IOVA
Iovance Biotherapeutics, Inc.2.2500
+0.0900+4.17%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Peak sales details, pipeline timelines surface
Q&A elaborated peak U.S. sales potential at $1B for melanoma Amtagvi alone, $10B for NSCLC, and sarcoma equivalent to melanoma, building on prepared optimism. Management teased a near-term TILVANCE-301 interim ORR readout against pembro's mid-30s% benchmark, plus ASCO/ESMO sarcoma presentation from deepening responses in six patients, eyeing a 40-patient registrational trial. Proleukin sales stabilized near 17% of total revenue, driven by Amtagvi demand despite distributor buy-in. They stayed non-specific on manufacturing success rates or scrap costs. Guidance arrives very soon. Momentum intact, watch pipeline catalysts.
Key Stats
Market Cap
893.18MP/E (TTM)
-Basic EPS (TTM)
-1.19Dividend Yield
0%Recent Filings
10-K
FY2025 results
Iovance Biotherapeutics reported FY2025 results with $263.5M total product revenue, up 61% y/y, driven by Amtagvi® sales of $220.0M (from $103.6M in FY2024) following U.S. accelerated approval for previously treated advanced melanoma, while Proleukin® fell 28% y/y to $43.5M amid U.S. re-stocking normalization. Q4 Amtagvi® momentum accelerated with sequential infusion growth, supported by ATC network expansion and real-world data showing 44% ORR, yet high COGS of 66% reflected manufacturing yields and patient drop-offs. Net loss widened 5% to $391.0M on $667M opex, including $300M R&D for TILVANCE-301 confirmatory trial and NSCLC registrational study IOV-LUN-202. Cash burn eased to $302M on $301M ATM proceeds, bolstering $303M liquidity amid restructuring to cut costs 19%. No annual guidance disclosed. Restructuring delays risk quarterly momentum.
8-K
Q4 revenue jumps 30%
Iovance reported Q4 2025 product revenue of $87M, up ~30% sequentially, with Amtagvi at $65M driving full-year $264M within guidance. Gross margin hit 50% via cost tweaks, while $303M cash lasts to Q3 2027. FDA Fast Track for lifileucel in NSCLC signals pipeline push. Revenue surges, yet losses persist.
8-K
Affirms $250-300M FY25 guidance
Iovance Biotherapeutics updated its corporate presentation on January 9, 2026, affirming expectation to hit full-year 2025 revenue guidance of $250-$300 million in Amtagvi's first full sales year. Cash stands at $307M as of September 30, 2025, funding operations into Q2 2027. Guidance holds firm. Real-world melanoma responses hit ~50%, beating trials.
10-Q
Q3 FY2025 results
Iovance posted Q3 revenue of $67.5M, up 15% y/y from $58.6M (derived), fueled by Amtagvi at $57.5M (up 37% y/y) while Proleukin dipped 40% y/y to $10.0M. Losses widened to $91.3M from $83.5M y/y, with operating loss at $94.9M versus $89.1M, driven by higher R&D and cost of sales amid scaling; net loss tracked operating closely, differing by <20%. Cash and equivalents stood at $158.1M plus $142.7M short-term investments, bolstered by $250.5M from equity raises, despite $249.8M YTD operating burn. August restructuring cut headcount 19% to extend runway. Restructuring aids cash burn. Competition from emerging T-cell therapies looms.
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