Jazz Pharmaceuticals (JAZZ, Financial) has received a significant endorsement from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The committee has issued a positive opinion supporting the conditional marketing authorization of zanidatamab. This investigational therapy is designed as a dual-targeted bispecific antibody aimed at the human epidermal growth factor receptor 2 (HER2) and is intended for use as a monotherapy.
The recommendation targets adult patients with unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) who have previously undergone at least one systemic therapy. This decision is rooted in the results from the Phase 2b HERIZON-BTC-01 trial, which assessed zanidatamab's efficacy in inoperable, advanced cases of HER2-positive BTC that had been previously treated.
This development marks an important step for Jazz Pharmaceuticals as it moves closer to offering a new treatment option for patients with this challenging cancer type. The positive CHMP opinion is a precursor to potential marketing authorization within the European Union.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 15 analysts, the average target price for Jazz Pharmaceuticals PLC (JAZZ, Financial) is $188.93 with a high estimate of $230.00 and a low estimate of $150.00. The average target implies an upside of 73.27% from the current price of $109.04. More detailed estimate data can be found on the Jazz Pharmaceuticals PLC (JAZZ) Forecast page.
Based on the consensus recommendation from 18 brokerage firms, Jazz Pharmaceuticals PLC's (JAZZ, Financial) average brokerage recommendation is currently 1.8, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Jazz Pharmaceuticals PLC (JAZZ, Financial) in one year is $163.94, suggesting a upside of 50.35% from the current price of $109.04. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Jazz Pharmaceuticals PLC (JAZZ) Summary page.
JAZZ Key Business Developments
Release Date: February 25, 2025
- 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.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Jazz Pharmaceuticals PLC (JAZZ, Financial) 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 (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.
