On August 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2025 and updated financial guidance for 2025 (Press release, Jazz Pharmaceuticals, AUG 5, 2025, View Source [SID1234654790]).

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"It has been a privilege to lead Jazz over my 22-year tenure. I am proud of what we have achieved on behalf of patients and confident that our new President and CEO, Renee Gala, will build on Jazz’s momentum and serve as a catalyst in driving long-term growth," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to see significant opportunity across our diversified portfolio in sleep, epilepsy, and oncology, as evidenced by the strong performance this quarter from our sleep portfolio with robust continued growth from Xywav in both narcolepsy and IH. We remain confident in the outlook of the business driven by multiple anticipated near-term oncology catalysts that each represent significant opportunities to drive greater revenue and create long-term value, most notably the top-line data readout for zanidatamab from the HERIZON-GEA-01 trial and upcoming PDUFA dates for dordaviprone and Zepzelca."

Key Highlights

•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25.
•Ziihera granted conditional marketing authorization by the European Commission in 2L BTC.
•Zepzelca and atezolizumab (Tecentriq) combination granted U.S. FDA Priority Review for 1L maintenance treatment of ES-SCLC based on positive data from IMforte trial; PDUFA action date of October 7, 2025.
•2025 Financial Guidance
◦Updating total revenue range to $4.15 – $4.30 billion representing 4% growth at the midpoint.
◦Raising lower end of net (loss)/income and (loss)/earnings per share ranges due to reductions in SG&A and R&D and improvement in the effective tax rate ranges.

Business Updates

Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 13% to $415.3 million in 2Q25 compared to 2Q24.
•Meaningful Xywav net patient adds in 2Q25 (approximately 625 patients) with approximately 15,225 active Xywav patients exiting 2Q25, comprised of:
◦Approximately 10,600 narcolepsy patients.
◦Approximately 4,625 idiopathic hypersomnia (IH) patients, with 400 net patient adds.
•Presented data at the SLEEP 2025 meeting including results from the Phase 4 open-label XYLO trial showing that a switch from high-sodium oxybate to the same dose of low-sodium oxybate was associated with clinically meaningful reductions in blood pressure. Additionally, two presentations from the DUET trial evaluating sleep architecture demonstrated the effectiveness of Xywav on improvements in sleep quality among patients with IH or narcolepsy.
•Xywav, which the U.S. Food and Drug Administration (FDA) describes as clinically superior to Xyrem by means of greater safety, is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only FDA-approved therapy to treat IH.

Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales were $35.3 million in 2Q25.
•Royalties from high-sodium oxybate AGs were $54.1 million in 2Q25.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 2% to $251.7 million in 2Q25 compared to 2Q24; underlying demand continues to be strong with year-over-year net product sales growth impacted by a number of factors, including inventory dynamics in the U.S. compared to 2Q24.
•Outside of the U.S., Epidyolex is approved in more than 35 countries.
•Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze/Enrylaze net product sales decreased 7% to $100.7 million in 2Q25 compared to 2Q24.
•While updates to pediatric treatment protocols for acute lymphoblastic leukemia (ALL) have been broadly adopted, pediatric asparaginase use as a class remains below levels seen prior to protocol implementation; Rylaze use within the asparaginase class remains broadly stable.

Zepzelca (lurbinectedin):
•Zepzelca net product sales decreased 8% to $74.5 million in 2Q25 compared to 2Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression of first-line (1L) limited-stage SCLC patients to the 2L setting.
•Zepzelca and atezolizumab were granted U.S. FDA Priority Review for 1L extensive-stage (ES) SCLC in the maintenance setting with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025.
•Potentially practice-changing data from the Phase 3 IMforte trial have been submitted to the National Comprehensive Cancer Network (NCCN) for consideration.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales were $6.0 million in 2Q25 following product launch in December 2024.
•The Company was granted conditional marketing authorization by the European Commission for Ziihera as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.

Corporate Development
Chimerix Acquisition:
•The Company completed its acquisition of Chimerix, Inc in April 2025 (Chimerix Acquisition), adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults.

Key Pipeline Highlights
Zanidatamab:
•The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 4Q25.
•New data presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from an ongoing Phase 2 trial of zanidatamab in combination with physician’s choice chemotherapy for the first-line treatment of HER2-positive metastatic GEA showed a median overall survival of 36.5 months after four-years of follow-up along with a 15.2 month median progression-free survival in patients who were centrally confirmed as HER2-positive.
•In August 2025, the Company initiated the Phase 2 EmpowHER-BC-208 trial to evaluate zanidatamab in patients with HER2-positive neoadjuvant and adjuvant breast cancer.

Dordaviprone:
•A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target PDUFA action date of August 18, 2025.
•The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.

Share Repurchases of Approximately $125 Million
The Company resumed repurchases of its ordinary shares in the second quarter of 2025 as part of the Company’s previously authorized and announced repurchase program. Under this share repurchase program, the Company is authorized to repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. As of June 30, 2025, $225 million remained outstanding under this authorization, reflecting the purchase of shares worth approximately $125 million during the second quarter of 2025.

Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands, except per share amounts) 2025 2024 2025 2024
Total revenues $ 1,045,712 $ 1,023,825 $ 1,943,553 $ 1,925,808
GAAP net income (loss) $ (718,470) $ 168,568 $ (811,011) $ 153,950
Non-GAAP adjusted net income (loss)1
$ (504,849) $ 360,656 $ (399,616) $ 539,086
GAAP earnings (loss) per share $ (11.74) $ 2.49 $ (13.28) $ 2.35
Non-GAAP adjusted earnings (loss) per share1
$ (8.25) $ 5.25 $ (6.54) $ 7.88

GAAP net loss for 2Q25 was $(718.5) million, or $(11.74) per diluted share, compared to GAAP net income of $168.6 million, or $2.49 per diluted share, for 2Q24.
Non-GAAP adjusted net loss for 2Q25 was $(504.8) million, or $(8.25) per diluted share, compared to non-GAAP adjusted net income of $360.7 million, or $5.25 per diluted share, for 2Q24.
The GAAP and non-GAAP adjusted net loss in 2Q25 included acquired in-process research and development (IPR&D) expense of $905.4 million representing the value allocated to dordaviprone in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In thousands) 2025 2024 2025 2024
Xywav $ 415,321 $ 368,472 $ 760,125 $ 683,772
Xyrem 35,349 62,180 72,590 126,412
Epidiolex/Epidyolex 251,730 247,102 469,467 445,818
Sativex 4,615 6,383 10,022 9,118
Total Neuroscience 707,015 684,137 1,312,204 1,265,120
Rylaze/Enrylaze 100,659 107,829 194,892 210,579
Zepzelca 74,541 81,047 137,574 156,147
Defitelio/defibrotide 48,106 45,421 88,768 93,097
Vyxeos 44,851 43,012 74,395 75,035
Ziihera 5,991 — 7,966 —
Total Oncology 274,148 277,309 503,595 534,858
Other 4,408 2,698 9,190 6,268
Product sales, net 985,571 964,144 1,824,989 1,806,246
High-sodium oxybate AG royalty revenue 54,138 54,164 103,084 104,111
Other royalty and contract revenues 6,003 5,517 15,480 15,451
Total revenues $ 1,045,712 $ 1,023,825 $ 1,943,553 $ 1,925,808

Total revenues increased 2% in 2Q25 compared to the same period in 2024.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $761.2 million in 2Q25, an increase of 3% compared to $738.3 million in 2Q24. The increase in 2Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales.
Oncology net product sales were $274.1 million in 2Q25, a decrease of 1% compared to $277.3 million in 2Q24. The decrease in 2Q25 was primarily due to lower net product sales of Rylaze/Enrylaze and Zepzelca, partially offset by the inclusion of Ziihera net product sales.