Full Press Release Details
Iovance Biotherapeutics Reports Financial Results
and Corporate Updates for Third Quarter and Year to Date 2024
Significant Demand for Amtagvi (Lifileucel)
Continues with $58.6M in
Total 3Q24 Product Revenue
Reaffirming Guidance of $160-$165M for FY24
and $450-$475M for FY25 of
Total Product Revenue
Marketing Authorization Applications Validated
and Accepted for Review by European Regulatory Authorities for Potential Approval Starting with the UK in 1H2025 and EU and Canada in
Enrollment Accelerating in IOV-LUN-202 Registrational
Phase 2 Trial in Post-anti-PD-1 NSCLC
SAN CARLOS, Calif., November 7, 2024 -- 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 third quarter and year to date 2024 financial results and corporate
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Iovance is executing a successful U.S. commercial launch of Amtagvi for patients with previously
treated advanced melanoma. Robust demand for Amtagvi and Proleukin continues to grow as our expanding network of authorized treatment
centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals.
Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As such, we are actively
pursuing additional regulatory approvals to expand our commercial footprint, driving growth beyond the U.S. into new markets with a high
prevalence of advanced melanoma. As a fully integrated company, 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."
Third Quarter and Year
to Date 2024 Financial Results, Corporate Guidance, and Updates
Product Revenue and Guidance
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma
Lifileucel Launch Expansion into New Markets
Iovance TIL Cell Therapy Pipeline Highlights
Third Quarter and Year to Date 2024 Financial
As of September 30, 2024, Iovance's
cash position is approximately $403.8 million, which includes net proceeds of approximately $200.0 million raised from an at-the
market (ATM) equity financing facility during the second and early third quarter of 2024. The current cash position and anticipated product
revenue are expected to be sufficient to fund current and planned operations into early 2026.
Net loss for the third quarter of 2024 was $83.5
million, or $0.28 per share, compared to a net loss of $113.8 million, or $0.46 per share, for the third quarter ended September 30,
2023. Net loss for the first nine months of 2024 was $293.6 million, or $1.03 per share, compared to a net loss of $327.7
million, or $1.44 per share, for the nine-month period ended September 30, 2023.
Revenue was $58.6 million for the third quarter
of 2024 and consisted of product revenue from Amtagvi sales as well as recurring revenue from Proleukin. Iovance recognized $42.1 million
in revenue from Amtagvi infusions that were completed during the third quarter of 2024 and $16.5 million in global revenue for Proleukin.
Revenue for the first nine months of 2024
was $90.4 million and reflected product revenue from Proleukin and Amtagvi. Revenue for the first nine months of 2023 was $0.7 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 third quarter
and first nine months of 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, beginning in
the second quarter of 2024.
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 September 30, 2024 was $39.8 million, primarily attributed to $8.3 million
in period costs associated with patient drop off and manufacturing success rates, $5.5 million for non-cash amortization expense for intangible
assets, and $3.9 million in royalties payable on product sales. Cost of sales for the three months ended September 30, 2023 was $4.3
million, primarily related to non-cash amortization for intangible assets.
Cost of sales for the nine months ended September 30,
2024 was $78.5 million, primarily related to $17.2 million in certain costs associated with patient drop off and manufacturing success
rates, $15.5 million in non-cash amortization expense for intangible assets, and $8.2 million royalties payable on product sales. Cost
of sales for the nine months ended September 30, 2023 was $6.4 million, primarily related to non-cash amortization for intangible
The increases in cost of sales in the third
quarter and year to date 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 $68.2
million for the third quarter of 2024, a decrease of $19.3 million compared to $87.5 million for the same period
ended September 30, 2023. Research and development expenses were $210.1 million for the first nine months of 2024,
a decrease of $46.5 million compared to $256.6 million for the same period ended September 30, 2023.
The decreases in research and development
expenses in the third quarter and year to date 2024 over the prior year periods were primarily attributable to the transition of Amtagvi
to commercial manufacturing, decreased costs associated with certain clinical activities, and the completion of pre-commercial qualification
activities in 2023. These decreases in research and development were partially offset by increases in headcount and related costs, including
stock-based compensation resulting from growth in headcount.
Selling, general and administrative expenses
were $39.6 million for the third quarter of 2024, an increase of $12.6 million compared to $27.0 million for
the same period ended September 30, 2023. Selling, general and administrative expenses were $110.5 million for the
first nine months of 2024, an increase of $33.5 million compared to $77.0 million for the prior year's nine-month
The increase in selling, general and administrative
expenses in the third quarter and year to date 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 Condensed 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/vxykqwaf. The live and archived webcast can be accessed in the Investors section of the Company's
website, IR.Iovance.com, for one year.
1. World Health Organization International
Agency for Research on Cancer (IARC) GLOBOCAN 2022.
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
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
Certain matters discussed in this press release
are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company,"