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Sumitomo Pharma H1 FY2026 Earnings Presentation (fiscal year ending March 2027): first-half results, an upward revision to the full-year forecast, resumption of the dividend, and an R&D update covering iPS cell therapies, enzomenib and the universal influenza vaccine. This is a Japanese-language deck (決算説明会資料) published on TDnet, the Tokyo Stock Exchange's timely disclosure system, on October 30, 2026.
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Sumitomo Pharma H1 FY2026 Earnings Presentation (fiscal year ending March 2027): first-half results, an upward revision to the full-year forecast, resumption of the dividend, and an R&D update covering iPS cell therapies, enzomenib and the universal influenza vaccine. This is a Japanese-language deck (決算説明会資料) published on TDnet, the Tokyo Stock Exchange's timely disclosure system, on October 30, 2026.
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Title slide for the FY2026 second-quarter (first-half) financial results briefing, dated October 30, 2026, presented by Representative Director and President Toru Kimura of Sumitomo Pharma Co., Ltd., with the tagline 'Innovation today, healthier tomorrows'.
Large angled green gradient panel on the left, title text block in green on the lower right, date and presenter beneath, logo and tagline bottom left.
Disclaimer that the material contains forecasts, outlooks, targets and plans based on assumptions at the announcement date, subject to known and unknown risks; actual results and development progress may differ materially; information on pharmaceuticals (including those in development) is not intended as advertising or medical advice.
Single-column text slide with three bullet paragraphs under a green section heading.
Section break introducing the FY2026 second-quarter (first-half) results overview.
Divider slide with mint-green banner, green tab shape at left and large green section title.
H1 revenue ¥266.5 billion (2,665 億円) vs ¥227.1 billion, +¥39.4 billion (+17.3%, of which ¥17.8 billion FX). Cost of sales 1,235 億円 (+37.7%); gross profit 1,430 億円 (+4.0%); SG&A 783 億円; R&D 238 億円 (+35.9%) on accelerated oncology trials and neuropsychiatry progress; other core items 12 億円 vs 501 億円 a year earlier. Core operating profit 421 億円 (−56.2%) but 140.4% of the 300 億円 H1 forecast; operating profit 423 億円; profit attributable to owners 382 億円 (−61.3%; 147.1% of the 260 億円 forecast). Revenue growth came from the US, outweighing lower Asia sales; gross profit growth was limited by the partial transfer of the Asia business. Average rate ¥159.49/$ vs ¥146.03. A red callout notes the full-year forecast has been revised (see p.8).
Wide P&L comparison table (prior H1, current H1, change, FX impact, %, H1 forecast and achievement %) with a grey commentary panel on the right and FX-rate footnotes below.
US H1 sales: ORGOVYX $681M (¥108.6 billion, +57.0% in yen), GEMTESA $407M (649 億円, +49.6%), MYFEMBREE $58M, RETHYMIC $20M, APTIOM $16M (−76.2% after loss of exclusivity), other $59M; total $1,240M / 1,978 億円 (+26.0%), 48.7% of the $2,622M (4,064 億円) full-year plan. Other in the prior year included $44M Pfizer deferred revenue and a $100M ORGOVYX sales milestone ($500M sales); the full-year plan includes $65M deferred revenue and a $325M milestone on reaching $1 billion ORGOVYX sales.
Product table with dual currency blocks (US$ million and ¥100 million), change and progress columns; footnote table detailing 'Other' components; commentary panel on the right.
Japan H1 sales total 446 億円 (+4.2%), 51.0% of the 876 億円 full-year forecast. Zeprion / Zeprion TRI contributed 82 億円 after in-house sales began; Latuda 73 億円 (+5.2%); Twymeeg 66 億円 (+31.4%, continued growth); Metgluco 38 億円; Equa / EquMet fell to zero (−75 億円) as the co-promotion ended; authorized generics 59 億円; other 129 億円. Product sales are stated at ex-factory prices.
Product revenue table with prior/current H1, change, full-year forecast and progress columns; bullet commentary box on the right.
H1 FY2026 by region: Japan revenue 446 / gross profit 196 億円 (−13, product mix); US revenue 1,978 / gross profit 1,197 億円 (+195 on higher sales); Other revenue 241 / gross profit 36 億円 (−127 after the partial transfer of the Asia business). Total gross profit 1,430 億円 vs 1,374 億円.
Three stacked tables (current H1, prior H1, change) by region with a regional commentary panel on the right.
Section break introducing the revised full-year FY2026 forecast.
Divider slide with mint banner and green tab, large section title.
Revenue forecast raised by 250 億円 to 5,650 億円 (+4.6%; FX +61), with US +187 億円 (GEMTESA and others) and Other +54 億円 (Europe). Gross profit 3,190 億円 (+240); SG&A 1,640 億円 (+90, more US promotion and license-related costs); R&D 520 億円; core operating profit 1,050 億円 (from 910, +15.4%); operating profit 1,040 億円; finance cost −50; tax 50; net profit attributable 940 億円 (from 770, +22.1%). ROE 24.1%, ROIC 17.6%. FX assumption moved from ¥155 to ¥157 per dollar. Red box: the company plans to resume dividends with a year-end dividend of ¥15 per share.
Forecast comparison table (May 13 forecast vs revised, change, FX impact, %) with ROE/ROIC rows, commentary panel at right and red-bordered dividend announcement at bottom right.
Revised FY2026 US forecast: ORGOVYX $1,359M (+$5M; 2,134 億円), GEMTESA $752M (+$66M; 1,180 億円, raised to reflect first-half price upside), MYFEMBREE $109M, RETHYMIC $38M, APTIOM $33M, other $415M; total $2,708M (+$86M) or 4,251 億円 (+187 億円, +4.6%). Other still includes $65M Pfizer deferred revenue and the $325M ORGOVYX $1 billion sales milestone.
Dual-currency forecast table comparing May 13 and revised figures with FX impact, footnote boxes for 'Other', commentary box at right.
ORGOVYX tracked plan: H1 sales $681M vs $664M plan (102% achievement), 144% of the prior-year period. Full-year forecast raised by $5M to $1,359M. Quarterly sales and bottle volume rise steadily from 2021 to Q2 FY2026 (sales approaching $350M per quarter). Waterfall: FY2025 actual $1,029M → original forecast $1,354M (+$325M) → volume −$9M, price +$14M → revised $1,359M, up $331M (32%) from FY2025.
Headline bullet, small KPI table top left, combined bar-and-line chart bottom left, forecast bridge waterfall chart on the right, product logo top right.
GEMTESA H1 sales $407M vs $347M plan (117% achievement, mainly a temporary price effect), 137% of the prior-year period. Full-year forecast raised by $66M to $752M. Waterfall: FY2025 actual $637M → original forecast $686M (+$49M) → volume +$12M, price +$54M → revised $752M, up $115M (18%) on FY2025. Quarterly sales and volume chart from 2021 to Q2 FY2026; data source Symphony Health Metys.
Same template as the ORGOVYX slide: headline, KPI table, quarterly bar/line chart and red waterfall chart.
Revised full-year regional view: Japan revenue 885 / gross profit 378 億円 (+23, Twymeeg upgrade and smaller-than-expected cost increase); US revenue 4,251 / gross profit 2,728 億円 (+191, price-driven revenue upgrade flows largely to gross profit); Other revenue 514 / gross profit 84 億円 (+26, higher Europe sales). Total gross profit 3,190 億円 vs 2,950 億円 in the May forecast.
Three stacked regional tables (revised forecast, May 13 forecast, change) with commentary sidebar.
Section break introducing the R&D update.
Divider slide with mint banner and green tab, large section title.
Psychiatry & neurology: DSP-0038 (Alzheimer's disease psychosis, Ph1), DSP-0187 (orexin 2 agonist, narcolepsy, Ph1), DSP-3456 (mGluR2/3 NAM, treatment-resistant depression, Ph1), DSP-0378 (GABA-A PAM, progressive myoclonic epilepsy / developmental and epileptic encephalopathy, Ph1), DSP-2342 (5-HT2A/5-HT7 antagonist, Ph1), DSP-0551 (Parkinson's tremor, Ph1), CT1-DAP001/DSP-1083 iPS-derived dopaminergic progenitors (Japan: post-marketing clinical trial underway, shown in red; US: Ph1/2), HLCR011 (iPS RPE cells, RPE tear, Japan Ph1/2), DSP-3077 (iPS retinal sheet, retinitis pigmentosa, US Ph1/2). Oncology: enzomenib (menin inhibitor, acute leukemia, Ph2), nuvisertib (PIM1, myelofibrosis, Ph1/2), SMP-3124 (CHK1, solid tumors, Ph1/2), DSP-0390 (EBP inhibitor, glioblastoma, Ph1). Other: KSP-1007 (β-lactamase inhibitor, cUTI/cIAI, Ph1), fH1/DSP-0546LP (influenza vaccine, Ph1).
Color-banded pipeline table by therapeutic area (green, peach, yellow) with columns for compound, mechanism, indication and stage; changes since July shown in red.
Amchepry (raguneprocel, CT1-DAP001/DSP-1083) for Parkinson's disease: first patient transplanted in Japan's post-marketing (Phase 4) clinical trial; in the US, transplants continue in the investigator-initiated trial and the first patient was dosed in the company-sponsored Phase 1/2. DSP-3077: multiple patients transplanted in the US Phase 1/2 for retinitis pigmentosa. Enzomenib received US Breakthrough Therapy designation (October 21) for relapsed/refractory KMT2A-rearranged acute leukemia. fH1/DSP-0546LP universal influenza vaccine: final one-year Phase 1 results announced.
Text slide grouped under three green area headings with colored square bullets and sub-points referencing detail pages.
Sites and patient intake were prepared; the first transplant took place in October 2026 at Kyoto University Hospital. Plan: about 1–2 transplants in FY2026, about 10 in FY2027 and 10–20 in FY2028, with Phase 4 participants prioritized and sites/patients expanded after completion. Site disclosure timeline: Kyoto University Hospital, then NHO Osaka Toneyama Medical Center, Juntendo University Hospital, Saitama Medical University Hospital, one Kansai site, one Tohoku site and one Chubu site. Links to patient, public and physician information pages; inquiries go to the company form, not hospitals.
Bullet summary on top, Gantt-style timeline with arrows for transplant schedule and site-disclosure milestones, information links and a dark-green notice bar at the bottom.
Multiple patients have received the retinal sheet in the US Phase 1/2 (NCT06891885) and the planned Q2 event was achieved. DSP-3077 is an allogeneic iPS-derived retinal sheet rich in photoreceptor precursor cells, transplanted once under the retina of the worse-seeing eye. Trial: open-label, single-arm dose escalation with the untreated fellow eye as control, 12 patients; primary endpoint safety and tolerability, secondary engraftment and efficacy. Cohorts of 4: Cohort 1 low dose (0.8–2.4 mm²) and Cohort 2 high dose (2.4–6.4 mm²) in patients with hand-motion to ~0.05 vision; Cohort 3 high dose with ~0.05–0.1 vision.
Two-column slide: left explains the product with retina cross-section illustrations and micrographs; right has a trial overview table and a cohort table with footnotes.
One year after dosing, safety and tolerability remained good and anti-LAH (long alpha helix) antibody titers stayed high; a controlled human infection challenge study is planned to start at the end of FY2026. European Phase 1: 144 healthy adults aged 18–40, randomized, placebo-controlled, double-blind, two intramuscular doses three weeks apart. No serious adverse reactions at four weeks post-dosing and no new safety concerns through one year. Exploratory analyses showed higher anti-LAH IgG1 titers and neutralizing activity against H1N1. A log-scale chart plots anti-LAH titers over ~365 days for antigen alone, placebo and three adjuvant doses (2.5, 5, 10 µg), with the 10 µg adjuvant arm highest. Joint research with AMED CiCLE and NIBN.
Left column of three summary boxes (trial outline, safety, exploratory analysis), large line chart on the right, liposome adjuvant illustration top right.
Milestone tracker by quarter: DSP-0378 initial proof of concept; CT1-DAP001/DSP-1083 first transplant in Japan post-marketing trial (done); DSP-3077 first US transplant in Ph1/2 (done); enzomenib in KMT2A-rearranged leukemia—Ph2 interim-analysis enrollment complete (done), topline interim results in Q3, filing targeted FY2027 Q1; enzomenib in NPM1-mutant AML—Ph2 enrollment started (done), interim-analysis enrollment complete in Q4; nuvisertib Phase 3 recommended dose decision (with FDA input); SMP-3124 Phase 2 recommended dose; fH1/DSP-0546LP one-year final results (done) and challenge study start in Q4.
Grid table with program rows, quarter columns and remarks; color-banded by therapeutic area, checkmarks for completed events and red text for changes.
Appendix contents: full-basis business results, financial position and cash flow, GEMTESA prescription trends, Japan product revenue forecast, product launch targets, and the regenerative and cell medicine pipeline list.
Divider slide with the appendix title on the left and a table of contents list on the right.
IFRS full-basis H1: revenue 2,665 億円 (+17.3%), cost of sales 1,235, gross profit 1,430, SG&A 787, R&D 238 (+35.6%), other income and expenses 18 (vs 528), operating profit 423 億円 (−56.0%), finance −29, profit before tax 394 (−57.6%), income tax 11, profit attributable to owners 382 億円 (−61.3%).
Single P&L table comparing prior and current H1 with change and percentage columns.
Balance sheet March to September 2026: total assets 8,046 → 8,511 億円; goodwill and intangibles 3,617; receivables 1,520; cash and short-term loans 443 → 778. Liabilities 5,121 → 4,199, with bonds and borrowings down 775 to 1,397 on repayment. Equity 2,925 → 4,311, share capital +489 and capital surplus +483 from a new share issue; equity attributable ratio 36.4% → 50.7%. Cash flow H1: operating 167, investing 5 (prior year 276 included proceeds from loss of control of a subsidiary), financing +176 (new share issue proceeds net of debt repayment); cash at period end 778 億円.
Balance sheet table on top and cash-flow table below, with callout boxes and arrows explaining key movements.
Total prescriptions (TRx) and new-to-brand prescriptions (NBRx) for GEMTESA versus other β3 agonists, monthly from April 2022 to September 2026; GEMTESA TRx and NBRx kept growing even after mirabegron generics launched in April 2024. GEMTESA TRx approaches roughly 280 thousand per month by late FY2026 on the chart (values read from bars, approximate). Source: Symphony Health Metys.
Two side-by-side stacked monthly bar charts (TRx and NBRx) with red GEMTESA segments over grey competitor segments.
Revised Japan full-year forecast 885 億円 (+9, +1.0%): Zeprion / Zeprion TRI 171, Latuda 139 (+3), Twymeeg 132 (+13, +10.9%, raised on strong performance), Metgluco 76, authorized generics 118 (+6), other 249 (−13).
Forecast comparison table with a single commentary box on the right.
Launch roadmap FY2026–2030: CT1-DAP001/DSP-1083 for Parkinson's disease (with RACTHERA) in Japan in FY2026 with post-marketing trial underway, followed by US development; HLCR011 for RPE tear in Japan around FY2028, then indication expansion; enzomenib for relapsed/refractory KMT2A-rearranged acute leukemia or NPM1-mutant AML in Japan and the US around FY2027; nuvisertib for myelofibrosis in Japan and the US around FY2028, each followed by indication expansion.
Horizontal roadmap with year header bar, program boxes on the left, launch boxes with country flags and arrows labelled for expansion.
Stage chart: RETHYMIC (congenital athymia, US) marketed; CT1-DAP001/DSP-1083 (Parkinson's) received conditional, time-limited approval in Japan in March 2026 with a Phase 4 trial underway, and is in US Phase 1/2 (UC San Diego IIT and company trial); HLCR011 (RPE tear, Japan Ph1/2); DSP-3077 (retinitis pigmentosa, Japan clinical research at Kobe Eye Center, US company Ph1/2); iPS-derived neural progenitors for spinal cord injury (clinical research at Keio University Hospital, now targeting subacute injury); nephron progenitor cells for kidney failure (non-clinical).
Matrix with product rows and development-stage columns from non-clinical to approval, green dots marking current stage, numbered footnotes for sites.
Closing slide with the Sumitomo Pharma logo and tagline 'Innovation today, healthier tomorrows'.
Centered logo on a white background.
Domande comuni su questa slide e il contenuto della presentazione sottostante.
It covers results for April–September 2026 (the first half of the fiscal year ending March 2027): core revenue of ¥266.5 billion (+17.3%), core operating profit of ¥42.1 billion, US and Japan product sales, an upward revision to the full-year forecast, a planned ¥15 year-end dividend, and an R&D update.
The original is a Japanese-language results briefing deck (決算説明会資料) titled 2026年度（2027年3月期）第2四半期決算 決算説明会資料, published on TDnet, the Tokyo Stock Exchange's timely disclosure system, on October 30, 2026. This page provides an English page-by-page summary; the slides themselves remain in Japanese.
Full-year revenue was raised from ¥540.0 billion to ¥565.0 billion, core operating profit from ¥91.0 billion to ¥105.0 billion, and net profit attributable to owners from ¥77.0 billion to ¥94.0 billion, helped mainly by higher GEMTESA pricing in the US and stronger European sales. The dollar assumption moved to ¥157.
ORGOVYX sold $681M in the first half (102% of plan) and its full-year forecast is $1,359M. GEMTESA sold $407M (117% of plan, partly a temporary price effect) and its forecast was raised by $66M to $752M. GEMTESA prescriptions kept growing after mirabegron generics arrived in April 2024.
The first patient was transplanted in Japan's Phase 4 trial of Amchepry, the iPS cell-derived dopaminergic progenitor product for Parkinson's disease. Enzomenib received US Breakthrough Therapy designation for relapsed/refractory KMT2A-rearranged acute leukemia, DSP-3077 retinal sheets were transplanted in several US patients, and one-year Phase 1 data for the universal flu vaccine fH1/DSP-0546LP were reported.
Japanese companies usually report in units of ¥100 million (億円). For example, 2,665 億円 equals ¥266.5 billion. US product sales are also shown in US$ million.
Yes. The page offers the original PDF and an editable PPTX converted from it, so you can reuse the table and chart layouts for your own results briefing or analysis.
It is useful for investors and analysts covering Sumitomo Pharma (TSE: 4506), people tracking relugolix, vibegron and iPS cell therapies, and IR teams looking for an example of a Japanese quarterly earnings presentation.
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