Full Press Release Details
Iovance Biotherapeutics Reports Financial Results
and Corporate Updates for Fourth Quarter and
Significant Demand for Amtagvi (Lifileucel)
Continues with Total Product Revenue of $73.7M in 4Q24 and $164.1M in FY24, Achieving Upper End of FY24 Guidance Range of $160M-$165M
Reaffirming FY25 Total Product Revenue Guidance
FY25 Cash Burn Anticipated to be Under $300M
2025 Regulatory Approvals for Amtagvi Expected
in the UK, EU, and Canada
Enrollment Accelerating Across Global Registrational
Frontline Advanced Melanoma and Previously
Treated Advanced NSCLC
SAN CARLOS, Calif., 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, today reported fourth quarter and full year 2024 financial
results and corporate updates.
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
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma
Launch Expansion into New Markets
1. World Health Organization International
Agency for Research on Cancer (IARC) GLOBOCAN 2022.
Recent Iovance TIL Cell Therapy Pipeline Highlights
Fourth Quarter and Full Year 2024 Financial
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,
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 https://edge.media-server.com/mmc/p/hw2g9axf/. The live and archived webcast can be accessed in the Investors section of the Company's
website, IR.Iovance.com, for one year.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader
in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a
transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer
cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's
Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation
in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information,
please visit www.iovance.com.
Amtagvi and its accompanying design marks, Proleukin , Iovance ,
and IovanceCares are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries.
All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements