Q4 2022 Calliditas Therapeutics AB Earnings Call
This call is being recorded your line is muted.
Welcome.
Welcome to the.
Therapeutics Q4 report.
For the first part of the conference call.
Disciplines will be and listen only mode.
During the questions and answers session participants are able to ask questions by dialing star five on the telephone keypad.
I will have the conference over to the Speaker C. A renee.
CFO Fredrik Johansson, Andrew Udall, President of North America, and Richard Phillips on CMO.
Please go ahead.
Welcome to the political Therapeutics Q4 report of 2022.
I would ask you to turn the page and initially just.
Bring your attention to our disclaimer page.
This is just related to forward looking statements and I refer you to the company's reports and other filings, including those which contain risk factors and other relevant information.
You can go to the next page.
So.
Thank you for joining us for the fourth quarter report of 2022, which includes a very successful year for <unk> in which we commercially launched the first ever approved medication I J nephropathy in the U S.
There has been great interest from the Prologist for medication, which targets the presumed origin of the disease.
And which does hold the potential of being disease modifying based on early insignificant impact in Egypt foreign patients at risk of rapid disease progression.
To further support our top line data, which we presented in late 2020, we published a full overview of the party data in October of 2022, and kidney International which was met with enthusiasm from physicians and took a special interest in the continued reduction approach and hearing all patients who had been off drugs for three months after.
The nine months initial treatment and the stabilization of easier for patients at risk of rapid disease progression.
Based on the many interactions with a <unk> it became clear that Egfr data as it becomes more and generally more available. This will clearly died their treatment decision as their treatment goal is obviously to preserve kidney function over their patients were there for excited as we approach the completion of the confirm.
It's really portion of our phase three trial.
We can go to the next page.
From an overall corporate perspective reported total revenues in queue for 429 million Swedish crowns.
Which equivalent to approximately $42.4 million auto pay a sales represented 167 million cramps or about $16.1 million.
For the here that took us a total revenues around 830 803 million Swedish crash equivalent to about $79 million again out of which to repair represented at 373 million Swedish cramps or $36.8 million.
Dollars, we're very proud of this resolved, especially in a market that actually was defined by strong macro headwinds, including volatile capital markets high inflation, increasing interest rates and unfortunately been ongoing war in Europe .
Against this backdrop, we have being able to over the last 18 months or so.
So a 1.2 billion crowns of Nondilutive capital, ensuring a successful launch, but first in class product into the U S market.
I do truly believe that we have a lot to be proud about for 2022.
We did decide during the year to also expand our USB sales team.
And we have recently also brought them in house <unk>, we have clearly seen that this expansion has already had an impact towards the end of the quarter.
We obviously continue to educate nephrologist Ah so have you seen the U S market today, we have an oral product, which can be added to physicians choice of optimize replicate and.
Which is based on a well characterized active ingredient with a differentiated approach of targeted treatment of the origin of the disease with a goal of specific down regulating I J one.
We believe that this has the potential to be disease modifying based on our early data and we do look forward to being able to share a longer term easier for data from our part B Rita.
We go to the next page.
So in December we also reported that we had out license <unk> too bye actress for the Japanese market.
This resulted in a 20 million dollar upfront payment with additional $80 million of developed a regulatory promotional milestones. We're very excited about being able to further expand the global franchise of <unk>.
Look forward to work with our new partners.
In November our other partners Ivers medicines had there China M P. Eight at filing accepted.
And in December and also the regulatory body recommended a priority to review from Africa, and China, and we look forward to having some results from that regulatory review towards the second half of this year.
And as you May know there are a lot of patience by a supreme patients in China.
Chinese market. This is a very very significant unmet medical need I will look forward to working with our partners Evers medicines to hopefully be able to address that need once the regulatory view has been completed.
In terms of our pipeline.
We reported in the previous quarter that there had been a slowdown in terms of side activation and I'm happy to report that that those have kind of picked up recruitment rates in our head and neck cancer trial of significantly improve.
And we are presently targeting the delivery of the buying market data previously have guided on in this year, we're hoping to be able to do that sometime around the middle of the year, obviously, depending on final arrangements for that Rita.
PVC child does remain challenging we've been planning to the range of activities in Q4, and Q1, and we will continue to work hard at trying to address someone will be the issues around Kennedy somewhat slow Iraq recruitment rate than what we would like to see.
In terms of further kind of financial highlights obviously, we didn't this quarter reported positive operating profit in queue for about 32.5 million Swedish cramps, and obviously also positive cash flow from operations.
We that leaves us with a very strong financial position for the end of the year with cash amounting to over a billion almost a billion 250 in terms of Swedish crowns around $119 million.
We believe them on that basis were funded to profitability based on continued deliver a sales from <unk> franchise globally.
In terms of some pro spirit events, if we go to the next slide please thank you.
So in February February the imagery announced that they had granted a conditional market authorization option paygo for the United Kingdom.
And that C. M. A is in process of being transferred to our European Partners Shada, who obviously holds the commercial rights for that area.
And also obviously based on the data the completion of the last visit by the last subject and our phase three trial on like the guard. We now have a clear view of when we will be able to share with you the top line data.
<unk> B and so we are presently targeting somewhere around the middle of March in order to be able to provide that information.
<unk>, let me see provide longterm need you for data complimenting really the easier for data that we saw at nine months, which was both a statistically significant eclinical meaningful.
Uhm for the year of 2023 mm, we believe that on the basis of the what we're seeing in the market and some of the other points that Andy will be covering with Ya.
We believe that we will have a U S based revenues from <unk>.
Somewhere between 120 $250 million and we believe that you know strong top line data from heartbeat could provide momentum to this uptake as the longterm E. G for data certainly will provide further insight into the potentially disease modifying activity of <unk>.
So with that if we go to the next page.
I will hand over to Richard Philippson, Chief Medical Officer, who will take you through a little bit more detail around the kidney international publication, which I mentioned in the beginning and which obviously hot generate a lot of interest broadly in the nephrology.
Area.
Thank you very much for me.
So if we move to the next slide.
Sure I'm running for life.
The results would portray you Vanessa cops phase three clinical trial were published online and can be international.
Right.
October of last year and subsequently in the serious issue to the print version of the drug.
I'd like to summarize the results presented in the palpitations.
So I'm moving to the next slide.
That's a very brief recap I'll tell Ya Vanessa.
<unk> 201 patients with only trained properly and randomize them in a one to one ratio to receive an African 60 milligrams once daily <unk>.
Nine months three months post treatment observation of treatment for patients continued into policy with the study which comprised a further 12 months of treatment.
<unk> runs on optimized rash located.
Medium Facetime, proteinuria, Egfr, reflecting a population of patients at high risk of kidney disease progression.
After nine months of treatment that was a highly statistically significant 27 per cent reduction in proteinuria measured by U P. C. All patients receiving Mexican <unk>.
Stabilization of you to call.
3.87, mils per minute treatment benefit compared to placebo.
What are we looking at the one year <unk> patients treated with Mexican versus those treated with placebo.
C N improvement of 3.37 miles per minute, representing a preservation of each of your fault of approximately 70 per cent the maximum possible effect.
This effect as consistent as it is in line with what we saw in the face to study and importantly, it compares favorably with all the treatments study Tonight, you know prophecy.
Treatment with <unk>.
<unk> and patience without hearing the Foxy results in a calculated preservation of you to your car off the 12 months of only 26 per cent of the maximum possible effect.
So I used to have a treatment was in line with what was expected for talks with release formulation will be desperately importantly, there were no severe infections requiring hospitalization.
So in summary, overall treatment with Mexican resulted in clinic came coltrane's improvements compared with optimize supportive care alone.
So moving to the next line.
And then colson observation relating to the effectiveness of column proteinuria in the park I study population.
<unk>, we're not immediate with no discernable effect following three months of treatment for all.
All of the effects become a parent so it's six months continues accumulative improvements at nine months.
<unk> protein uric continued to improve even off the treatment has been discontinued.
Nine months.
So at 12 months after three months of treatment. There was a 52 per cent reduction in proteinuria Python.
So the next slide.
When we look up improvements in proteinuria associated with <unk>, you see an interesting observation in patients with high levels of <unk>.
Specifically, we see an earlier separation of approach and you're a cubs so.
Drug me three months.
14 per cent reduction <unk> treated versus placebo patients.
You have a less importance why I'm, so sorry to all patients in the lexicon frequently treated group showed improvements in proteinuria irrespective.
Iceland proteinuria levels.
Waiting for the next line.
This of your improvement approaching Uranus translated early divergent Egfr Cups, and these patients each of your fault declined by over 10 mils per minute over the 12 month period.
Super group compared to a reduction.
1.1 miles per minute.
<unk> group.
<unk> of nearly.
Nine miles per minute 12 months.
It's worth noting that each you fall remained stable during the three month follow up period when patients have discontinued treatment with no evidence of deterioration in need you called during this three month follow up period.
I'm moving to the next slide.
So in summary for the policy <unk> <unk> primary and secondary endpoints in the <unk> <unk> <unk> <unk>.
The effects of Mexican on Proteinuria <unk>.
Gradual accumulative with continued improvement after discontinuation of treatment.
And in patients with higher baseline proteinuria and early or beneficial effect on proteinuria is observed which translates to clearly divergent egfr trajectories.
<unk> <unk> treated patients.
So that concludes my part of the presentation.
Thanks Richard.
515 please.
The fourth quarter was another strong quarter to finish the first calendar year of the commercialization of car for Ya.
Net sales of more than $16 million brings us to $36.8 million net sales. After the first 11 months of promotion.
At 310, new patient enrollments in the quarter, which has the 2022 total more than a thousand enrollments, which were written by over 640 unique Nephrologist. In addition, we continue to see the average enrollment per prescriber growing and we anticipate this rate will continue to go.
<unk> as many of the Nephrologist now have patience on therapy for several months and experiencing positive results as was demonstrated in our clinical trials that Richard just reviewed with Ya.
As it relates to market access is mentioned last quarter, we really reached our target of over 90 per cent of U S lives, having coverage for <unk> in the middle of the year, which we are very proud of the.
The payer mix has reached a steady state without much changed from the last quarter approximately three quarters of our patients have either private commercial insurance for cashback customers with the remainder of our business coming from government insured patients.
Sharpei, you'll touch points and the high quality of our patient service programs are extremely important to us and continue to exceed industry standards.
The less we continue to assess our program to identify areas of improvement and to determine if additional resources are needed to maintain this high level of service during a period when our patient population continues to grow.
Are targeted reach and promotional programs remain effective as demonstrated by the awareness of <unk> growing to over 90% of Nephrologist and market research surveys conducted prior to the end of 2022.
Most important and rewarding to us during the fourth quarter and early this year are the increasing number of success stories that are being recorded as more and more patients have taken sharpei O for extended periods of time next lot. Please.
2023 promises to be another exciting year of growth for <unk> and our commercial organization.
While we felt the initial positive impact of the expansion of our field during the fourth quarter. We look forward to the full impact from the impressive commercial team that we've assembled.
<unk> demonstrated a clear reduction in proteinuria in the early impacts on Egfr demonstrated caught a are unprecedented and extremely important.
In addition to the increase in positive patient experience.
Experiences, we along with an fraud G community anxiously await the results of part B to gain increasing information on the lasting impact of <unk> on this chronic kidney disease.
Dissipate this information in the first half of 2023 and look forward to sharing the results with Nephrologist and the I T N community.
Lastly, we are enthusiastic about the progress and availability of Sharpei on the U S can paygo in Europe , and Mexican as it grows around the globe.
G nephropathy is a rare orphan disease in the global patient and K O L experience and education will be important in the continued growth and success of the brand in our company.
With that I'm gonna turn it over to our CFO Fredrik Johansson.
Thank you very much and good afternoon, and good morning, everyone.
First per cent to you different national review for the fourth quarter of 2022, and the roster per cent between your numbers for 2022.
It's all numbers per cent, if you are <unk> unless otherwise stated.
<unk>, we are proud to report for 129 million net revenues for the courtroom.
Centered lost your <unk> reported revenues of 31 from.
2 million.
<unk> <unk>.
Pay your primary sensation <unk> product.
Product sales for the quarter amounted to 167.3 million or $64 million.
Rove all the 36.
46% compared to the third quarter.
In addition, we also recorded 260.2 million for the period revenues related to transactions with your partners, especially from the <unk> signing feet from Dirty out yourself lessons C. But also <unk> milestone from Everest relating to China.
The total operating expense for fourth quarter them up to three minutes 8.7 million compared to 253, three from Seinfield lost Ya.
<unk> to the third quarter <unk> increase by around 96 million from Q3.
<unk>, mainly due to certain costs related to marketing activities were concentrated Q4 instead of spread out Q3 two four.
Certain one time cost and also a cost increase and a quarter from us expansion of our sales force in Q4.
I'm very pleased to report that the increased revenue for the quarter <unk> operating profit of 20.
20 to confirm you April 4th quarter compared to an operating loss of 285 million 44.
2021.
442, we also had a positive cash flow from operating activities of <unk> compared to a negative cash flow used an operating activities of 161 for three new <unk>.
And a positive cash flow was mainly received through we receive payments in the quarter from her license and activities from the increase of the <unk>.
<unk>, maybe lost rode on the 25 million dollar from Korea flown facility, which is not fully utilised, bringing your castro from financing activities in the 442221826.
This leaves us with a net increase in cash and a quarter pounder.
111.2 million.
Health cash position.
Of 1 billion 249 Amelia.
And.
Take the next line.
Just a quick summary financial can you take away from the full financial year of 2022.
For the full year of 2022, we're we're happy to report 802.9 million net revenues for the period.
<unk> 50 per cent.
For the year compared to 2021, where we reported revenues of 220 943 million.
Pay your next product sales for your amount to 372.2 million 436.8 million dollar.
Related to out license perfection for royalties for 427.4 million compared to reported revenues from her pleasant transaction for the full year of trying to turn one of 229 <unk>.
Total operating expenses for 2022, the amount of two <unk> 209 from 6 million compared to 753.8 million for the full year of 2021.
Out of the total operating expenses for a four year old.
2022 marketing your film expenses increased by Freedom is 35 from 6 billion to 515 <unk>.
Compared to one O seven nine from 6 million me for the full year 20.
2021.
Increase in marketing so expenses originates from the commercials to pay you in the U S, including a sales force compared to 2021, when we were in preparation modem.
Prior to the start of the <unk>.
The cost for research and development for 22 minutes, you've increased by treat yourself would you be willing to 447 million compared with 340.
57.5 million for the previous year.
The increase in R&D expenses reasons, primarily from them growing operations for the system of surprise.
The cost for administration for the full year or 2022, and three 548.9 million to 259.5 million compared to <unk> 2021.
The increase in costs between the ears was primarily related to general cost increase registration due to over a social graph increased costs for compliance increased complexity being accompanied commercial stage.
Operating loss improved by 100 and to confirm William and the amount of 221.9 million for a full year of 2022 compared to an operating loss of 524 confirm meaningful 2021.
The cash flow used in upgrading activities for the full year of 2022 amount of two 311.4 million compared to <unk>.
61.
<unk>.
Mm used for 2021.
Or cash from financing activities.
Where 576 million for the full year of 2022 compared to 445.2 million for 2021.
Two places without increasing cash for 2022 of 259.5 million compared to decrease in Casper trying to 21 54.
And finally and again, we are very happy with a cash position of 1 billion 249 at the end of the year.
That was all for me and I'll back to you <unk>.
Thank you so as I mentioned upfront mm 20th 22 was a very successful year for <unk>.
We saw overall revenue growth in 2022 over 250 per cent.
Reaching over 800 million Swedish cramps, which shows obviously strong revenue from the ear, both from product sales and partner income.
In terms of the <unk>. It came in line with our guidance, which we have provided of around $37 million for the year and $16.1 million for the corner.
There is clear excitement in the Nephrologist area around the our ability being able to share a part a data was very clear from interactions that D. A S N.
And I think it is considered very interesting in terms of the specifics of the data, which Richard covered previously which seems to stand out from other product at potential product candidates.
In terms of the sales force as we mentioned we did expand this towards the end of the year and so we are seeing continued penetration into the prescriber base and look forward to you know having continued continued growth in uptake in 2023.
In terms of commercial partnerships, obviously, we mentioned in Japan.
The license next to come to my actress N I J nephropathy, obviously, an additional kind of nondilutive cash rates of $20 million, but also obviously very importantly, we look forward to work with a new partner and expand the Netflix on global franchise.
In China as I mentioned, the NDA was accepted.
And the towards the end of last year, and we're looking forward to the regulatory review process and the ultimate decision, which we expect to happen towards the second half of this year.
In terms of guidance, obviously, we mentioned that you know based on these patients better seeing really kind of the beginning of patients success stories.
Pier recommendations in the market and that kind of a mentor me 319 combination with streamlined market access the publish data and I came in towards the end of last year.
We're expecting net sales of <unk> in the U S.
$120 million to $150 million.
And with that that concludes the presentation and we're happy to take any kind of questions.
If you wish to ask a question. Please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question. Please dial star five again on your telephone keypad.
The next question comes from Muy Raycroft from Jeffries.
Please go ahead.
Okay.
Protecting a strong.
Sure.
120 to 150 million so can you walk us.
That went into it like potential treatment duration beyond nine months.
P S F b.
<unk> so competition from trivia getting approved.
So I think that obviously there are there any other multitude of a.
Variety of kind of inputs into that estimate uhm, but I think that obviously it is based on is that kind of briefly mentioned you know we are now having patience on drug for a longer period of time, we're hearing a lot more about you know kind of patient successes physician successes. There was more there was a buzz in terms of peer to peer recommendations.
And obviously also the data that fairly recently got into the you know get into the market you know from our kind of publication. So I think that there is and obviously we are expecting additional kind of data. This year, which we also believed him can impact and momentum of the uptake very specifically in terms of.
Xactly when these kind of you know when momentum really picks up and have it go with that sandwich difficulty.
To judge them, but I think in terms of.
Any other kind of potential approve what we don't really think that's gonna have any any real impact on our on our kind of projections for 2023.
Okay. Thank you and then the other question based on the expectations for that idiot for data on the <unk>.
Like and how much and how you think it will impact the label this is Marty.
Franklin perfect.
Yeah, well, obviously, that's going to really be charged in conversations with the F. D. A <unk> and so I think that's that will truly just depend on the strength of the data that we see coming out of that trial.
Okay. Thank you so much.
The next question comes from Annabel Mimi from stifle.
Please go ahead.
Hi, Thanks for taking my questions. Congratulations on on the progress. So just in terms of the success stories that you're you're you're hearing estimate of anecdotal have you started saying.
<unk> stay on drug for longer than nine months drug spin out for I guess about a year now. So I think you can have some metrics around that so are you, saying I'm Sandra beyond nine months are there restrictions around patience uhm.
Getting treated if they're responding well and just a little bit of a color around that and then you know when you think about.
Egfr data if it's positive do you have any additional initiatives for new educational efforts around that.
Label and for you know work with Payors, and you know potentially I'm prepaid terms or ease of of Onboarding or a facility if that data actually come out positive any kind of work that you're doing there too to streamline the process. Thanks.
Okay and did you want to take the first one yeah sure. So I'll I'll comment on the duration of therapy, you're absolutely right. We are now seeing patients that have been on therapy greater than nine months, while it's obviously, but first patient styron products, but the good news is what we're saying is it really seems to be determined.
By the physician Alright. This is a heterogeneous progressive disease and as we've always said we want these decisions to be made by the nephrologist. The treating physician. So we are seeing that we have definitely a good portion of patients that are on for more than nine months and some that stop at nine months of treatment. I think this is going to be based on patient <unk>.
<unk> and like you said the more.
Market access.
It hasn't been a barrier to this and so these patients are able to continue.
As long as they qualify you know and there are still taking their medication there.
In terms of kind of Egypt for a data point that you mentioned, obviously, yes, we do have quite a lot of activities in preparation for that data and yes, I mean, obviously that will be a a kind of a separate F. D. A with you with a full kind of 360 patience.
And obviously with the end point ask communicated in terms of Egfr. So yes, our expectation is that that may very well lead to you know expansion of label to a different label. Because obviously, we would have we would be able to kind of have like a you know we will have different data to support some of that development.
And if you have any additional comments on Martha yeah, Yeah sure. So so <unk> you know once it's published.
P. I should say once it's announced and then published there is we are permitted to share some of this information certainly with Payors and confidential.
I think we've been very pleased with our management to date, but certainly obviously what could only improve from there with positive data. So we do anticipate sharing it as soon as possible and hopefully that'll have some even further favorable treatment.
Okay, great. Thank you.
The next question comes from <unk> from Citigroup.
Please go ahead.
Hi, Renee <unk>. Thanks can you comment I know it's early in the launch but can you comment at this point on what was your market share it looks like.
The United States in your record.
Statistics for the prescribers, it's 42 and the enrollments.
739, <unk> can you can you connect to your guidance in terms of how many prescribed as you would expect.
2023, the number.
Slightly under 2023 banks.
So basically what we said before it's really mean it when we're looking at what can be done are mapping our market research a lot of work before we call launched we really identify that probably the the prescribing.
Let me just kind of the most relevant for us would be around 3000 704000, nephrologist. So obviously from that perspective, you know, we really only kind of.
We have a very small amount of really kind of scratching the surface in terms of wherever you know what we can do with regards to that based on where we are on our first kind of 11 months of commercial activity.
Uhm, but obviously there is in in the actual kind of enrollment in prescribers is obviously this combination of refills and actually kind of patient staying on drugs, then, we'll new enrolling enrollments et cetera, and obviously then when those enrolling this actually happen and so I think it's very very difficult at this point in time to kind of share.
Because it's a multitude of factors that go into that.
Okay, and then just on the duration question.
Is it fair to assume that pretty much everyone. That's starting is going through the nine months or or is there a discontinuation rate you were observing.
For some patients with what's the nine months.
I I I think it's it's hard to answer that obviously cause patients are continually moving through the process, but I think as far as discontinuation rates, it's probably similar to assume similar to our trial and phase three that's probably the best I could give as far as estimates on discontinue.
Right.
Okay, and then just going back to the Heartbeat data I mean sort of ask the appointment let me ask you a different way.
You kind of characterized how're you wood wood frame the base case for what that data will look like what was the bull case look like for that data <unk> and also what my fever.
The less optimal bear case for that <unk>.
So I guess that'll be saving so we're looking for yeah for two things obviously, one would obviously be to kind of see you know the duration of durability of the person or a reduction we do have the three months kind of you know already kind of across all patients that we're seeing between the nine in the 12 months Uhm and then so the question is really not <unk>.
Be persistent you know across the entire population and some of the population because it is a heterogeneous great a patient. So we know that they kind of develop and heterogeneous way, but I think obviously the longer we can see that kind of protein or a reduction will continue to doctrine. I think obviously you know that would make us that that would be kind of you know go towards a stronger and stronger.
Case, the longer that we can show that.
In terms of the you know the other aspect is obviously, then egfr and I think that'll be C. Again, you know the the longer that we can show that there is kind of a a difference in any GFR kind of trajectory between the treatment group in the placebo Group. Then obviously again you know that goes too.
What kind of disease modification. So so I think that those are kind of the obvious kind of you know directionally. What we would we would find would be yeah, we'd be looking for kind of in the trial and then I think it really comes down to you know is is this really kind of very homogeneous population is it heterogeneous you know we're gonna see slightly.
Different kind of you know things depending on on kind of what type of profile. These patients had when they came into the trial et cetera. So I think that would really kind of be my view I Dunno, Richard do you have anything to add.
No I don't think so I think that that really summarizes the physician pretty nicely actually.
[noise], Okay, great. Thank you.
The next question comes from <unk> from Burritos Securities.
Please go ahead.
Hi, congratulations on the great progress with <unk> and Osama upfront milestones received from global partnerships.
My first question is where do you see a need to increase the field for further considering the competitive <unk> F D a approval.
We'll start with a <unk>.
Andy Joshua So we assess this kind of information or.
At different points in currently there's no plan to increase our sales force, but I would say that if it made sense and.
Optimizing the product and the brand we will certainly would consider doing so at some point, but there's no set plans on doing so at this point.
Okay. Thank you regarding the European market could you provide some thoughts on the sales up.
<unk> is a.
Truly reflected on the royalty he can call me <unk> do you have any description with that'd.
You are able to provide.
And did you want that for sure sure I I think that the information is our phone is pleased with the uptake today to know they launched in September and data shows that they have just shy of about 70 patients on therapy before the end of the calendar year, which puts them on mark.
But with a estimated they would be in and they feel very encouraged at this launch so far in Germany I didn't hear the second part of the question can you repeat that.
So is that spelled fully reflected on the royalty income symptoms to do you have any congestion with further that'd be we're able to provide so yeah, that's pretty much it.
Okay.
And sorry that and the last question. So the Orange the call is over just give me a SEC.
Can we expect to remain faithful over the coming years and what is the strategy with Netflix.
The next stage to kind of partner or do plan to finance authentication by yourself.
So <unk>.
Can you repeat the orange it was R&D costs are we expected I, if I understand you correctly, you're asking if the warranty costs are going to stay. The same is that was that your first part yeah, yeah, yeah, yeah exactly.
Yeah.
We would expect it to two two same basic.
Basically.
We we do have.
A new program without <unk>, which will increase the cost a.
A little bit better would be new material increases I'm pretty sure it was <unk>.
And in terms of kind of our kind of ongoing plans for you know kind of doing development ourselves or with partners, which I believe what's your second part of the question Uhm, obviously, what we communicated before so I can sit there if they're rare disease programs and obviously, all 40, something that fits very well into our existing franchise. It's.
It's a regional asset there was really nothing approved and I'll post a really significant unmet medical need and we're super excited about being able to start that clinical trial, and obviously T. B C. As another rare disease, where we believe that we could commercialized.
[noise] ourselves again, not in all geographic territory spraying select geographic territory Uhm heading that cancer is obviously different because that really is a parallel kind of if you want to call a parallel.
Pass that released more to characterize the modem action of this drug the kids are so much kind of preclinical data that exists and head and neck and to the extent that the biomarker data that would be that if we get very strong biomarker data.
From that trial, we would not plan to take you know that R&D effort onwards, which would then go into potentially several you know several China solid tumor types and we'd be very very significant R&D program.
So we would then look to really partner that asset to the extent that.
There'd be strong data and there'll be interest from a big pharma to do Sir.
Okay, great. Thank you very much for taking your questions.
The next question comes from Ingrid how from Brian Danny.
<unk>.
Please go ahead.
Oh, Hi, Hi, good afternoon. Thank you for taking my question.
I have a couple of actually so first on the price I know it is close to 14.2 K start off in the beginning of next year should we expect any price increase 40 here and what would be reasonable number to you soon and then I have a.
<unk>.
Okay. So we we did take a price increase at the end of January six 8% in line with the increased costs and inflation.
Type of factors that go into these kind of decisions.
Okay, Thank sandy and I think for a follow up.
Mentioned that you're still.
I'm quite far from reaching the number off you need prescribed price that you have for your targets physicians at the moment what is keeping you for natural increasing this number a little bit fast or is it a matter of salesforce size or just time that you need to get you those counts.
This is <unk>.
Rare disease, so there's not but they don't see the patients every day, we see the physicians and it's a process that they go through it's an educational process no one's talk to them before about RGA nephropathy. The source of the disease and this data is unique to them seeing something like this so it just.
Six time different physicians have different adoption rates, some adopting slow as far as one patient at a time, where others put multiples on so I don't I don't think it's I think it's going very well I don't think it's slower than we saw it as far as reaching our target you have to cast is wider than that to get these prescribers on.
Board.
Thanks, and you said May I ask one quick last question on the finances as well. So you mentioned that you have enough cash to reach profitability and would you feel comfortable with the same one that could be possible, how you're looking into that.
No.
We will not specific specify a specific time point.
Given that we.
We do have a.
<unk> guidance and also we would.
We are also.
Stopping the program so adding on.
<unk> <unk>, so we are not.
Specifying that to trust specific.
Of course.
But it is clearly kind of our direction and our focus obviously to get there. So I mean that hasn't changed at all.
It's just difficult to kind of again no. When this momentum is really gonna pick up is kind of peer to peer and then we're going to start seeing that kind of which we have started to see but it's difficult to kind of judge exactly the impact of that so in our our kind of focus in direction. There is obviously still.
<unk>.
Alright, well, thank you very much.
The next question comes from Rummy Cat <unk> from Nice S C I capital.
Please go ahead.
I got congrats on the progress and thanks for taking my questions. Two quick ones for me, but and your guidance do you expect net sales will kind of continue literally growing or is that an infection coin coin to be around successful <unk> data for approval by the F. D. A.
Cetera.
And then with regards to market access are you seeing big differences between commercial on Medicare lives or our coverage and prior art.
Across the board.
I think that I would say I think that to some extent uptake is is <unk>. You know this is kind of based on you know just.
Just kind of education and people understanding and understanding mode of action and seeing patients access. It suggests I think there's a kind of an underlying kind of you know <unk>.
Taken in growth.
Obviously, we are expecting you know that all physicians you don't want to see more data.
So we're expecting obviously that that that would be kind of you know could provide additional momentum to do that I personally don't think that the that the ultimate approval per se would be kind of a major change apart from obviously the label impact that could obesity.
Quite significant but but in terms of kind of the way the physicians will be using it in the Meanwhile, but I know and did you have a different day, yeah, no I think pretty much all the factors that you say go into things over the you're an uptake, meaning they're going to certainly get increased comfort heartbeat would be certainly.
The catalyst, but I think it's just time that <unk>.
Well, we'll take care of increased growth within three successes you asked about market access is and the difference between the different channels. So so just to be clear. There's two things number one as far as coverage is concerned over 90 per cent of U S. Lives. So the coverage is is great for.
Or even the government subsidize as well as commercial.
Patients. So that's all U S laws and then when you look at our specific book of business, where the patients come from and you're looking at I G. Nephropathy, that's when when I discuss around 70 per Sandra or almost 75, if you want to look at that's private insurance and cash paying patients.
The government subsidized does that makes sense.
Definitely.
And I guess, but prior opposites pretty much the same.
Yeah, there's similar types of coverage.
It's it's as you would anticipate a specialty product being covered.
And.
And that's that's how it's been across both commercial as well as government subsidized.
Got it thank you guys.
The next question comes from Eric Hot Guard from Connie T.
Go ahead.
Alright, thanks for taking my questions.
Uh huh.
My.
First time of your peers, so competitive considering.
This combination <unk> <unk>.
I was just wondering from my point of view and also return on investment going to do it.
Is that something you're planning on <unk>.
The.
Quick follow up on previous <unk> the list price increase.
Did you expect us to sort of.
Hold on to the fries.
Well thank you.
So I guess I'll have Richard gave it to you on this as well I guess in terms of the S. G. L. T choose you know.
This is really a compliment I mean, we are a locally targeted medication, we're not really focused on the stomach and distribution of the drugs. So and we know obviously today that they will you know there are quite a few patients who are on S. G. L. T test today and also onto our pay when we talk to physicians I think a lot of people you know all the.
<unk> personal you've been in contact with anyone talk to you uhm.
I would consider this to be highly complimentary mean S. D. L. T. Ts are obviously, they're approved and C. K D. Not specifically, Nigeria, I don't think people look at them as being kind of Dizzy.
Disease, modifying or anything like that I think but I think they're very safe and I think they do obviously provide some hardy vascular protection your general counter cardio protection et cetera. So we do already see that being used in quite a lot of kind of patients already with <unk> and as I said it seems to be kind of a positive you from there.
Prologist perspective, but I'm not Richard if you have anything to add.
Yeah, I mean, I think you know we have a.
And acted internal program looking potential studies, so that we can undertake.
To develop.
French fries, <unk> and certainly were interested in.
You know how the treatments that are available.
I completely agree with britney's comments.
Absolutely no reason why <unk>.
Mexican complicated can talk to the nurse jokes you too Sir.
The mechanisms of action a completely different uhm complimentary. So you know I think it's something that way.
Actively watching and considering.
And as far as the price increase its impact I I'm not sure I completely understand the question, but I mean in general the patient out of pocket costs are typically a percentage if it's co insurance or it's a set amount and.
We have zero out of pocket cost for commercially covered patients and no patient will ever.
Receive our medication due to affordability. So it's not gonna have an impact on patient out of the pockets really from that aspect.
Sorry, it was more of like a <unk>.
<unk> fries, so $6 for some <unk>.
A similar increase in not the prize or all the <unk> coming.
Coming in Yeah, no no we don't contract with payers number one so so it won't have but but it should have the similar we're not going to see a change any notice or anything change.
Gross to that Ah you should using our calculations.
Thank you so much.
The next question comes from Sebastien Van der Sloot from V. L. K.
Please go ahead.
Hi, This is Sarah Sebastian dropping for today. Thank you for taking my questions and congrats on the progress a couple of questions from hours.
For the three D read out of Egypt, <unk> assume that you will meet the primary and phones with the physical significance uhm.
Hong Kong.
<unk> <unk> <unk> K O L. For this is different from Egypt would.
It would be considered to be the minimum bar.
Currently meaningful what would you consider.
<unk> and then that for a follow up question.
Well I'll take a crack at that and Richard you can compliment that I mean, I think that my view is actually talking to <unk> physicians that there isn't a specific number or a minimum bar that they would be looking at I think it is more about trying to actually you know what can you see in terms of you know what's the difference.
And Egfr kind of development in the placebo versus the active arm, but I don't know Richard if you have a different experience in your interactions with chaos.
No I totally agree with us it's not like.
<unk> K O L experts have some magic number in there.
Head that says this is the G called the after <unk>.
I think it's about.
Clearly we need to meet her primary end point for this study and there's also a number of different important secondary endpoints are supported data I think we need to take a holistic look for the information that we get.
The outcomes of puppy look at all of that information. So I I I I I don't think you can simply say this is the number that we have to achieve.
Okay got it but then okay you may <unk>.
Right on the statistics for what difference is the trial powered I'll need your car.
Well I mean, we we thought you typically come in on the sort of the details statistics of the of the clinical trials to be honest.
Okay got it and then the final question is on the <unk> I was just wondering what the biological rational and the preclinical data is it supports <unk> Netflix.
Reno place.
Richard.
[laughter].
Sure.
Uhm.
<unk> briefly in summary, <unk> <unk> genetic disease is clear Genesic <unk> syndrome sick disease coalition.
And patience with all posts disease.
Developers.
Progressive renal failure relating to it.
Maryland, Nephropathy Uhm boy a significant component of that is a is a <unk> and fibrosis and we know from and maybe post from previous presentations.
Mm that's set to Max it has a very important role in five to Genesis relating to.
The <unk> the <unk>.
Generation of reactive oxygen species paulson.
Paulson in activating five botanic pathway. So from that point of view, there's a clear underlying rationale and we have supporting preclinical.
<unk> from relevant.
Mouse model that does indeed support that hypothesis service like me now.
Clinical data that.
Just sort of uhm biological.
Biochemical logical.
Comes with support that thesis, that's Netflix could have beneficial effects in Opal syndrome.
Okay got it thank you very much.
Hmm.
The next question comes from Johan <unk>. Please.
Please go ahead.
Q.
<unk>.
Congratulations.
Good.
Very interesting really.
Continue.
Saying add on.
Second dosing could you.
Regarding the <unk>.
Sorry.
Can I get any more inside too.
The needle you so.
The extended those sort of second dose.
Yes, I'll start and then may be Richardson complementary.
Smart be obviously, we are not kind of we are not re dosing as part of the protocol in the park day. It really just an initial treatment and then there is a follow up period.
Which is observational uhm, but as I think I mentioned in the history report obviously there is an open label extension that's available for patients who have concluded the <unk> the faith Street.
So once they've been in the study for two years.
They have an ability to then enroll into an open label extension, where all patients will be given active treatment for nine months and.
And I think we mentioned there obviously there was.
Significant numbers screen failures and those are.
<unk> over 60 per cent of those are even related to the <unk>.
The patient's like you don't qualify.
Due to the fact that they do not have one grandma proteinuria. So they are not considered strictly according to the guidelines to be in that kind of higher population, but there will obviously be patient. So we'll have enrolled into that open label extension.
So we will be getting additional information from that study, which obviously is also still blinded ongoing uhm, but once that study obviously once we were able to kind of look into that study that is probably more likely to give us some more information around re treatment et cetera.
But obviously I'm sure that in the park the way, we'll be we'll see some trends and see some information regarding how proteinuria reduction performs any GFR et cetera, Sir Richard do you Wanna compromise on that.
Sure. So so just to make sure it's clear how the <unk>. So it's <unk> in the sense that everyone in the.
<unk> extension received active treatment.
But as blind date in the sense that investigate you took some patience does know.
The original randomized treatment walls and the pivotal studies. So that's what it says that that gives us an opportunity to get some really interesting information at the end of the study and you expect that study to complete and I'll be 2024. So.
<unk> spelled C.
The performance of patience two days previously received <unk> have received a second cause <unk> compared to people patients who received placebo [noise].
In the original study and then once once received the call Sir <unk> extension. So some very interesting information will come out with that that follow up study.
Excellent.
For this is.
To be expected in the first half of 24.
<unk>.
Yes, most likely I would think.
Even if it's a relatively added <unk>.
Is there any sort of.
From real life in town so.
Continue country.
<unk>.
Transportation has been.
<unk> <unk>.
The second part of that question can be <unk>.
Changing characteristics invitation quite often when a new product.
<unk>.
Severe <unk> and as time goes on.
Specialist scream more comfortable.
<unk>.
For verification.
And did you want to say that yeah. So I I think I. If I heard you correctly is nonetheless, a therapy those folks that are on at a longer period of time, we're not saying anything different with those patients are tolerating the medication and we're not hearing back anything any anything noteworthy of patients that have been.
No one longer than the nine months.
And then your comment about the patient population for the physicians that uptake yeah I think that's.
Naturally I think when when a new product launches physician.
Something on maybe a more severe patient and then they'll move to more of a comfort zone or additional patients with it with success that they achieve with the patient population. That's what we were talking about earlier I think we're starting to get these success stories more and more from our field report it back to us.
Some patients and that can only encouraged physician prescribing and wanting to treat additional patients.
And then finally.
It's K a.
Market actually fifth grade.
Great.
<unk>.
Change in ma'am.
Prescriber characteristics.
Nevertheless specialists on the coffee.
<unk>.
More activities.
Specialist.
<unk>.
Center.
Yeah.
<unk> great interest.
The ball.
I would say this there has been a change in that make up a lot of times, it's an individual physician adoption comfort level and when you see them and how often that determines their uptake so over time with the screen an increase in.
New prescribers as you wouldn't anticipate and that's a lot of times black on there based really on their adoption comfort level and their understanding of the product of clinical information some wanna see more information than others. So there's really no one answer.
As far as that's related I don't think there's any difference in the new prescribers I will say, though are targeting Ah segmenting and targeting has been pretty pretty accurate as far as who we anticipated would be the higher rollers. The patients so that seems to be accurate in charge.
This is <unk>.
The most with our sales force.
And <unk>.
<unk> and the feedback from.
Sales and marketing payment or commercial.
T.
Yeah, No no no real surprises know nothing of note.
Okay. Thank you alright.
Thanks.
Okay.
There are no more questions at this time, so I have the conference back to the speakers for any closing comments.
Thank you very much for participating in the queue for a call for 2023, we look forward to talking to you again 421 of 2023.
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