Jazz Pharmaceuticals plc (JAZZ) Q1 2026 Earnings Call Transcript
Neutral Other 10.45B Ireland
Next Earnings
2026-05-04
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Jazz delivered a 2025 record revenue run, launched Modeyso, advanced zanidatamab and Zepzelca/ Epidiolex franchises, and secured favorable regulatory and litigation outcomes, while guiding for modest 2026 growth amid rising generics pressure on Xywav.
⭐ Key Highlights
Record revenue year
Jazz reported 2025 total revenue of $4.3 billion, a new record and 21st consecutive year of topline growth.
Modeyso launch momentum
Modeyso launched in 2025 with $48 million in revenue in 2025 and is expected to reach a peak opportunity exceeding $500 million in the U.S.
Zepzelca expanded use
FDA approved Zepzelca in combination with atezolizumab for first-line maintenance in extensive-stage SCLC, expanding addressable market.
Zanidatamab progress
Phase III Horizon GEA data showed a substantial OS benefit; FDA Breakthrough designation granted; potential launch in GEA in 2H2026.
Epidiolex and regulatory/Litigation milestones
Epidiolex achieved blockbuster status with $1.1 billion in 2025 revenue; Epidiolex ANDA litigation settlements extended runway into late 2030s.
Chimerix deal and voucher sale
Chimerix acquisition enabled Modeyso and a deferred tax asset; Jazz sold a priority review voucher for $200 million, with half to Jazz.
✔Positive Signals
- Record 2025 revenue of $4.3B and 2024-2025 momentum across Xywav, Epidiolex, and Modeyso
- Modeyso generated $48M in 2025 with potential >$500M peak opportunity in the U.S.
- Zanidatamab Phase III data showed >7 months OS improvement in first-line GEA and FDA Breakthrough designation for GEA
- Epidiolex achieved blockbuster status with $1.1B in 2025 revenue and expanding adult/long-term care opportunities
- Settlement of Epidiolex ANDA litigation extending revenue runway into late 2030s; voucher sale added $200M gross proceeds
✖Negative Signals
- Two multisource generics entering High-Sodium Xyrem market and Hikma AG royalty step-down pressure 2026
- Xywav revenue expected to be flat to up mid-single digits in 2026 amid evolving sleep competitive landscape
- Branded sleep franchise at risk from generic competition, potentially weighing on overall Rare Sleep growth
- Guidance implies only modest overall 2026 revenue growth (~2.5% mid-point), signaling macro/competitive headwinds
- Uncertainty around real-world duration of Modeyso treatment and potential need for ACTION trial readout to meet peak guidance
📊Financial Results
- Q4 2025 revenue: $1.2B; full-year 2025 revenue: $4.3B (record).
- Non-GAAP adjusted net income 2025: $522M; non-GAAP adjusted EPS: $8.38.
- Cash from operations 2025: ≈$1.4B; ending cash and investments: $2.4B.
- Revenue drivers: strong contributions from Xywav, Epidiolex, and Modeyso; Xyrem decline due to generics.
- Balance sheet remains strong with capacity to fund pipeline and corporate development.
🔮Future Guidance
- 2026 total revenue guidance: $4.25B to $4.50B (≈2.5% growth at midpoint).
- Non-GAAP gross margin: 90%–91% (slight decline vs 2025 due to higher royalties from Modeyso/Ziihera and potential tariffs).
- Non-GAAP SG&A: $1.26B–$1.32B; R&D: $725M–$775M (higher due to zanidatamab and preclinical programs).
- Non-GAAP effective tax rate: 11.5%–13.5%; fully diluted shares: 65–66 million.
- Xywav revenue expected to be flat to up mid-single digits; two generic high-sodium oxybate products entering the market in 2026; impact expected more in second half.
- Zanidatamab potential second-half 2026 launch in GEA pending regulatory timing and ongoing interim OS data (mid-2026 delivery anticipated).
💡Interesting Insights
- Jazz recognizes a strategic opportunity to partner or acquire to extend the sleep-wake franchise, while pursuing aggressive rare-disease expansion; ongoing orexin exploration is viewed as potentially complementary rather than a standalone replacement for Xywav.
Detailed Analysis
AI-generated summary of Jazz Pharmaceuticals plc earnings call transcript.
Jazz's 2025 results reflect a transformational year: record revenue of $4.3B, a 10% Q4 growth to $1.2B, and launches/accessions across rare disease and oncology, including Modeyso, Ziihera (zanidatamab), and Zepzelca in first-line maintenance. Substantial R&D progress was highlighted by the zanidatamab Phase III data showing meaningful OS and PFS benefits, plus regulatory milestones (FDA Breakthrough designation in GEA) that could accelerate approvals and potential launch in 2H2026. The company settled major Epidiolex ANDA disputes extending long-term revenue visibility and used the Chimerix acquisition to secure Modeyso and tax benefits, while selling a priority review voucher for $200M. With a strategic shift toward rare disease and a strong balance sheet, Jazz seeks durable growth via Epidiolex, Modeyso, Ziihera, and an expanding rare disease pipeline, even as Xywav faces increased generic competition and a modest 2026 revenue outlook.
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