Slides
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February 26, 2025 DAIICHI SANKYO CO., LTD. Oncology Business Briefing FY2024
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Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from Daiichi Sankyo’s outlook or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantee that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material, but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof. The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain. This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. Forward-Looking Statements 2
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Agenda Presenter Opening Remarks Sunao Manabe Executive Chairperson & CEO Oncology Business Overview Ken Keller Global Head of Oncology Business US Oncology Overview - US Business Performance - Establishing Daiichi Sankyo’s Position in Oncology - Launch Readiness for Key Events in 2025 Dan Switzer Head of US Oncology Business Division EU Oncology Overview - EU Business Performance - Establishing Daiichi Sankyo’s Position in Oncology - Launch Readiness for Key Events in 2025 Markus Kosch Head of EU Oncology Business Division Closing Remarks Ken Keller Global Head of Oncology Business Q&A All 3 Oncology Business Briefing – Agenda
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Presenters Sunao Manabe Executive Chairperson and CEO Ken Keller Global Head, Oncology Business Dan Switzer Head, US Oncology Business Division 4 Markus Kosch Head, EU Oncology Business Division
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Ken Keller Global Head, Oncology Business President & CEO, Daiichi Sankyo, Inc. • Joined Daiichi Sankyo in 2014 • Revamped U.S. business structure to focus on multiple oncology launches including ENHERTU® as part of Daiichi Sankyo’s 2025 Goal • More than 30 years of experience in the pharmaceutical industry including 22 years at Amgen • Held senior regional and global leadership roles supporting major biologics including Aranesp®, Enbrel®, Neulasta®, Neupogen®, Prolia®, Vectibix®, and Xgeva® • Board Member of the PhRMA (Pharmaceutical Research and Manufacturers of America) 5
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Dan Switzer Head, US Oncology Business Division, Daiichi Sankyo, Inc. • Joined Daiichi Sankyo in 2005 (20 years) • Responsible for the commercialization and performance of all in-line and near-term oncology assets in the U.S. • Launched multiple pharmaceuticals and biologics at DSI and oversaw multi-billion-dollar franchises • Serves as member of the Daiichi Sankyo, Inc. Board of Directors • Held various leadership roles with increasing responsibility across marketing, market access and business analytics 6
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Markus Kosch Head, EU Oncology Business Division, Daiichi Sankyo Europe • Joined Daiichi Sankyo in 2021 • Leads European and Canada oncology business at Daiichi Sankyo governing 18 countries • Boarded physician in internal medicine, practiced in nephrology and oncology at the University Hospital in Münster until 2005 where he still teaches • Over 20 years' experience in pharmaceutical industry in senior global, regional and country leadership roles at Wyeth and Pfizer • Launched medicines in lung, GI cancers, hematology and breast including Palbociclib across Europe • Board Member of the EFPIA (European Association of Pharmaceutical Industry)
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We will achieve our 2025 Goal, Global Pharma Innovator with Competitive Advantage in Oncology, and will shift to further growth towards our 2030 Vision 持続的 成長 2030 Vision Innovative Global Healthcare Company Contributing to the Sustainable Development of Society ◆ Global top 10 in oncology ◆ Additional growth pillars being source of revenue and profit ◆ New products being source of profit in each business unit ◆ Contributing to sustainable development of society through our business As of FY2020 ◆ Oncology business launched ◆ Edoxaban growing ◆ Regional value being enhanced ◆ AZ strategic alliance ◆ Increased RD investment 5 - Year Business Plan (FY2021 - FY2025) Achieve FY2025 Goal “Global Pharma Innovator with Competitive Advantage in Oncology” and shift to further growth 5-year business plan (FY2021-FY2025) for sustainable growth 8 AZ: AstraZeneca, FY: fiscal year, RD: research and development
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Ken Keller Global Head, Oncology Business President & CEO, Daiichi Sankyo, Inc. • Joined Daiichi Sankyo in 2014 • Revamped U.S. business structure to focus on multiple oncology launches including ENHERTU® as part of Daiichi Sankyo’s 2025 Goal • More than 30 years of experience in the pharmaceutical industry including 22 years at Amgen • Held senior regional and global leadership roles supporting major biologics including Aranesp®, Enbrel®, Neulasta®, Neupogen®, Prolia®, Vectibix®, and Xgeva® • Board Member of the PhRMA (Pharmaceutical Research and Manufacturers of America) 9
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Our DESTINY clinical development program has transformed the oncology treatment landscape and Daiichi Sankyo *CY2024 Internal sales report: Global sales (DaiichiSankyo and AstraZeneca total revenue) **Granted Breakthrough Therapy Designation in U.S ***Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy BC: breast cancer, EGFR: epidermal growth factor receptor, FY: fiscal year HR: hormone receptor, NSCLC: non-small cell lung cancer, Non-sq: non-squamous, PD-(L)1: programmed death (ligand) 1, TLR: top line results, TNBC: triple negative breast cancer TROP2: trophoblast cell surface antigen 2 ENHERTU® revenue > $3.7B per annum* Strong commercial execution across the globe and prepared to optimize our new growth opportunities in FY25 • ENHERTU® has achieved leadership positioning in it’s first 4 indications in every fully launched country/region • US approvals for new indications expand the eligible patient opportunity in HER2+ tumor agnostic and chemo naïve HR+/HER2 low and ultralow mBC (DESTINY- Breast06) Multiple new ENHERTU® growth catalysts expected near term • High unmet need patients would benefit from earlier use of ENHERTU® - 1L HER2+ mBC (DESTINY-Breast09) - Neoadjuvant HER2+ BC (DESTINY-Breast11) - Adjuvant*** HER2+ BC (DESTINY-Breast05) Expanding Oncology Portfolio DATROWAY® • Approved in US/JP - 2/3L HR+/HER2 low or negative BC (TROPION- Breast01) • Submitted and accepted for priority review in US** - EGFRmut mNSCLC with prior systemic therapies (TROPION-Lung05) • Expected TLR in FY2025 - 1L PD-1/PD-L1 ineligible TNBC (TROPION-Breast02) - 1L Non-AGA NSCLC (AVANZAR) Global Oncology Business is nearing an inflection point with multiple new growth catalyst approaching 10
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*Please refer to NCCN.org for full recommendation language; content on this slide current as of February 2024 Current NCCN Clinical Guideline Recommendations(19)*: Subsequent line regimen if disease progression for HER2+ (IHC 3+) biliary tract cancers For 2L or subsequent therapy for advanced or metastatic HER2-amplified (IHC 3+) small bowel cancer Subsequent line regimen for locally advanced/metastatic and therapy for recurrent HER2+ (IHC 3+) pancreatic cancer For 2L+ unresectable locally advanced, recurrent, or metastatic HER2+ gastric/GEJ/esophageal cancer For 2L or subsequent therapy (or initial treatment for pMMR/MSS unresectable metachronous metastases, with previously FOLFOX/CAPEOX within past 12mos) for advanced or metastatic HER2-amplified (IHC 3+) colon or rectal cancer Second-line therapy over T-DM1 for recurrent unresectable (local or regional) or stage IV HER2+ breast cancer Treatment option for patients with brain metastasis with HER2+ breast cancer For 2L+ HER2+ (IHC 3+ or 2+) cervical cancer For 2L patients with HER2 IHC 0+, 1+ or 2+/ISH negative breast cancer (HR+ and HER2- with Visceral Crisis or Endocrine Refractory) Breast GI GYN NCCN CATEGORY 2A NCCN CATEGORY 1 NCCN CATEGORY 1 NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A Lung Add’l Rec’s Recurrence therapy for platinum-resistant HER2+ (IHC 3+ or 2+) ovarian cancer For 2L+ HER2+ (IHC 3+ or 2+) vaginal cancer For 2L+ HER2+ (IHC 3+ or 2+) endometrial cancer For 2L+ HER2+ (IHC 3+ or 2+) vulvar cancer For recurrent or metastatic HER2+ salivary gland tumors with no surgery or radiotherapy options Targeted therapy option for metastatic NSCLC with ERBB2 (HER2) mutations Subsequent therapy option for advanced or metastatic HER2+ (IHC 3+) NSCLC Subsequent line regimen for HER2+ (IHC 3+) non-nasopharyngeal cancers with no satisfactory alternative treatment options For subsequent line locally advanced or metastatic HER2+ (IHC 3+) bladder cancer For HER2+ (IHC 3+) occult primaries (adenocarcinoma and squamous cell) GYN (cont’d) NCCN CATEGORY 2B NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A NCCN CATEGORY 2A Preferred Option Useful in Certain Circumstances FDA Approval in HER2 low mBC Aug 2022 FDA Accelerated Approval in 2L+ HER2+ (IHC 3+) metastatic Tumor agnostic Apr 2024 FDA Accelerated Approval in 3L HER2+ mBC Dec 2019 FDA Approval in 2L HER2+ mGC Jan 2021 FDA Approval in 2L HER2+ mBC May 2022 FDA Accelerated Approval in HER2-mutant NSCLC Aug 2022 Dec June Jan Mar JuneMay Aug Apr 2019 2020 2021 2022 2023 Jan 2024 2L: second-line. BTD: Breakthrough Designation, GEJ: gastroesophageal junction HER2: human epidermal growth factor receptor 2, IHC: immunohistochemistry, IV: intravenous, mBC: metastatic breast cancer, mGC: metastatic gastric cancer,. NCCN: national comprehensive cancer network, NEJM: new England journal of medicine, NSCLC: non -small cell lung cancer, pMMR/MSS: proficient mismatch repair/microsatellite stable, T-DM1: trastuzumab emtansine, The DESTINY clinical development program has yielded 8 BTD, 6 NEJM and 19 NCCN recommendations Sep 2025 Jan HR+/HER2 low or ultralow mBC Jan 2025 DB-06 ENHERTU® is a standard of care and paradigm-changing drug 11 NCCN CATEGORY 2A For 1L patients with no Germline BRCA1/2 mut and/or IHC HER2 0+, 1+ or 2+/ISH negative breast cancer (HR+ and HER2- with Visceral Crisis or Endocrine Refractory)
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December 20 2019 Unresectable or metastatic HER2 positive breast cancer (3L+) August 6 2022 Unresectable or metastatic Post-chemo HER2 low breast cancer January 15 2021 Unresectable or metastatic HER2 mutant non-small cell lung cancer (2L+) August 12 2022 Locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (2L+) April 6 2024 Unresectable or metastatic HER2 positive tumor agnostic (2L+) May 5 2022 Unresectable or metastatic HER2 positive breast cancer (2L) January 27 2025 Unresectable or metastatic Chemo naive HR+/HER2 low or ultralow breast cancer 2L: second-line, 3L: third-line, HR: hormone receptor To date, ENHERTU® has expanded to six indications, based on the DESTINY clinical development program Full Approval 12
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Global ENHERTU® net sales have exceeded 140 Bn JPY per quarter Overall, global net sales in FY2024 Q3 was 143.1 Bn JPY; +8.7% sequential q-o-q growth and +39.5% vs FY2023 Q3 driven by US and Europe US Europe Japan ASCA 1106.6 Bn JPY cumulative global net sales since 1st launch 3.2 5.2 7.1 8.4 9.4 13.0 13.8 16.8 21.9 31.3 48.2 60.2 67.8 81.7 91.6 102.6 ENHERTU® GLOBAL NET SALES BY REGION 143.1 131.7129.6 119.9 *Incl. Gross profit share in AstraZeneca territory In the US, FY2024 Q3: 79.5 Bn JPY +11.5% vs. prior quarter; +22.6 Bn JPY (+39.6%) vs. prior year In the EU, FY2024 Q3: 39.0 Bn JPY +10.4% vs. prior quarter; +13.5 Bn JPY (+52.9%) vs. prior year US EU *Daiichi Sankyo Financial Results Reference Data ASCA: Asia, South and Central America, Bn: billion, FQ: fiscal quarter, FY: fiscal year, JPY: Japanese Yen, q-o-q: quarter over quarter 13
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ENHERTU®: strong global performance *CY2024 Internal sales report: Global sales (Daiichi Sankyo and AstraZeneca total revenue) **Internal market research results *** 3L HER2+ metastatic gastric cancer is approved in Japan. There is no current 2L approval in Japan for metastatic gastric cancer 2L: second-line, HR: hormone receptor, IHC: immunohistochemistry, YOY: year over year Chemo naive HR+/HER2 low or ultralow Metastatic Breast Cancer 2L+ HER2 Mutant Metastatic Lung Cancer JP APPROVAL: AUG 2023 2L+ HER2+ Metastatic Gastric Cancer *** JP APPROVAL: SEP 2020 2L+ HER2+ (IHC3+) Metastatic Tumor Agnostic Post-chemo HER2 low Metastatic Breast Cancer JP APPROVAL: MAR 2023 2L HER2+ Metastatic Breast Cancer JP APPROVAL: NOV 2022 >60 countries/ regions Robust commercial footprint >39% YOY Accelerating momentum throughout the globe and major catalysts in place for 2025-27 $3.7B* in revenue delivered in CY 2024 with US and EU leading the way 131 K patients across breast, lung, gastric cancer and tumor agnostic More than Achieved #1 Market share** in 100% of fully launched countries 14 US APPROVAL: AUG 2022 | EU Approval: OCT 2023 US APPROVAL: JAN 2021 | EU Approval: DEC 2022 US APPROVAL: Apr 2024| US APPROVAL: AUG 2022 | EU Approval: JAN 2023 US APPROVAL: MAY 2022 | EU Approval: JULY 2022 US APPROVAL: Jan 2025|
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ENHERTU® has led the way in the growing ADC market 0.2 0.5 1.3 2.5 3.7 2019 2020 2021 2022 2023 2024 CY Sales (USD $B) Enhertu Kadcyla Adcetris Trodelvy Polivy Elahere Padcev Zynlonta Besponsa Blenrep Tivdak Source: Evaluate Pharma, accessed February 4, 2025 Note: Sales were converted to USD based on the currency conversion rate of the relevant year. ADC: antibody drug conjugate, CY: Calendar year; FY: Fiscal year 2024 ADC revenues are analyst estimates excluding Kadcyla, Poliivy which are actual reported revenue ENHERTU sales are based on DS internal reported revenues (Global DS+AZ total revenue) 15 ® ® ® ®® ®®®® ® ®
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ENHERTU® is at an inflection point as TLR from key clinical trials have the potential to move it earlier and broader Moving earlier is the primary opportunity In the next three years, ENHERTU® is positioned to become the biggest breast cancer drug ever. 16TLR: topline results
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ENHERTU® is DESTINED for more as key clinical trial results and new indications seek to go earlier and broader HR+/HER2 low & ultralow chemo naive metastatic breast cancer DESTINY -Breast06 HER2 positive metastatic breast cancer (1L) DESTINY -Breast09 HER2 positive early breast cancer (neoadjuvant) DESTINY -Breast11 HER2 positive early breast cancer (adjuvant*) DESTINY -Breast05 LUNG AND GASTRIC INDICATIONS BREAST INDICATIONS Future Indications 2027+ 2025-2026 Potential New Indications HER2 positive gastric cancer (2L) DESTINY -Gastric04 HER2 mutant metastatic NSCLC (1L) DESTINY -Lung04 HER2 positive gastric cancer (1L) DESTINY -Gastric05 HER2 positive biliary tract cancer (1L) DESTINY -BTC01 *Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy 1L: first-line, 2L: second-line, HR: hormone receptor, NSCLC: non-small cell lung cancer 17 HER2 positive ovarian cancer (1L) DESTINY -Ovarian01
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DESTINY-Breast09 advances ENHERTU® to the first line mBC setting DESTINY-Breast03 results provide optimism T-DXd* R 1:1:1 Trastuzumab Pertuzumab T-DXd* Pertuzumab Taxane STUDY DESIGN • HER2+ mBC • DFI >6 months from last chemo or HER2-targeted therapy in Neo adjuvant/adjuvant setting • No prior systemic treatment for mBC except for endocrine therapy Stratification factors : • De novo vs recurrent (cap at 50% de novo) • HR-positive vs negative • PIK3CAm (detected vs not detected) POPULATION Primary: • PFS (BICR) Secondary: • OS • PFS (Inv. assessed) • ORR, DoR • PFS2 • PRO/HRQoL • PK/ADA • Safety and tolerability Exploratory: • TTF, TFST, TSST • BMFS, CNS - PFS • Patient reported tolerability • Exploratory biomarkers ENDPOINTS • *Patients can continue with trastuzumab if T-DXd is discontinued due to toxicity. • Use of endocrine therapy is allowed for HR-positive participants after discontinuation of taxane or after 6 cycles of T-DXd. • Taxane can be paclitaxel or docetaxel. • Pertuzumab-blinded in the T-DXd arms. N=1157 Pertuzumab Placebo DESTINY-Breast09 STUDY DESIGN ~3K ~4K* MARKET INSIGHTS THP efficacy leaves room for improvement • mPFS 19m • 12m landmark OS 65% THP • ORR 80% THP Real-world attrition rates across first- to third-line therapies in patients with HER2-positive metastatic breast cancer. Indicates that 29.6% of patients did not receive treatment beyond the first line **Incremental to DB-01 & 03 INCREMENTAL ELIGIBLE PATIENT POPULATION** *Germany, France, Italy, Spain, UK ADA: anti-drug antibody, BMFS: Brain metastasis free survival, BICR: blinded independent central review, CNS: Central nervous, DFI: Disease Free Interval, DOR: duration of response, HRQoL: Health-related quality of life, HR: Hormone receptor, mBC: metastatic breast cancer, OS: overall survival, ORR: objective response rate, PRO: Patient report outcome, PK: pharmacokinetics, PFS: progression-free survival, R: randomization, THP: Taxane+Trastuzumab+Pertuzumab, T-DXd: Trastuzumab deruxtecan, TTF: Treatment time to failure, TFST: Time to First Subsequent therapy TSST: Time to subsequent therapy 18
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DESTINY-Breast11 and DESTINY-Breast05 advances ENHERTU® into the early-stage BC setting, seeking to cure more patients Neo Adj HER2+ eBC: first launch in curative intent setting & earliest opportunity for use DESTINY-Breast11 STUDY DESIGN ELIGIBLE PATIENT POPULATION ~12K ~12K* MARKET INSIGHTS High desire to improve pCR of ddac-THP • pCR of 56% with ddAC-THP • High confidence association with DFS and OS Surgery R 1:1:1 Paclitaxel QW + trastuzumab + pertuzumab Q3W (THP) x4 cycles T-DXd Q3W x4 cycles Doxorubicin + cyclophosphamide Q2W (dd-AC) x4 cycles • HER2+ EBC • HR+ or HR- (HR- capped at 30%) • T> 5 cm or N+ or inflammatory BC Paclitaxel QW + trastuzumab + pertuzumab Q3W (THP) x4 cycles Trastuzumab deruxtecan (T-DXd) Q3W x8 cycles Stratification factors: • HR Status (HR+, HR-) • HER2 IHC (IHC3+, Other) N = 927 Arm A Arm B Arm C Primary Endpoint: • pCR (ypT0/Tis ypN0) Secondary Endpoints: • pCR (ypT0 ypN0) • 3-yr EFS • 3-yr IDFS • OS • HRQoL • Safety • PK and immunogenicity Population On-study treatment Endpoints Post-neoadjuvant therapy will be determined by investigator and administered as per local SOC, strong recommendations outlines in protocol. DFS: Disease-free survival, eBC: early breast cancer; EFS: Even-free survival; IDFS: Invasive disease-free survival; HRQoL: Health-related quality of life, OS: Overall survival; pCR; Pathologic complete response, PK: pharmacokinetics; R: randomization; THP: Taxane+Trastuzumab+Pertuzumab; *Germany, France, Italy, Spain, UK 19
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DESTINY-Breast05 and DESTINY-Breast11 advances ENHERTU® into the early-stage BC setting, seeking to cure more patients DESTINY-Breast05 STUDY DESIGN ELIGIBLE PATIENT POPULATION ~4K ~4K* MARKET INSIGHT Efficacy improvement is desired • 3-year IDFS rate is 83% T-DM1 • Previous HTH clinical trials versus T-DM1 is encouraging • Selecting for higher risk patients Breast cancer diagnosis • HER2-positive • Non-metastatic (T1-4,N0-3,M0) Preoperative treatment • At least 16 weeks • Includes taxane + trastuzumab Breast Cancer Surgery • Evidence of remaining disease after preoperative treatment • All cancer removed at surgery Key Patient Eligibility R 1:1 Patient Population: • HER2+ eBC with residual disease following neoadjuvant therapy with high risk of recurrence • Centrally confirmed HER2+ status • ECOG PS: 0-1 n = 1600 Stratification Factors Endpoints Additional Notes 1) Operative status at disease presentation1 (operable, inoperable) 2) Post-neoadjuvant pathological nodal status2 (positive, negative) 3) Tumor hormone receptor status (positive, negative) 4) HER2-targeted neoadjuvant therapy approach (single, dual) • Primary: ‒ IDFS • Key secondary: ‒ DFS • Exploratory: ‒ PROs (QoL) ‒ Biomarkers ‒ PK • Randomization within 12 weeks of surgery • Adjuvant radiotherapy and/or endocrine therapy per protocol and local guidelines. • Secondary: ‒ DRFI ‒ BMFI ‒ OS ‒ AEs 1 Operable = clinical stages T1-3,N0-1,M0; Inoperable = clinical stages T4,N0-3,M0 or T1-3,N2-3,M0 2 Positive = ypN1-3, negative = ypN0 Follow-up: • 40 (+7) Day Safety FU • Disease FU • Long-term FU Investigational Arm: Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg q3w for 14 cycles (n = 800) Control Arm: Trastuzumab emtansine (T-DM1) 3.6 mg/kg q3w for 14 cycles (n = 800) High risk of disease recurrence • Inoperable at presentation (before neoadjuvant therapy) or • Pathologically positive axillary lymph nodes following neoadjuvant therapy *Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy AE: adverse event; BMFI: Brain metastases-free interval; DFS: Disease-free survival; DRFI: Distant recurrence-free interval; eBC: early breast cancer; ECOG PS: Eastern Cooperative Oncology Group performance status; FU: follow-up; HER2: Human epidermal growth factor receptor 2; IDFS: Invasive disease-free survival; OS: Overall survival; PK: pharmacokinetics; PRO: patient reported outcome; QoL: quality of life R=randomization *Germany, France, Italy, Spain, UK Adjuvant* HER2+ eBC: notable next step in the BC treatment journey, with competitor (Kadcyla®) 20
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*Not considering overlapping with ENHERTU eligible patients' population(DB-04/DB-06) **US, Germany, France, Italy, Spain, UK, JP ***US only. There is potential for additional upside in patient eligibility from recently approved TKI+CTx regimens, such as FLAURA2 in the future if 1L use grows significantly ****NSQ (Non-Squamous) TROP2 Positive AGA: actionable genomic alterations, CY: calendar year, CHMP: Committee for Medicinal Products for Human Use, EGFR: epidermal growth factor receptor, FDA: Food and Drug Administration, HR: hormone receptor, NSCLC: non-small cell lung cancer, PD-(L)1: programmed death (ligand) 1, TLR: topline results, TNBC: triple negative breast cancer, TROP2: trophoblast cell surface antigen-2 NSCLC Breast Approval / Expected approval Expected TLR HR+ and HER2 low or negative metastatic breast cancer (2L/3L) TNBC, PD-1/PD-L1 ineligible (1L) EGFR mutated, previously treated (incl. EGFR directed therapy) (2L+) Non-AGA, Durvalumab combo (1L) • US: Approval on January 17, 2025 • JP: Approval on December 27, 2024 • EU: Recommended for approval by CHMP • Eligible patients**: 2L HR+/HER2- mBC ~42k* • FDA has accepted a new application and granted Priority Review and Breakthrough Therapy Designation • PDUFA date: July 12, 2025 • Eligible patients*** ~3K+ (US) • DATROWAY® versus chemotherapy • Expected TLR timing: FY2025 H1 • Eligible patients**: ~14k • DATROWAY® + durvalumab + carboplatin versus pembrolizumab + histology-specific platinum-based chemotherapy • Expected TLR timing: CY2025 H2 • Eligible patients**: ~56k**** TROPION -Breast02 TROPION -Lung05 AVANZAR TROPION -Breast01 Expanding oncology portfolio: DATROWAY® expected approvals and pivotal data in 2025 21
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Potential for nine launches with ~3X increase in patient opportunity in 2025-2026 2025-2026 Potential New Indications HR+ and HER2 low or negative metastatic breast cancer (2L/3L) HR+/HER2 low & ultralow chemo naïve metastatic breast cancer DESTINY -Breast06 HER2 positive metastatic breast cancer (1L) DESTINY -Breast09 HER2 positive early breast cancer (neoadjuvant) DESTINY -Breast11 HER2 positive early breast cancer (adjuvant*) DESTINY -Breast05 LUNG AND GASTRIC INDICATIONSBREAST INDICATIONS TNBC, PD-1/PD-L1 ineligible (1L) TROPION -Lung05 *Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy EGFR: epidermal growth factor receptor, HR: hormone receptor, NSCLC: non-small cell lung cancer, PD-(L)1: programmed death (ligand) 1, TNBC: triple negative breast cancer, HER2 positive gastric cancer (2L) DESTINY -Breast06 HER2 mutated metastatic NSCLC (1L) DESTINY -Breast09 EGFR mutated, previously treated (incl. EGFR directed therapy) (2L/3L) TROPION -Breast01 TROPION -Breast02 DESTINY-Breast06 DESTINY-Breast09 DESTINY-Breast11 DESTINY-Breast05 DESTINY-Gastric04 DESTINY-Lung04 TROPION-Breast01 TROPION-Breast02 TROPION-Lung05 22
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Dan Switzer Head, US Oncology Business Division, Daiichi Sankyo, Inc. • Joined Daiichi Sankyo in 2005 (20 years) • Responsible for the commercialization and performance of all in-line and near-term oncology assets in the U.S. • Launched multiple pharmaceuticals and biologics at DSI and oversaw multi-billion-dollar franchises • Serves as member of the Daiichi Sankyo, Inc. Board of Directors • Held various leadership roles with increasing responsibility across marketing, market access and business analytics 23
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• Field Sales – Oncology Breast • Field Sales – Oncology Lung • Field Sales – Oncology Hematology • Account Managers • Field Reimbursement Managers • Oncology Nurse Educators • National Account Managers • Strategic Value & Access Marketing • Strategic Contracting & Pricing • Medical Science Liaisons • Medical Value Liaisons • Medical Diagnostics • Medical Education & Information • HEOR US OBD possesses comprehensive commercial & medical capabilities across five core functions, highlighted by large customer-facing teams Customer-facing teams account for ~70% of US OBD headcount • Regional Marketing Liaisons • Product / Brand Teams • Omni-Channel Marketing • Market Research & Data Analytics • Sales Operations • Training – All Customer Facing Roles • Training – Leadership Development MEDICAL AFFAIRS SALES BUSINESS OPERATIONS MARKETING MARKET ACCESS HEOR: health economics and outcomes research, OBD: oncology business division, Customer and Patient CARE Team 24
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ENHERTU® revenue growth continues in the US 25 US net sales exceeded 79 Bn JPY in FY Q3 ‘24 *DS External reported sales Bn: billion, FQ: fiscal quarter, FY: fiscal year, JPY: Japanese Yen, q -o-q: quarter over quarter 664.2 Bn JPY cumulative US net sales since 1st launch ENHERTU® US NET SALES US US 3.2 5.0 6.3 6.7 7.7 9.6 10.1 11.9 13.8 20.0 35.3 44.5 44.8 51.6 54.3 57.0 79.5 71.368.9 62.7 Overall, US net sales in FY2024 Q3 was 79.5 Bn JPY; +11.5% sequential q-o-q growth +22.6 Bn JPY (+39.6%) vs FY2023 Q3
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ENHERTU® – US revenue split over time (launch – December 2024) 26 Although breast indications make up ~85% of the total Net Revenue for ENHERTU®, non-breast indications continue to expand treatment and revenue opportunities for the brand BC: breast cancer; HR: Hormone receptor, mBC: metastatic breast cancer, mGC: metastatic gastric cancer, NSCLC: non-small cell lung cancer $0 $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 Jan - Mar 2020 Apr - Jun 2020 Jul - Sep 2020 Oct - Dec 2020 Jan - Mar 2021 Apr - Jun 2021 Jul - Sep 2021 Oct - Dec 2021 Jan - Mar 2022 Apr - Jun 2022 Jul - Sep 2022 Oct - Dec 2022 Jan - Mar 2023 Apr - Jun 2023 Jul - Sep 2023 Oct - Dec 2023 Jan - Mar 2024 Apr - Jun 2024 Jul - Sep 2024 Oct - Dec 2024 Net Revenue ($USD in 000's) HER2+ mBC HER2 Low mBC HER2+ mGC HER2mut and HER2+ mNSCLC HER2+ Tumor Agnoistic
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Growth opportunities remain within ENHERTU® current indications 27 HER2+ mBC Achieved ENHERTU® is currently the dominant market leader (Market share>60%) for 2L HER2+ mBC in US FY2024 Q3 vs FY2024 Q2: +9.5%* FY2024 Q3 vs FY2023 Q3: +24.9%* Opportunities • Cement magnitude of benefit, particularly among low DB-03 users and across patient types (including HR+/HER2+ patients) • Increase confidence in benefit/risk profile through further education on AE identification & management HR+/HER2 low mBC Achieved ENHERTU® has become the market leader (Market share>50%) in the post chemo setting FY2024 Q3 vs FY2024 Q2: +9.4%* FY2024 Q3 vs FY2023 Q3: +30.3%* Opportunities • Pivot to DB-06 at FDA approval in early Q1’CY25 driving pre-chemo use • Displace chemo (IV & oral) and expand to a broader population with HER2- ultralow Tumor Agnostic Achieved ENHERTU® is approved in the US, and has achieved a high market share in HER2+ IHC tested patients FY2024 Q3 vs FY2024 Q2: +8.9%* FY2024 Q3 vs FY2023 Q3: +166.4%* Opportunities • Increase awareness of the HER2+ indication and improve IHC testing rates from current levels of ~30% to become a new standard of care • There is still room to grow market share even in the HER2+ IHC tested patients *Sales revenue (USD) HCP: health care provider, HER2: human epidermal growth factor receptor 2, IHC: immunohistochemistry, mBC: metastatic breast cancer,
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Slow adopters continue to increase utilization as evidence and experience grows 28Source: Internal database – Patient market share of ENHERTU® vs Kadcyla wk: week 30% 35% 40% 45% 50% 55% 60% 65% 70% 75% 80% ENHERTU® Market Share (vs Kadcyla®) - Focus Accounts vs All Other Focus Accounts All Other Accounts • Focus accounts have grown share (relative to Kadcyla®) from 40% to 55%- 60% over the past 12 months
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NOT TODAY connects ENHERTU® to people living with mBC, reflecting their truth. …And as the cultural pendulum swings towards authenticity and away from the warrior mentality, NOT TODAY follows suit, empowering women to take back what cancer has stolen from them. ENHERTU® NOT TODAY DTC Campaign 29DTC: direct to consumer, HR: hormone receptor, mBC: metastatic breast cancer,
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DESTINY-Breast06 Study • The primary endpoints is PFS (BICR) in HER2 low • TLR was obtained in 2024 ENHERTU®: HR+/HER2 low or HER2 ultralow, chemo naive opportunity • There remains unmet need in HR+ / HER2 low breast cancer for patients who progress after ≥1 endocrine-based therapy • There were previously no targeted therapies specifically approved for patients with HER2 ultralow expression. • ENHERTU® is now the first targeted therapy approved to treat HER2 ultralow expressing patients, following FDA approval of DESTINY-Breast06 • Statistically significant and clinically meaningful PFS benefit vs. chemotherapy • Consistent results in HER2- ultralow mBC • No new safety signals were identified • Major market patient opportunity of ~ 18k* *US+Germany+France+Italy+Spain+UK+JP BICR: blinded independent central review, CI: confidence interval, HR: hazard ratio, ICC: investigator’s choice of chemothera py, PFS: progression-free survival, OS: overall survival, Q3W: once every three weeks, TLR: topline results TPC mPFS: 8.1 mo ENHERTU® mPFS: 13.2 mo Hazard ratio 0.62 95% CI 0.52–0.75 P<0.0001* Δ5.1 mo Hazard ratio 0.64 95% CI 0.54–0.76 P<0.0001** TPC mPFS: 8.1 mo ENHERTU® mPFS: 13.2 mo Δ5.1 mo PFS (BICR) in HER2 low PFS (BICR) in ITT (HER2 low and HER2 ultralow) 30
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HER2 ultralow further broadening the HER2 spectrum B R O A D E R HER2 low in post-ET population E A R L I E R Move ahead of chemo ET regimen Chemo ET regimen Chemo Chemo ENHERTU® New classification defined as IHC 0 with membrane staining With the DB-06 approval ~90% of all mBC patients will be eligible for ENHERTU® DESTINY-Breast06 was designed to move ENHERTU® earlier in the treatment paradigm and further broaden the eligible patient population 31DB-06: DESTINY-Breast06, ET: endocrine therapy, IHC: immunohistochemistry, mBC: metastatic breast cancer
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DESTINY-Breast04 HER2 Spectrum HER2+ HER2- low HER2– HER2+ HER2- low HER2– HER2- ultralow HER2 Spectrum Past HER2 Binary Classification HER2+ HER2– ENHERTU® HER2 low and ultralow indication expands the patients we can help 32IHC: immunohistochemistry Defined as IHC 0 with membrane staining, ultralow is new to the HER2 spectrum DESTINY-Breast06
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HER2 ultralow patients are not identified on reports today; ONCs will need to drive re-evaluation of existing patients with IHC 0 results HER2 IHC Score 0 HER2 Status Negative IHC 0 with membrane staining “score” is not distinctly recognized by CAP Biomarker Templates or ASCO-CAP guidelines A N T I C I PAT E D I D P R O C E S S ONCs to contact PATH if IHC 0 PATH/Lab reports result PATH/Lab determines re-evaluation approach Ordering Re-Evaluation Reporting Call-to-Action (if majority pts treated earlier) Ask your PATH to re-evaluate IHC 0 results to identify any membrane staining Current Reporting Recommendation ONC: oncologist, PATH: pathologists 33
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HER2 IHC testing in solid tumors website • Testing for HER2 can inform patient care in breast and gastric cancer, among other tumor types. • With recent clinical advancements, consistency of HER2 IHC assessment in solid tumors across the full spectrum of expression is of paramount importance. • “HER2Know” provides a collection of clinical cases, tools to assess your HER2 IHC scoring consistency, and a range of educational resources to help you refine your approach to HER2 IHC scoring. Breast Cancer Watch peer-led videos, investigate challenging clinical case reviews, practice your HER2 IHC scoring with a quiz, and more. Gastric Cancer View guidelines for HER2 IHC testing in gastric cancer and a downloadable guide to support your clinical practice. https://www.her2know.com/ 34 HER2: human epidermal growth factor receptor 2, IHC: immunohistochemistry “HER2Know” has expanded its website to include content on HER2 in tumors beyond breast cancer
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ENHERTU®: HER2 positive tumor agnostic opportunity • There were previously no approved HER2-directed therapies particularly for those who have progressed on or are refractory to standard of care therapies, and unmet need for effective therapies for certain HER2 positive solid tumors • ENHERTU® is now the first approved HER2-directed therapy for certain HER2 expressing solid tumors after achieving FDA approval in the HER2+ Tumor Agnostic Indication • Showed the pre-specified target for objective response rate (ORR) and demonstrated durable response across multiple HER2 positive advanced solid tumors in heavily pretreated patients • No new safety signals were identified • Major market patient opportunity of ~ 17k* *US+Germany+France+Italy+Spain+UK+JP CI: confidence interval, FDA: Food and Drug Administration HR: hazard ratio, ORR: overall response rate, OS: overall survival, PFS: progression-free survival, Q3W: once every three weeks, TLR: topline results 35
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Tumor agnostic opportunity is sizable with ~6,000 addressable HER2+ (IHC3+) patients across tumor types in the US *IHC3+ prevalence in pancreatic ~1%-7%, assumed average of 4% for chart Source: SEER_May2023 BTC: biliary tract cancer, CRC: colorectal cancer, GI: gastrointestinal, Gyn: gynecological, IHC: immunohistochemistry, NSCLC: non-small cell lung cancer Significant opportunity for ENHERTU® in HER2+ (IHC3+) patients across tumors IHC3+ Prevalence 7% 12% 4% 9% 2% 4%* 7%9% 4% ~600 ~200 ~400 ~850 ~3,000 ~400 ~600 ~400 ~900 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 Endometrial Cervical Ovarian Bladder NSCLC BTC CRC Pancreatic Rare Patients HER2 IHC3+ Population (labeled #s) Total 2L+ Incidence LungBladderGyn GI Other OUT OF SCOPE FOR TODAY BladderGynLung GI 5-year survival across these tumors ranges from 2% to 25%, highlighting unmet need for improved treatment options 36
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IHC testing rates for tumor agnostic remain low and patients do not have the opportunity to be prescribed ENHERTU® *Unweighted average of Endometrial, Cervical, Ovarian Testing data is from Diaceutics National Test Rate, FY: fiscal year, IHC: immunohistochemistry, NSCLC: non-small cell lung cancer, Q: quarter, TA: Tumor Agnostic, IHC Testing rate across the tumors (FY24 Q3) Gynecological* Bladder NSCLC Breast Testing No testing Approximately 30% >90% 37
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Presentation & Diagnosis Primary Treatment Biomarker Testing Systemic Treatment Health Care Decision Makers (HCDM) Influence patient access to care throughout patient journey (from presentation through treatment) PATHS Primary decision-makers both in terms of ordering IHC testing and selecting treatment MED ONCS GYN ONCS THORACIC ONCS GI ONCS GU ONCS NURSES MDT Critical role in pt management Patients Critical role in patient ID ~30% of HCPs (across med oncs and specialists) capture ~80% of cumulative patient volume Tumor agnostic environment is complicated by the wide variety of stakeholders involved in managing a dispersed patient population The number of tumors with this indication will require mobilization of different teams across the alliance ENHERTU® tumor agnostic HCP targeting requires differentiated engagement due to the variety of stakeholders involved across tumors GI: gastrointestinal, GU: genitourinary, GYN: gynecological, HCP: health care provider, ID: identification, IHC: immunohistochemistry, MDT: multidisciplinary team, ONC: oncologist, pt: patient, TA: Tumor Agnostic, Sources: DS Analysis based on Symphony data 38
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The eligible patient opportunity in the US expands ~2x by 2026 0 10000 20000 30000 40000 50000 60000 2020 2021 2022 2023 2024 2025 2026 HER2+ mBC HER2+ eBC HER2 low BC Gastric Lung Tumor agnostic E L I G I B L E O P P O R T U N I TY F O R E N H E R T U® ( U S ) * Calendar Year BC: breast cancer, eBC: early breast cancer; mBC: metastatic breast cancer Eligible Patients are based on internal estimates
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TROPION-Breast01 Study • The dual primary endpoints are PFS and OS • TLR was obtained in September 2023 DATROWAY®: 2L/3L HR+/HER2 negative breast cancer opportunity • There remains unmet need in HR+ / HER2 low or negative breast cancer for patients who progress on and are not suitable for endocrine therapy and were previously treated with 1-2 prior line(s) of chemotherapy • DATROWAY® is now approved for HR+ HER2 low or negative breast cancer patients who have received prior endocrine-based therapy and chemotherapy • Statistically significant and clinically meaningful efficacy (PFS) vs. chemotherapy • Convenient Q3W dosing schedule • Stomatitis/oral mucositis was effectively managed with dose reductions/delay • No grade 4 or 5 ILD events BICR, blinded independent central review; CI, confidence interval; CHMP: committee for medicinal products for human use; FDA: Food and Drug Administration, HR, hazard ratio or hormone recptor; ICC, investigator’s choice of chemotherapy; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; TLR, topline results • Us: FDA Approval on January 17, 2025 • JP: Approval on December 27, 2024 • EU: Recommend for approval by CHMP PFS by BICR: primary endpoint ICCDato-DXd 4.9 (4.2–5.5) 6.9 (5.7–7.4) Median PFS, months (95% CI) 0.63 (0.52–0.76)HR (95% CI) <0.0001P-value Number at risk Dato-DXd ICC 365 249 158 66 15 4 367 205 93 26 8 1 53.3% 37.5% 38.5% 18.7% 25.5% 14.6% 0 3 6 9 12 15 Time from randomisation (months) 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Probability of PFS Dato-DXd (n=365) ICC (n=367) 40
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DS oncology franchise can provide benefit to nine out of 10 mBC patients Potential indications for DATROWAY® in TNBC could reach 100% of mBC in near future Source: npj Breast Cancer volume 7, Article number: 1 (2021) *TROPION-Breast01 indication: HR+/HER2- (IHC0, 1+ or 2+/ISH-) mBC mBC: metastatic breast cancer, HR: hormone receptor, IHC: immunohistochemistry, ISH: in situ hybridization, TNBC: triple negative breast cancer 41
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Pooled Analysis of TROPION-Lung05 and TROPION-Lung01 • Primary endpoints: ORR (TL05), PFS and OS (TL01) • BLA for Accelerated Approval submitted to FDA in Nov 2024 • Granted Breakthrough Therapy Designation in Dec 2024 • Expected approval: FY2025 H1 (US) (PDUFA date: July 12, 2025) DATROWAY®: EGFR mutated, previously treated NSCLC Opportunity • There is an unmet need for effective therapies in EGFRm NSCLC following disease progression on TKI treatments (2L+) • BLA* will be a Priority Review and has received Breakthrough Therapy Designation, allowing for an expedited regulatory review. • 2L+ EGFRm NSCLC will represent DATROWAY® first approval in mNSCLC • Robust clinical data with ORR 42.7%, mDOR 7.0 months, mPFS 5.8 months, and mOS 15.6 months** • Outcomes for patients with prior Osimertinib were similar to the overall pooled population • Stomatitis/oral mucositis was effectively managed with dose reductions/delay • The most common ocular surface event was dry eye (grade 1 or 2) • No grade 4 or 5 ILD events • US patient opportunity of ~3k+*** *Biologics license application **Pooled analysis of TL01 and TL05 ***US only. There is potential for additional upside in patient eligibility from recently approved TKI+CTx regimens, such as FLAURA2 in the future if 1L use grows significantly BICR: blinded independent central review; BLA: biologics license application, CI: confidence interval; EGFR: epidermal growth factor receptor, FDA: food and drug administration, HR, hazard ratio; ICC, investigator’s choice of chemotherapy; ILD: interstitial lung disease, mDOR: median duration of response, NSCLC: non-small cell lung cancer, ORR: overall response rate, OS: overall survival; PDUFA: prescription drug user fee act, PFS: progression-free survival; Q3W: once every three weeks; TLR: topline results, TKI: tyrosine kinase inhibitor, TRAE: treated related adverse events 42 Basis for Accelerated Approval: ORR of 42.7%
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Markus Kosch Head, EU Oncology Business Division, Daiichi Sankyo Europe • Joined Daiichi Sankyo in 2021 • Leads European and Canada oncology business at Daiichi Sankyo governing 18 countries • Boarded physician in internal medicine, practiced in nephrology and oncology at the University Hospital in Münster until 2005 where he still teaches • Over 20 years' experience in pharmaceutical industry in senior global, regional and country leadership roles at Wyeth and Pfizer • Launched medicines in lung, GI cancers, hematology and breast including Palbociclib across Europe • Board Member of the EFPIA (European Association of Pharmaceutical Industry)
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31 15 12 89 101 35 72 48 16 8 67 9 14 DS Headcount* in EU Ʃ = 567 (Projection FY24) 16 Mature and professionalized organization across HQ and 18 markets Regional and local investment in key capabilities including Governmental Affairs, Patient Advocacy, OVAP, Training and Learning, etc. Right resourcing to support new asset and indication launches 8 EU OBD as mature organization with investment in key capabilities and right resourcing to support asset and indication launches across 18 markets *Headcounts for EU Oncology Business Division DSCA: Daiichi Sankyo Canada, EUCAN: Europe & Canada, HQ: headquarters, OBD: Oncology Business Division, OVAP: Oncology Value, Access, and Pricing 44 DS presence No DS presence + Daiichi Sankyo Canada 26
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FQ1'21 FQ2'21 FQ3'21 FQ4'21 FQ1'22 FQ2'22 FQ3'22 FQ4'22 FQ1'23 FQ2'23 FQ3'23 FQ4'23 FQ1'24 FQ2'24 FQ3'24 Europe 257.5 Bn JPY cumulative EU net sales since 1st launch 1.2 1.4 2.3 4.1 6.7 7.0 8.6 14.8 17.8 21.4 25.5 37.2 ENHERTU® EU NET SALES 39.0 35.335.2 HER2+ mBC HER2low mBC HER2mut NSCLC HER2+ mGC Others Revenues by Indication EU region has realized significant ENHERTU® revenue growth EU net sales have exceeded 39 Bn JPY per quarter *Financial results reference data Bn: billion, FQ: fiscal quarter, FY: fiscal year, mBC: metastatic breast cancer, mGC: metastatic gastric cancer, NSCLC: non-small cell lung cancer, JPY: Japanese Yen, q-o-q: quarter over quarter 45 EU Overall, EU net sales in FY2024 Q3 was 39.0 Bn JPY; +10.4% sequential q-o-q growth +13.5 Bn JPY (+52.9%) vs FY2023 Q3
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18 PT 17 TRFR NL 164 GR DSEIEDE 135 IT 110 ES 44 UK 34 ND 32 CHAT 27 BE 0 24 MSC*** YTD Performance: revenue realized per country Revenue Dec’24 YTD (mEUR) 16 12 4 2 11 CA** 650* Germany, Italy and France contribute >60% of year-to-date overall revenue *DaiichiSankyo booked revenue countries+Canada **CA: AZ booked revenue country ***MSC = Mid-sized countries including Austria, Switzerland, Turkey, Greece, Belgium, Portugal, Ireland, Netherlands AT: Austria, BE: Belgium, CA: Canada, CH: Switzerland, DE: Germany, ES: Spain, FR: France, GR: Greece, IE: Ireland, IT: Italy, NL: Netherlands, ND: Nordics, PT: Portugal, TR: Turkey, UK: United Kingdom, YTD: year to date 46 62.8%
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Archetypes based on commonalities in key decision-drivers Description Key Characteristics Countries Clinical Value-based Markets Government dictates reimbursement based on clinical outcomes versus available products. • Strong focus on clinical attributes – H2H comparison preferred • Comparator selection important • Indirect treatment comparison (ITC) not always accepted – especially in Germany Cost-effectiveness Markets Government dictates reimbursement policy based on the value of improved outcomes over displaced treatment. • Product price is an integral part of the cost- effectiveness model • Clinical value needs to be in line with product price • Surrogate endpoints tend to be sufficient or can be leveraged Budget Impact-driven Markets Affordability of drugs is a key driver for access. In these markets decision making is typically devolved to a regional level. • Decision driven by new treatment's impact on current healthcare budget vs. SoC • Regional payer engagement is important to facilitate formulary inclusions England Scotland Ireland The Netherlands Portugal Sweden Norway Italy Spain Austria France Germany Belgium Luxembourg Finland Denmark One key difference between US and EU is the solid chain-link between regulatory approval and HTA and reimbursement decisions on country level EMA: European Medicines Agency, FDA: Food and Drug Administration, HTA: health technology assessment, H2H: head-to-head, SoC: standard of care EMA approval does not automatically imply reimbursement across all European markets and typically comes later than FDA approval in the US At a country level, HTA and reimbursement decisions are typically made following regulatory approval Each country in Europe makes decisions based on different aspects which can be split into 3 archetypes i.e., clinical value, cost-effectiveness, budget impact Therapeutic options are typically more limited than in the US 47
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Number of indication currently reimbursed 12345 Lung DL-01/02 HER2 low DB-04 Gastric DG-01/02 50+ national reimbursements HER2+ mBC 2L+ DB-03 DB04 in AP and GC in 3L+ To date, 50+ national reimbursement successes for ENHERTU® have been achieved across markets and indications 3L: third-line, AP: accelerated approval, GC: gastric cancer, mBC: metastatic breast cancer 48
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4 5 8 12 7 23 10 12 17 UK Spain Scotland Italy ENHERTU time to reimbursement (months) Average time to reimbursement for new oncology drug in Europe HER2+ mBC 2L+ availability to patients versus industry oncology average (months) France FR access was granted through AP pre EMA Note: Germany not included as it can launch with EMA approval ENHERTU® achieved record time to reimbursement for DESTINY-Breast03 with DS OVAP teams leading on pricing and access NB: The median time to availability is the days between marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list). DE has been excluded as reimbursement is automatically granted post EMA approval Sources: Internal Tracker; EFPIA Patients WAIT Indicator 2023; AP: accelerated approval, EMA: European Medicines Agency, DE: Germany, FR: France, OVAP: Oncology value, access, and pricing 49
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Key growth opportunities in FY25 remain in ENHERTU® current indications as well as upcoming indication expansions 50HR: Hormone receptor, mBC: metastatic breast cancer HER2+ mBC Achieved ENHERTU® is currently the dominant market leader (>70%) for 2L HER2+ mBC in most countries Opportunities • Maximum DB-03 effort to drive 2L HER2+ BC penetration, reach 70+% new patient share across the region • Reinforce patient management of ILD through real world data and education in some countries HR+/HER2low mBC Achieved ENHERTU® has become the market leader in several key countries in the post chemo setting Opportunities • 2L - 4L HER2 low mBC approximately 30%-40% market share in EU. • Launch ENHERTU® in HER2 low mBC segment (DB-04) in remaining EUCAN markets and achieve broad penetration in all launched markets; • DB-06 is filed in Europe with the goal for eventual approval and move earlier and go broader (HER2 ultralow) in the future Tumor Agnostic Achieved ENHERTU® is approved in the US, and has achieved a high market share in HER2+ IHC tested patients Opportunities • Opportunity for ENHERTU® tumor agnostic indication is under evaluation in EUCAN
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2L HER2+ mBC new patient shares - ENHERTU® naïve patients (FY24Q3) - N=321 N=371 N=286 N=390 HR+ HER2 low mBC new patient ENHERTU® naive overall (Pre and Post-chemo) Share (2L+) (FY24Q3) N=159 N=102 N=155 N=137 DE FR ES IT ENHERTU Others DE FR ES IT ENHERTU Others 30~40% >70% HER2+ 2L mBC shares in key EU markets, ambition to continue growth; early launch countries show strong uptake in HER2 low segment Source: Internal market research results FYQ3’24 DE: Germany, ES: Spain, FR: France, IT: Italy, mBC: metastatic breast cancer, 51 ® ®
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CY 2022 2023 2024 2025 1H 2H 1H 2H 1H 2H 1H FDA Regulatory approval EMA Regulatory approval UK DE FR IT ES DB-04 DB-04 DB-04 DB-03 DB-04 Example: Germany, France, Italy, Spain, UK DB-03 DB-03 DB-04 DB-06 DB-03 DB-03 DB-04 DB-03 DB-03 DB-06 The filing was accepted and working with regulatory authority throughout the review process EU is in earlier stage of launches versus US 52 Official commercial reimbursement status CY: calendar year, EMA: European Medicines Agency, FDA: Food and Drug Administration, H: half
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0 5000 10000 15000 20000 25000 30000 35000 40000 2020 2021 2022 2023 2024 2025 2026 HER2+ mBC HER2+ eBC HER2 low BC Gastric Lung 53 The eligible patient opportunity in the EU for ENHERTU® will grow to >37k in 2026 Calendar Year *France, Germany, Italy, Spain, UK BC: breast cancer; eBC: early breast cancer, mBC: metastatic breast cancer E L I G I B L E O P P O R T U N I TY F O R E N H E R T U® ( E U ) *
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DATROWAY® in Breast Cancer (TROPION-Breast01) DATROWAY® first launches expected with TROPION-Breast01 in FY25 with full launch strategy under assessment DATROWAY® received a positive CHMP opinion in January; expected approval will further drive growth momentum in FY2025 CHMP: committee for medicinal products for human use, HR: hormone receptor 54
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Closing remarks 55
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INDICATION TRIAL CURRENT STANDARD OF CARE OPPORTUNITY** IN MAJOR MARKETS*** HR+/HER2 low and ultralow chemo naïve mBC DESTINY-Breast06 chemotherapy ~ 18k HER2+ 1L mBC DESTINY-Breast09 THP ~ 8k HER2+ High Risk Adjuvant BC DESTINY-Breast05 Kadcyla® Trastuzumab + pertuzumab ± chemotherapy ~ 10k HER2mut 1L NSCLC DESTINY-Lung04 IO combo IO mono IO + chemotherapy ~ 2k HER2+ BC Neoadjuvant DESTINY-Breast11 TCHP ~ 27k HER2+ 2L mGC DESTINY-Gastric04* ENHERTU® Ramucirumab ± chemotherapy IO ~ 3k *For confirmatory approval in Europe and approvals in Japan and China **DB-06, DB-09, DL-04, DG-04 is incremental eligible patient opportunities to current indications *** US, France, Germany, Italy, Spain, UK, Japan We are entering a catalyst rich period ET: endocrine therapy, HR: hormone receptor, IO: immuno-oncology therapy, mGC: metastatic gastric cancer, mBC: metastatic breast cancer, NSCLC: non-small cell lung cancer, THP: docetaxel + trastuzumab + pertuzumab, TCHP: carboplatin + docetaxel + trastuzumab + pertuzumab 56
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• ENHERTU® • DATROWAY® • HER3-DXd • I-DXd • R-DXd • Early-stage BC • Metastatic BC • NSCLC • SCLC • Gastric cancer • Ovarian cancer • Other G7 Eligible patient opportunity (000s)* • ENHERTU® • DATROWAY® • Grow from 7 to 13 indications • >3x increased opportunity to benefit patients By 2030, Daiichi Sankyo’s intent is to have five marketed ADCs in over 30 indications; opportunity to help ~700K patients *US, France, Germany, Italy, Spain, UK, Japan ADC: antibody drug conjugate, BC: breast cancer, , DXd: deruxtecan, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer 57 2025-2026 Plan 5 Approved ADCs >30 Approved Indications 2 Approved ADCs in 7 indications 2030 Aspiration 0 100 200 300 400 500 600 700 800 2024 2025 2026 2027 2028 2029 2030 Eligible patient opportunity
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0 5 10 15 20 25 30 35 GLOBAL ONCOLOGY PRODUCT SALES ($B) Daiichi Sankyo remains highly confident we will reach and exceed our goal to be a top 10 oncology company Source: EvaluatePharma, accessed November 21, 2024 *MAT = Moving Annual Total (MAT Sept 2024 refers to October 2023 – September 2024 period) 58
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Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1125 Email: DaiichiSankyoIR_jp@daiichisankyo.com 59