Q3 2022 Calliditas Therapeutics AB Earnings Call
Such and welcome everybody to the Q3 report.
With me on today's call I have Fredrik Johansson, our Chief Financial Officer, Richard Philippson, Chief Medical Officer.
Mr. Andrew <unk> President of North America.
So if you go to page two please.
Like to draw your attention to the disclaimer page related to forward looking statements and refer you to the company's reports and other filings, including those filings would contain risk factors and other relevant information.
So if we turn to page three please.
So some of the Q3 highlights.
So in this quarter.
Leaves us achieved another major milestone as we received formal conditional approval of <unk> in Europe .
Subsequent to achieving this we immediately started the transfer process of our market authorization.
Our commercial partner in Europe <unk>.
In order to enable a swift commercial launch in Europe .
During this quarter. We also received milestone payments amounting to $12 5 million euros from starter.
We have previously announced.
The results from the Q3 commercial activity of TARP Hail resulted in $12 1 million of net sales for the quarter.
Which reflects the consistent build of our commercial launch plans and.
And we're very encouraged by the strong level of interest and engagement that we're seeing especially since the publication of our part a data.
Which both Richard will cover later in the presentation and Andy will take you through some more color with regards to our commercial activities.
Also later in the presentation.
Based on the visibility we have today in our pipeline of our axes and revenues, we expect to have revenues in the range of $35 million to $40 million for this year.
This is in line with our internal plans and we expect strong continued growth based on recently published data the importance of which really should not be underestimated as well as additional data expected in the first half of next year.
With regard to support.
Activities, we've experienced a lag in site recruitment rates, which seem mainly to be due to continued backlog.
Retaining to COVID-19, and the reduction of staff levels of clinics and hospitals I would say.
Really do not seem to kind of be back at the level that they were prior to the pandemic.
This has created an impact on our recruitment levels and so we do expect the head and neck cancer data was pushed into first half of next year and the interim analysis also to be pushed in.
To be conducted in the first half of 2024.
If we turn the page please.
Looking at post period events.
Regarding events took place post the period Q3, I've already mentioned that there was a publication of clinical data in October .
Something which we've been very aware of obviously that physicians have been waiting eagerly for and.
Some of you might have had a chance to listen to Dr. Barratt or Dr. Lafayette discussing this recently.
In early November of this year at both the kidney week a S N, which is a large largest kidney Congress held annually held in the U S.
Well attended and we had a commercial payer focused booth as well as the medical Affairs group there with a live presentation dedicated pathophysiology, but they got the kidney connection was presented by Dr. <unk> and Dr. Wadhwani present novel approach of our payout in light of the recently published data.
It was also biomarker presentation related or biomarker related poster.
The <unk> study.
It was a very positive experience apart from obviously, the the very nice thing you'll see everybody in person again.
I had the opportunity to interact with a large number of nephrologist, who provided insights into their practice and treatment paradigms.
Feedback on the party data all with all extremely valuable input.
And so with that.
I suggest that I hand over to our CMO, Richard Phillipson, who will take you through a brief overview of the date on question Richard.
Thank you right.
I'm now on page.
Great.
So I'd like to start by saying how delighted we are the result of the park.
The mythical trial were published online by could be international on the 19th Kubota Cobra.
I'd also like to extend my thanks, and congratulations to all of you all because involved in producing this important publication that we believe will be a valuable resource for her.
And practicing physicians in Iga nephropathy.
I will provide a summary outcome presented in the publication, but both groups.
The scripts.
The trial design.
Yeah.
The methodology, which form the basis for FDA accelerated approval of pop player comprises two Paul Okay and puffy.
Patients with biopsy proven Iga nephropathy, proteinuria greater than one Gram per day, and Egfr 35 to 19 move per minute.
With well control blood pressure was optimized routes in the basin.
We enrolled into part of the study and randomized to receive <unk> payout.
A 16 milligram per day.
Or placebo for nine months treatment period.
The primary endpoint was assessed at the end of the nine months treatment period treatment with discontinued patients would then observed three months.
Since then and could be as a study which is a 12 month period of observation without treatment.
A total of 200 patients were enrolled and possibly for the primary analysis about the study with the primary endpoint being changed from baseline in proteinuria.
The key secondary endpoint was changed from baseline in Egfr.
This part of the study read out with positive results in November 2020.
The patient population for the policy analysis or the median age of 44 years, approximately 67% will mail and approximately 86% worldwide.
Perfect control on it.
Enrollment was excellent and baseline <unk> and Egfr reflected the high risk population enrolled into the study.
I'll say, a little bit more about pulp be later in the presentation.
Next slide.
With respect to the key outcomes of powerplay of Metagogue top Io demonstrated a statistically significant and clinically meaningful reduction in proteinuria at nine months with stabilization of Egfr.
Specifically, there was a 34% reduction in <unk> treated patients.
It's a 5% reduction in placebo treated patients.
The difference was highly statistically significant.
Patients receiving treatment with top players.
A minimal loss of Egfr <unk> seven mode per minute over the nine months compared to a loss of just over full mil per minute in placebo treated patients.
The majority of adverse reactions were mild or moderate in severity. The most frequently reported adverse reactions with hypertension peripheral edema muscle.
Muscle spasms, Anthony dermatitis weights increase dyspnea basically mirror.
Perhaps you have fatigue.
It's worth noting that there were no reports of severe infections requiring hospitalization.
Next slide.
When we look at the profile of Proteinuria changeover time, apparently effectively co pay was gradual and cumulative with the benefit of the treatment on proteinuria emerging over the first few months of treatment.
Proteinuria continues to improve through to nine months when treatment was discontinued and importantly, a further improvement in proteinuria would seem that the 12 month visit when patients have been off treatment for three months 12 months. It was a 52% reduction in proteinuria versus baseline of 48% when corrected for placebo.
Yeah.
We also noted the proteinuria reduction was consistent across all baseline subgroups, including baseline proteinuria from baseline Egfr.
Next slide.
Turning to the profile of Egfr change over time, we saw early separation of the Egfr curves with an initial modest increase in egfr in patients treated with top here with.
The separation of the Egfr Cubs was maintained throughout the treatment period.
Again importantly, it was also maintained that the 12 month visit where patients have been op treatment for three months.
Slide.
When we look at subgroups of patients with higher levels of baseline proteinuria.
Particularly high risk of disease progression, we found that there was a more pronounced treatment benefit on egfr.
Here, we see presented the Egfr trajectories for a subgroup of patients with baseline UPC greater than or equal to one five gram per correct.
It's worth noting that particularly rapid decline of egfr in patients receiving placebo.
The loss from baseline of over eight mills come in at nine months.
In comparison to our prior treated patients had essentially stable egfr the loss of less than one mil per minute over the nine month period.
The Egfr trajectories of the two treatment groups clearly diverged in the separation between the two groups was maintained at 12 months.
Next slide.
I've already described part B of methodology as a post approval observational of treatment follow up to confirm the long term renal benefit observed proteinuria reduction.
The final analysis will be performed on approximately 360 patients which includes the 200 patients that comprised the Ponce analysis population.
The primary endpoint will evaluate kidney function through Egfr change makes it over the two year period.
Completion of enrollment of the 360 patients was achieved in January 2021, and.
And we expect the final readout in the first half of 2023.
Next slide.
Finally, I will briefly mentioned in the open label extension to the <unk> trial is open label extension or early is open to all patients who complete the two year unethical trial, but it is optional.
Eligibility requirements for entry into the open label extension are broadly similar to the pivotal trial in particular, the proteinuria requirement to sustain the business slightly lower Egfr limited 30 Mil per minute.
By the end of quarter, three approximately 180 patients adopting to enter screening for the early and the screen failure rate has been approximately 41%. The most common reasons for screen failures proteins proteinuria levels below the required minimum of one gram per 24 hours, which represents.
61% of all screen failures.
As the pivotal <unk> trial remains blinded, we cant draw any conclusions from this.
Observation apart from the low levels of both proteinuria and Egfr or the main reasons for screen failure will.
Look forward, one blinding and Africa study once it is completed which will provide us with further insight into these observations.
I'll now hand over to Andy for the commercial update.
Thanks, Richard Please go to slide 15.
The third quarter was another quarter of solid growth as we continue to build on our success from the first half of the year.
<unk> net sales of more than $12 million brings us more than $20 million.
Net sales dollars of net sales in the first eight months of promotion.
As announced after last quarter, we began expansion efforts in July . This growth included. The addition of 20 sales territories, which gives us a total of 60 sales executives expanding our reach and call frequency to our target audience.
We are impressed with the caliber of talent, we continue to attract most of which coming to us with rare disease and nephrology experience.
While the Onboarding and training took place during the quarter, we anticipate to begin to feel the impact of the additional educators in the fourth quarter.
September enrollments were strong after the anticipated slower July and August summer holiday period, with the quarter total of enrollments of 281.
And prescriber receptivity remains positive as we grew our prescriber base of 480 unique prescribers since launch and this total includes addition of 166 new prescribers during the third quarter. In addition.
We continue to see the average enrollments per prescriber growth. We anticipate this rate will continue to grow as many physicians now have patients on therapy for several months and are experiencing positive results as was demonstrated in our clinical trials.
As it relates to market access we have reached our target of over 90% of U S lives have coverage for our payout, which is impressive for a specialty company.
Payer mix has reached a steady state without much change from last quarter, we have less than 25% of our business coming from government insured patients and the remaining being either private commercial insurance or cash paying customers.
During the quarter, we added resources to our tour payout touch points dedicated team in order to maintain the high service levels for increasing patient population.
Our reach and promotional programs remain effective with the awareness of <unk> growing to over 80% of Nephrologists and market research surveys.
The final highlight of the third quarter with Iga nephropathy foundations spark patient summit meeting the interactions with the advocacy group leaders in patients continues to motivate and provide encouragement to our team and the potential this market represents.
Next slide please.
These last several weeks post Q3.
<unk> has been encouraging.
The receptivity in reaction to the death regard publication and information Richard reviewed with you has been nothing short of extremely positive from the nephrology community.
This was demonstrated with inbound notifications upon publication as well as in person during the annual meeting of the American Society of Nephrology that Renee had mentioned earlier.
The in person ASM meeting was a great opportunity for us to reach educate them interact with our target audience.
Traffic at our booth and attending our sponsored educational events was impressive the nephrology market is clearly eager to learn more and more about Iga nephropathy and helps our payout thats fits for their patients.
As our first patients are nearing the nine month, Mark we are hearing of more and more to our payer patient success stories. We anticipate these successes coupled with further nephrologist and patient experience will result in continued growth of torque payroll over the next several months as we eagerly anticipate the results of part B of the Mirth regard trial in the first.
Half of 2023.
I'll now turn it over to Frederic to provide you the financial overview.
Thank you Amit, let's continue to slide 17.
So good afternoon, and good morning, everyone I will now present to you the financial overview for the first nine months of 2022 and all numbers presented here are meeting surplus always unless otherwise stated.
We achieved 370 to $3 8 million in net revenues for the nine months period for the same period last year, we reported revenues of $192 million.
This is the third quarter, we reported net product sales following the FDA accelerated approval in December last year with the startup sales and January earlier this year.
Also the $373 $8 million in net revenue.
Net product sales nine months period amounts to $205 million or.
For 2017.
$27 million were up $123 4 million or $12 $1 million came in the third quarter, an increase of 94% compared to the second quarter and was in line with our internal expectations.
Addition, we recorded $163 8 million for the nine months period in revenues related to up licensing transactions, where we in the third quarter recorded $135 million fee revenue.
Startup for the conditional approval and launch.
As you remember we also received an upfront fee in the first quarter from a risk of $28 8 million, which was equivalent to $3 million used for the extension of the emphasis license contract to South Korea.
Our total operating expenses for the nine month period amounted to $821 million compared to $500 5 million for the same period last year.
In the third quarter total operating expenses was $292 2 million compared to the second quarter of this year, our opex increased by around $20 million a quarter to quarter, which is mainly attributable to the current FX headwinds, we still see future weaker SDK against both the U S dollar.
After the total operating expenses for the nine months marketing and selling expenses increased by $214 3 million to $323 3 million compared to 109 for the same period last year.
The increase in marketing and selling expenses will just originates for not having a full commercial team in place from the start of Q1 this year.
The cost for research and development increased by $55 3 million to $312 5 million compared to $257 2 million for the same period previous year.
Increase in R&D expenses for region is primarily from the ongoing operations for the <unk> trial.
We're operating loss amounted to $464 million for the nine months period compared to an operating loss of $302 3 million for the same period last year.
For the third quarter alone, we had an operating loss of $36 2 million compared to an operating loss of $209 8 million from second quarter.
Cash flow used in operating activities for the nine months amounted to <unk>.
$541 4 million compared to 301 3 million for the same period previous year.
Third quarter cash flow used in operating activities amounted to $127 million compared to $225 2 million for the second quarter.
This was an improvement of almost $100 million between the quarters and it was mainly driven by increased net sales of <unk>.
As of September 30.
We report a strong cash position of $736 2 million down from 846 days from the second quarter.
In addition to our cash at the end of September there is trying to $5 million on Houston, just curious credit facility and we expect approximately $160 million in.
And cash payments from milestones from starting at rest in the fourth quarter for the start of milestones were recognized as revenue in the third quarter.
The progress of the commercial launch of <unk> in the third quarter continued to support our view that based on our current operational plan and our current cash position.
We believe that we have sufficient funds for our planned operations and capital.
Expenditures until we become cash flow positive on a monthly basis, which is currently predicted for the first half of 2020.
Subject to continued successful commercialization of <unk>.
Next slide please.
Just let me give a quick summary of the financial key takeaways.
Yes.
On the revenue side it was very encouraging.
We sold chaparral net sales of 100.
Sure.
$3 4 million to $12 $1 million.
To growth of 9% to 4% from Q2 looks very encouraging.
So I'll also encouraged that we managed to see the milestones of $135 million from startup recognized in Q3.
The $20 million increase in operating expense between the Q2 to Q3.
What's maybe the FX driven future.
S K.
Cash used in operating expenses significantly improved.
From Q2, Q3, mainly driven by increased net sales of <unk>.
And.
We think that we are well funded with a cash position of $736 2 million.
And please.
Be aware of that.
Approximately $110 million of the sort of milestones that was recognized in revenue in Q3 are due for payment in Q4 and Haynesville.
September cash position.
I think this was all for me.
Thank you <unk>.
Thank you Fredrik.
So if you turn to page to page 19.
These are just some key takeaways.
We've already know entrees.
So basically we are very pleased with our results and progress during Q3 in this very first year after achieving approval <unk> payout.
We've achieved over $35 million revenues to date with product sales representing over $20 million makes.
Makes us very encouraged about the future we.
We continue to penetrate the nephrology prescriber base and as Andy mentioned, we are starting to not hear very positive patient experiences from the field.
Im confident that we have the right team in place ensuring that we will continue to execute on our plan.
And as Fredrik mentioned in Q3, we do see lower net cash burn compared to Q2.
When taking also wanted just taken product sales into account, which should we expect to continue in Q4 and onwards.
<unk> set for a very stable financial position.
So with that.
We're happy to take any questions that there might be operator.
Thank you if you wish to ask a question. Please press star one on the telephone keypad. If you wish to withdraw your question you may do so by pressing zero to the council.
And our first question comes from <unk> from chapter Sugar.
Please go ahead. Your line is now open.
Hello, Thanks for taking my questions. So I was wondering I mean.
In the report you mentioned 732 patients enrolled from January to the end of Q3. So I'm wondering how many of these women under 30 patients were actually on treatment in Q3. Thank you.
So I think that at this point in time, we're not really separating this out and the reason for doing that is that it's it's a multifactorial.
<unk> from actually kind of going from enrollments down too.
It kind of receiving revenues and this is mainly due to the fairly complex.
Healthcare system in the U S.
Which really requires a fairly extensive process for spec for all specialty products.
Do you really kind of dose for verification et cetera in order for four.
We're shipping to take place, but obviously, we provided some of those metrics.
As Andy has gone through.
It does become kind of.
Not very helpful. At this early stage to provide this once we're actually in a more stable state I think this is a number that we'll be happy to.
Report on.
Okay. Thank you.
The other question then on R&D cost I was wondering if you could provide a split of how much you're spending on mystic on relative to <unk>.
And I'll save programs. Thank you.
Yes sure.
We are not separate DTC.
But so.
So yes, we are sort of on.
On the last mile of them over the next one.
Subjects, we of course spending less R&D costs on the <unk> program and to certain exit programs ongoing and fully running.
The majority of the R&D.
Costs are going towards the two systems.
Okay. Thank you.
Thank you. The next question comes from <unk> <unk> from Citigroup. Please go ahead. Your line is now open.
Hi team. This is al Sheikh Mubarak on for Yigal, Thanks for taking my questions.
I just wanted to ask about the timing of your <unk> listing in China by Everest and the steps even part of the commercial strategy and if so maybe what would you expect in terms of pricing discounts in China, and maybe what hasn't ever publicly said about the launch in China if anything.
Sure. So obviously as they're kind of adverse that's become closer and closer to filing in China. They've obviously spend some more time also doing more market research et cetera. So this is also why we have they've shared with us in terms of.
Their estimate now kind of biopsy proven patients in China.
Number is somewhere kind of estimated to be around $5 million, which is obviously significantly higher than what we had been aware of previously.
In terms of the actual pricing et cetera, we have not.
We don't have any access to that at this point in time, so actually I can't share anything with regards to that with you at this time.
Assumption is that we're still working on those.
On that.
In terms of the filing obviously they target how it's always been for them to file and.
Getting acceptance.
First half obviously now it's in the Q4 period, we would expect.
Obviously, if the filing is accepted then the indications that we've received from Everest is because they had breakthrough designation that they would expect the review period.
No more than 12 months.
Put a potential approval.
Towards the.
Second half of next year.
So I think this is it is very exciting I think as we mentioned before obviously this is a.
It's a strong contributing factor quite comment for younger people in China actually have Iga nephropathy is the reason for their dialysis.
And I think that it would be super exciting.
Do you have a drug available there as well to address this fairly large patient population.
We are going to have to.
We'll share with you once we hear funding from our partner in terms of what their <unk>.
Plans are with regards to.
Other metrics of their commercialization.
Okay totally understandable.
Maybe maybe one more on the.
Launched in Europe , I know you are not being as specific necessarily on timing.
But I guess generally can you give us any color on how far away the actual launches maybe year and a reasonable assumption or is that more of a 2023 thing.
No. They have actually touched on has launched they launched the product they.
Launched in Germany.
So it is now available in Germany. It is one of the one of the few countries in Europe , where you're actually able to launch.
Kind of immediately more or less immediately after approval.
The other kind of countries in Europe require kind of a negotiation with regards to pricing and market access et cetera. So we would expect started to roll out the product in other European geographies or not a European countries.
As those kind of negotiations progress, but the product has been launched.
It was launched in late September early October refined.
Not mistaken.
In Germany.
Okay. Okay I got it so I assume we will see some revenues falling in this quarter from that.
And then last question for me just in terms of the U S launch.
I guess in order to hit the midpoint of your sort of guided range.
It seems like you might see a little bit of deceleration in the fourth quarter.
In terms of U S sales. So I'm wondering what's behind your fourth quarter assumptions is there was there a component of inventory stocking that.
May drive a little bit of a slowdown in the fourth quarter.
Thanks.
No. There is no kind of inventory stocking component and I'm not sure that we are expecting any deceleration in Q4, I think it's more a metric in terms of the time it takes.
Just to kind of front enrollment too.
Revenue generation, but Andy maybe you want to take this.
Yes no.
Agree with your assessment there.
Not at all a deceleration I think were.
We're looking to continue the growth in.
That target.
I mean, a very healthy fourth quarter.
Okay, great. Thanks for all the color.
Yes.
Thank you. The next question comes from Dan <unk> from <unk> Securities. Please go ahead. Your line is now open.
Hi, everyone and thank you for taking my question and congrats on the great numbers. One question on the unique prescribers. So.
Many in percentage are there less in the U S is it that you are around that 20% of the available prescribed what's currently or.
Sure.
I'm, sorry can you repeat that sorry.
So the unique prescribers that you reached thus far.
And relative to like how much in percentage, 3% of the prescribers are available in the U S.
Oh, I see sorry, sorry.
So Andy do you want to take that I mean in terms of our target 3500, I think sure yeah, Yeah, I mean, it's not even 10% or it's a little bit more license I'm, sorry than 10% of.
Probably what we would anticipate that peak of prescribers, but this is.
Not every prescribers is equal in other words as far as their prescribing their patient load et cetera. So so we're very pleased with the.
The amount of prescribers that we've already.
That have already initiated.
Patients on top of it.
Okay. Thank you and the follow up on that could you give us some color on the incentive model for the sales force and.
When we can expect that the 20 additional ftes are fully trained as said already now.
End of Q3, yes.
Lesson learned maybe from the lessons learned from the first quarters.
Do you have any plans that you could share that could increase the efficiency of your sales force.
Yeah.
So good questions. The answer is they were all they were all trained.
They are in the field.
So they are fully compliant and trained and that took place during Q3.
And so the timing I think we think we're going to well some.
Feel impact quicker than others, a lot of that is due to relationships and when they're they've been in this space prior.
And the fortunate part for US is that the vast majority of the 20 new.
Sales executives come.
Come with experience in this market. So we're very pleased with that as far as lessons learned this is a process that takes continued education and repeat calls.
Some are quicker uptake than others and they like to see the data and we're pleased with the fact that now we have a publication.
That provides this data so that they want to see.
Peer reviewed journal.
Indicating exactly the results are a further than.
And then what we can promote quote unquote.
For the reps. That's also beneficial so I think theres a lot of positive.
Momentum coming out of Q3 that we've seen at the very beginning of Q4 and.
I think the impact of the increased reach and frequency.
Coupled with the data will be exciting plus I think the last piece of it really is the successes were started the year I think there are prescribers that you could understand they put a patient or two on the product they want to wait a few months to see the success and once you build on that and if you.
<unk> success with some patients youre going to want to expand your usage. So we're starting to get to that point now.
Okay. Thank you and the last follow up.
Considering the but theres still a lot of prescribers out there left.
Possibility that they would increase the sales force next year. Additionally.
Right.
Do I see that possibility.
We don't close off the possibility to anything it's not the plan it really isn't the plan right now, but there is a way that you assessed that and you look and you see are we reaching enough people with the right frequency. So we're constantly looking at this information and.
It is not in the plans today to expand further.
Okay. Thank you very much.
Thank you.
Question come from Jacob Michael from Kempen. Please go ahead. Your line is now open.
Hi, there and thanks for taking my question.
I'm just curious if there are any taxes that can predict why the approval process may take longer for some patients compared to others.
Maybe if you can provide any color on the challenges that patients experience and the process to get approval.
Sure Andy do you want to start.
Sure sure so.
As you know in the states, there's thousands of different plans and they have different policies.
That they go through so that could make.
That's one factor right there that can make the approval process take different amounts of time for different patients, but every time there is an approval for <unk>.
Every specialty product you have to remember there are several players involved so you have the positioning of the patient and the payer.
And so so some some payers require different.
Levels of evidence or information so that can take time.
Times it requires a physician to provide this information that could take time and some of the offices are more equipped than others to handle providing this level of evidence and then there's also parts of that where it's contacting the patient you want to coordinate the shipment date exactly when theyre going to receive it to make sure that they are there.
Receive their medications. So so theres a lot of different factors that can add up.
Cause differences, we've been very pleased to date with those that are receiving their medications.
That it's under 30 days I think if you look at industry standards I feel pretty good that where it's currently sits but as I've indicated in prior quarters, we're not going to be satisfied with that and we're always looking for ways to make it.
More efficient quicker so that when the prescription is.
<unk> has enrolled so we can get them the medication as quickly as possible.
And I would say that one of the things that we.
Let me have kind of heard as well as experience.
<unk> is obviously that they are not necessarily.
They don't have huge amounts of specialty products would've been reprieved over the last 10 years.
And so for some of these kind of offices in Brazil Nephrologist.
Having to deal with administration related to any specialty product is something different in relatively new and so this is something where again we have made sure that we are make sure that we have enough resources in kind of the TARP pay of touch points in comp to really try and make this as easy as possible for them, but I do.
I think that this is a little bit of a.
Novelty and obviously this is something that they are going to have to deal with any product that kind of comes to market here. So but that is something where we have specifically in terms of lessons learned and some of the things is that we.
That is something that we've listened to taken onboard and actually again, we're trying to be as helpful. As possible in this process because it is unfortunately, just a structural issue.
With regards to kind of U S health care.
Okay. Thank you very much okay.
Yes.
Thank you. The next question comes from enrollment cap camera from <unk> capital. Please go ahead. Your line is now open.
Hey, guys. This is oliver from lifestyle for Ronnie Congrats on the.
Updates and thank you for taking my questions I just had two questions today.
First while the launches still early have you identified any trends in the patients receiving <unk> and second is the expanded sales force fully deployed and what proportion of Nephrologists treating again Amit.
Yes.
So Andy do you want to take this.
Sure.
As far as the specific patients it's too early to give you trends.
You have to remember that there is one product that's actually indicated now and so this is where they are.
Their usage has been pretty broad, meaning patients are coming to us both.
First diagnosed as well as those that have been.
Diagnosed several years earlier, we have some that are more severe than others.
And some that have left so I can't really give you too much color. Unfortunately on the trends in the patients I know, we are seeing more patients per prescriber and that kind of stuff will typically increase over time as comfort levels. Some people want to start with their most severe patients and then they will move to <unk>.
Sure.
Less severe probably as they get more and more comfortable.
As far as.
The expansion of the sales force and reach I think was the question.
That that is typically.
There's a lot of factors that go into that obviously geography et cetera, but we typically have formulas that we use when youre looking at a specialty sales force as far as their number of calls they can make in a day.
And the number of different unique prescribers and how what how much you want their frequency you want a higher frequency from for some prescribers versus others.
Theres no exact number that I'm really going to discuss now, but we feel that the expanded 20 provides us really really strong reach and the appropriate frequency that we're going to need.
Got it thank you very much.
Thank you. The next question comes from Annabel <unk> from <unk>. Please go ahead. Your line is now open.
Hi, Thanks for taking my question.
Just wanted to ask about the data that you presented at.
At ASN as well as the publications you mentioned that it was very enthusiastic feedback from the physicians.
I guess.
Can you if you could get a little bit more granular in terms of how they responded to that does that.
Do they <unk>.
<unk> any motivation to keep patients on treatment longer keep it intermittent based on what their object. These observations are and have any of the drugs that they've used to date shown this kind of continuing benefit post removal of treatment.
They would start to think about how to use this drug differently.
And then I.
I guess as a.
Carry on to that does this give you any further.
What does this potentially mean for part D. Just to give you further comfort that the part D is going to.
Readouts.
Positively or I guess, what kind of extrapolation scheming. Thank you.
Okay, why don't I start and I'll hand over to Richard.
So I think that obviously, what we heard at ASN and I think and other interactions. The key here is obviously that all <unk> not just in Iga nephropathy.
The experience from the treating physician as well as this comes through in a lot of the larger.
Analytical papers that have been published et cetera is that.
It kind of.
<unk> kind of a significant and durable kind of proteinuria reduction.
It's something that physicians really assume will lead to.
Benefit for their patients and that's really how they have been treating this patient population for a long time. So I think that the this differentiated profile and to answer your question I mean at least we have not met anyone so far I have not met anyone anyway. So far.
That can show to any other drug that shows this particular profile in terms of that you get the significant continued benefit when you actually withdraw the drug. So I think the benefits are obviously they look at a benefit in term and early benefit in terms of Egfr is obviously very good most drugs that actually have a negative impact in Egypt.
To start with.
So that was kind of a positive. The fact that the continued kind of approach and a reduction I think athene is.
A very intriguing and very interesting by physicians.
That is kind of that six.
Significant and durable and obviously this is what we ultimately have to wait for part B to see how long this kind of durability, we have but I think those are really the things that they find it is.
Extremely interesting and I think the last part is obviously be.
The Egfr stabilization.
Really from an immediate perspective in these patients at risk of rapid progression is obviously also something that they find.
Very important because these patients obviously at the end of the day.
It is all about trying to preserve kidney function.
In all of these patients and <unk> generic has obviously.
They look at that as a forerunner to that China.
Effect obviously.
But before we go into part D and maybe I'll hand over to Richard to reflect on what interactions you may have had with physicians.
Well I think it's very similar I mean, I Echo your comment.
I think the.
Profile of effects that we see.
Intriguing and differentiated.
And then particular.
The cumulative.
<unk> and protein area that we see.
During the treatment period, and that's where it is or if he said I mean I think.
Typically important observation that the continued improvement in <unk>.
It's an area of the patients have discontinued treatment and that's also reflected in data library.
Showed which.
Also confirmed.
Maintenance of separation of the Egfr curve.
Discontinuation of treatment.
So I think I think there's a great deal of.
Positive.
Reflections on that from the physician community.
And I think that certainly obviously, we're not going to provide a prediction of exactly what will happen in part b, but I mean, it certainly makes us comfortable the study as well as the volume that we're seeing the appropriate.
The relevant treatment effects in terms of improvements in proteinuria.
We've already seen that translate through to stabilization of Egfr and we're very encouraged.
What that means in terms of the final analysis for part B.
Okay I would just add.
Yes.
The final piece there is.
He is obviously just the.
In terms of the only the only thing that we can do is really kind of then looked at what the what the screening criteria and what we're seeing in the open label extension, what we've kind of shown is obviously that there is a significant portion of patients obviously.
Who.
Hi, proteinuria below one gram, where obviously the entire population did have proteinuria above one gram.
Inclusion of the start of the study it is speculation obviously because it sound is still blinded, but I still think that it's a very interesting observation.
But that is obviously, what we're seeing after two years.
And a fairly significant number of the patients.
Okay. That's very helpful. Thank you.
Thank you and the next question comes from Maury Raycroft from Jefferies. Please go ahead. Your line is now open.
Hi, congrats on the quarter and progress and thanks for taking my questions.
You mentioned 180 patients went into screening for the open label extension and there was a 41% failure rate. There can you clarify if all of those patients who are not qualified because of the low <unk> less than one gram or what are the other reasons for screen failure and can you remind what are some of the measures you are collecting in objectives for that the open label extension study.
<unk>.
Sure I'll, let Richard take the second part of that.
Study.
Last question.
In terms of the.
In terms of its greenfield so basically what we've said is that out of the 180 patients are screened 106 are enrolled and so the remainder screen.
Screen failed and so for those patients.
The largest the biggest reason for screen failure really.
Over 60% was.
The fact that they did not qualify approach and our answer they had they had personnel have less than one gram.
The second.
Most most.
Most significant reason was that they had too low of an egfr. So the Egfr was bill.
Below.
<unk> 30 Mega liters per minute.
And then there is a range of other.
Other kind of reasons, but those were the two kind of.
Most significant reasons for screen failure.
Okay.
So Richard I tell you one of the yes, yes. So in terms of your other points. So for this study.
Data collected will be similar to the data that we've collected in the pivotal study so we'll be evaluating the effects of treatment on them.
<unk> Egfr.
Over the nine months treatment period.
As well as other.
Outcomes, obviously safety and Tolerability.
Yes.
We'll be.
Collected safety data will be collected.
Got it.
Its helpful and makes sense.
I had another question too just for the phase III part B. After even data is there a bar for what proportion of patients you get into a complete remission or for a certain amount of durability that you need in order to make claims around that and add that to your label.
If you could just talk about what additional.
<unk> label, you could make based off of the part B data.
Yeah.
So I guess if the attendant.
Most.
Yes.
The most obvious I guess, obviously in terms of part being really would be.
The the impact on Egfr right. So obviously in terms of what we have to date really is to kind of just the impact on proteinuria, which as we all know is a surrogate. So so I think this is really kind of considered.
More of a hard endpoint, then proteinuria reduction generally by the regulators and so I think that that data is also obviously going to be critical in terms of.
Disease modification for example.
What is what are you going to be able to say exactly when do these disease modification is it's difficult to kind of have a view on here, but I think that that's obviously kind of one avenue I think that.
Another Avenue is as you say in terms of.
If you can if we can show have some views at least on the durability of response and the kind of the.
Consequences of that on Egfr is obviously also going to be something I think that everyone's going to be very interested in and I think that.
How long will this affect lap because obviously this is more unique focus on the kind of treating the origin of the disease and so I think theres a lot of interest around that I do think that physicians in general are very positively inclined towards.
Inquiry.
Increasing that proteinuria reduction over time, which is what we've seen.
And obviously also then kind of the durability of it but I think in terms of what we can see in the label as always I think thats going to be ultimately a negotiation with the regulators, which is always very difficult to do.
You kind of have a view on at this point in time, but.
I think those are kind of the type of areas, but we will obviously be discussing with them.
Got it that makes sense. That's helpful. Thank you for taking my questions.
Thank you. The next question comes from <unk> <unk> from Redburn. Please go ahead. Your line is now open.
Thank you for taking my questions two follow ups in the patients that were in the extension OLED grew from 74 days for Rob earlier, you clarify that 61% or.
45 ish.
Continue due to the newly added levels.
Sure.
29 ish can you say anything.
To what extent.
The group that are too low Egfr represents in this group.
Well I mean again as I said, because it's blinded. It is it is kind of this is speculation because we won't be able to underline. This trial until the completion of the phase III program is a hall.
But one could obviously speculate and assume that.
There are some patients who would have been in this trial for two years.
Who would have entered into the trial with a fairly low egfr.
And may therefore over the two year period.
Being a situation where they're egfr is below 30.
And if it was below Saturday they would not be included in the open label extension.
And as we've seen there obviously our patients at risk of kind of rapid progression is hard.
Quite a significant decline in their egfr.
So that I think but again that would be speculation.
Yes, so we don't.
At this stage that we can save five or whatever.
Second largest group.
Yes.
Yes and.
All so.
<unk>.
Of course, now Paramount in patients being treated more than 20.
Hi, Martin.
Is there any indication on the second dose for any of these patients for US also from a blind.
So is it okay I'm not sure what that means all patients obviously have been treated for nine months and are then observed.
After that period of time.
And so obviously are you referring to so obviously for those patients who go into.
Yes, I am thinking about the group.
The 24 months.
And that must be higher amounts of patients that have done that.
Yes, exactly yes.
Yes exactly.
That's what we refer to us.
Patients who have exited that study out of those who have finished the trial of two years, that's what we're saying 180.
Screen for the open label extension and 106 as of the end of Q3 were enrolled into that study and are therefore.
Receiving an additional.
Or are there first.
China treatment.
Nine months. So obviously, that's not enough we do not know whether this is patients who are retreated or whether these are patients who were in the placebo group and therefore are getting their first treatment that is something that we don't know since the trial is blinded, but a 106 of them are as of now enrolled in the open label extension.
Yes of course the patients themselves.
Okay.
Secondly for himself.
Yes, no I think that would fit.
For me and congratulations on good thoughts and I think.
Earlier.
Alluded to early on.
Dave.
Dynamics between unique prescribers and the number of patients.
And what's also very useful to get a feel for the dynamics between prescribers.
And failed.
Time that takes at this stage anyway.
Thank you well thank you very much.
So with that thank you very much to everybody who participated and we look forward to sharing our Q4 report with you in February .
You very much.
Yes.
[music].
Okay.
Yeah.