On May 6, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2025 and updated financial guidance for 2025 (Press release, Jazz Pharmaceuticals, MAY 6, 2025, View Source [SID1234652579]).
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"In the first quarter of 2025, our focus on commercial execution resulted in total revenues of $898 million, led by the strong performance of Xywav and Epidiolex. In addition, our team continues to receive positive feedback from healthcare providers on the launch of Ziihera in its first approved indication of 2L HER2+ BTC. We are affirming our 2025 total revenue guidance range of $4.15 – $4.40 billion, reflecting our confidence in our commercial portfolio delivering top-line growth this year," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to make meaningful progress across our pipeline. We are pleased to report that we have submitted a supplemental New Drug Application for Zepzelca for maintenance therapy in first-line extensive-stage small cell lung cancer. In addition, we recently completed the acquisition of Chimerix, adding a near-term commercial opportunity to our late-stage pipeline that addresses a significant unmet need for patients with H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. We also advanced multiple trials across our zanidatamab development program and expect top-line data readout from the HERIZON-GEA-01 trial in 1L GEA in the second half of 2025."
Key Highlights
•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 2H25.
•Submitted sNDA for Zepzelca in combination with atezolizumab (Tecentriq ) as maintenance therapy in 1L ES-SCLC based on the potentially practice-changing results from the Phase 3 IMforte trial. Data from trial to be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025.
•Acquisition of Chimerix added dordaviprone to late-stage pipeline, representing near-term commercial opportunity; PDUFA target data of August 18, 2025.
•Top-line growth expected in 2025; affirmed 2025 total revenue guidance of $4.15 – $4.40 billion, representing 5% growth at the midpoint.
◦Total revenue guidance is underpinned by expected continued growth of Jazz’s diversified commercial portfolio.
Business Updates
Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 9% to $344.8 million in 1Q25 compared to 1Q24.
•Meaningful Xywav net patient adds in 1Q25 (approximately 450 patients) with approximately 14,600 active Xywav patients exiting 1Q25, comprised of:
◦Approximately 10,375 narcolepsy patients.
◦Approximately 4,225 idiopathic hypersomnia (IH) patients, with 325 net patient adds.
•Two presentations at the American Academy of Neurology Annual Meeting provided updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or IH. The results demonstrated statistically significant improvements from baseline to end of treatment in Epworth Sleepiness Scale (ESS) scores, reduced sleep stage shifts, increased deep sleep and reduced number of awakenings among adults with narcolepsy treated with Xywav. In adults with IH, Xywav treatment showed improvements in ESS and IH Severity Scale scores.
•Xywav is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only U.S. Food and Drug Administration (FDA)-approved therapy to treat IH.
Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales decreased 42% to $37.2 million in 1Q25 compared to 1Q24.
•Royalties from high-sodium oxybate AGs were $48.9 million in 1Q25.
Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 10% to $217.7 million in 1Q25 compared to 1Q24.
•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 8% to $94.2 million in 1Q25 compared to 1Q24. This decrease was driven by headwinds from an update to Children’s Oncology Group (COG) pediatric treatment protocols for acute lymphoblastic leukemia made in mid-2024 that impacted timing of asparaginase administration.
•The impact to Rylaze net product sales due to COG protocol updates is expected to normalize during 2Q25.
Zepzelca (lurbinectedin):
•Zepzelca net product sales decreased 16% to $63.0 million in 1Q25 compared to 1Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression in first-line (1L) limited-stage SCLC patients to the 2L setting.
•The Company submitted a supplemental New Drug Application (sNDA) for Zepzelca’s use in combination with atezolizumab as maintenance therapy in 1L extensive-stage (ES) SCLC for patients who have not progressed after induction chemotherapy.
•Potentially practice-changing data from the Phase 3 IMforte trial, which showed a statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival for the Zepzelca and atezolizumab combination for ES-SCLC patients receiving this treatment in the first-line maintenance setting, was accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. This is the first presentation of data from the IMforte trial.
Ziihera (zanidatamab-hrii):
•Ziihera net product sales were $2.0 million in 1Q25 following product launch in December 2024.
•On April 25, 2025, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab in 2L BTC (biliary tract cancer). The CHMP recommendation is being reviewed by the European Commission.
Corporate Development
Chimerix Acquisition:
•The Company completed its acquisition of Chimerix in April 2025, 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 2H25 based on the most recent assessment of progression events. Recruitment for the trial has been completed.
•New data from an ongoing Phase 2 trial of zanidatamab in combination with chemotherapy for the first-line treatment of HER2-positive metastatic GEA, including more mature overall survival data, was accepted for a rapid oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
•The Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous T-DXd treatment continues to enroll patients.
•The Phase 2 pan-tumor trial to evaluate HER2-positive solid tumors continues to enroll patients.
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 Prescription Drug User Fee Act (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.
•Data on the efficacy and safety of dordaviprone from prospective clinical trials of adult and pediatric recurrent H3 K27M-mutant diffuse glioma patients was accepted for an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
Financial Highlights
Three Months Ended
March 31,
(In thousands, except per share amounts) 2025 2024
Total revenues $ 897,841 $ 901,983
GAAP net loss $ (92,541) $ (14,618)
Non-GAAP adjusted net income1
$ 105,233 $ 178,430
GAAP loss per share $ (1.52) $ (0.23)
Non-GAAP adjusted EPS1
$ 1.68 $ 2.63
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1.Commencing with the first quarter of 2025, we are no longer including an adjustment for non-cash interest expense in the Company’s non-GAAP adjusted financial measures and for the purposes of comparability, non-GAAP adjusted financial measures for the first quarter of 2024 have been updated to reflect this change. See "Non-GAAP Financial Measures" below.
GAAP net loss for 1Q25 was $(92.5) million, or $(1.52) per diluted share, compared to $(14.6) million, or $(0.23) per diluted share, for 1Q24.
Non-GAAP adjusted net income for 1Q25 was $105.2 million, or $1.68 per diluted share, compared to $178.4 million, or $2.63 per diluted share, for 1Q24.
The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172.0 million related to certain Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146.3 million (net of tax of $25.7 million) or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended
March 31,
(In thousands) 2025 2024
Xywav $ 344,804 $ 315,300
Xyrem 37,241 64,232
Epidiolex/Epidyolex 217,737 198,716
Sativex 5,407 2,735
Total Neuroscience 605,189 580,983
Rylaze/Enrylaze 94,233 102,750
Zepzelca 63,033 75,100
Defitelio/defibrotide 40,662 47,676
Vyxeos 29,544 32,023
Ziihera 1,975 —
Total Oncology 229,447 257,549
Other 4,782 3,570
Product sales, net 839,418 842,102
High-sodium oxybate AG royalty revenue 48,946 49,947
Other royalty and contract revenues 9,477 9,934
Total revenues $ 897,841 $ 901,983
Total revenues for 1Q25 were in line with 1Q24.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $654.1 million in 1Q25, an increase of 4% compared to $630.9 million in 1Q24. The increase in 1Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales.
Oncology net product sales were $229.4 million in 1Q25, a decrease of 11% compared to $257.5 million in 1Q24. The decrease in 1Q25 was primarily due to lower net product sales of Zepzelca, Rylaze/Enrylaze and Defitelio/defibrotide. In 1Q25, Rylaze net product sales were negatively impacted due to an update to the COG pediatric treatment protocols for ALL, which impacts the timing of asparaginase administration.