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Jazz Pharmaceuticals plc (JAZZ)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $1.046B, up 2% year over year; non‑GAAP diluted EPS was $(8.25) driven by a $905.4M acquired IPR&D charge tied to dordaviprone, which impacted results by ~$14.75 per share .
  • Sleep portfolio strength continued: Xywav net sales rose 13% YoY to $415.3M with robust net patient adds (+625 QoQ; 15,225 active) across narcolepsy and IH; Epidiolex grew 2% YoY to $251.7M amid U.S. inventory dynamics .
  • Oncology faced headwinds (Zepzelca −8% YoY to $74.5M; Rylaze −7% YoY to $100.7M), but multiple near‑term catalysts remain: Zepzelca priority review for 1L ES‑SCLC (PDUFA Oct 7, 2025), HERIZON‑GEA‑01 top‑line in 4Q25, and Modeyso (dordaviprone) PDUFA Aug 18 (FDA approval announced Aug 6) .
  • Guidance narrowed: total revenue $4.15–$4.30B (lowered top end), SG&A and R&D ranges reduced, non‑GAAP tax rate lowered to 27–37%, and non‑GAAP EPS raised at the low end to $4.80–$5.60; GAAP outlook incorporates the IPR&D expense and litigation settlements .
  • Leadership transition: Renee Galá named President & CEO effective Aug 11; management emphasized diversified growth drivers and upcoming regulatory catalysts as stock‑reaction narrative points .

What Went Well and What Went Wrong

What Went Well

  • Xywav momentum: net sales +13% YoY to $415.3M; net patient adds ~625 QoQ; “Xywav remains the only low‑sodium oxybate … and the only FDA‑approved therapy to treat IH” .
  • Epidiolex demand: net sales +2% YoY to $251.7M despite inventory dynamics; management “remain[s] confident in achieving blockbuster status in 2025” .
  • Pipeline/regulatory setup: Zepzelca sNDA priority review for 1L ES‑SCLC maintenance (PDUFA Oct 7) and HERIZON‑GEA‑01 top‑line in 4Q25; “potentially practice‑changing” IMforte data submitted to NCCN .

Quotes:

  • Bruce Cozadd: “We remain confident in the outlook … driven by multiple anticipated near‑term oncology catalysts … PDUFA dates for dordaviprone and Zepzelca” .
  • Renée Galá: “XiWave delivered another strong quarter … benefits of low sodium and individualized dosing continue to resonate” .
  • Robert Iannone: IMforte showed reduced risk of progression or death by 46% and risk of death by 27% vs atezolizumab alone; “practice changing” .

What Went Wrong

  • Non‑GAAP loss/EPS miss driven by accounting: acquired IPR&D expense of $905.4M for dordaviprone weighed on GAAP and non‑GAAP results (per‑share impact ~$14.75) .
  • Oncology pressure: Zepzelca −8% YoY due to 2L competition and protocol changes delaying 1L limited‑stage patients’ progression to 2L; Rylaze −7% YoY with pediatric protocol shifts reducing class usage vs pre‑implementation levels .
  • SG&A mix and cost headwinds: GAAP SG&A rose to $358.4M (34.3% of revenue), reflecting higher compensation and portfolio support; non‑GAAP SG&A $310.3M (29.7%) .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Total Revenues ($USD Millions)$1,088.173 $897.841 $1,045.712
GAAP Diluted EPS ($)$3.11 $(1.52) $(11.74)
Non-GAAP Diluted EPS ($)$6.60 $1.68 $(8.25)
GAAP Gross Margin (%)87.4% 87.5% 88.2%
Non-GAAP Gross Margin (%)91.6% 91.7% 92.3%
GAAP SG&A ($USD Millions; % of rev)$369.287; 33.9% $514.013; 57.2% $358.399; 34.3%
GAAP R&D ($USD Millions; % of rev)$240.500; 22.1% $180.652; 20.1% $189.972; 18.2%

Segment/Product Net Sales ($USD Millions)

ProductQ4 2024Q1 2025Q2 2025
Xywav$400.964 $344.804 $415.321
Xyrem$49.290 $37.241 $35.349
Epidiolex/Epidyolex$275.047 $217.737 $251.730
Sativex$5.173 $5.407 $4.615
Rylaze/Enrylaze$101.487 $94.233 $100.659
Zepzelca$78.328 $63.033 $74.541
Defitelio/defibrotide$57.650 $40.662 $48.106
Vyxeos$53.247 $29.544 $44.851
Ziihera (zanidatamab-hrii)$1.051 $1.975 $5.991
High-sodium oxybate AG Royalty$55.307 $48.946 $54.138
Other Royalty & Contract$7.655 $9.477 $6.003

KPIs (Xywav patient metrics)

KPIQ4 2024Q1 2025Q2 2025
Active Xywav Patients (approx.)14,150 14,600 15,225
Net Adds QoQ (approx.)+525 +450 +625
Narcolepsy Patients (approx.)10,250 10,375 10,600
IH Patients (approx.)3,900 4,225 4,625 (net adds ~400)

Estimate vs Actual (Wall Street Consensus – S&P Global)

MetricQ2 2025 ConsensusQ2 2025 Actual# of Estimates
Revenue ($USD Millions)$1,047.20*$1,045.71*16*
Primary EPS ($)$(6.25)*$(8.25)*16*
EBITDA ($USD Millions)$(411.40)*$392.98*—

Values retrieved from S&P Global.*

Highlights:

  • Revenue was approximately in line (slight miss of ~$1.5M) versus consensus; EPS missed due to the $905.4M IPR&D expense related to the Chimerix acquisition; management quantified ~$14.75 per‑share impact on non‑GAAP .

Guidance Changes

MetricPeriodPrevious Guidance (May 6, 2025)Current Guidance (Aug 5, 2025)Change
Total Revenues ($B)FY 2025$4.15–$4.40 $4.15–$4.30 Lowered top end
GAAP Gross Margin (%)FY 202588% 88% Maintained
GAAP SG&A ($M)FY 2025$1,640–$1,723 $1,620–$1,693 Lowered
GAAP R&D ($M)FY 2025$835–$895 $805–$865 Lowered
GAAP Effective Tax Rate (%)FY 20250%–10% 4%–16% Raised range (mix effects)
GAAP Net Loss ($M)FY 2025$(615)–$(450) $(565)–$(450) Raised lower end
GAAP Diluted LPS ($)FY 2025$(10.00)–$(7.50) $(9.25)–$(7.50) Raised lower end
Non‑GAAP Gross Margin (%)FY 202592% 92% Maintained
Non‑GAAP SG&A ($M)FY 2025$1,470–$1,530 $1,450–$1,500 Lowered
Non‑GAAP R&D ($M)FY 2025$760–$810 $730–$780 Lowered
Non‑GAAP Effective Tax Rate (%)FY 202535%–45% 27%–37% Lowered
Non‑GAAP Net Income ($M)FY 2025$250–$350 $300–$350 Raised lower end
Non‑GAAP Diluted EPS ($)FY 2025$4.00–$5.60 $4.80–$5.60 Raised lower end

Notes: Guidance reflects acquired IPR&D ($905.4M) and certain Xyrem antitrust settlements ($172.0M) .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024; Q1 2025)Current Period (Q2 2025)Trend
Sleep (Xywav) growth driversXywav +16% YoY in 2024; #1 branded narcolepsy; IH expansion +13% YoY; +625 net adds; strong IH execution and nurse educator support Strengthening
Epidiolex trajectory+15% YoY 2024; blockbuster in 2025 targeted +2% YoY; inventory timing headwind; still targeting blockbuster Steady demand; near‑term inventory noise
Oncology (Zepzelca)sNDA planned 1H25; IMforte data practice‑changing Priority review; PDUFA Oct 7; 2L competition pressuring sales Transition to earlier line expected
Zanidatamab (HERIZON‑GEA‑01)Top‑line expected 2H25 Refined to late 4Q25; disclosure likely qualitative topline first Timing refined; confidence maintained
Dordaviprone (Modeyso)NDA accepted; priority review; PDUFA Aug 18 Management prepared for launch; FDA approval announced Aug 6 Catalyst realized post‑Q2
Supply chain/tariffsNot highlightedLimited tariff exposure; U.S. supply/CMOs mitigate; inventory coverage into 2026 Risk mitigated
Macro/MFN pricingNot highlightedMonitoring MFN proposals; potential exposure for Rylaze & Epidiolex; uncertain timing/scope Emerging risk watch

Management Commentary

  • Strategic focus: “We remain confident in the strength of our diversified portfolio … as we prepare for anticipated approval of dordaviprone and approval of Zepzelca in an earlier line of treatment” – Bruce Cozadd .
  • Commercial execution: “XiWave delivered another strong quarter … net product sales increasing 13% YoY … ~625 net patient adds” – Renée Galá .
  • Oncology pivot: “IMforte results are practice changing … submission granted priority review with Oct 7 PDUFA” – Robert Iannone .
  • Modeling detail: “We’ll have 14 shipping weeks in Q3 and 13 in Q4; last year was the opposite” – Philip Johnson .
  • Leadership: “Renee … will build on Jazz’s momentum and serve as a catalyst in driving long‑term growth” – Bruce Cozadd ; CEO appointment effective Aug 11 .

Q&A Highlights

  • Xywav IH sustainability: Growth supported by consumer digital campaigns, HCP education, and field nurse educators improving titration/persistence; opportunity largest in IH given unique approval .
  • Zepzelca headwinds and recovery path: 2L competition (e.g., tarlatamab) and adoption of immunotherapy in 1L limited‑stage delaying progression; strategy focuses on 1L ES‑SCLC maintenance approval and guideline inclusion .
  • Zanidatamab topline disclosure: Expect qualitative top‑line (primary/secondary endpoints met) before detailed statistics; benchmarks from TOGA/JACOB/KEYNOTE‑811 inform clinical meaningfulness framing .
  • Orexin vs oxybate: Mechanisms viewed as complementary; Xywav improves nighttime sleep architecture; internal orexin program JZP‑441 in small NT1 cohort underway .
  • Tariffs/MFN: Minimal tariff exposure due to U.S. manufacturing; MFN scope/timing unclear, potential exposure where government business is higher (Rylaze, Epidiolex) .
  • Dordaviprone launch: Concentrated academic call point; long patent runway (to 2037) and dedicated team to augment footprint .

Estimates Context

  • Revenue and EPS were approximately in line (revenue slight miss) and EPS below consensus due to the non‑tax‑deductible IPR&D charge; non‑GAAP EPS $(8.25) vs consensus $(6.25)* .
  • Consensus participation: ~16 estimates for revenue and EPS; EBITDA consensus negative due to modeling of expense mix in the quarter*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Sleep franchise is the core growth engine; Xywav’s IH adoption and differentiated profile support durable expansion even with potential orexin entrants .
  • Near‑term oncology catalysts can reaccelerate growth: Zepzelca 1L ES‑SCLC PDUFA (Oct 7) and zanidatamab HERIZON‑GEA‑01 readout (late 4Q) are stock‑moving events; Modeyso FDA approval announced Aug 6 expands rare oncology footprint .
  • Q2 headline loss is accounting‑driven; underlying operations showed resilient gross margins (non‑GAAP 92.3%) and strong operating cash flow ($519M 1H) .
  • Guidance de‑risked: narrowed revenue, reduced SG&A/R&D, lower non‑GAAP tax rate, and raised low‑end EPS; execution against catalysts is key to second‑half trajectory .
  • Watch macro/policy risks (MFN pricing) and competitive dynamics in 2L SCLC; management is pivoting Zepzelca to earlier line to offset pressures .
  • Technical modeling: CFO’s shipping weeks detail (Q3: 14; Q4: 13) affects quarterly sales phasing; inventory dynamics particularly relevant for Epidiolex .
  • Leadership transition is a potential sentiment driver; new CEO’s focus on disciplined capital allocation and corporate development could catalyze portfolio evolution .

Additional Notes and Disclosures

  • Q2 results and guidance: Jazz furnished an 8‑K with press release detailing results and updated guidance .
  • Cash, debt, liquidity: Cash/investments $1.7B; long‑term debt principal $5.4B; undrawn revolver $885M (as of June 30) .
  • Share repurchases: ~$125M bought in Q2; $225M remains under $500M authorization .
  • Upcoming events: Company planned investor webcast for Modeyso on Aug 27 .

All company figures and statements are sourced from Jazz’s Q2 2025 press release and 8‑K, Q2 earnings call transcript, and prior quarter materials as cited above.