Iovance Biotherapeutics (IOVA) upgraded its full-year outlook Thursday after reporting that sales of its melanoma therapy AMTAGVI accelerated sharply in the second quarter, lifting gross margins and reinforcing a balance sheet the company says will carry it well past 2027.
AMTAGVI (lifileucel) revenue rose 51.7% sequentially to $91 million in the April-June period from $60 million in the first quarter, the company said at the Wells Fargo 21st Annual Healthcare Conference. Gross margins jumped to 56% in the second quarter from 41% in the first, with a trailing-twelve-month margin of 48.4%. Management set a long-term non-formal target of approximately 70%, noting that PROLEUKIN sales settled at roughly 16% of total revenue at steady state after a prior inventory normalization following a price increase.
PROLEUKIN sales came in at $9 million for the second quarter, down from $11 million in the first period. Iovance expects the product's contribution to plateau near 16% of total revenue once inventory dynamics normalize.
On the balance sheet, cash, equivalents and investments topped $300 million at quarter-end, giving Iovance a current ratio of 4.35 and a cash runway extending into the second half of 2028. The company's stock market capitalization stood at $3.69 billion as of the conference.
Payer coverage for AMTAGVI now spans more than 250 million lives in the U.S., and about 95% of Americans live within a two-hour drive of an authorized treatment center, according to management.
Clinical readouts bolstered the outlook. Real-world response rates in true second-line melanoma patients exceeded 50%. In the Phase 2 registrational lung-cancer program IOV-LUN-202, an interim dataset showed a 26% response rate across 39 patients; the trial aims for roughly 80 patients, with final readout expected in the fourth quarter of 2024 after enrollment completion this year. A supplemental biologics license application for AMTAGVI in lung cancer is planned for 2027.
Data from the sarcoma program SARATOGA showed a 50% deep response rate in the first six evaluable patients, while early results in serous endometrial cancer reported a 40% response rate and 100% disease control rate. Next-generation cell therapy programs IOV-4001 and IOV-5001 remain in development alongside the lead TILVANCE-301 Phase 3 trial in first-line melanoma.
Iovance said it would provide a full-year 2024 guidance update later in the current quarter.
