Iovance Biotherapeutics (NASDAQ:IOVA) highlighted accelerating commercial demand for its tumor-infiltrating lymphocyte (TIL) cell therapy AMTAGVI and progress across its pipeline during its fourth-quarter and full-year 2025 earnings call, while also pointing to improving margins and an extended cash runway driven by operational optimization.
2025 financial results: revenue growth and margin improvement
Interim CEO and President Dr. Frederick Vogt said the company delivered “substantial revenue growth” and “strengthened our financial performance” in 2025, driven primarily by AMTAGVI adoption and cost discipline. He said Iovance reported 30% revenue growth and its “best-ever” 50% margin from cost of sales in the fourth quarter.
Roche also said gross-to-net adjustments were minimal at less than 2% overall in 2025. Fourth-quarter gross margin from cost of sales increased to 50% from 43% in the third quarter, which she attributed to operational optimization, disciplined capital use, and the company’s move to fully internalize manufacturing at its Iovance Cell Therapy Center (ICTC).
On the balance sheet, Roche said Iovance ended 2025 with approximately $303 million in cash and expects that cash position to fund operations into the third quarter of 2027, aided by cost savings initiatives.
Commercial update: AMTAGVI demand, treatment centers, and earlier-line use
Chief Commercial Officer Dan Kirby said the company’s 2025 commercial progress centered on three areas: expanding its Authorized Treatment Center (ATC) network, penetrating the community market to improve referrals to ATCs, and increasing use of AMTAGVI earlier in the treatment journey.
Kirby said both new community centers and high-volume academic centers contributed to the company’s “highest-ever quarterly demand for AMTAGVI” in the fourth quarter, which drove revenue. He also said campaigns aimed at healthcare professionals and patients have had a “positive impact” as Iovance works to build awareness and access in the community setting.
On treatment timing, Kirby cited real-world data he said showed “unprecedented efficacy,” including more than 1 in 2 patients responding in the second-line setting and 1 in 3 patients in later lines of therapy. He said initiatives at academic ATCs are enabling earlier tissue procurement and earlier treatment for certain patient types, including patients with BRAF mutations who have limited options beyond targeted therapy once health status declines.
Vogt said Iovance expects “remarkable revenue growth” in 2026 driven by AMTAGVI and plans to provide revenue guidance “in the very near future.” In response to analyst questions, management said it was taking additional time early in the year to ensure projections are well supported, but expects to provide total product guidance and potentially quarterly guidance.
Proleukin dynamics and pricing
Management addressed quarter-to-quarter variability in Proleukin revenue, noting wholesaler ordering patterns. Roche said all three distributors ordered in the fourth quarter, with some buy-in. Kirby said the primary driver of Proleukin demand is AMTAGVI utilization and that reordering began in the first quarter of 2026, with two wholesalers having already placed orders and the third expected to follow.
Vogt added that for full-year 2025, Proleukin revenue represented about 17% of total revenue, consistent with prior commentary that it would contribute in the mid-teens over the long term.
Kirby also said the company implemented a 9% price increase on both products effective February 1, 2026, and that wholesalers typically buy ahead of such price increases.
Pipeline and regulatory progress: melanoma, NSCLC, and new sarcoma data
Iovance emphasized pipeline expansion for lifileucel and continued development work in melanoma. Vogt said the FDA granted Fast Track designation for lifileucel in previously treated non-squamous non-small cell lung cancer (NSCLC), which he said validates clinical trial data and reflects unmet need.
Friedrich (speaking during the prepared remarks and Q&A) said enrollment is accelerating in the phase 3 TILVANCE-301 trial evaluating AMTAGVI, including a comparison of pembrolizumab plus TIL versus pembrolizumab monotherapy in frontline advanced melanoma. He said the trial has dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS), and the ORR endpoint provides an opportunity for an earlier interim read. Referencing KEYNOTE-006, he said the ORR benchmark for pembrolizumab monotherapy was in the mid-30% range, with real-world ORR likely around 30% or slightly below. He also cited encouraging data from the company’s C-02 Cohort 1A, which showed response rates “up into the 60% range,” supporting confidence in the ORR endpoint.
For NSCLC, Friedrich said lifileucel in the IOV-LUN-202 registrational trial has shown an ORR of 26%, disease control rate of 72%, and a median duration of response that was not yet reached after more than 25 months of follow-up. He said updated data is planned for presentation at a medical meeting this year and that the company expects to complete enrollment in 2026 to support a supplemental biologics license application. Vogt said Iovance is targeting a potential accelerated approval and launch in the second half of 2027.
Separately, the company discussed early sarcoma data. Brian reported initial results from a pilot trial in previously treated advanced undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS). Among six evaluable patients, he said the confirmed ORR was 50%, describing responses as deep and improving over time. Management contrasted these findings with second-line standard-of-care outcomes described on the call as response rates below 5% and median overall survival under one year.
On next steps, the company said it plans to initiate a single-arm registrational trial “as soon as possible.” Mark (responding in Q&A) said prior FDA approvals in soft tissue sarcoma subtypes have ranged from about 30 to 60 patients, predominantly around 40 patients, and that Iovance expects a similar patient count for its registration strategy in these two subtypes. Management also said it is evaluating additional sarcoma subtypes beyond UPS and DDLPS.
Manufacturing and operations: ICTC transition and scaling
Igor said Iovance achieved its largest manufacturing volume and highest commercial manufacturing success to date in the fourth quarter. He said all lifileucel manufacturing has transitioned to the company’s ICTC facility, a milestone intended to improve capacity utilization, reduce cost of sales, and further improve gross margin.
Igor also said the company completed routine annual maintenance at ICTC around year-end and minimized manufacturing disruption by leveraging a contract manufacturer and increasing internal capacity around the maintenance window. He described ICTC as a modular facility capable of uninterrupted supply even during future annual maintenance periods.
Asked about drivers of improving manufacturing success, management said it was seeing gains from both internal manufacturing process improvements and better tumor procurement practices supported by the commercial and medical affairs teams working with ATCs and physicians.
Looking ahead, Vogt said the company is focused in 2026 on accelerating the U.S. launch, expanding the pipeline into new indications and next-generation products, and continuing operational excellence initiatives aimed at profitability, with additional detail expected when Iovance issues its 2026 revenue guidance.
About Iovance Biotherapeutics (NASDAQ:IOVA)
Iovance Biotherapeutics, Inc is a clinical‐stage biotechnology company specializing in the development and commercialization of tumor‐infiltrating lymphocyte (TIL) immunotherapies for the treatment of solid tumors. The company’s lead product candidate, lifileucel (formerly LN‐144), is an autologous TIL therapy in late‐stage clinical development for patients with advanced melanoma. Iovance’s pipeline also includes next‐generation TIL programs such as LN‐145 for cervical and other human papillomavirus (HPV)‐related cancers, as well as exploratory studies in head and neck, non‐small cell lung, gastric and other solid tumor indications.
Iovance’s TIL platform harnesses a patient’s own immune system by isolating, expanding and reinfusing tumor‐reactive lymphocytes.
