• Total Annual Revenue: Over $4 billion for 2024.
• Fourth Quarter Revenue: Nearly $1.1 billion, highest ever for the company.
• Adjusted Net Income (Non-GAAP): $1.37 billion for 2024.
• Cash from Operations: Approximately $1.4 billion for 2024.
• Cash on Hand: $3 billion at the end of 2024.
• Xywav Net Product Sales: $401 million in Q4 2024, $1.5 billion for the full year, up 16% year-over-year.
• Epidiolex Net Product Sales: $275 million in Q4 2024, $972 million for the full year, up 15% year-over-year.
• Oncology Revenue: Grew 9% in 2024 to over $1.1 billion.
• Rylaze Net Product Sales: $101 million in Q4 2024, $411 million for the full year, up 4% year-over-year.
• Zepzelca Net Product Sales: $78 million in Q4 2024, $320 million for the full year, up 11% year-over-year.
• Ziihera Net Product Sales: Approximately $1 million in Q4 2024.
• 2025 Revenue Guidance: $4.15 billion to $4.4 billion, representing 5% growth at the midpoint.
• Non-GAAP Adjusted SG&A Guidance for 2025: $1.25 billion to $1.31 billion.
• Non-GAAP Adjusted R&D Guidance for 2025: $720 million to $770 million, an 8% decrease from 2024.
• Adjusted Net Income Guidance for 2025: $1.4 billion to $1.5 billion.

• Warning! GuruFocus has detected 7 Warning Signs with JAZZ.

Release Date: February 25, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) reported a record year in 2024 with over $4 billion in total annual revenue and nearly $1.1 billion in fourth-quarter revenue.
• The company achieved several important R&D milestones, including the accelerated approval of Ziihera in the U.S. for second-line HER2-positive biliary tract cancer.
• Epidiolex net product revenues grew 15% in 2024 compared to 2023, and it is poised to reach blockbuster status in 2025.
• The oncology portfolio grew 9% in 2024 to a record of more than $1.1 billion, despite temporary impacts from changes to pediatric protocols.
• Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) achieved its 2024 guidance, delivering top-line growth at the upper end of its range and $1.37 billion in adjusted net income on a non-GAAP basis.

Negative Points

• The company faces potential revenue erosion from Xyrem due to the entry of high sodium fixed-dose, branded oxybate, and authorized generic competition.
• Rylaze's revenue was temporarily impacted by changes to pediatric protocols, affecting its performance in the second half of 2024.
• The HERIZON-GEA-01 Phase III trial data readout for zanidatamab in first-line gastroesophageal adenocarcinoma has been delayed to the second half of 2025.
• There is uncertainty regarding the impact of true generic Xyrem on Xywav revenue, which depends on several factors, including the recognition of the value of low sodium by HCPs, patients, and payers.
• The company anticipates modest revenues from Ziihera due to the small BTC patient population, although a successful launch is key for future growth opportunities.

Q & A Highlights

Q: Can you provide an update on the orexin 441 trial and the Epidiolex patent settlement? A: Bruce Cozadd, CEO, stated that the Epidiolex settlements with all 10 ANDA filers extend to the very late 2030s, but confidentiality provisions limit further details. Robert Iannone, EVP, Global Head of R&D, mentioned that there are no updates on the orexin 441 trial yet, but they expect it to help define a better therapeutic index.

Q: For the HERIZON-GEA trial, can you confirm the enrollment numbers and comment on the event rate's impact on the trial's success probability? A: Robert Iannone confirmed that they are completing enrollment for the upsized 918 patient target. The slower accrual of events could indicate a significant effect from the experimental arms, but they remain blinded to the results. The control arm has been consistent across similar trials, so no surprises are expected there.

Q: Why hasn't Jazz Pharmaceuticals engaged in significant M&A since the GW acquisition, and how does the Epidiolex patent settlement affect future M&A strategy? A: Bruce Cozadd explained that after the GW acquisition, they focused on reducing leverage, which limited larger transactions. The zanidatamab transaction was a significant focus. Philip Johnson, CFO, added that they have delevered significantly and are actively looking for opportunities in their verticals, including epilepsy, to build growth prospects.

Q: What are the expectations for Zepzelca's performance and potential guideline inclusion for the first-line maintenance indication? A: Renee Gala, COO, noted that Zepzelca had strong performance despite fewer buying days in Q4. They plan to file for first-line extensive-stage small cell lung cancer in the first half of the year and hope to get on treatment guidelines once data is available. They expect growth in Zepzelca but will not promote first-line use until approval.

Q: Can you provide an update on the CEO search and how it might impact M&A strategy? A: Bruce Cozadd stated that the CEO search is ongoing, and they are not in a hurry, focusing on making the right choice. The company is well-positioned for M&A with strong operating results and financial resources, ready to leverage infrastructure and add growth opportunities.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.