• Fourth Quarter Revenue: $391.1 million, an increase of 10.5% year over year.
• Full Year Revenue: $1.534 billion, an increase of 18.3% year over year.
• PYLARIFY Sales (Q4): $266 million, up 15.7% year over year.
• PYLARIFY Full Year Sales: $1.058 billion, an increase of 24.3% year over year.
• DEFINITY Sales (Q4): $86.2 million, up 17.9% year over year.
• DEFINITY Full Year Revenue: $317.8 million, up 13.6% year over year.
• Gross Profit Margin (Q4): 68%, consistent with the full year result of 68.3%.
• Operating Profit (Q4): $151.8 million, a decrease of 8.4% year over year.
• Adjusted Net Income (Q4): $115.4 million, a decrease of 5.9% year over year.
• Adjusted EPS (Q4): $1.59, a decrease of 9% year over year.
• Free Cash Flow (Q4): $141.4 million, an increase of $41.1 million year over year.
• Cash and Cash Equivalents: $912.8 million.
• 2025 Revenue Guidance: $1.545 billion to $1.61 billion, an increase of 1% to 5% over 2024.
• 2025 Adjusted EPS Guidance: $7.00 to $7.20, an increase of 3.5% to 6.5% over 2024.
• 2025 Free Cash Flow Guidance: $550 million to $600 million.

• Warning! GuruFocus has detected 2 Warning Sign with LNTH.

Release Date: February 26, 2025

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

Positive Points

• Lantheus Holdings Inc (NASDAQ:LNTH) achieved over $1 billion in sales for PYLARIFY, marking it as the first radiodiagnostic blockbuster.
• The company announced strategic transactions to enhance capabilities in Alzheimer's Diagnostics and Oncology Therapeutics, expected to drive double-digit revenue growth starting in 2026.
• CMS issued a rule enhancing payment for specialized diagnostic radiopharmaceuticals, supporting long-term innovation.
• DEFINITY, the market-leading ultrasound-enhancing agent, saw a 17.9% year-over-year increase in sales.
• Lantheus Holdings Inc (NASDAQ:LNTH) reported a strong free cash flow of $493.1 million for the full year, with plans to expand it further in 2025.

Negative Points

• Operating expenses increased, with significant costs tied to business development activities and potential acquisitions.
• The company recorded an unrecognized loss of $119.1 million related to its equity investment in Radiopharm Theranostics.
• Gross profit margin decreased by 130 basis points year over year due to prior year royalty milestones.
• The strategic partnerships and other revenue segment saw a 66.2% decline in the fourth quarter.
• The guidance for 2025 indicates only a 1% to 5% increase in net revenue, reflecting potential challenges in maintaining high growth rates.

Q & A Highlights

Q: Could you provide a status update on the MIRROR study and its implications for PYLARIFY? Is the timing still on track? A: The MIRROR study is assessing the use of PSMA PET with PYLARIFY in intermediate favorable settings. It continues to enroll, and we expect the last patient in by the fourth quarter of 2025. This study aims to influence guidelines and expand the addressable market for staging populations, potentially increasing from 145,000 to 175,000 scans annually by the end of the decade. - Paul Blanchfield, President

Q: With the new reimbursement changes effective January 1, how are the competitive dynamics in the US PSMA PET market affecting PYLARIFY? A: The new reimbursement code is beneficial for PYLARIFY, and we have secured multiyear contracts with the majority of our customers. Despite competitive pressures, PYLARIFY's clinical and commercial differentiation, including its longer half-life and broad payer access, supports its market leadership and pricing premium. - Brian Markison, CEO; Paul Blanchfield, President; Amanda Morgan, Chief Commercial Officer

Q: Can you discuss the potential for CMS to adopt an ASP-based methodology for PYLARIFY and its impact on growth? A: CMS may establish ASP-based payment rules by January 2026, with draft rules expected in July. If adopted, ASP would support the payment dynamics of PSMA PET diagnostics, potentially enhancing PYLARIFY's growth. Our guidance for 2025 is based on the current MUC payment structure. - Brian Markison, CEO; Paul Blanchfield, President

Q: What are your broader ex-US commercial plans for pipeline assets, especially with the addition of Neuroseq? A: While our focus remains US-based, the acquisition of Life Molecular Imaging and Neuroseq will strengthen our international footprint. We aim to explore opportunities in other markets, particularly the EU, but will proceed cautiously without significant upfront investments. - Brian Markison, CEO

Q: How are you building the data set to highlight the competitive differentiation for MK-6240 and NAV-4694? A: MK-6240 has shown significant advantages in detecting early tau tangles and is involved in over 100 clinical trials. It is recognized as an extraordinary asset, with partnerships in place with major pharma companies. NAV-4694 is shaping up similarly, with potential sensitivity advantages over blood tests. - Brian Markison, CEO

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