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Mittwoch, 01.05.2024 16:05 von PR Newswire | Aufrufe: 139

Jazz Pharmaceuticals Announces First Quarter 2024 Financial Results and Affirms 2024 Financial Guidance

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PR Newswire

DUBLIN, May 1, 2024

– 12% year-over-year revenue increase from combined key growth drivers: Xywav^®, Epidiolex^®and Rylaze^® –
– Oncology revenues grew 13% year-over-year –
– Submitted zanidatamab BLA for 2L BTC; expect to launch in 2025 or earlier –
– Top-line Phase 2b data from suvecaltamide trial in essential tremor expected in late 1H24 –
– 2024 total revenue guidance affirmed at $4.0 to $4.2 billion –

DUBLIN, May 1, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2024 and affirmed guidance for 2024.

"In the first quarter of 2024, we delivered combined double-digit year-over-year growth from our key growth drivers: Xywav, Epidiolex and Rylaze. We also significantly advanced our zanidatamab program with the completion of the BLA for 2L BTC," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We believe the robust growth in patients benefitting from Xywav underscores the appreciation physicians and patients have for the long-term health benefits of reducing sodium and expect Xywav to remain the oxybate of choice. We see continued demand for Rylaze as the only non-E. coli asparaginase regimen that provides sustained activity throughout the course of treatment, and we expect continued growth of Epidiolex to be driven by geographic expansion, optimized dosing and data demonstrating its beyond-seizure benefits. Growing and durable revenues from Xywav, Epidiolex and Rylaze, coupled with our pipeline progress, drive our confidence in delivering on our guidance and objectives for 2024."

Key Highlights

Key growth drivers:
- Xywav net product sales grew 14% year-over-year.
- Epidiolex/Epidyolex^® net product sales grew 5% year-over-year.
- Rylaze/Enrylaze^® net product sales grew 20% year-over-year.
Zanidatamab:
- Completed the zanidatamab BLA submission seeking accelerated approval in 2L BTC.
- Updated data with longer follow-up, including overall survival (OS) findings, from the HERIZON-BTC-01 trial will be presented at ASCO Annual Meeting 2024.
- Plan to initiate Phase 3 EMPOWHER trial in late-line HER2+ breast cancer in 2H24.
Multiple near-term, late-stage pipeline catalysts anticipated:
- Suvecaltamide top-line data from Phase 2b trial in ET in late 1H24.
- Top-line data from Epidyolex Phase 3 trial in Japan in 2H24.
- Top-line PFS data from zanidatamab in Phase 3 1L GEA targeted for late 2024.
- Top-line data from Zepzelca^® 1L SCLC Phase 3 trial at the end of 2024 or early 2025.
Affirmed 2024 total revenue guidance of $4.0 to $4.2 billion.

Business Updates

Key Commercial Products

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

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Xywav net product sales increased 14% to $315.3 million in 1Q24 compared to the same period in 2023.
As the only low-sodium oxybate and the only therapy approved to treat idiopathic hypersomnia (IH), expect Xywav to remain the oxybate of choice.
There were approximately 12,950 active Xywav patients exiting 1Q24, with 275 net patient adds in IH.
Data presented at 2024 AAN Annual Meeting demonstrated the real-world impacts of Xywav:
- Results from the RHYTHM study demonstrated patients with IH experienced higher odds of comorbid conditions across multiple clinical categories, including cardiovascular conditions.
- A review of five clinical studies evaluating the impact of once- and twice-nightly oxybates on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy found oxybate was effective in improving these measures regardless of dosing.

Xywav for Narcolepsy:

There were approximately 9,900 narcolepsy patients taking Xywav exiting 1Q24.

Xywav for Idiopathic Hypersomnia (IH):

There were approximately 3,050 IH patients taking Xywav exiting 1Q24.

Xyrem^® (sodium oxybate) oral solution:

Xyrem net product sales decreased 64% to $64.2 million in 1Q24 compared to the same period in 2023.

High-Sodium Oxybate Authorized Generic (AG) Royalties:

Royalties from high-sodium oxybate AGs were $49.9 million in 1Q24.
The Company expects high-sodium oxybate AG royalty revenue to exceed $200 million in 2024.

Epidiolex/Epidyolex (cannabidiol):

Epidiolex/Epidyolex net product sales increased 5% to $198.7 million in 1Q24 compared to the same period in 2023. Epidiolex/Epidyolex growth was negatively affected by inventory drawdown in 1Q24.
Outside of the U.S., Epidyolex is approved in more than 35 countries with additional launches and reimbursements anticipated through the end of 2024.
Long-term and real-world data of treatment-resistant epilepsy were presented at 2024 ANN Annual Meeting:
- Data from a long-term Expanded Access Program study demonstrated Epidiolex was associated with a sustained reduction in treatment-resistant, focal-onset seizures through 144 weeks, with an acceptable safety profile.
- Updated interim results of seizure and non-seizure outcomes from the BECOME-TSC survey of caregivers of patients with tuberous sclerosis complex (TSC) reported improvements in seizure frequency and severity and in cognition, language and communication in patients.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):

Rylaze/Enrylaze net product sales increased 20% to $102.8 million in 1Q24 compared to the same period in 2023.

Zepzelca (lurbinectedin):

Zepzelca net product sales increased 12% to $75.1 million in 1Q24 compared to the same period in 2023.
Enrollment in the Phase 3 trial evaluating first-line (1L) use of Zepzelca in combination with Tecentriq^® (atezolizumab) in small cell lung cancer, in partnership with Roche, was completed in 1Q24; expect top-line progression-free survival (PFS) data readout at the end of 2024 or early 2025.

Key Pipeline Highlights

Zanidatamab:

Completed the zanidatamab biologics license application (BLA) seeking accelerated approval from the U.S. FDA for second-line (2L) biliary tract cancer (BTC). If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S.
The Company's plans to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA) are proceeding.
Updated data with longer follow-up, including OS findings, from the HERIZON-BTC-01 trial will be presented at the ASCO Annual Meeting 2024.
A confirmatory trial in 1L metastatic BTC is ongoing.
The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is ongoing and the Company is targeting top-line PFS data in late 2024.
The Company plans to initiate a Phase 3 trial, EMPOWHER, in the second half of 2024 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.

Suvecaltamide (JZP385):

Enrollment was completed in the Phase 2b essential tremor (ET) trial in 1Q24; top-line data readout is anticipated late 1H24.
A Phase 2 trial in patients with Parkinson's disease tremor is ongoing.

Financial Highlights

	Three Months Ended March 31,
(In thousands, except per share amounts)	2024	2023
Total revenues	$ 901,983	$ 892,812
GAAP net income (loss)	$ (14,618)	$ 69,420
Non-GAAP adjusted net income	$ 182,215	$ 285,261
GAAP earnings (loss) per share	$ (0.23)	$ 1.04
Non-GAAP adjusted EPS	$ 2.68	$ 3.95

GAAP net loss for 1Q24 was $(14.6) million, or $(0.23) per diluted share, compared to a GAAP net income of $69.4 million, or $1.04 per diluted share, for 1Q23.

Non-GAAP adjusted net income for 1Q24 was $182.2 million, or $2.68 per diluted share, compared to a Non-GAAP adjusted net income of $285.3 million, or $3.95 per diluted share, for 1Q23.

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)	2024	2023
Xywav	$ 315,300	$ 277,761
Xyrem	64,232	178,130
Epidiolex/Epidyolex	198,716	188,909
Sativex	2,735	7,098
Total Neuroscience	580,983	651,898
Rylaze/Enrylaze	102,750	85,927
Zepzelca	75,100	67,181
Defitelio/defibrotide	47,676	39,079
Vyxeos	32,023	36,700
Total Oncology	257,549	228,887
Other	3,570	3,434
Product sales, net	842,102	884,219
High-sodium oxybate AG royalty revenue	49,947	2,096
Other royalty and contract revenues	9,934	6,497
Total revenues	$ 901,983	$ 892,812

Total revenues increased 1% in 1Q24 compared to the same period in 2023, driven by higher Oncology product sales of 13%, primarily due to continued growth in Rylaze/Enrylaze, which increased 20% to $102.8 million in 1Q24 compared to the same period in 2023, partially offset by lower neuroscience revenues. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, of $630.9 million decreased in 1Q24 compared to the same period in 2023, primarily due to decreased Xyrem revenues, reflecting the adoption of Xywav by existing Xyrem patients, high-sodium oxybate competition and changes to formulary coverage, partially offset by increased royalty revenue received on net sales of high-sodium oxybate AG products and increased Xywav and Epidiolex/Epidyolex net product sales.

Operating Expenses and Effective Tax Rate

Three Months Ended

March 31,

(In thousands, except percentages)

2024

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