Bio Pharmaceuticals Presentation (Astra Zeneca
Bio Pharmaceuticals Presentation (Astra Zeneca
AstraZeneca's 2024 Investor Day highlights the urgent need for innovative strategies to manage chronic diseases. The focus on BioPharmaceuticals leads to transformative advancements aimed at tackling escalating healthcare challenges. Insights on potential market movements, novel treatments, and key pipeline catalysts position AstraZeneca at the forefront of health solutions for the future, paving the way for impactful growth.
Bio Pharmaceuticals Presentation (Astra Zeneca
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BioPharmaceuticals
Ruud Dobber, EVP and President, BioPharmaceuticals Sharon Barr, EVP, BioPharmaceuticals R&D
- · Silencer Wainua
- · Depleter - ALXN2220
- · Inhaled biologic - AZD8630 (iTSLP)
- · oGLP-1 - AZD5004 monotherapy and combinations
- · dapagliflozin combinations
- + baxdrostat HTN and beyond
- + balcinrenone HF and CKD
- + zibotentan liver/kidney function
- 15 Collaboration partners: Ionis ( Wainua ); BridgeBio (acoramidis).
- · Very low doses enable combinations and maintain selectivity
- · Long half-life (26-30 hours) ensures 24-hour control
- · Reduce blood pressure and provide additional organ protection in once-daily dosing
- · Selectivity allows lower doses
- · Positive effects on blood pressure, LDL and HbA1c
- · No risk of hyperkalaemia
- · Small molecule
- · Strong target engagement
- · Once-daily dosing
- · Combinations across obesity, weight management, and type-2 diabetes
- · Selective amylin agonist
- · Once-weekly dosing
- · Adjunct for additional fat-specific weight loss
- · Replacement therapy for incretin intolerance
- · Triple peptide agonists
- · Once-weekly dosing
- · Fat-specific weight loss
- · Organ protection
Forward looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter 'the Group') provides the following cautionary statement: This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected or targeted revenues, margins, earnings per share or other financial or other measures (including the Financial Ambition Statements described in this presentation). Although the Group believes its expectations and targets are based on reasonable assumptions and has used customary forecasting methodologies used in the pharmaceutical industry and risk-adjusted projections for individual medicines (which take into account the probability of success of individual clinical trials, based on industry-wide data for relevant clinical trials at a similar stage of development), any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's control, include, among other things: the risk of failure or delay in delivery of pipeline or launch of new medicines; the risk of failure to meet regulatory or ethical requirements for medicine development or approval; the risk of failures or delays in the quality or execution of the Group's commercial strategies; the risk of pricing, affordability, access and competitive pressures; the risk of failure to maintain supply of compliant, quality medicines; the risk of illegal trade in the Group's medicines; the impact of reliance on third-party goods and services; the risk of failure in information technology or cybersecurity; the risk of failure of critical processes; the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives; the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce; the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change; the risk of the safety and efficacy of marketed medicines being questioned; the risk of adverse outcome of litigation and/or governmental investigations; intellectual property-related risks to the Group's products; the risk of failure to achieve strategic plans or meet targets or expectations; the risk of failure in financial control or the occurrence of fraud; the risk of unexpected deterioration in the Group's financial position; the impact that global and/or geopolitical events may have, or continue to have, on these risks, on the Group's ability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition There can be no guarantees that the conditions to the closing of the proposed transaction with Fusion will be satisfied on the expected timetable, or at all, or that 'FPI-2265' (Ac225-PSMA I&T) or any combination product will receive the necessary regulatory approvals or prove to be commercially successful if approved. There can be no guarantees that the conditions to the closing of the proposed transaction with Amolyt Pharma will be satisfied on the expected timetable, or at all, or that eneboparatide ('AZP-3601') will receive the necessary regulatory approvals or prove to be commercially successful if approved.
This presentation includes references to new molecular entities and life-cycle management programmes that are being investigated in current or future clinical trials, and as such have not been approved by any regulatory agency. For a list of new molecular entities and indications in development, see pages 7-11 of the Clinical Trials Appendix that accompanied AstraZeneca's Q1 2024 results.
Basis of AstraZeneca ambitions, forecasts and targets
AstraZeneca ambitions, forecasts and targets in this presentation (the 'Financial Ambition Statements') are derived from AstraZeneca's most recent risk-adjusted mid- and long-term plans, adjusted for developments in the business since those plans were finalised. Financial Ambition Statements presented are based on management's risk-adjusted projections for individual medicines and individual clinical trials. Estimates for these probabilities are based on industry-wide data for relevant clinical trials in the pharmaceutical industry at a similar stage of development adjusted for management's view on the risk profile of the specific asset. The peak year revenue (PYR) potential for individual medicines referred to in this presentation are the maximum estimated Total Revenue to be recognised by AstraZeneca in a single calendar year, during the lifecycle of the medicine, and are based on management's latest non-risk adjusted forecast estimates. Estimates are based on customary forecasting methodologies used in the pharmaceutical industry. Peak year revenue may occur in different years for each NME depending on trial outcomes, approval label, competition, launch dates and exclusivity periods, amongst other variables. The peak year revenue figures are derived from net sales at nominal values and are not risk-adjusted or time-value discounted. The development of pharmaceutical products has inherent risks given scientific experimentation and there are a range of possible outcomes in clinical results, safety, efficacy and product labelling. Clinical results may not achieve the desired product profile and competitive environment, pricing and reimbursement may have material impact on commercial revenue forecasts. By their nature, forecasts are based on a multiplicity of assumptions and actual performance in future years may vary, significantly and materially, from these assumptions. The Financial Ambition Statements in this presentation are based on Q1 2024 exchange rates; AZ undertakes no obligation to update those statements based on future currency movements
Addressing an escalating burden for people, health systems and society
The most prevalent chronic diseases
Escalating with ageing populations
Overwhelming health systems and economies
2bn+ estimated to have chronic diseases* 1-3
Top 5 causes of death by 2040 will include CV disease, COPD and CKD 4
24m
deaths each year from chronic diseases 7
$22tn economic burden from chronic diseases* by 2030 8,9
1. British Heart Foundation Global Heart & Circulatory Diseases Factsheet. 2. GBD 2019 Chronic Respiratory Diseases Collaborators. EClinicalMedicine. 3. Chew NWS et al. Cell Metab. 2023. 4. Foreman KJ. Lancet. 2018. 5. WHO/Ageing and health. 6. Aïdoud A et al. J Am Heart Assoc. 2023. 7. WHO/Noncommunicable diseases. 8. Bloom DE, World Economic Forum. 2011. 9. Hacker K. Mayo Clin Proc Innov Qual Outcomes, 2024. Acronym definitions can be found in Glossary.
BioPharmaceuticals - transforming the care of chronic diseases
Therapy area leadership
Industry-leading portfolio
Strong growth delivered
BioPharmaceuticals - next wave of growth to 2030 and beyond
6
Critical trends transforming BioPharmaceuticals care
7
Advancing new areas and next-generation therapeutics
Expanding modalities
Novel combinations
Disease modification
Building amyloidosis leadership
Weight management and risk factors
Reaching under-treated patients in respiratory
8
Selected key BioPharmaceuticals pipeline catalysts
Cardiovascular, Renal and Metabolism
Mina Makar, SVP, Global CVRM
Martin Cowie, Interim SVP Late-Stage Development, CVRM
CVRM 2023 Total Revenue >$10bn, leadership in cardiorenal
Delivering double-digit growth year-on-year
Farxiga annualising >$6bn and established as foundational care across HF, CKD and T2D
11
Focus on CVRM diseases where burden remains
Market potential and CAGR: EvaluatePharma WW Sales by Indication combined consensus + Omnium product forecasts to 2030; All epidemiology figures refer to worldwide prevalence using 2024 as base year, except ATTR-CM which reflects G7 (US, EU5 (Germany, France, UK, Italy and Spain) and Japan. 1. Ionis 2022 Annual Report. 2. WHO - Hypertension Fact Sheet. 3. NCD Lancet 2021. 4. WHO - Global Health Observatory Raised Cholesterol. 5. Foti et al. Kidney Int. 2021 Mar 6. Jager et al. Nephrology Dialysis Transplantation (2019). 7. LabCorp data. 8. Internal RWD analysis. 9. WHO - Obesity Fact Sheet. 10. Zobair et al., Hepatology. Acronym definitions can be found in Glossary.
Strong portfolio of novel mechanisms and combinations
Wainua - launch in polyneuropathy unlocks significant opportunity in cardiomyopathy
ATTR-CM
300-500k patients with ATTR-CM 3-6
5-10% of heart failure with preserved ejection fraction 7,8
Wainua only monthly approved self-administered PN therapy
Exploratory data support potential ATTR-CM efficacy
*Peak Year Revenue, non-risk adjusted. Epidemiology reflects G7 (US, EU5 ( Germany, France, UK, Italy and Spain) and Japan. 1. Rintell D et al. Orphanet J Rare Dis. 2021;16(1):70. 2. González-Duarte A et al. Neurol Ther. 2020;9(1):135-149. 3. Ionis 2022 Annual Report. Accessed March 15, 2023. 4. Hawkins PN et al. Ann Med. 2015;47(8):625-638. 5. Witteles RM et al. JACC Heart Fail. 2019;7(8):709-716. 6. Gertz M et al. BMC Fam Pract. 2020; 7: Maurer MS et al. Circ Heart Fail. 2019;12(9):e006075. 8. Nativi-Nicolau JN et al. Heart Fail Rev. 2022;27(3):785-793. 9. Coelho T (2023) JAMA; 330(15):1448-1458. 10. Masri A (2023) J Card Fail; S1071-9164(23)00894-1. Acronym definitions can be found in Glossary. Collaboration partner: Ionis ( Wainua ).
Evaluating Wainua in largest ATTR-CM trial to assess different sub-populations
Wainua Phase III CARDIO-TTRansform trial
Leveraging CVRM and Rare Disease expertise in ATTR-CM
Complementary mechanisms
1. Alexion, AstraZeneca Rare Disease has rights to acoramidis in Japan. Acronym definitions can be found in Glossary.
baxdrostat - new potential treatment for aldosterone dysregulation, a key driver of hypertension
1.3bn patients with hypertension
50% of treated are uncontrolled 1,2
baxdrostat
aldosterone synthase inhibitor
Elevated aldosterone leads to HTN, CKD and HF
Significant reduction in systolic blood pressure in Phase IIb
AZD0780 (oPCSK9) - for dyslipidaemia in high-risk cardiovascular disease
Novel dual mechanisms with dapagliflozin in Phase III
Strong foundation with >60 million patients on dapagliflozin monotherapy across CKD, HF and T2D 4
balcinrenone/dapagliflozin - potential to improve outcomes for patients with HF and CKD
Traditional MRAs increase hyperkalaemia 4-7
MIRACLE Phase IIb 8: : reduced UACR without hyperkalaemia
baxdrostat/dapagliflozin - potential to further slow progression of chronic kidney disease
600m
people with CKD
and hypertension
1,2
Faster decline in renal function with higher aldosterone 3
baxdrostat/dapa ASI/ SGLT2i
Phase III programme ongoing
zibotentan/dapagliflozin - to delay worsening of kidney function and prevent liver disease complications
10% CKD with high proteinuria 1
123m liver cirrhosis, ~5-10% with portal hypertension 2-5
zibotentan/dapagliflozin ET A RA/ SGLT2i
ET A /SGLT2 - complementary mechanisms
Reduced albumin in ZENITH-CKD Phase IIb 6
Going beyond obesity to improve quality of weight loss and manage comorbidities
1. World Obesity Atlas 2023. Excludes children under 5 years. 2. TriNetX (US EHR data), November 2020. Obesity defined as ICD10 codes E66.0, E66.1 , E66.2 , E66.8 , E66.9; T2D defined by ICD10 code E11; CKD defined by eGFR levels between 15 and 75 (CKD stages 2-4); heart failure defined by ICD10 code 150; NASH/NAFLD defined by ICD10 codes K75.81 and K76.0; dyslipidaemia defined by LDL>70. *% adds up to more than 82.2m as many patients have several co-morbidities. Acronym definitions can be found in Glossary.
Delivering durable weight loss, addressing cardiometabolic risk and protecting organs
Three high potential assets progressing to Phase IIb
Two Phase IIb trials planned in 2024
Phase IIb trial planned in 2024
Phase IIb trial planning underway
Multiple high-value opportunities and rich near-term catalyst path support growth to 2030 and beyond
