Yes, thank you very much for your kind introduction. And ladies and gentlemen, thank you very much for joining us for PAION’s earnings call and the financial results of 2020.

My name is Ralf Penner, I’m PAION’s Vice President, Investor Relations and I’d be moderating today’s call. I am joined by Jim Phillips, PAION's CEO, as well as Abdelghani Omari, our Chief Financial Officer.

Within the next half hour, we’re going to highlight some of the 2020 achievements, give details on the financial results, highlight the most important events and provide a pipeline and strategy update and financial outlook. After this initial presentation, we will be happy to take your questions.

I would like to point out that the slides for the presentation can be accessed by webcast in parallel to this conference call. The webcast details has been posted on our website and were also given in yesterday’s press release.

If you have not already opened the webcast link, you may want to do so now. This conference call is being recorded and the replay will be available later today and will be posted on our website.

Before we get started, I would like to remind you that today's call may include forward-looking statements and that actual results may vary from PAION's current anticipations. I would also like to refer to the disclaimer included in the presentation slides.

After these initial remarks, I believe that we should start right now with the presentation. Jim, please go ahead.

Thank you, Ralf. So we're going to talk about the corporate overview then a little bit about our products and their commercial plans we have for them, and then I'll hand to Abdel for the financial results.

So as you can see from this first slide, our mission is very clear. Now we’re becoming a leading specialty pharmaceutical company in the field of anesthesia and critical care.

And to do that, we're bringing new products to market that helps all of the stakeholders in our ecosystem, which is patients, doctors, investors, and of course the providers of healthcare. Next slide, please Ralf.

So, when you look at our business now compared to a year-ago, we’re a specialty pharmaceutical company, we now have three products rather than just one which was pre-approval this time last year. And now we have a three that fit very well together, which as you'll see during the presentation.

Outside of Europe, we have commercial partners in many parts of the world. And we'll be looking to extend those partnerships to the parts of the world, we're not yet represented in this year.

And as the 12th of January, I love to disclose cash amounts €22 million. I think most of you by now would know myself and Abdel, so I will just move on to the next slide please, Ralf.

Okay, in terms of our listing, we’re listed in the Frankfurt Stock Exchange, our performance last year on the price is good, this year obviously we said different with the start and with the increase in capitalization that we're undertaking at the moment. But our market cap around €150 million is key and the target price from the analysts is more than double our current share price.

Next slide, please. Our strategy just to renew your acquaintance with our strategy is to become an innovative leader.

So there's not generic products, this is protected, patent protected new products in anesthesia and critical care over the next three years is to create leading commercial capabilities as we're already doing in Europe. It's to launch our three products in these key European markets over this year and into 2022 and then drive rapid revenue growth from these three and reach profitability around the end of 2023 or early 2024 as we really grow to become a leading specialty pharmaceutical company in this field.

But what we'll also be doing is continuing to explore what we can do to drive longer-term growth, these products gives us 10 years of growth but beyond that we need to be looking to refresh our product suite in the future, so it's important to keep looking. Next slide.

Okay, so last year 2020 was a really important year for PAION, it’s a year of delivery of a lot of key value drivers for the business. So to summarize these, we have three product approvals in two different indications and those approvals were across the world in Japan, China and the U.S.

Following those, we had two successful product launches as you'll see later on in China and Japan and we received our first royalties and of course royalties are really important for the business going forward as they grow and become sustainable. Our revenues were very much on target at €19.7 million and we achieved a positive EBITDA of €1.9 million.

We completed our European General Anesthesia Phase 3 programs so that we could prepare for a second filing in Europe at the end of this year for that indication and we started a major transformation from being research and development focused towards the commercial focused business. Just after the end of the year of course we then did a deal with a American company to bring two further new products which are approved and ready to launch in Europe thus giving us the breadth of pipeline to enable us to invest in the commercial side of the business.

Next slide please. In terms of what we're expecting to see this year, we've already achieved three key milestones this year BYFAVO’s commercial launch in the U.S.

at the end of January was critical for us and for growth of royalties in the future. Then we had a positive opinion from the CHMP in Europe for our approval for procedural sedation and then of course the approval has just been received in the last days.

So through the rest of the year we'll be looking at European commercial launches for three products that we have, we’ll be looking to report on partner sales, growth and launch activities in other territories in the world and then around the end of this year, we'll be looking to file the second indication in general anesthesia in Europe for BYFAVO. Next slide please.

So now we'll move on to a little bit more detail about the products we have, next slide please. So when you look at our three products we have the original PAION product BYFAVO, Remimazolam, which is approved in Japan for general anesthesia, in China and the U.S.

and now Europe for procedural sedation and of course we have a third potential use of intensive care use for sedation where there are some trials underway as we speak. With the two new products.

we have rights to sell these products in the European Union, in the European Economic Area and Switzerland and the BUK GIAPREZA for use in basically septic shock in patients in the intensive care and XERAVA for complex abdominal infections again often to the intensive care use product. So three products ready to launch in the European market and already launched elsewhere in the world.

Next slide please. What this do for PAION, as a company we now see products with a potential peak sales of more than €300 million this would be projected around the year 2028.

Of those product sales, we see roughly half of it coming from our own BYFAVO European sales, around another €60 million coming from royalties mainly from the U.S. but also from Asia and other territories and then the two new products GIAPREZA and XERAVA contributing another €100 million of sales going forward.

So you see that if you look to the right side of this slide, graphs of our revenue growth going forward. We see last year, good revenue with small profit, but basically driven by milestone payments.

This year, you'll see us dip back into losses as we invest in commercial rollout. But a big changes most of the revenue we see this year is going to be related to products, through product, drug product sales, through royalties, and through our own sales in Europe.

And then when you push out to 2025 and 2026, you see very fast growth as very high profitability of our EBITDA levels reach upwards of €75 million towards €100 million over that time period. Next slide, please.

So some of you may ask why we brought in these two new products, BYFAVO alone was not strong enough to cause us to invest without risking commercial activities. And what we've done by bringing in two new products is bring in three products together, whichever very strong overlapping, we need to sell them to within the hospital groups.

They’re all very novel, they will come with a strong IP, and they all have a clear market position that we can appreciate. And what that leads to is we can we utilize one Salesforce, one commercial team, and therefore drive bridge profitability that we could with BYFAVO alone.

Next slide, please. So we'll now talk a little bit more about BYFAVO Remimazolam and when we think about Remimazolam, it's the first novel sedative or anesthetic for the last 13 years.

There are two generic products in the market Propofol and Remimazolam and what you can see within this slide is that both of these have some negative effects. And what has been designed into Remimazolam is this novel drug is that it keeps the best properties that each of these medications has, but it removes or lessens the downsides of them.

So with Propofol, this is cardiovascular depression, which has problems in causing post operative morbidity, so illness or mortality and it's irreversible with Remimazolam, they can be reached sedation with. So with Remi, we've seen a vast improvement in the clinical effects of the drug compared to the old generic.

Next slide, please. Well, now look at Europe, the opportunities in procedural sedation where we just been approved in Europe.

So we see somewhere between 15 and 20 million procedures a year in the top five countries in the European Union, of which roughly half are gastrointestinal, which means colonoscopies or endoscopies, and 90% of these sedatives to keep the patients comfortable while the procedure is undertaken. So this is the largest market for BYFAVO in Europe.

And then the other uses can be in bronchoscopies or cataract surgery, cardiac procedures, and dentistry going forward as well as in the emergency room. So this gives a view of a very large market European setting.

Next slide, please. What's also driving this market is that the number of colonoscopies that take place in the European Union is increasing, increasing numbers of countries are screening all patients or all population over a certain age to prevent the incidence of bowel cancer.

And so the U.K. is one example.

Germany is another and more recently, there are plans in Scandinavian countries to introduce this as well. So it's increasing demand for procedural sedation as this market grows.

And of course, alongside that, we have population growth as the population ages, there are more people that need these procedures. Next slide please.

Just to give you a view of the landscape, and what we see in European countries is very diverse usage between Midazolam and Propofol. So, in some countries, like the U.K., Midazolam is prevalent and in other countries like Germany, Propofol is used more and so we have to manage our introductions to market, according to which of these two competitive products is dominant.

Next slide please. So we're now preparing to launch our portfolio over the next 12 months, starting in the second half of this year.

And realistically, there will be a staggered sequence. It’ll vary country to country depending mainly on pricing and reimbursement discussions.

But we'll be targeting nearly all of the mid to large sized hospital accounts across the European territories where we will be going commercial in this timeframe. I think it's clear to say that it's a very exciting time for the company with three products to launch.

But the reason stagger the launches is so that commercial teams are very focused on each product as it comes to market and there is no opportunity for confusion as the product as there might be two products will launch together. Next slide please.

Little bit more on GIAPREZA and XERAVA. So GIAPREZA is a product set, basically this is called as a vasoconstrictor.

So it closes the blood vessels down to maintain blood pressure. And this is being used in the intensive care unit setting after other therapies have failed.

So it's a third line therapy, and it's life saving, potentially. What we do know is that we're very excited to be able to launch this product, we have seen quite a lot of demand already from our partner La Jolla both in the U.S.

and also from European centers. And we think that pricing and reimbursement work that has already been done and we will be going forward with very supportive for premium pricing for this product.

Next slide, please. XERAVA it’s a novel antibiotic, its technical name is eravacycline, generic name and it's approved for complex intraabdominal infections.

And this means things like perforations after appendicitis, where you have multiple different types of bacteria, causing the infection. And it's very exciting in that it's broad spectrum to treat some of the infections that other antibiotics have become resistant.

And it has the potential in the future, maybe become a first line therapy before bacteria are identified. Although it will start as a second line therapy.

What we'll also be doing with this product is competitively pricing it compared to other novel antibiotics. And I think it's fair to say because of the increasing antibiotic resistance to the older antibiotics, including cephalosporins that that the introduction of novel antibiotics is welcomed in both the medical community and by the payers in Europe.

Next slide please. Our plans in Europe are shown here.

So we’ll keep our European HQ in Aachen Germany, as it's always been. And that will essentially be running the things that you need to run at the European level like supply chain and quality assurance and supportive ongoing development work.

But we’ll run our subsidiaries in the U.K., France as and when we’re ready, the Netherlands, Nordic which are already starting to become operational, then Germany, Austria, Switzerland at some point in the future and also HQ. So the first countries you can see here were going to be the U.K., Netherlands and the Nordics and their country structure is very lean.

So we have just a very small core team to build the commercial capabilities within each country. Next slide, please.

Sizing in total, assuming we roll out into every country, we'd be looking at a mixture of what's called key account managers doing more formal selling as medical science liaison managers who are essentially doing scientific work alongside them. This leads to a total team in the fields of around 58 across Europe and that's what we're now beginning to invest in with our partners in South.

Next slide, please. So when you look at the turning that into launch activities, we're now going through this organizational build-up with the local management having just been established, we'll be looking to start to deploy our field for our sales teams in June.

We'll be ready with supply chain at the same time, and then start to work on formulary inclusion, which is so critical to getting sales from July on those. And as you know, we just received the market authorization.

So these activities are all now go. Next slide please.

And then just to remind you of our intellectual property for BYFAVO or Remimazolam. In Europe, we have formulation patents out to the 2033.

And elsewhere in the world, a similar sets of patents which have roughly similar same time period. But we're also still working on broadening our intellectual property portfolio and looking at novel ways to extend the life of BYFAVO as a commercial product.

What we see in the global market is the Global and anesthesia market is worth around $4 billion per year. And even before the introduction of a novel sedative anesthetic was growing at 3.7%, compound annual growth rate per annum.

So we see the potential for BYFAVO itself globally through our partners as well as by ourselves around a $1 billion a year and that drives our revenue potential for our own sales and through partner royalties of more than €200 million per annum. Next slide please.

A reminder now on our partnership for BYFAVO around the world, so in the U.S., we have Acacia Pharma as we'll see in a couple of slides, Japan Mundipharma again we will report in a couple of slides and China Yichang Humanwell and these are the three launched countries. We have a new partner in Taiwan TTY Biopharm.

And then we have Hana Pharm for Asia, and in Canada, Pharmascience and Russia we know we have company. Next slide, please.

What's more important, of course is where we've launched what's happening in the market. And I think both for China and Japan, we're very, very happy to seen combined sales in the first few months of €2.6 million.

Japan, the pricing is higher than we expected, China we have very good pricing too. And in Japan, more than 400 hospitals have listed the product by year-end.

And in China, there are 39 provinces. We’re changing well upon and launched more than 31 of the provinces which others have higher prices.

And when you look at the royalties, you see that larger percentage of royalties came from Japan based on a higher royalty rate that we get from the Japanese partner. But both are significant, and they're very good start to building royalties globally for the future.

Next slide please. Then in the U.S., it's much more recent launch, so the launch was at the very end of January.

But we were very pleased to hear the pricing that Acacia have launched at $9 per dose. So roughly double being so in China, for example.

But what we do hear from our partner is that there is good uptake, it’s already on formulary in seven different accounts and that is what takes time to start to generate sales and a lot of enthusiasm being heard in all three countries. While we launched from the anesthesiologist and then healthcare professionals for a novel for them to use.

And I’m now going to hand to Abdel who will take you through the financials for 2020.

Thank you, Jim. Good afternoon everyone.

So let's start with cash position and financing. For the end of 2020, we have cash of close to €19.7 million as we reported after the balance sheet, we have drawn the first two tranches of in total €12.5 million from the loan agreement with the European Investment Bank, the third tranche of €7.5 million is planned to be drawn down shortly after the currently ongoing capital increase, This capital increase with subscription rights will lead to gross proceeds of €7.8 million, it is backstopped by an institutional investor and is expected to be completed shortly.

A total of close to 5.1 million new shares will be issued at a subscription price of €154 per share. With these proceeds, our liquidity runway is into the first half of 2022 based on current planning, we expect increasing revenues in the coming years as Jim just presented from license agreements as well as from our own commercialization in parts of Europe and considering the necessary build-up of commercial infrastructure, we have a financing requirement in the mid double-digit million range in the coming years on to breakeven which is towards end ’23 or early 2024.

The required funds could be raised through different financing measures and including further partnerships. Let’s now move to the P&L on the next slide.

Revenues for 2020 amounted to €19.7 million mainly resulted from milestone payments in connection with the market approvals of Remimazolam in the U.S. and Japan as well as the license extension tied with Hana Pharm in January 2020 to include six additional countries in Southeast Asia.

Research and development expenses amounted to €10.3 million which is a decrease of €2.8 million compared to 2019, these expenses mainly related to the Phase 3 study in general anesthesia, the decrease compared to 2019 is mainly due to lower expenses for the study but also due to lower expenses for production development. On the other hand, SG&A expenses amounted to €7.5 million which is an increase of €2.5 million compared to the previous year, this results from a slight decrease of general administrative, increase of selling expenses.

So general administrative expenses decreased by €0.3 million to €3.2 million and selling expenses increased by €2.8 million to €4.3 million. This increase mainly results from pre-commercial activities and the build-up of the supply chain for Remimazolam.

The decrease of the admin expenses was due to one-off expenses incurred in 2019 in connection with the loan agreement with the EIB and the issue of convertible notes. In total, net income of €2.2 million was incurred compared to a net loss of €7 million in 2019.

Now let's move to the balance sheet and headcount on the next slide. Total assets increased by €3.2 million compared to end of 2019 and this increase is mainly due to three effects, first the tax credit claim on the balance sheet increased by about €0.8 million because we received the claim for 2019 in the beginning of 2021.

So this was the setting on the balance sheet at the end of 2020, then at the end of 2020 we had inventories of €1.8 million on the balance sheet and in addition cash increased by €0.9 million compared to end of 2019. This increase comes almost completely from positive cash flows from operating activities.

As you can see on the lower left hand side, equity increased by €6.6 million to now €21.3 million at the end of 2020. This change mainly results from the net income of the year, and the conversion of the remaining convertible notes into new shares.

At the beginning of 2020, the nominal amount of these convertible notes was €4.2 million. Total equity ratio was 76% at the end of 2020.

The staff development is illustrated on the lower right hand side, compared to an average number of 44 employees in 2019, we had 43 employees on average in 2020. Finally, I'd like to give an outlook for 2021 on the next slide.

So regarding revenues, we expect these to amount to about €8 million to €9.5 million this year, which approximately €7.5 million to €9 million expected from existing license agreements. And again, they're off about €5 million to €6 million from Remimazolam API sales to our licensees as well as royalties and approximately €2.5 million to €3 million will come from milestones.

Revenues from our own commercialization of BYFAVO will be apprised on XERAVA in selected European countries will amount to approximately €0.5 million, then we expect the cost of revenues in the range of €3.5 million to €4 million and since our focus will be on commercial activities, we expect SG&A expenses in the range of €18 million to €20 million. Approximately 10% of that is related to non-cash amortization.

Research and development expenses will amount to between €1.5 million to €5.5 million and this leads to a total expected EBITDA of between minus €16.5 million and minus €21.5 million for the full-year. I think this concludes the financials and the presentation and with this one, I’ll hand back to you, Ralf.

Yes, thank you very much Jim and Abdel for the presentation. And we would like now to start the Q&A session and are happy to answer your questions.

Yes, good afternoon. Thanks very much for taking my questions.

I've got three. First of all, into clicking the annual report, I noticed that the presentation of milestones and royalty rates has changed from the usual presentation, particularly in China.

You're now showing a royalty rate of 5% looking the note for last year. I think you said the royalty rate would go down to 5% in case of commercialization of a competing Remi product in China.

So I mean, presumably that's now happened. I just wonder if you could say something about that.

Secondly, I mean you mentioned trials in connection with the ICU, I was wondering if you could enlarge on that. And to also if you could enlarge on your cooperation with Syneos Health.

That's it.

Okay, it's Jim Phillips. I'll try to answer all three and maybe Abdel will help you with the first one.

So as regards to Hungry as a competitor in China to[indiscernible] our partner, they have a different form of Remimazolam which is apparently in the market and as a result that the royalty rate has been managed to the 5% level from the original 10% level. But the overall outlook is good and we reported sales from China and the royalties seems to be a very big markets as we have very big opportunity.

As regards to Syneos Health, so they are a contract sales force provider and we’ll be working with them on a limited time basis to manage the risk of building quickly commercial infrastructure. So the teams will be working exclusively for us, but they will be just formerly employed by Syneos Health at least for the first year to two years until we're ready and comfortable to bring them in-house and in certain countries that's a legal requirement.

The third question trials in sorry, trials in intensive care we just had one single Phase 2 investigator initiated study in COVID patients underway at the moment and that's in the middle of recruitment for that study and the output that will help us in strategizing the next steps for intensive care.

Okay, so just back on Syneos, so you expect the relationship with Syneos to last about two years?

Yes, I mean there's flexibility built into that but what we didn't want to do was to manage all of the HR side of building sales forces in multiple countries given our last set of competencies and size at the moment, so having a large partner with those capabilities is really helpful for us.

Okay, thanks very much.

Okay, thank you very much for the questions. And again thank you very much for joining us for PAION’s earnings call and the financial results of 2020.

I hope that we have been able to answer your questions but of course please feel free to give me a call afterwards if this is not the case or you may have additional questions, if you would like to listen to this call again, please visit our website where the replay will be posted later today and from now I say goodbye and thank you very much for your continued interest in PAION.