Q2 2021 Calliditas Therapeutics AB Earnings Call
[music].
Ladies and gentlemen, welcome to the Kennedy to Therapeutics Q2, 2021 report.
Operator: Welcome to the Caleditas Therapeutics Q2 2021 report. Today, I am pleased to present the CEO, René Lucander, the CFO, Freddie Cahonson, and the President of North America, Andrew Udell. For the first part of this call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. Speakers, please begin.
Today I am pleased to present the C E O really luganda CFO Fredrik Johansson and the President of North America, Andrew you know.
First part of this call all participants will be in listen only mode and afterwards, there will be a question and answer session.
Speakers please begin.
Speaker: Thank you. We start on page two with a forward-looking statement. This presentation contains forward-looking statements. Any forward-looking statements in this presentation are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that could cause actual events or results to be materially different from those expressed or implied by any forward-looking statements contained in this presentation. Can either have cautioned you not to place due reliance on any forward-looking statements, which speak only as of the day they are made? That is, such claims are an obligation to the public.
Thank you we start page two our forward looking statement.
Presentation contains forward looking statements and of course looking statements. In this presentation are based on management's huh.
Patients and beliefs and are subject to a number of risks uncertainties and important factors may cause actual events or results to differ materially from those expressed or implied by any forward looking statements contained in this presentation.
I think there's of course with you not to place undue reliance on any forward looking statements, which speak only as of today. They are made.
That is up in flames and application.
Speaker: publicly update or revive any such statements to reflect a change in expectation
Publicly update or revise any such statements to reflect any changes in expectations.
Speaker: such statements to reflect and change in expectations or in events, conditions, circumstances on which any such statements are based or that may affect the likelihood the actual result will differ from those that are forth in the 40-bidden state. Any forward-looking statements containing this presentation represent colleagues who only as the data off and should not be a reliable source on apps representing its news of any such. Thank you, Frederick, and welcome everybody to Kedia Therapeutics' Q2 Report. I will start the presentation on page three and, just as a quick reminder of our development pipeline and ongoing clinical trials. The Nesigrk trial is, as you're aware, fully recruiting.
Events conditions or circumstances on which any such statement maybe thing.
Or that may affect the likelihood that actual results could differ from those set forth in forward looking statements and forward looking statements contained in this person faces with SUNS collections own less of data off of and should not be relied upon.
Use of any substance.
Thank you Fredrik.
And welcome everybody to our kidney decides he takes he to report.
I will start the presentation on page three.
Just as a quick reminder of our development pipeline and ongoing clinical trials.
And then at the Dart trial is as you are aware fully recruited it is continuing on plan and is expected to conclude in Q1 2023.
Fredrik Johansson: It is continuing on plan and is expected to conclude in Q1, 2023. We also remain on track to start our clinical trials related to Setsamakid in the second half of this year, and the open-label extension study continues to enroll patients as they have as they complete phase three studies. So with that, going to the next page, during Q2, the main highlights really related to regulatory events. So in Q2, we reached a major milestone with a filing for conditional approval in IGA, nephropathy, with the EMA.
We remain on track to start our clinical trials related to set some accent in the second half of this year.
And the open label extension study continues to enroll patients.
As they have as they complete the phase three study.
So without going to the next page.
During Q2.
The main highlights really related to regulatory.
Event.
And so in the in Q2, we reached a major milestone with the filing for conditional approval in Iga nephropathy with the EMA.
Fredrik Johansson: Having received acceptance of the Acceleral Review review already in April, we expect to receive the first round of questions in Q3, and we're excited to engage with the regulator during the coming month. Our interactions with the FDA are ongoing, and the review process is expected to conclude on the 15th of September, which is the target due date communicated to us by the agency. Consistent with previous presentations and interactions, we will not comment on what type of questions or interactions we're having with the FDA, nor will we comment on any potential inspections or audits or other related questions. After having just kind of covered the main activities in Q2, I then go over and hand over to M.D. Udell, who is our president of North America.
Having received acceptance of accelerated review already in April we expect to receive the first round of questions in Q3, and we're excited to engage with the regulator during the coming months.
Our interactions with the FDA.
It's ongoing and the review process is expected to conclude on the 15th of September which is the target for due for they've communicated to us by the agency.
Consistent with previous presentations and interaction that we will not comment on what type of question for interactions, we're having with the FDA nor will we comment on any potential inspection audits or other related questions.
After having just kind of probably the main activities in Q2, I've been a little over and hand over to M. D.
No.
Our president of our north.
Fredrik Johansson: I'm sorry, actually. There is another page missing. Sorry. I will not.
America.
Unfortunately, there was another page five.
I will not there's actually an additional page.
Fredrik Johansson: There is actually an additional page, but before I do that, I really go to other activities in Q2. I apologize for that. So the other activities in court, so this is page five, focused mainly around operational execution across the board, a lot of which we were focused on the pre-commercial activities in the U.S., where we've made substantial investments in preparation for the potential approval of NECAFOM. And in addition, we continue to prepare for the launch of active assessment studies, which are due to start in the second half of this year.
Before I do that I already talked to other activities in Q2 apologize for that.
So there'll be other activities in the quarter. So this is page five because it's mainly around operational execution across the board.
A lot of which we were focused on the pre commercial activities in the U S, where we made substantial investments in preparation for the.
The potential approval of Mexico.
And in addition, we continue to prepare for the launch of our fifth such studies, which are due to start in the second half of this year.
Fredrik Johansson: And finally, obviously, we had resources directed at securing additional capital, both for the pre-commercial as well as the post-commercial phase of NEPAON, something which I will address in somewhat more detail shortly. But before I do that, we will now hand over to, and you can say, President of North America, who's going to cover a little bit about the market opportunity and these activities that we have been conducting in Q2 regarding putting us in a position for launch ready. So with that, Andy, over to you.
And finally, obviously, we had resources threatened to securing additional capital both for the pre commercial as well as the post commercial phase of Mexican something which probably will address that in somewhat more detail shortly.
But before I do that we will now hand over to Andy <unk> President of North America is going to cover a little bit about the market opportunity. These activities. So we have been conducting a in Q2 regarding putting up a minute and as a service.
Prolonged failure, so with that.
Over to you.
Andrew Udell: Thanks, Renee, and on slide six, I will start.
Thanks, Renee and on slide six.
I will start so we continue to be very encouraged by the results of our research and the market opportunity as you can see on this slide and a robust reporting 468, Iga nephropathy patients and chart audits for these patients conducted earlier this year.
Andrew Udell: We continue to be very encouraged by the results of our research and the market opportunity. As you can see on this slide, in a robust report of 468 IGA nephropathy patients in chart audits for these patients conducted earlier.
Andrew Udell: Year patients arrive to their nephrologist upon referral already in CKD stage 2 or 3A. So upon diagnosis, about 70% arrive in CKD stage 2 and 3A, and if you want to add in CKD stage 3B, you're over or at about 90% of the patient When we look at the patients that do arrive to the nephrologist, when we look at what they're taking, the majority of them are And if you ask the nephrologist, 88% of them are on an optimal dose in this unsatisfied market.
Patients arrive to their nephrologist upon referral already in CK D stage, two or three a 70% of these patients. So that's upon diagnosis of 70% arrive and CK D stage, two and three a and if you want to add in CK D stage.
Three b, you're over or added about 90% of the patients when we look at the patients that do arrive to the nephrologist when we looking what they're taking the majority of them are already on supportive care greater than 50% of them are already on ace or arb therapy.
88% of them are on an optimal dose in this unsatisfied market.
Andrew Udell: Physicians seed the patients three times a year.
<unk> seed the patients three times a year they conduct at least one lab tests looking at Egfr Your analysis there.
Andrew Udell: They conduct at least one lab test looking at EGFR, urinalysis. They are on multiple meds, as you can see here, almost five medications concomitantly. And they consider proteinuria and especially EGFR to be the most valuable measure when they're assessing their patients and their progress. Go to the next slide, please.
There are multiple meds as you could see a year almost five medications concomitantly and they consider the nephrologist consider proteinuria, and especially egfr to be the most valuable measure when they're assessing their patients and their progress if.
If we go to the next slide please.
Andrew Udell: We continue to prepare for the earliest possible commercialization of our product, including market access where our main objective is to reduce and minimize any barriers for patients to receive the product, and to finalize and work with our trade and distribution partners, which are world-class and well-known partners. We have national account managers that are already making calls on payers to prepare the market. We have launched our disease awareness campaign, as you can see here. As mentioned, that's been going on for a while, and our Salesforce readiness is well on its way, with our sales leadership onboarded and in our preparations right now, final preparations to onboard about 40 salespeople.
We continue to prepare for the earliest possible commercialization of our product.
This includes market access with where our main objective is to reduce and minimize any barriers for patients to receive the product. We continue to finalize and work with our trade and distribution partners, which are world class and well known partners.
We have national account managers that are already making calls on payers to prepare the market.
We have launched our disease awareness campaign as you can see here as mentioned and that's been going on for a while and our sales force readiness is well on its way with our sales leadership on boarded and our preparations right now final preparations to onboard about 40 sales representatives.
Andrew Udell: sales representatives provide us with the most ample and appropriate reach and frequent size of this audience. It's with that
To provide us ample of brand.
And appropriate reach and frequency of the size of this audience.
Andrew Udell: It's with that now that I'll hand it back over to Renee on slide 8.
It's with that now I'll hand over back over to Rene.
Renee Aguiar: So continuing on the next page, looking at post-period events. The post appeared closed, and the company experienced several significant positive events, which I just would like to touch on very briefly. We secured a strong commercial partner in Europe for the commercialization of Methicon. This is obviously in line with what we have been communicating previously. We're very excited to welcome Stata to the Kalidicist team, and we're truly delighted to have secured such a strong partner for the commercialization of Methadon in Europe.
Thank you Randy.
So continuing on the next page page looking at post period event.
Suppose the paired close the company for several significant positive events, which I just would like to touch on very briefly.
We secured a strong commercial partner in Europe for the commercializing commercialization of Mexico and this is obviously in line with what we have been communicating previously.
We're very excited to welcome startup T that can lead to 15.
And we're truly delighted to have secured such a strong partner for the commercialization of ethical and in Europe.
Renee Aguiar: We also signed a credit agreement that provided access to a total of $75 million of non-valued financing for the company, out of which $25 million is accessible post-signing, and the remainder is subject to FDA approval or certain revenue levels being achieved. Finally, we successfully closed a top-up round of equity at about a 4.8% discount, raising 324 million Swedish crowns, representing less than 5% dilution, with the majority of the issue being taken up by our significant existing shareholders.
We also signed a credit agreement provided access to a total of $75 million of non dilutive financing to the company out of which $25 million is acceptable post signing and the remainder are subject to FDA approval or certain revenue levels being achieved.
Finally, we successfully close to top up round of equity are at about a 4.8% discount raising 324 million Swedish crown.
Representing less than 5% dilution and where the majority of the issue being taken up by our significant existing shareholders are collectively these initiatives to ensure that we are well capitalized for a successful product launch subject to accelerated approval.
Renee Aguiar: Collectively, these initiatives ensure that we are well capitalized for a successful product launch, subject to accelerated approval. It also puts us on a path towards being cash flow positive, potentially in the medium term, and mitigates the need for capital raising in the near term, which is also reflected by the 90-day lock-up we signed as part of the recent financing. We have thus removed the risk related to macro events or other issues potentially impacting capital markets in the second half of the year, and we believe that, being well capitalized, we can now have full control over the successful commercialization of NEPAGON over both the near and medium terms.
It puts us on a path towards being a.
Cash flow positive potential in the medium term and mitigates the need for Taco raise in the near term.
Which is also reflected by the 90 day lock up we signed as part of the recent financing.
We have renamed the risks related to macro events or other issues are potentially.
Potentially.
Impacting capital markets in the second half of the year, and we believe that being well capitalized. We can now have full control over the successful commercialization of methadone.
With the near and medium term.
Renee Aguiar: If we then take the go to the next page, just before I hand over to our CFO, Frederick Johansson, just a brief summary overview in terms of year to date. So obviously, we read positive data from our phase three study in November of last year. We presented the overall profile with the study population's primary endpoints, as well as the overall safety profile. We have had dossier filings accepted by both the FDA and AMA for approval.
And if we don't take the go to the next page just before I hand over to our CFO.
Great.
Seth.
Just a brief summary overview.
In terms of our year to date. So obviously, we read out positive data from our phase III study in November of last year.
We presented the overall profile of the study population are primary end points are as well as the overall safety profile.
We have had filed filings are accepted by both the FDA and EMA for approval.
Renee Aguiar: Both of these are being reviewed on an accelerated basis, and we believe that we have a very robust data package with a differentiated mode of action targeting the origin of the disease, and the potential for disease modification, addressing a significant unmet medical need in this patient population. We also believe that we have a significant lead over other development programs taking place in IGA neopropocity at this point in time, and we look forward to receiving the response from the regulatory agencies with whom we are engaging at the moment. So with that, I'm going to hand over to Frederick Johansson. We will take us through the financials. Thank you then. So, next slide. Good afternoon, M1, and good morning.
Both of these are being reviewed on an accelerated basis.
And we believe that we have been very robust data package for the differentiated mode of action targeting the origin of the disease and the potential for disease modification addressing a significant unmet medical need in this patient population.
We also believe that we have a significant lead over other development programs, taking place in Iga nephropathy.
This point in time, and we look forward to receiving the response from the regulatory agencies with whom we are engaging at the moment.
So with that I'm going to hand over to try to steal Hanson, who will take us through the financials.
Thank you for that so next slide.
Good afternoon, everyone and good morning.
Fredrik Johansson: I will present to you the financial overview for the first six months of this year, and all numbers are presented to you in the million specifications as always, stock week as expected to report new revenue for this. For total operating expenses for the period, amount to 310.2 million compared to 139, 4,040% lost. And under the total operating expenses, the cost for research and development increased by $62.6 million to $165.1 million compared with $102.5 million for the same year previously.
Same to you the financial overview for the first six months of visa Europe little numbers or presented to you meeting six that's always.
So software is expected to be 40, new revenue for the period.
Total operating expenses amounted to 314 million compared to 139.4 million fusin huge last year.
And although the total operating expenses for research and development increased about 60 people in 16 to 165.4 million compared with 102 five.
She was previously.
Fredrik Johansson: Increasing the expenses or even exposing the method of trials for the Nesdaa Precipdust and the Open Label Extension Study are ongoing, and the preparations, and product development for the September 6 trials, which are planned to stop related to this year. The sales and administration expenses amounted to $114.2 million for the period to be compared with $36.8 million for the same period last year. The increase of 106.4 million years is primarily related to the intensified preparations for commercial and manipulative activities in the US, as we continue to invest and prepare to be ready to commercialize Neficon in the US in Q4 once approval is obtained. And this leads us to an operating loss of 310.2 million for this period, compared to an operating loss of 138.9 million for the centrist last year.
Increasing the expenses or even the social the mythical Clos, but a necessity in subjects into open label extension study ongoing.
The preparation.
In product development for the system as its trials, which are planned for yourself.
The sales and administration expenses sensus amounted to one of them slips from four 2 million for the theory to be competitive so to speak.
And for the same periods last year.
The increase of 100 and system for medium.
Sears is primarily related to get a sense as far as preparations for commercial and medical affairs CBD in the U S.
As we continue to invest and prepare to be ready to commercialize commercialized and ethically.
In Q4.
This leaves us with an operating loss of 310.2 million.
So this peer comparison.
One of them stood at eight 9%.
Yes.
Fredrik Johansson: The cash flow used in operating activities for the period amounted to $267.1 million in the past 85 for 10 million for the previous year. And remember, last year, at the beginning of the year, we received the China deal of milestone payments from Everest and 192 to start using the US dollar. The cash used in investing activities for Pfeard was 18.8 million, and this is mainly related to miles contained in the NACD PUDD's license.
The cash flow used in operating activities for the period amounted to $7.1 million consult is applied with them for the previous year.
I remember last year beginning of the year.
You see the China deal.
Some famous one amongst them cheap.
Most of them.
The test was used in investing activities for fear of agents that they play with them and this is mainly related to a small something within the pulse of this license.
Fredrik Johansson: The cash flow used in financing activities cost 10.3 million since we continue to purchase minority shares in one care tax. We now own over 90% of shares in Caltech, and we have recently initiated a free-up process to reach 100%, which will have it today in. We had a strong cash position at the end of June of 709 from 3m6. After the close of the quarter, we completed an unequity race of 324 million before concession costs.
Cash flow used in financing activities was 10 from C media since we continue to persist in the north of chefs even test it.
We now own over 90% of the shares you they've helped us and we have recently initiated a process to reach 100%.
And before.
We had a strong cash position at the end of June of 709 units at all.
After the close of the quarter, we've completed an equity raise is freedom from the floor.
Just before concession costs in Q3, with one 2 million.
Fredrik Johansson: In Q3, the 20 million Euro initial payment under the European Commercial Eritation Agreement for Mexico is tabled. We also expect to be able to throw down the 25 million U.S. B, and 75 million U.C. loan facility designed in July with Kweb's capital and to draw down an additional 25 than U.S.D after potential use approval in Mexico. Based on our current operational plan for current cash position and amounts of over under all 11 facilities, we believe we have sufficient funds for planned operations in capital expenditures until we become cashable, which is currently projected for the first half of 2023, subject to medical receiving accelerated approval in the U.S. and successful commercial. That was all for me, and now that's easy. Thank you very much. I think we have concluded our presentation. And we are happy to take questions to the extent that there are any questions.
Mr payments under the European commercialization agreements for Mexico in this table.
We also expect to be able to slow down, but it's really fun.
I'm just I'm surprised me was the loan facility with some some July just curious capital.
To draw down an additional 25 season.
You will see all sorts essentially use approval of Mexico.
Based on our current operational plan for cone cash sufficient and amounts available under the loan facility. We believe we have sufficient funds to fund operations and capital expenditures until we become cash flow positive.
Which countries predicted for the first half of the sweep subject to Mexican receiving accelerated approval in the U S.
And its successful commercialization.
That was for the least.
The mouth off season.
Thank you very much I think we have that concludes our presentation and we are happy to take questions to the extent that there are any questions.
Thank you.
Operator: If you do have a question for the speakers, please press 01 on your telephone key Now, the first question comes from the line of Liggen-Nochomovitz of Citigroup. Please go ahead.
If you do have a question for the speakers. Please press zero one on your telephone keypad.
The first question comes from the line of young and not some of its whole Citigroup. Please go ahead.
Yigal Nochomovitz: Thank you. Hi, Renee M-Theme. Thank you very much for taking the questions. Renee, could you talk a bit about how your commercial launch strategy may or may not differ between the U.S. and Europe, and are there features of the IGA patient population when comparing the U.S. and European markets that may necessitate a different marketing approach for NEPAcon? Thank you. Sure.
Thank you hi, Rene and team. Thank you very much for taking the questions Renee could you talk a bit about how your commercial launch strategy may or may not differ between the U S and Europe and are there features would be actually a patient population when comparing the U S and European markets May necessitate a different marketing approach from Evercore.
Thank you.
Sure.
So in terms of the the approaches to the European and the U S market, obviously, they differ in the way that some of the U S perspective, we.
Renee Aguiar: So in terms of the approaches to the European and the U.S. market, obviously, they differ in the way that from the U.S. perspective, we are planning to launch and commercialize an ethic on ourselves in that market. So obviously, from that perspective, we have conducted a lot of market research and, you know, spent a lot of time and effort trying and understanding that market to the best possible ability that we have.
We are planning to launch and commercialize our Mexico and ourselves in that market.
I would say from that perspective, we have conducted a lot of market research in and not spend a lot of time and effort.
Just trying to understand that market.
With each of them to the best possible ability that we have in Europe. Obviously, we are going to commercialize with a partner and so not launch strategy will really be decided and managed by star now rather than trying to buy up.
Renee Aguiar: In Europe, obviously, we are going to commercialize with a partner, and so that launch strategy will really be decided and managed by Stada rather than kind of by us. And so I think, obviously, we will be, you know, collaborating and sharing information, et cetera.
And so I think well, obviously, we will be collaborating and sharing information et cetera.
But I think that really is the kind of fundamental difference I don't think that you know so far we have not seen or experienced any significant differences in our kind of patient populations or in how kind of patients necessarily are being treated.
Renee Aguiar: But I think that really is the kind of fundamental difference. I don't think that, you know, so far we have not seen or experienced any significant differences in the kind of patient populations or in how different kinds of patients necessarily are being treated in the two different regions. And I think, from that perspective, we wouldn't necessarily expect there to be any significant difference in kind of how those programs get deployed. But I think obviously the main difference is really, you know, who will kind of be driving the strategy around the actual launch system.
And the two different regions and I think so from that perspective, we wouldn't necessarily expect there to be any significant difference in kind of how those programs get deployed but I think obviously the main difference is really.
You know, who who will kind of be driving.
The strategy around the actual launch themselves.
Great. Thank you.
Our next question comes from the line of Moody's Raycroft of Jefferies. Please go ahead.
One is as far as you know on for Maury. Thank you for taking our questions.
Operator: Our next question comes from the line of Morrie Croft of Jeffries. Please go ahead. This is Farizenon for Mori. Thank you for taking our questions. So, how are you thinking about your commercial investment trajectory, and what milestones are you looking to achieve in order to trigger a new tranche of investment?
How are you thinking about your commercial investment trajectory and what milestones are you looking to achieve in order to trigger a new tranche of investment.
I'm sorry.
Or what is it triggered what a new tranche of investment sorry, it's not where you want it.
For the next upcoming year in like how are you thinking about the commercial investment trajectory.
Maurice Thomas Raycroft: I'm sorry, in order to trigger what a new tranche of investment, sorry, is that what you were? for the next app.
Okay.
But why don't I start and then Andy.
You know feel free to add from your perspective.
Maurice Thomas Raycroft: For the next upcoming year, like how are you thinking about commercial investment?
Hum, obviously are our kind of our investment in the commercial launch it's something obviously that we are you know we have spent a lot of time doing as I said a lot of market research a lot of interactions on the market access side I think we have spent a lot of time once upon a defining sales.
Renee Aguiar: Okay, well, why don't I start and then Andy, you know, please, you know, feel free to add from your perspective. Obviously, our kind of investment in the commercial launch is something that we have, you know, we have spent a lot of time doing, as I said, a lot of market research, and a lot of interactions on the market access side. I think we have also spent a lot of time kind of defining.
Oratory, and really kind of trying to get as granular as we possibly can be in terms of identifying and finding these patients are effectively are.
Renee Aguiar: in sales territories and really kind of trying to get as granular as we possibly can be in terms of identifying and finding these patients effectively in order to kind of have a successful launch as possible, obviously, in terms of commercialization. And so I think it's really been built mainly on all of the, you know, market research activities, and market access interactions that we've had to date, which we think. puts us in a very good position to have some, you know, some visibility on how we should affect and drive a commercial launch to be a successful approach. But Andy, do you have anything you want to add?
In order to kind of have a N a S.
A successful launch as possible obviously in terms of commercialization.
So I think it's really been built mainly on all of the.
Market research activities market, all axis interactions that lead times are.
Date, which we think puts us in a in a very good position.
She should have some you know some visibility on how we should affect and drive the commercial launch to be as successful as possible.
But Andy do you have anything you want to add.
Oh not too much other than you know we look to see how things. If the question is how things are going to change over the period of time of 12 months I mean are we.
Andrew Udell: Not too much other than, you know, we look at how things are going to change over the period of time of 12 months. There is a lot of demand right now, and it seems like it's certainly a very hungry market for products to help this unsatisfied patient population.
There is a lot of demand right now and it seems like it's certainly a very hungry market for our products to help this unsatisfied patient population.
As is typical for a launch you have to it takes a little time for payer approval and that's a constant.
Andrew Udell: As is typical for a launch,
Andrew Udell: It takes a little time for payer approval, and that's a constant process that we will pursue to improve market access, but we're encouraged about all the research and everything that we've done to date and what we're
Constant process that we will continue to pursue to improve market access, but oh, we're encouraged about all the research and everything that we've done to date and what we're hearing.
Andrew Udell: done to date and what we're hearing.
Got it.
Speaker: And then the other question was, you're not making comments on the regulatory review process, but is it safe to assume that everything is on track and all the answers, all the questions, have been answered satisfactorily so far?
And then the other question was making comments on the regulatory review process, but is it safe to assume that everything is on track and all the answers all the questions have been answered satisfactorily so far.
Speaker: We're expecting the decision to be kind of coming out on the targeted PDFA data as communicated.
We're expecting the decision to to be kind of it should come out on the targeted could do for data.
Hum.
Communicated.
Okay. Thanks.
Operator: Our next question comes from the line of Annabel Samimi of Stiefel. Please go ahead.
Our next question comes from the line of Annabel Sammy Ho Stifel. Please go ahead.
Annabel Eva Samimy: Hi, thanks for taking my question. I had a couple.
Hi, Thanks for taking my question a couple first I guess as you're approaching commercialization.
Annabel Eva Samimy: First, I guess, as you're approaching commercialization, have you had any further discussions with payers on pricing, and have your strategies changed as the competitive landscape is evolving? And now that you're approaching commercialization, and you're kind of, I guess, putting the feet to the fire, the payers' feet to the fire, and really, you know, providing that access. So they continue to view desinide as a different steroid rather than one that will have to come after they step through other steroids.
Any further discussion with payers on <unk>.
Pricing and have you or your strategy has changed and the competitive landscape is evolving and now that you're approaching commercialization and you're kind of I guess, putting the seats. The fire there the parents feet to the fire and really you know providing that access or they continue to view it.
Last night as a different steroid rather than one that will have to come after are they stepped through other steroids I guess, that's the first question and the second is I guess I know, it's difficult to compare studies, but maybe you can remind us what.
Annabel Eva Samimy: I guess that's the first question. And the second is, I know it's difficult to compare studies, but maybe you can remind us what the profile of your patient population was in an Enfacard study versus that in a sparse sentence study that just read out. I believe you had patients that were not responsive to Aynarp therapy anymore. Does that mean that patients were really maxed out on their protein urea reductions and can we really think about these two groups of different patient populations? Okay, thanks. Andy, why don't you address the first question, and I will address the second one. Well, we continue to do our work. It's a process to launch
What's the profile of your patient population wasn't enough of card study versus that in the first sentence study that just read out I believe you had patients that were not responsive to ace and arb therapy anymore.
Does that mean that patients were really Max out on their proteinuria reductions. If you really think about these two.
Two groups of different patient populations.
Okay. Thanks.
Andy why don't you address the first question and I will address the second one.
Sure.
We continue to do our work, it's a process to launch and work with the payers and to date, we continue to be further and further actually encouraged with these discussions with payers. We have advisory boards have done a lot of work and are encouraged as I said on how they view us so nothing's really changed in there.
Andrew Udell: and work with the payers, and to date, we continue to be further and further actually encouraged by these discussions with payers; we have advisory boards,
Andrew Udell: and have done a lot of work and are encouraged, as I said.
Andrew Udell: on how they view us. So nothing's really changed in that aspect. We still see things moving towards what we've indicated in the past, if not more encouraging. As far as them viewing Budesinide or requiring step-through,
That aspect, we still see.
Things moving towards what we've indicated in the past if not more encouraging.
As far as the viewing budesonide or requiring step through.
Andrew Udell: For these decisions, we look at the patient.
These decisions we look at the patient population, we look at a lot of Ah patient history. These charts and we don't see once again a lot of barriers to.
Andrew Udell: population, we look at a lot of patient history, these charts, and we don't see, once again, a lot of barriers.
Andrew Udell: a lot of barriers to
Andrew Udell: access for these patients based on what has been done today. I don't
Access for these patients based on what has been done today I don't think that people are going to require people start new course of steroids or something that's not approved that would be a little.
Andrew Udell: that people are going to require people to start a new course of steroids or something that's not approved, that that would be a little...
Andrew Udell: It was surprising to us prior to using a product that was specifically designed, tested, and intended for a specific disease.
Surprising to us prior to using a product that was specifically designed tested and approved for a specific disease.
Yeah.
Renee Aguiar: Okay, so with regard to the second question, with regard to any kind of differences between the two studies, again, just, you know, based on the kind of published design and methodology paper on the Protect study, I guess that, you know, what we can read out is obviously that the proteinuria is the same in terms of over a gram of proteinuria as an inclusion criteria. There's a slightly lower EGFR cut off in the protect study in terms of it being 30 milliliters, but there's also no limit on the upper end of EGFR in the protect study.
Okay. So with regards to the second question.
With regards to the you know any kind of differences are with regards to the two studies.
And again, just I you know based on the kind of published design and methodology paper on the protect study I guess that you know what we can read out is obviously that being the proteinuria is are the same in terms over one gram of proteinuria as an inclusion criteria.
There's a slightly lower egfr shut off into protect.
In the protect study in terms of it being 30 millimeters, but theres also no limit.
On the upper end of Egfr in the protect.
Buddy.
Renee Aguiar: Other differences, regards inclusion obviously relates to blood pressure. So in the Netsa Guard study patients with 140 over 90 or higher would be excluded, as they would not be considered to be well controlled with regards to their blood pressure. So there's a difference there. Also in the Nessigard study, obviously we did not encourage treatment with additional anti-hypertensive agents, and we did not allow for the semi-cordibusteroids or other immunotherapy, it's a press of therapy to be used at the discretion of the investigator, to what extent these are, you know, have any impact or not, you know, obviously, difficult to say, but I think that really is the only answer to your question I think that I can provide, which is that, you know, generally inclusion, exclusion criteria are very similar, and I think those are the differences that, you know, we have identified based on the kind of public information.
Other differences dos inclusion, obviously relates to blood pressure in the met the guard.
Saudi patients with 140 over 90 or higher would be excluded as they would not have considered to be well controlled with regards to their blood pressure.
And so there is a difference there.
Also in the Mercer Guard study, obviously, we did not encourage treatment with additional ample hypertensive agents and we did not allow for systemic corticosteroids or other immunotherapy. It's effective ferentz. If it can be used at the discretion of the investigators.
To what extent means or have any impact or not and obviously, it's difficult to say, but I think that really isn't the only answer to your question I think that I can provide which is that you know generally inclusion exclusion criteria are very similar and I think those are the differences are that are.
We have identified based on the kind of public information.
Great. Thank you.
Operator: Our next question comes from the line of Romi Cateuilla of LifeSci Capital. Please go ahead.
Our next question comes from the line of roaming Petrova of lunchtime capital. Please go ahead.
Rami Azeez Katkhuda: Hi guys. Thanks for taking my questions.
Hi, guys. Thanks for taking my questions.
Rami Azeez Katkhuda: Two for me.
Rami Azeez Katkhuda: I guess, first, can you provide any indication of how Strata is thinking about the pricing and commercialization plans?
Two for me I guess first can you provide any indication on how <unk> thinking about the pricing and commercialization plan for NEP on in Europe.
Rami Azeez Katkhuda: and commercialization plan for NEPCON in Europe, and then second
Rami Azeez Katkhuda: Given their somewhat complementary mechanisms, do you kind of envision NEPCON being used in combination with Sparsensin in the real world setting? Uh,
And then secondly, given there's somewhat complementary mechanism you kind of envision netcom being used in combination with <unk> sensing in the real world setting.
Renee Aguiar: So in terms of the Stadda question, I think that it's a little bit too early. We have very recently kind of concluded our interactions with them. And I think we are, you know, we're starting to engage with them on terms of more than an operational basis to address some of these questions or explore some of these questions. I don't think at this point in time I have a clear answer to kind of exactly how they are planning to proceed in the kind of, you know, the European market. But obviously, they have significant resources across all the European markets, and they have a lot of experience in terms of, you know, launching products in Europe.
So in terms of the stuff that question I think that it's a little bit too early I mean, very recently and that kind of concluded or Oh, my interactions with them and I think we are you know where we're starting to engage with them on terms of them on an operational basis.
Cheap to address some of these questions I explore some of these testing.
I think at this point in time are there.
I have a clear and search of kind of how exactly they are planning to to proceed in the kind of you know in in the European market, but obviously they are they have significant resources across all the European markets and they have a lot of experience.
In terms of of launching a product in Europe, but again I don't have any specific.
Renee Aguiar: But again, I don't have any specific details of that yet, and I think we will be able to provide that as kind of the as we progress the collaboration a little bit.
Detail about yet and I think we will we will be able to provide that as kind of the as we progress the collaboration a little bit further.
Renee Aguiar: In terms of any kind of assumptions or kind of comments around views together or not, I mean, I guess that the data that we have so far seems very promising with regard to Trebir. I think that we need to understand quite a lot more in terms of the impact on EGFR and the study population. use of concomitant medication, you know, all of these things are important to kind of get an understanding of before, you know, one can make any kind of comments on that.
In terms of any any kind of assumptions are all kind of comments around used together or not I mean, I guess that the data that we have so far.
It seems a very promising promising with.
With regards to our trivia I think that in terms of we'd need to understand quite a lot more in terms of both the impact on Egfr <unk> and.
The study population the use of concomitant medication you know all of these things I think are important to kind of get an understanding on before.
No one can have any kind of comments on that however, you know in you know in theory.
Renee Aguiar: However, you know, in theory, I don't see any reason why they couldn't be used together. I think ours obviously has a local focus in terms of the origin of the disease, and I think that that, you know, should be able or could be able to be combined with any other systemic approach. And so I think, in general, we wouldn't see why that would be a problem.
Theory, I don't see any reason why they couldn't be used together I think ours, obviously has a local focus in terms of the origin of the disease.
And I think that that should be able it could be able to be combined with any other systemic approach.
And so I think in general we wouldn't see why that would be necessarily a problem.
Operator: Our next question comes on the line of
Makes sense. Thank you.
Our next question comes from the line of you on a nurse overtime.
Johan Unnerus: line of Yuan Uneris of Red Eye. Please go ahead. Thank you for taking my question. It's more of a follow-on since
Go ahead.
Thank you for taking my question.
More of a full alone.
Johan Unnerus: subject has been discussed. Yes, the
Cause it's subject to being discussed.
Yes, the U b.
Johan Unnerus: Results from Spartanton caused a lot of uncertainty, obviously. One difference is that they include patients with filtration rates that are more impaired, I guess, more like 3B in that context. Is there any, are you focusing more on patients that have less, in part, filtration?
The results from <unk>.
Hum.
Boston, Portland, and caused a lot of uncertainty obviously is the is it the.
One difference is that the they include patients with filtration rates that are.
More impact I guess more like three b.
Thanks.
Is there any are you focusing more on patients that aren't.
Hum.
Johan Unnerus: Can you take the view that it's rational to begin with Nepicon?
Penetration is it.
Can we take the view that it's a rough snow too.
Johan Unnerus: Epicon being a local targeted therapy with more perhaps support in the less impaired filtration. And again, I think it's very difficult to have any kind of clear view on this, because all we have at the moment is really just kind of, you know, top-line data related to proteinuria. I think that the changes between kind of 30 and 35 and ETFR are obviously clear. What impact that might have, we'd have to actually see the data in terms of subgroup analysis or stratified information to see if there is any particular subgroup that has a different, you know, a different.
Beginning of an ethical being.
Local target.
Therapy with more perhaps support in the in the less impact penetration.
I mean again I think it's very difficult to have any any China no clear view on this because all in all we have at the moment is really just kind of top line data related to proteinuria and I think that the changes between kind of 65 in Egfr, obviously, a clear at what impact that my top we'd have to actually see.
The data in terms of subgroup analysis are stratified information to see if there is any particular subgroup and that has a you know a different.
Johan Unnerus: a different kind of approach or a different effect or not. So I think at this level, you know, with a very limited kind of, you know, top-line data that's come out, I think we're not really in a position to comment on anything until we see far more detailed information and, as well, obviously, some impact on the EGFR. So long-term filtration rates in 2023 will be most interesting.
<unk> kind of approach will be different effects or not so I think at this level you know with a very limited kind of topline data that's come out I think we you know we're not really in a position to comment on anything until we see a far more detailed information and as well obviously some insights on egfr.
So long term penetration rates in 'twenty to 'twenty three the most interesting though.
Renee Aguiar: about Died and Denmark. Yes,
Are you in that market.
Renee Aguiar: Yes, I mean, obviously, we have provided some information on EGFR at nine months, which we believe is very supportive. I think that, you know, it would be interesting, obviously, for us to see the longer-term impact as well, you know, in early 2023 on the population, for sure.
Yes, I mean, I think that obviously, we have provided some information on Egfr at nine months, which we believe is a very supported a I think that you know it would be interesting obviously for us to see the longer term impact as well you know in early 2023 on the <unk>.
Populations for sure.
Renee Aguiar: And I think this goes for all development programs in IGA nephropathy. Obviously, we are all trying to treat the underlying kidney disease, and hence I think, you know, the impact on EGFR is obviously important under any circumstance. But yes, we are obviously looking forward to the longer-term outcome data that we will see in 2023 as well.
And I think this goes for all development programs in Iga Nephropathy are obviously, we are all trying to treat the underlying kidney disease.
And hence I think you know the impact on Egfr is obviously important under any circumstance, but yes, we are.
Obviously looking forward to the.
The longer term outcome data that we will see in 2020 three as well.
Thank you.
Yeah.
Operator: Our next question comes from the line of Christopher Udi of SEB. Please go ahead. Hi there, thanks for taking my questions. It's sort of looking forward to the next steps beyond me.
Our next question comes from the line of Christopher U D O S E P.
Go ahead.
Hi, there. Thanks for taking my question. It's so looking forward to the next steps be.
So again.
Christopher Winston Uhde: I again, and take the focus on Bedezanide here or Nethicon here.
And taking a the focus on it doesn't I hear or nothing on here.
Christopher Winston Uhde: My first question is, in terms of the AIH and PBC projects, I think, to contrast them a little bit with
My first question is.
In terms of the a H N P B C projects.
Well <expletive> to contract them a little bit with.
Christopher Winston Uhde: Again, where it's very clear that, to me at least, you've got trial data where you're targeted, approach
So again, we're it's I think it's very clear that.
Uh huh.
To me and he said that.
You've got trial data.
Where your targeted.
Uh huh.
Our approach on treating the source of the disease.
Christopher Winston Uhde: treating the source of a disease in IGA nephropathy is a little bit different from AIH and PBC, where you're
Judy nephropathy is a little bit different from the H M. P B C, where you're targeting the liver.
Christopher Winston Uhde: Targeting the liver and therefore any
Christopher Winston Uhde: B-designite, a generic B-designite as well, should, in theory, be able to target, get
And therefore.
It is not a generic.
Generic budesonide is well it shouldn't really be able to target are.
Christopher Winston Uhde: It, get the same amount of Bedizanide to that site. Is there, let's say,
You get the same amount of B does not to that site.
Hmm.
Is there a let's say.
Christopher Winston Uhde: same protection against interchangeability in those two diseases, would you say, as there is in IgA nephotopathy from generic
The same.
The protection against entertain interchange ability in those two diseases would you say Oh, there is an iga nephropathy from Kinner IP that was made.
Renee Aguiar: Sorry, a long-winded question. So I guess with regard to PBC, we have decided to proceed into a pivotal phase two, three, not with methacone, but with set an acid. So obviously, based on the, you know, phase 2A information that was obtained on Sethamacid in, we have made adjustments and, obviously, also been in conversation with the regulators. And so for PBC, we will really go forward and take it forward with regard to set an accident at this point in time.
So long with the lung into question, but.
So that's one thing.
So I guess with regards to the P. D. C. We have decided to proceed into a pivotal phase two three not with NASA con, but that's what I said.
And so obviously based on the phase Iia Ah information that was obtained on Stefan I sit N P. B C.
We have made adjustments and obviously also been in conversation with the regulators and so.
For P B C.
Will really go forward and take it forward with regards to sit down I sit at this point in time.
Renee Aguiar: With regard to AIH, you know, we have been in conversations with the regulators in the US regarding this, but also, in that particular program we would look to use, most likely we would look to use Dr. Fout, would have been in-licensed some time ago because, obviously, that was the actual compound that had clinical data, and there's a trial basically that's been performed already in AIS that showed benefits. over some kind of standard of care.
With regards to AI age.
I've been in conversations with the regulators in the U S. Regarding this but also in that particular program. We would we would look to use most likely we would look to use stuff the south with the in license.
I'm trying to go cause obviously again that we will see actual compound that has clinical data.
Hum.
Trial basically that's been performed already in AI age that showed benefit over kind of a standard of care. So so I think that that's really kind of our plants are in terms of both a H N. P. D C. At this point.
Renee Aguiar: So I think that that's really kind of our plans in terms of both AAH and PBC at this one time. Okay, great, that really clarifies that. And can you just comment at all on a bit more detail?
Okay, Great, that's really clarifies, but and can you just comment at all on on a bit more detail on the status of discussions with regulators.
Renee Aguiar: A bit more detail on the status of discussions with regulators around the AIH.
Around the E I H.
Renee Aguiar: for both the EMA and FBA. Actually, we're not in conversations with the EMA on this.
And the FDA.
Actually we are not in conversations with EMA and is it just purely kind of U S program that we're looking to them to do.
Renee Aguiar: It's a purely kind of US program that we're looking to do. In terms of those interactions, we've had good feedback. I think that, you know, we feel reasonably confident that we are able to agree on kind of a late stage program in AIH. But there is additional interaction that is required in order for us to be able to provide any kind of guidance in a public forum. So we will, I'm going to have to come back to that.
In terms of those interactions.
So we you know we have had good feedback I think you know we are now we feel we.
Oh, so confident that we are able to change.
It has changed to agree on kind of a late stage program NIH, but there is additional interaction.
That is required in order for us to kind of be able to provide any kind of guidance in a public forum. So we will have going to have to come back to you on that.
Christopher Winston Uhde: Okay, thanks. Can you just explain, by the way, why you wouldn't be seeking to work with the EMMs?
Okay. Thanks can you just explained by the way why why.
It wouldn't be seeking to work with the email list.
Renee Aguiar: Again, because it's actually a licensing agreement, we only have the rights for the U.S.
Again, because actually we this is a it's a licensing agreement we only have the rights for the U S.
Christopher Winston Uhde: Okay, great. Thank you very much.
Okay. Thank you very much.
Thank you.
Operator: Our next question comes from the line of Edwin Chong of
Our next question comes from the line of Edwin Zhang.
Edwin Chong: Chong of H.C. Royenwright said, Please go ahead.
H C. Wainwright. Please go ahead.
Edwin Chong: Hi, thanks for taking my questions. Congratulations on all the progress.
Hi, Thanks for taking my question Congrats on all the progress.
Edwin Chong: A question on the EU. Now you have a commercial partner in place in Europe. I wonder if you could comment more on this selection process. And if there's anything new that you have learned about the NEPCOM opportunity in the EU, in particular, what are your current thoughts on EU pricing on average compared to the US? Thanks.
Question on you know you have a commercial partner in Europe.
Wonder if you could comment more on the selection process.
And if there is something you got to you have learned on the netcom opportunity you can.
Puppy cooler what is your current thoughts on your pricing your average compare to the U S.
Yeah.
Renee Aguiar: Sure. So we conducted a kind of competitive process with regard to selecting our partner for Europe. And so this was a process that had a fairly large number of different parties involved. I think it was a very, very robust process. And we had some very hard choices to make towards the end of that process.
Sure.
So so we conducted a kind of a competitive process with regards to selecting a partner for Europe.
And so this was a a process that had a fairly large number of Ah different parties involved I think it was very kind of a it was a very robust process and we had a we had some very hard choices to make towards the end of that process.
Renee Aguiar: In terms of the selection of Stata, I mean, I think that this is something obvious. Stata is a very large organization. I mean, it is privately held, but it has over 12,000 staff. I mean, their revenues are in excess of $3 million on an annual basis.
In terms of the selection of sought out and I think that this is something obviously thought as a very large organization and it is partly to help itself, but it's the over 12000 stuff I mean their revenue saw are in excess of $3 million on an annual basis.
Renee Aguiar: They're very profitable, and they have a very strong, you know, kind of strong presence across Europe, and particularly a very strong presence in Germany, which is obviously a key market when it comes to launching products in Europe, also with the help of Christ. And this is obviously also something that is, you know, that we believe is strategic for them in terms of their focus that they are building up. They're building up their pillars both in terms of kind of OTC as well as specialty products.
They're very profitable and they have a very strong a strong presence across Europe, and particularly a very strong presence in Germany, which is obviously a key market.
When it comes to launching products in Europe are also with regards to pricing.
And this is obviously also something that is you know that we believe are strategic for them.
In terms of their focus that they are building up.
They're building up their pillars, both in terms of kind of OTC as well as specialty products.
Renee Aguiar: And I think this is a good fit with regard to the efforts and resources that they're investing in their specialty products division. In terms of pricing, again, I mean, obviously, this process ended not fairly recently. And so I think we're going to have to wait a little bit in order to give Schroda a little bit of time to provide more guidance in terms of how they have looked at, you know, potential pricing in Europe.
And I think this is a good fit with regards to the efforts.
It's just that they're investing in their specialty products division.
In terms of pricing again, I mean, obviously this is a process and it not a fairly recently.
And so I think where we're going to have to wait a little bit in order to Davis.
They just felt a little bit of time to provide more guidance in terms of holiday looks huh.
And I was just you know potential pricing in Europe, and so again I think we're gonna have to come back to you with more information on that.
Renee Aguiar: And so again, I think we're going to have to come back with more information on that. All right, in the US, I assume you have passed the manufacturer facility inspection at this time. In terms of production, are you ready to meet market demand after approval? I hope the pandemic does not impact the supply chain and drug production. Thank you.
Alright.
Uh huh.
Assume you have talked to the manufacturer, especially to your production at this time.
In terms of the production.
Are you ready to meet the market demand after the approval on hopes of the pandemic does not impact our supply chain and the production. Thanks.
Renee Aguiar: We feel that we are very well prepared on all fronts with regard to the kind of supply of product, you know, for the commercial launch. And so I think that, you know, there are obviously a lot of activities and a lot of things that have been planned and put in place over a very long period of time in order to ensure that we are in a position to do that.
We feel that we are very well prepared and on all on all fronts with regards to kind of supply of product.
For the commercial launch.
And so I think that you know they are they are obviously a lot of activities and a lot of Oh kind of things that have been planned and put in place over a very long period of time in order to ensure that we are in a position to do that.
Renee Aguiar: Obviously, there are, you know, there are always things that can happen in a supply chain, obviously, but I think that we feel very good about where we are in terms of the preparations that we've made on the supply chain side. Great, we look forward to positive news in the coming weeks. Good luck.
Obviously, there you know there're always things that can happen in the supply chain clearly.
But I think that we feel very good about where we are in terms of the preparations that we've made on the supply chain stuff.
Great. We look forward to the positive in Europe again, becoming big good luck.
Edwin Chong: positive news in the coming weeks. Good luck. Thank you. May I remind everyone that if you would like to ask a question, please press 01 on your telephone. And there are no further questions at this time. Please go ahead, speakers. Thank you.
Thank you.
My own remind the room, but if you would like to ask a question. Please press zero one on your telephone keypads.
And there are no further questions at this time. Please go ahead speakers.
Thank you very much. Thank you all for participating in the Q2 report and we look forward to speaking to you again.
Operator: Thank you very much. Thank you all for participating in this Q2 report. We look forward to speaking to you again at the end of the next quarter.
At the end of the next quarter. Thank you.
Operator: Thank you.
Yes.
[noise].
Okay.
Yeah.