Swedish Orphan Biovitrum AB

Ladies and gentlemen, welcome to the Q2 2023 reports conference call and live webcast. I am Alice, the Coruscant operator. I would like to remind you that all participants have been listed on remote and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

Yeah, thank you so much, and welcome, everybody. This is Guido Oelkers, CEO of Solvi. As you can see from the Q2 report that we published earlier this morning, we're obviously super excited about the performance in 2023 so far and delighted to welcome you to the second quarter 2023 conference call for investors and analysts. We posted this presentation on our website, SUBI.com, and we would like to, and, you know, let's go to the next slide, you know, the safe harbor statement as per usual. We would like to remind you of the usual provisions. Unless I state it otherwise, we will make comments that most relate to second quarter performance in 2023 at constant exchange rate in million Swedish krona. Today we plan to cover the key aspects of our quarterly report. I'm joined by Henrik Stenqvist, our CFO, and Armin Reidinger, Swedish scientific and medical advisor and a member of the EXCOMM. We plan to review the presentation first and then open up for Q&A at around 2 p.m. Swedish time. And for those on the phone, please join the queue for questions by pressing star 1. we propose that you ask only one or two questions at a time as per usual. So let's go right to the beef and go to the first slide. You know, we successfully delivered on our strategy in the last quarter. We saw significant top-line growth of 16% at constant rate and 26% at actual rate for the quarter. And this brings us to 6% growth at constant rate for H1, respectively, 15% as reported. This reflects a strong performance both in hematology and immunology, and in particular, our launch medicines, which have been growing over 80% for the quarter at constant rate. Hematology revenues were growing at 18%, and the growth was mainly driven by Our launch product stopped delayed in Asper Valley, whereas we had stable sales from our foundation business with Elocta and Alprolix. Our stronghold position in hemophilia provides us with an excellent platform ahead of the expected launch of FNS Octococc Alpha and confirms our strength in rare hematology. Immunology reflected strong growth of Kineret and Gamifront. Our ambition to build a leading rare hematology franchise was evidenced by the closing of the CTI Wonjo acquisition. The acquisition offers considerable strategic opportunities by capitalizing on our hematology expertise and on Wonjo's potential for patients worldwide. Our R&D pipeline progressed with two milestones. We submitted FNS Octococc Alpha to the European Medical Medicine Agency. FNS Octococc has great potential to become the new standard of care for hemophilia A. Hence, this was a very important milestone for our company. Yesterday, the FDA approved nilcivimab for RSV, and this has been a big or an important milestone for our company as well as we are benefiting from royalties. in the U.S. We have strong momentum in the SOBI business, taking together with the CTI platform. We have raised our revenue guidance for the year to high single-digit growth accordingly. So all four elements of our SOBI strategy contribute to this performance. It's about building our leadership in rare hematology, building our pipeline and allowing us to capture value from it, building an immunology franchise and growing it, and this is evidenced by the strong leap of Gamifan performance and our regional expansion and becoming a true global player in rare disease. Moving to the next slide, please. And we are very excited to have enclosed this transaction with CTI because it provides us with a range of benefits, both immediately and in the long term. WONJO is a very promising medicine. It is well differentiated as it targets JAK2 and IRAC and ACVRV1 while sparing JAK1. It therefore addresses an unmet medical need in severe thrombocytopenic myofibrosis. WONJO complements SOVI very well. Myofibrosis is a blood cancer. SOVI has extensive experience in thrombocytopenia with stop-to-let In addition, the CTI team has developed formidable expertise in hemato-oncology, which will expand our collective capabilities and create new opportunities for the future. It will be highly accretive to revenue margins. We already recorded the first sales in June at 36 million kroner. And as I said, we are raising our guidance for 2023 partially because of the acquisitions. Please turn to page number six. So when integrating CTI, we make sure that we fully capture, you know, Wanzhou's value. In the first weeks, we seamlessly, the seamless continuation of Wanzhou operation has been our focus. We successfully retained key talents and started the cultural and business integration. There's a lot of energy and engagement on both sides. which makes me very optimistic. We also started the lifecycle management planning to define how we expand into new indications and territories beyond the U.S. It is one of the areas that CTI has not been able to fully embark on due to their size. With our experience and capabilities, we can add a lot of additional dimensions to unleash WANJO's potential. All in all, that we are very thoughtful about building Onjo's franchise up to its potential and creating leverage with a newly formed SOBI organization comprising of top talents from CTI and SOBI professionals. This goes beyond the realization of savings. We have ambitious near-term goals for our hematology franchise and see exciting opportunities in the area of lifecycle management and development. Let's turn to page number seven. So just to share a little bit of excitement on Prakritinib. Prakritinib is a well-positioned for growth, and we will explore its further benefits to patients with myofibrosis and beyond. Real-world insights into benefit of Wonjo in different patient population to extend its benefits and enable a wider patient access. We also want to embark on the following, therefore, very strong scientific rationale for the benefit of paracetamol in other diseases with underlying inflammation-driven pathophysiology, regulatory submissions in international markets. So these are the key drivers. It's insight into new opportunities. It's providing a new strategic rationale into other indications, and then obviously taking advantage of our global footprint. We want to share our excitement about CTI, and in particular Bonjo, or Prakritinib, or it's called generically, to provide you with additional insights. Hence, we host an event with Professor John Mascarenas from Mount Sinai tomorrow. He is one of the foremost experts in the field and will give you an overview on latest data and possibilities, He will be joined by Sarah Buckley, who is our new global medical lead for the franchise at Sobe, who will provide an in-depth understanding on the subject matter as well. Now it's time to turn to slide number eight, and Henrik, would you like to take this?

Sure. Thank you, Guido. Hello, everyone. So as many of you will have seen, Sobe today called for an EGM, on August 15th for the purpose of carrying out the rights issue of approximately $6 billion with preferential rights for existing shareholders. The proceeds will be used to partly finance the CTI acquisition of approximately $17.3 billion, corresponding to about one-third of the equity value. Considering SOBE's momentum, this quantum gives us an appropriate starting point post the acquisition for further deleveraging and financial flexibility. Following an authorization by the EGM, the intention is to launch the rights issue soon thereafter, and the terms of the rights issue will be set by the Board shortly before the launch. And as previously announced, Investor B, our main shareholder, has undertaken to subscribe for their pro-rata share of the rights issue, corresponding to about 36.2% of the shares. In addition, Fjärde Oppe Fonden, Polar Capital, Handelsbanken Fonden, and Swedbank Rover, together representing about 12.8% of the shares, have expressed an intention to subscribe for their respective pro-rata share. So altogether, shareholders representing about 49.1% of the shares have undertaken to subscribe or expressed their intention to subscribe to their respective pro-rata share of the rights issue. I think I now hand back to Guido.