After experiencing a significant decline in share price in recent years, Iovance Biotherapeutics (IOVA) looks to turn the page with FDA approval and the successful launch of its flagship treatment, Amtagvi (Lifileucel). The company anticipates robust growth in FY2025 with expansion into new global markets. Further, ongoing efforts to enhance its cell therapy pipeline are also being worked on for Iovance. Financial results for Q3 2024 earnings surpassed expectations, and the company remains optimistic about future growth. The stock trades at historically low levels, making this a potential window of opportunity for investors willing to bear the risk of a newly commercial-stage biotech.
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Poised to Expand after Successful Launch
Iovance Biotherapeutics is a commercial-stage biotechnology firm specializing in developing and commercializing cell therapies to treat metastatic melanoma and other solid tumor cancers. Two of the company’s primary offerings include Amtagvi, an autologous T cell immunotherapy that was the first FDA-approved T cell therapy for a solid tumor indication, and Proleukin, an interleukin-2 product, both aimed at treating metastatic cancers.
Amtagvi was successfully launched in 2024, and Iovance is poised to expand its reach. Regulatory submissions are either submitted or being prepared for 2024 and 2025 in various markets. In the European Union, a marketing authorization application (MAA) has been validated and accepted for review by the European Medicines Agency, with potential approval anticipated in the second half of 2025. The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has received an MAA for possible approval in the first half of 2025.
Health Canada has considered a new drug submission (NDS) eligible for a Notice of Compliance with Conditions (NOC/c), prioritizing a 200-day review process for potential NDS approval by mid-2025. Additional regulatory submissions are planned for 2025 and 2026 in markets with sizable populations of previously treated advanced melanoma patients, specifically Australia (first half of 2025) and Switzerland (second half of 2025).
What Else Is in the Pipeline
Additionally, Iovance is developing LN-145 for non-small cell lung cancer (NSCLC) and solid tumors and IOV-4001, currently in Phase 1/2 of the IOV-GM1-201 trial, also targeting NSCLC. The company has formed collaborations and licensing agreements with several prominent institutions and companies, including the National Institutes of Health, the National Cancer Institute, H. Lee Moffitt Cancer Center, The University of Texas M.D. Anderson Cancer Center, Cellectis S.A. (CLLS), Novartis Pharma AG (NVS), and Boehringer Ingelheim Biopharmaceuticals GmbH.
Iovance has registered over 230 granted or allowed U.S. and international patents and patent rights, particularly for Amtagvi and other TIL-related technologies. These patent rights are expected to maintain Amtagvi’s exclusivity until 2038. Additionally, Iovance has a strong patent portfolio focused on genetically engineered TIL products, including those derived from either core biopsies or peripheral blood and TIL product combinations with checkpoint inhibitors.
Surprising Financial Results
Iovance exceeded top-and-bottom-line expectations in its recently reported Q3 2024 results. Revenue of $58.6 million surpassed analysts’ projections by $4.78 million. This uptick in revenue was driven by the sale of its pharmaceutical products Amtagvi and Proleukin, with the former accounting for $42.1 million of the total income. The company reported a GAAP EPS of -$0.28, exceeding expectations by $0.02.
As of the quarter’s end, the company reported a cash position of $403.8 million. That, and expected product revenue, should adequately fund operations, including manufacturing expansion, well into early 2026.
Management has issued forward guidance, anticipating revenue will continue to trend upward. Projected total product revenue ranges from $160 to $165 million for 2024 and $450 to $475 million for 2025.
Analysts Are Bullish
The stock has been on an extended downward trend, shedding over 58% of its value in the past three years. It trades near the bottom of its 52-week price range of $5.57 – $18.33, demonstrating negative price momentum as it trades below major moving averages.
Yet, analysts following the company remain bullish on IOVA stock. For instance, Goldman Sachs (GS) analyst Andrea Tan recently reiterated a Buy rating and $22.00 price target on the shares, noting the successful launch of Amtagvi, management’s FY25 revenue guidance, and other treatments in the pipeline that could further drive the stock.
Nine analysts recently recommended that Iovance Biotherapeutics be rated a Strong Buy overall. Their average price target for IOVA stock is $24.17, representing a potential upside of 286.72% from current levels.
IOVA in Summary
Iovance is well-positioned for upside growth, highlighted by the successful launch of its flagship treatment, Amtagvi. With regulatory submissions already underway across several international markets, the company’s anticipated growth in FY2025, robust patent portfolio, and positive forward guidance indicate an opportunity that may be attractive to investors with a tolerance for the inherent risks of commercial-stage biotech.
