Full Press Release Details
Iovance Biotherapeutics Reports Fourth Quarter
Financial Results and Corporate Updates
Amtagvi (lifileucel) U.S. Launch Fully
Underway Following U.S. Food and Drug Administration (FDA) Approval as the First and Only One-Time, Individualized T cell Therapy for
a Solid Tumor Cancer
Amtagvi Regulatory Submissions on Track in the
European Union, United Kingdom, and Canada
Amtagvi Patients Identified at Nearly All of
the 30 Authorized Treatment Centers (ATCs), with Approximately 50 ATCs Anticipated to be Ready by the End of May 2024
SAN CARLOS, Calif., February 28, 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 fourth quarter and full year 2023 financial results
and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Throughout 2023, we executed toward our first approval and commercial launch while advancing our pipeline.
We are seeing healthy demand and momentum for Amtagvi following the recent U.S. FDA approval in advanced melanoma. To expand the
launch globally, we plan to submit regulatory dossiers in the European Union in the first half of 2024 and in Canada and the United Kingdom
in the second half of 2024. We are also excited about our robust development pipeline across solid tumor cancers. As a fully integrated
company, Iovance is well positioned to execute on our regulatory, pipeline, manufacturing, and commercial launch activities to advance
our mission to remain the global leader in TIL therapy."
Recent and Fourth Quarter
2023 Highlights and Corporate Updates
Amtagvi (lifileucel):
U.S. Approval and Launch Highlights in Advanced Melanoma
Launch Expansion into New Markets and Indications
Iovance TIL Therapy Clinical Pipeline Highlights
Fourth Quarter and Full Year 2023 Financial Results
Iovance had $346.3 million in cash, cash equivalents,
investments and restricted cash at December 31, 2023, compared to $478.3 million at December 31, 2022. With the net proceeds of approximately
$197.1 million raised in the February 2024 follow-on stock offering and anticipated revenue from Amtagvi and Proleukin, the cash position
is expected to be sufficient to fund current and planned operations well into the second half of 2025.
Net loss for the fourth quarter ended December
31, 2023, was $116.4 million, or $0.45 per share, compared to a net loss of $105.3 million, or $0.64 per share, for
the fourth quarter ended December 31, 2022. Net loss for the year ended December 31, 2023 was $444.0 million, or $1.89 per share,
compared to a net loss of $395.9 million, or $2.49 per share, for the year ended December 31, 2022. The net loss for the year ended December
31, 2023 includes amortization of intangible assets acquired as part of the Proleukin transaction.
Revenue for the fourth quarter and year ended December 31, 2023, was
$0.5 million and $1.2 million, respectively, and comprised of product sales following the Proleukin acquisition in May 2023. There
was no revenue for the fourth quarter and year ended December 31, 2022. Cost of sales for the fourth quarter and year ended December 31,
2023, was $4.4 million and $10.8 million, respectively, and comprised of cost of inventory associated with sales of Proleukin as
well as $3.9 million and $9.7 million, respectively, of non-cash amortization expenses of the acquired intangible asset for developed
technology. There was no cost of revenues for the fourth quarter and year ended December 31, 2022.
Research and development expenses were $87.5 million for
the fourth quarter ended December 31, 2023, an increase of $6.9 million compared to $80.6 million for the
same period ended December 31, 2022. Research and development expenses were $344.1 million for the year ended December 31, 2023,
an increase of $49.3 million compared to $294.8 million for the same period ended December 31, 2022.
The increases in research and development expenses in the fourth quarter
and the year ended December 31, 2023, over the prior year periods were primarily attributable to increases in headcount and related costs
to support internal manufacturing and clinical development activities, manufacturing costs to support increased production and commercial
manufacturing readiness, clinical trial costs driven primarily by the initiation of our Phase 3 TILVANCE-301 clinical trial, and facility
and related costs to expand manufacturing capacity.
Selling, general and administrative expenses
were $29.9 million for the fourth quarter ended December 31, 2023, an increase of $3.4 million compared to $26.5
million for the same period ended December 31, 2022. Selling, general and administrative expenses were $106.9 million for the
year ended December 31, 2023, an increase of $2.8 million compared to $104.1 million for the same period ended December 31, 2022.
The increase in selling, general and administrative
expenses in the fourth quarter and the year ended December 31, 2023, compared to prior year periods was primarily attributable to increases
in headcount and related costs to support the growth in the overall business and related corporate infrastructure, professional fees and
travel costs, including costs associated with Proleukin integration. These increases were partially offset by a decrease in stock-based
compensation expenses, legal and other costs. For additional information, please see the Company's Selected Condensed Consolidated
Balance Sheet and Statement of Operations below.
Webcast and Conference Call
in the live conference call Q&A, please register at https://register.vevent.com/register/BI289df7d30f474a72a72e1c4f7a754c92.
To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/6gd5c9ve. The live and
archived webcast can be accessed in the Investors section of the Company's website, IR.Iovance.com. The archived webcast will be
available 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
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," "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 and Proleukin, for which we obtain U.S. Food and Drug Administration
("FDA"), European Medicines Agency ("EMA"), or other regulatory authority approval; the risk that the EMA or other
regulatory authorities may not approve or may delay approval for our biologics license application ("BLA") submission for
lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential
pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets