ASTRAZENECA PLC BioPharmaceuticals
Ruud Dobber, EVP and President, BioPharmaceuticals Sharon Barr, EVP, BioPharmaceuticals R&D
Investor Day • 2024
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
2 | Investor Day • 2024 |
Addressing an escalating burden for people, health systems and society
The most prevalent | Escalating with ageing | Overwhelming health |
chronic diseases | populations | systems and economies |
2bn+
estimated to have chronic diseases* 1-3
Top 5
causes of death by 2040 will include CV disease, COPD and CKD4
1 in 6 | 24m |
aged 60+ by 20305 | deaths each year |
from chronic | |
diseases7 |
Up to | $22tn |
98% | economic burden |
will have multiple | from chronic |
chronic conditions6 | diseases* by 20308,9 |
*Cardiovascular disease, respiratory conditions, and metabolic diseases such as diabetes and/or CKD. All statistics based on estimates in referenced sources.
- 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.
- 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 3 found in Glossary.
Investor Day • 2024
BioPharmaceuticals - transforming the care of chronic diseases
Therapy area leadership | Industry-leading portfolio | Strong growth delivered |
Growing medicines | BioPharmaceuticals medicines Total Revenue | |
in cardiorenal | $18.4bn | |
#1 medicine | ||
$12.8bn |
Leadership in asthma and transforming COPD
Recent NME launches
Protecting vulnerable patients from respiratory infections
2019 1 | 2023 |
CVRM R&I | V&I |
4 1. V&I medicines in 2019 are Synagis and Flumist. Partners: Amgen (Tezspire), Ionis (Wainua) and Sanofi (Beyfortus). Acronym definitions can be found in Glossary. | Investor Day • 2024 |
BioPharmaceuticals - next wave of growth to 2030 and beyond
Illustrative only, not to scale | Launching NMEs |
baxdrostat | |
dapa FDCs | |
Existing portfolio | tozorakimab |
IVX-A12 |
Loss of exclusivity
Brilinta
Farxiga
2023 | 2030 |
Beyond 2030
Amyloidosis combinations
to address full spectrum
of disease
Weight management
and risk factors
Expanding modalities
in respiratory care
Auto-immune disease
Cell therapy, T-cell engagers
CAR-Treg
5 Partners: Amgen (Tezspire) and Ionis (Wainua). Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Critical trends transforming BioPharmaceuticals care
Expanding modalities
Early diagnosis
Novel combinations
Disease modification
Emerging biology
1
12
13
14
15
Disruptive innovations to transform care
Intervening before disease progression to drive better outcomes
Dual mechanisms of action to treat interconnected disease
Advancing from symptom management to clinical remission
Identifying new areas of disease to fuel a differentiated pipeline
6 Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Advancing new areas and next-generation therapeutics
Expanding modalities
Building amyloidosis
leadership
- Silencer - Wainua
- Depleter - ALXN2220
Reaching under-treated patients in respiratory
- Inhaled biologic - AZD8630 (iTSLP)
Novel combinations | Disease modification | ||
Weight management | Treat with curative intent | ||
and risk factors | in auto-immune diseases | ||
• | oGLP-1 - AZD5004 | • | Cell therapy |
monotherapy and combinations | autologous and allogeneic CAR-T | ||
• | dapagliflozin combinations | • | T-cell engager bispecifics |
+ baxdrostat HTN and beyond | • | CAR-Treg armoured Tregs |
- balcinrenone HF and CKD
- zibotentan liver/kidney function
7 Partners: Ionis (Wainua) and Eccogene (AZD5004). Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Selected key BioPharmaceuticals pipeline catalysts
2024
2025
2025+
Fasenra ORCHID
Phase III chronic rhinosinusitis
with nasal polyps
Tezspire WAYPOINT
Phase III chronic rhinosinusitis
with nasal polyps
AZD0780 (oPCSK9) PURSUIT
Phase IIb dyslipidemia
baxdrostat BaxHTN
Phase III hypertension
Breztri KALOS/LOGOS
Phase III asthma
Fasenra RESOLUTE
COPD
Saphnelo TULIP SC
Phase III systemic lupus
erythematosus
Wainua CARDIO-TTRansform
Phase III ATTR-CM
zibo/dapa ZENITH HP | ZEAL
Phase III CKD with high proteinuria |
Phase IIb liver cirrhosis
balci/dapa BalanceD-HF| MIRO-CKD
Phase III heart failure with CKD |
Phase IIb CKD
baxdro/dapa BaxDuo-ARCTIC
Phase III CKD with HTN
AZD6234 (LA amylin)
Phase IIb obesity
Saphnelo IRIS | DAISY
Phase III lupus nephritis | Phase III systemic sclerosis
Tezspire CROSSING
Phase III eosinophilic esophagitis
tozorakimab LUNA | TILIA
Phase III COPD | Phase III severe viral lower respiratory tract disease
IVX-A12
Phase III RSV/hMPV vaccine
8 zibo = zibotentan; dapa = dapafliglozin; balci = balcinrenone; baxdro = baxdrostat. Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Cardiovascular, Renal and Metabolism
Mina Makar, SVP, Global CVRM
Martin Cowie, Interim SVP Late-Stage Development, CVRM
Investor Day • 2024
CVRM 2023 Total Revenue >$10bn, leadership in cardiorenal
Delivering double-digit growth
year-on-year
CVRM Total Revenue ($m)
11,000
10,000
9,000
8,000
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
2020 | 2021 | 2022 | 2023 |
Farxiga annualising >$6bn and established as foundational care across HF, CKD and T2D
Farxiga Total Revenue ($m) | Heart | Type-2 | ||||
failure | diabetes | |||||
7,000 | ||||||
6,000 | 35% | 34% | ||||
5,000 | ||||||
Split of | ||||||
4,000 | Farxiga new | |||||
3,000 | patient share | |||||
2,000 | 31% | |||||
1,000 | ||||||
- | 2015 | 2017 | 2019 | 2021 | Chronic kidney disease | |
2013 | 2023 |
10 Acronym definitions can be found in Glossary. | Investor Day • 2024 |
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AstraZeneca plc published this content on 21 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 May 2024 09:54:01 UTC.
