On April 29, 2022 AstraZeneca reported that First quarter 2022 results (Press release, AstraZeneca, APR 29, 2022, View Source [SID1234613203])

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Financial performance (growth numbers at CER)
‒ Total Revenue increased 60% to $11,390m, reflecting growth across the Company, the contribution of the Alexion medicines and several Vaxzevria contracts that are expected to complete delivery by half year 2022
‒ Total Revenue from Oncology increased 25%7, including a milestone payment; Product Sales from Oncology increased 18%. Total Revenue from CVRM8 increased 18%, R&I9 increased 4% and Rare Disease increased 7%10 ‒ Operating Margin in the quarter benefitted from phasing of costs
‒ Core EPS increased 20% to $1.89
‒ FY 2022 guidance at CER reiterated Key milestones achieved since the prior results
‒ Key data: Enhertu11 in HER212-low breast cancer (DESTINY-Breast04), AZD8233 in hypercholesterolaemia (ETESIAN, Phase IIb) and publication of data for Lynparza in prostate cancer (PROpel) and nirsevimab in RSV13 (MELODY/MEDLEY)
‒ Key approvals: Saphnelo and Evusheld in the EU, Ondexxya in Japan, and in the US, approvals of Ultomiris for gMG14 and Lynparza15 for early breast cancer (OlympiA)
‒ Other key milestones: US FDA16 Breakthrough Therapy Designation for Enhertu in HER2-low breast cancer (DESTINY-Breast04), Priority Reviews for Enhertu in HER2-mutant metastatic non-small cell lung cancer (DESTINY-Lung01), and Imfinzi and tremelimumab in advanced liver cancer (HIMALAYA), and EMA17 accelerated assessment for nirsevimab in RSV (MELODY/MEDLEY) Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "2022 has started strongly for AstraZeneca.

Farxiga achieved $1bn revenue in the quarter and our Oncology medicines delivered Product Sales growth of 18%, despite COVID-19 continuing to impact cancer diagnosis and treatment. High-level results from the DESTINY-Breast04 trial pointed to Enhertu’s potential to redefine treatment of HER2-low metastatic breast cancer, and Ultomiris became the first and only long-acting C5 inhibitor approved for generalised myasthenia gravis in the US. Today we have unveiled plans for a new strategic research and development centre in the heart of Cambridge, Massachusetts’ scientific hub. In line with our sustainability commitments, it will be designed to the highest environmental standards.

Our investments in pioneering science give us confidence of further advances in the years to come." 2 Guidance The Company reiterates FY 2022 guidance at CER. Total Revenue is expected to increase by a high teens percentage Core EPS is expected to increase by a mid-to-high twenties percentage

‒ The CER growth rates include the full-year contribution of Vaxzevria in both FY 2021 and FY 2022
‒ Total Revenue from COVID-19 medicines is anticipated to decline by a low-to-mid twenties percentage, with an expected decline in sales of Vaxzevria being partially offset by growth in Evusheld sales. The majority of Vaxzevria revenue in 2022 is expected to come from initial contracts. The Gross Margin from the COVID19 medicines is expected to be lower than the Company average
‒ Core Operating Expenses are expected to increase by a low-to-mid teens percentage, driven in substantial part by the full year integration of Alexion expenses
‒ Emerging Markets Total Revenue, including China, is expected to grow mid-single-digits in FY 2022. China Total Revenue is expected to decline by a mid-single-digit percentage in FY 2022, primarily due to continued NRDL and VBP programme impacting various medicines.

The Company remains confident in the longer term outlook for Emerging Markets, driven by a large market opportunity, broader patient access and an increased mix of new medicines

‒ A Core Tax Rate between 18-22% AstraZeneca continues to recognise and actively manage the heightened risks from COVID-19 and geopolitical and supply chain uncertainties on overall business performance. Variations in performance between quarters can be expected to continue.

The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign-exchange rates for April to December 2022 were to remain at the average of rates seen in Q1 2022, it is anticipated that there would be a low single-digit adverse impact on Total Revenue and a mid single-digit adverse impact on Core EPS versus the financials at CER.

The Company’s foreign-exchange rate sensitivity analysis is contained in Table 15. Corporate and business development In April 2022, AstraZeneca and Harbour BioMed (HBM) committed to a global out-license agreement for HBM7022, a pre-clinical bispecific antibody targeting Claudin18.2 and CD3. AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialisation of HBM7022. HBM shall receive an upfront payment of $25m with the potential for additional payments up to $325m pending achievement of certain development, regulatory and commercial milestones. HBM is also eligible to receive tiered royalties on net sales. Sustainability summary AstraZeneca published its eighth annual Sustainability Report and Sustainability Data summary, released in conjunction with the 2021 Annual Report. The report outlines progress on strategic priorities, material focus areas, challenges and aims for the future.

AstraZeneca continues to provide urgent humanitarian support in Ukraine and neighbouring countries. To date, AstraZeneca has committed over $7m to response efforts, including donations of:

‒ Medicines to the Company’s humanitarian relief partner Direct Relief, which is working directly with the Ukrainian Ministry of Health
‒ Medicines via The Red Cross affiliates in neighbouring countries
‒ $2m to support relief agencies working in Ukraine, Poland and surrounding areas with a focus on providing healthcare and humanitarian assistance.

Funding is being provided to Project HOPE, working with and through the World Health Organization, and International Medical Corps
‒ More than $1m to UNICEF and The Red Cross Reporting changes for Q1 2022 AstraZeneca’s Total Revenue and Product Sales tables in FY 2022 include a new disease area: BioPharmaceuticals: Vaccines & Immune Therapies (V&I). This incorporates revenues from Vaxzevria, Evusheld, FluMist, Synagis and nirsevimab.

In the FY 2021 quarterly and annual reports, Vaxzevria and Evusheld revenues were shown under COVID-19, and FluMist, Synagis and nirsevimab revenues were shown under Other Medicines. In addition, revenue from Koselugo have moved from Oncology to Rare Disease, and revenue from Andexxa has moved from Rare Disease to BioPharmaceuticals: CVRM.

The growth rate for each disease area has been calculated as though these changes had been implemented in FY 2021. Conference call A conference call and webcast for investors and analysts will begin today (29 April 2022) at 11:45 BST. Details can be accessed via astrazeneca.com.