0:13
We are going to introduce you to EUROAPI, a CDMO player in the field of many molecules including tides and you may not know so much about us.
0:25
So we are listed company as you can tell with this first slide with the disclaimer and giving you key facts and figures about the company.
0:36
So the company was indeed listed on May 6th of 2022 Euronext Paris being a fully independent company debt free at inception.
0:48
And this is key because you know, being debt free at inception allows us to have a very important investment power in the field of our business lines, 2 business lines to EUROAPI, the CDMO activity and the API catalogue.
1:08
Oops, I can hold it.
1:11
OK, this is not the right version.
1:16
So I need to maybe go back.
1:21
Yeah.
1:21
Do you have any, the last version?
1:23
Do you know how I can use it?
1:25
You have the V3 normally.
1:29
OK, Alright.
1:31
Well I will play with this one.
1:33
That's OK.
1:34
Alright.
1:35
So what is our strategy at EUROAPI?
1:38
So we have a four-pronged approach.
1:41
Clearly the very first strategy is to accelerate our CDMO activity.
1:48
Second is to expand our differentiated presence and you'll see that we have a focus on tides, on high potent APIs and also on complex chemistry.
1:57
We'll come back to the differentiators later.
2:00
And we also have the development of our product portfolio mentioned, the second business line on API catalogue that's deals with it and also the improvement of our operating performance with the industrial performance, procurement excellence and also capital expenditure optimisation for the most part.
2:21
So this is how we are implanted in Europe.
2:23
There are 6 development and production sites, as you can see.
2:27
So we are not going to go into details for Haverhill (UK) and Elbeuf in France and Vertolaye or Brindisi in Italy and Budapest.
2:36
But what is of interest for the event today is Frankfurt in Germany with the development and production of oligonucleotides and peptides.
2:48
They are today in the company about 600 customers.
2:51
All of our sites are FDA and EMA inspected.
2:55
We have 8 CDMO core platforms, so one of which is dedicated to oligo and peptides and these are the current capacity within the with the company at 2,000 cubic metres of chemical capacity, 6,000 for fermentation and we are today about 3,500 employees.
3:18
So we have a strong heritage from Sanofi and this clearly can show here is you know this quality compliance of all of our sites.
3:32
We are regularly inspected as I mentioned before and also by our customers.
3:37
Every 15 days we have a customer audit at one of our sites.
3:41
This is all for our customers.
3:45
An important also topic nowadays is on energy and environment.
3:49
We've been committed to the ISO 14001 for more than 20 years.
3:57
As you know, as an industrial player, we are also convinced that we have activities that should fit in and you know, in a sustainable model with a respect for the environment regarding the energy is the same.
4:15
But it's been 10 years that we've been involved in this ISO 5001 standard.
4:23
And so far we've been, you know, purchasing about 80% of our electricity from renewable sources and this is going to be 100% in 2025.
4:39
So when it comes to CDMO activities, this is what we offer to our customers.
4:44
So you know, clearly from the early development to the commercial phase, you see the 8 core platforms here on the screen with tides as one of the of our main ones.
4:58
But there are also other modalities regarding also small molecule.
5:03
We can do small molecule by fermentation or by organic chemistry and also some centres of excellence for spray drying and micro-ionisation I think.
5:16
But the special focus today is on tides.
5:20
Well, clearly also at EUROAPI, you know, we are definitely into giving the best service possible.
5:28
And we have expertise in the company that we put for the benefit of our clients.
5:36
And that goes through also these important words such as reliability, quality, business continuity, which is also key today in this in the, you know, landscape.
5:49
So I guess that even if it was not my version, I will give the floor to you your version Thorsten, thank you.
6:03
So thanks a lot and thanks for the opportunity to give you a little bit more insight into the capabilities and capacities we do have in the Tides platform and I'm representing the R&D organisation and the Tides platform.
6:16
I'm heading the R&D Germany and I’m also the CMC head for oligonucleotides and peptides for your API.
6:24
Looking at that, we have as you have seen by Joelle, we have been founded last year, but we have a long tradition in working with oligonucleotides and peptides.
6:36
So the first activities on the side in Frankfurt with the peptide activities on solution phase are already back in the 70s.
6:43
So we were one of the pioneers on dealing with peptides already early on in the 70s.
6:50
And we have installed our first activities on solution and solid phase activities on oligonucleotides in the early 2000s with the installation of the solid phase equipment in 2004 for oligonucleotides and for the peptides.
7:04
So we have more than two decades of experience running in a clinical and an industrial scale for oligonucleotides and peptides.
7:13
So also you see there are some commercial products we have worked for.
7:17
For example, one of the largest peptides which are commercialised at the moment is LIXISENATIDE, which is a 44mer.
7:27
For those who knows it's already a BLA with the ruling of the FDA governance by 40 above is a BLA.
7:34
And we also had a project with one of the pioneers in ASOs in the time of oligonucleotides 2014, MIPOMERSEN, It was launched at that time, but it received a negative opinion by the FDA at that time.
7:50
It might be too early for the oligonucleotides already in 2014, but it was a pioneering one.
7:55
And we were the site who actually did the whole clinical development together with our colleagues at Genzyme and did also the stuff for the dossiers and the regulations for the FDA and for the EMA.
8:08
So there is great experience already in a pioneering field of the oligonucleotides within the company and within the team because we were able to keep the team, keep the equipment from that.
8:20
And having still that experience in the team and starting with a good basis, even if we are a new company looking a little bit at our capabilities and we will focus on that for the oligonucleotides, peptides and also for the downstream processing.
8:37
Here we are expressing really the full capabilities from the development scale throughout the clinical phases towards the commercial scale.
8:46
So we have equipment available at the moment ranging from an OP10 with a small milligram scale ranging for the first kind of studies with that oligonucleotides and then have a couple of OP100 and OligoSynth available for the scaling capabilities into the tox studies into the first GMP scaling with the OligoSynth. OP400 enabled our machine to provide really the first GMP batches where we can go into phase one with, we are about to install an AK biosystem up to 150 mmols roughly 600 grams.
9:24
If you calculate that, it will be operational between in mid 2024.
9:31
So we will have complementary machinery for the GMP clinical phases up to 600 grams, installed an oligo process up to 1 mol at the moment, which is arranging around 3kg material. And we are setting up at the moment our plans in order to welcome a new oligo process.
9:48
Hopefully at that time it will be the biggest of the scale at 2 mol.
9:52
What we available at the moment is 1.8 mol.
9:55
So we are ranging around 1.8.
9:57
If you can get one for 2mol, we will install that and that aims to be ready by 2026.
10:02
So you see we are increasing our capabilities and capacities, but already having a decent team available to do that and team can do that from early development capabilities up to commercialisation, industrialisation and has experience across that port for the oligonucleotides.
10:22
If you look at the peptides, we have a kind of similar set up.
10:26
We also as I said have a long history in the peptide field.
10:30
With the development team, we have great experience of taking over projects.
10:36
Are we in the development stage, in the early development stage, preclinical to tox.
10:42
And then having also set up the equipment ranging from a couple of milligrams up to the kg scale.
10:51
We’re having GMP installed to CS Bio 936 which are ranging around 1kg of material and the GMP at the moment.
11:01
And then having also a commercial facility which is ranging up to 6mol synthesiser, 280 litres stainless steel where we that's one of the machines where we're producing also the LIXISENATIDE.
11:14
So there's a commercial facility and we have the capability to take on some capacities also in that field for the clinical development and also for commercial scale.
11:29
Complemented with that is a downstream processing capability.
11:33
Again, we also keep an eye on being a strength if the team that there is a development team available at scale with the upstream processing team with the synthesis team.
11:46
So there's always in the same range the philosophy to have an equivalent team available to do the downstream processing.
11:54
So we starting also here with the low quantity scaling of the chromatography in the development team is capable and used to work as an integrated team, a real project team as we are coming out of a pharma company.
12:09
This is a really a strength of us that we are used to work in a project team progressing a compound from the early development stages, preclinical towards the clinical stages into industrialization.
12:22
And the team as we try to keep them as much as we can constant throughout the process and having experts in all of the stages in that field from the early development to the industrialisation and commercialisation.
12:36
If you look at that we have in all of those always the TFF capability, the freeze-drying capabilities at scale with the development and later on also with the commercialisation.
12:48
What we do have is at the moment we have two DSP systems, Nova Sep systems up ranging to a diameter of 450 millimetres.
12:57
That's two systems we have.
12:58
We use them as multiple DSP downstream processing systems, so they are able to do high pressure and medium and low pressure.
13:06
So we use them for peptides and oligonucleotides.
13:09
We are installing at the moment a third system, which is a 80 centimetre column purely dedicated only for oligonucleotides, which is ranging up to 3kg of material per batch.
13:21
This will be set up finally at the end of the year.
13:25
So we will be operational beginning next year to mid next year with the first commercial batches.
13:30
It's these large-scale downstream processing capability for oligonucleotides.
13:35
We have a couple of freeze dryers available ranging even starting from the low lab scale.
13:39
We have a couple of grammes milligrams in freeze drying at flask or table ones and then ranging to the industrial scale for multiple kgs.
13:49
So we have a couple of 100kg ice capability that's ranging a couple kg freeze drying capacities and on site and we are installing another one at the moment which should be also available mid next year.
14:04
So we are expanding our capabilities already in that field and try to keep up with the demand which is upcoming and we see that exciting field of the oligonucleotides and peptides.
14:19
Nothing is USP and DSP without analytics.
14:22
I think you have seen the talk before us.
14:26
I think it's coming all with a great analytics before great talk and it's a necessity and just to show you we have all the capacities of an analytics.
14:36
So same philosophy.
14:38
We have a team established and have that history working with teams across the stages and we are doing phase dependent analytical scaling.
14:50
So we have the development team which is starting also in the preclinical with the development of methods with the applications and taking over methods from customers if they already have one or we can we have the ability to do full method development for oligonucleotides and peptides and have the capability then to do the validation steps as needed as level 1, 2 and 3 towards commercialisation.
15:16
As the team was involved also in getting the industrialization and the launch of oligonucleotides and peptides.
15:23
They are also used to working with dossier activities, regulations and some of our colleagues have even been defending a couple of things in front of the EMA and FDA.
15:33
So also that is available as a heritage of that.
15:36
We are used to being a pharma company and driving our own portfolio, but now we are fully dedicated to the CDMO and to our customer, but still having that background of information and knowledge available for our customers.
15:51
So you can see just from that what we have on that it's everything we have available in order to serve what is needed in order to run the project.
16:01
As I said, fully integrated analytical.
16:04
So we can do that starting from the raw material classification and measurements, we can do that to the intermediates process and final drug substance release.
16:14
We also can work on help you with some of the DP analytics.
16:21
We don’t have our own DP facility, but as we are used to work with the DP colleagues formerly so we have still some knowledge and can help there.
16:30
And that's always a question with the customer and we work together with the customer to get out the best result for that one.
16:39
Innovation is still at the heart of the R&D team.
16:43
So we and you know, it's demanding in terms of solvent consumption, waste generation, optimisation of the oligonucleotides and peptides.
16:52
And with the demanding switch towards common diseases, there needs to be innovations done in the near future in order to welcome larger amounts, bigger scale with less solvent, less waste, less energy consumptions.
17:09
So we are really at the heart of that and in our R&D organisation.
17:15
And this is what is a little bit depicted here.
17:18
We have the background to do that.
17:20
We have to set up to do an innovation from early innovation towards our development team towards industrialization and commercial platform establishment.
17:30
And we do that with the background of that what we have a heritage of 20 years in oligonucleotides, almost 40 years in peptides.
17:38
And as we are chemical, we're also a chemical company in the past.
17:41
We have a tradition in Frankfurt at the Hoechst Industry Park of more than 100 years to be a chemical company.
17:48
So the team here of mine and R&D also comprises the process development and the chemical development team.
17:53
So we have all three modalities at an equivalent expertise level available in Frankfurt, which is I think a unique setup for your API.
18:01
We have a great heritage we can look at and with the expertise we can look at. Just a bit of a glance where we are thinking and where we are thinking to influence the current innovation space and we do that across the board.
18:18
We are starting with our process in the solid phase synthesis and to do that for peptides and oligonucleotides because I personally think there is a great synergy between the two that you do inventions and innovations and peptides could really help the oligonucleotides and vice versa.
18:37
So we're using our best knowledge to do that.
18:39
So we are optimising in synthesis.
18:41
We try to optimise also our process control systems in the process to optimise our solvent consumption reagent consumptions for peptides and oligonucleotides, we are looking to easily clean them.
18:54
And we also looking into for example, for the peptides and the flow synthesis together with the colleagues at PeptiSystems, we think it's a promising technology over there with the PeptiSystem and flow rate.
19:06
We have seen initial great results on that in the chromatography in the downstream processing, we're using YMC system continuous chromatography.
19:14
We think that's a valuable technology which will exist in parallel to the classical batch chromatography.
19:20
And we really working on that in the development team at the moment to more establish easy clean technologies.
19:27
We also looking into greener synthesis, really getting away from DMF because there is always these talk around DMF banning in the future.
19:37
So we're working really on cleaner technologies, and we are in a good place to really establish that.
19:43
And also in the final API, we're looking at the freeze-drying activities, really high energy consumption.
19:51
And we're looking as a chemical company, we used to do conjugations post synthesis modifications.
19:57
We are used to do that and we are really looking into optimisation of that because conjugation can cost you a lot of API final material.
20:05
If you do not do it right, you will lose 40% of your final API.
20:09
And just in the conjugation step, but we are used to optimise chemical processes as well as we are used to get good APIs of peptides and oligonucleotides.
20:19
Thus, this is also something we are looking into.
20:25
Coming to some take home messages and I will give that to Julien and then we are open for questions on that.
20:32
Thank you, Thorsten, stay close.
20:35
Well, I think you said it all Thorsten, it's an easy segue for the last two slides.
20:42
Clearly, you know, this is all for our customers and we are really happy to have this EUROAPI company with this expertise, with this site, with this knowledge and heritage as well, because this is all for our customers.
20:59
So, you know, we are often asked, you know, what makes you be different?
21:04
Well, I think you touched upon that quite often in your talk, Thorsten, but you know, this is years of experience and also this ability to scale our processes, your processes in an environment that is, you know, the right one to allow this scale up to large scale.
21:24
Because as Thorsten said, this is happening.
21:28
I mean, big wave in oligonucleotide, continuous wave in peptide, this is happening.
21:35
So we need to be also there to respond to your needs.
21:41
Analytics, you mentioned it's important to say that there is no transfer.
21:46
You know, it's all in house.
21:47
You know we are going to do it for you from preclinical to the commercial phase and the innovation part is giving us an edge, several edges.
21:59
This is what we also incorporate in our offers as know-how.
22:03
So it's no IP that we are going to just fight with you on.
22:06
It's just know-how this is something that's for your IP is your IP.
22:09
We don't want to develop you know any IP there.
22:12
It's pure, you know, technology that is for you in terms of track records, OK, we're coming from a big pharma that big pharma was there two years ago, and we already signed quite a certain number of contracts of companies entrusting us.
22:28
We have this system in place.
22:30
You know, the big pharma, the previous big pharma is a client.
22:34
It's just a client just like everybody else.
22:36
And this is super important for you to understand that with your API, we mentioned that it's depth free at inception, as I said in the introduction.
22:50
So yeah, heavy investment to follow the pace of these big trendy molecules in the field.
23:00
And yeah, still some availability for 2023.
23:05
And I think that this is also at stake when you come to us, that you also want to have these flexibility, this agility and you need to find empty capacity.
23:14
We have, and I will finish with this also more operational part that when you come with an RFP, then you know, you need to be told how long it's going to take.
23:26
You need to be also having this discussions, technical discussions with Thorsten’s team.
23:31
We've also the BDs we are there also to facilitate also these meetings, this brainstorming, just to make sure that you know, you get what you want.
23:41
So I think I'm finished with the presentation.
