Release Date: February 27, 2025

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

Positive Points

• Iovance Biotherapeutics Inc (NASDAQ:IOVA) achieved the upper end of their 2024 revenue guidance, with total product revenue of $164.1 million.
• The company has a robust manufacturing network with a capacity to supply more than 1,200 patients annually, and plans to expand this capacity further.
• Iovance Biotherapeutics Inc (NASDAQ:IOVA) has favorable medical coverage policies, with approximately 75% of AntagB patients covered by private payers and broad reimbursement access.
• The company is on track with its XS launch expansion plans, aiming for three new approvals and early access in several new markets.
• Iovance Biotherapeutics Inc (NASDAQ:IOVA) has a strong intellectual property portfolio with over 250 granted or allowed patents, providing exclusivity through at least 2042.

Negative Points

• The company reported a net loss of $372.2 million for the full year 2024, although this was an improvement from the previous year.
• There are challenges in scaling up ATCs, with only 13% of them having infused more than 10 patients, indicating room for growth but also current limitations.
• The company faces competition from potential new entrants in the market, which could impact their market share.
• Manufacturing and operational costs remain high, with cost of sales for the full year 2024 at $124 million.
• There is uncertainty regarding the timing and success of future regulatory approvals and market expansions, which could affect revenue projections.

Q & A Highlights

• Warning! GuruFocus has detected 3 Warning Signs with IOVA.

Q: Fred, could you provide an update on the number of patients infused thus far in the quarter and explain the confidence in the full-year 2025 guidance? A: We are not providing infusion numbers at this time as they can be prone to overinterpretation. However, we have confidence in our 2025 guidance due to the potential growth at our Authorized Treatment Centers (ATCs). Only 13% of our 70 ATCs have infused more than 10 patients, indicating significant upside potential as we move forward. Fred Bose, Interim CEO

Q: How should we interpret the spike in IL-2 revenues this quarter? Is it indicative of future TIL demand? A: IL-2 revenue is indeed a leading indicator for Antag sales. The spike reflects uptake by all major U.S. wholesalers, and we expect restocking in 2025. IL-2 could represent a significant portion of our 2025 revenue guidance, potentially reaching $80 to $100 million or more. Fred Bose, Interim CEO

Q: What are physicians saying about the potential for a new entrant in the market later this year? A: We view the potential new entrant as similar to an existing product, with clinical data not comparable to ours. Their patient population is much earlier in treatment stages, whereas our product addresses a more real-world population of metastatic melanoma. We do not anticipate significant impact on our launch. Fred Bose, Interim CEO

Q: Was there a slowdown in infusions in the back half of the quarter, and did you see any seasonality in Q4? A: We did not observe any seasonality. There was a manufacturing maintenance period, which is typical in cell therapy. However, no significant slowdown due to holidays was noted. Fred Bose, Interim CEO

Q: Is the potential price increase included in the 2025 guidance, and how will global expansion impact it? A: Yes, the price increase planned for April is factored into the guidance for both Proleukin and Antag. Currently, the guidance does not include any contribution from global expansion. Fred Bose, Interim CEO

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