Full Press Release Details
Iovance Biotherapeutics Reports Financial Results
and Corporate Updates for Second Quarter and First Half 2024
Strong Momentum Continues for Amtagvi
(Lifileucel) U.S. Launch with $31.1 Million in Total 2Q24 Revenue
Total Product Revenue Guidance of $53-$55 Million
for 3Q24, $160-$165 Million for FY24, and $450-$475 Million for FY25
SAN CARLOS, Calif., August 8, 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 second quarter and first half 2024 financial results and corporate
Frederick Vogt, Ph.D., J.D., Interim President and Chief
Executive Officer of Iovance, stated, "The first half of 2024 ushered in our first FDA approval and the start of our U.S.
commercial launch of Amtagvi for patients with previously treated advanced melanoma. Amtagvi and Proleukin demand
remains strong and continues to increase as authorized treatment centers (ATCs) adopt Amtagvi and community referral networks are
mobilized to drive patients to ATCs. These demand trends, as well as broader utilization of Amtagvi among an expanding ATC network,
are expected to accelerate quarterly growth throughout this year and next year. We expect this growth to continue in 2025, 2026 and
beyond. Additionally, we continue to expand our global commercial footprint, proprietary manufacturing capabilities,
and broad clinical pipeline. As a fully integrated company, Iovance is well positioned to remain the global
leader in innovating, developing, and delivering TIL cell therapy for patients with cancer."
Second Quarter and First
Half 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
Second Quarter and First Half 2024 Financial
As of July 24, 2024, Iovance's unaudited
cash position is approximately $449.6 million, which includes net proceeds of approximately $200.0 million raised from an at-the
market (ATM) equity financing facility during the second and 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. Iovance had $346.3 million in
cash, cash equivalents, investments, and restricted cash at December 31, 2023.
Net loss for the second quarter of 2024 was $97.1
million, or $0.34 per share, compared to a net loss of $106.5 million, or $0.47 per share, for the second quarter
ended June 30, 2023. Net loss for the first half of 2024 was $210.1 million, or $0.76 per share, compared to
a net loss of $213.9 million, or $0.98 per share, for the six-month period ended June 30, 2023.
Revenue was $31.1 million for the second quarter
of 2024 and consisted of product revenue from the initial quarter of Amtagvi sales as well as recurring revenue from Proleukin. Iovance
recognized $12.8 million in revenue from Amtagvi infusions that were completed during the second quarter of 2024 and $18.3 million in
global revenue for Proleukin.
Revenue for the first half of 2024 was $31.8
million and reflected product revenue from Proleukin and Amtagvi. Revenue for the first half of 2023 was $0.2 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 second quarter
and first half 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
Cost of sales for the three and six months
ended June 30, 2024 was $31.4 million and $38.6 million, respectively, primarily related to costs associated with sales of Amtagvi
and Proleukin, certain costs associated with patient drop off and manufacturing success rates, non-cash amortization expense for intangible
assets, and royalties payable on product sales. Cost of sales for both the three and six months ended June 30, 2023 was $2.1 million,
primarily related to non-cash amortization for intangible assets.
The increases in cost of sales in the second
quarter and first half of 2024 over the prior year periods were primarily attributable to the initiation of commercial manufacturing and
related costs for the U.S. launch of Amtagvi during the first half of 2024.
Research and development expenses were $62.1
million for the second quarter of 2024, a decrease of $24.2 million compared to $86.3 million for the same period
ended June 30, 2023. Research and development expenses were $141.9 million for the first half of 2024, a decrease of $27.2
million compared to $169.1 million for the same period ended June 30, 2023.
The decreases in research and development
expenses in the second quarter and first half of 2024 over the prior year periods were primarily attributable to the transition of Amtagvi
to commercial manufacturing, decreased costs associated with certain clinical activities in the first half of 2024, and the completion
of pre-commercial qualification activities in 2023. These decreases in research and development were partially offset by increases in
stock-based compensation resulting from growth in headcount.
Selling, general and administrative expenses
were $39.6 million for the second quarter of June 2024, an increase of $17.7 million compared to $21.9 million for
the same period ended June 30, 2023. Selling, general and administrative expenses were $71.0 million for the first half
of 2024, an increase of $21.0 million compared to $50.0 million for the same six-month period ended June 30,
The increase in selling, general and administrative
expenses in the second quarter and first half of 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/uhudv42k. 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 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
Certain matters discussed in this press release
are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we,"
"us," or "our") within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA").
Without limiting the foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends,"
"forecast," "guidance," "outlook," "may," "can," "could," "might,"
"will," "should," or other words that convey uncertainty of future events or outcomes and are intended to identify
forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience
and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such