• Total Product Revenue (Q3 2024): $58.6 million, exceeding guidance of $53 million to $55 million.
• Amtagvi Revenue (Q3 2024): $41 million.
• Proleukin Revenue (Q3 2024): $16.5 million.
• Year-to-Date Total Product Revenue (2024): $90.4 million.
• Amtagvi Revenue Year-to-Date (2024): $54.9 million.
• Proleukin Revenue Year-to-Date (2024): $35.5 million.
• Net Loss (Q3 2024): $83.5 million or $0.28 per share.
• Net Loss (First Nine Months 2024): $293.6 million or $1.03 per share.
• Gross Margin (Q3 2024): $25.6 million against revenue of $58.6 million.
• Cash Position (as of September 30, 2024): Approximately $403.8 million.
• Research and Development Expenses (Q3 2024): $68.2 million.
• Selling, General and Administrative Expenses (Q3 2024): $39.6 million.
• Full Year 2024 Revenue Guidance: $160 million to $165 million.
• Full Year 2025 Revenue Guidance: $450 million to $475 million.
• Cash Burn Guidance (Full Year 2024): $320 million to $340 million, excluding one-time expenses.

• Warning! GuruFocus has detected 2 Warning Signs with IOVA.

Release Date: November 07, 2024

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

Positive Points

• Iovance Biotherapeutics Inc (NASDAQ:IOVA) reported third-quarter total product revenue of $58.6 million, surpassing their guidance of $53 million to $55 million.
• Amtagvi's adoption and demand are strong, with 126 patients infused since its launch, indicating robust market acceptance.
• The company has favorable medical coverage policies, with approximately 75% of Amtagvi patients covered by private payers.
• Iovance Biotherapeutics Inc (NASDAQ:IOVA) is expanding its network of authorized treatment centers (ATCs), aiming to reach 70 ATCs by year-end.
• The company is on track to achieve its full-year 2024 revenue guidance of $160 million to $165 million and anticipates significant revenue growth in 2025 and beyond.

Negative Points

• The company reported a net loss of $83.5 million for the third quarter of 2024, although this is an improvement from the previous year.
• There are concerns about potential impacts on infusion schedules due to upcoming holidays, which could affect revenue projections.
• The cost of sales remains high, with $39.8 million reported for the third quarter, impacting gross margins.
• Research and development expenses, although decreased, remain substantial at $68.2 million for the third quarter.
• The company is still working on optimizing manufacturing processes to improve turnaround times and reduce costs.

Q & A Highlights

Q: Can you discuss the potential impact of upcoming holidays on patient infusions and whether this might affect your annual guidance? A: Frederick Vogt, Interim CEO, explained that while there might be a lull during the holidays due to patients and physicians taking time off, the company has accounted for this in their projections. They expect to perform well in the quarter despite any holiday-related slowdowns.

Q: How do you anticipate the IL-2 stocking levels to change over time, and what are the dynamics affecting these levels? A: Frederick Vogt noted that they are currently stocking with three major distributors in the U.S. and expect the numbers to remain steady, with potential for growth in 2025 as all main distributors are stocked up.

Q: Can you provide more details on preconditioning happening before Amtagvi arrives at ATCs and whether this reflects improved manufacturing out-of-spec rates? A: Frederick Vogt confirmed that experienced ATCs are increasingly comfortable with preconditioning before Amtagvi's arrival, reflecting confidence in the manufacturing process and out-of-spec rates.

Q: How are the 82 infusions from the last quarter distributed across the months, and what drives the month-to-month growth? A: Frederick Vogt stated that there was month-over-month growth in infusions, driven by increased manufacturing capacity and demand at ATCs. Improved manufacturing success rates also contribute to this growth.

Q: What are the operational levers to achieve the 70% gross margin goal, and how are you progressing towards it? A: Frederick Vogt and Jean-Marc Bellemin, CFO, explained that scaling up the launch, especially using the ICTC facility, helps reduce costs. They are also focusing on operational excellence and process optimization to improve margins.

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