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Iovance Biotherapeutics, Inc. IOVA incurred a first-quarter 2025 loss of 36 cents per share, wider than the Zacks Consensus Estimate of a loss of 25 cents. In the year-ago quarter, the company reported a loss of 42 cents per share.
Quarterly revenues totaled $49.3 million, entirely from the sales of its two marketed drugs. This figure missed the Zacks Consensus Estimate of $80.5 million. In the year-ago quarter, Iovance recorded total revenues of $0.7 million. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar)
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 $43.6 million from Amtagvi sales during the first quarter compared with $48.7 million in the previous quarter. The reported figure missed our model estimate of $69 million, as the drug’s sales were affected by a reduction in capacity due to an annual scheduled maintenance of the Iovance Cell Therapy Center (iCTC), the company’s internal manufacturing facility. Per IOVA, over 80 patients were infused during the quarter.
Proleukin added $5.7 million during the quarter compared with $0.7 million in the year-ago period. Yet, the metric missed our model estimate of $19 million as this drug’s sales are tied to Amtagvi intake. Proleukin is used in the Amtagvi treatment regimen.
Research & development expenses totaled $76.9 million, down 4% from the year-ago quarter’s level. The decline was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter.
Selling, general and administrative expenses surged 40% from the prior-year quarter’s figure to $43.9 million. This uptick can be attributed to an increase in headcount and other related costs.
Although Iovance has resumed full manufacturing capacity, it has significantly lowered its product revenue guidance for the full year. It now expects this metric to be between $250 million and $300 million compared to the prior guidance of $450-$475 million. Per the company, this revision reflects anticipated growth in authorized treatment centers (ATCs), adoption trends and patient referral timelines.
Shares of Iovance plummeted nearly 39% in after-market trading yesterday, likely due to the curtailed guidance. Year to date, the stock has plunged 57% compared with the industry’s 8% decline.
Iovance expects Amtagvi infusions to grow in the second quarter compared to the first, projecting between 100 and 110 commercial patient infusions in the second quarter of 2025. It also expects further acceleration in the second half of the year, supported by broader utilization across its network of over 80 ATCs and expansion into large community practices.
The company reiterated its previously issued cash burn guidance for the year, which is expected to remain below $300 million.
Iovance 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.
The company also noted that it is ‘well-positioned in the current macroeconomic and geopolitical environment.’ IOVA expects minimal impact of Trump’s tariffs as all its marketed products are manufactured in the United States.
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. Iovance is targeting 15 ATCs outside the United States by the end of this year to support the initial product launch in these markets. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected later this year.
Iovance is 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 also remains on track to share an update from the phase II IOV-LUN-202 study (in the second half of 2025), which evaluates Amtagvi in post-anti-PD-1 NSCLC. If results from the study are positive, the company 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.
Iovance currently has a Zacks Rank #4 (Sell).
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Some better-ranked stocks from the industry are Adaptive Biotechnologies ADPT, Beam Therapeutics BEAM and Elevation Oncology ELEV, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have improved from 92 cents to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 cents to 65 cents.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 55% year to date.
Estimates for Beam Therapeutics’ 2025 loss per share have narrowed from $4.45 to $4.30 over the past 60 days, and the same for 2026 loss has improved from $4.94 to $4.65.
Beam Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 3.14%. Year to date, its shares have lost 31%.
In the past 60 days, estimates for Elevation Oncology’s 2025 loss per share have narrowed from 83 cents to 61 cents. Loss per share estimates for 2026 have narrowed from 88 cents to 44 cents during the same time. Year to date, shares of ELEV have declined 36%.
Elevation Oncology’s earnings beat estimates in two of the trailing four quarters and missed the mark on the remaining occasions, the average surprise being 5.10%.
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This article originally published on Zacks Investment Research (zacks.com).
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