AstraZeneca PLC (NASDAQ:AZN) Q3 2022 Earnings Call Transcript

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Ruud Dobber: Thank you, Susan. Now turning to Slide 22. Biopharmaceuticals delivered over $15 billion in sales year-to-date, reflecting 21% growth at constant exchange rate. Performance in the third quarter contributed $4.7 billion, a 4% increase at CER, driven by underlying strength of our diverse portfolio. CVRM delivered almost $7 billion in the year-to-date, with Farxiga delivering its third consecutive blockbuster quarter, and is now reimbursed in 101 countries for CKD and 112 countries for heart failure. In our respiratory and immunology business, strong performance of recent launch medicines offset the continuous decline of Pulmicort following VBP inclusion in the prior year, leading to 4% growth overall at constant exchange rate inclusive of milestones.

Extinct the third quarter, Fasenra is the established market leader in severe eosinophilic asthma and achieved expanded leadership within the IL-5 Five class with year-to-date revenues exceeding $1 billion. Despite achieved 70% new to brand market share with roughly 70% of utilization coming from patients who are new to biologics. Saphnelo continues to gain market share in the overall SLE markets and achieved 48% new to brands share of the I.V. markets. Our V&I portfolio delivered $3.7 billion in the year-to-date, and as expected, we saw a sharp decline in Vaxzevria sales in the third quarter due to the conclusion of initial contracts and softening demands, while Evusheld delivers $537 million in the third quarter revenues reflecting initial demand generation efforts.

Evusheld continues to play an important role around the world, protecting the immunocompromised, we have no other option for protection against COVID-19. Looking ahead to 2023, we expect fundamentals will continue to drive growth, despite certain previously mentioned dynamics, including Symbicort patent expiry in the U.S., as well as the full impact of SoC VBP including in China, which we will — which we anticipate taking effect this month. With that, I will now turn the call over to Mene to cover our biopharmaceuticals pipeline.

Menelas Pangalos: Thank you, Ruud, and please turn to Slide 23. During the quarter, we presented data across our biopharmaceuticals portfolio. In CVRM, as I mentioned last quarter, we presented results from Farxiga’s delivered trial at ESC. The analysis showed that Farxiga reduced the risk of cardiovascular death by 18% in patients with heart failure, with preserved ejection fraction. In addition, a pre-specified pooled analysis of and deliver demonstrated a reduction in CV deaths of 14% and a reduction in death from any cause by 10% in heart failure patients irrespective of ejection fraction. These important data sets confirm Farxiga’s efficacy in preventing and delaying cardio renal disease. At ISA, we presented interim analysis from the eplontersen Phase III NEURO-TTRansform trial in hereditary transthyretin-mediated amyloid polyneuropathy.

Eplontersen demonstrated a greater than 80% mean reduction in the co-primary endpoint of serum TTR concentration and improved symptoms and quality of life in patients with polyneuropathy. And we look forward to sharing these results with regulators. Please move to Slide 24. Last week, our long acting RSV antibody Beyfortus was approved in the E.U., and this week it was also approved in the U.K. Beyfortus has the potential to transform RSV protection as the first and only single-dose preventive option for the broad infant population. Approval was based off our MELODY and MEDLEY clinical program, which demonstrated a 79.5% efficacy against medically attended lower respiratory tract infection caused by RSV. Importantly, that efficacy was shown over the full length of the RSV season.

But RSV we presented the results in long-term extension trial DESTINATION, which confirmed the long-term efficacy and safety profile for Tezspire. Consistent with previously reported PATHWAY and NAVIGATOR studies. In NAVIGATOR, Tezspire demonstrated a sustained reduction in the analysed asthma exacerbation rate over 104 weeks of 58% irrespective of inflammatory biomarkers. During the period, we also provided an update on the results from the MESSINA Phase III trial in eosinophilic esophagitis. Fasenra achieved near complete depletion of tissue eosinophils consistent with this mechanism of action. However, this did not translate into an improvement in dysphasia symptoms. We will continue to analyze the complete data set to share with the scientific community.

Please move to the next slide and I’ll now hand over to Marc to cover rare disease.

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