Sijmen de Vries
Management
Good morning or good afternoon, ladies and gentlemen. Welcome to our First Quarter 2023 Results Call. And before I go into the call, I would like to have the next slide and show you the forward-looking statement slide, 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 change in the future. And without – having said that, next slide, please. I'm here with my three colleagues, Anurag Relan, our Chief Medical Officer; Stephen Toor, our Chief Commercial Officer; and Jeroen Wakkerman, our Chief Financial Officer. And they will be speaking after me. And I will start with a brief introduction. So next slide, please. And then the next one as well. So basically what Pharming is all about is that we are building a sustainable rare business and that rare business will be able to be funded from the positive cash flows that we continue to generate from RUCONEST. And you have seen over the last quarters that these cash flows from RUCONEST have helped us to prepare and fund and the launch of Joenja 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 Joenja approved and where in the last quarter where we will be reporting on sales from our single product. Because going forward, as you have seen from the press release, we will start a recording sales for Joenja in United States as well. So it's an important demarcation, I would say, in the history of our company that we are now going to work to get revenues from two products, albeit for the time being on only one major geography at the United States of America. But that will soon change as well. So therefore, you can see what we're up to. We're up to successful commercialization of Joenja for APDS and Anurag Relan will talk about that later, 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 that are in the midst to late stage of development in rare diseases to actually further fill our pipeline and use and leverage further our commercialization infrastructures that we have in the U.S. and in Europe, and that we are building up in additional markets as well. And if you look at the next slide at the pipeline, you see that it is, and we have now specified it in terms of the various leniolisib activities that are taking place outside the United States. You see that we have a lot of stuff on our plate and a lot of things to look forward to. And first and foremost, of course, the leniolisib approval in the European Union and the UK, but also the pediatric projects, the Japan projects, and the Canadian and Australian projects and last, not least, the additional indications for leniolisib, but it means that we can actually further down the line have space in the capacity and 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 and/or merger and acquisition opportunities in the market. Let me just go back to – for a moment, go back to RUCONEST and that is why, we are so very proud. Next slide, please, of the product like RUCONEST, 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 treats the root cause of hereditary angioedema by replacing that missing protein that dysfunctional or missing human C1 esterase inhibitor. And it has proven over the years to be well tolerated and effective. And it is the second most prescribed product details for the acute attacks. And you can't come much closer to 100% efficacy and reliability. And that's important because patients are relying on RUCONEST where they have either a very severe form of the disease and have very high frequency attacks and cannot get by with the significantly improved prophylactic therapies or which increasingly is the case. They actually rely on RUCONEST for being able to treat their breakthrough attacks, which almost half of the patients still suffer from in very varying frequencies. They rely on RUCONEST as their breakthrough medication. And there, we see an increasing use of RUCONEST, under that, thank God for the patients with strongly improved prophylactic therapies. And we can do all these successes here because we have, as I was already alluding to a very strong commercialization infrastructure. Next slide, please. That is consisting of all these functions that you need. And you see on the slide here, all these functions that you need to be successful in commercializing rare disease assets. And that is where today we look forward with very much confidence to further success of growing the company. And with the next slide, please. With the approval of leniolisib recently, we now are embarking on a growth trajectory going forward because as I said earlier, we will now be able to report on two products that are generating revenue for a company, a strong RUCONEST franchise that continues to show single-digit revenue as we expect for this year. And on top of that, we are expecting, Joenja sales from Q2 onwards to be increasing going forward. And it's now time, I think, to hand over to my colleague, Dr. Anurag Relan, our Chief Medical Officer, to dive a little bit into the APDS and into Joenja. Anurag, over to you.