Meet AZN Management: Oncology 2021 ASCO Annual Meeting Dave Fredrickson, Executive Vice President, Oncology Business Unit
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Meet AZN management: Oncology 2021 ASCO Annual Meeting Dave Fredrickson, Executive Vice President, Oncology Business Unit 7 June 2021 Interactive event for investors and analysts. This webinar is being recorded. https://astrazeneca.zoom.us/s/99688625459 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 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. 2 AstraZeneca Oncology We are leading a revolution in oncology to redefine cancer care Our ambition is to provide cures for cancer in every form. We are following the science to understand cancer and all its complexities to discover, develop and deliver life-changing treatments and increase the potential for cure. Our clinical strategy With our portfolio and is designed to help pipeline, we strive to transform survival revolutionalise cancer care Catalysing changes We are driven by our in the practice of people, our passion and medicine to transform our culture of innovation the patient experience 3 Oncology: a leading, diversified portfolio1 Lung cancer Multiple cancers Multiple cancers Blood cancers • Stage IV NSCLC2 • Stage III, unresectable • Ovarian, breast, • Breast cancer (3L9, • Chronic lymphocytic - EGFRm3 (1L4) NSCLC pancreatic, prostate HER2+10) and gastric leukaemia - T790M5 (2L6) cancers8 cancer (2L, HER2+) • Extensive-stage SCLC7 • Mantle cell lymphoma • Adjuvant EGFRm NSCLC • Merck collaboration • Daiichi Sankyo collab. Next Next Next Next Next • Neo-adjuvant and Stage • Early / advanced stages • Adjuvant breast, earlier • Earlier use, HER2 low • Combinations, other III, unresectable EGFRm of several cancers, use in prostate cancer, and other cancers blood cancers NSCLC and new combinations combinations (lung, colorectal) combinations What’s next: a rich early to mid-stage pipeline, including combinations and several new Phase III medicines 1. Approved medicines only 2. Non-small cell lung cancer 3. Epidermal growth factor receptor mutation 4. 1st line 5. Substitution of threonine (T) with methionine (M) at position 790 of exon 20 mutation 6. 2nd line 7. Small cell lung cancer 8. Exact patient population varies by indication 9. 3rd line 10. Human epidermal growth factor receptor 2 positive. 4 Oncology: strong launch and commercial execution capabilities Lung cancer Multiple cancers Multiple cancers Blood cancers $m 1,2 00 60 0 60 0 50 250 1,0 00 50 0 50 0 40 200 80 0 40 0 40 0 30 150 60 0 30 0 30 0 20 100 40 0 20 0 20 0 10 50 20 0 10 0 10 0 0 0 0 0 0 Q3 2015Q1 2016Q3 2016Q1 2017Q3 2017Q1 2018Q3 2018Q1 2019Q3 2019Q1 2020Q3 2020Q1 2021 Q2 2017 Q1 2018 Q4 2018 Q3 2019 Q2 2020 Q1 2021 Q1 2015Q1 2016Q1 2017Q1 2018Q1 2019Q1 2020Q1 2021 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q4 Q12017 Q22018 Q32018 Q42018 Q12018 Q22019 Q32019 Q42019 Q12019 Q22020 Q32020 Q42020 Q12020 2021 US Europe Established Rest of World (RoW) Emerging markets Total revenue at actual exchange rates; product sales only for Lynparza. 5 90 abstracts with Data 74 presentations highlights ASCO 2021 • Lynparza • One plenary session (Lynparza OlympiA Phase III adjuvant breast Another strong OlympiA Phase III trial) cancer presence • 12 oral presentations • Calquence ELEVATE-TN Phase III 4-year • 14 poster discussions follow-up ELEVATE-RR Phase III vs ibrutinib • 3rd plenary 47 posters • Imfinzi session in a row PACIFIC Phase III 5-year overall • 16 abstracts (publication only) survival • Enhertu, datopotamab deruxtecan, other potential new medicines from the pipeline Source: ASCO 2021 accepted abstracts. 24 additional presentations at ASCO 2021 will feature AstraZeneca medicines and potential new medicines but were not supported by AstraZeneca. 6 Agenda Lung cancer Breast cancer Haematology ‘What’s next’ Q&A 7 Lung cancer Mohit Manrao, Global Franchise Head, Tagrisso and lung cancer Greg Rossi, Global Franchise Head, Immuno-Oncology For additional questions and IR support, please email [email protected]. Transforming lung cancer by embracing entire patient journey Translating science to evidence, and evidence to practice Personalise treatment Diagnose and treat early Improve quality of care • NSCLC and SCLC • Increase screening and early diagnosis • Integrated remote care • Digital therapeutics and convenient • Tumour drivers and resistance • Opportunity for patients to get mechanisms (TDR) and immuno- treatment in curative setting dosing oncology (IO) • Healthcare equity and sustainability • Biomarker-driven treatments across 5-year survival13 % at diagnosis24 EGFR, HER2, exon 141, others Stage I 68–92% 26% • 2 Digital pathology and ctDNA -based Stage II 53–60% 9% personalised interventions Stage III 13–36% 25% (locally advanced) Now Next Stage IV 0–10% 40% tremelimumab (metastatic) savolitinib ceralasertib datopotamab deruxtecan Later diagnosis drives poor outcomes in NSCLC 1. Loss of exon 14 transcription in the mensenchymal-epithelial transition (MET) gene 3. Goldstraw et al., J Thorac Oncol. 2016; 11(1):39–51 4. EpiCast Report: NSCLC driving tumour growth 2. Circulating tumour DNA. Epidemiology Forecast to 2025, GlobalData, 2016. 9 Tagrisso: changing treatment expectations in EGFRm NSCLC Continuing to push the boundaries of science and patient care Reshaping the treatment paradigm Enabling maximal patient benefit globally by moving into earlier lines of NSCLC GloballyGlobally -Embeddedembedded Accessaccess • First EGFR TKI1 to overcome T790M resistance 2L 67 91 2015 2L • Best-in-class blood-brain barrier penetration • Excellent tolerability profile, convenient oral dosing Including 44 90 China NRDL • 1L EGFR standard of care 1L 2017 1L • Only EGFR TKI with OS2 > 3 years and unsurpassed PFS3 Reimbursed/Early Access • 4 Best-in-class CNS risk reduction Adjuvant 8 22 55 App roved 2020 Adjuvant Strong momentum in patient reach > 250,000 Unparalleled Stage IB-IIIA efficacy (80% relative risk) 210,274 § Protection against distant recurrences, 96,770 including in the CNS § Strongest-rated 29,466 3,812 10,365 curative-intent therapy in NSCLC (ESMO-MCBS) 2016 2017 2018 2019 2020 2021 YTD Established clinical leadership Bench to bedside excellence 1. Tyrosine kinase inhibitor 2. Overall survival 3. Progression-free survival 4. Central nervous system. Source: abstract LBA5, ASCO 2020. Source: AstraZeneca. 10 Tagrisso: building new EGFRm