Q1 2023 Pharming Group NV Earnings Call
[music].
I don't know if the body and welcome to the farming Q1 results Conference call. My name is Sam and I'll be your coordinator today. If you have a lot to ask a question. During the presentation you may do so by pressing star one.
Thank you Pat.
Now how do you guys Joe.
So im going to freeze.
To begin please go ahead.
Sam.
Good morning, or good afternoon, ladies and gentlemen, welcome to our first quarter 2020 results call.
Before I go into the call I would like to have the next slide and show you. The forward looking statements might as we will be making some forward looking statements.
That are based upon our future expectations, and our current expectations and assumptions and as you know they may they may change the future.
And without having said that next slide please.
I'm here with my three colleagues Andre <unk>, our Chief Medical Officer, Steven <unk>.
Our Chief commercial officer, and you don't walk them on our Chief Financial Officer, and David will be speaking after me and I will split.
Brief introduction. So next slide please and then the next one as well.
So basically what farming is all about.
We are building a sustainable business and their business.
We'll be able to be funded.
From the cash flows that will be continuing to generates from <unk> and.
And you have seen over the last quarters that these.
Cash flows from <unk> have helped us to prepare and funds right.
Launch of Joe.
Joe and John in the United States.
And the further pipeline development that we have been doing so we're in a very favorable position and today marks the first quarter in which we have been able to actually get <unk> approved.
And we're in the last quarter, where we will be reporting on that.
Sales from our single product because going forward as you have seen from the press release, we will start recording sales for Gilenya in the United States as well. So it is an important demarcation I would say in the history of our company that we are now going to work.
Net revenues from two products, albeit for the time being.
Only one major geography, the United States of America, but will soon change as well.
So therefore, you can see what we're up to we're up to successful commercialization of joint venture for Aps and <unk>.
<unk> will talk about nature, and additional rare disease indications, where we cannot give you any specifics yet, but we will do that in the second half of the year.
And of course, we still are looking for additional projects.
In mid to late stage of development in rare diseases to actually further.
<unk> fill our pipeline and use and leverage further our commercialization infrastructure that we have in the U S and in Europe and that we are building up additional markets as well and if you look at the next slide the pipeline.
Do you see that it is and we have now a specified it in terms of the various lending <unk> activities that are taking place outside the United States you see that we have a lot of stuff on our plate things to look forward to.
First and foremost of course, the <unk> approval in the European Union and the UK, but also the genetic project to jackpot in projects in our Canadian and Australian projects and last not least the additional indications millennials, but it means that we can actually further down the line.
Space in the capacity in our commercialization capacity to launch additional products. Hence why we are very continue to be very active to look for additional in licensing opportunities in other rare diseases.
Our merger and acquisition opportunities in the market.
Let me just.
Go back to <unk> for a moment to go back to <unk> and that is why we are so very proud next slide please.
<unk> because.
It helps us getting a $200 million business. If you look back last 12 months with an outlook for single digit revenue growth and it continues to take a unique place in the market because it's the only recombinant treatment that teach the root cause of territory angioedema by replacing the missing protein that dysfunctional or missing.
One <unk> inhibitor and.
It has proven over the years to be well tolerated and effective.
It is the second most prescribed product detail for acute attacks and you cant come much closer to a 100% efficacy reliability and that's important because patients are relying on <unk>.
They have either a.
Very severe form of the disease and have very high frequency attacks and cannot get by with the significantly improved.
<unk> therapies.
Sure.
Increasingly as the case, they actually Ryan <unk> for being able to treat that breakthrough attacks, which.
Almost half of the patients still suffered from in very varying frequencies. They rely on <unk> as their breakthrough medication is actually increasing that we see an increasing use of <unk> <unk> for the patients the strongly improved prophylactic therapies.
And we can do all the successes here.
Because we have as I was already alluding to.
Very strong commercialization infrastructure.
Please.
That is consisting of all these functions that you need and you see on the slide here. All these functions as you need to be successful in commercializing.
Rare disease assets and that is where today, we look forward to a very much confidence to further success.
Growing the company and.
The next slide please with the approval of plenty oldest ship recently, we now are embarking on a growth trajectory going forward.
Because as I said earlier, we will now be able to.
To report on two products that are generating revenue for our company.
Our strong <unk> franchise that continues to show single digit revenue as we expect for this year and on top of that we are expecting joined your sales from Q2 onwards to be increasing going forward and it is now time.
I think to hand over to my colleague Dr. <unk> <unk>, our chief Medical officer to dive limit into the Aps and into Joanne <unk> over to you.
Thanks Simon.
Look at the launch of Joanne journalist review, a little bit about atvs.
On the next slide that <unk> is a rare primary immune deficiency also known as an inborn error of immunity that will only first characterize just a little over 10 years ago in 2013.
I think that it affects approximately 500 patients and some of the countries that you see listed there and Thats based on the prevalence of one five per million to date, we have already identified more than 500 of these patients across these areas.
The treatment options until recently have been quite limited for Atvs patients, who will talk a little bit about that but this is really the treatment has been limited because it's only been focused on the symptoms of the disease. These symptoms began early in childhood, but do not address the root cause of it.
Yes.
And the signs and symptoms, Barry and we'll talk a little bit about what those look like but.
Even within our family and this results in significant delays and especially due to the delayed onset of the diagnosis.
The diagnosis itself is actually quite simple to make one when the clinician thinks of it and that's really through this genetic testing that can provide a definitive diagnosis.
Next slide.
But as we sit here <unk> really impact patients in many ways. There is of course, the physical manifestations. When you see that really in the top left with the recurrent infections that these patients have.
Large.
Allison clients.
They have numerous infections that lead to damage in their lungs, and a whole slew of symptoms. There that you can see due to these to this due to this progressive serious disease that develops early in trial.
On top of the physical manifestations.
Will impact on these patients' quality of life.
Of course, there is.
The social aspects, where they can't work or can't go to school or to their normal daily activities Theres, the mental aspect being afflicted with a chronic disease.
The treatment up till now has really been focused on the symptom symptomatic management and then lastly, the treatment burden frequent hospitalizations unnecessary surgeries. Many times numerous doctors visits just to get a diagnosis and that really being limited in terms of what can be offered.
On the next slide we can see what causes Etfs.
This is due to a genetic defect at least to this high productivity of this pathway the <unk> pathway and that.
When that pathway is over active that results in this dis regulated environment for the B and T cell to develop properly when these cells of the immune system developed properly.
A chain reaction set off on the right side, you can see all of the symptoms that result.
Because of this hyperactive pathway, leading to this immune balance.
Of course, it's a primary immune deficiency, so youll see recurrent infections.
These can be in the lungs.
Upper respiratory tract of lower respiratory tract.
It can be also be commonly associated with herpes viruses, especially EBV and CMV viruses.
One of the hallmarks of the disease is linear proliferation. So what we see that as in these patients is swollen lymph nodes and enlarged spleen and also disruption there lymphoid tissue across their body. They also can have gastro intestinal manifestations and commonly because the immune systems are.
Hmm is not functioning properly.
Autoimmune issues, including Cytopenia as in other autoimmune disorders, and as I mentioned earlier bronchiectasis, which is a competition in their lung.
This is irreversible also commonly develops in these patients the.
The most severe manifestations and what often takes these patients' lives.
Development of lymphoma into this untapped liberal proliferative processing is immune imbalance that occurs as a result of this disrupted.
<unk> activity.
On the next slide we can see sort of the.
Treatment options that were available to manage these patients prior to the approval of John John in the U S. On the one hand on the left you can see it was limited to trying to address the immune deficiency using antibiotics.
To prevent infections to treat infections, but also using immune globulin replacement therapy as a way to augment their own immune system on the right side you see the issues that were faced with these patients in terms of immune dysregulation. So try them trying to control the immune system with steroids or other immune suppressants, including trucks line.
<unk> inhibitors, none of these therapies, however were approved for <unk> treatment.
In the rare cases some of these patients were given a stem cell transplant, although transplantation itself is a high risk procedure in these patients.
On the next slide we can see what Joe Enzo now offers and as an immune modulator that addresses the root cause of this hyperactivity Acura hyperactive halfway excuse me in these patients and is designed to treat that caused by normalizing this pathway pre K delta pathway.
As a result, what we see as a normal balance of the development of the immune system cells.
We can see that when we measure the immature cells in the functional cells now progressed normally through their development path.
On the next slide.
We can see a summary of what this Joe NGL approval now offers to patients.
It is indicated for patients who are 12 years of age and older who have atvs.
I'll be reviewing with you some of the randomized data, but net.
Randomized study met both primary endpoints.
And we are also going to review some of the secondary endpoints and exploratory measures that we're seeing in this study.
The drug was generally well tolerated and they're worth pathogen withdrawals due to drug related adverse events.
And on the right side, you can see some of the other data that we generated with <unk>, specifically that would have long term data showing.
<unk> reductions, including discontinuation and the use of immune globulin replacement therapy.
As well as reductions in infection rates.
These study results were consistent with what was observed in the double blind placebo controlled study, including long term data on lymphadenopathy as well as some other immune phenotype.
And Steve will report in a few minutes, we are well positioned to hit the ground running with Gilenya.
Next slide.
There is a depiction of a.
The label as well as the packaging.
And on the next slide we can see some of the data from the randomized control study as I mentioned <unk> met both co primary endpoints.
Which saw reduction in lymph node size on the left as well as an improvement in the nine T cell tower compared to placebo. This strongly indicated a correction of the underlying defect and you can see that when you see the size of the lift outs decrease relative to placebo as well as on the right side.
You can see how the naive b cell proportionate increased in these patients again relative to placebo. Both measures were statistically significant and these were both.
These were the two co primary endpoints in the study.
Next slide.
And when we look at the open label data what we saw is over time a reduction in the number of days that these patients have.
Factions over the course of the year and we saw that reduce.
The longer productive or on Gilenya at the same time, what was observed and this was again spontaneous really in the study where these where physicians and patients were able to stop using.
In many cases irt's therapy, and many of them also reduce the use of IRT therapy as the study progressed.
Okay.
Next slide.
Now looking ahead, we have a number of other milestones later this year.
Steve will report on the launch that's been started just last month.
And that sort of connection we are under review under that Europe , and we're continuing to expect a Chr key opinion later this year with an approval two months later.
We also expect to file in the UK later this year with an approval soon thereafter.
We're also expecting to start the Japanese clinical study, which was a small study and up to five patients to support a regulatory submission there and we'll be doing that in the first half of this year still.
We of course had started earlier this year a pediatric study in children ages four to 11 and that is going on and we expect to start our second pediatric study and.
In the third quarter of this year and even younger children.
Next slide.
Turning now toward another program that we have at an earlier stage program and this is the partnership with Orchard therapeutics to develop an ex vivo autologous stem cell gene therapy for HIV, we're continuing to make progress on developing the factor here to enhance expression levels.
Vectra is now being tested in a number of HIV disease models in animals, and we anticipate being able to provide further updates as we move toward preparing an IND filing later this year.
Excellent.
And I'll turn it over here to Steve to give you a commercial update.
Yeah.
Good morning, everybody.
Over the next four slides im going to provide you with an overview of the Q1 <unk> performance and some early insights as to the progress of the Joe engine launch just six weeks of approval.
As Youre aware.
Hey, monkey wide issues that impacted some government insured patients, resulting in a delay product shipments.
Our internal data and external data showed significant declines for all acute prophylactic products, some sort of all acute and prophylactic products and that impacted all company serving HLA patients each.
The issues are resolved late in the quarter and has affected patients started shipping <unk> sales accelerated in the product stage, the highest positive return or bounce back of all the acute products in the market.
With the Hela market, what issues and disruption behind us we feel good that was in March and also strong sales in April as the recovery continued and we.
So of course as a slide to lose to see strength in the underlying business more especially high volumes of new patient enrollments.
Our growth in prescribing physicians.
We therefore expect sales to strengthen through Q2, and we continue to forecast low single digit revenue growth for <unk> in 2023.
Yeah.
So now, let's turn to the joined the launch.
As can be seen in this slide following us, bringing all of these rare rare disease commercialization experience to bear in the U S. Our first of many launches on our must win market.
We have 54 sales people and sales leaders and that's comprised of the <unk> sales team, where we think 30% of the patients are treated by customers already very well served by farming.
And the new Joanne institutional team and this team focuses on central locations or centers of excellence to which we expect the other 70% of <unk> patients to either currently be treated all be referred to in between these two teams. We have the vast majority of the Ips market covered in the U S.
And importantly feed a note sales colleagues are comprised of experienced rare disease, especially in hospital representatives.
Sales leaders with launch experience and importantly patient finding experience.
And as with the recognize team that successfully turned around the brand will re acquisition from Valeant.
We've stopped that team with award winning salespeople to drive a successful launch.
So there are feet on the street there other identified patients importantly, as you see here. We also have clinical educators to drive finally, my opinion family testing.
This is critical because this is not the same with dominant disease. So other members of the family are highly likely to have a pds.
It's important for them that they get access to.
To join <unk> as quickly as they can and of course as an important source of new patients for farming.
We also have a dedicated full service <unk> patient services program that it shows once the patients diagnosed they're zero distractions and challenges to addressing or to getting into a patient's hands.
And I think that's important in what is a complex market to navigate.
The program covers all of the basics of the filling of prescriptions financial aid and ongoing to support.
Sure Inherence and continued access to medication.
And in terms of staffing this is why we believe.
We are really differentiating for many of our competitors in the rare disease space, we have care coordinators, providing a single point of contact often the same person delivering consistent service and care and providing reassurance to patients and their families.
Less versus the more traditional Commoditized call Center model, we had the clinical education.
I mentioned already there to support and educate patients and caregivers and importantly, we have clinical pharmacist that will be available 24 hours a day to process joined your prescriptions also any questions patients might have.
And speed up approval rates, which having these guys on team really allow us to happen.
Importantly, we've also followed with Penn through Rx, which many of you are familiar with the U S market.
You'll note that.
They are an excellent value partner specializing in rare and ultra rare conditions.
It gives them unique insights and really helps them to deliver for our patients and the way that they expect in Wyoming aspects.
So this dedicated program and stuff should speed access to medication minimize bureaucracy and mistakes.
CAGR as I said to the very specific needs of these patients.
Thanks, a lot.
Before I get to the early results I just wanted to briefly about the value proposition that Joanne J, which Oh alright.
Articulated very clearly earlier, so we should remember that joined <unk> as the only indicated treatment for Pds.
Precision medication, so when the patient test positive.
ACP and the payer know their prescribing of proving the right treatment for the right treatment option for the patient.
And Julien just disease modifying so it's working on the root cause of <unk>.
For both the immune deficiency and Dysregulation.
Our phone and therefore is launching a part of the physicians in the underserved patients need and we have as I've outlined.
Infrastructure services to get products in the patient's hands as quickly as possible. So let's look quickly at the progress so far next slide please.
So I think as you all know the launch multi preparation was rigorous and thorough.
As expected we are off to a very good start.
First fully reimbursed commercial shipments of Ginger occurred just two weeks after FDA approval.
To date, we've shipped to 23 patients all on payer appropriate product about half from the early access So open label extension programs and we continue to make good progress transitioning. These 25 patients to pay product. The other half of those ship patients or patients that are new to Joe engine.
So most of the EAP patients to erode on pay therapy with <unk>.
Working through the elderly patients and all this while simultaneously building a new patient case load.
Importantly for the U S. In the area of market access managed care, we continued to make good progress with national and regional payers, including state Medicaid programs to prepare for clinical review of coverage policy development.
And we expect to see those develop in the next 90 to 100 days.
So when patients have been approved pretty quickly through the medical exception process.
Looking at Medicare specifically, our teams have done an excellent job getting joann J covered right Bds patients with already two thirds of the states list and the product and just see six weeks.
So as you can see.
Prepaid we're off to a faster impressive start only six weeks since we launched <unk>.
Unlike greatly look forward to updating you enjoying <unk> launch progress later in the year. When we can share. The Q2 results were both reconnect and Georgia and with that I'd like now to hand over to you Rune, who will cover the financials.
Yes, Thank you very much Steve and good morning, good afternoon.
Next slide leaves as Steve mentioned earlier as you can see on this slide the first quarter results were lower.
And that was due to the AE market factors, which impacted the entire industry.
So those industry wide factors have since results and we can confirm that we are strongly recover and if we look at the quarter January was in line with last year.
February is where we faced headwinds.
March had a strong recovery and so had April .
We've almost made up all of the shortfall and expect to recover the remainder.
We therefore continue to expect single digit growth in <unk> revenues for 2023.
And on the slide you see that the revenues in Q1 were $42 $5 million, that's 9% down on last year for the reasons I mentioned gross profit developed in line with that it went down by 8% to $38 5 million.
The operating cost increased from 40 million to 53 million and that was on the back of.
Let me illustrate with both of them.
R&D investments.
Sales and marketing costs.
Operating profit and net profit.
Reduced.
The operating loss was $13 7 million from a net loss of $12 2 million. So the short of this quarter is that the <unk>.
<unk> shifted from Q1 to Q2, and we've seen that in April .
And with regards to cost we are investing in lending Allison and obviously, we havent recorded any.
Our revenues in Q1, yes.
Neil.
But that will change in Q2.
We then go to the next slide please on the on the cost development you see that we are continuing to invest in the launch of the gen window.
Look at the longer term trends.
The quarters that are shown here starting with the R&D.
Our records at the bottom, we see a reduction in quarterly R&D costs in.
In Q2.
And that is because of reduced investments in insurance Genic platform do you see a uptick again in Q1 this year because of linear Allison.
Looking at the G&A general and admin costs.
Developments, we've seen a slight growth per quarter.
The last the last quarters, which basically means investment.
Of company growth.
Q1 was higher than.
Then last year.
Q1, 2023, but lower than previous years.
The big number in Q4 by the way to 17 six that you see.
Because of an impairment of a building so thats not.
This cost.
The marketing and sales costs, the biggest bracket, we've seen a quarterly growth of marketing and sales costs in 2022 with more investments and to join John launch, especially obviously in Q4 last year.
And I should note that the marketing and sales expenses for U S launch are high in this period.
Also in Q3.
And going forward, we will see an increase in our marketing and sales costs in other key markets, mainly Europe and the U K in the trailing eight quarters as we prepare for launch.
So you get an indication of opex levels for the remainder of the year and therefore for full year the.
Q4, 2022, and the Q1 2023 opex levels.
Good indicators, albeit it may increase moderately.
If we then go to the next slide is about the cash flow. The cash went down from $207 million to 180 $185 million at the end of Q Q1.
And the key reason is the net cash flows.
Used in operating activities.
Cash.
Loss was $10 2 million from operations.
Working capital increased by by $12 million and that was mainly because of an increase and we're going to go on.
And that is in the Latam was because of a phasing.
The cash flows used in financing activities is due to your regular interest in lease cost and we have some some positive foreign exchange effects going into cash too.
And the $95 million.
Then the outlook on the next slides.
We.
Continue to expect low single digit growth in <unk> revenues for the full year.
Joining <unk> was approved in the first quarter on the 24th of March by the FDA and we have been commercializing in the U S. Since early April 2023.
We expect in Europe , a positive <unk> opinion in the second half of this year the marketing authorizations with solo two months later.
Subject to the positive outcome of the <unk> review, we will file our form.
U K approval.
With the image alright.
We will continue to.
In.
<unk> growth accelerated and that will obviously be focused on the <unk> launch.
And we will provide further details of our plans to develop <unk> in additional indications in the second half of this year.
And just to finish off with we will continue to look for.
Late stage opportunities in rare diseases.
In licensing or in potential acquisitions.
So we're still open for investments very much in that area.
Hi.
With that this concludes the presentation and I would like to go through the next slide and open up for questions and answers to any.
Of the people who are attending.
Recall from the funding side, thank you very much.
Thank you if you would 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 <unk>.
I am prepared to ask a question. Please ensure your line is something you should likely.
Our first question comes from Alastair Campbell RBC. Your line is now open. Please go ahead.
Thanks, So much yeah, a couple of questions. Please.
First of all on the <unk>.
I understand what's going on here.
Is this a feature basically sales which would have happened.
Or is there actually genuinely a shortfall in sales.
I understand.
The disruption.
Would you be more likely to get maybe something like mid singles.
Low single digits.
Question two is I know, it's very very early but just to get a bit of insights into the patients.
Systems two <unk>.
I'm joined Jeff.
At this stage do you have sort of a sensors.
Severity of his patients.
Across the spectrum of severity or and you can come.
The year end and if I can push my luck with 23 patients on therapy now what do you think a good number it would be sort of exiting <unk>.
Yeah.
You are breaking up.
Third question.
Sorry, the question was.
Given you've got 23 patients on <unk> now.
What do you think you'll.
Exit number for the end of the year.
Thanks.
Let me answer the last one and ill.
I'll go back to Stephen on the first two quick questions.
We don't give.
As you can appreciate it's early days and we don't give any sort of.
No.
Forward looking statements on what we think.
Is it a reasonable number I think it's too early.
But you obviously agree with us that already having 23 patients on <unk> therapy, and many more in the enrollment process.
Gives you a good indication that we prepared to launch very carefully.
Steve talks.
Talking about how well we are progressing with getting the reimbursement sorted for Joanne Joe.
So.
Let's keep it at this and obviously over the coming quarters. We will continue to report on those patient numbers and going forward, we will give some more indications as and as and when we see a clear trend of rising.
So thats.
The answer to question number three I'm, sorry, I can't go any in any further detail.
I would like to go back to Steven about your question with regards to <unk> sales in the first quarter.
And.
If there is any sort of differentiation in the severity of Joanne J patients Steve over to you.
Thank you Sean.
Terms of the routine ourselves I really think our guidance wouldn't have changed there was disruption in the first quarter, which pushed patients out a little in terms of.
Delivery of product.
So at this point, we're playing catch up so I think the the guidance would remain the same as it was in mid to late March when we last gave it we chose to expect low single digit revenue growth.
In terms of the severity of patient so I don't have deep insights, what I would hypothesize and perhaps in but I would argue if he's got anything to add is that these are patients largely already identified at least half of them in the open label extension.
Were identified therefore, they were exhibiting simpsons symptoms or at least at the moderate end of the scale.
Yes.
Let me answer the question.
Yes, that's correct.
I'm, sorry, I was just going to.
Alright.
I think the key point is that there was a mix of patients here. So we have patients who were in the study.
Or have now started to enter commercial pay product we have patients who were in the expanded access program and we also have 90 and so these are patients who are not.
In the expanded access program or in the study are now.
Seeing Joanna and you're all set for the first time.
Okay. The answer to your question.
That's good thank you alright, thank you.
Our next question comes from Sheila Hernandez from CLK.
Your line is now I think please go ahead.
Yes. Thank you for taking my question.
We can ask could you expand on the reimbursement disruptions affecting the HPE market.
And thank you guys showed an increase in <unk>.
Sales this quarter whats fair to circumstances that led to a more pronounced disruption on your end.
And a second question you mentioned that you expect quarterly fluctuations for refinish sales. So what are the drivers behind this flex breakthrough. Thank you are anticipating thank you.
And these questions back to Steven.
Suddenly the disruption was primarily in the government sector and some of those patients saw a disruption to the co pays and the cost of access and medication.
Which is what resolved itself.
We went through the quarter I cant comment to the company to the sales obviously have other companies what I will say is if you look at our Symphony data for example in the specifically the Metis database.
You see that every company saw significant disruption in Q1, so I cant comment to that but I can say that.
The disruption was specifically within the government insured patients sector and it resolved satisfactorily and all those patients certainly on the <unk> side and are receiving their medications.
And the other question I'm sorry.
Yes Sandy.
You mentioned that you expect quarterly fluctuations are frequent a sale. So what are the drivers behind these fluctuations that you anticipate.
Apologies I missed that so.
His name is it tends to be obviously more a combination of seasonal and just the length of the selling month. So for example, we tend to see some dips.
During the significant U S holidays, so independence day Thanksgiving in around Christmas.
So it is not at all.
During the holiday season, as well where patients will stocking ahead of going on vacation.
Then.
And then not order as much during the periods when they're away. So it's.
Things to do.
Given by the lower large numbers right, we have a certain amount of patients and when the change in their order and patents changes then you'll see changes in our order rates and therefore quarterly fluctuations so theres nothing of real significance beyond that.
Okay. Thank you.
Thank you.
Okay.
As a reminder, if you'd like to ask a question. Please press star followed by one on your telephone keypad now.
In your mind a staphylococci.
Okay.
Well, just I mean, there's no more questions.
Okay.
Our next question comes from Simon Scholes of Berlin, Samuel and is now open. Please go ahead.
Yes Hello.
We've taken the decision to discontinue pump.
I remember a few years ago, you expect to teach them.
We expect it.
Youll.
Product sensitive element to have quite that.
Quite a benign side effect effect.
Compared with the current market leader.
I was wondering if you could comment on your decision to discontinue given.
Given your expectation of that.
The positive side effect profile and also whether you took the decision to discontinue maybe.
Maybe because it would have taken too long to bring the product to market like that played a role.
Yes.
So quick question Simon.
I think there is still a significant unmet medical need in Palm Bay.
So that's not necessarily the case and we did not simply see differentiating features that you felt confident enough to go forward with with investing in the in the.
Projects.
So therefore, we better be.
We decided.
Decided to stop buying in this project.
And there's also of course, new developments on the horizon.
Where other than protein replacement therapies for instance, the <unk> receptor.
<unk> are being developed as we speak so we felt it was appropriate to stop this.
Bearing.
Not seeing any of the differentiating features that was the main reason to make this decision.
Okay. Thanks very much.
Any more questions from analyst.
If you would like to ask a question. Please press star followed by one on your tenor. Thank you that now.
Yeah.
No further questions I'll hand back to the management team for any closing remarks, okay. Thank you very much ladies and gentlemen, thanks for attending this this first quarter results conference.
We are seeing in the beginning of the call.
This.
First quarter marks a clear demarcation.
We got a second product approved here.
We have a established commercialization infrastructure in the U S and we're building that up in Europe . So we're preparing.
Rigorously for the launch of <unk>.
Many of those who are outside of the U S.
I Hope you are.
You agree that we are off to a very good launch.
With regards to <unk>.
Joanne Johnson, United States because of the fact that we already have these 23 patients on <unk>.
<unk> therapy within six weeks after launch which is not a given youre rare diseases.
And many more are already in the process. So we look forward to very much forwards I would say to coming back to you next quarter and report on not one but two products that will drive our revenue and.
And of course.
Last but not least <unk>.
<unk> confident I would like to again say that we remain confident in the robustness of our <unk> business going forward. So thank you very much for being here again.
We look forward to.
I'd say to you again on the next quarter results in the beginning of August . Thank you.
Goodbye.
[music].
Okay.