Core Viewpoint - Iovance Biotherapeutics has innovative cancer therapies but faces challenges in market performance despite regulatory approval of its key therapy, Amtagvi [1][2]. Company Overview - Iovance Biotherapeutics specializes in developing therapies using tumor-infiltrating lymphocytes (TILs) to target cancer cells [3]. - The company’s flagship product, Amtagvi, is a personalized treatment for melanoma that received FDA approval last year [3][4]. Market Performance - The stock has declined by 74% over the past 12 months, trading under $4 per share, which is close to its 52-week low [2]. - Analysts have a bullish outlook, with price targets ranging from $6 to $32, and an average target of $19.54 [2]. Product Details - Amtagvi takes 34 days to manufacture and is administered in specialized treatment centers, which complicates its rollout [4]. - Iovance reported $164.1 million in revenue last year and has only begun to address the 20,000 eligible melanoma patients in the U.S. [5]. Market Potential - There are an estimated 325,000 annual melanoma cases worldwide, indicating a significant market opportunity for Iovance [6]. - The company is seeking regulatory approvals in additional countries, potentially expanding its patient base by 2025 [5][8]. Future Projections - Iovance anticipates product revenue for Amtagvi to be between $450 million and $475 million in 2025 [9]. - The company has a pipeline of over a dozen programs, including trials for non-small cell lung cancer, which could serve as catalysts for growth [10]. Financial Outlook - Iovance aims to keep its cash burn under $300 million for 2025, which is below its projected revenue range [11]. - The company improved its net loss per share from $1.89 in 2023 to $1.28 in 2024, indicating progress in financial performance [12].

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After working as a Registered Nurse for several years, I transitioned into financial analysis, earning my MBA and developing expertise in healthcare & technology investments. Since 2017, I've published investment analyses on Seeking Alpha, focusing on thorough valuation modeling. My approach centers on examining core assumptions that drive stock valuations, particularly through detailed discounted cash flow analysis. I provide readers with various scenarios to help them understand potential outcomes. The pr ...

Core Insights - Iovance Biotherapeutics reported a narrower loss of 26 cents per share for Q4 2024, compared to a loss of 45 cents per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of 27 cents [1][7] - The company generated total revenues of $73.7 million in Q4 2024, significantly up from $0.5 million in the year-ago quarter, and exceeding the Zacks Consensus Estimate of $72.1 million [2][7] Revenue Breakdown - Iovance's revenue for Q4 2024 was driven by sales from two marketed drugs: Proleukin and Amtagvi [3] - Amtagvi sales reached $48.7 million in Q4 2024, up from $42.1 million in Q3 2024, although it fell short of the model estimate of $57 million [4] - Proleukin contributed $25 million in sales during the quarter, a significant increase from $0.5 million in the year-ago period, surpassing the model estimate of $15 million [5] Operating Costs - Research and development expenses decreased by 17% to $72.2 million compared to the previous year, attributed to the transition to commercial manufacturing of Amtagvi [6] - Selling, general, and administrative expenses increased by 42% to $42.5 million, driven by higher headcount and related costs [6] Full-Year Performance - For the full year 2024, Iovance reported total revenues of $164.1 million, a substantial increase from $1.2 million in the previous year [7] - The company incurred a loss of $1.28 per share for 2024, an improvement from a loss of $1.89 per share in the prior year [7] Future Guidance - Iovance reiterated its revenue guidance for 2025, expecting product revenues to be between $450 million and $475 million, with cash burn projected to be under $300 million [8] - The company anticipates significant growth in total product revenues for 2026 and beyond, with gross margins expected to exceed 70% in the coming years [9] Pipeline Updates - Regulatory applications for Amtagvi in melanoma are under review in the EU, UK, and Canada, with potential approvals expected this year [13] - Iovance is conducting a phase III study evaluating Amtagvi combined with Merck's Keytruda for frontline advanced melanoma [14] - The company is also accelerating enrollment in a phase II study for Amtagvi in post-anti-PD-1 non-small cell lung cancer, with updates expected by year-end [15]

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2024 Earnings Conference Call February 27, 2024 4:30 PM ET Company Participants Sara Pellegrino - SVP, IR and Corporate Communications Fred Vogt - Interim CEO and President Dan Kirby - CCO Igor Bilinsky - COO Jean-Marc Bellemin - CFO Friedrich Graf Finckenstein - CMO Conference Call Participants Andrea Newkirk - Goldman Sachs Peter Lawson - Barclays Ben Burnett - Stifel Colleen Kusy - Baird Yanan Zhu - Wells Fargo Securities Asthika Goonewardene - Truist Reni ...

Iovance Biotherapeutics (IOVA) Q4 2024 Earnings Call March 01, 2025 01:56 AM ET Company Participants Sara Pellegrino - Senior Vice President, Investor Relations and Corporate CommunicationsFrederick Vogt - Interim CEO, President, General Counsel & Corporate SecretaryDan Kirby - Chief Commercial OfficerIgor Bilinsky - Chief Operating OfficerJean-Marc Bellemin - Chief Financial OfficerFriedrich Graf Finckenstein - Chief Medical OfficerAndrea Newkirk - Biotechnolgy Equity ResearchBenjamin Burnett - DirectorNic ...

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 3.70%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.31 per share when it actually produced a loss of $0.28, delivering a surprise of 9.68%.Over the last four quarters, the ...

FDA Approvals and Product Launches - Amtagvi® (lifileucel) received FDA approval on February 16, 2024, for treating adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody [596]. - The company plans to launch Amtagvi® in additional markets, including the EU, UK, Canada, Switzerland, and Australia, with potential annual addressable patients exceeding 20,000 [588]. - The iCTC is the first FDA-approved facility for commercial TIL cell therapy, allowing the company to control manufacturing capacity and product quality [606]. Manufacturing and Capacity - The iCTC manufacturing facility has a capacity to treat several thousand cancer patients annually, with ongoing expansion expected to increase capacity to over 5,000 patients per year [606]. - The company has conducted over 700 patient treatments with TIL cell therapy products in clinical trials, demonstrating the viability of its proprietary manufacturing processes [605]. Financial Performance - Revenue for the year ended December 31, 2024, increased by $162.9 million, or 13,698%, compared to the same period in 2023, driven by the acquisition of worldwide rights to Proleukin® and the commercial launch of Amtagvi® [631]. - Amtagvi® generated revenue of $103.6 million in 2024, while Proleukin® contributed $60.5 million, marking a significant increase in product sales [631]. - The company began generating revenue for Amtagvi® in the second quarter of 2024 following its FDA approval in February 2024 [631]. Clinical Trials and Research Development - The company is conducting multiple clinical trials for lifileucel in various cancers, including advanced melanoma, non-small cell lung cancer, and endometrial cancer, with significant patient enrollment expected [612]. - IOV-4001, a next-generation TIL cell therapy, is currently in a Phase 2 clinical trial for advanced melanoma and NSCLC, utilizing TALEN® gene-editing technology [612]. - IOV-5001, another next-generation TIL therapy, is in IND-enabling studies, with a pre-IND meeting planned with the FDA in Q1 2025 [613]. Expenses and Financial Outlook - The company anticipates an increase in selling, general, and administrative expenses as it executes the launch of Amtagvi® and expands its market presence [627]. - Research and development expenses are expected to continue as the company conducts clinical trials for various product candidates, with a potential decrease in these expenses as commercial activities increase [625]. - The company expects to continue incurring net losses in the future as it invests in clinical and internal research and development programs [644]. Intellectual Property - The company has established a leading intellectual property portfolio with over 75 U.S. patents related to TIL cell therapy, which are expected to extend to October 2037 or January 2038 [615]. Cash Flow and Liquidity - As of December 31, 2024, the company had $330.1 million in cash, cash equivalents, and investments, indicating a strong liquidity position [659]. - Cash used in operating activities decreased by $8.8 million to $353.0 million in 2024, reflecting improved revenue generation from product commercialization [669]. Acquisitions and Inventory - Proleukin® (aldesleukin) was acquired in May 2023, providing an additional revenue source and securing the supply chain for the treatment regimen [603]. - The Proleukin® inventory previously held by distributors has been substantially sold, leading to significant re-stocking demand from specialty distributors in the second and third quarters of 2024 [631]. Tax and Regulatory Matters - The income tax benefit for 2023 was $3.5 million, resulting from the realization of deferred taxes for operations in the UK [657]. - The company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements, effective for fiscal year 2025 [703]. Market and Currency Considerations - The majority of product sales during the year ended December 31, 2024, were denominated in U.S. dollars, with some sales in foreign currencies [708]. - Foreign currency transaction gains and losses were immaterial for the years ended December 31, 2024, and 2023 [708].

Corporate Overview February 2025 © 2025, Iovance Biotherapeutics, Inc. © 2025, Iovance Biotherapeutics, Inc. 1 1 Forward-Looking Statements Certain matters discussed in this presentation 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," "potent ...