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Business Insider
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Jazz Pharmaceuticals presents late-breaking phase 4 data showcasing Xywav
Jazz Pharmaceuticals (JAZZ) 'announced late-breaking Phase 4 data evaluating treatment benefits of Xywav oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies. Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.' Confident Investing Starts Here:
Yahoo
7 hours ago
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Jazz Pharmaceuticals Presents Late-Breaking Phase 4 Data Showcasing Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution Treatment Outcomes in Narcolepsy at SLEEP 2025
First presentation of the Phase 4 XYLO switch study reports blood pressure reductions in patients with narcolepsy when switching from twice-nightly high- to low-sodium oxybate Novel intermediate analysis from the DUET trial cohort of patients taking >9 grams evaluated safety and changes in daytime sleepiness in adults with narcolepsy taking Xywav dosages of 9-12 grams per night For U.S. media and investors only DUBLIN, June 9, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced late-breaking Phase 4 data evaluating treatment benefits of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies (APSS). Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night. "People living with narcolepsy have an increased risk of developing cardiovascular and cardiometabolic comorbidities," said Richard J. Kovacs, MD, MACC, Chief Medical Officer, American College of Cardiology and Q.E. and Sally Russell Professor of Cardiology, Indiana University School of Medicine, and XYLO Steering Committee member. "Results from the XYLO study reinforce the importance of monitoring cardiovascular indicators, including blood pressure, and the need to minimize exposure to excess sodium in this at-risk population. Reducing cardiovascular risk and disease is an important goal for all healthcare providers." "People with narcolepsy live with a complex, severe disorder and often must combat excessive daytime sleepiness and associated symptoms — but the challenges they face are not only limited to sleep," said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. "Results from the XYLO interim analysis add to the overwhelming body of evidence demonstrating the positive implications of limiting unnecessary sodium intake, and emphasize how choosing low-sodium oxybate, Xywav, rather than twice-nightly high-sodium oxybate helps reduce excessive sodium burden, a modifiable risk factor for cardiovascular disease, in people with narcolepsy." Phase 4 XYLO Results Show Impact of Switching from Twice-Nightly High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People with NarcolepsyThe open-label, single arm Phase 4 XYLO switch trial (n=43) met its primary endpoint of change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline (taking twice-nightly high-sodium oxybate) to end-of-treatment (after six weeks on low-sodium oxybate, Xywav), with a −4.1 (−6.9, −1.4; P=0.0019) mmHg change. These results show that switching from twice-nightly high-sodium oxybate to the same dosage of low-sodium oxybate, Xywav, for approximately 6 weeks reduced daily treatment-related sodium intake and was associated with clinically meaningful blood pressure reductions in participants with narcolepsy, which was paralleled by 24-hour urinary sodium reduction. XYLO results are consistent with the extensive body of evidence on the benefits of reducing sodium intake. The study also achieved key secondary endpoints, including mean change in ambulatory daytime SBP (-5.1 mmHg; P=0.0003) and mean change in seated resting (in-office) SBP (-9.2 mmHg; (P<0.0001). The change in mean nighttime ambulatory SBP was −2.0 (P=0.1265) mmHg. Exploratory endpoints evaluated change in 24-hour, daytime ambulatory, seated resting, and nighttime ambulatory diastolic blood pressure. Overall, treatment-emergent adverse events (TEAEs) occurred in 32.8% of participants and were all mild or moderate in severity and consistent with the known safety profile of Xywav. Phase 4 DUET Data Evaluated Effectiveness and Safety of Xywav in Adults with Narcolepsy Taking Dosages of 9-12 GramsThis intermediate analysis, which evaluates a cohort of adults with narcolepsy from the DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, demonstrated improvements in EDS on the Epworth Sleepiness Scale, the study's primary endpoint, in 24 participants taking 9-12 grams of Xywav twice-nightly, as compared to 9 grams at baseline. The current recommended dosage of Xywav for adults with narcolepsy is 6-9 grams per night. Following dose optimization, the average Xywav dose during the stable-dose period was 11.2 g/night. Participants with narcolepsy in this intermediate cohort analysis also experienced improvements on the Narcolepsy Severity Scale. Additionally, participants showed minimal changes in the number of central apnea events, mean oxygen saturation (SpO2) levels, or the mean percent of total sleep time with SpO2 <90% from BL to EOT. The DUET trial is a Phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on EDS, polysomnography parameters, and functional outcomes in adults with narcolepsy or IH. Overall, TEAEs were all mild or moderate and consistent with the known safety profile of Xywav at lower dosages. The full abstracts will be available online at About NarcolepsyNarcolepsy is a chronic, debilitating neurologic sleep disorder characterized by the inability to maintain continuous sleep at night and sustained wakefulness throughout the day. This leads to symptoms that can include fragmented or disrupted nighttime sleep, excessive daytime sleepiness, and cataplexy.1 Patients with EDS due to narcolepsy experience sleep attacks, called cataplexy, and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.2,3 These sleep attacks may happen at inappropriate or potentially dangerous times such as during driving, cycling, eating, or mid-conversation.4 There is no cure for narcolepsy, therefore this EDS is lifelong and has a substantial negative impact on a person's ability to function psychologically, socially and professionally.5 Patients with narcolepsy are at increased risk for hypertension, cardiometabolic morbidity, stroke, myocardial infarction, heart failure, cardiac arrest, and death.6,7,8,9 As narcolepsy is a chronic condition that requires lifelong, nightly treatment, early access to an effective, low-sodium treatment can transform lives and reduce the impact of narcolepsy on a person's physical and mental health.5 About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solutionXywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1640 mg at the equivalent dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night. Xywav is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake. Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults. The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.10 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.10,11 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS. Important Safety Information for Xywav WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. Central Nervous System DepressionXYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving CNS stimulants. Abuse and MisuseThe active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS. ContraindicationsXYWAV is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Warnings and PrecautionsCentral Nervous System DepressionThe concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered. After first initiating treatment and until certain that XYWAV does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter. Abuse and MisuseXYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely. XYWAV and XYREM REMSBecause of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS. Notable requirements of the XYWAV and XYREM REMS include the following: Healthcare Providers who prescribe XYWAV are specially certified XYWAV will be dispensed only by the central pharmacy that is specially certified XYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use Further information is available at or 1-866-997-3688. Respiratory Depression and Sleep-Disordered BreathingXYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy. Depression and SuicidalityIn Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required. In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment. Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality while taking XYWAV. Other Behavioral or Psychiatric Adverse ReactionsIn Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV. In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV. Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored. ParasomniasParasomnias can occur in patients taking XYWAV. In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively. In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Most Common Adverse ReactionsThe most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM. Additional Adverse ReactionsAdverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability. Adverse reactions that occurred in ≥2% of patients in clinical studies with oxybate (but not in Study 1) and which may be relevant for XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation. Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB RWP) (up to 42 weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment. In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache). Drug InteractionsXYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of XYWAV. Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of XYWAV and divalproex sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with divalproex sodium. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of XYWAV and divalproex sodium is warranted. Pregnancy and LactationThere are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. XYWAV should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant from XYWAV or from the underlying maternal condition. Pediatric UseThe safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers. Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established. Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established. Geriatric UseIn general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hepatic ImpairmentThe starting dose of XYWAV should be reduced in patients with liver impairment. Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses. Dependence and ToleranceThere have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required. In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV. Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen. Please see full Prescribing Information, including BOXED Warning here: About Jazz PharmaceuticalsJazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Contacts: Media:Kristin BhavnaniHead of Global Corporate CommunicationsJazz Pharmaceuticals plcCorporateAffairsMediaInfo@ Ireland +353 1 637 2141U.S. +1 215 867 4948 Investors:Jeff MacdonaldExecutive Director, Investor RelationsJazz Pharmaceuticals plcInvestorInfo@ +353 1 634 3211U.S. +1 650 496 2717 References: Sateia, M. J. (2023). International Classification of Sleep Disorders-Third Edition, Text Revision (ICSD-3-TR). Chest, 146(5), 1387–1394. PubMed. Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007;369(9560):499-511. Colten HR, Altevogt BM, Institute of Medicine (US) Committee on Sleep Medicine and Research, eds. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006. Peacock J, Benca RM. Narcolepsy: clinical features, co-morbidities & treatment. Indian Journal of Medical Research. 2010;131(2):338-349. National Health Service. Narcolepsy – Overview. 2019. Accessed June 2025. Ben-Joseph RH, Saad R, Black J, et al. Cardiovascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1203. Black J, Reaven NL, Funk SE, et al. Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease (BOND) study. Sleep Med. 2017;33:13-18. Ohayon MM, Black J, Lai C, et al. Increased mortality in narcolepsy. Sleep. 2014;37(3):439-444. Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013;14(6):488-492. Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021. United States Drug Enforcement Agency. Drug Scheduling. Accessed June 2025. View original content to download multimedia: SOURCE Jazz Pharmaceuticals plc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
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JAZZ Q1 Earnings Call: Revenue and Profit Miss, Product Pipeline Drives Outlook
Biopharma company Jazz Pharmaceuticals (NASDAQ:JAZZ) fell short of the market's revenue expectations in Q1 CY2025, with sales flat year on year at $897.8 million. On the other hand, the company's outlook for the full year was close to analysts' estimates with revenue guided to $4.28 billion at the midpoint. Its non-GAAP profit of $1.68 per share was 63.9% below analysts' consensus estimates. Is now the time to buy JAZZ? Find out in our full research report (it's free). Revenue: $897.8 million vs analyst estimates of $986.6 million (flat year on year, 9% miss) Adjusted EPS: $1.68 vs analyst expectations of $4.66 (63.9% miss) Adjusted EBITDA: $206.5 million vs analyst estimates of $399.6 million (23% margin, 48.3% miss) The company reconfirmed its revenue guidance for the full year of $4.28 billion at the midpoint Management lowered its full-year Adjusted EPS guidance to $4.80 at the midpoint, a 79.4% decrease Operating Margin: -6.2%, down from 7.3% in the same quarter last year Free Cash Flow Margin: 46.3%, up from 28.9% in the same quarter last year Market Capitalization: $6.72 billion Jazz Pharmaceuticals' first quarter results reflected a flat revenue performance and significant shortfall on non-GAAP earnings relative to Wall Street expectations. Management attributed this outcome primarily to strong demand in the neuroscience portfolio, particularly Xywav and Epidiolex, which offset near-term headwinds in oncology products such as Rylaze and Zepzelca. CEO Bruce Cozadd highlighted execution on commercial efforts, stating the company remains 'confident in the blockbuster potential' of Epidiolex and is seeing 'continued momentum' for Xywav, especially in idiopathic hypersomnia. For the remainder of the year, management's guidance is anchored by anticipated regulatory milestones and commercial launches in oncology. The company's strategy includes leveraging recent acquisitions, such as Chimerix, to expand its rare oncology presence and prepare for upcoming product launches like Dordaviprone. Management also addressed ongoing litigation settlements and tariff risks, noting that inventory planning and flexible manufacturing are expected to minimize impacts for 2025. Jazz Pharmaceuticals' Q1 performance was shaped by mixed trends across its portfolio, with neuroscience products showing growth and oncology products experiencing headwinds. Several strategic actions—including a major acquisition and regulatory filings—also influenced the quarter's results and future positioning. Neuroscience Portfolio Growth: Xywav and Epidiolex led revenue growth, with Xywav patient additions driven by targeted disease education campaigns and Epidiolex benefiting from expanded use in adult and long-term care settings. Management emphasized Xywav's status as the only FDA-approved therapy for idiopathic hypersomnia, supporting market expansion. Oncology Pressure and Pipeline: The oncology portfolio saw declines, primarily due to protocol changes affecting Rylaze and competitive dynamics for Zepzelca. Management expects normalization of Rylaze revenue and highlighted upcoming data presentations for Zepzelca's first-line use, which could shift its growth trajectory if included in treatment guidelines. Chimerix Acquisition and Dordaviprone Launch: The acquisition of Chimerix added Dordaviprone, a therapy for rare brain tumors, to the pipeline. Management described Dordaviprone as a "meaningful and durable revenue opportunity" due to its potential frontline use and patent protection into 2037. Supply Chain and Tariff Preparedness: Jazz outlined its extensive manufacturing footprint in the U.S. and Europe, noting that diversified supply and inventory management should mitigate the impact of enacted and potential tariffs for the rest of the year. Strategic R&D Progress: Multiple regulatory milestones are on the horizon, including FDA and European reviews for new oncology indications. Upcoming data from pivotal trials in HER2-positive cancers and the anticipated launch of Dordaviprone are expected to be key product catalysts. Looking ahead, Jazz's guidance relies on continued neuroscience portfolio growth and the successful advancement of its oncology pipeline, while also navigating cost pressures and regulatory developments. Oncology Regulatory Milestones: Management believes that data readouts and regulatory decisions for products like Dordaviprone and zanidatamab will be critical to expanding the oncology business and supporting revenue growth. Neuroscience Market Expansion: The company expects further demand for Xywav, especially in idiopathic hypersomnia, to drive patient growth, while Epidiolex is positioned to achieve blockbuster status through expanded indications and access initiatives. Tariff and Litigation Risks: While management downplayed tariff impacts for 2025 due to inventory and manufacturing flexibility, future regulatory changes or litigation expenses remain uncertainties that could affect margins and adjusted earnings. Jason Gerberry (Bank of America): Asked about Xywav's supply chain resilience if tariffs escalate, with management confirming U.S. manufacturing capacity can supply the domestic market and minimize tariff risk. Jessica Fye (JP Morgan): Inquired about Jazz's overall manufacturing footprint and contingency plans for biopharma tariffs, with management highlighting geographic diversification and a strategy of building U.S. inventory. David Amsellem (Piper Sandler): Questioned the long-term outlook for Zepzelca in the face of new competition, with executives citing upcoming first-line data as potentially expanding its patient base and duration of therapy. Annabel Samimy (Stifel): Sought updates on Rylaze's adoption in adolescent and young adult segments, with management acknowledging slow but steady momentum and confidence in normalization by next quarter. Joseph Thome (TD Cowen): Asked about Dordaviprone's Phase III trial status and regulatory review, with Jazz noting ongoing enrollment outside the U.S. and no current issues with the FDA review timeline. In the coming quarters, the StockStory team will watch for (1) pivotal data releases for zanidatamab in HER2-positive gastroesophageal cancer, (2) the FDA's decision on Dordaviprone and progress in its confirmatory frontline trial, and (3) signs of sustained growth in Xywav and Epidiolex patient populations. Successful integration of Chimerix and the impact of evolving tariff policies will also be important to monitor as the year progresses. Jazz Pharmaceuticals currently trades at a forward P/E ratio of 4.7×. Should you load up, cash out, or stay put? See for yourself in our free research report. Donald Trump's victory in the 2024 U.S. Presidential Election sent major indices to all-time highs, but stocks have retraced as investors debate the health of the economy and the potential impact of tariffs. While this leaves much uncertainty around 2025, a few companies are poised for long-term gains regardless of the political or macroeconomic climate, like our Top 9 Market-Beating Stocks. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Tecnoglass (+1,754% five-year return). Find your next big winner with StockStory today. 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Yahoo
07-05-2025
- Business
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Jazz Pharmaceuticals (NASDAQ:JAZZ) Misses Q1 Sales Targets
Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Jazz Pharmaceuticals's recent performance shows its demand has slowed as its annualized revenue growth of 4.3% over the last two years was below its five-year trend. A company's long-term sales performance is one signal of its overall quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Luckily, Jazz Pharmaceuticals's sales grew at a solid 13.2% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Originally founded in 2003 and now headquartered in Ireland following a 2012 tax inversion merger, Jazz Pharmaceuticals (NASDAQGS:JAZZ) develops and markets medicines for sleep disorders, epilepsy, and cancer, with a focus on treatments for patients with limited therapeutic options. "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. Operating Margin: -6.2%, down from 7.3% in the same quarter last year The company reconfirmed its revenue guidance for the full year of $4.28 billion at the midpoint Is now the time to buy Jazz Pharmaceuticals? Find out in our full research report . Biopharma company Jazz Pharmaceuticals (NASDAQ:JAZZ) fell short of the market's revenue expectations in Q1 CY2025, with sales flat year on year at $897.8 million. On the other hand, the company's outlook for the full year was close to analysts' estimates with revenue guided to $4.28 billion at the midpoint. Its non-GAAP profit of $1.68 per share was 63.9% below analysts' consensus estimates. Story Continues Jazz Pharmaceuticals Year-On-Year Revenue Growth This quarter, Jazz Pharmaceuticals missed Wall Street's estimates and reported a rather uninspiring 0.5% year-on-year revenue decline, generating $897.8 million of revenue. Looking ahead, sell-side analysts expect revenue to grow 6.4% over the next 12 months, an improvement versus the last two years. This projection is above average for the sector and implies its newer products and services will spur better top-line performance. Software is eating the world and there is virtually no industry left that has been untouched by it. That drives increasing demand for tools helping software developers do their jobs, whether it be monitoring critical cloud infrastructure, integrating audio and video functionality, or ensuring smooth content streaming. Click here to access a free report on our 3 favorite stocks to play this generational megatrend. Operating Margin Operating margin is an important measure of profitability as it shows the portion of revenue left after accounting for all core expenses – everything from the cost of goods sold to advertising and wages. It's also useful for comparing profitability across companies with different levels of debt and tax rates because it excludes interest and taxes. Jazz Pharmaceuticals has done a decent job managing its cost base over the last five years. The company has produced an average operating margin of 11%, higher than the broader healthcare sector. Analyzing the trend in its profitability, Jazz Pharmaceuticals's operating margin decreased by 15.3 percentage points over the last five years, but it rose by 15.3 percentage points on a two-year basis. Still, shareholders will want to see Jazz Pharmaceuticals become more profitable in the future. Jazz Pharmaceuticals Trailing 12-Month Operating Margin (GAAP) This quarter, Jazz Pharmaceuticals generated an operating profit margin of negative 6.2%, down 13.6 percentage points year on year. This contraction shows it was less efficient because its expenses increased relative to its revenue. Earnings Per Share We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. Jazz Pharmaceuticals's EPS grew at a remarkable 9.2% compounded annual growth rate over the last five years. However, this performance was lower than its 13.2% annualized revenue growth, telling us the company became less profitable on a per-share basis as it expanded. Jazz Pharmaceuticals Trailing 12-Month EPS (Non-GAAP) We can take a deeper look into Jazz Pharmaceuticals's earnings to better understand the drivers of its performance. As we mentioned earlier, Jazz Pharmaceuticals's operating margin declined by 15.3 percentage points over the last five years. Its share count also grew by 9%, meaning the company not only became less efficient with its operating expenses but also diluted its shareholders. Jazz Pharmaceuticals Diluted Shares Outstanding In Q1, Jazz Pharmaceuticals reported EPS at $1.68, down from $2.68 in the same quarter last year. This print missed analysts' estimates, but we care more about long-term EPS growth than short-term movements. Over the next 12 months, Wall Street expects Jazz Pharmaceuticals's full-year EPS of $20.19 to grow 15.8%. Key Takeaways from Jazz Pharmaceuticals's Q1 Results We struggled to find many positives in these results as it lowered its full-year EPS guidance and missed on revenue and EPS. Overall, this quarter could have been better. The stock traded down 3.2% to $107.50 immediately following the results. Jazz Pharmaceuticals didn't show it's best hand this quarter, but does that create an opportunity to buy the stock right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free.
