Iovance Biotherapeutics, Inc. IOVA incurred a fourth-quarter 2024 loss of 26 cents per share, narrower than the Zacks Consensus Estimate of a loss of 27 cents. In the year-ago quarter, the company reported a loss of 45 cents per share.

During the quarter, the company generated total revenues of $73.7 million, entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $72.1 million. In the year-ago quarter, Iovance recorded total revenues of $0.5 million.

See the Zacks Earnings Calendar to stay ahead of market-making news.

More on IOVA’s Earnings

Iovance currently has two marketed drugs in its portfolio, the IL-2 product Proleukin (aldesleukin) and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for advanced melanoma indication.

This marked the third quarter of recording revenues from Amtagvi sales since its approval in February. Iovance recorded $48.7 million from the drug’s sales during the fourth quarter compared with $42.1 million in the third, driven by encouraging patient demand. Sales of the drug missed our model estimates of $57 million.

Proleukin added $25 million during the quarter compared with $0.5 million in the year-ago period. Per management, the surge in sales can be attributed to the drug’s use in the Amtagvi treatment regimen. The metric beat our model estimate of $15 million.

Discussion on IOVA’s Operating Costs

Research & development expenses totaled $72.2 million, down 17% from the year-ago quarter’s level. This downside was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter.

Selling, general and administrative expenses surged 42% from the prior-year quarter’s figure to $42.5 million. This upside can be attributed to an increase in headcount and other related costs.

Full-Year 2024 Results

Iovance generated total revenues worth $164.1 million in 2024 compared with $1.2 million in the year-ago period.

The company incurred a loss of $1.28 per share for 2024 compared with a loss of $1.89 in the year-ago period.

IOVA’s Guidance

For 2025

Iovance reiterated its previously issued product revenue guidance for 2025. It expects this metric to be between $450 million and $475 million. Management forecasts cash burn for the year to be under $300 million.

Beyond 2025

The company expects significant growth in total product revenues for 2026 and beyond. It expects gross margins to increase over time and surpass 70% in the next several years.

Updates on IOVA’s Pipeline & Other News

Despite the better-than-expected fourth-quarter results, shares of Iovance fell nearly 19% in after-market trading yesterday. This was due to a warning in the company’s annual SEC filing where management cautioned investors of facing economic uncertainty due to geopolitical conflicts and inflation, that could harm its business and market performance.

Year to date, the stock has lost 29% against the industry’s 6% growth.

Image Source: Zacks Investment Research

Regulatory applications for Amtagvi in melanoma indication are currently under review in the European Union, the United Kingdom and Canada, with potential approvals expected throughout this year. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected later this year.

IOVA is also evaluating Amtagvi, combined with Merck’s PD-L1 inhibitor, Keytruda, in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication.

Iovance is accelerating enrolment in the phase II IOV-LUN-202 study, which evaluates Amtagvi in post-anti-PD-1 NSCLC. An update from this study is expected before this year’s end. If the study's data is positive, management expects to secure label expansion for the drug from the FDA in the given indication in 2027. Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications.

IOVA’s Zacks Rank

Iovance currently has a Zacks Rank #4 (Sell).

Iovance Biotherapeutics, Inc. Price

Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote

Our Key Picks Among Biotech Stocks

Some better-ranked stocks are argenx ARGX, Pacira BioSciences PCRX and 89bio ETNB. ARGX and PCRX each currently sports a Zacks Rank #1 (Strong Buy) and ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for argenx’s 2025 earnings per share (EPS) have increased from $2.07 to $3.13 in the past 60 days, while the same for 2026 has increased from $9.08 to $10.85. ARGX’s shares have gained 2% year to date. 

argenx's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 339.37%.

Estimates for Pacira BioSciences’ 2025 EPS have increased from $3.16 to $3.20 in the past 60 days and the same for 2026 has risen from $2.79 to $3.59. PCRX’s shares have surged 35% year to date.

Pacira’s earnings beat estimates in two of the trailing four quarters, missed once and met in the other, delivering an average surprise of 7.13%.

Estimates for 89bio’s loss per share have narrowed from $3.22 to $3.19 for 2025 in the past 60 days. The loss per share estimate for 2026 has narrowed from $3.19 to $2.51 in the same time frame. ETNB’s shares have risen 19% year to date.

89bio’s earnings beat estimates in two of the trailing four quarters and missed in the other two, delivering a negative average surprise of 37.49%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Pacira BioSciences, Inc. (PCRX) : Free Stock Analysis Report

argenex SE (ARGX) : Free Stock Analysis Report

Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report

89BIO (ETNB) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research