Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance

DUBLIN, Feb. 28, 2024

DUBLIN, Feb. 28, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the full year and fourth quarter of 2023 and provided guidance for 2024.

"2023 was a year of continued strong execution that delivered top- and bottom-line growth and over $3.8 billion in total revenue. Sleep¹ revenue exceeded $1.9 billion, Oncology revenue surpassed $1 billion and Epidiolex remains on track to deliver on its blockbuster potential, demonstrating our progress towards Vision 2025 targets. We also meaningfully advanced our late-stage pipeline and are pleased to note enrollment of the Phase 3 Zepzelca^® trial in first-line small cell lung cancer has been completed," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "Looking to 2024, we expect double-digit percentage revenue growth across combined key growth drivers: Xywav, Epidiolex and Rylaze. We look forward to multiple near-term, late-stage pipeline catalysts and anticipate completing the rolling BLA submission for zanidatamab in second-line biliary tract cancer in the first half of 2024. We expect our disciplined capital allocation to enable investment in our key commercial growth drivers for near-term growth, in our pipeline for long-term growth and to provide flexibility for corporate development."

Key Highlights

• Achieved first $1 billion revenue quarter.
• Key growth drivers:
  • Xywav net product sales grew 33% year-over-year; annualizing² at $1.35 billion.
  • Epidiolex/Epidyolex^® net product sales grew 15% year-over-year; annualizing² at over $900 million.
  • Rylaze net product sales grew 40% year-over-year; annualizing² at over $400 million.
• Initiated zanidatamab 1L BTC confirmatory trial in 1Q24.
• Multiple near-term, late-stage pipeline catalysts anticipated:
  • Completion of rolling BLA submission for accelerated approval in 2L BTC in 1H24.
  • Top-line PFS data from zanidatamab in Phase 3 1L GEA targeted for late 2024.
  • 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 data from Zepzelca 1L SCLC Phase 3 trial at the end of 2024 or early 2025.
• The Company will host a virtual zanidatamab R&D Day on Tuesday, March 19, 2024.
• 2024 total revenue guidance of $4.0 to $4.2 billion, 7% top-line growth at the mid-point.
• Total revenue guidance is underpinned by expectations of continued growth in net sales of Xywav in IH, Epidiolex/Epidyolex, our Oncology therapeutic area, and royalties on net sales of authorized generics of Xyrem^® offset by a continued decline in net sales of Xyrem.

_______________________

1 Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium authorized generic royalty revenues.

2 Based on 4Q23 net product sales. ARIVA.DE Börsen-Geflüster Kurse Jazz Pharmaceuticals 105,025 $ -0,03%

Business Updates

Key Commercial Products

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

• Xywav net product sales increased 33% to $1,273.0 million in 2023 and increased 20% to $337.0 million in 4Q23 compared to the same periods in 2022.
• As the only low-sodium oxybate and the only therapy approved to treat IH, expect Xywav to remain the oxybate of choice.
• There were approximately 12,300 active Xywav patients exiting 4Q23.
• Results from the real-world TENOR study were published in Sleep Medicine. The most common reason cited for switching to Xywav was long-term health benefits due to lower sodium content of Xywav.
• A review of scientific evidence was published in Neurology and Therapy showing oxybate regimens impart substantial and highly similar medical benefit on subjective and objective measures of sleep and daytime function regardless of dosing.

Xywav for Narcolepsy:

• There were approximately 9,525 narcolepsy patients taking Xywav exiting 4Q23.

Xywav for Idiopathic Hypersomnia (IH):

• There were approximately 2,775 IH patients taking Xywav exiting 4Q23.

Xyrem (sodium oxybate) oral solution:

• Xyrem net product sales decreased 44% to $569.7 million in 2023 and decreased 57% to $106.7 million in 4Q23 compared to the same periods in 2022.

High-Sodium Oxybate Authorized Generic (AG) Royalties:

• Royalties from high-sodium oxybate AGs were $75.9 million in 2023 and $39.4 million in 4Q23.
• The Company expects high-sodium oxybate AG royalty revenue to exceed $200 million in 2024, which reflects an increase in the fixed-rate royalty structures of the AG agreements in 2024.

Epidiolex/Epidyolex (cannabidiol):

• Epidiolex/Epidyolex net product sales increased 15% to $845.5 million in 2023 and increased 16% to $240.6 million in 4Q23 compared to the same periods in 2022.
• Outside of the U.S., Epidyolex is approved in more than 35 countries with additional launches and reimbursement anticipated through the end of 2024.
• Long-term and real-world data of treatment-resistant epilepsy were presented at AES 2023:
  • Data from long-term Expanded Access Program study demonstrated Epidiolex was associated with a sustained reduction in treatment-resistant, focal-onset seizures through 144 weeks.
  • Interim results from the BECOME-TSC survey of caregivers of patients with tuberous sclerosis complex (TSC) demonstrated improved day-to-day function, cognition, language and communication and emotional and social function in patients.

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

• Rylaze net product sales increased 40% to $394.2 million in 2023 and increased 26% to $101.7 million in 4Q23 compared to the same periods in 2022.
• Initiated European rolling launch of Enrylaze (JZP458; a recombinant Erwinia asparaginase or crisantaspase), marketed as Rylaze in the U.S. and Canada, in 4Q23.

Zepzelca (lurbinectedin): 

• Zepzelca net product sales increased 7% to $289.5 million in 2023 and increased 3% to $74.0 million in 4Q23 compared to the same periods in 2022.
• 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, is complete; expect top-line progression-free survival (PFS) data readout at the end of 2024 or early 2025.

Key Pipeline Highlights

Zanidatamab:

• Initiated the zanidatamab rolling biologics license application (BLA) submission in 4Q23 for accelerated approval in second-line (2L) biliary tract cancer (BTC) and expect to complete the rolling submission 1H24.
• Initiated confirmatory trial in 1L metastatic BTC, where there remains unmet patient need, in 1Q24.
• 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 increased enrollment in the trial from 714 to 918 to improve statistical power for overall survival analysis, while maintaining PFS top-line readout.
• Data presented at SABCS in heavily pretreated patients with HER2+/HR+ metastatic breast cancer demonstrated 67% PFS at six months with a median PFS of 12 months.
• In addition to achieving clinically meaningful improvements, data presented at the ASCO Gastrointestinal Cancers Symposium in January 2024 demonstrated that patients who responded to zanidatamab also reported improved quality of life with less pain interference in the Phase 2b HERIZON-BTC-01 trial.

Suvecaltamide (JZP385):

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

JZP898:

• Initiated a Phase 1 first-in-human clinical trial in solid tumors in 4Q23.

Corporate Development

KRAS Inhibitor Program Agreement:

• In February 2024, the Company acquired Redx Pharma's KRAS inhibitor program, which includes G12D selective and pan-KRAS molecules, further expanding Jazz's early-stage oncology pipeline.

Ion Channel Targets Agreement:

• In November 2023, the Company and Autifony announced an exclusive global license and collaboration agreement to discover and develop drug candidates for two different ion channel targets associated with neurological disorders.

Continued Repurchases under Previously Announced $1.5 Billion Share Repurchase Program

The Company continued repurchases of its ordinary shares on the open market in the fourth quarter of 2023 as part of its previously authorized and announced share repurchase program. As of December 31, 2023, approximately $161 million remained available and authorized for share repurchases, after the purchase of approximately $100 million of shares during the fourth quarter of 2023. The timing and amount of repurchases under the program will depend on a variety of factors, including the price of the Company's ordinary shares, alternative investment opportunities, restrictions under the Company's credit agreement, corporate and regulatory requirements and market conditions.

Financial Highlights

GAAP net income for 2023 was $414.8 million, or $6.10 per diluted share, compared to a GAAP net loss of $(224.1) million, or $(3.58) per diluted share, for 2022. GAAP net income for 4Q23 was $94.2 million, or $1.42 per diluted share, compared to a GAAP net loss of $(240.7) million, or $(3.82) per diluted share, for 4Q22. 

Non-GAAP adjusted net income for 2023 was $1,295.8 million, or $18.29 per diluted share, compared to $933.6 million, or $13.20 per diluted share, for 2022. Non-GAAP adjusted net income for 4Q23 was $345.3 million, or $5.02 per diluted share, compared to a Non-GAAP adjusted net loss of $(4.2) million, or $(0.07) per diluted share, for 4Q22. 

Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues

	Three Months Ended December 31,				Year Ended December 31,
(In thousands)	2023		2022		2023		2022
Xywav	$      337,019		$      281,384		$   1,272,977		$      958,425
Xyrem	106,721		247,496		569,730		1,020,453
Epidiolex/Epidyolex	240,622		206,998		845,468		736,398
Sativex	5,137		4,721		19,668		16,825
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