We formally launched Airsupra last month for adult patients. And over time, we hope to see primary care physicians in the United States changed 50 years of prescribing habits. As mentioned, we are off to a strong start and are only halfway through the first RSV season that Beyfortus has been available for infants. Following continued strong demand and the recent approval in China, we are planning for a substantial increase in capacity in 2024. We continue to invest behind the Farxiga brands with growth being driven across the global — across the globe by recent launches in heart failure and chronic kidney disease. In the coming years, we aim to continue to build on this franchise with new combination medicines in development that address unmet needs in hypertension, heart failure and CKD, and with additional enemies in our late-stage and early-stage pipeline.
Our CVRM portfolio is set to expand and evolve over the mid-to long term. We recently commenced a Phase III trials for baxdrostat in uncontrolled and resistant hypertension as well as for zibotentan, combined with dapagliflozin, addressing patients with CKD and high proteinuria. Eplontersen is also being evaluated for the treatment of ATTR cardiomyopathy, which is estimated to affect up to 0.5 million patients worldwide. Our Phase III cardio transform trial is the largest of its kind and is powered to show a cardiovascular mortality benefit, and we are very pleased to share today that we have obtained Fast Track designation from the FDA for our cardiomyopathy regulatory file. I will now hand over to Sharon to present the latest development from the biopharma pipeline.
Sharon Barr: Thank you so much, Ruud. I wanted to take this opportunity to highlight our current portfolio in immunology as well as provide more color on our recent business development deals focused on immune-mediated disease. In Safnello’s, pivotal Phase III litcells in systemic lucerathermatosis, we saw positive changes in cutaneous lupus. We are building on this and expanding into new indications. We have started enrolling patients in our Phase III DAISY trial of Safnelo in patients with systemic sclerosis, a chronic disease characterized by diffuse fibrosis and vascular abnormalities in the skin, joints and internal organs, which can be fatal. We also have plans to initiate 2 other Safnelo Phase III trials this year in cutaneous lupus and myositis.
Our recent business development deals have accelerated our ambitions in immune-mediated diseases. Emerging data from Dr. SETH [ph] Academic Group has shown the potential for long-term remission with CAR-Ts in systemic lupus erythematosus. Part of our definitive agreement to acquire Gracell includes autologous CAR-Ts with an ongoing Phase I investigator-initiated trial with GC012S, the CD19 and BCMA CAR-T in 15 Chinese patients with SLA. We look forward to sharing the Phase I data at an upcoming conference. Our collaboration with Quell is designed to develop multiple engineered T-regulatory cell therapies, which have the potential to be transformative in type 1 diabetes and inflammatory bowel diseases. T-reg cell therapies have a unique approach of modulating the immune system to reduce inflammation and prevent immune-mediated damage to tissues.
Quell’s innovative platform of armored T-regs could enable sustained clinical benefit. And finally, our collaboration with Cellectis allows us to explore the potential of an allogeneic CAR-T platform. Off-the-shelf availability from allogeneic CAR-T cells is expected to reduce the time and cost associated with manufacturing. With these innovative transformational cell therapies as well as our internal capabilities, we are building a platform for a pipeline in immune-mediated diseases with transformative potential. I will now hand over to Marc, who will cover our rare disease portfolio.
Marc Dunoyer: So thank you, Sharon, and for rare disease, the total revenue achieved $7.8 billion in 2023, up 12% year-over-year driven by growth in neurology indications, increased patient demand and launches in new markets. In the quarter, Ultomiris grew 38% and plus 52% for the full year, driven by knowledge indication with the vast majority of growth coming from generalized mastenagravis patients were naive to branded treatments. As previously indicated, Ultomiris revenues were broadly in line with Soliris for the year. But if you look at the fourth quarter, Ultomiris revenues exceeded Soliris. Our conversion strategy is progressing well with the majority of patients already converted across PHN, Atypical haemolytic uraemic syndrome and gMG in our major markets.
We continue to launch both medicines globally and expect the CFI franchise, Soliris and Ultomiris revenues to remain sustainable and durable. Beyond complement, both Strensiq and Koselugo grew 13% and 48%, respectively, driven by continued patient demand. I’m also delighted to announce that we have started enrolling patients in our Phase III trials for translating amyloid cardiomyopathy as well as for hypophosphatasia. Alexion 2220 is a monoclonal antibody designed to deplete toxic amyloid fibrils in the heart with the potential to treat TTR cardiomyopathy in combination with standard of care stabilizes or silences. Our Phase III trial is recruiting a broad range of patients with moderate and severe disease. It has been designed with hard cardiovascular endpoints all-cause mortality and cardiovascular events, which are extremely important for patients and clinicians as well as for regulators and payers.
We have begun enrollment in our Phase III program, on Fortis ALPHA in hypophosphatasia, including 2 trials in the pediatric setting, investing both naive and switch patients as well as a larger trial in naive adults and adolescents. These trials represent a broad set of hypophosphatasia patients, including those with both skeletal and functional improvements. We believe that this product with every 2-week dosing and lower volume injections, coupled with improved manufacturing creates a significant opportunity to increase the addressable population by 3x as compared to Strensiq. We have made great progress in our late-stage pipeline with 9 Phase III programs underway and our tenth program, Ultomiris in IgAN is initiating soon. With that, I’m please announce — will get to Pascal.
Pascal Soriot : Thank you, Marc. I move to the last slide. This is really to show you that over the next few months, we have quite a number of catalysts that are going to drive us across oncology, biopharm, but also rare diseases. And you have a few here that are listed. Of course, a number are missing. We also have FLORA that will deliver updated OS data in the course of 2024. But some of the most important once they are going to drive the growth of several of our important products, LoRa Tagrisso Destine6 driving an HER2, TROPION Breast02 with that of the exit [ph], the Waypoint study, studying Tezepelumab in chronic cynositis with nasolpolyps, and finally, [indiscernible] Imfinzi. But there is, of course, a lot more than this.
The other point I wanted to make in conclusion is that the midterm pipeline is actually emerging very rapidly. We have some very good data coming up out of our bispecifics portfolio, and there will be more data points communicated in the course of this year. Our ADCs will have more data also to share about our ADCs and how this pipeline is shaping up. We have an emerging metabolism portfolio that we don’t talk much yet, but is actually progressing very nicely. We have a very exciting PCSK9 that is making good progress. Baxostat is for hypertension is in Phase III. And finally, we have, of course, the oral GLP-1 agent, we license sale and the beauty about those agents is that they can be combined. They can be combined with ADC, they come in combine between themselves.
And so we have here a metabolism portfolio that is really starting to take good shape. And beyond the products I mentioned, there’s more to come, of course, in obesity but also in cardiovascular — in heart disease and in renal disease. Cell therapy, we will this year, communicate some of our mid stage studies progression. And finally, we were also be communicating information about our new DDA pipeline, and in particular, the PARP 1 selective. So as you can see here, quite a lot of new data coming up, both from the Phase III pipeline but also from mid-stage pipeline that will give you a sense for what is coming up and why we believe — why we are so excited where we believe we can continue to drive top line growth over the next 10 years. And drive improvement in profitability as a result of this.
Finally, I want to invite you all to our R&D Day. This will be in Cambridge at the DISC, our new R&D center. You will see, as you — for those of you who join us on the 21st of May, you will see this is a fantastic site, and our teams are very excited to be there, and I’m sure it will drive further momentum in our R&D productivity. The reason we do this R&D day, as I said before, we’ve just completed our 10-year journey that we started in 2014 were engaging in the next phase of our – in the next 10 years. And we thought it’s a good time to sit back and update our strategy and show you why we are so confident that the future is bright for AstraZeneca. So with this, I’ll stop here and then open the floor for questions.
