Iovance posts record $99M Q2 revenue as Amtagvi demand triples awareness

Iovance Biotherapeutics posted record second-quarter revenue of $99.3 million, up 66 percent from a year earlier, as demand for its tumor-infiltrating lymphocyte therapy Amtagvi nearly tripled unaided physician awareness and the FDA granted fast-track designation for a new sarcoma indication. The San Carlos, California-based company, which trades on Nasdaq under IOVA, reported U.S. Amtagvi sales of about $91 million, up 40 percent from the fourth quarter.

"Second-quarter revenue reached a record $99.3 million with gross margin of 56 percent, driven by continued U.S. Amtagvi demand," Frederick Vogt, interim president and chief executive officer, said.

Gross margin climbed to 56 percent on higher sales volume, cost optimization and maturing internal manufacturing. Iovance narrowed its second-quarter net loss to $47.3 million, or 11 cents a share, from $111.7 million, or 33 cents, a year earlier. Research and development spending fell about 6 percent from the first quarter to $58.9 million, the fourth straight quarter of improvement.

The FDA granted fast-track designation for lifileucel in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma after early data showed a 50 percent objective response rate in the first six evaluable patients. The registrational SARATOGA trial is underway, with results to be presented at the European Society for Medical Oncology meeting in Madrid from Oct. 23-27. Iovance is also reviewing its full-year revenue guidance of $350 million to $370 million after the beat, with an update due in the third quarter.

Amtagvi's commercial expansion

The authorized treatment center network has grown to more than 95 U.S., Canadian and Australian centers, with at least 110 expected active by the end of 2026. Community centers now represent a third of the network. Manufacturing turnaround time is 31 days or less using the only scaled, centralized commercial process approved by the FDA for TIL therapy. Real-world studies by Iovance and its centers show objective response rates of 50 percent or greater.

Australia's Therapeutic Goods Administration approved Amtagvi in June, the third global approval after the U.S. and the European Union. The company resubmitted its application in the United Kingdom in early July, with a decision possible later this year, and expects Swiss approval in the first half of 2027. A resubmission to the European Medicines Agency is on track for 2027.

Pipeline breadth and next-generation programs

Beyond melanoma, Iovance is advancing lifileucel in metastatic non-squamous non-small-cell lung cancer, where enrollment in the registrational cohorts is nearly complete and a supplemental biologics license application is planned for 2027. The U.S. market opportunity there is about seven times that of advanced melanoma. The TILVANCE-301 trial is testing lifileucel with pembrolizumab in frontline melanoma, and IOV-END-201 is targeting metastatic serous endometrial cancer.

Next-generation programs include IOV-4001, a PD-1 inactivated TIL therapy in Phase 1/2 trials for melanoma and lung cancer, and IOV-5001, an IL-12 tethered therapy targeting colorectal, triple-negative breast and other solid tumors. IOV-3001, a modified IL-2 analog, is advancing through dose escalation.

Iovance holds about $304 million in cash, funding operations into the second half of 2028, and owns or licenses more than 400 granted patents with exclusivity through at least 2042. Analysts' median price target is $8, with Chardan Capital's Geulah Livshits at $14 and Barclays' Etzer Darout at $11. Two Sigma Investments added 9.3 million shares in the first quarter, while Long Focus Capital cut 6.5 million.

This article is for informational purposes only and does not constitute investment advice.