4578
BUY
Conviction: 3/5
$33B
Otsuka Holdings Co Ltd
Current: $9210
Investment Thesis
Navigating LOE trough (Abilify Maintena generics, Jynarque orphan exclusivity expired) while launching two potential blockbusters: VOYXACT (sibeprenlimab, first-in-class anti-APRIL for IgAN, approved Nov 2025) and centanafadine (first-in-class NDSRI for ADHD, PDUFA July 2026). FY2026 is the trough year (-25% OI guided) — the thesis is that new launches + Rexulti growth offset the LOE drag from 2027 onward.
Bull Case
VOYXACT eGFR data converts to full approval, becomes multi-billion IgAN franchise. Centanafadine approved, captures meaningful ADHD share. Rexulti Alzheimer agitation grows faster than expected. Asimtufii fully replaces Maintena volume. Jynarque generic erosion slower than feared.
Bear Case
FY2026 trough deeper than guided — Jynarque cliff + Maintena generics accelerate. VOYXACT eGFR data disappoints, accelerated approval withdrawn. Centanafadine gets CRL. Ulotaront remains dead after Phase 3 failures. Pipeline thin beyond 2027.
Drug Portfolio (15)
Rare Disease
Small molecule
ORAL
Immunology
Monoclonal antibody
SC
Neurology
Small molecule
ORAL
Neurology
Small molecule
ORAL
Neurology
Small molecule
IM
| Drug | Stage | Role | Ownership | Area | Modality |
|---|
| Abilify Maintena | APPROVED | ORIGINATOR | 80% | Neurology | Small molecule |
| Ulotaront | PHASE3 | LICENSEE | 100% | Neurology | Small molecule |
| Repinatrabit | PHASE3 | ORIGINATOR | 100% | Rare Disease | Small molecule |
| Quabodepistat | PHASE3 | ORIGINATOR | 100% | Infectious Disease | Small molecule |
| Nuedexta | APPROVED | ORIGINATOR | 100% | Neurology | Small molecule |
| Moizerto | APPROVED | ORIGINATOR | 100% | Immunology | Small molecule |
| Deltyba | APPROVED | ORIGINATOR | 100% | Infectious Disease | Small molecule |
| DAWNZERA | APPROVED | LICENSEE | 0% | Rare Disease | Antisense oligonucleotide |
| Ulefnersen | PHASE3 | LICENSEE | 100% | Neurology | Antisense oligonucleotide |
| Lupkynis | APPROVED | LICENSEE | 0% | Immunology | Small molecule |
Financials (USD)
| Period | Revenue ($M) | Gross Margin | R&D | SG&A | Op Income | Op Margin | Net Income | EPS |
|---|
| 2024A | $16,533 | — | $0 | $0 | $2,157 | — | $2,287 | $633.76 |
| 2025A | $16,467 | — | $0 | $0 | $3,196 | — | $2,421 | $685.06 |
| 2026E | $16,800 | — | $0 | $0 | $2,400 | — | $1,767 | $504.94 |
Catalysts (5)
VOYXACT - IgA Nephropathy - Ph3 - eGFR Confirmatory Data (VISIONARY)
CLINICAL
SM
Otsuka IR; FDA accelerated approval requirement; VISIONARY trial design
Early 2026
Ulotaront - Schizophrenia - Ph3 - Relapse Prevention (DIAMOND 5)
CLINICAL
SM
ClinicalTrials.gov; Otsuka pipeline update 2025
H2 2026
Ulefnersen - FUS-ALS - Ph3 - Topline (FUSION)
CLINICAL
ClinicalTrials.gov NCT04768972; Ionis pipeline updates
H2 2026
Centanafadine - ADHD - FDA PDUFA Decision
REGULATORY
SM
Otsuka press release Jan 27, 2026; FDA PDUFA date
July 24, 2026
Repinatrabit - PKU - Ph3 - Topline (NCT06971731)
CLINICAL
ClinicalTrials.gov NCT06971731; Otsuka press release Dec 2025
Early 2027
Data from Supabase · Updated 2026-03-24