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IOVA Soars 28% on Narrower-Than-Expected Loss in Q3, Revenues Up Y/Y
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Key Takeaways
Iovance posted a Q3 loss of $0.25 per share, beating expectations and improving from last year.
Quarterly revenue rose 15% year over year to $67.5M, led by strong Amtagvi demand despite a miss.
Cost optimization efforts lifted gross margin to 43%, extending Iovance's cash runway into 2027.
Iovance Biotherapeutics (IOVA - Free Report) incurred a third-quarter 2025 loss of 25 cents per share, narrower than the Zacks Consensus Estimate of a loss of 29 cents. In the year-ago quarter, the company reported a loss of 28 cents per share.
Quarterly revenues rose 15% year over year and 13% sequentially to $67.5 million, generated entirely from the sales of the company’s two marketed drugs. However, the top line missed the Zacks Consensus Estimate of $70.3 million.
More on IOVA’s Earnings
Iovance currently has two marketed drugs in its portfolio, the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication.
Iovance recorded about $57.5 million from Amtagvi sales during the quarter, up 37% year over year and 6% sequentially, driven by robust demand. This figure missed the Zacks Consensus Estimate of $58 million and our model estimate of $61 million.
Proleukin added $10 million during the quarter, down 40% year over year. The metric also missed both the Zacks Consensus Estimate of $15 million and our model estimate of $14 million.
Discussion on IOVA’s Operating Costs
Research & development expenses totaled $75 million, up 12% from the year-ago period, driven by higher employee costs and clinical expenses incurred during the quarter.
Selling, general and administrative expenses declined 12% from the prior-year quarter’s figure to nearly $36 million, mainly due to a fall in stock compensation expenses.
As a result of a restructuring plan initiated in August, Iovance has started experiencing the benefits of cost optimization. The company reported a gross margin increase to 43% during the quarter, a significant rise compared with 5% in the previous quarter, driven by improved operational efficiency. With this progress, management now expects its existing cash balance of $307 million (as of September 2025-end) to fund operations into the second quarter of 2027 compared with the prior forecast of funding through the fourth quarter of 2026.
Shares of Iovance rose 28% yesterday following the earnings announcement, as investors reacted positively to the improving profitability trend. However, the stock is still down 69% year to date against the industry’s 11% growth.
Image Source: Zacks Investment Research
IOVA’s Guidance
Iovance reiterated its product revenue guidance for the full year, driven by strong demand for both of its marketed products. It expects this metric to be between $250 million and $300 million.
The company expects significant growth in total product revenues for 2026 and beyond. It also expects gross margins to increase through near-term optimization of manufacturing capacity utilization over the next several years.
Updates on IOVA’s Pipeline & Other News
Regulatory applications for Amtagvi in the melanoma indication remain under review in Australia, Switzerland and the United Kingdom, with potential approvals expected in the next two years. Earlier this year, Iovance voluntarily withdrew its regulatory filing in the European Union due to a lack of alignment with the EMA on the clinical data supporting the submission. The company is currently in discussions with the agency and intends to finalize a strategy for resubmission.
Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory trial seeking full approval for Amtagvi in the melanoma indication.
Alongside its earnings results, Iovance also announced a new registrational study called IOV-MEL 202, which will evaluate Amtagvi in advanced melanoma patients previously treated with anti-PD-1 therapy, primarily outside the United States.
Beyond melanoma, Iovance is developing Amtagvi for other indications. Earlier this week, the company reported interim data from the phase II IOV-LUN-202 study, evaluating the drug in previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Data showed that patients treated with the drug achieved an objective response rate (ORR) of about 25.6% compared with the ORR of 12.8% observed with the standard-of-care chemotherapy. Based on these results, the company plans to progress toward a regulatory filing with the FDA next year.
Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications. Initial results from the endometrial cancer study are expected in early 2026.
The company plans to report data from the phase II IOV-GM1-201 study, evaluating IOV-4001 in previously treated advanced melanoma, in the first quarter of 2026.
EPS estimates for Alkermes’ 2025 have increased from $1.78 to $1.96, while those for 2026 have risen from $1.69 to $1.77 in the past 60 days. ALKS stock has gained 10% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average negative surprise of 4.58%.
In the past 60 days, estimates for CorMedix’s earnings per share (EPS) have increased from $1.24 to $1.85 for 2025. During the same time, EPS estimates for 2026 have increased from $2.09 to $2.49. Year to date, shares of CRMD have rallied 33%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 34.85%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.25 to $7.29 for 2025. During the same time, EPS estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 68%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
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IOVA Soars 28% on Narrower-Than-Expected Loss in Q3, Revenues Up Y/Y
Key Takeaways
Iovance Biotherapeutics (IOVA - Free Report) incurred a third-quarter 2025 loss of 25 cents per share, narrower than the Zacks Consensus Estimate of a loss of 29 cents. In the year-ago quarter, the company reported a loss of 28 cents per share.
Quarterly revenues rose 15% year over year and 13% sequentially to $67.5 million, generated entirely from the sales of the company’s two marketed drugs. However, the top line missed the Zacks Consensus Estimate of $70.3 million.
More on IOVA’s Earnings
Iovance currently has two marketed drugs in its portfolio, the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication.
Iovance recorded about $57.5 million from Amtagvi sales during the quarter, up 37% year over year and 6% sequentially, driven by robust demand. This figure missed the Zacks Consensus Estimate of $58 million and our model estimate of $61 million.
Proleukin added $10 million during the quarter, down 40% year over year. The metric also missed both the Zacks Consensus Estimate of $15 million and our model estimate of $14 million.
Discussion on IOVA’s Operating Costs
Research & development expenses totaled $75 million, up 12% from the year-ago period, driven by higher employee costs and clinical expenses incurred during the quarter.
Selling, general and administrative expenses declined 12% from the prior-year quarter’s figure to nearly $36 million, mainly due to a fall in stock compensation expenses.
As a result of a restructuring plan initiated in August, Iovance has started experiencing the benefits of cost optimization. The company reported a gross margin increase to 43% during the quarter, a significant rise compared with 5% in the previous quarter, driven by improved operational efficiency. With this progress, management now expects its existing cash balance of $307 million (as of September 2025-end) to fund operations into the second quarter of 2027 compared with the prior forecast of funding through the fourth quarter of 2026.
Shares of Iovance rose 28% yesterday following the earnings announcement, as investors reacted positively to the improving profitability trend. However, the stock is still down 69% year to date against the industry’s 11% growth.
Image Source: Zacks Investment Research
IOVA’s Guidance
Iovance reiterated its product revenue guidance for the full year, driven by strong demand for both of its marketed products. It expects this metric to be between $250 million and $300 million.
The company expects significant growth in total product revenues for 2026 and beyond. It also expects gross margins to increase through near-term optimization of manufacturing capacity utilization over the next several years.
Updates on IOVA’s Pipeline & Other News
Regulatory applications for Amtagvi in the melanoma indication remain under review in Australia, Switzerland and the United Kingdom, with potential approvals expected in the next two years. Earlier this year, Iovance voluntarily withdrew its regulatory filing in the European Union due to a lack of alignment with the EMA on the clinical data supporting the submission. The company is currently in discussions with the agency and intends to finalize a strategy for resubmission.
Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory trial seeking full approval for Amtagvi in the melanoma indication.
Alongside its earnings results, Iovance also announced a new registrational study called IOV-MEL 202, which will evaluate Amtagvi in advanced melanoma patients previously treated with anti-PD-1 therapy, primarily outside the United States.
Beyond melanoma, Iovance is developing Amtagvi for other indications. Earlier this week, the company reported interim data from the phase II IOV-LUN-202 study, evaluating the drug in previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Data showed that patients treated with the drug achieved an objective response rate (ORR) of about 25.6% compared with the ORR of 12.8% observed with the standard-of-care chemotherapy. Based on these results, the company plans to progress toward a regulatory filing with the FDA next year.
Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications. Initial results from the endometrial cancer study are expected in early 2026.
The company plans to report data from the phase II IOV-GM1-201 study, evaluating IOV-4001 in previously treated advanced melanoma, in the first quarter of 2026.
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 from the sector are Alkermes (ALKS - Free Report) , CorMedix (CRMD - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While ALKS and CRMD each sport a Zacks Rank #1 (Strong Buy) at present, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
EPS estimates for Alkermes’ 2025 have increased from $1.78 to $1.96, while those for 2026 have risen from $1.69 to $1.77 in the past 60 days. ALKS stock has gained 10% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average negative surprise of 4.58%.
In the past 60 days, estimates for CorMedix’s earnings per share (EPS) have increased from $1.24 to $1.85 for 2025. During the same time, EPS estimates for 2026 have increased from $2.09 to $2.49. Year to date, shares of CRMD have rallied 33%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, the average surprise being 34.85%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.25 to $7.29 for 2025. During the same time, EPS estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 68%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.