AstraZeneca : Enhertu and breast cancer

Meet AZN management: ASCO 2020

Virtual breakout 2:Enhertuand breast cancer

José Baselga, Mika Sovak, Jon Wildin

IR moderator: Tom Waldron

1 June 2020

Webinar is being recorded

Forward-looking statements disclaimer

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 revenues, margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable assumptions, 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 failure to obtain, defend and enforce effective intellectual property (IP) protection and IP challenges by third parties; the impact of competitive pressures including expiry or loss of IP rights, and generic competition; the impact of price controls and reductions; the impact of economic, regulatory and political pressures; the impact of uncertainty and volatility in relation to the UK's exit from the EU; the risk of failures or delays in the quality or execution of the Group's commercial strategies; 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, data protection or cybercrime; the risk of failure of critical processes; any expected gains from productivity initiatives are uncertain; the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce; the risk of failure to adhere to applicable laws, rules and regulations; the risk of the safety and efficacy of marketed medicines being questioned; the risk of adverse outcome of litigation and/or governmental investigations; the risk of failure to adhere to increasingly stringent anti-bribery and anti-corruption legislation; 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; and the impact that the COVID-19 global pandemic 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. Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast.

Enhertu: 3L, HER2+ metastatic breast cancer

Strong launch despite COVID-19 challenges; ILD monitoring in place

ILD1monitoring programme

• •Understanding mechanism

  Evaluation of potential predictive/prognostic clinical and biomarkers to identify patients at risk

• •Monitor

  Optimise methods for monitoring and use of innovative digital technologies to allow for early intervention

• •Manage

  Education and awareness around management guidelines

Reduction in overall risk and severity of ILD for patients receivingEnhertu

Collaboration revenue at actual exchange rates.

1. Interstitial lung disease.

Enhertu: future clinical development programme

Opportunities across breast cancer, HER2 low and other tumours

Beyond breast cancer

Expand into other cancer types: gastric, NSCLC, CRC4and others

Combination trials withImfinzi(HUDSON and BEGONIA)

ASCO 2020

.1. Hormone-receptor positive 2. Cyclin-dependent kinase 4/6 inhibitor 3. Triple-negative breast cancer 4. Colorectal cancer.

Enhertu: randomised Phase II OS data in gastric cancer

DESTINY-Gastric01 trial presented at ASCO 2020

Confirmed ORR1by ICR2

CR PR SD PD

Not evaluable

Confirmed DCR

Best percentage change from baseline in tumour size

34.5% (n = 41)

42.9% (n = 51)

11.8% (n = 14)

2.5% (n = 3)

85.7% (n = 102)

8.4% (n = 10)

(CR + PR + SD), n (%)Median confirmed DOR

ORR (CR + PR) by ICR, n (%)

95% CI, 78.1-91.5

11.3 months

95% CI, 5.6-NE

51.3% (n = 61)

95% CI, 41.9-60.5; P < .0001

42.9% confirmed ORR

95% CI, 33.8-52.3

1. Objective response rate 2. Independent central review. Source: ASCO 2020, abstract 4513.

3. Breakthrough therapy designation 4. Orphan durg designation.