time to actually convert enrollment into revenues as there might be some market access friction.

During that period of time.

In terms of the we're also obviously, we're very excited about being having per payer being selected as a potential blockbuster drug to watch by clarity.

We believe that the disease modifying profile up to our payout will continue to drive significant demand from nephrologist and become a fundamental part of standard of care in <unk>.

We're also looking forward to actually a potential full EMA approval of King paid off in the first half of this year.

And obviously, we know that the <unk> our partner Star is working on rolling out the product and across other kind of geographies and in Europe as we speak.

And with regards to other ex U S markets World as I've already mentioned.

We are looking forward to our partner Everest medicines I'm doing it.

Rene Aguiar-Lucanda: In terms of the, we're also obviously very excited about having Tarpaio selected as a potential blockbuster drug to watch by Clarivate. And we believe that the disease-modifying profile of Tarpaio will continue to drive significant demand from nephrologists and become a fundamental part of the standard of care in Igam. We're also looking forward to a potential full EMA approval for Quimpego in the first half of this year. And obviously, we know that our partner Stata is working on rolling out the product across other geographies in Europe as we speak. And with regard to other ex-US markets, as I've already mentioned, we are looking forward to our partner Mevers Medicines rolling out their commercial launch, which they have targeted for Q2 of this year. Next page, please.

I think rolling out their commercial launch, which they have targeted for Q2 of this year.

Next page please.

So some post period events. So as I've already mentioned, we received a notice of allowance for any painful payout.

This was subsequently issued and entered into the Orange book in February of this year.

And we believe that this significantly enhances product protection for <unk> beyond 2029.

We also appointed myriad turns fan as President North America. She brings very strong commercial rare disease experience to this position with a background from Shire is Sanofi Genzyme and threat that we are very excited to welcome her to the team and I'm sure that you will hear more from her over the year and she's settles into the position.

Next page please.

So obviously, we are covering Q4, but actually 2023 as a whole has really been an incredibly eventful and successful year.

So so many pivotal events for the company.

And that's obviously included the successful readout of and I forgot the phase III clinical trial, the filing for approval with both FDA and EMA the publication of the data and the lamps at.

Rene Aguiar-Lucanda: So some post-period events. As I already mentioned, we received a notice of allowance for a new payment for Tarpaio. This was subsequently issued and entered into the Orange Book in February of this year. And we believe that this significantly enhances product protection for Tarpaio beyond 2029. We also appointed Maria Ternsen as President of North America.

The interim readout of certain accept data from head and neck cancer, where we're hoping to read out that full data set in the first half of this year.

As I mentioned, obviously the patents on the China conditional approval and ultimately obviously the full approve our payroll by the F D. A.

So we are extremely excited of what we have achieved this year.

And we are looking forward to an equally exciting if not more exciting 'twenty 'twenty four.

When we will see when we bring that we start the year with a full approval in the IGON population at risk of disease progression with a new indication, reflecting the strong egfr data.

Rene Aguiar-Lucanda: She brings very strong commercial rare disease experience to this position with a background in Shires, Sanofi, Gensyme, and Sarepta. We are very excited to welcome her to the team, and I'm sure that you will hear more from her over the year as she settles into the position. Night.

So with that I'm going to hand over to Richard.

Ellipse our CMO.

Thanks very much.

So I'd like to take a moment just to look back to the end of last year and with the license who've had a strong presence at the American Society of Nephrology annual meeting in Philadelphia in November 2023.

Rene Aguiar-Lucanda: So obviously, we are covering Q4, but actually, 2023 as a whole has really been an incredibly eventful and successful year, which saw so many pivotal events for the company. This obviously included the successful readout of the Nefigar Phase III clinical trial, the filing for approval with both FDA and EMA, the publication of the data in the Lancet, and the interim readout of cetonaxib data from head and neck cancer, where we're hoping to read out that full data set in the first half of this year. As I mentioned, obviously, the patents and the China conditional approval, and ultimately, obviously, the full approval of TARPADO by the FDA. So we are extremely excited about what we have achieved this year, and we are looking forward to an equally exciting, if not more exciting, 2024, when we will start the year with a full approval in the IgM population at risk of disease progression with a new indication reflecting the strong EGFR data. So with that, I'm going to hand over to Richard Philipson, our CMO. Thanks very much, Rene.

We had a total of seven posters and an oral presentation and additionally, a commercially sponsor put up tier to presented by Dr. Jim Tumlin.

And this together demonstrates our commitment towards getting nephropathy and rare kidney diseases.

So I'd now like to take a moment to highlight some of the data and analyses that were presented at ASN next slide please.

Okay.

So firstly professor Richard Lafayette presents a analyses of the <unk> phase III trials as I said.

The focus of the presentation was the time to 30% reduction in Egfr, all kidney failure, which was the secondary endpoints of the trial.

The time to this composite endpoint was significantly delayed with a 55% reduction in the risk of achieving this event in patients treated with <unk> <unk>.

<unk> to placebo.

Its particularly noteworthy that this outcome was consistent irrespective of baseline U P. C L.

Thanks, Mike.

Another presentation at ASN was a muddled analysis of clinical outcomes in patients and in Mexico trial, compared with a matched registry cohort receiving supportive care only.

We used in Mexico to your Egfr total slope outcome to calculate a hazard ratio for the clinical outcome of kidney failure egfr less than 15 miles per minute or sustained double I assume correct me using the income meta analysis as reference.

This muddled analysis showed the predicted median delay to the clinical outcome of $12 eight years, when comparing Mexico with placebo.

Furthermore, with multiples analysis predicted the approximately 50% fewer patients would reach the clinical outcome within 10 years again, when comparing <unk> with placebo.

Excellent.

Yeah.

We also presented biomarker analyses confirming previous findings from the phase <unk> trial.

As you know circulating immune complexes containing coli calix hubs related Iga when deposited in the MS. Andrea Mcchrystal Meritless elicits, an inflammatory response and drives the decline in kidney function seen in patients with Iga nephropathy.

Richard Phillips: So I'd like to take a moment just to look back on the end of last year and we're delighted to have had a strong presence at the American Society of Nephrology annual meeting in Philadelphia in November. We had a total of seven posters and an oral presentation, and additionally, a commercially sponsored product theatre presented by Dr. Jim Tomlin, and this together demonstrates our commitment to hygiene, property, and rare kidney diseases. So I'd now like to take a moment to highlight some of the data and analyses that were presented at ASM. First of all, Professor Richard Lafayette presented analyses of the Nefigard Phase III trial at ASN.

We have shown in samples taken from 160 patients in the <unk> trials that Mexico significantly reduced levels of circulating immune complexes throughout the treatment period compared to placebo supporting that disease modifying effect of treatment.

These biomarker observations are in line with what we saw clinically with respect to micro haematuria with significantly fewer patients treated with medical have micra hematuria during observational follow compared to patients who had received placebo.

Okay.

So I'd now like to hand over to Maria Riley President North America.

Thank you very much Richard slightly.

So as Rene mentioned earlier Q4 represented a very strong performance in terms of enrollment forms we had our best quarter since launch and saw a significant increase in number of new enrollments received by our patient services hub RP O touch points.

During the quarter, we had 555, new enrollments, bringing the total for 2023 to over 1700.

Richard Phillips: The focus of the presentation was the times of 30% reduction in EGFR or kidney failure, which was the secondary end point of the trial. The time to this composite endpoint was significantly delayed, with a 55% reduction in the risk of achieving this event in patients treated with methacrylate compared to placebo. It is particularly noteworthy that this outcome was consistent irrespective of baseline UPCI.

During the quarter. We also had more than 300, new prescribers, who made the decision to prescribe <unk> for the first time.

Since launch we now have over 6800 health care providers, who have prescribed <unk> payoffs.

As we have communicated in previous quarters, we had.

Very good payer coverage and more than 90% of U S lives are covered.

And we are also reporting quarterly net sales of $32 6 million U S dollars.

Next slide please.

The fourth quarter contained some significant events our collegiate us.

As noted earlier on December 20th we received full approval for <unk> pay off from the F. D. A R.

Richard Phillips: Another presentation at ASN was a modelled analysis of clinical outcomes in patients in the Nefigard, compared with a matched registry cohort receiving supportive care only. We used the Nethigard two-year EGFR total slope outcome to calculate a hazard ratio for the clinical outcome of kidney failure, EGFR less than 15 mils per minute, or sustained doubling of serum creatinine, using the income meta-analysis as reference. This model's analysis showed a predicted median delay to the clinical outcome of 12.8 years when comparing Nefacon with placebo. Furthermore, the modeled analysis predicted that approximately 50% fewer patients, would reach the clinical outcome within 10 years, again, when comparing Nefacon with... We also presented biomarker analyses confirming previous findings from the Phase 2b nephigen, As you know, circulating immune complexes containing poorly galactosylated IgA when deposited in the mesangium of the glomerulus elicit an inflammatory response and drive the decline in kidney function seen in patients with IgA nephritis.

Our full approval label reflects the reduction of kidney loss in adults with icon at risk of disease progression.

Propel is the first and only product to receive this indication for the treatment of Ida.

And our new Naval that label is based on the data that was published earlier in 2023 in the onset.

As a reminder, our phase III trial met the primary Egfr endpoint and demonstrated highly statistical significance.

Having a full approval label increases our addressable market and in order to meet the growing market opportunity. We also made the decision to expand our commercial and medical organizations in Q3.

Today, we have over so we're 70 at rare disease account managers, who are responsible for the sales of <unk> and.

We've also expanded other field functions such as reimbursement managers, a thought leader liaisons, bringing our total field based organization to around 100 employees.

Alright, it prior to the full approval, we had 90% payer coverage with our payoff with a new label in hand, our expanded payer and reimbursement teams are engaging with U S. Payers to ensure policies are updated to reflect that new indication.

Next slide please.

We are very excited about the opportunity ahead of US we have already seen the very positive reaction. The phase three data has had a nephrologist when introduced to the strong clinical results of our payoff.

We now have an opportunity to promote our full approval label with an increased presence across sales reimbursement marketing and medical affairs.

While we anticipate the strong data to result in more enrollments. We do expect it will take some time for payers to update their policies.

So the impact of the new label will be fully realized in the second half of 'twenty 'twenty four.

Richard Phillips: We have shown in samples taken from 160 patients in the NEFICAR trials that NEFICON significantly reduced levels of circulating immune complexes throughout the treatment period compared to placebos, supporting the disease-modifying effect of the treatment. These biomarker observations are in line with what we saw clinically with respect to microhaematuria, where significantly fewer patients treated with Neficon had microhaematuria during observational follow-up compared So I'd now like to hand over to Maria, our President of North America.

We are also anticipating a seasonal impact to Q1 due to the open enrollment process, which is typical for this time of the year.

In 2024, we're also expecting an update to the legal treatment practice guidelines.

These guidelines have the potential to broaden the definition of the at risk population and also supports the use of <unk> as the only fully approved drug with impact on Egfr.

Today, we are already seeing that the majority of patients who reached nine months treatment continue on par payoff.

And then the first half of 'twenty 'twenty four we're expecting new data from our open label expansion call.

The open label expansion dataset will provide us with additional clinical information on the potential benefits of a repeat course of nine months of treatment with heart fail.

Maria Thornson: Thank you very much, Richard. Next slide, please. So, as Renee mentioned earlier, Q4 represented a very strong performance in terms of enrolment forms. We had our best quarter since launch and saw a significant increase in the number of new enrollments received by our patient services hub, Tarpeo Touch. During the quarter, we had 555 new enrollments, bringing the total for 2023 to over 1,700.

And with that I'll hand, it over to our CFO Fredrik Johansson for the financials.

Thank you Maria.

Good afternoon, and good morning, everyone. I will now now present to you the financial review for the fourth quarter of 2023, and as always all numbers presented to you our immediate sick unless otherwise stated.

Historically, we report 403 to $1 6 million in net revenues for the quarter for the same quarter last year, we reported net revenues of $429 million.

Please note that in the comparison quarter last year milestones of $257 9 million were included predominantly from the op license of Mexico to be after school job.

For 'twenty to 'twenty three we report.

1 billion $206 9 million in net revenues for the full year.

Maria Thornson: During the quarter, we also had more than 300 new prescribers who made the decision to prescribe Tarpale for the first time. And since launch, we now have over 1,600 health care providers who have prescribed Tarpaio. As we have communicated in previous quarters, we have very good payer coverage, and more than 90% of U.S. lives are covered, and we are also reporting quarterly net sales of $32.6 million US dollars. Bye.

For last year, we reported net revenues of $802 9 million.

<unk> net product sales for the quarter amounted to $347 3 million or so to $2 6 million, which.

Which is a reported increase of 108% from the same quarter previous year and over 20% growth quarter over quarter for.

For the full year of title III surfing on that product sales amounted to $1.075 billion for $101 $4 million, which is a reported increase of 189% from the full year of 'twenty two.

The remaining $104 3 million in revenues in the quarter really are related to our partnerships primarily from milestone fees from Everest medicines in connection with the China approval adults with contribution from royalties from startup for Europe.

Our total operating expenses for the quarter amounted to 308 to $7 5 million compared to 397 million for the same quarter last year for.

Maria Thornson: The fourth quarter contains some significant events for Calliditas. As noted earlier, on December 20th, we received full approval for Tarpeyo from the FDA. Our full approval label reflects the reduction of kidney loss in adults with IGAN at risk of disease progression. Torpeo is the first and only product to receive this indication for the treatment of IgM.

For the full year of 2003 or total operating expenses amounted to 1 billion $519 5 million compared to $1 $209 6 million for the full year of 'twenty two.

The cost for research and development increased by $4 4 million in the quarter to $106 7 million compared with $102 2 million for the same quarter previous year.

And we continue to primarily invest in our pipeline, where we have three expected data readouts this year, including to read out in head and neck phase II trial, which is expected in the first half of this year.

Maria Thornson: And our new label is based on the data that was published earlier in 2023 in The Lancet. As a reminder, our Phase 3 trial met the primary EDFR endpoint and demonstrated highly statistical significance. Having a full approval label increases our addressable market, and in order to meet the growing market opportunity, we also made the decision to expand our commercial and medical organizations in Q3. Today, we have 78 rare disease account managers who are responsible for the sales of Tarpaio. And we have also expanded other field functions, such as reimbursement managers and thought-leading liaisons, bringing our total field-based organization to around 100 employees. Already prior to full approval, we had 90% payer coverage for Tarpaio, and with a new label in hand, our expanded payer and reimbursement team are engaging with U.S. payers to ensure policies are updated to reflect the new indicators. Next slide.

The cost for sales and marketing increased by $6 7 million in the quarter to 198 5 million compared to $191 9 million for the same quarter previous year.

The increase was primarily related to sales and marketing of the figure in the U S. Wherever during the quarter continued preparations to be prepared for it to pay a full approval.

We received in the end of the quarter.

We are very pleased that we made on operating profit in the quarter of $41 8 million compared to 32.

5 million for the same quarter last year.

We are also very pleased that we were cash flow positive from operating activities in the quarter were cash from operating activities was $22 8 million compared to 230 million for the same quarter previous year.

In the fourth quarter, we refinanced our credit facility.

$92 million you were low from a serious capital to extending Crestone appeared to the end of 2026 weeks.

Paid back to six to 8 million Youll requires long wants to new credit was agreed and the cash flow from financing activities in the quarter.

Whilst $285 million in originates.

Originated from the net of the loan activities.

This leaves us with a net increase in cash in the quarter of $229 million and we continue to have a healthy cash position of 970 to $3 $7 million were approximately $93 6 million at the end of the quarter.

In our year end report today, we also provided an outlook for total net sales for this year.

We expect continued revenue growth this year and we estimate our total net sales for 2024 to be between 150 and $180 million.

As the commercial revenue over time will incorporate growing sales from both Europe and China, We will provide an outlook on this basis going forward.

Maria Thornson: We are very excited about the opportunity ahead of us. We have already seen the very positive reaction that Phase 3 data has had on nephrologists when introduced to the strong clinical results of Tarpayo. We now have an opportunity to promote our full approval label with an increased presence across sales, reimbursement, marketing, and medical affairs. While we anticipate the strong data to result in more enrollments, we do expect it will take some time for payers to update their policies. So the impact of the new label will be fully realized in the second half of 2020. We are also anticipating a seasonal impact in Q1 due to the open involvement process, which is typical for this time of year.

So pay revenues will obviously make up the bulk majority of the sales also this year and we do not expect potential milestone revenues from our partners to be material in comparison to product sales.

For me and now back to Ronan.

Thank you very much next paycheck, so so some key takeaways for the quarter.

Obviously, the full approval of <unk> in the U S, reflecting a new label, incorporating egfr and with it a much broader patient population was obviously the key event for this quarter.

Data supporting this disease modification profile of the local motive action of long term patient benefits of treatment with propel.

Have you heard shared at our recent Nephrology conference.

Q4, net revenues of 347 million Swedish crowns are equivalent to $32 6 million and total net product revenues in excess of $100 million for the year.

Frederick Johansson: In 2024, we're also expecting an update to the clinical treatment practice guidelines. These guidelines have the potential to broaden the definition of the at-risk population and also support the use of tarpayo as the only fully approved drug with an impact on EGFR. Today, we are already seeing that the majority of patients who reach nine-month treatment continue on Tarpayo. And in the first half of 2024, we're expecting new data from our Open Label Expansion Colony. The Open Label Expansion Dataset will provide us with additional clinical information on the potential benefits of a repeat course of nine months of treatment with tarpehine. And with that, I will hand it over to our CFO, Frederik Johansson, for the financials. Thank you, Maria. And good afternoon and good morning, everyone.

And we also saw record enrollment numbers in the quarter, increasing quarter over quarter by more than 50%.

Fredrik mentioned, the positive cash flow from operations and a strong cash position.

$94 million.

And obviously, we've seen the positive momentum from the nephrology market focused on the Egfr data increased awareness of longitudinal data related to progression, Oh, bygone patients and positive patient experiences.

Including the ability obviously for patients to have intermittent treatment rather than being forced into chronic medication.

And we believe that this will be this disease <unk> profile, what's our payout will continue to drive significant demand from nephrologist and become the cornerstone of standard of care in <unk>.

The total revenue guidance for 2024, reflecting strong growth expectations.

Of the range of $1 $50 million to $180 million really concludes the events of this quarter and obviously looking into 'twenty onto this year of 2024.

So I want to just close out. This Q4 presentation I was saying that we are super excited about what 2020 for brink's as being the category leader in a growing market.

Frederick Johansson: I will now present to you the financial overview for the fourth quarter of 2023. And as always, all numbers presented to you are in medium spec unless otherwise specified. To start with, we report $451.6 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of $429 million.

A patient centric message and we believe that the new label will certainly continue to drive demand and clear patient benefits and so with that I'd like to open up for questions.

If you wish to ask a question. Please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question. Please dial pound key six on your telephone keypad.

Okay.

The next question comes from Maury Raycroft from Jefferies.

Frederick Johansson: Please note that in the comparison quarter last year, milestones of $257.9 million were included, predominantly from the uplifting of Nefekom, to be after Skorja. For 2023, we report $1,206,000,000 in net revenues for the full year. For last year, we reported net revenues of 802.9 million.

Please go ahead.

Hi, good morning, Thanks for thanks for taking my question and congrats on the progress I was wondering if you can talk about assumptions and key drivers behind your revenue guidance of $150 million to $180 million for the year and how the 555 patients start forms in fourth quarter.

And what you're seeing so far in the first quarter.

Those numbers are factoring into your 2020 for guidance.

Sure.

So in terms of what we've done is we've kind of triangulate. It a couple of different ways to look at this obviously.

In terms of the well.

Well, we're expecting to see is basically kind of a little bit of a year of two halves right. So we are not we're not sure of how really how quickly we can get through that kind of pnp committees of the payers and how quickly they will change the rules to really kind of comply.

Frederick Johansson: Tarpayo Net product sales for the quarter amounted to $347.3 million or $32.6 million, which is a reported increase of 108% from the same quarter the previous year and over 20% growth quarter over quarter. For the full year of 23, TherapeiaNet product sales amounted to $1,075,000 or $101,400,000, which is a reported increase of 189% from the full year of 23. The remaining 104.3 million in revenues in the quarter are related to our partnerships, primarily milestone fees from Everest Medicines in connection with the China approval, but also with contributions from royalties from Stata for Europe. Our total operating expenses for the quarter amounted to $387.5 million, compared to $388.7 million for the same quarter last year.

Comply with the ore to be aligned with the new label. So obviously they are what we are expecting is that the we might see some of that market access friction where actually physicians are writing prescriptions as per the label, but obviously, where payers are still applying the rules of the old label.

So that is something where I think that we would we are expecting to see strong growth in enrollment, but we are expecting that that might take a longer period of time.

To actually convert those enrollments into revenues.

And this is something that is just a little bit of an unknown to us I think the second half we are expecting the second half to be strong.

I think that and where are these some of those market access friction should be resolved.

I think that in terms of another item that is a bit unknown for this year is obviously when they could eagle guidelines are.

We're going to be available.

Our assumption really here has been that there's been quite a lot of delays, it's unclear when they will actually be coming out.

And so our assumption really is that the kidney code guidelines will not actually kind of come out until probably the second half of this year and maybe even in a fairly late in the year so on that basis.

Frederick Johansson: For the full year of 2023, our total operating expenses amounted to 1,519,500,000 compared to 1,209,600,000 for the full year of 2020. The cost for research and development increased by 4.4 million in the quarter to 106.7 million compared with 102.2 million for the same quarter of the previous year, and we continue to primarily invest in our pipeline, where we have three expected data readouts this year, including the readout in the head and neck phase two trial, which is expected in the first half of this year. The cost for sales and marketing increased by 6.7 million in the quarter to 198.5 million compared to 191.9 million for the same quarter last year.

We've also assumed that we're not going to really see any benefit necessarily from the new kidney guidelines coming out this year.

In terms of the I mean, the other thing that we've looked at is just really also looking at other launches and consensus expectations.

For other products in terms of the renal space.

And so we think that this kind of guidance and particularly.

Considering that obviously those other renal launch is.

Also involve chronic treatment that this type of kind of spam that we're in is very consistent with where those other launches either have taken place or where expectations are with regards to consensus for some of those other treatments. This year.

So this is really kind of where are we from where we've taken our our kind of our the input for some of this guidance.

And so I think that we really want to make sure that we are on a on a very stable footing as to any kind of guidance that we're providing with regards to the franchise. This year.

Got it.

Frederick Johansson: The increase is primarily related to sales and marketing of tapestry in the U.S., where we continued to make preparations to be prepared for the full approval that we received at the end of the quarter. We are very pleased that we made an operating profit in the quarter of $41.8 million compared to $32.3 million. $5 million for the same quarter last year. We are also very pleased that we were cashflow positive from operating activities in the quarter, where cash from operating activities was $22.8 million compared to 230 million for the same quarter last year. In the fourth quarter, we refinanced our credit facility with a 92 million euro loan from Ethereum Capital to extend the interest-only period to the end of 2020. We paid back the 68 million euro CARES loan once the new credit was agreed, and the cash flow from financing activities in the quarter was 208.5 million euros, which originated from the net of the loan.

Is there anything more you are saying about first quarter so far.

As expected.

Or I guess any more color you can provide on that.

So I think what we're seeing is and we were expecting as I said, we are going to have that kind of first quarter seasonality.

In terms, so I would not expect kind of the Q1 to be.

Particularly strong because of that because of that impact that we saw last year and I think what we're seeing in so far this year as well.

Enrollments continue to be very encouraging.

And so again I think we're seeing a lot of demand and I think it's more of that kind of structural issues with the kind of U S payer system et cetera, and changing of any.

In insurance plans et cetera.

That seems to be impacting some of that conversion, but that's probably what I can say so far about the quarter.

Okay, and then maybe one other question for me and then ill hop back in the queue for the PMT committees to get the updated label through that process is there anything you're doing to expedite the process and how do you assess progress along the way.

So yeah I mean, we obviously, we started already to try to communicate with a lot of the PMT Committee. Its just based on the publication in the lancet.

But in reality, obviously, no one is really going to schedule any kind of Pnp committees until they know what the label looks like and that there is truly a new label to this stuff.

Frederick Johansson: This leaves us with a net increase in cash of $229 million, and we continue to have a healthy cash position of 973.7 million, or approximately 93.6 million dollars at the end of the quarter. In our year-end report today, we also provide an outlook for total net sales for this year. We expect continued revenue growth this year, and we estimate our total net sales for 2024 to be between $150 and $180 million. As commercial revenue over time will incorporate growing sales from both Europe and China, we will provide an outlook on this basis going forward. Tapeo revenues will obviously make up the vast majority of sales also this year, and we do not expect potential milestone revenues from our partners to be material in comparison. That was all from me, and now back to you, René.

So obviously there has been quite a lot of interactions prior to this to try to.

To kind of prepare for those meetings, but.

No no. None of these plans really have to kind of take meetings or do anything our plan anything until you actually have a final label in hand.

Obviously, we have as Maria mentioned, we've added some resources in this area and it's obviously something that we're considering to be.

Uh huh.

High importance for the organization.

Obviously these first six months.

Got it okay. Thanks for taking my questions I'll hop back in the queue.

Okay.

The next question comes from <unk> Divan from Guggenheim Securities.

Please go ahead.

Great. Thank you so much for taking my questions, though if I could ask two just a buzzword or broader IBM market and I'm wondering if you have any sort of updated thoughts you obviously.

And all the excitement in a thin and I think just broadly speaking about more patients getting diagnosed and treated for IBM now. So I'm curious if you have any sort of updated views them, so central market size, especially in the U S or globally.

And then second there's obviously.

Really from me emerging competition from the mid to late stage pipeline, specifically from the April April Bath inhibitor. So I'm curious sort of if those sort of make it to the market over the next two to three years, how you see those sort of impacting top payers play from a treatment paradigm. If at all thank you yeah sure.

Rene Aguiar-Lucanda: Thank you very much. Next page. Here we go. So, some key takeaways for the quarter.

So I think we are consistently just.

Little bit of a kind of a repeated message really I guess from our perspective, but I think what we've seen consistently is that you know this obviously is not an acute disease right. It is a progressive disease.

Rene Aguiar-Lucanda: So obviously, the full approval of Tarpaio in the U.S., reflecting a new label incorporating AGFR and with a much broader patient population, was obviously the key event for this quarter. Data supporting this disease modification profile, the local mode of action, and the long-term patient benefits of treatment with PrEPAO were, as you heard shared at a recent nephrology conference. Q4 net tar pay revenues of 347 million Swedish crowns, equivalent to $32.6 million, and total net product revenues in excess of $100 million for the year.

And it does develop over a reasonably kind of long period of time doesn't have any kind of immediate mortality risks.

So I think on that basis, I think a large part of that kind of <unk> population.

Has probably not been treated particularly aggressively or potentially not at all apart from really with aces and arbs and other blood pressure related medications.

So I do think that the notice of the longitudinal data as well as some of the clinical.

Trial data showing placebo group deterioration on all the patients that actually have.

That are on kind of blood pressure related medication or have already had reductions in proteinuria.

Which clearly do not seem to translate into kind of Egfr stabilization I think that that data is continuing to kind of make its way through the nephrology community and I think there is a really kind of active dialogue in terms of how how how should this kind of potentially impact the treatment paradigm. So I think that we are seeing a growing.

Rene Aguiar-Lucanda: And we also saw record enrollment numbers in the quarter, increasing quarter to quarter by more than 50%. Frederick mentioned the positive cash flow from operations and the strong cash position of $94 million. And obviously, we've seen the positive momentum from the nephrology market focused on the EGFR data, increased awareness of longitudinal data related to progression of IgAN patients and positive patient experiences, including the ability for patients to have intermittent treatments rather than being forced into chronic medication. And we believe that this disease mode profile of tarpaulin will continue to drive significant demand from nephrologists and become the cornerstone of standard of care in Id The total revenue gradients for 2024 are reflecting strong growth expectations in the range of 150 to 180 million dollars, really completing the events of this quarter and obviously looking into this year 2024.

Part of that market.

But again I think this will probably be a market that will develop and grow continue to grow over time as some of these kind of as more data really kind of makes its way into the and to kind of peer reviewed journals.

And as I think nephrologist.

Ultimately use some of these available medications and see actually what impact do these medications really having real life.

So I think that it is a growing market opportunity for sure, but I think we still have a little bit of time until that's reached its.

It's Pete.

What kind of potential.

In terms of the pipeline.

So I guess, it's always a little bit difficult to kind of make.

Lots of statements really on a small population in phase two b.

But I think that'll be it from a kind of a mechanistic perspective.

Assuming that you know.

Everything everything lines up and actually some of these results are reproducible.

And also obviously safety data is critical for this I think that you know without really having that kind of whole picture of understanding what the product profile really looks like and therefore, not really understanding which patient population might be appropriate for that treatment. It's quite a difficult question to answer.

Rene Aguiar-Lucanda: So I want to just close out this queue for presentation by saying that we are super excited about what 2024 brings as being the category leader in a growing market with a patient-centric message, and we believe that the new label will certainly continue to drive demand and clear patient benefit. With that, I'd like to open up for questions. If you wish to ask a question, please dial pound key, 5, on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key, 6, on your telephone keypad. The next question comes from Morrie Raycroft from Jeffreys. Please go ahead. Good morning.

Sir.

But obviously as part of your first question. It's also very difficult to know as these kind of treatments that are already available today continue to penetrate the the population. It's also very difficult to know actually what is actually the the unmet medical need going to be in this patient population in 2027.

But I think from a mechanistic perspective, I'm going to hand over to Richard to give his view from that from that perspective sure. Thanks from me.

So I think it's an interesting question.

But with Mexico top payers as we've.

Spoken about many times the <unk>.

Premium that's being designed to target the past purchase and the distal Liam.

Rene Aguiar-Lucanda: Thanks for taking my question and congrats on the progress. I was wondering if you can talk about assumptions and key drivers behind your revenue guidance of 150 to 180 million for the year and how the 555 patients start forming in the fourth quarter and what you are seeing so far in the first quarter. How are those numbers factoring into your 2024 guidance? Sure. So in terms of what we've done, we've kind of triangulated a couple of different ways to look at this. So obviously, in terms of the what we're expecting to see is basically kind of a little bit of a year or two halves, right? So we are not, we're not sure of how really, kind of how quickly we can get through the kind of P&T committees of the payers and how quickly they will change the rules to really kind of comply with or, you know, to be aligned with the new label.

Hum and it's B cell modulator.

In that region.

And it has low systemic bioavailability around 90% and if it comes to remove phy deliver a first class metabolism, but when we look at these other treatments you mentioned the April release mechanism I mean these are systemic treatments.

Which are acting.

The difference here.

So if you like within the pathogenesis of Iga nephropathy.

So taking those kinds of considerations and the tap into accounts and also noticing what rent is already said about where we need to answer more about these treatments they need to build up a greater understanding of the safety et cetera, but all of those things being equal there isn't a fundamental reason why these two.

Treatments couldn't be given together given that they are acting different places at different levels within the pathogenesis of the disease.

Okay.

Okay. Thank you. Thank you very much for your insights.

Okay.

The next question comes from Eagle know come of it's from Citi.

Please go ahead.

Hi team. This is carly on for Yigal. Thanks, so much for taking our questions.

Maybe just a follow up on some of your prior comments I'm curious if you can talk a little bit more about the characteristics of patients being prescribed <unk> with respect to baseline proteinuria.

Rene Aguiar-Lucanda: So obviously, there, what we are expecting is that we might just see some of that market access friction where actually physicians are writing prescriptions as per the label, but obviously, where payers are still applying the rules of the old label. So that is something where we are expecting to see strong growth in enrollment, but we are expecting that that might take a longer period of time to actually convert those enrollments into revenue, and this is something that is just a little bit of an unknown to us. I think the second half, we are expecting the second half to be strong.

You mentioned the market access piece that they are working through but im curious if youre seeing any shift toward increasing intent to prescribe to.

Patients with lower baseline proteinuria with the updated label.

Sure. So I think in terms of what we've seen to date.

I would say that obviously because of the the label that we had up until December.

Clearly the language in the label said generally 1.5, so clearly it doesn't it wasn't a cutoff and so clearly we have prescribers and successfully also kind of obviously getting to patients below one five but because the label obviously D. The overall there has clearly been a shift to the more kind of advanced patients.

Rene Aguiar-Lucanda: I think that and where some of those market access frictions should be resolved. I think that in terms of another item that is a bit unknown for this year is obviously when the Cádigo guidelines are going to be available. Our assumption really here has been that there's been quite a lot of delays. It's unclear when they will actually be coming out.

Population, where serious patient population.

I don't have a specific kind of break out of how that kind of works, but I do know there obviously its a overall it hasn't been had that impact of having to shift.

The label, obviously just became available in December.

And so actually we have internally obviously produced material trained our sales force et cetera. So we're really just kind of have rolled that out fairly recently into the market.

Rene Aguiar-Lucanda: And so our assumption really is that the Cádigo guidelines will not actually come out until probably the second half of this year, and maybe even fairly late in the year. So on that basis, we've also assumed that we're not going to really see any benefit from the new Cádigo guidelines coming out this year. In terms of the other thing that we've looked at is just really looking at other launches and consensus expectations for other products in terms of the renal space. And so we think that this kind of guidance, and particularly considering that, obviously, those other renal launches also involve chronic treatment. That this kind of kind of spam that we're in is very consistent with where those other launches either have taken place or where expectations are with regard to consensus for some of those other treatments.

So it's a bit early to kind of know.

What extent if at all.

There has been any real impact from the label.

At this point in time.

Okay got it that's helpful. And then we wanted to ask about the phase two data coming up for certain exit and head and neck cancer.

Just curious to know a little bit more about what you are looking to see in that data set and what you think would be an attractive profile for for potential partners for that program. Thank you sure I'm going to hand over to Richard to just describe a little bit about what we what the data readout is going to contain and then I'll I'll give you a sense of what I think might be coming.

So just as a reminder, this is a couple of blind randomized controlled trial, we're giving such a Mexico placebo on top of <unk> in patients with recurrent or metastatic head and neck cancer.

And.

We expect to have the results as Renee said.

A little later in this half.

And the primary endpoint in that study is change in tumor size.

And we think this is a.

Imports and pinpoint it.

Rene Aguiar-Lucanda: So this is really kind of where we've taken the input for some of this guidance, and so I think that we really want to make sure that we are on a very stable footing as to any kind of guidance that we're providing with regard to the franchise this year. And is there anything else you're saying about the first quarter so far? Is it as expected? Or, I guess, any more color equalization?

In a study at this stage of development is a little bit more sensitive and just looking at response rates. For example, although we will also be looking at.

Response rates.

We will have data from progression free survival.

We also hope to have transcriptome make face are available at the same time as well so that will give us a very comprehensive view of the impacts of the clinical impact of the treatment and also.

Rene Aguiar-Lucanda: on that. So I think what we're seeing, and we're expecting this, is that we are going to have that kind of first quarter seasonality in terms of I would not expect kind of the Q1 to be, you know, particularly strong because of that, because of that impact that we saw last year. And I think we're seeing it so far this year as well.

The impacts of the treatment of tumor biology level and clearly what we want to see.

A significant reduction in tumor size in patients who are receiving sets a maximum.

Copa <unk> Memphis patients.

Who are receiving placebo and proposed timber lease you map, but we're going to it's still it's we think it's a well designed trial.

Rene Aguiar-Lucanda: I think enrollments continue to be very encouraging. And so again, I think we're seeing a lot of demand. And I think it's more the kind of structural issues with the US payer system, etc., and changing insurance plans, etc. That seems to be impacting some of that conversion, but that's probably what I can say so far about the quarter.

An appropriate number of patients in the study I think we need to take also.

Talked about the primary endpoint, but we really need to take all of the endpoints in to account a look the impact of the treatment on the tumor biology as well.

Understanding the benefits of the treatment.

Yeah, and I would just I would've thought to that is obviously this patient population has a very poor outlook. I mean, these are kind of relapsed metastatic.

Kind of Ah patients with head and neck cancer and first line treatment really timber lease amount has a very very limited response rate of 15% to 20%. So in terms of.

Rene Aguiar-Lucanda: Okay, maybe one other question for me, and then I'll hop back in the queue. For the P&T committees to get the updated label through that process, is there anything you're doing to expedite the process, and how do you assess progress along the way? So, yeah, I mean, we've already started to try to, you know, communicate with a lot of the P&T committees just based on the publication in the Lancet. But in reality, obviously, no one is really going to schedule any kind of P&T meetings until they know what the label looks like and that there is truly a new label for these stuff. So, obviously, there have been quite a lot of interactions prior to this to try to kind of prepare for those meetings.

Talking to Kols and getting some input from them.

Obviously, you know even kind of an increase of that to the kind of high Twenty's would certainly be considered clinically very relevant. So so I think that you know the so I think both us as Richard mentioned as well as kind of progression free survival I think that that would kind of be that taken together is really I think what people would be looking for.

In terms of this being kind of a highly successful study.

Okay, great. Thanks very much.

The next question comes from Rummy Cat Cuda from Nice N C I capital.

Please go ahead.

Okay.

Hey, guys congrats on the update and thanks for taking my questions as well two quick ones from me first the language unbelievable Ford can paygo is a bit more strict than what we saw with the accelerated approval of the asset in the states I guess do you expect it to be a difference in label language for a full approval as well.

So you're absolutely correct and I think it's always difficult to know how the two regulators are going to kind of actually affect the same day that they don't always see eye to eye and don't always agree.

Rene Aguiar-Lucanda: But, you know, no, none of these plans really have to kind of take meetings or do anything or plan anything until you actually have a final label in hand. So, obviously, we have, as Maria mentioned, we've added some resources in this area, and it's obviously something that we are considering to be of kind of high importance for the organization. Obviously, these are the first.

But but certainly.

R R.

Our hope would clearly be that.

Label and can Paygo is very much you know very similar to if not the same as the labor a label in the U S.

Got it got it and then I guess, if the open label extension data is positive as well is there a potential for the recommended duration of therapy language to kind of be removed from the tour pay a label.

So I think that obviously, it's something that we have been discussing and I think we'll continue to discuss I mean, when you know when the right time is to maybe kind of go and have some interactions with the regulators both based on kind of real world data that we are observing as well as some of the data from our clinical trials and potential data in other kind of phase.

Rene Aguiar-Lucanda: Got it. Okay. Thanks for taking my questions, Ahabek. The next question comes from Vamil Divan from Guggenheim Securities. Please go ahead.

Rene Aguiar-Lucanda: Great, thank you guys so much for taking the time to answer my questions. I'd like to ask two questions, just about zero, the broader IDN mark, and I'm wondering if you have any sort of updated thoughts. You obviously mentioned all the excitement at ASN, and I think, broadly speaking, about more patients getting diagnosed and treated for IgM now, so I'm curious if you have any sort of updated views on sort of potential market size, especially in the U.S., or if you want to And then second, there's obviously noise from emerging competition from the mid- to late-stage pipeline, specifically from the, you know, April-Daph inhibitors, so I'm curious if those sort of make it to the market in the next two to three years, how you see those sort of impacting TARPAYO's place in the treatment paradigm, if at all. Thank you.

Four studies. So so there there is certainly something that we are keeping in mind as to when.

When we have the appropriate amount of data or the type of data. We think it is a relevant we certainly intend.

Intend to go and have additional interactions with the regulator.

Got it I guess do you guys know what percentage of patients currently on treatment for a less than or greater than nine months.

No.

You mean like in the in your like overall, no I don't actually know.

Okay.

Thank you again thank.

Thank you.

The next question comes from Annabel <unk> from Stifel.

Please go ahead.

Hi, Thanks for taking my question I had a couple here I guess.

You know in terms of the.

Enrollments you saw a nice pick up do you have any sense.

The extent to which.

No.

The pickup in enrollments was from the new prescribers versus.

Your older Prescribers, who had just seen the Egfr data and I guess, you know with the data how much can we see the enrollment pick up from there I understand that it may not necessarily translate into sales, but perhaps enrollments continue.

Rene Aguiar-Lucanda: Yeah, sure. So I think we are consistently just, I mean, a little bit of a kind of repeated message really, I guess, from our perspective, but I think what we've seen consistently is that, you know, this obviously is not an acute disease, right? It is a progressive disease, and it does develop over, you know, a reasonably kind of long period of time, doesn't have any kind of immediate mortality risk.

Our first question.

Then the.

The second question is related to the magnitude of K Daigo guidelines are there any analogs that you have that.

That sort of helped us I don't know.

Yeah.

Sort of more.

By what the impact of K Daigo could have on on an uptick in sales or is it just still primarily you know all you know.

Rene Aguiar-Lucanda: So, on that basis, I think a large part of the IgM population has probably not been, you know, treated particularly aggressively or potentially not at all, apart from really with ACEs and ARBs and other blood pressure-related medications. So, I do think that the, you know, the longitudinal data, as well as some of the clinical trial data showing placebo group deterioration of patients that actually have, that are on some kind of blood pressure-related medication or have already had reductions in proteinuria, which clearly do not seem to translate into any kind of EGFR stabilization. I think that that data is continuing to kind of make its way through the nephrology community. And I think there is a really kind of active dialogue in terms of how, you know, this should potentially impact the treatment paradigm.

Yeah.

The payers that are the gatekeepers here and that's pretty much. It you know who we have to count on.

So I.

I guess those are great questions and I havent follow up after that.

Okay.

So I actually don't have a you know at hand.

The kind of breakdown of the enrollments in terms of.

New kind of prescribers versus versus existing but.

Because obviously, there's always the possibility that new prescribers would have prescribed for more than one patient.

Obviously this is you know, but I guess the best estimate really would be that you know out of 555 romance at least just over 300 of those would be kind of from new prescribers.

The remaining kind of 200.

The easy assumption is that these are kind of repeat prescribers.

But again I cant guarantee that but I think that would kind of be my my best estimate at this point in time.

In terms of the magnitude impact of kidney you I mean, I think that that'll be if he could be quite sizable.

Because obviously today the that's the what's been discussed or at least a different conference at the podiums et cetera is and it's based on this longitudinal data is is one gram.

Rene Aguiar-Lucanda: So, I think that we are seeing a growing part of that market. But again, I think this will probably be a market that will develop and grow, and continue to grow really over time as some of these kind of, as more data really kind of makes its way into the, into peer-reviewed journals. And as I think nephrologists ultimately, you know, use some of these available medications and see actually what impact these medications really have in real life. So, I think that it is a growing, you know, kind of market opportunity for sure. But I think we still have a little bit of time until that's reached its kind of, you know, its peak, you know, its potential.

And appropriate definition to use in the guidelines to define patients at risk of disease progression.

And I think what's been discussed and debated. It's you know again in this forum.

Is that you know maybe that should be reduced.

If that level is reduced to <unk> 75, or five then obviously that would have a very significant potential impact on the addressable population that would be on label.

So I do think that it is a kind of a very you know could be a very significant trigger again, probably not an immediate impact again, but certainly I think could I could have a very significant impact on the overall addressable market.

Okay, and if I can get a little bit more into the weeds. So I guess, we spoken to a couple of care well. It's one of the things that stood out was that.

The way they selected some patients were the ones that had clearer in flint inflammation or inflammatory markers were the ones that were more suitable for.

Rene Aguiar-Lucanda: In terms of the pipeline, so I guess it's always a little bit difficult to kind of make a lot of statements really on a small population in phase 2b, but I think that, obviously, from a kind of mechanistic perspective, assuming that, you know, everything lines up and actually some of these results are reproducible. And also, obviously, safety data is critical for this. I think that, you know, without really having that kind of overall picture of understanding what the product profile really looks like and therefore not really understanding, you know, which patient population might be appropriate for that treatment, it's quite a difficult question to answer. But obviously, as part of your first question, it's also very difficult to know as these kinds of treatments that are already available today continue to penetrate the population.

Sure.

With treatment versus any of the.

The.

Roz inhibitors.

Do you have a sense.

How many patients that have.

U P. C ours below 1.5 are in this inflammatory state and and the extent to which you know.

Expanding that is going to really tap into that entire market or just a portion of the market, but we're more inflammatory.

So maybe you can sort of.

I don't know.

Address that a little bit.

I think that's actually a very kind of difficult question Chi to kind of answer appropriately actually based on the information. We have I mean, I would say that we know this is a very heterogeneous disease. You can have patients that actually have decline of egfr with virtually no proteinuria.

And you cannot and I think the only I mean, the relevant way I guess I'm looking at this would probably be a biopsy, but which are do you have any comment on that.

And also I don't think in the in the sort of commercial prescribe assessing with not necessarily going to have available to us all the information relating to the economy.

Aspects of the patients condition that youre, referring to related to kind of inflammatory status et cetera sort of inflammatory biomarkers.

Levels of marker he materials et cetera, that's not necessarily going to be information.

We're collecting and we have available to us so I think it would be difficult to really comment on that.

Okay, and I guess, one one last simple question just to clarify when you're when you have discussions with payers, who said you know they they they'd like the label in hand do they not have access to this label at this point.

Rene Aguiar-Lucanda: It's also very difficult to know exactly what the unmet medical need is going to be in this patient population in 2027, but I think from a mechanistic perspective, and I'm going to hand over to Richard to give his view from that perspective. So I think, you know, it's an interesting question, but with Nethikon Tarpaio, as we've spoken about many times, treatment that's been designed to target the PAIRS patches in the distal ileum, and it's a B-cell modulator in that region. And it has a low systemic bioavailability; around 90% of nephrocon is removed by the liver on first class metabolism.

Or is there another playbook do they need a physically putting their hand for them to pay attention.

So I mean, no I mean, obviously the the the label language is now available, but obviously they do not have to see anyone or meet anyone or have any meetings with regards to anything around the label unless you have a new label, which obviously they have to go through a new kind of PMT Committee. So it's really more of a matter of days.

Have their own process that they go through whether this is a new drug or a new label update or anything else that would drive them to have to have a PNT committee.

So it's really more a matter of how they obviously have other things that they are also scheduled so when Tim they when will they agreed to put this on their schedule. So when will they actually greet to go through this.

Richard Phillips: When we look at these other treatments, you mentioned the April bliss mechanism, I mean these are systemic treatments that are acting on a different hit, if you like, within the pathogenesis of IgA nephropathy. So taking those kinds of considerations into account, and also noting what Renee's already said about, we need to understand more about these treatments. They need to build up a greater understanding of safety, et cetera. But all of those things being equal, you know, there isn't a fundamental reason why these treatments couldn't be given together, given that they act in different places at different levels within the pathogenesis of the disease. Okay, thank you. Thank you very much again. The next question comes from Yigal Nochomovitz from Citi. Please go ahead. Team, this is Carly on behalf of Yigal.

Because there is a requirement for them to go through this kind of formal process.

And therefore also then issue any kind of potential update or change of the rules that that that they apply.

Based on this new label. So it's really kind of the same as when we originally started is that are you.

You can always do things on a medical exception basis right.

But obviously it gets easier when you actually have gone through the Pnp committees and there is a more standardized way for the payors to address a certain drug so which is why you can certainly almost I mean this will also depend a lot on on kind of how how much energy and persistence do the intriguing.

A physician.

I have to go through potentially these kind of.

Appeals processes until those rules had been amended and that is just difficult to say.

Okay. Okay, great. Thank you.

The next question comes from Arthur <unk> from H C. Wainwright. Please.

Please go ahead.

Yeah.

Hello, Good morning.

Rene Aguiar-Lucanda: Thanks so much for taking our questions. Maybe just to follow up on some of your prior comments. Curious if you can talk a little bit more about the characteristics of patients being prescribed Tarpayo with respect to baseline proteinuria. I know you mentioned the market access piece that you're working through, but curious if you're seeing any shift toward increasing intent to prescribe to patients with lower baseline proteinuria with the updated label. Sure. So, in terms of what we've seen to date, I would say that obviously, because of the label that we had up until December, clearly the language in that label said generally 1.5. So clearly, it wasn't a cutoff.

Wireless caller your line is now a muted.

Please go ahead.

Hi, Keith.

Congrats on progress thanks for taking my question so.

Regarding the launch in China could you give us some update on the preparedness or that part and remind us what's the latest ROE to support the launch.

Sure.

So so obviously the commercial launch will be carried out by Everest medicines and actually as you may be aware I mean, they are the C. E. O. There actually has a very kind of substantial and significant experience from other commercial companies in China.

And so I think actually that the team that's been brought on board.

It is actually quite impressive and it seems to have a lot of experience in terms of launching products in China.

In terms of the.

The actual kind of activity, obviously I think they have had they have been preparing for this for quite a long time.

Rene Aguiar-Lucanda: And so clearly, we've had prescribers and successfully getting to patients below 1.5. But because of the label, obviously, the overall, there has clearly been a shift to the more kind of advanced patient population, more serious patients. I don't have a specific kind of breakdown of how that kind of works, but I do know that obviously it's a, you know, overall impact of having the shift. The label obviously just became available in December, and so actually we have internally, you know, obviously produced material, trained our sales force, etc.

And obviously as we know this is a much much larger population than.

And what we have here and in.

In Europe, and the U S. I guess my my best kind of it was actually I went too when I went to China to Shanghai.

To kind of visit some of the nephrology units and some of the hospitals there.

I mean, it's clear that you know a lot of these hospitals have large numbers of patients.

They actually just kind of have on their roster and they're very well aware of all of this kind of the the potential arrival of his medications. So.

So I think that it's really kind of a you know it's a it seems to have a good expectation I think the early access program was very successful.

And as far as I'm aware that the company is really targeting a launch in in Q2 of this year. So obviously we.

Rene Aguiar-Lucanda: So we're really just kind of, you know, have rolled that out fairly recently into the market. So it's a bit early to kind of know to what extent, if at all, there's been any real impact from the label at this point. Okay.

We will not have any kind of direct involvement in that commercial launch.

Okay. Thanks for that color.

Just a quick follow up on the open.

Open label study.

Could you give us more color what.

Exactly the data still looks like regarding the size and the data points.

Rene Aguiar-Lucanda: That's helpful. And then we wanted to ask about the phase two data coming up for setonaxib in head and neck cancer. Just curious to know a little bit more about what you're looking to see in that data set and what you think would be an attractive profile for potential partners for that program. Thank you. Sure, I'm going to hand it over to Richard to describe a little bit about what the data readout is going to contain, and then I'll give you a sense of what I think might be helpful.

Thanks.

Ah So I guess that my understanding really isn't all up Richard you can correct me if I'm wrong.

But this really is just it's an open label study. So everyone. Obviously is going to be on drug and inclusion criteria were very similar to the inclusion criteria for the phase three so slightly lower kind of egfr levels, but actually the approaching around kind of what's the same and so I believe it's about 120 19 under the 19th.

The exact Ah patients.

That have been enrolled into the trial.

And our expectation is obviously cause not to this date, obviously has not been unblinded.

Richard Phillips: So just as a reminder, this is a double-blind randomized control trial where we're giving setonaxib or placebo on top of pembrolizumab in patients with recurrent or metastatic head and neck cancer. And we expect to have the results, as Renia said, a little later in this half. And the primary endpoint in that study is change in tumor size, and we think this is an important endpoint in a study at this stage of development. It's a little bit more sensitive than just looking at response rates, for example. Although we will also be looking at response rates. We will have data on progression-free survival and we also hope to have transcriptomic data available at the same time as well, so it will give us a very kind of comprehensive view of the impact of the clinical impact of the treatment and also the impact of the treatment at a tumor biology level, and clearly, what we want to see But, you know, we're going to, it's not, it's, we think it's a well-designed trial.

So even if it's an open label study, obviously, we do not know what kind of treatment.

The patients had prior to entering this open label.

But we would expect that the majority of these patients would be placebo patients as they still qualified.

As being kind of at risk, but we would also expect that there is a group of patients who will have who will be retreated and our assumption is that that would be skewed towards those patients. They probably had a more severe disease coming into the phase III. Since obviously, they might've had very significant improvements both of them.

Kind of Egfr in proteinuria, potentially but obviously, we're still qualifying as being at risk.

After that kind of a two year period have been spending that in the phase III.

So that it is real and in terms of the data, it's really kind of very similar data. So it's really proteinuria and egfr.

So you mean, it's all kind of a similar dataset from that perspective.

Got it. Thank you very much for taking my question.

Sure.

Thanks.

Okay.

The next question comes from Christopher <unk> from Seb Enskilda.

Please go ahead.

Hi, there thanks for taking my questions I just have a few follow ups. So I.

I think in terms of average duration of therapy.

I think previously I believe you said it was around six to seven months. So far people are more.

More prescribing along the lines of systemic steroids in terms of that are.

Are you seeing now.

That's starting to improve since the data was presented an approval.

And then my second question, you gave a little bit of flavor on re treatment for those who are already growing nine months, but do.

Do you have any indications so far on the average frequency for the patient's overall who've been getting Oh.

Rene Aguiar-Lucanda: There are an appropriate number of patients in the study. I think we also need to take, you know, I've talked about the primary endpoint, but we really need to take all of the endpoints into account and look at the impact of the treatment on tumor biology as well when we understand the benefits of the treatment. Yeah, and I would just add to that obviously this patient population has a very poor outlook. I mean, these are kind of relapsed metastatic patients with head and neck cancer.

And I guess then my third question is so in terms of the.

Yeah.

Returning prescribers and I'm not sure how much you can say given what you've said earlier, but are you getting a sense of whether the prescribers who prescribed previously are getting better at converting enrollments to treatments quickly navigating the reimbursement.

Days better if you will thank you.

Thanks.

So in terms of average duration. What we did is we followed this kind of patient cohort and I think we reported this I think in Q2 of last year that actually showed us at that point in time that the average treatment duration was about eight months.

And so what we would be expecting and I think we'll probably follow a cohort shortly and try and see what that looks like maybe towards the end of the year, a really kind of we would expect that to kind of be increasing at this point and the reason why it would be increasing is obviously, partly as you say there is that kind of habit, but.

Rene Aguiar-Lucanda: And first line treatment, which has a very, you know, very limited response rate of 15 to 20%. So in terms of, you know, talking to KOLs and getting some input from them. You know, obviously, even kind of an increase of that to the kind of high 20s would certainly be considered, you know, clinically very relevant. So, I think that, you know, both as Richard mentioned, as well as kind of progression-free survival, I think that would kind of be the, you know, taken together is really, I think, what people would be looking for in terms of this being kind of highly successful. Okay, great. Thanks very much.

Still sits and actually I think it goes for almost all drugs and there is a sense of nephrologists that you've tried something for six months and then see kind of what happened.

So I think that we would expect that to kind of continue to improve based on additional education Medical affairs intervention et cetera to really explain the difference in terms of the local action et cetera of these particular drugs, so that would be our expectation.

In terms of REIT treatment I think it is too early for us to kind of comment in any great.

Kind of detail on that and we have seen kind of you know we treatment happening, but I think we're going to wait in terms of collecting some more information on that before we really comment on it.

In terms of returning prescribers.

I wish that I could tell you.

Rene Aguiar-Lucanda: The next question comes from Romi Katkuda from LifeSCI Capital. Please go ahead. Hey guys, congrats on the updates and thanks for taking my questions as well. Two quick ones from me.

But these kind of prescribers, who prescribe before.

We're getting better at it Unfortunately I'm not sure that that's the case I think it just comes from the fact that this is a rare disease and so it might have been three or four months between them kind of prescribing it before and prescribing it now and unfortunately theres been hundreds of patients in bits.

Rene Aguiar-Lucanda: First, the language on the label for Contego is a bit more strict than what we saw with the accelerated approval of the asset in the States. I guess, do you expect there to be a difference in label language for full approval as well? You're absolutely correct, and I think it's always difficult to know how the two regulators are going to kind of actually assess the same data. They don't always, you know, see eye to eye and don't always agree, but certainly, you know, our hope would clearly be that the label on Kimpego is very much, you know, very similar to, if not the same as, the label in the US. Got it, got it.

In that period of time.

For these nephrologist so I do.

No.

I think it's unclear at this point in time, how much better.

Theyre getting actually kind of you know.

Submitting compete prescriptions.

But we are still hopeful that we're going to get there.

Yeah.

Thank you so much.

The next question comes from Johan <unk> from Redeye.

Please go ahead.

Great. Thanks for taking our questions. The first one considering the enrollment in the.

Unique subscribers and also the price increase it seems like the guide is rather conservative.

We expect you to take a rather proactive approach due in 'twenty, four and perhaps update the guide more actively.

Rene Aguiar-Lucanda: And then I guess if the open label extension data is positive as well, is there potential for the recommended duration of therapy language to be removed from the TARPEO label? So I think that obviously it's something that we, you know, have been discussing and I think we'll continue to discuss when the right time is to maybe kind of go and have some interactions with the regulators, both based on kind of real world data that we are observing, as well as some of the data from our clinical trials and potential data, you know, in other phase four studies. So, certainly something that we are keeping in mind is when we have the appropriate amount of data or the type of data we think is relevant, we certainly intend to go and have additional interactions with the regulators. I got it.

Yes.

That would not be that wouldn't be in any possibility I think that obviously as we get some of these things become clear both in terms of how quickly we can get through Pnp committees.

They could even guidelines may or may not become available et cetera, and you know when it becomes a little bit more clear on that I think that could certainly that could certainly imply that we would that.

We would kind of provide more and more accurate guidance as time goes on.

Great.

To the second question is what about the irregularities in time, but these pnp committees tend to meet them.

Well that happened several times here or when something is needed to be handled.

It does vary actually plan to plan I mean, some of the bigger plans are more kind of structured they may have like a quarterly meeting et cetera on the otherwise might have monthly meetings, but yes. There is a certain cadence that they all have that's in which case. They will obviously do more than just one drop as you'll have several kinds of cases.

But they will kind of addressing one meeting but.

But it is not necessary. It it's unusual that he would be AD hoc it's.

It's more kind of a structured process that is.

Yeah.

I have agenda for either then on a kind of.

Mainly kind of quarterly basis.

So later.

During the first half should have.

Some insight into this dynamic already.

Absolutely and as I said this is clearly something that we do.

The organization, we are very focused on them and this is clearly something where we are working very actively driving.

Rene Aguiar-Lucanda: I guess, do you guys know what percentage of patients currently are on treatment for less than or greater than nine months? No, you mean, overall? No, I don't actually, no.

Driving that.

Process as much as we possibly can from the outside.

But there's a limit of 52 to how much we can we can impact that but there certainly is a is a lot of focus on it.

And regarding the backlog related to the private the commercial pay as you said this is not an acute illness, but it isn't a chronic illness and a specialist will continue to monitor the patients that the backlog is unlikely to disappear there are a few.

Rene Aguiar-Lucanda: Okay, no worries. Thank you again. Thank you. The next question comes from Annabel Samimi from Steiffel. Please go ahead. Hi. Thanks for taking my question. I had a couple here.

There are few alternatives.

Certainly yes, there are kind of there are few alternatives I think what you might find is that physicians get frustrated they cancel it.

Rene Aguiar-Lucanda: I guess, you know, in terms of enrollment, you saw a nice pickup. Do you have any idea the extent to which the pickup in enrollments was from new prescribers versus your older prescribers who had just seen the EGFR data? And I guess, you know, with the data, how much can we see the enrollments pick up from there? I understand that it may not necessarily translate into sales, but perhaps the enrollments will continue. So, that's our first question. And then the second question is related to the extent of the KDIGO guidelines. Are there any analogs that you have that could sort of help us?

They kind of meet their patient. The next time you know in a couple of months they kind of submit again to try and have better better lots at this time, so I think it'll be a mixture of those.

Those physicians, who will have it be a little bit more patient.

And be willing to kind of go through the the authorization process and some of those other prescribers, who are who make kind of.

Come back when they when they think that actually the rules have been updated.

So they they don't have to kind of go through jumped through the same hopes I think it'll probably be a mix of both.

Rene Aguiar-Lucanda: I don't know, more quantify what the impact of KDIGO could have on an uptick in sales, or is it just still primarily the payers that are the gatekeepers here, and that's pretty much, you know, who we have to count on. I guess those are questions, and I have a follow-up to ask. OK. Um, so I actually don't have a, you know, at hand, the kind of breakdown of the enrollments in terms of, you know, new, new kind of prescribers versus, uh, existing. But, um, cause obviously there's always the possibility that new prescribers would have prescribed for more than one patient. So obviously, this is, you know, but I guess the best estimate would be that, you know, out of 555 enrollments, at least 300 of those would be kind of from new prescribers.

Great and finally, if I may regarding the <unk> study.

Some of these patients will be repeat patients a few clarified earlier and some of them will be a flight to the more severe stage and earlier into the thought is as being the bulk of the consistency that during the period. The Egfr has been stabilized is that what can be.

B.

<unk> from this early study of course, we have to wait for the actual defaults, but.

What should we expect.

I think from a mechanistic perspective, I mean, we wouldn't expect it to be any different in the open label extension that we've seen both in our face to be in our phase III.

So yes, we would expect to see a very similar outcome, where actually when patients are on treatment.

It does stabilize their kidney function.

Very good thank you.

Thank you.

The next question comes from Suzanne Van Voss, who is in from V. L. K.

Please go ahead.

Hi team. This is suzanne thanks for taking my question.

A small follow up regarding the excess friction that you mentioned to face in the first half should we expect you to the data markets on the progress that you make with it bears as part of the quarterly earnings updates or.

Rene Aguiar-Lucanda: The remaining kind of 200, you know, the easy assumption is that these are kind of repeat prescribers. But again, I can't guarantee that, but I think that would be my best estimate at this point in time. In terms of the magnitude of the impact of Cadigo, I mean, I think that that obviously could be quite sizable. Because obviously, what's been discussed, or at least at different conferences, at podiums, etc.

Given its importance could there be some communication about that separately.

Sort of milestones.

And then I have another question after this one.

I think we will probably report as part of the quarterly updates.

I think obviously I mean, if there is something that we consider as being very important then we can always I mean, we could always consider doing something I hope, but I guess my assumption would be that we would we would report on a quarterly basis.

As we have it.

Got it Alright, and then maybe on Europe can you provide some color on what the sales development looked liked for Kim bagel and what was the.

Rene Aguiar-Lucanda: And based on this longitudinal data, is one gram an appropriate definition to use in the guidelines to define patients at risk of disease progression? And I think what's been discussed and debated, again, in these forums is that maybe that should be reduced. So if that level is reduced to 0.75 or 0.5, then obviously that would have a very significant potential impact on the addressable population that would be on label. So I do think that it is a kind of very, you know, could be a very significant trigger again, probably not an immediate impact again, but certainly, I think it could have a very significant impact on the overall addressable market. Okay. And if I can get a little bit more into the weeds.

2023 seals.

Total in the year.

So I think we have a bias.

Kind of royalty numbers, but I don't know if we have anything fredrik what would you be.

On a kind of yes, we have the royalty number which we are separate in our reporting.

Overall for the full year, we reported approximately four communities.

In royalties.

Yeah.

And flagship they don't start is obviously, a very large company they don't necessarily break this out or or kind of disclose any of these details.

So therefore, we don't really have access to to those type of.

Numbers.

But obviously, we are aware of the fact that the.

They are they are gaining kind of approval and acceptance is from a variety of European countries UK, obviously being the most recent one and it's my understanding that there in kind of negotiations with at least four other geographic regions and in Europe with a hope to obviously reach the conclusion conclusion. They are also fairly shortly.

Rene Aguiar-Lucanda: So, I guess we've spoken to a couple of KOLs. One of the things that stood out was that the way they selected some patients was the ones that had clear inflammation or inflammatory markers were the ones that were more suitable for TARPAYO treatment versus any of the RAS inhibitors. Do you have a sense of how many patients that have UPCRs below 1.5 are in this inflammatory state and to what extent? You know. Yigal Nochomovitz, Calliditas Thera, So maybe you can sort of...

But that is the kind of insight that I missed.

Hi.

Alright, thank you.

Okay.

There are no more questions at this time, so I hand, the conference back to the speakers for any closing comments.

Thank you very much and thank you very much for listening to this Q4 report from 2023, and we look forward to meeting you again, when we get to report our Q1.

Rene Aguiar-Lucanda: I don't know, address that a little bit. Um, I think that's actually a very kind of difficult question to kind of answer uh appropriately based on the information we have. I mean, I would say that we know this is a very heterogeneous disease; you can have patients that actually have decline of EGFR with virtually no proteinuria, and you can, and I think the only relevant way, I guess, of looking at this would probably be a biopsy, but Richard, do you have any comments on that? Well, I think, and also I don't think in the sort of commercial prescriber setting we're not necessarily going to have available to us all the information relating to this, aspects of the patient's condition that you're referring to relating to kind of inflammatory status, etc., so inflammatory biomarkers, levels of microhematuria, etc., that's not necessarily going to be information that we're collecting and have available I think it'd be difficult to really comment on that.

Which is due in may of this year. Thank you very much.

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Rene Aguiar-Lucanda: Okay, and I guess one last simple question. Just to clarify, when you had discussions with payers, you said, you know, they'd like the label in hand. Do they not have access to this label at this point? Is there another label that they need to physically put in their hand for them to pay attention to?

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Rene Aguiar-Lucanda: So, I mean, obviously, the label language is now available, but obviously, they do not have to, you know, see anyone or meet anyone or have any meetings with regard to anything around the label unless they have a new label, which obviously they have to go through a new kind of P&T committee. So it's really more the matter of them having their own process that they go through, whether this is a new drug or a new label update or anything else that would drive them to have to have a P&T committee. So it's really more a matter of how, you know, they obviously have other things that they're also scheduled for. So when can they, you know? When will they agree to put this on their schedule? So when will they actually agree to go through with this? Because there is a requirement for them to go through this kind of formal process and therefore also then issue any kind of potential update or change of the rules that they apply based on this new label.

No.

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Rene Aguiar-Lucanda: So it's really kind of the same as when we originally started. You can always do things on a medical exception basis, right? But obviously, it gets easier when you actually have gone through the P&T committees, and there is a more standardized way for the payers to address a certain drug. So, which is why you can certainly always, I mean, this will also depend a lot on kind of how much energy and persistence the treating physician has to go through potentially these kinds of appeals processes until those rules have been amended. And that is just difficult to say. Okay, okay, great.

No.

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Rene Aguiar-Lucanda: Thank you. The next question comes from Arthur He from HC Wainwright. Please go ahead. Hello, good morning, good day. Wireless caller, your line is now unmuted.

Rene Aguiar-Lucanda: Please go ahead. Hi, Irene and team, congrats on the progress. Thanks for taking my question. So.

Rene Aguiar-Lucanda: Regarding the launch in China, could you give us some update on the preparedness on that part and remind us what's the Calliditas' role to support the launch? Sure, so this is a commercial launch will be carried out by Everest Medicines and actually as you may be aware, I mean they The CEO there actually has a very kind of substantial and significant experience from other commercial companies in China And so I think actually that the team that's been brought on board Is actually quite impressive and seems to have you know a lot of experience in terms of launching products in China In terms of the The actual kind of activity obviously, I think they have had they have been preparing for this for quite a long time And obviously as we know this is a much much larger population Than what we have here in you know in Europe and the US I guess my best kind of view is actually I went to when I went to Shanghai To kind of visit some of the nephrology units and some of the hospitals there I mean, it's clear that you know, a lot of these hospitals have large numbers of patients that they actually just kind of have on their roster and they're very well aware of of this kind of the the potential arrival of this medication, so So I think that it's really kind of a you know, it's a it seems to have a good expectation I think the early access program was very successful And as far as I'm aware that the company is really targeting a launch in in Q2 of this year so obviously We will not have any kind of direct involvement in that commercial, Thanks for that color. And just a quick follow-up on the the open label study. Could you give us more color of what exactly the data set look like regarding the size and the data points?

Okay.

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Rene Aguiar-Lucanda: Thank you. So I guess that my understanding really is, and Richard, you can correct me if I'm wrong, but this really is just an open-label study, so everyone obviously is going to be on the drug and inclusion criteria. We're very similar to the inclusion criteria for phase three, so slightly lower EGFR levels, but actually, the protein cutoff was the same. And so I believe there are about 120 or so, 119 to be exact, patients that have been enrolled into the trial.

Rene Aguiar-Lucanda: And our expectation is, obviously, because this data has not been unblinded. So even if it's an open-label study, obviously, we do not know what kind of treatment the patients had prior to entering this open label. But we would expect that the majority of these patients would be placebo patients as they still qualified as being kind of at risk. But we would also expect that there is a group of patients who will have, who will be retreated, and our assumption is that that would be skewed towards those patients who probably had a more severe disease coming into phase 3 since, obviously, they might have had very significant improvements both in EGFR and proteinuria potentially, but obviously So that is really, and in terms of the data, it's really kind of very similar data, so it's really protein area, EGFR, you know, safety, I mean, it's all kind of a similar data set from that. Thank you very much for taking my question. I'll talk to you guys soon.

No.

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Rene Aguiar-Lucanda: The next question comes from Christopher Youd from SEB in Skilda. Please go ahead. Hi there, thanks.

Rene Aguiar-Lucanda: I just have a few follow-ups, of Average Duration of Therapy, so far. More prescribing ahead, in terms of that. Are you seeing now that that's starting to improve?

Uh huh.

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Rene Aguiar-Lucanda: And then my second question, you gave a little bit of a flavor of what's already going on, but do you have any indication so far on the average? And I guess then my third question, term, and turning prescribers. I'm not earlier, but are you getting a sense of whether... subscribers, like navigating.

Rene Aguiar-Lucanda: Thanks. So in terms of the average duration, what we did is we followed this kind of patient cohort, and I think we reported this, I think, in Q2 of last year. That actually showed us at that point in time that the average treatment duration was about eight months. And so what we would be expecting, and I think we'll probably follow a cohort, you know, shortly and try and see what that looks like, maybe towards the end of the year. Really, kind of, we would expect that to be kind of increasing at this point.

No.

Okay.

Yeah.

Yes.

Okay.

Rene Aguiar-Lucanda: And the reason why we'd be increasing is obviously, partly as you say, there is that kind of habit that kind of still sits, and actually, I think it goes for almost all drugs, and there is a sense among nephrologists that you try something for six months and then see kind of what happens. So I think that we would expect that to kind of continue to improve based on additional education, medical affairs intervention, etc. to really explain the difference in terms of the local action, etc., of this particular drug.

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Rene Aguiar-Lucanda: So that would be our expectation. In terms of retreatment, I think it is too early for us to kind of comment in any great kind of detail on that. You know, we have seen some kind of, you know, retreatment happening, but I think we're going to wait in terms of, you know, collecting some more information on that before we really comment on it. In terms of returning prescribers, I wish that I could tell you that these prescribers who prescribed before are getting better at it. Unfortunately, I'm not sure that that's the case. I think it just comes from the fact that this is a rare disease.

Okay.

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Rene Aguiar-Lucanda: And so it might have been three or four months between them kind of prescribing it before and prescribing it now. And unfortunately, there have been hundreds of patients in between that period of time for these nephrologists. So I do, you know.

Uh huh.

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Rene Aguiar-Lucanda: I think it's unclear at this point in time how much better they are getting at actually kind of, you know, submitting complete prescriptions, but we are still hopeful that we're going to get there. The next question comes from Johan Unniras from Red Eye. Please go ahead.

Rene Aguiar-Lucanda: Great, thanks for taking our questions. The first one, considering the enrollment and the unique subscribers and also the price increase, it seems like the guide is rather conservative. Should we expect you to take a rather proactive approach during 24 and perhaps update the guide more actively? Yes, that would not be, you know, that wouldn't be an impossibility.

Yes.

Okay.

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Rene Aguiar-Lucanda: I think that obviously as some of these things become clearer, both in terms of how quickly we can get through P&T committees, you know, when the Cadegal guidelines may or may not kind of become available, etc., you know, when it becomes a little bit more clear on that, I think that could certainly, that could certainly imply that we would, you know, provide more and more accurate guidance as time goes on. Great, and that leads us to the second question. What about the regularity and time that these PMT committees tend to meet? And will that happen several times a year or when something is needed to be handled? It does vary, actually, from plan to plan. I mean, some of the bigger plans are more kind of structured.

Rene Aguiar-Lucanda: They may have like a quarterly meeting, et cetera, and otherwise might have monthly meetings. But yes, there is a certain cadence that they all have that, you know, in which case they will obviously do more than just one drug. They'll have several kinds of cases that they will kind of address in one meeting. But it's not necessarily it's unusual that it would be ad hoc.

No.

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Rene Aguiar-Lucanda: It's more of a structured process that they have an agenda for either then on a kind of, you know, mainly kind of quarterly basis. So during the first half, you should have some insight into this dynamic already. Absolutely, and as I said, this is clearly something that within the organization, we are very focused on, and this is clearly something where we are working very actively at driving that process as much as we possibly can from the outside, but there's a limit, obviously, to how much we can impact that, but there certainly is a lot of focus.

Uh huh.

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Yes.

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Rene Aguiar-Lucanda: And regarding the backlog relating to private commercial pay, as you said, this is not an acute illness, but it is a chronic illness, and specialists will continue to monitor the patients. The backlog is unlikely to disappear. There are few, very few alternatives.

Rene Aguiar-Lucanda: Certainly, yes, there are few alternatives. I think what you might find is that physicians get frustrated, they cancel it, they kind of meet their patients the next time, in a couple of months, they kind of submit again to try and have better luck this time. So I think it'll probably be a mixture of those physicians who will be a little bit more patient and willing to kind of go through the authorization process, and some of those other prescribers who may kind of come back when they think that actually the rules have been updated so that they don't have to kind of go through, jump through the same hoops.

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Rene Aguiar-Lucanda: Great. And finally, if I may, regarding the OPE study, some of these patients will be repeat patients, as you clarified earlier. Some of them will be at a slightly more severe stage. In earlier studies, it's been rather consistent that during the active period, the EGFR has been stabilized.

Rene Aguiar-Lucanda: Is that what we can expect from this OLE study? Of course, we have to wait for the actual results, but what should we expect? From a mechanistic perspective, I wouldn't expect it to be any different in the open-label extension that we've seen both in our phase 2b and our phase 3. So yes, we would expect to see a very similar outcome where, actually, when patients are on treatment, it does stabilize their kidneys.

Rene Aguiar-Lucanda: Very good, thank you. The next question comes from Suzanne Van Vosuizen from VLK. Please go ahead. Hi team, this is Suzanne. Thanks for taking my question. A small follow-up regarding the access friction that you mentioned faced in the first half.

Rene Aguiar-Lucanda: Should we expect you to update the market on the progress that you make with the payers as part of the quarterly earnings updates, or? Given its importance, could there be some communication about that separately on important milestones? And then I have another question after this. I think we will probably report this as part of the quarterly updates. I think, obviously, I mean, if there is something that we consider being very important, then we can always, we could always consider doing something at home.

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Rene Aguiar-Lucanda: But I guess my assumption would be that we would we would report on a quarterly basis and as we have, got it all right and then maybe on europe can you provide some color on what the sales development looked like for kim pego and what was the 2023 sales in total in europe, So I think we have our kind of royalty numbers, but I don't know if we have anything, Frederick, what would you be? Yes, we have the royalty number which we separate in our reporting and overall for the full year we reported approximately 40 million SEK in, Royalties. Yeah and so actually they don't, Strada is obviously a very large company, they don't necessarily break this out or kind of disclose any of these details, so therefore we don't really have access to those type of numbers, but obviously we are aware of the fact that they are gaining kind of approval and acceptances from a variety of European countries, UK obviously being the most recent one, and it's my understanding that they're in kind of negotiations with at least four other, you know, geographic regions in Europe with a hope to obviously reach a conclusion, they're also fairly short, but that is the kind of insight that I have this time.

Thank you.

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Rene Aguiar-Lucanda: All right, thank you. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments. Thank you very much and thank you very much for listening to this Q4 report from 2023, and we look forward to meeting you again when we get to report our Q1, which is due in May of this year. Thank you very much. As a computer scientist, he and Hooves originated from e-mail signals that could have been manipulated by a computer and distributed. Some e-mails may not even reproduce anywhat of the real e-mail messages and shielded mail that his colleagues had ever had visiting them. Some e-mails are quicker than others, allowing his coworkers and friends to reach out without any task to do.

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