AstraZeneca PLC (NASDAQ:AZN) Q4 2022 Earnings Call Transcript

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Our geographic expansion continues, leveraging AstraZeneca footprint and we launched in 11 more countries in 2022. This figure includes China where Soliris has launched in PNH and atypical HUS late in 2022. Our rare disease medicines are now available in 57 countries and we are well on track to achieve 100 countries by 2030. Please move to the next slide. I wanted to spend some time discussing our approach to where conversion from Soliris to Ultomiris is now well over 80% for both patients and payers who switch for both convenience and cost reasons. PNH is a little rare life threatening, blood disorder characterized by intravascular hemolysis, IVH which is caused by an uncontrolled activation of the complement system. Elevated LDH is a biomarker for EVH and our C5 inhibitors have over 83,000 patient years of experience and long-term safety and efficacy data, demonstrating C5 continued and sustained LDH reduction for patients.

The large majority of the patient on Ultomiris are very well controlled. There is a subpopulation about 10% to 20% of patients that do experience clinically meaningful extravascular hemolysis while they are on C5 inhibitors based on patient data from the 2 larger studies conducted in PNH patients. We have developed danicopan an oral Factor D as an add-on therapy for these patients and we plan to submit our data to regulators in the first half of this year. Please move to next slide. Here, I wanted to showcase 2 of our planned Phase III trials for the year. The first is Ultomiris in cardiac surgery associated acute kidney injury, part of label expansion plans for Ultomiris. Acute kidney injury is a high unmet medical need, causing patients to endure loss of kidney function, renal replacement therapy and risk or mortality.

For patients with CKD, the risk of following cardiac surgery is increased by 60% to 80%. We will focus on the subset of those patients with kidney ischemia where complement laser. This program is unique as we plan to use Ultomiris in a preventative way a single dose given prior to surgery in these ages patients, an exciting opportunity with blockbuster potential. Another Phase III plan for this year is 1850 which is our next generation as 1850 has been optimized by our researchers for longer half-life to allow for less frequent dosing. We have also built it to have a better enzymatic activity so that we can dose at lower volumes and to have a superior manufacturing process. We believe that this improved therapy will allow us to deliver more than 2x the addressable population relative to Strensiq.

This gives us great opportunity for geographic expansion, bringing this medicine to more HPP patients where there are no other treatment options. And with that, please turn to Slide 3 and I will hand the call back to Pascal.

Pascal Soriot: Thank you, Marc. Can you move please to slide — to the next slide. As we said before, we delivered a great performance in 2022. And very importantly, we made significant progress with our pipeline. We are very confident that 2023 will be another great year for our company with the growth of our underlying business more than offsetting the decline in demand for our COVID medicines. We’re expecting to announce the results of at least 18 Phase III trials in 2023. And of course, had a handful of significant ones to look at for — on this slide, as you can see on the left-hand side. Our pipeline progress, together with the strength of our strategic product portfolio makes us confident to deliver — to deliver industry-leading growth for many years to come.

We expect to launch at least 15 new medicines by 2030. Lastly, we have set bold targets for our company to reduce emissions. And I very much hope that leading by example, to address climate change will inspire others to do so as much as they can. With that, I will hand the call back to Andy.

Andy Barnett: Thank you, Pascal. And our speakers now will be joined by other members of our executive team to go to the Q&A. With that, Pascal, I’ll hand over to you to start the Q&A.

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