On February 27, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported fourth quarter and full year 2024 financial results and corporate updates (Press release, Iovance Biotherapeutics, FEB 27, 2025, View Source [SID1234650709]).
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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "In 2024, we successfully drove strong early adoption for our U.S. commercial launch of Amtagvi for patients with previously treated advanced melanoma. Strong demand and growth are continuing and on track to accelerate for both Amtagvi and Proleukin in 2025 and beyond in the U.S. and globally. Our top commercial priorities are to drive broader adoption and utilization, increase patient referrals, add large community practices to our authorized treatment center (ATC) network, expand the U.S. market, and secure regulatory approvals in three new markets outside the U.S. I am confident that Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer."
Fourth Quarter and Full Year 2024 Financial Results, Corporate Guidance, and Updates
Product Revenue and Guidance
Fourth Quarter 2024 Total Product Revenue: Iovance recognized total revenue of $73.7 million from sales of Amtagvi and Proleukin during the fourth quarter ended December 31, 2024.
Amtagvi Revenue: Product revenue was $48.7 million from U.S. Amtagvi sales in the fourth quarter of 2024, reflecting strong adoption with increasing demand. Amtagvi revenue is recognized upon patient infusion.
Proleukin Revenue: Product revenue also included $25.0 million in Proleukin sales in the fourth quarter of 2024. Proleukin is used in the Amtagvi treatment regimen and other commercial, clinical, manufacturing, and research settings, which provide additional revenue. Proleukin revenue is generally recognized upon delivery to distributors and ATCs.
Full Year 2024 Total Product Revenue: Total product revenue was $164.1 million and achieved the high end of the company’s guidance range of $160 to $165 million for the full year 2024. Full year product revenue included the first three quarters of sales following the U.S. launch of Amtagvi on February 20, 2024. The full year 2024 product revenue for Amtagvi and Proleukin was $103.6 million and $60.5 million, respectively.
Significant Amtagvi Growth Potential at Approximately 70 ATCs in 2025: Amongst current ATCs, 76% completed tumor resections, 64% infused one or more patients, and 13% infused more than 10 patients, highlighting significant growth potential at existing ATCs.
Full Year 2025 Total Product Revenue Guidance: Iovance is reaffirming total product revenue guidance within the range of $450 to $475 million for 2025, the first full calendar year of Amtagvi sales. Amtagvi adoption is on track to continue accelerating throughout 2025 with broader utilization, higher demand, and growth in community referrals. Iovance also expects significant growth in total product revenue for full year 2026, and beyond.
Gross margins are expected to increase over time and remain on track to surpass 70% over the next several years. In line with anticipated growth in Amtagvi demand, Proleukin revenue is also expected to increase significantly in 2025 and beyond.
Full Year 2025 Expense Guidance: Cash burn for full year 2025 is expected to be under $300 million, including completion of construction of the Iovance Cell Therapy Center (iCTC) manufacturing expansion.
Cash Position: As of February 26, 2025, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $422 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations, including manufacturing expansion, into the second half of 2026.
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma
The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication.
Approximately 70 U.S. ATCs are active across 32 states and 95% of addressable patients live within 200 miles of an ATC. Additional U.S. ATCs will be added steadily throughout 2025, focusing on quality ATCs with a high volume of eligible patients, including large community practice ATCs.
Community referral activities are increasing throughout the U.S. to drive additional patient volume to these ATCs. Large community practices are currently onboarding, creating a new and significant opportunity for more patients to receive Amtagvi after frontline therapy.
Manufacturing turnaround time is aligning with launch expectations of approximately 34 days from inbound to return shipment to ATCs. Efforts are underway to shorten the turnaround time in 2025. The commercial manufacturing experience remains consistent with prior clinical experience.
Amtagvi is a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network guidelines for treatment of cutaneous melanoma.
Reimbursement remains successful, with an average financial clearance time of about three weeks.
Approximately 75% of Amtagvi patients are covered by private payers. To date, payers or plans covering more than 250 million lives have added Amtagvi to policies since its launch.
Launch Expansion into New Markets
Amtagvi has the potential to address more than 20,000 patients annually with previously treated advanced melanoma across the U.S. and initial global markets with significant populations of previously treated advanced melanoma patients.1
Regulatory dossiers are under review, submitted, or planned across multiple international markets for lifileucel for the treatment of adult patients with unresectable or metastatic melanoma after anti-PD-1 and targeted therapy. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all markets.
A marketing authorization application (MAA) was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for potential approval in the first half of 2025.
A new drug submission (NDS) to Health Canada was accepted for a prioritized 200-day review process through the Notice of Compliance with Conditions (NOC/c) policy for potential approval in mid-2025.
An MAA for all EU member states was accepted for review by the European Medicines Agency for potential approval in the second half of 2025.
Named patient programs are planned in the UK, France, Germany, Canada, Switzerland, and Australia in 2025 to provide reimbursed access to treatment prior to approval or final pricing and are also expected to provide initial revenue from these markets.
Additional regulatory submissions remain on track in 2025 and 2026, including Australia in the first half of 2025 and Switzerland in the second half of 2025.
A total of 15 active ATCs are targeted by year-end to support initial launch markets outside the U.S.
Recent Iovance TIL Cell Therapy Pipeline Highlights
Lifileucel in Frontline Advanced Melanoma
Strong momentum continues with global site activation and patient enrollment in the registrational TILVANCE-301 trial, which is intended to support accelerated and full U.S. approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, as well as full approval of Amtagvi in post-anti-PD-1 melanoma.
Lifileucel in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
Iovance expects to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC.
The IOV-LUN-202 trial is intended to support a potential accelerated approval of lifileucel in post-anti-PD-1 NSCLC in the U.S., with an anticipated regulatory decision in 2027. The FDA previously provided positive regulatory feedback on the proposed potency matrix in NSCLC and the IOV-LUN-202 clinical trial design.
Enrollment in IOV-LUN-202 continues with high demand at clinical sites in the U.S., Canada, and Europe with additional site activations underway in new regions with strong track records for enrollment in NSCLC studies.
Lifileucel in Frontline Advanced NSCLC
Iovance is pursuing a frontline therapy strategy to integrate lifileucel plus pembrolizumab following chemotherapy for patients with EGFR wild type NSCLC, representing most patients with an unmet medical need in this setting. This regimen will be investigated in a new Cohort 3D in IOV-COM-202 trial. Cohort 3D results will inform a registrational and confirmatory trial design in frontline advanced NSCLC.
Lifileucel in Endometrial Cancer
Iovance is actively enrolling in the IOV-END-201 Phase 2 trial which is investigating lifileucel for advanced endometrial cancer patients who have progressed after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status.
IOV-END-201 is supported by preclinical and manufacturing success data, as well as positive feedback from gynecological oncology experts. Initial results from IOV-END-201 are expected in the second half of 2025. There are no currently approved therapies for endometrial cancer following frontline post-anti-PD-1 therapy and chemotherapy, representing a significant opportunity for TIL cell therapy to address an additional unmet medical need in the post-anti-PD-1 treatment setting.
Next Generation TIL Pipeline
PD-1 Inactivated TIL Cell Therapy (IOV-4001): The Phase 2 efficacy portion of the IOV-GM1-201 trial in previously treated advanced melanoma and NSCLC continues to enroll rapidly. Iovance utilizes the TALEN technology licensed from Cellectis to develop other investigational gene-edited TIL cell therapies with multiple knockout targets to potentially improve efficacy.
Next Generation Interleukin-2 (IL-2) for TIL Treatment Regimen: A Phase 1/2 clinical trial was initiated to investigate IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen. Non-human primate and IND-enabling studies of IOV-3001 demonstrated the potential for improved safety with strong effector T cell expansion.
Next Generation, Cytokine-Tethered TIL Therapy: IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy. A clinical trial of a prior generation IL-12 TIL therapy at the National Cancer Institute showed improved efficacy with low cell doses, without the use of IL-2, and provides the rationale for modifications in IOV-5001 to enhance TIL efficacy while optimizing safety. In preclinical studies, IOV-5001 drove superior antitumor activity in a simulated tumor microenvironment. Iovance plans to submit an IND in 2025 to support clinical development for multiple indications.
Manufacturing Capacity Expansion
The iCTC, and an FDA-approved legacy contract manufacturer, currently have capacity to treat several thousand patients annually.
The company completed annual scheduled maintenance at the iCTC and successfully restarted full production.
Expansion is currently underway for the iCTC campus to supply TIL cell therapies to more than 5,000 patients annually in the next few years.
Iovance is also developing a manufacturing network to address more than 10,000 patients annually.
Corporate Updates
Dan Kirby joined Iovance’s Executive Leadership Team in the newly created role of Chief Commercial Officer in February 2025.
Raj Puri, M.D., Ph.D., was promoted to the newly created role of Chief Regulatory Officer in November 2024.
Iovance currently owns more than 250 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide Amtagvi with exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.
Fourth Quarter and Full Year 2024 Financial Results
As of February 26, 2025, Iovance’s cash position is approximately $422 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations into the second half of 2026.
Net loss for the fourth quarter of 2024 was $78.6 million, or $0.26 per share, compared to a net loss of $116.4 million, or $0.45 per share, for the fourth quarter of 2023. Net loss for the full year 2024 was $372.2 million, or $1.28 per share, compared to a net loss of $444.0 million, or $1.89 per share, for the full year 2023.
Revenue was $73.7 million for the fourth quarter of 2024 and consisted of product revenue from Amtagvi and Proleukin sales. Iovance recognized $48.7 million in revenue from Amtagvi infusions that were completed during the fourth quarter of 2024 and $25.0 million in global revenue for Proleukin. An additional $0.5 million in cash was received in the fourth quarter of 2024 for Amtagvi sales that will be recognized as revenue in the first quarter of 2025. Revenue for the fourth quarter of 2023 was $0.5 million for global sales of Proleukin.
Revenue for the full year 2024 was $164.1 million and reflected product revenue of $103.6 million from Amtagvi and $60.5 million from Proleukin. Revenue for the prior full year period 2023 was $1.2 million for global sales of Proleukin which Iovance began to recognize during the three-month period ended June 30, 2023.
The increases in revenue in the fourth quarter and full year 2024 over the prior year periods were primarily attributable to the U.S. launch of Amtagvi, including revenue recognized for Amtagvi, as well as significant growth in U.S. Proleukin revenue for use in the Amtagvi treatment regimen and global Proleukin sales.
Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi. Cost of sales for the three months ended December 31, 2024 was $45.5 million, primarily attributed to $9.1 million in period costs associated with patient drop off and manufacturing success rates, $5.9 million for non-cash amortization expense for intangible assets and fair value mark up of inventory, and $6.0 million in royalties payable on product sales. Cost of sales for the three months ended December 31, 2023 was $4.4 million, primarily related to non-cash amortization for intangible assets.
Cost of sales for the full year 2024 was $124.0 million, primarily related to $26.3 million in certain costs associated with patient drop off and manufacturing success rates, $26.2 million in non-cash amortization expense for intangible assets and fair value mark-up of inventory, and $14.2 million royalties payable on product sales. Cost of sales for the full year 2023 was $10.8 million, primarily related to non-cash amortization for intangible assets.
Increases in cost of sales in the fourth quarter and full year 2024 over the prior year periods were primarily attributable to the initiation of product sales, commercial manufacturing, and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024.
Research and development expenses were $72.2 million for the fourth quarter of 2024, a decrease of $15.3 million compared to $87.5 million for the fourth quarter of 2023. Research and development expenses were $282.3 million for the full year 2024, a decrease of $61.8 million compared to $344.1 million for the full year 2023.
The decreases in research and development expenses in the fourth quarter over the prior year period were primarily attributable to the transition of Amtagvi to commercial manufacturing. This decrease was partially offset by increases in headcount and related costs, including stock-based compensation, and clinical trial costs. The decrease in research and development expenses in the full year 2024 over the prior full year period was primarily attributable to the transition of Amtagvi to commercial manufacturing and lower clinical costs. These decreases were partially offset by increases in headcount and related costs, including stock-based compensation and lab and consumable costs.
Selling, general and administrative expenses were $42.5 million for the fourth quarter of 2024, an increase of $12.6 million compared to $29.9 million for the same period ended December 31, 2023. Selling, general and administrative expenses were $153.0 million for the full year 2024, an increase of $46.1 million compared to $106.9 million for the prior full year period.
The increase in selling, general and administrative expenses in the fourth quarter and full year 2024 compared to the prior year periods was primarily attributable to increases in headcount and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as legal costs and costs incurred to support the commercialization of Amtagvi and Proleukin.
For additional information, please see the Company’s Selected Consolidated Balance Sheets and Statements of Operations below.
Webcast and Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.