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Daiichi Sankyo H1 FY2026 Earnings Presentation (April-September 2026): a 40-page Japanese-language results deck published on TDnet (Tokyo Stock Exchange timely disclosure) on October 30, 2026. Revenue rose 19.7% to ¥1,167.2 billion (11,672 億円) and operating profit rose 34.4% to ¥193.8 billion, driven by Enhertu and Datroway, with the full-year forecast unchanged from July.
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Daiichi Sankyo H1 FY2026 Earnings Presentation (April-September 2026): a 40-page Japanese-language results deck published on TDnet (Tokyo Stock Exchange timely disclosure) on October 30, 2026. Revenue rose 19.7% to ¥1,167.2 billion (11,672 億円) and operating profit rose 34.4% to ¥193.8 billion, driven by Enhertu and Datroway, with the full-year forecast unchanged from July.
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Title slide for Daiichi Sankyo's FY2026 second-quarter results briefing (2026年度 第2四半期 決算説明会), presented by President and CEO Hiroyuki Okuzawa on October 30, 2026, with the tagline 'Passion for Innovation. Compassion for Patients.'
Grey title band with a blue-green wave graphic, company logo top right, presenter name and date in the lower left
Japanese-language disclaimer: plans, forecasts and R&D information are forward-looking and subject to risks; investigational compounds are not approved by the FDA or other regulators for the indications under development; the document is not a solicitation to buy or sell securities.
Full-width text block under a grey header bar
Four sections: (1) FY2026 Q2 consolidated results, (2) business update, (3) R&D update, (4) appendix. Section 1 is highlighted.
Numbered agenda list on the left, laboratory photo (pipette over a well plate) faded into the right side
H1 revenue up 19.7% year on year as Enhertu and Datroway grew strongly with help from a weaker yen; revenue passed ¥1 trillion by Q2 and is on track for a record full year. Operating profit rose 34.4% on revenue growth and an improved cost-of-sales ratio. The FY2026 consolidated forecast is unchanged from July.
Two KPI rows, each with a cyan label box (Revenue +19.7%, Operating profit +34.4%) and grey bullet panel; forecast note at the bottom
H1 FY2026 vs H1 FY2025 (億円): revenue 11,672 vs 9,754 (+1,919, of which FX +739); cost of sales 2,398 incl. CMO loss compensation 43 (vs 210); SG&A 4,661 incl. DXd ADC profit share 2,024; R&D 2,401; core operating profit 2,213 (+46.9%); non-core income 1 and expenses 277; operating profit 1,938 (+34.4%); profit before tax 1,929; net income attributable to owners 1,515 (+15.8%); EPS ¥83.22 (+18.0%). FX: USD/JPY 159.37 (vs 146.04), EUR/JPY 184.35 (vs 168.06). A callout explains the CMO compensation: 210 億円 last year related to minimum purchase obligations after the HER3-DXd launch timing changed; this year 43 億円 = -116 (FX translation and partial reversal) + 159 (lump-sum payment to a CMO to remove future obligations).
Financial table with prior-year, current-year, change and FX-impact columns on the left; boxed explanation of CMO compensation on the right; footnotes on core operating profit definition
Revenue rose 1,919 億円 (1,180 億円 excluding FX). Drivers: Oncology Business Unit +1,143 (Enhertu +864, of which US +738 and Europe +126; Datroway +266), ASCA (Asia/Latin America) +115 (Enhertu +137), AstraZeneca and Merck upfront and milestone income +266, FX +739. Decreases: Japan Business Unit and others -83 (Vimpat -115, Efient -103, Lixiana -89, partly offset by Enhertu +66, Tarlige +64), American Regent -254 (Venofer -162, GE injectables -74), EU Specialty +8 net (Nilemdo/Nustendi +94, Lixiana -81). FX breakdown: USD +394, EUR +215, Asia/LatAm +131.
Horizontal waterfall from 9,754 to 11,672 on the left; colour-coded increase/decrease panels by business unit on the right
Operating profit up 496 億円 from 1,442 to 1,938. Revenue +1,919 offset by cost of sales -11 (CMO compensation -167, other COGS +177), SG&A -969 (DXd ADC profit share +693, other SG&A +276), R&D -232 (weaker yen and higher investment in 5DXd ADCs and Next Wave) and non-core items -210 (non-core income 43 to 1; non-core expenses 108 to 277, including EU Specialty restructuring 216, intangible amortisation 99, a Pacritaxel impairment 30 and a -69 reversal of Odawara plant compensation).
Waterfall chart on the left with dotted connectors to four explanation panels on the right; small non-core table
Net income attributable to owners rose 207 億円 to 1,515. Operating profit +496 was offset by financial income/expenses -200 (FX loss deterioration -140, higher interest paid -23, lower dividends -13, securities valuation -5, equity-method -5), income taxes +74 (398 vs 324; effective rate 20.6% vs 19.9%) and non-controlling interests 15.
Waterfall on the left, two grey explanation panels with a tax table on the right
During analysis of Q1 FY2026 results the company found an SG&A discrepancy; investigation identified aggregation errors and the FY2025 results were restated on July 31, 2026. Remediation: the board discussed issues and countermeasures as a material financial-reporting matter, aggregation is being automated with multi-layer reviews and stronger quarterly-trend and year-on-year analysis, and the effectiveness of the strengthened processes will be verified and monitored regularly.
Background bullets above a rule line; boxed list of three remediation actions below
A company-wide transformation program to sharpen resource allocation and strengthen profitability, competitiveness and organisation. Target: more than ¥200 billion (2,000 億円) of optimisation over five years to support the 6th mid-term plan, reinvested in profit and future growth. Three pillars: external cost optimisation (procurement via a unified global ERP), AI-driven business process transformation (multiple use cases defined) and structural reform (simplifying organisation and operations). The house graphic shows 2030 targets: Oncology Global Top 5 and Next BGTs, under the vision 'Trusted Healthcare Innovator'.
House diagram on the left with circular arrows for profit contribution and growth investment; three icon cards on the right
Agenda repeated with section 2, business update, highlighted.
Same agenda layout as page 3 with the second item highlighted
Enhertu global product sales were 4,645 億円 in H1 FY2026, up 1,461 億円 (+45.9%) and 51.9% of the July full-year forecast, which was raised to 9,153 億円 (+205). By region: US 2,710 (+55%), Europe 1,028 (+26%), ASCA 662 (+49%), Japan 245 (+37%), versus 3,184 a year ago and 2,613 two years ago. Enhertu quickly became US market leader in first-line HER2-positive breast cancer and gained the No.1 new-patient share in the US post-neoadjuvant setting. New launches: 1L HER2+ breast cancer in China (Aug) and Japan/Europe (Sep); post-neoadjuvant in China/Europe (Oct); HER2+ solid tumours in China (Oct). UK reimbursement for HER2-low breast cancer completes coverage across the five major EU markets; NCCN upgraded 1L HER2+ breast cancer to Category 2A preferred.
Stacked regional bar chart for three years on the left with growth-rate arrows; headline sales box and three grey-headed update sections on the right
Datroway global product sales were 483 億円, up 326 億円 (+207.2%) and 41.4% of the July forecast, now raised to 1,189 億円 (+20). By region: US 391, Japan 70, ASCA 13, Europe 10 (versus 157 a year earlier). About 9,800 patients have been treated cumulatively, roughly 1.4x the prior quarter. Datroway is establishing US leadership in EGFR-mutated NSCLC, and 1L TNBC launched in Europe (Jul), Japan (Sep) and China (Oct); Germany granted reimbursement and Brazil launched across HR+/HER2- breast cancer, TNBC and EGFR-mutated NSCLC.
Two stacked bars (FY2025 Q2 vs FY2026 Q2) on the left; sales headline and update sections on the right
Datroway will be combined with ivonescimab, Summit's PD-1/VEGF bispecific antibody. Daiichi Sankyo/AstraZeneca bring Datroway (approved for TNBC in more than 30 countries and regions, more than 20 ongoing trials); Summit brings ivonescimab (17 global Phase 3 trials). Trials will be run by Daiichi Sankyo or AstraZeneca with costs split three ways and each company keeps rights to its own drug. Scope covers multiple cancers including breast and lung; the first Phase 3 is in 1L TNBC.
Two hexagonal panels joined by a plus sign with circular stat badges; three-column overview / scope / first trial section below
From April 2027 a Commercialization Unit will consolidate commercial activities across oncology and specialty businesses, combining five regional businesses (North America, Europe, Japan/Asia/Pacific, China, Latin America) with six global functions (Global Commercial Excellence, Global Oncology Alliance Management, Business Strategy and Analytics, Marketing/Access/Pricing, Global Medical Affairs, Global Specialty Business). Strategic aims: optimise resource allocation, standardise commercial processes and systems, and develop talent, to support more than 20 indication launches by 2030 and global top-5 oncology status by 2035.
Banner with launch date, world map with region and function lists on the left, numbered strategic points and goal box on the right
Agenda repeated with section 3, R&D update, highlighted.
Agenda list with the third item highlighted
In the Phase 3 DESTINY-Lung04 trial, Enhertu monotherapy showed a statistically significant and clinically meaningful PFS improvement over pembrolizumab plus platinum doublet chemotherapy: median PFS by BICR 14.3 months (95% CI 12.4-16.5) vs 8.3 months (7.0-9.9), hazard ratio 0.63 (0.50-0.79), p<0.0001, n=227 per arm, a roughly 6-month difference. It is the first and only randomised Phase 3 to beat this regimen in first line; no new safety signals were seen; data cut-off June 9, 2026. Regulatory discussions will proceed.
Kaplan-Meier PFS curve with number-at-risk rows and results table on the left; five bullet conclusions on the right
Approvals: 1L HER2-positive metastatic breast cancer (DESTINY-Breast09) in China (Aug 2026) and Japan and Europe (Sep 2026); HER2-positive early breast cancer post-neoadjuvant (DESTINY-Breast05) in China and Europe (Oct 2026); HER2-positive (IHC 3+) solid tumours (DESTINY-PanTumor03 and other trials) in China (Oct 2026).
Three horizontal rows with an orange left accent, indication on the left and approval timeline on the right; footnotes
Datroway in 1L metastatic or unresectable TNBC (TROPION-Breast02) approved in Europe (Jul 2026), Japan (Sep 2026, HR-negative/HER2-negative breast cancer label) and China (Oct 2026). TROPION-Urothelial04 in high-risk muscle-invasive urothelial cancer (adjuvant) started in August 2026. For I-DXd, the US application in previously treated extensive-stage SCLC (IDeate-Lung01) was voluntarily withdrawn in September 2026.
Three rows with blue and yellow left accents; indication left, status right
R-DXd 5.6 mg/kg continued to show the best risk-benefit profile among doses tested. In CDH6-positive patients at 5.6 mg/kg (n=61), confirmed ORR was 49.2% (95% CI 36.4-62.1), median DOR 7.0 months and median PFS 7.9 months. Safety (n=69) was manageable with no new signals; the most common TEAE was nausea (72.5%), followed by anaemia (56.5%) and fatigue (55.1%). Treatment-related ILD/pneumonitis occurred in 4 patients (5.8%; one grade 1, three grade 2), with no grade 5 events. Data cut-off February 2, 2026.
Efficacy waterfall and spider plots on the left, horizontal TEAE bar chart in the centre, summary bullets on the right
Landscape of pivotal ovarian cancer trials by line of therapy (early stage, 1L induction, 1L maintenance, platinum-sensitive 2L+, platinum-resistant 2L+) against BRCA (mutation 15%, wild type 85%) and HRD/HRP (50% each) segments. Enhertu: DESTINY-Ovarian01 (HER2+ 1L maintenance) and DESTINY-PanTumor02 (HER2 IHC 3+, approved tumour-agnostic). R-DXd: REJOICE-Ovarian01 (PROC), plus planned REJOICE-Ovarian03 (maintenance), -04 (1L) and -05 (PARPi progressors).
Matrix grid with patient segments on the left axis and therapy lines as columns; coloured boxes show trials by status
Expected key data (as of October 2026): Datroway TROPION-Lung15 (EGFR-mutant NSCLC after osimertinib, 2L+) in H2 FY2026; AVANZAR (1L non-squamous NSCLC with durvalumab and carboplatin) moved to H1 CY2027; TROPION-Lung07, TROPION-Lung08, TROPION-Breast03 and TROPION-Breast05 in FY2027; I-DXd IDeate-Lung02 (ES-SCLC 2L) in FY2027.
Two-column table grouped by product with coloured left bars
A virtual (Zoom) sustainability dialogue for investors is scheduled for Wednesday, November 25, 2026, 16:00-17:30 JST, featuring Representative Director and Global HR / Corporate Affairs Head Takashi Matsumoto, independent outside director and Chair of the Board Takaaki Nishii, and Global Sustainability Head Keiko Harada. It will be available on demand afterwards.
Three speaker portraits with names and titles, then a two-row date/format table and an on-demand note
Q&A panel: President and CEO Hiroyuki Okuzawa, Global R&D Head John Tsai, Director and Global Oncology Business Head Ken Keller, and Senior Executive Officer and CFO Tomohiro Kodama.
Four speaker cards in a 2x2 grid with portraits and gradient underline bars
Agenda repeated with section 4, appendix, highlighted.
Agenda list with the fourth item highlighted
The FY2026 forecast is unchanged from July (億円): revenue 23,400; cost of sales 5,500 including CMO loss compensation 800; SG&A 9,300 including DXd ADC profit share 3,950; R&D 5,000; core operating profit 3,600; non-core expenses 400; operating profit 3,200; profit before tax 3,340; net income 2,510. The 800 億円 CMO provision for CY2028 is still expected from Q3 onward; the 43 億円 already booked in H1 (-116 reversal/FX, +159 lump-sum payment) is expected to be offset by further reversals of the FY2025 provision through CMO negotiations and transfer of manufacturing lines.
Forecast table on the left linked to a callout box; small waterfall of the CMO compensation on the right
H1 non-core expenses totalled 277 億円 (cost of sales 60, SG&A 216). Q2 additions of 54: EU Specialty restructuring -23, product intangible amortisation 48, Pacritaxel impairment 30. Q1 items of 222: EU Specialty restructuring 240, reversal of Odawara plant investment-cancellation compensation -69, amortisation 51, other 0.
Detailed table with full-basis columns (COGS, SG&A, R&D, total) and a core-basis column
Reconciliation of H1 FY2025 under the old and new core definitions: core operating profit moves from 1,586 to 1,507 億円 after adjustments for CMO loss compensation (-127), inventory write-downs (-46), product intangible amortisation (+96) and other (-2). Cost of sales becomes 2,387 (CMO compensation 210 now shown separately), SG&A 3,692; reported operating profit is unchanged at 1,442.
Bridge table from old-definition to new-definition columns with adjustment columns in between
H1 revenue by unit (億円, FY2025 to FY2026): Japan business 2,499 to 2,327 (-172); Daiichi Sankyo Healthcare 459 to 483; Oncology business 2,730 to 4,226 (+1,496) with Enhertu 2,561 to 3,738, Datroway 101 to 401, Turalio 30 to 20, Vanflyta 38 to 67; American Regent 968 to 779 (-189) with Injectafer 226 to 214, Venofer 269 to 116, GE injectables 409 to 366; EU Specialty 1,368 to 1,492 with Lixiana 968 to 973, Nilemdo/Nustendi 286 to 417, olmesartan 103 to 90; ASCA 1,179 to 1,425 (+246).
Single table with business units and product sub-rows, FX rates beneath
Japan product revenue (億円, H1 FY2025 to H1 FY2026): Lixiana 732 to 643; Tarlige 322 to 385; Pralia 226 to 241; Enhertu 179 to 245; Belsomra 97 to 86; Canalia 77 to 70; Minnebro 53 to 66; Ranmark 100 to 100; Datroway 56 to 70; Loxonin 59 to 65; Emgality 63 to 70; Inavir 0 to 7.
Table with product name, therapeutic category, two-period figures and change
Total 5DXd ADC revenue was 5,743 億円 in H1 (+2,053) against a raised full-year forecast of 12,314 (+310 vs July). Enhertu 5,000 (product sales 4,645, upfront/milestones 355), forecast 10,621; Datroway 544 (product 483, milestones 61), forecast 1,303; HER3-DXd 60, forecast 120; I-DXd 76, forecast cut by 41 to 143 after removing expected product sales; R-DXd 64, forecast 128.
Table by ADC with sub-rows for product sales and upfront/milestone income; actual, YoY, forecast and change-vs-July columns
AstraZeneca alliance income 415 億円 in H1 (+246), full-year forecast 1,581 (+127), with 7,375 received to date (end of September 2026); Enhertu development milestones 298 and expected sales milestones of 969 for the year. Merck alliance income (HER3-DXd, I-DXd, R-DXd upfront and Quid-related amounts) 199 (+20), forecast 390, with 6,978 received to date.
Table grouped by product and item, colour bars per ADC, alliance subtotal rows
As of October 2026: DESTINY-Breast05 approved in the US (H1) and Europe/China (H2); DESTINY-Breast09 approved with pertuzumab in Japan/EU/China (H1), monotherapy top-line results expected FY2027; DESTINY-Breast11 neoadjuvant approved in the US; DESTINY-Lung04 top-line results obtained; DESTINY-PanTumor02 approved in Europe; DESTINY-PanTumor03 filing accepted in China (H1) and approved (H2).
Milestone table with project, regimen/trial and FY2026 H1, H2 and FY2027 columns
NSCLC: TROPION-Lung07 and TROPION-Lung08 top-line results expected FY2027; TROPION-Lung15 in H2 FY2026; AVANZAR in H1 CY2027. Breast: TROPION-Breast02 approved in Japan/US/Europe (H1) and China (H2); TROPION-Breast03 and -Breast05 top-line results in FY2027. MIUC: TROPION-Urothelial04 with rilvegostomig started.
Milestone table grouped by tumour type
I-DXd in ES-SCLC: IDeate-Lung01 US filing accepted and then withdrawn in H1 FY2026; IDeate-Lung02 top-line results expected FY2027. R-DXd in platinum-sensitive ovarian cancer: Phase 3 REJOICE-Ovarian03 (2L maintenance), REJOICE-Ovarian04 (HRD-negative 1L maintenance) and REJOICE-Ovarian05 (2L after PARP inhibitor progression) planned to start in H2 FY2026.
Milestone table with yellow (I-DXd) and purple (R-DXd) project bars
Vanflyta (QuANTUM-First, FLT3-ITD-positive AML 1L) approved in China; DS1025 Phase 1 in solid tumours started; DS2001 Phase 1 in autoimmune disease (healthy volunteers) started; Mimlit measles-mumps-rubella combination vaccine approved in Japan, all in H1 FY2026.
Short milestone table with colour legend for oncology, specialty medicine and vaccines
Phase 1, Phase 1/2 and Phase 2 studies for Enhertu, Datroway, HER3-DXd, I-DXd and R-DXd, including DESTINY-Breast08, DESTINY-Lung03, BEGONIA, TROPION-Lung02/04, HERTHENA-Breast01/02/03, KEYMAKER-U01 and -U06 substudies, IDeate-PanTumor01/02, IDeate-Lung03, IDeate-Prostate02, ORCHARD, NeoCOAST-2, REJOICE-GI01 and REJOICE-PanTumor01, with US breakthrough and orphan designations marked. Small text is legible but dense.
Three-phase column grid of colour-coded trial cards
Phase 2/3, Phase 3 and filing-stage studies: DESTINY-Breast09, -Gastric05, -Lung04, -Lung06, -BTC01, -Ovarian01, -Endometrial01/02, ARTEMIDE-Gastric01; TROPION-Lung07/08/10/14/15/17, AVANZAR, TROPION-Breast03/04/05, TROPION-Urothelial03/04; HERTHENA-Breast04; IDeate-Lung02, IDeate-Esophageal01, IDeate-Prostate01; REJOICE-Ovarian01/03/04/05. Under review: DESTINY-Breast05 in Japan.
Phase-based grid of trial cards with a separate filing column
Next Wave pipeline: Phase 1 DS-1103 (anti-SIRPα), Ezharmia combinations, DS-2243 (HLA-A*02/NY-ESO bispecific T-cell engager), DS3610 (EGFR STING agonist ADC), DS5361 (NMD inhibitor), DS9051 (targeted protein degrader), DS1025 (anti-CD25 ADC), DS2001 (anti-ORAI1 antibody); Phase 1/2 DS-3939 (TA-MUC1 ADC), gocatamig (MK-6070/DS3280, DLL3 trispecific), DS3790 (anti-CD37 ADC), DS-7011 (anti-TLR7 for lupus); Phase 2 Ezharmia in B-cell lymphoma; Phase 3 Vanflyta QuANTUM-Wild.
Four phase columns of compact trial cards
Contacts for the material: Daiichi Sankyo IR/SR Department for investors and Corporate Communications for media, each with a Tokyo phone number and email address.
Centred contact panel with cyan header and two columns
Questions courantes sur cette diapositive et le contenu de présentation sous-jacent.
The original is in Japanese (2026年度 第2四半期決算説明会資料, the FY2026 Q2 earnings briefing material) and was published on TDnet, the Tokyo Stock Exchange's timely disclosure system, on October 30, 2026. This page summarises every slide in English and keeps amounts in the company's ¥100 million (億円) units.
Daiichi Sankyo's fiscal year runs from April to March, so FY2026 is April 2026 to March 2027 and H1 (the cumulative second quarter) is April to September 2026.
Revenue was 11,672 億円 (about ¥1.17 trillion, +19.7%), core operating profit 2,213 億円 (+46.9%), operating profit 1,938 億円 (+34.4%) and net income attributable to owners 1,515 億円 (+15.8%). The weaker yen added 739 億円 to revenue.
Enhertu product sales reached 4,645 億円 (+45.9%), and the full-year forecast was raised to 9,153 億円. Datroway sales tripled to 483 億円 (+207.2%), with about 9,800 patients treated cumulatively, and its forecast was raised to 1,189 億円.
No. The consolidated forecast is unchanged from July: revenue 23,400 億円, core operating profit 3,600 億円, operating profit 3,200 億円 and net income 2,510 億円, still including an 800 億円 CMO loss compensation provision.
DESTINY-Lung04 showed Enhertu beat pembrolizumab plus chemotherapy in 1L HER2-mutant NSCLC (median PFS 14.3 vs 8.3 months, HR 0.63). Enhertu and Datroway won new approvals in China, Japan and Europe, R-DXd posted a 49.2% ORR in platinum-resistant ovarian cancer, and the US filing for I-DXd in SCLC was voluntarily withdrawn.
Yes. Besides the original PDF, a PPTX converted from the PDF is available to download. Japanese fonts and complex tables may need small layout fixes after conversion.
Official IR site with earnings materials, including English versions of results presentations
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