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Astellas Pharma H1 FY2026 Earnings Presentation

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Part of Investor presentation examples · Japanese investor presentation examples

Astellas Pharma H1 FY2026 earnings presentation (Q2 FY2026, six months to September 30, 2026), presented by President and CEO Naoki Okamura on November 4, 2026. This is a Japanese-language deck (2026年度第2四半期(中間期)決算概況) released on TDnet, the Tokyo Stock Exchange's timely disclosure system. It covers first-half results (revenue ¥1,270.9 billion, up 23.4%; core operating profit ¥424.9 billion, up 50.3%), an upward revision of the FY2026 forecast to revenue of ¥2,330 billion and core operating profit of ¥700 billion (30.0% core margin), and pipeline progress across PADCEV, IZERVAY, VYLOY, VEOZAH, XOSPATA, setidegrasib, ASP2138, ASP546C, ASP6958/VIR-5500 and cell and gene therapy programs. Figures are in ¥100 million (億円); Astellas' fiscal year FY2026 runs from April 2026 to March 2027.

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Description

Main Topic

Astellas Pharma H1 FY2026 earnings presentation (Q2 FY2026, six months to September 30, 2026), presented by President and CEO Naoki Okamura on November 4, 2026. This is a Japanese-language deck (2026年度第2四半期(中間期)決算概況) released on TDnet, the Tokyo Stock Exchange's timely disclosure system. It covers first-half results (revenue ¥1,270.9 billion, up 23.4%; core operating profit ¥424.9 billion, up 50.3%), an upward revision of the FY2026 forecast to revenue of ¥2,330 billion and core operating profit of ¥700 billion (30.0% core margin), and pipeline progress across PADCEV, IZERVAY, VYLOY, VEOZAH, XOSPATA, setidegrasib, ASP2138, ASP546C, ASP6958/VIR-5500 and cell and gene therapy programs. Figures are in ¥100 million (億円); Astellas' fiscal year FY2026 runs from April 2026 to March 2027.

Key Benefits

  • •Full first-half P&L in ¥100 million (億円): revenue 12,709 vs 10,301, core operating profit 4,249 (33.4% margin) vs 2,826, operating profit 3,166, interim net profit 2,415
  • •FY2026 forecast revision table: revenue raised by ¥110 billion to 23,300 (億円), core operating profit raised by ¥80 billion to 7,000, full-basis operating profit raised to 4,600
  • •Strategic-brand sales split: total 3,339 (+51%), PADCEV 1,583, IZERVAY 562, VYLOY 459, VEOZAH 307, XOSPATA 429, alongside XTANDI 5,337
  • •Pipeline maps, milestone calendars through FY2029 and per-asset data slides (enfortumab vedotin, zolbetuximab, fezolinetant, gilteritinib, KRAS G12D degrader setidegrasib, Claudin 18.2 portfolio)
  • •Reference section with FX sensitivity, balance sheet and cash flow, debt balance, intangible assets, capital allocation and dividend history, and the ¥200 billion SMT cost-optimization target
  • •A real Japanese large-cap pharma investor deck with clean red-and-white tables, ideal as a model for bilingual or Japan-market earnings presentations

Target Audience

  • •Investors and analysts covering Astellas Pharma (TSE: 4503) and Japanese pharmaceuticals
  • •Biotech and pharma IR teams designing half-year earnings decks
  • •Equity research associates building models of oncology and ophthalmology franchises
  • •Business-development and competitive-intelligence teams tracking ADCs, T-cell engagers, Claudin 18.2 and KRAS G12D programs
  • •Students studying Japanese corporate disclosure and IFRS core-profit reporting

Use Cases

  • •Reviewing Astellas' H1 FY2026 results and upgraded full-year guidance
  • •Benchmarking a pharma earnings deck structure: highlights, P&L, product sales, cost items, forecast revision, pipeline, appendix
  • •Building a pipeline milestone timeline or development-stage chart for a drug portfolio
  • •Teaching how Japanese companies present results in ¥100 million (億円) units with FX impact columns
  • •Comparing Claudin 18.2 modalities (antibody, T-cell engager, ADC) in a portfolio slide

Unique Value Propositions

  • •Page-by-page English summary of a Japanese-only disclosure, with original ¥ figures and units preserved
  • •Combines a financial results section with 29 pages of clinical and pipeline reference data
  • •Shows how a Japanese pharma major presents an upward guidance revision and a 30% core margin target
  • •Free PDF download of the original 43-page TDnet deck

Slide Pages (43)

Detailed view of each slide page, including layout, key content and visual elements.

Page 1
Title slide

Cover: FY2026 Q2 (Interim) Financial Results Overview

Content

Title slide for Astellas Pharma's FY2026 second-quarter (interim) results, presented by President and CEO Naoki Okamura on November 4, 2026, with an aerial photo of the Astellas Tsukuba Research Center.

Layout Structure

Split layout: left white panel with logo, red title, presenter and date; right half full-bleed aerial photograph

Key Visual Elements

  • •Astellas star logo
  • •Bold crimson Japanese title
  • •Aerial photo of Tsukuba research campus
  • •Thin red top rule
Page 2
Disclaimer

Cautionary Statement

Content

Forward-looking statement disclaimer listing risks such as changes in the pharmaceutical market and regulation, FX fluctuations, launch delays, sales underperformance, failure to create competitive new drugs and IP infringement; notes that pipeline information is not advertising or medical advice.

Layout Structure

Single text column with heading, two dense paragraphs, red footer band with page number and logo

Key Visual Elements

  • •Full-width paragraph text
  • •Crimson footer band
  • •Page number badge
Page 3
Executive summary

FY2026 Q2 Highlights

Content

Progress ahead of plan with full-year forecast raised: revenue +23% and core operating profit +50% year on year, driven by strategic brands, cost optimization and favorable FX; forecast raised by ¥110 billion (+1,100億円) in revenue and ¥80 billion (+800億円) in core operating profit to ¥700 billion core OP and a 30% core margin; pipeline wins include EU approval of PADCEV in cisplatin-eligible MIBC, VEOZAH filings in Japan and China, two Phase 3 first-subject-dosed (setidegrasib NSCLC, ASP2138 G/GEJ), PoC for ASP6958/VIR-5500 in mCRPC, and three new clinical programs (ASP388B, ASP2020, ASP2767).

Layout Structure

Heading with two red tagline subtitles, then three labeled sections (results, forecast revision, pipeline) of checkmark bullets, footnotes at bottom

Key Visual Elements

  • •Red section labels
  • •Checkmark bullet lists
  • •Bolded key percentages and yen figures
  • •Footnote definitions
Page 4
Agenda

Agenda

Content

Two-part agenda: I. FY2026 Q2 consolidated results and FY2026 full-year forecast revision (highlighted); II. Pipeline progress.

Layout Structure

Two stacked rows each with a square Roman-numeral tile and section label; active section in red

Key Visual Elements

  • •Red tile 'I' and grey tile 'II'
  • •Section titles beside tiles
  • •Generous white space
Page 5
Financial data table

FY2026 Q2 Financial Results

Content

P&L table in ¥100 million (億円): revenue 10,301 to 12,709 (+2,407, +23.4%, FX +993); cost of sales 2,479; SG&A 4,304 including US XTANDI co-promotion 1,318, other SG&A 2,985 (ratio 23.5%, -3.4ppt); R&D 1,677 (13.2%); core operating profit 2,826 to 4,249 (+50.3%, margin 33.4%, FX +412); amortization 713; operating profit 1,994 to 3,166 (+58.8%); profit before tax 3,175; interim net profit 1,476 to 2,415 (+63.6%); initial FY2026 forecast column (revenue 22,200, core OP 6,200). H1 FX: US$1 = ¥159, €1 = ¥184 (prior year ¥146 / ¥168).

Layout Structure

Full-width financial table with columns for prior year, current year (red header), change, % change, FX impact and initial forecast; core basis on top, full basis below

Key Visual Elements

  • •Red-highlighted current-period column
  • •Bold totals rows
  • •Ratio sub-rows in small type
  • •FX footnote
Page 6
Product performance

FY2026 Q2 Results: Key Products

Content

Strategic brands grew more than 50% year on year: total ¥333.9 billion (3,339億円, +1,134, +51%); PADCEV 1,583 (+55%), IZERVAY 562 (+65%), VYLOY 459 (+73%), VEOZAH 307 (+34%), XOSPATA 429 (+25%); full-year strategic-brand forecast raised to ¥680 billion mainly on PADCEV (1L mUC globally and US MIBC); XTANDI 5,337 (+12%), flat ex-FX, with H2 decline expected from the US IRA.

Layout Structure

Left table of product logos with H1 sales and year-on-year change; right pink commentary panel per brand; XTANDI row separated at bottom

Key Visual Elements

  • •Product brand logos
  • •Red growth figures
  • •Pink commentary box
  • •Separated XTANDI row
Page 7
Cost analysis

FY2026 Q2 Results: Cost Items

Content

SG&A excluding US XTANDI co-promotion rose 7.9% (down 0.3% ex-FX), ratio 23.5%, 3.4ppt better, with about ¥10 billion of SMT savings from the global capability center, AI/digital and shared promotional materials; R&D rose 17.0% (9.9% ex-FX), ratio 13.2%, with about ¥11 billion more pipeline spend (setidegrasib, ASP2138, ASP546C, ASP6958/VIR-5500) offset by about ¥8 billion SMT savings; total SMT optimization about ¥22 billion year on year.

Layout Structure

Two headline bullets above a four-column grid table: cost item, year-on-year change, ratio to revenue, explanatory bullets

Key Visual Elements

  • •Red emphasized phrases in headline
  • •Grey-shaded grid table
  • •Nested checkmark bullets
Page 8
Guidance / forecast

FY2026 Full-Year Forecast Revision

Content

Forecast in ¥100 million (億円): revenue 23,300 vs initial 22,200 (+1,100; PADCEV, mirabegron, FX) and FY2025 actual 21,392; SG&A 8,150 including XTANDI co-promotion 2,300; other SG&A 5,850 (25.1%); R&D 3,600 (15.5%); core operating profit 7,000 vs 6,200 (+800, margin 30.0%); full-basis operating profit 4,600 (+650). Revised FX assumption US$1 = ¥158, €1 = ¥181 (H2: ¥156 / ¥177).

Layout Structure

Two headline bullets, then table with FY2025 actual, initial forecast, revised forecast (red header), difference and a 'main revision items' commentary column

Key Visual Elements

  • •Red revised-forecast column
  • •Red positive deltas
  • •Commentary bullets in right column
  • •FX assumption note
Page 9
Section divider

Agenda: Pipeline Progress

Content

Agenda divider repeated with section II, Pipeline progress, now highlighted.

Layout Structure

Same two-tile agenda layout with the second section active in red text

Key Visual Elements

  • •Red tile I
  • •Grey tile II
  • •Red active section label
Page 10
Timeline / roadmap

Strategic Brands: Lifecycle Management Progress

Content

Quarterly FY2026 regulatory and clinical timeline: PADCEV in MIBC (EV-303 cisplatin-ineligible EU approval June, China filing July, Japan decision pending; EV-304 cisplatin-eligible Japan filing May, US approval July, EU approval October; EV-309 bladder-preservation Phase 3 start June); IZERVAY China filing May; VYLOY Phase 3 LUCERNA enrollment complete in July with data in FY2027; VEOZAH STARLIGHT 3 met primary endpoint in April, Japan filing August, China filing October; HIGHLIGHT 1 (VMS in breast cancer) data in FY2027.

Layout Structure

Gantt-style matrix: product logo and indication rows against 1Q-4Q FY2026 and FY2027 columns, with pink (regulatory) and yellow (clinical) milestone boxes; blue text marks new progress

Key Visual Elements

  • •Product logos as row labels
  • •Color-coded milestone chips
  • •Blue text for new updates
  • •Legend top right
Page 11
Pipeline overview

Pipeline Progress

Content

Stage map (Pre-PoC, PoC achieved, Phase 3/pivotal, launched) by therapeutic area: two Phase 3 FSDs (setidegrasib NSCLC in September, NCT07566052; ASP2138 G/GEJ in August, NCT07673887), PoC for ASP6958/VIR-5500 in mCRPC, new clinical entries ASP388B (iADC, Phase 1b/2), ASP2020 (cell therapy, Phase 1b) and ASP2767 (gene therapy, US IND cleared), and discontinuation of ASP5541; also lists ASP2998, ASP1002, ASP5834, ASP546C, ASP7317, AT845, ASP2957, ASP2246.

Layout Structure

Left: chevron stage header over a grid of program boxes grouped by area (cancer, ophthalmology, neuromuscular) with modality tags; right: red 'key progress' bullet panel

Key Visual Elements

  • •Chevron stage arrows
  • •Program boxes with modality tags (ADC, TCE, TPD, cell, gene, mRNA)
  • •'New' labels
  • •Product logos at launched stage
  • •Strikethrough for discontinued asset
Page 12
Pipeline deep dive

Focus Area Progress (1/2): Immuno-Oncology

Content

Key milestones: ASP2138 (subcutaneous CLDN18.2 x CD3 T-cell engager) Phase 3 FSD in 1L G/GEJ in August with PDAC PoC call in FY2026; ASP6958/VIR-5500 (dual-masked PSMA x CD3 TCE) achieved PoC in mCRPC and FDA Fast Track, registrational plans under review. New programs: ASP388B, a B7-H3 dual-payload immune-stimulating ADC (topoisomerase I inhibitor plus STING agonist) with Phase 1b/2 FSD in September; option on Audax's IL-12 antibody-cytokine fusion DAX-044, Phase 1 to start in 2027.

Layout Structure

Two columns: left 'key milestones' cards, right 'new programs' cards, each with grey header bar and red accent, plus molecule schematics

Key Visual Elements

  • •Target and microscope icons
  • •Masked T-cell engager diagram
  • •ADC antibody illustration
  • •Audax logo
Page 13
Pipeline deep dive

Focus Area Progress (2/2): Regeneration and Vision Preservation

Content

Next-generation ophthalmology programs enter the clinic: ASP2020, iPS-derived retinal pigment epithelium cells using HLA-edited universal cell technology for Stargardt macular dystrophy (Phase 1b FSD in August, NCT07734064; FDA Fast Track and rare pediatric disease designation); ASP2767, an AAV gene therapy delivering BDNF and TrkB for glaucomatous optic neuropathy (US Phase 1/2 IND cleared, NCT07770685; FDA Fast Track).

Layout Structure

Two side-by-side program panels with grey title bars, bullet lists and anatomical retina illustrations below

Key Visual Elements

  • •Eye cross-section illustrations
  • •Retina cell layer diagrams
  • •Subretinal cannula graphic
  • •AAV vector icon
Page 14
Conclusion / key takeaways

Key Takeaways

Content

Strong momentum leads to a raised full-year forecast and an expected 30% core operating margin; pipeline advancing at every stage in line with Corporate Strategic Plan 2026. Business momentum: strategic brands up more than 50%, SG&A held flat (ex-XTANDI co-promotion and FX), forecast raised. Pipeline: LCM regulatory milestones for PADCEV and VEOZAH, two Phase 3 FSDs, ASP6958/VIR-5500 PoC, three new clinical programs.

Layout Structure

Red headline statement, then two columns with circular icons and colored header bars (dark red: performance; pink: pipeline), bullet lists beneath

Key Visual Elements

  • •Circular chart and plant icons
  • •Dark red and pink header bars
  • •Bold bullet leads
  • •Link to Corporate Strategic Plan 2026
Page 15
Section divider

Appendix (Reference Materials)

Content

Section divider introducing the reference materials appendix.

Layout Structure

Left crimson panel with white title; right photo of Astellas logo signage on a building facade

Key Visual Elements

  • •Full crimson panel
  • •Building signage photo
  • •Curved panel edge
Page 16
Key metrics / KPI cards

Strategic Brands: Peak Sales Forecasts (as of October 2026)

Content

Peak sales expectations: PADCEV ¥400-500 billion (4,000-5,000億円, based on total product sales including Pfizer-booked Americas sales), VYLOY ¥100-200 billion, XOSPATA ¥100-200 billion, IZERVAY ¥200-400 billion, VEOZAH ¥150-250 billion.

Layout Structure

Five equal columns with product logo, color-coded therapeutic area band (green oncology, blue ophthalmology, purple women's health) and a card showing peak sales range

Key Visual Elements

  • •Product logos
  • •Color-coded category bands
  • •Large green and blue numbers
  • •Footnote on PADCEV basis
Page 17
Capital allocation / data visualization

Capital Allocation Policy

Content

Three priorities: business investment for growth first, raising dividends based on profit and cash plans, and opportunistic share buybacks with surplus cash; Gross Debt/EBITDA kept at 1.0-1.5x to retain capacity for large investments. Dividend history bar chart from ¥14 (FY05) to ¥78 (FY25) and a forecast ¥80 for FY26, with at least ¥2 annual increases through the Corporate Strategic Plan 2026 period (FY27-FY30 bars illustrative).

Layout Structure

Three numbered pink policy boxes across the top, centered policy sentence, then a large dividend-per-share bar chart with a callout

Key Visual Elements

  • •Numbered red circles
  • •Crimson bar chart with lighter future bars
  • •Upward arrow callout
  • •Data labels on bars
Page 18
Financial data table

FX Rates (Actual)

Content

Average H1 rates: US$ ¥146 to ¥159 (¥13 weaker yen), euro ¥168 to ¥184 (¥16 weaker); FX increased revenue by ¥99.3 billion (993億円) and core operating profit by ¥41.2 billion (412億円).

Layout Structure

Small table at top left with currency rows and red current-period header, two impact bullets below, remainder white space

Key Visual Elements

  • •Compact FX table
  • •Red column header
  • •Bullet impact summary
Page 19
Financial data table

FY2026 Forecast: FX Rates and Sensitivity

Content

Forecast FX assumptions revised from US$ ¥150 to ¥158 and euro ¥180 to ¥181 (H2 assumption ¥156 / ¥177); a ¥1 weaker yen versus assumption adds about ¥8.6 billion revenue and ¥2.7 billion core OP for the dollar, and about ¥3.8 billion revenue and ¥1.7 billion core OP for the euro.

Layout Structure

Two tables stacked: FX assumptions (initial vs revised vs change) and sensitivity matrix by currency for revenue and core operating profit

Key Visual Elements

  • •Grey header tables
  • •Red revised-forecast header
  • •Sensitivity matrix
Page 20
Financial data table

Balance Sheet and Cash Flow Highlights

Content

In ¥100 million: total assets 35,670 (March 2026) to 35,278 (September 2026); cash 2,816 to 2,382; equity attributable to owners 18,290 to 19,817 (ratio 51.3% to 56.2%). H1 cash flow: operating 2,701 (vs 2,826), investing -819, free cash flow 1,882 (vs 2,524), financing -2,304, including CP/short-term borrowings +1,047, new bonds/loans 500, repayments -2,966 and dividends -699.

Layout Structure

Two stacked tables: balance sheet snapshot and cash flow comparison, red headers for latest period

Key Visual Elements

  • •Alternating grey rows
  • •Red latest-period column
  • •Indented sub-items
Page 21
Financial data table

Funding Balance Highlights

Content

Interest-bearing funding fell from ¥589.9 billion (June 2026) to ¥424.9 billion (September 2026): non-current 3,200 to 2,700 (bonds 2,200; long-term loans 1,000 to 500); current 2,699 to 1,549 (CP 300 to 749, short-term loans 0 to 300, current long-term loans 1,399 to 500, current bonds 1,000 to none). Figures in ¥100 million (億円).

Layout Structure

Single table with June and September columns, grouped non-current and current liabilities with sub-rows

Key Visual Elements

  • •Red September header
  • •Grouped shaded rows
  • •Indented sub-items
Page 22
Financial data table

Major Intangible Assets (as of September 30, 2026)

Content

Intangible assets in ¥100 million with foreign-currency reference: IZERVAY US 5,200 ($3,304M), IZERVAY ex-US 480 ($305M), VEOZAH 815 (€450M), gene therapy technology from the Audentes acquisition 570 ($362M), VYLOY 520 (€400M), ASP6958/VIR-5500 378 ($240M), ASP7317 271 ($172M), ASP546C 230, AT845 114 ($73M).

Layout Structure

Two-column value table (yen and foreign currency) with asset names on the left, footnotes below

Key Visual Elements

  • •Clean striped table
  • •Dual-currency columns
  • •Footnote markers
Page 23
Data visualization / strategy

Disciplined Cost Optimization

Content

Target of ¥200 billion (2,000億円) recurring cost optimization during Corporate Strategic Plan 2026 (FY2026-FY2030) to fund pipeline reinvestment and keep high margins: Sustainable Margin Transformation achieved ¥65 billion in FY2024-2025, with ¥40 billion planned in FY2026, ¥45 billion in FY2027 and additional measures; levers include insourcing, global capability center, AI/digital, XTANDI and mirabegron lifecycle-based cost optimization, and a more agile operating model.

Layout Structure

Stepped waterfall-style bar chart (grey, yellow, red) with a bracket to the ¥200 billion target, plus a red-bordered box of key measures

Key Visual Elements

  • •Staircase bar chart
  • •Yellow FY labels
  • •Vertical bracket to target
  • •Large red target number
Page 24
Pipeline overview

Development Pipeline

Content

Full pipeline grid by area as of October 2026: prostate cancer (XTANDI, ASP6958/VIR-5500), urothelial cancer (PADCEV, enfortumab vedotin bladder preservation), upper GI and pancreatic cancer (VYLOY, zolbetuximab with pembrolizumab, ASP2138, setidegrasib, ASP546C), AML (XOSPATA and gilteritinib studies), solid tumors (setidegrasib NSCLC, gilteritinib ALK+ NSCLC, ASP1002, ASP5834, ASP2998, ASP388B), ophthalmology (IZERVAY, ASP7317, ASP2020, ASP2767), VMS (VEOZAH, fezolinetant in breast cancer) and neuromuscular/neurology (AT845, ASP2957, ASP2246).

Layout Structure

Dense multi-panel grid of color-coded therapy-area tables, each listing assets with phase indicators (numbered circles 1-3 or 'launched')

Key Visual Elements

  • •Color-coded area headers (green, blue, orange, purple)
  • •Phase dot indicators
  • •Launched tags
Page 25
Timeline / roadmap

Upcoming Key Milestones

Content

FY2026: PoC decisions for AT845 (Pompe) and ASP2138 (pancreatic); FY2027: VYLOY Phase 3 LUCERNA data and VEOZAH HIGHLIGHT 1 data; FY2028: setidegrasib 2L+ NSCLC Phase 3 data; FY2029: setidegrasib 1L pancreatic and ASP2138 1L G/GEJ Phase 3 data. Phase 3/pivotal starts planned in FY2026-2027 for ASP7317 and ASP546C; PADCEV EV-309 data in FY2028-2030; IZERVAY prefilled syringe launch in FY2028-2029.

Layout Structure

Four red chevron year headers across the top with milestone lists under each, lower band for Phase 3 starts and lifecycle items with product logos

Key Visual Elements

  • •Red chevron arrows
  • •Product logos
  • •Checkmark milestone lists
  • •Dotted divider
Page 26
Process / progress tracker

Development Progress Since Last Earnings

Content

Stage transitions since the previous announcement: Phase 1 entry for ASP2020 (Stargardt) and ASP388B (cancer); Phase 3 entry for ASP2138 (gastric/GEJ) and setidegrasib (NSCLC); filings for fezolinetant (menopausal VMS, Japan and China); approval of enfortumab vedotin in cisplatin-eligible MIBC (EU); discontinuation of ASP5541 (prostate cancer, Phase 2).

Layout Structure

Five red chevrons (Phase 1, Phase 2, Phase 3, filing, approval) with assets listed underneath and a grey 'discontinued' box below

Key Visual Elements

  • •Chevron process arrow
  • •Grey discontinued label
  • •Definitions footnote
Page 27
Market sizing table

Enfortumab Vedotin (EV) (1/4): Nectin-4 Targeted ADC - Addressable Patients

Content

Addressable patients across the US, Germany, France, Italy, Spain, UK, Japan and China (Astellas estimate): MIBC cisplatin-ineligible EV-303 38,000; cisplatin-eligible EV-304 59,000; bladder preservation EV-309 34,000; 1L mUC EV-302 115,000; 2L+ mUC EV-301 49,000. Partnered with Pfizer.

Layout Structure

Centered table with merged MIBC label, pivotal trial column and patient-count column, footnotes and Pfizer logo

Key Visual Elements

  • •Pink merged row labels
  • •Dark red header
  • •Pfizer logo
Page 28
Clinical trial table

Enfortumab Vedotin (EV) (2/4): Clinical Trials

Content

EV-303/KEYNOTE-905 (cisplatin-ineligible MIBC, n=595): US approval November 2025, EU approval June 2026, Japan filing January 2026, China filing accepted July 2026. EV-304/KEYNOTE-B15 (cisplatin-eligible MIBC, n=808): US approval July 2026, EU approval October 2026, Japan filing May 2026, China filing accepted July 2026. EV-309 (bladder preservation vs chemoradiation, n=390): FSD June 2026. Phase 2 EV-209 (n=240): FSD April 2026.

Layout Structure

Four-row trial table: trial name, NCT number, design, sample size, regulatory status; blue text for new events

Key Visual Elements

  • •Red row accents
  • •Underlined NCT links
  • •Blue new-progress text
  • •Pfizer logo
Page 29
Clinical data comparison

Enfortumab Vedotin (EV) (3/4): Clinical Data by Disease Stage

Content

Comparison of nine EV trials from MIBC to previously treated mUC: EV-304 EFS HR 0.53 and OS HR 0.65 with pCR 55.8% vs 32.5%; EV-303 EFS HR 0.40, OS HR 0.50, pCR 57.1% vs 8.6%; EV-302 PFS HR 0.48, OS HR 0.51 (33.8 vs 15.9 months), ORR 67.5% vs 44.2%; EV-103 and EV-201 cohort results (ORR 44-73%); EV-301 OS HR 0.70 (12.9 vs 9.0 months), ORR 41% vs 18%.

Layout Structure

Wide matrix table: disease stage headers across columns, endpoints (OS, EFS/PFS, pCR/ORR, DoR) as rows, with checkmarks and footnote symbols

Key Visual Elements

  • •Red multi-level header
  • •Early vs late stage banner
  • •Dense small-type cells
  • •Pfizer logo
Page 30
Study design diagram

Enfortumab Vedotin (EV) (4/4): Development in MIBC

Content

Study schemas for three Phase 3 MIBC trials: EV-303/KEYNOTE-905 (EV+pembrolizumab perioperative vs cystectomy alone, n=595, 1:1:1, primary EFS), EV-304/KEYNOTE-B15 (EV+pembro perioperative vs neoadjuvant cisplatin+gemcitabine, n=808, primary EFS) and EV-309 (EV+pembro vs concurrent chemoradiation, n=390, primary BI-EFS and OS); one cycle = 21 days.

Layout Structure

Three horizontal study-design schematics with colored arm bars, a vertical cystectomy bar and endpoint bullets at right

Key Visual Elements

  • •Pink and grey treatment arm bars
  • •Star marker for pCR
  • •Arrow evaluation periods
  • •Cycle-length box
Page 31
Clinical data / chart

Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody

Content

38% of screened gastric/GEJ patients in SPOTLIGHT and GLOW were CLDN18.2-positive; Phase 2 ILUSTRO cohort 4B (zolbetuximab + nivolumab + mFOLFOX6) mPFS 14.8 months overall, 18.0 months in CLDN18.2-high and 23.6 months in CLDN18.2-high CPS ≥1 (ASCO GI 2026); Phase 3 LUCERNA (n=500, 1L with pembrolizumab + chemo) completed target enrollment.

Layout Structure

Left overview and latest-data bullets, right Kaplan-Meier PFS curve, bottom trial table

Key Visual Elements

  • •Kaplan-Meier curve with annotations
  • •Grey section header bars
  • •Trial table with NCT links
Page 32
Disease background / clinical trial table

Fezolinetant: NK3 Receptor Antagonist

Content

Explains the quality-of-life burden of vasomotor symptoms and the post-WHI decline in hormone therapy use; trials: Japan Phase 3 STARLIGHT 2 (n=410) and STARLIGHT 3 (n=277) with Japan filing August 2026; China Phase 2 (n=150) with filing accepted October 2026; Phase 3 HIGHLIGHT 1 in breast cancer patients on adjuvant endocrine therapy (n=540), FSD August 2024.

Layout Structure

Two text columns of context at top, then a trial table grouped by country and indication

Key Visual Elements

  • •Bullet text columns
  • •Grouped trial table
  • •Blue new-progress text
Page 33
Treatment pathway diagram

Gilteritinib: FLT3 Inhibitor

Content

Treatment-pathway diagram for FLT3-mutated AML positioning PASHA, PrE0905, VICEROY, GOSSAMER, MORPHO and ADMIRAL; PASHA (HOVON, n=766) missed its primary endpoint vs midostaurin; PrE0905 (n=181) topline presented at ASH 2024; VICEROY (n=70) FSD January 2023; Phase 1 in ALK-fusion NSCLC (n=40) FSD October 2025.

Layout Structure

Flow diagram at top showing induction, consolidation, transplant and maintenance, trial table below

Key Visual Elements

  • •Red trial labels on flow
  • •Boxed treatment stages
  • •Trial status table
Page 34
Mechanism of action / clinical data

Setidegrasib: KRAS G12D Degrader (1/2)

Content

KRAS G12D mutation present in about 40% of pancreatic and 5% of NSCLC cases; 2L+ NSCLC Phase 3 vs docetaxel (N=356, primary PFS and OS, NCT07566052) with data expected FY2028; Phase 1 monotherapy data at ELCC 2026 and in NEJM showed mPFS 11.2 months and ORR 37.5% in second or third line.

Layout Structure

Left overview with degrader mechanism illustration; right NSCLC panel with randomization schema and PFS curve

Key Visual Elements

  • •E3 ligase and proteasome mechanism diagram
  • •Randomization schema boxes
  • •Kaplan-Meier curve
Page 35
Clinical data / comparison table

Setidegrasib: KRAS G12D Degrader (2/2)

Content

1L pancreatic Phase 3 with mFOLFIRINOX or NALIRIFOX (N=614, primary OS, NCT07409272), interim data expected FY2029; 1L Phase 1 data at ASCO GI 2026 (600 mg + mFOLFIRINOX: ORR 7/12, 58.3%; DCR 10/12, 83.3%); AACR Pancreatic Cancer 2026 translational data show about 95.5% KRAS G12D protein degradation and a resistance profile distinct from inhibitors daraxonrasib and HRS-4642.

Layout Structure

Left: schema and waterfall plot; right: blue-header resistance comparison table

Key Visual Elements

  • •Red waterfall plot
  • •Response-rate box
  • •Teal-header comparison table
  • •Blue new-progress heading
Page 36
Pipeline asset profile

ASP2138: CLDN18.2 x CD3 T-Cell Engager

Content

Subcutaneous bispecific for gastric/GEJ and pancreatic cancer (CLDN18.2-positive in about 70% of G/GEJ and 60% of PDAC); ESMO 2025 data with standard of care: 1L ORR 62.5% (15/24) and 12-week DCR 100%, 2L ORR 37.5% (9/24); 1L G/GEJ Phase 3 (N=570, primary OS and PFS, NCT07673887) in CLDN18.2 low-to-intermediate patients with data in FY2029; PDAC PoC decision in FY2026.

Layout Structure

Two columns: overview with mechanism graphic and latest data; current status with Phase 3 schema and waterfall chart

Key Visual Elements

  • •T-cell engagement illustration
  • •Randomization schema
  • •Multi-color waterfall chart
Page 37
Pipeline asset profile

ASP546C: CLDN18.2-Targeted Antibody-Drug Conjugate

Content

ADC with proprietary topoisomerase I inhibitor payload (DAR 8) and MediLink TMALIN linker, FDA Fast Track in gastric cancer, global rights ex-Greater China; China Phase 2 at ASCO 2026: 2L+ G/GEJ (n=26) ORR 65.4%, DCR 84.6%, mPFS 5.7 months, mOS 11.7 months; 2L+ pancreatic (n=30) ORR 26.7%, DCR 83.3%, mPFS 4.1 months, mOS 10.0 months; global Phase 1b/2 ongoing and China Phase 3 run by Evopoint.

Layout Structure

Left overview and status panels with ADC icon; right two survival curves each paired with a red-header data table

Key Visual Elements

  • •ADC antibody icon
  • •Kaplan-Meier curves
  • •Red-header efficacy tables
Page 38
Comparison table

Claudin 18.2 Targeted Therapy Portfolio

Content

Compares VYLOY (monoclonal antibody), ASP2138 (T-cell-redirecting bispecific) and ASP546C (ADC) on modality, mechanism, clinical data and future potential: VYLOY as standard of care in CLDN18.2-high G/GEJ (about 38% of patients), ASP2138 expanding to low-to-intermediate expressers (about 35%) with subcutaneous dosing, ASP546C aiming at chemo-free regimens across all CLDN18.2-positive patients.

Layout Structure

Three-column comparison table with antibody icons in headers and color-coded columns (grey, yellow, pink)

Key Visual Elements

  • •Antibody icons in blue, yellow and red
  • •Color-coded columns
  • •Red emphasized phrases
Page 39
Strategy / market opportunity

Pancreatic Cancer: Accelerating Development Targeting KRAS G12D and CLDN18.2

Content

About 176,000 1L and 40,000 2L pancreatic patients across seven major markets; KRAS G12D in about 40% and CLDN18.2 in about 60% of PDAC; setidegrasib 1L Phase 3 (N=614, interim data FY2029), ASP2138 Phase 1 with PoC decision in FY2026, ASP546C Phase 1b/2 FSD in May 2026.

Layout Structure

Headline statistics at top, two pink panels split by biomarker (KRAS G12D, CLDN18.2) with program cards

Key Visual Elements

  • •Large red patient numbers
  • •Pink program cards
  • •Randomization schema
Page 40
Pipeline asset profile

ASP6958/VIR-5500: Dual-Masked PSMA x CD3 T-Cell Engager

Content

Prostate cancer program in Phase 1 (NCT05997615) that achieved PoC in mCRPC and FDA Fast Track; initial dose-escalation data at ASCO GU 2026 in heavily pretreated mCRPC: ORR 45%, one patient treated about 300 days, no dose-limiting toxicities and mostly Grade 1 CRS without prophylaxis; PSA response waterfall at ≥3000 µg/kg Q3W.

Layout Structure

Left overview with protein-structure graphic and status bullets; right latest-data bullets and PSA waterfall chart with response table

Key Visual Elements

  • •Masked TCE structure graphic
  • •Multi-color PSA waterfall
  • •Response rate inset table
Page 41
Pipeline asset profile

ASP7317: Retinal Pigment Epithelium Cells

Content

RPE cell transplant for geographic atrophy secondary to AMD (about 5 million patients globally); Phase 1b (NCT03178149) achieved PoC in severe vision loss; ARVO 2026 data showed no intraocular inflammation, rejection or tumor signals, and mean BCVA in the study eye improved by 9.08 letters at week 52 vs -5.75 in the fellow eye (cohorts 2/2b, n=3-5).

Layout Structure

Left overview with eye and retina illustration and status; right line chart of BCVA change over 52 weeks

Key Visual Elements

  • •Retinal transplant illustration
  • •Two-line BCVA chart
  • •Magenta data labels
Page 42
Technology explainer

Universal Cell Technology to Avoid Immune Rejection

Content

Explains HLA gene editing of clinical-grade human iPS cell lines with rAAV: removing HLA class I/II avoids T-cell attack and expressing a single-chain HLA-E avoids NK-cell attack (B2M-/HLA-E, 2x TK, RFXANK-/-), from Universal Cells, an Astellas company.

Layout Structure

Left process icons and wild-type vs universal cell diagram; right red headline bullet with sub-points and reference notes

Key Visual Elements

  • •Cell diagrams with HLA markers
  • •Blue arrow
  • •Universal Cells logo
  • •Process icons
Page 43
Pipeline asset profile

AT845: AAV8 Gene Therapy Expressing Human GAA

Content

Muscle-specific AAV8 gene therapy for Pompe disease (incidence about 1 in 40,000; standard enzyme replacement therapy requires biweekly infusions); Phase 1/2 FORTIS (NCT04174105) with FDA RMAT designation in February 2025 and additional analyses toward a PoC decision; WORLDSymposium 2026 follow-up: 5 of 6 participants with more than one year of follow-up stayed off ERT for 1-3.5+ years; FVC and 6MWT change charts.

Layout Structure

Left overview with AAV8 capsid icon and status; right two spaghetti line charts of FVC and six-minute walk test

Key Visual Elements

  • •AAV8 capsid icon
  • •Individual-patient line charts
  • •Grey section headers

Frequently Asked Questions

Common questions about this slide and the underlying presentation content.

What does the Astellas Pharma H1 FY2026 earnings presentation cover?

It is Astellas' 43-page results deck for the first half of FY2026 (April to September 2026), presented on November 4, 2026. It covers the consolidated P&L, key product sales, cost items, the upward revision of the full-year forecast, pipeline progress, and a reference section with FX, balance sheet, cash flow, intangible assets, capital allocation and per-asset clinical data.

Is this deck in Japanese, and where was it originally published?

Yes. The original is a Japanese-language earnings presentation (決算説明会資料) titled 2026年度第2四半期(中間期)決算概況, released on TDnet, the Tokyo Stock Exchange's timely disclosure system. The page text here is an English summary of each slide; amounts keep the company's units, such as ¥100 million (億円).

What were Astellas' key H1 FY2026 numbers?

Revenue was ¥1,270.9 billion (12,709億円), up 23.4% year on year, and core operating profit was ¥424.9 billion (4,249億円), up 50.3%, for a 33.4% core margin. Operating profit was 3,166億円 and interim net profit 2,415億円. FX added about 993億円 to revenue and 412億円 to core operating profit.

How did Astellas revise its FY2026 forecast?

Revenue guidance rose by 1,100億円 to 23,300億円 and core operating profit by 800億円 to 7,000億円, implying a 30.0% core operating margin; full-basis operating profit rose to 4,600億円. The revised FX assumption is US$1 = ¥158 and €1 = ¥181. FY2026 runs from April 2026 to March 2027.

Which products drove growth?

The five strategic brands grew 51% to 3,339億円: PADCEV 1,583, IZERVAY 562, VYLOY 459, XOSPATA 429 and VEOZAH 307 (all 億円). XTANDI was 5,337億円, up 12% but roughly flat excluding FX, with a decline expected in the second half because of the US Inflation Reduction Act.

Can I download this presentation and use it as a template?

The original PDF can be downloaded free from this page. It is a useful reference for structuring a pharma or biotech earnings deck, with a highlights page, red-accented financial tables, pipeline stage maps, milestone timelines and asset profile slides. 2Slides can help you build a similar deck from your own content.

What pipeline highlights are in the deck?

EU approval of PADCEV in cisplatin-eligible MIBC, VEOZAH filings in Japan and China, first patients dosed in Phase 3 trials of setidegrasib (NSCLC) and ASP2138 (gastric/GEJ cancer), proof of concept for ASP6958/VIR-5500 in mCRPC, and three new clinical programs: ASP388B, ASP2020 and ASP2767. ASP5541 was discontinued.

Sources & further reading

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