Q2 2022 Pharming Group NV Earnings Call
Hello, everybody and welcome to the farming first half of 'twenty to 'twenty two results my.
My name is Sam and Ob coordinate vehicles a day.
If you'd like to ask a question during the presentation you may do so by pressing star followed by one on your telephone keypad.
How do you guys do your host some enterprise the sea Eagle farm into begin Simon. Please go ahead.
Thank you very much Sam good morning, or good afternoon, ladies and gentlemen.
Very pleased to bring you the first half results for 2022 today and before I do that I would like to draw your attention to slide number two the forward looking statement slide.
Because this presentation may contain forward looking statements and as you know forward looking statements are neither historical facts, nor assurances of future performance. Instead. They are based upon our current beliefs expectations and assumptions regarding the future of our business future plans or strategies or the government bonds on clinical results and other future conditions.
Please take note of that.
And then I would like to move on to the next slide and I will be presenting today. These results together with my two colleagues Dr. <unk>, Our Chief Medical Officer, and you didn't walk among our Chief Financial Officer, So, let's move to the first bit and take a look at the strategic and operational highlights.
And as you have seen today and that is on slide number five you can see that.
We have formulated some strategic objectives.
<unk> are slightly different than what you were used to over the past years, because we've done a thorough review of our business. During the first half. This year. So we're really focusing and there's nothing new here on building a sustainable business by focusing on the <unk> sales of maximizing news.
Furthermore, we're focused on marketing approval launch and commercialization of linear ownership in key markets like the U S U K and the European area.
And last but not least we're looking at on Lai ongoing pipeline development and management of the rare disease assets and that means that and you can see that on the next slide number six and we are now really focusing our business to become a business that is focused on you being sustainable business.
Stable business that is focused on rare diseases and on the left.
<unk> side, you see the most important pillar that hasnt changed at all the engine of our business continues to be refinanced and refinanced is and will be providing the positive cash flows that will help fund all the Lady oldest ship development plans and all the pipeline development plans that we currently have in our portfolio.
So.
And we do not my eyes as said before 40, focusing on the maximization of commercialization of <unk> in all major international markets with our own sales forces.
And on the next step in the middle of the Slide you see there the middle pillar and that is the successful commercialization of many ownership.
The lifecycle management of future indications and lineal Zip.
Is going to be introduced for its first indication subject of course to regulatory approval.
Is it new disease, a P. S N Doctor Anorak Roland will talk to you about that a little bit more in detail later on and it is a rare.
Primary immune deficiency, and we believe going to literature that there's about one and half in 1 million.
Of the population that is suffering from this disease, which means that if you estimate that you will come to around 1350 patients in the U S Europe and Japan.
And we have already without any a systematic searching activity so far identified more than 400 potential Ah patients and we keep finding them.
On a regular basis before.
Before we have really started.
Systematically searching for these for these patients and to give you. One example in an informal registry in France, we have identified some 60 potential patients, which means that already and that's of course very important when you go into a rare diseases recently discovered.
That is already one of them that means that we have already one in a million identified. So we expect therefore, not you know at least some thousand patients. If you add them all up together for the U S Europe and Japan.
Could we could well be identified and that is like I said without any systematic searching and that might be well be more because it's a new disease again.
In addition to that.
We have discovered that and that is the good work of Novartis from which we in licensed the product. They have done extensive research collaborations and looking at other possible opportunities for linear ownership and we are determined and we are making up our minds at the moment, which one would be the most favorable one to develop going forward and we will be providing you with <unk>.
And using that in the near future hopefully about at which new additional.
Shipment program for linear ownership.
We would we will be starting.
And then last not least on the right hand side, we are and we will continue to be hunting for new assets and the market new assets that are able that we are able to launch within the coming say three years from the moment of acquisition. The so called late stage clinical.
It's in late stage of clinical development through in licensing or merger and acquisition opportunities and then of course. The early stage of our pipeline will continue to be developed namely O T. L. One O five our ex vivo hematopoietic stem cell there.
Gene therapy candidate for Harry Jerry Angioedema, and last not least the crew to prudent development of our recombinant off of glucose today's enzyme replacement therapy for Pompe disease. So that's.
Let's look at Soma, the strategic highlights in the linear lucid progress on Tonight and was seven so we're very pleased today to basically report you that we remain on track for the commercial approval of linear ownership in the U S UK and Europe and in the USA and you've seen in the branch lease that we recently filed the NDA with the FDA.
On the 29th of July .
We also have received and it is very important, especially when you're dealing with a new disease that we have received the ICD 10 classification for a P. D. S. That's of course very important because it's a new disease and if you're unable to actually describe to disease. It means that patients can be classified as such.
And that you can actually start discussing with insurance companies for instance, about the reimbursement all such products in the radios once ninos. It comes to the market. So very helpful and very important that we have actually achieved this milestone in the United States already.
And we believe that.
We remain on track at this point in time for the anticipated commercial approval by the FDA in Q1 2023, because as you well know.
Of course subject to the FDA granting us the accelerated review.
It means that within 60 days after 29 to July the FDA will come back.
With a letter confirming the status and the acceptance for review and.
If the accelerated.
Review is granted then six months after that the Paducah. So called <unk> date is June which means that it will be by the end of March which means that we are on track to hope we got the approval to enter the U S markets in the in Q1 of next year and on the right hand side you see the progress we have made in the United Kingdom.
And at the European Union during.
During the first half of this year very early onwards, we received the positive response from the European Authority on the Patriotic investigation, but very important of course, because it said it is a disease that is also has a lot of pediatric patients and although we already have the adolescence from.
12 and onwards, coupled in our current and our current.
Uh huh.
A regulatory file is of course important to also start pediatric trials for those children.
From one onwards as soon as possible on top of that the Europe . The Europe . The UK authority granted all Steve promising innovative medicine designation for the treatment of Aps for children in one year of age from one year of age.
And that is of course, the similar type of.
Agreements of approval that the Europeans guide was for the U K.
Then we were very pleased of course that.
And as earlier announced it this isn't as announced earlier this week that the EMA granted <unk> accelerated assessment.
For our current file and as you have seen in the press release, we're aiming to actually bring the file to the EMA in October of this year. So we remain on track that for with the filings for EMA and the U K authority in the second half of 2022.
Now, let's move limits further towards the back in the in the pipeline in the early stage compounds a few words about dogs.
Two O T L. One O five.
On slide number eight you can see that we.
We make we are making significant progress together with our partner Orchard Therapeutics, who are responsible for this part of the collaboration in enhancing the expression levels and the of the lengthy viral vector and that will give us sufficient.
C one inhibitor expression.
N D M in the AR.
In the stem cells and we are now testing. These in preclinical disease models, and we look forward to and to providing further updates as we move towards preparing and I. So called I N D filing which is other words technical word for the approval to start human clinical trials and on the <unk>.
Right hand side Pompeii, we continued to work on a next generation of our glucose of days.
From our own transgenic platform for the treatment of Pompeii and we're currently engaging some preclinical studies, where we will seek for differentiating features versus the current standard of care that is.
That is on the market, Florida for Bombay and as soon as the results become available we will update the markets on this.
And then let me move to slide number nine are about the programs. We are discontinuing the both of the programs acute kidney injury in preeclampsia.
With regards to preeclampsia, we we had to conclude that.
Discontinuing further investment in development is the best way forward, which is we think very unfortunate, but it has to do with a combination of the difficulty in getting clinical trials going and a very lengthy and costly developments are.
Very lengthy and very costly development.
Lends it won't has to make for a search indication and the same thing goes for acute kidney injury, we have decided to de prioritize the large scale production. Therefore of C. One inhibitor are afforded in Florida.
From the generic cattle herd because that is not necessary for dairy and Jodi Mark we have sufficient more than sufficient production capacity in Agra rabbits transgenic model for territory angioedema.
Because the metrics deep prioritize of course, the herd will still be maintained because we're looking for strategic options to actually see if someone wants to in license.
This compound to take over these assets from us and that means that also the phase <unk> clinical trial in AK items currently running a Switzerland will continue while we consider other strategic options that we are creating as we speak and of course, we will update the market in the future as and when news becomes available about such such.
Options that may become available.
And then I'm coming to the end of the operational highlights here on slide number 10 with regards to <unk>. We're very pleased that we were able to book almost $97 million of sales in first half of 2022.
In line with the with the guidance that we gave to single digit increase in sales for 2022 version in 2021, and we're very pleased that this is supported by an underlying positive trends of what we talked about before an ever increasing number of physicians prescribing <unk> and an increasing number of patients.
Using <unk>. So we see it ought to do is a continued need for safe reliable acute treatment options for heritage and new demand. Despite the effect of course that the market is moving has moved to prophylaxis.
No doubt all prophylaxis treatments suffered from 144 more or less from breakthrough attacks and Ed.
And safe and reliable acute treatment options remains.
Option remains necessary.
What you can see here is of course that as usual the market.
Is the main market driving the refinish sales continued to be the United States and that's of course you know.
Inherit area into demand not only for us, but for everybody in territory and your demos.
And it means that <unk> can continue to develop continue to give us the stable revenues, which bill and I.
It will allow us to allocate resources to gilenya only send button.
With a few of accelerating future growth by through linearity soup sales and we continue to give guidance last not least for the rest of the year too.
To for single digit growth versus 2021, Florida for refinanced sips and it's important to note that <unk> supports therefore, the possibility and thats important wider while any ownership. So important it will support the fact that we are morphing ourselves from a one product company that is depending on the major mainly one geography.
<unk> towards a two products.
I'd, probably that is depending on multiple geographies, namely United States Euro.
Europe , and Japan and that is I think a very significant step forward again with significant transformational process in the middle of which the company is Sterne Agee. So thank you very much. This is the first bit and I'll now hand over to my colleague Dr. Unranked RASM to give you a bit more insights into a P. D S and linear ocean overdue interact.
Thank you Tom.
What I'd like to do today is quickly review some of the critical features that EPS walk you through some of the data that we've shared earlier.
All of our plans with that data and then I'll talk a little bit about the future with linear Olson.
As you know Aps is a rare serious primary immune deficiency that affects both b and T cell development and it's caused by variance in the genes that encode sub units.
<unk> K Delta and dry complex.
As a result of those variants each patient with Atvs.
Two key features and we'll talk about those features in terms of what that causes in terms.
Clinical aspects of the disease, but also what it causes and what we looked at specifically in the clinical trials.
So the first feature is Olympic proliferation of this again.
The abnormal development of these being on T cells, and what that means local proliferation.
So we will look at also with Adenopathy Youll see a large screen deliveries and you can also see what's called lymphoid hyperplasia in different parts of the.
We closed off the air.
Airways as well over in the Gi tract.
That in and of itself is problematic for the company.
More serious when that becomes called malignant.
And that can lead to something called various types of <unk>.
And you'll see the list of lymphoma.
<unk> patients and we do know that number of these patients develop Oklahoma.
Years of Oliver proliferation going on unchecked.
At the same time, what those local proliferation you also.
Probable.
Fee and immune deficiency, each to infections and as a consequence of the infections we see.
A lot of the same issues that you might expect in terms of the mobile.
On top of that a couple of Butler proliferation.
A confluence of infection and linker proliferation.
With serious problems again Gi tract.
Causes liver issues.
And at the same time, there is an issue with autoimmunity.
Various parts of this condition, where the B and T cells are not working properly.
Don't develop properly don't mature properly it leads to a number of serious problems.
And outside for tool what we can see is the results from the double blind placebo controlled study that reported earlier this year and specifically, we see that linear wholesale reduced <unk>.
That Napoli.
One of the hallmarks of the disease, where we see those unchecked proliferation of these patients will see a statistically significant result, and the co primary endpoints there in <unk>.
So the size of the lymph nodes in these patients.
Relative to placebo.
On the right side, you can see that on an individual patient basis again.
And in those patients on the left side in dark blue.
Let me also for three months versus the patients on placebo, who did not.
Similar improvement.
Global co primary endpoint is on slide 14, where we can see the improvement in the percentage of naive. So naive b cells are important because these are b cells.
Properly matured properly and as a result.
Sections.
Nobody will encounter.
And you'll see again statistically significant result on the left in terms of where patients treated with any wholesale versus those patients treated with placebo and importantly, as you can see on the right panel is that this starts very quickly.
Patients with lineal proportionate why you'd be felt increases rapidly and sustained over the course of this three month period versus the patients on placebo don't have that increase.
And so what's the relevant tools.
<unk>.
That these patient b cells network functioning properly.
Those two functions and developing properly.
Fight infections.
Soften the earlier slide the consequence of having those infections repeated basis.
On slide 15, we can see it in general and you also was safe and well tolerated over this three month period.
You can see the grade of the adverse events that were reported and when you also patients versus placebo patients.
You'll see that they are very similar in terms of severity. There were no deaths reported in this study with no adverse events that led to discontinuation of study treatment or no serious adverse events that were related to the study treatment and in general the incidence of serious adverse events were lower when you're also treated patients.
He was treated with placebo.
And then lastly, what we have on slide 16 are some results from that.
Long term use of logs.
These data here are the data from the initial cohort of six patients and these patients now have actually been on therapy.
For several years, which is the data from the first two years and you've.
See that IGF levels in these patients in general are increased at baseline and will begin treatment with linear Allison you start to see improvement and normalization of their IGF levels and then in some cases, we will consume the dashed line, where patients were not able to confirm.
The new therapy, we start to see their IGF levels go back up to normal resume therapy, you'll start to see those levels go back down again.
We'll have data actually going.
Obviously on these patients going out several years well beyond two years up to six years in some patients and on top of that we have from a broader group of patients.
From those who were in the initial double blind placebo controlled study continue to the extension study and we anticipate being able to share that data later this year at various scientific and medical conferences show similar results.
An improvement in.
The function and development.
Immune system over longer periods of time as well as in a larger group of patients to show that over time. When he also is well tolerated.
I think again that you might say well what is the consequence of this.
IGF levels come down while these patients.
IGN levels are increased because the b cells are not transitioning properly paas himself not transitioning properly to produce <unk> and thats why their IGF levels were high and interestingly enough we're not surprisingly.
IGN levels come down we also see that these patients are able to stop or decrease the use of immune globulin supplementation services.
B therapy, such as <unk> and.
And this reflects normalization of winter.
Cell function.
Overall, what we see is a.
The improvement in these patients immune system development over the short term.
Staying over longer periods of time when treated with laidlaw.
The therapy that seems to be quite well tolerated and we look forward to on slide 17, you see our claims with lending also we filed our southern mentioned the new drug application with FDA with last week.
We anticipate further filings.
In the UK later this year.
And as I had mentioned.
<unk> is a condition that affects children and we have children enrolled as the youngest age 12 and the clinical trial has been.
Completed, but we also.
We anticipate being can start pediatric settings. This year one of their children, which I think is going to be important to be able to change. The course of this disease over a longer period of time.
You also heard Simon mentioned.
We completed regulatory milestones for next year, but we're also planning to start.
Clinical study in Japan, because again, there are patients that have been identified with EPS.
Limited treatment options.
And we think this will be an important therapy to be able to offer to those patients.
So quite a bit of things happening over the past half year as well as coming up over the next one to two years with linear Allison and I look forward to updating you more on that as we move forward.
With that I'm going to turn it over to my colleague Jerome Walker.
CFO .
Financial highlights.
Thank you very much.
Right.
Please turn over to page 19 operation.
So we had a good first half of 2022 and that is reflected in a number of financial Kpis are revenues went up 4% compared to the first half in 2000.
'twenty one.
Net profit increased by one third to compared to last year.
We had positive cash flows although offsets.
Exchange rate effects.
We did an important transaction in the first half of the year, we reduced our stake.
And by a connection our manufacturing partner.
In that transaction we received.
A one off cash payment of $7 $5 million and we recognized a gain of $12 8 million Dulles and I will go through the details of that transaction later in the presentation.
<unk>.
Moving to slide 20, and the financial highlights of Q2 2022.
Revenues went up from 49, 7% to 50.1 million U S. Dollar so that's an increase of 1%.
Gross profit $46 1 million, which is an increase to two 4% versus last year.
So a good development in gross profit.
Operating profit at a spectacular increase from $10 9 million to $17 eight and that is amongst all this driven by the.
By a connection transaction and net profits.
Was 515.7 million.
Increase.
Almost.
$1 million versus the same period last year.
Then the first half of 2022 and the financial highlights of that periods. So the total revenues went up by <unk> by 4% that as mentioned by Simon It will supported by more.
More doctors prescribing refinished and serving more patients.
The gross profit increased in line with the revenue, even slightly better to $87 $9 million.
And that means a gross margin of 91%.
And the operating profit increased by 20% to $20.6 million.
And that includes an increase in Opex more details later.
And offset by the gain on the disposal of the bio connection shares.
And the net profit for the first half EBITDA also increased by 33% to $19 2 million U S dollars.
Sure.
On the next slide a bit more detail on what happens in terms of the of the profit.
So the profit before tax increased in the first half of 2021 from 20 million to 23.8 million you will see when the slight comes up the the drivers of these of this growth in profit before tax.
First the underlying business the gross profit increased by $4 1 million.
Because of the increase in revenue and also because of the higher gross margin.
We spent more on R&D in the periods ends are in total $5 1 million more than last year.
And the two key drivers of that was on the firsthand Lenny ownership. So we are as we announced earlier we are increasing our spend on linear ownership. This is amongst others. The.
Manufacturing.
The preparation.
But also 1 million more on O T L <unk> five.
The product that we are developing together with the Orchard therapeutics.
We had an increased <unk>.
Spending your own on G&A that was.
Mainly related to phasing.
And.
We had an increased spending on marketing and sales and here again the key drivers for this increase is linear ownership.
Think about the activities to find patients.
So the $6 three out of the seven eight is because of the Daniela ship and the remainder is basically in more trouble calls that our people spend is visiting more doctors than we could last year from the from the backlash of Covid is still at the time.
Financial results are $1 2 million up and the $12 seven other is mainly by our connection that transaction with the profit of disposal on 12 of $12 8 million U S. Dollars. So overall profit before tax for the first half of 2022.
We're at $23.8 million.
Then moving to slides 23.
A development of the cash flow the cash flow was fairly stable went down slightly from $191 $9 million at the beginning of this year to $190 million at the end of Q2.
And we generated $4 6 million from operating activities and that is the normal operating cash flow, but also some in some increase in working capital, especially in the inventories.
The net cash flow from investing activities.
Was mainly from.
The cash that we receive for buyer connection as I mentioned before $7 5 million and we had $1 6 million of normal the normal capex, sorry normal capex.
And on the financing our cash flow the $3 3 million negative that was the usual interest on loans and lease payments and what have you and the negative exchange rate effect in the cash of $9 2 million.
Basically from the cash that we have in a euro functional currency, so with that the cash and cash equivalents ended up at $190 million and that is a good war chest for either buying more.
Licenses or two to spend on the M&A activities.
Then a little bit more detail on the next slide on the buyer connection transaction.
Obviously, it had a very positive financial impacts.
And.
What was this deal about well, we bought the stake and buy a connection in April 2019 for an amount of $4 1 million and that represented 43.85% of the shares and buy a connection.
In April 2022, so three years later.
We did several transactions first all of the transactions were sold follow it and that was followed by a partial reinvestment of 22.98% in bio connection.
And we received a $7 5 million cash payments.
So if you look at the.
Blocks at the bottom of the slide you see at the end of Q1 2022.
Value on the balance sheet that we had for by a connection was valued at the net equity value. It was just ordinary shares $6 6 million.
In the transaction we kept.
Part of the buyer connection holding and that is calculated at the bottom our share versus the original $6 6 million that is now $3. Five so that is still being valued the ordinary shares at equity value.
Then the value of the pressure is to fair market value was $8 4 million and we received $7 5 million in cash.
So the total value represented in the transaction was $19 4 million and as the initial value was $6 6 million the gain on the disposal was $12.8 million, which is.
Non taxable.
So overall, a very positive transaction on bio connection we keep related to bio connection we are still a minority shareholder and will support future growth.
But.
We're very happy with this transaction overall and with that I would like to hand over back to Sam.
Thank you very much share you Rune and yes, then we come to the end of this.
Part of the presentation of the of the meeting by.
Looking at slide number 25 for the outlook of the remainder.
As I was stating before we continue to guide for a single digit growth in group revenues from <unk> sales for the remainder of 2022. However, it could be quarterly fluctuations also as a result of.
Hope, it's still being in that being a potential issue.
We remain as stated before we remain on track with the regulatory filings to EMA and the U K authority in the second half of 2022 as stated.
To bring it to the EMA in October .
Commercial approval for Lady ownership.
Subject of course to the positive outcome of the FDA review and the granting of the priority review is envisaged to take place at the end of Q1 'twenty three.
With an anticipated launch and commercialization of the U S. Starting soon thereafter.
In the next quarter.
And then as we stated before we continue to allocate significant resources to watch the anticipated launch and commercialization of any ownership.
And last but not least.
The investment and continued focus on potential acquisitions and in licensing all of those new late stage development opportunities are in essence in rare diseases is a very important and remains a very important part of our activities and our focus.
And with that I would like to continue this presentation part of the meeting and hand over back to the operator.
For to answer any questions that you may have thank you for your attention.
Thank you if you'd like to ask a question. Please press star followed by one on your telephone keypad now if you change your mind. Please press star followed by cheap when preparing to ask a question. Please ensure your line is on mute it locally.
Our first question comes from Jive, Thank goodness from H C. Wainwright Joe Your line is now open. Please go ahead.
Hey, guys. Good morning, and good afternoon. Thanks for taking the question so first.
But maybe a little hey, there.
Little housekeeping, so with regard to the decisions for acute kidney and preeclampsia I was just curious.
How meaningful are the maintenance cost for the cattle herd because I can totally understand why you need to have that for potential pipeline expansion, but I just wanted to have a sense of the cost.
Yeah. The good news is Joe.
Cattle and we don't have we don't need that many comps to actually produce significant amounts of C. One inhibitor to support those bigger indications also and of course, whilst the program is still in our clinical trials.
It is a relatively minor amount of cattle. So the costs are not that to maintain that cattle herd or are not at all that significant hence of course and that is of course, because you know if you wanted to sell an asset.
And then you keep it intact is S as intact as possible. Hence why it is it was it is not a very difficult decision to maintain the herd a switch that you can offer not only not phase two b clinical program, but also to hurt that actually Kansas sustained not that that program in the long term.
That answers your question Jim.
It certainly does and then just switching to linear oldest fib.
It was.
I think very important news that you guys were assigned to diagnosis code for Atvs. So I was just curious.
Have you before that even happened can you describe any levels of conversations that you've had with any of U S carriers and what you're planning now to be able to ensure the most efficient launch.
And potential reimbursement through carriers.
Yeah, Yeah, I can tell you a little bit about that.
Yes, we have of course started to discuss this and as you rightfully point out.
Having an ICD 10 code is not an easy it's not an easy task to get for a new disease and they don't give these things out very lightly, especially for rare diseases. So we were very pleased that we both got a recognition that a P. D. Edge is it is it rare and severe disease and hence needs an ICD 10 code and of course with that in hand.
And we are now preparing.
And actually have them over the coming over the coming time to have these discussions with those with those carriers to make sure that as and when the product becomes available it is readily.
It can be readily pneumonia patients are classified but also the a b carriers can move quickly.
In terms of reimbursing the products. So yes, we are very much working on that and I can tell you also that we receive generally a very receptive audience in that respect.
No. That's helpful. And then just quickly I guess.
As Ana Rog.
Alluded to in his prepared comments with regard to the pediatric program. I believe you mentioned that the program would be starting this year any other details with regard to sort of the size and potential timing to be able to get that supplement into the FDA.
And Mark could you could you take that question. Please.
Sure Hi.
Hi, Joe So, yes, we're quite exactly two clinical trials to be able to treat children and in the first study would go down.
Ages as young children with agents.
With a score and the second study would go down to children as young as age one.
In both studies.
We're planning to start as quickly as possible.
At least one of them this year in terms of treating the first patient.
Five of the studies.
These are against studies that are the size.
Why would the rarity of the condition.
So they're not large studies.
And we haven't given any guidance in terms of when we anticipate completing those studies as we move towards getting those first patients will be able to give you more look into the future in terms of when those studies will be completed as well as when we'd be able to file supplements to gain.
Younger population.
Still helpful color and thank you guys.
Thanks Yale.
Our next question comes from Hot testing from Oppenheimer <unk> co.
Your line is now open. Please go ahead.
Great. Thank you for the questions I just have two quick questions and really nice update and congratulations on getting ready to file.
When you listen to the United States.
One question is on linear listed.
And Rob.
Simon John as Youre doing research on what would be appropriate comps.
From a pricing perspective can you give us any color. There are insights also your pharmacodynamic modeling.
That you'd probably downward with linear let's say it is not offering any.
Any insights also as to how you think about this product and how the <unk>.
Yes.
And then secondly on <unk>.
Increasingly.
Competitive field with a lot of new market entrants Simon how are you thinking about lifecycle management for <unk> going forward.
Hello, Thank you for the question.
Okay, maybe I start with the second question first and in that case.
Our tonnage with regards to <unk> there is no additional lifecycle management.
And lifecycle management projects planned nor in progress.
<unk>. This we stayed as continues to feel the.
The unmet need, especially for those patients that are severely affected by our heritage and Eudemon, which are not sufficiently on all helped by any of the other products, including prophylactic therapies that is has has been the sort of main stay of on and off on them of our patient population in the Boston and continue.
Used to be an important part of not despite the fact of course at there has been much better therapeutic options, Florida for prophylaxis on the market.
Having said that.
What we now see as well is in that as a continuing trend while we also see an ever increasing number.
And patients coming into <unk> and prescribers, you're using weakness is the fact that with the shift.
The paradigm.
And paradigm for prophylaxis shifting over the last few years away from C. One inhibitor towards Bridie Keating Kelly Green inhibition.
It has become very clear it will be coming more and more clear not choosing a C. One inhibitor as breakthrough therapy is a rational choice and that is the underlying trend that we see and therefore, we continue to believe that as long as there is you know bradykinin iconic <unk> inhibitors and that is the.
The only thing that's being inhibitor is being developed as we speak also to new future products. We continue to believe that there is a significant opportunity remaining for <unk> as the only see one of history's inhibitor on the market.
For acute treatment, hence why.
We decided that and that is the matter of the natural.
The way how C. One inhibitor functions the biological half life.
Is determined.
You need to dose once or twice a week with these kind of products. If you want to go into prophylactic therapy. It means that you cannot compete.
Competing on.
Hum convenience with C. One inhibitor, hence why it doesn't make any sense to continue to should do not in our markets is driven mainly by convenience. So strong spots that we have is remains in a strong spot and therefore, we.
We have conclude that that's the best way for what to do to continue to manage and commenced.
With regards to any ownership.
Yes of course, we are doing a lot of work with regards to Pharmacopeia economics.
The value actually Lennie ownership gunmen it can bring.
To patients and to the health care system in general.
As you understand from the complexity and the severity of the disease. These patients consume broader launch.
Mounts off of health care resources and also has a.
Hum.
Roger.
Diminished quality of life of course, because they spend a lot of time.
If.
If they are lucky that they get diagnosed they spend a lot of time actually in hospitals at various.
These type of clinics. So basically speaking, yes, we're doing that and we have of course, not yet decided on pricing for the compound because we are in the middle or not but we are determined to basically.
<unk> prices.
Bryce this kind of product in a in a typical way for these kind of rare disease compounds and of course, we will further update the market as and when the product becomes available in the market I hope that answers your question and high touch.
Yes, those are great Simon. Thank you so much and that's on a rock in utero.
Thank you.
Our next question comes from Simon skull to first Berlin.
Someone your line is now open. Please go ahead.
Yes, Hello, Thanks for taking my questions are difficult too.
I mean, I think you had 59 marketing and sales personnel ever all at the end of last year.
I was just wondering how many.
Do you expect to have by the end of this year and how many you might have by the middle of next year by the time lineal the cities launched.
And then secondly, you've also had been alluding to a possible capital market access to finance future acquisitions.
I was wondering.
If you can comment on the likelihood of that.
But any future capital market financing it will be non dilutive.
Okay. So the first question Simon.
We just.
Hired or are in the process of hiring an additional 25.
Our people our colleagues in the United States here to actually go.
Start out a more systematic patient identification.
Identification.
Possibilities and disease education.
Those those are those colleagues will be tuning intuit salesforce in.
And after the protocol has been approved.
That's that would be no additional changes in that and if you think about the expansion for the European commercial presence I would say that we're sort of lending.
A lot less in that respect, but I would say that the combined.
Chris probably below 10 initially for the coming in are coming at a time in and let's say looking at 'twenty two in 20 years.
Okay.
Okay.
Done with regards to your question about.
Acquisitions and capital market access.
Yes, we believe that we have access to significant amounts of non dilutive capital.
Given our.
Our balance sheet.
And given our commercial our commercial performance.
We do not only believed that we know that.
And you know as and when we find interesting.
Interesting M&A opportunities.
Dose.
We'll possibly also be financed of course with the body does kind of non dilutive.
Financing on the other hand.
That depends of course on the science of such an M&A transaction.
We have of course taken to NASDAQ listing because of the fact that we have a currency in hand, with the NASDAQ shares which.
Which is well recognized in the U S of course, and which we also think conserve too.
Paid for such acquisition.
And also changed the shareholder base as a result of that.
Drive a lot more liquidity to launch the NASDAQ market that also remains of course.
Yeah.
A distinct possibility and it depends of course on what kind of transaction, we do with regards to the likelihood of that yeah. That's a good question.
It is of course relevant.
Only when it is 100% what I can tell you not on a regular basis.
We have evaluations and we have due diligence ongoing and we have further.
Even further.
The discussions with potential parties, because it's a very interesting time to put it mildly to be in the market now of course with a lot of the industry suffering from the current drought shall we say all of the capital markets for the for the biotech industry in general, Hence, we are eating and not unfavorable position.
Despite of course being hurt ourselves in terms of market capitalization, but still we are in and not unfavorable situation, we feel and that's where I V.
Increased even though our activities.
To look for in licensing Smash M&A opportunities.
Long winded answer I apologize.
No that was very interesting thanks very much.
Vision.
As a reminder, if you'd like to ask a question today. Please press star one on your telephone keypad now.
Our next question comes from the line of Jacob Macau from Kempton Jacob Your line is now open. Please go ahead.
Hi, there and thanks for taking my question I've just got two today.
What are the factors that drove your decision to deprioritize kidney injury and have you already have conversations regarding licensing of the athlete.
And my second question is how soon after approval can we expect sales to.
The ramp up in the U S and EU.
Yeah. The audio was not very clear, but I think you were asking a question about if we already had discussions discussions with regards to the 8-K I did you know.
Uh huh.
Is that right.
Yes.
No.
No. We recently took the decision and we have not yet entered into any discussions we have some potential targets in our minds, but we still need to approach those and we will do that as soon as possible obviously.
Secondly, Jacob with regards to our deep sales.
Let's assuming this Purdue for day to all of the end of March typical for industry typical industry practice is that in the United States. Obviously, you have to you cannot import your drug before you have a.
Positive Paducah.
Results from the F D. A so it means not a theres a number of your logistical.
<unk> have to work and you also of course have.
To.
Repair a few other things, but I would say typical for the industry would be that.
Somewhere within two months I would say from the producer date, you should see the first our sales and we have every intention of course to stay within the kind of industry standards going forward, we're working very hard to preparing ourselves for the for such a for such entry of the commercial sales.
So I hope that answers your question.
Thank you.
Gotcha.
And there are no further questions. So I'll hand back to Simon for any closing remarks.
Thank you very much for the year and yesterday evening gentlemen, Thank you very much Florida for attending our conference here over the first half result.
I would like to remind you that we are.
Finding the company in a very important point and it said, it's timing of big transformation from being not at one product one geography company wants that's a multiple products and multiple geography, a company to build a sustainable commercial unprofitable business.
And for the shorter term we of course continue to give the single digit growth.
Guidance for our revenues.
Regulatory filings since we discussed that we are on track with and we aren't expecting to commercial approval subject of course with the FDA granted <unk> priority review and a positive outcome in Q1, 'twenty three and we continue to significantly invest in the preparations for the launch of a lady ownership and last but not least.
Because we are have the capability to leverage our commercialization.
Our corrupt is both in the U S and in Europe with more rare disease products, we continue to hunt aggressively.
You get additional in licensing opportunities.
The mini oldest ship that we can launch within three years from the acquisition Audion magazine and or the M&A transactions.
Of such assets that are that we can launch we do not we know three years from now.
Thank you very much for your attention and we look forward to updating you on our next location with.
Macau reset with our results. Thank you very much goodbye.
This concludes today's call. Thank you for joining you may now disconnect your lines.
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Okay.
Okay.
Yeah.
Yes.
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Yes.
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