Full Press Release Details
Iovance Biotherapeutics Reports Financial Results
and Corporate Updates for First Quarter 2025
1Q25 Total Product Revenue of $49.3M
FY25 Total Product Revenue Guidance Revised
FY25 Operating Expenses Reduced and 2H26 Cash
Runway Guidance Maintained
2025 Regulatory Approvals for Amtagvi Expected
in the UK, EU, and Canada
On Track to Report Updated Clinical Data for
Registrational Trial
in Previously Treated Advanced NSCLC in 2H25
SAN CARLOS, Calif., May 8, 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 first quarter 2025 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "During the start of the new year, our first quarter revenue was impacted by a significant reduction
in capacity during the annual scheduled maintenance at the Iovance Cell Therapy Center (iCTC). Since full production has now resumed
at the iCTC, we now expect infusions to grow in the second quarter as compared to the first quarter. Additionally, based on our
experience to date, we are revising full-year 2025 revenue guidance to reflect recent launch dynamics. In the first 12 months of our U.S.
launch, we have executed toward our long-term adoption goals by treating more than 275 Amtagvi patients and generating more than $210
million in revenue. Beyond the U.S. launch, we are on track this year for potential Amtagvi regulatory approvals in three new ex-U.S.
markets as well as a clinical data update from our registrational trial in non-small cell lung cancer."
First Quarter 2025 Financial
Results, Corporate Guidance, and Updates
Product Revenue and Guidance
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma
Launch Expansion into New Markets
Recent Iovance TIL Cell Therapy Pipeline Highlights
First Quarter 2025 Financial Results
As of March 31, 2025, Iovance's cash position is approximately
$366 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 first quarter of 2025 was $116.2 million,
or $0.36 per share, compared to a net loss of $113.0 million, or $0.42 per share, for the first quarter of 2024.
Revenue was $49.3 million for the first quarter of 2025 and consisted
of product revenue from Amtagvi and Proleukin sales. Iovance recognized $43.6 million in revenue from Amtagvi infusions that were completed
during the first quarter of 2025 and $5.7 million in global revenue for Proleukin. Revenue for the first quarter of 2024 was $0.7 million
for global sales of Proleukin.
The increase in revenue in the first quarter 2025 over the prior year
period was primarily attributable to the U.S. launch of Amtagvi, including revenue recognized for Amtagvi, as well as Proleukin revenue
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 first quarter 2025 was $49.7 million, which included $15.0 million for period costs associated with patient drop off and manufacturing
success rates, $5.4 million for non-cash amortization expense for intangible assets and fair value mark up of inventory, and $1.3 million
in royalties payable on product sales. For the first quarter 2024, cost of sales of $7.3 million was primarily related to non-cash amortization
for intangible assets.
Increases in cost of sales in the first quarter over the prior year
period were primarily attributable to costs associated with the initiation and growth of product sales, certain costs associated with
patient drop off and manufacturing success rates, 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 $76.9
million for the first quarter of 2025, a decrease of 4% compared to $79.8 million for the first quarter of 2024.
The decreases in research and development expenses in the first quarter 2025 over the prior year period were primarily attributable to
the transition of Amtagvi to commercial manufacturing. This decrease was partially offset by higher headcount and related costs, including
stock-based compensation, and clinical trial costs resulting from continued enrollment in existing trials.
Selling, general and administrative expenses
were $43.9 million for the first quarter of 2025, an increase of 40% compared to $31.4 million for the first
quarter of 2024. The increase in selling, general and administrative expenses in the first quarter compared to the prior year period 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 marketing and 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/wi5b4tnt. 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
statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future
performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual
results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied
by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ
materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S.
Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include,
but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related
to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration
("FDA") approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ("EMA") approval;