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 ...

Exhibit 99.1 Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Fourth Quarter and Full Year 2024 Significant Demand for Amtagvi® (Lifileucel) Continues with Total Product Revenue of $73.7M in 4Q24 and $164.1M in FY24, Achieving Upper End of FY24 Guidance Range of $160M-$165M Reaf irming FY25 Total Product Revenue Guidance of $450M-$475M FY25 Cash Burn Anticipated to be Under $300M 2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada Enrollment Accelerating Acros ...

Significant Demand for Amtagvi® (Lifileucel) Continues with Total Product Revenue of $73.7M in 4Q24 and $164.1M in FY24, Achieving Upper End of FY24 Guidance Range of $160M-$165M Reaffirming FY25 Total Product Revenue Guidance of $450M-$475M FY25 Cash Burn Anticipated to be Under $300M 2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada Enrollment Accelerating Across Global Registrational Trials in Frontline Advanced Melanoma and Previously Treated Advanced NSCLC SAN CARLOS, Calif., F ...

Significant Demand for Amtagvi® (Lifileucel) Continues with Total Product Revenue of $73.7M in 4Q24 and $164.1M in FY24, Achieving Upper End of FY24 Guidance Range of $160M-$165M Reaffirming FY25 Total Product Revenue Guidance of $450M-$475M FY25 Cash Burn Anticipated to be Under $300M 2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada Enrollment Accelerating Across Global Registrational Trials in Frontline Advanced Melanoma and Previously Treated Advanced NSCLC SAN CARLOS, Calif., F ...

Industry Overview - The fourth-quarter 2024 earnings season for the Medical sector is concluding, with major companies reporting results, primarily in pharma/biotech and medical devices [1] - As of February 19, 85.2% of companies in the Medical sector reported quarterly earnings, with 82.7% surpassing earnings estimates and 78.8% exceeding revenue expectations [2] - Year-over-year earnings increased by 14.2%, while revenues rose by 9.4%, with overall fourth-quarter earnings expected to increase by 13.8% and sales by 9.3% compared to the previous year [2] Company Summaries Viatris (VTRS) - Viatris has a mixed earnings surprise history, beating estimates in two of the last four quarters with an average surprise of 0.33% [4] - For the upcoming quarter, Viatris has an Earnings ESP of -3.51% and a Zacks Rank of 4, with a consensus estimate for earnings per share at 57 cents [6] - Sales growth is anticipated from emerging markets and business expansion in Greater China, alongside improved performance in the generics business due to new product launches [7] Perrigo (PRGO) - Perrigo also has a mixed earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 8.41% [8] - The company has an Earnings ESP of -4.92% and a Zacks Rank of 4, with a consensus estimate for earnings per share at 92 cents [8] - Revenue declines are expected in its Consumer Self Care segments due to lower net product sales in the U.S. and unfavorable currency movements [9] Novavax (NVAX) - Novavax has struggled, missing earnings expectations in three of the last four quarters, with an average negative surprise of 56.95% [11] - The company has an Earnings ESP of -48.54% and a Zacks Rank of 3, with a consensus estimate for a loss per share at 75 cents [11] - Vaccine sales for Novavax are expected to be minimal during the quarter [12] Intellia Therapeutics (NTLA) - Intellia has a mixed earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 4.02% [13] - The company has an Earnings ESP of +35.03% and a Zacks Rank of 2, indicating a good chance of an earnings beat, with a consensus estimate for a loss per share at $1.32 [14] - Revenue is likely to be driven by collaboration revenues, with updates on clinical-stage pipeline candidates expected during the conference call [15] Iovance Biotherapeutics (IOVA) - Iovance has a mixed earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 5.55% [16] - The company has an Earnings ESP of +7.90% and a Zacks Rank of 4, with a consensus estimate for a loss per share at 27 cents [16] - Revenue growth is anticipated from sales of its marketed drugs, Proleukin and the recently-approved TIL therapy Amtagvi [17]

Core Insights - Iovance Biotherapeutics, Inc. will report its fourth quarter and full year 2024 financial results and corporate updates on February 27, 2025 [1] - A live audio webcast will be hosted by management to discuss these results at 4:30 p.m. EST on the same day [2] - The company aims to be a global leader in tumor infiltrating lymphocyte (TIL) therapies for cancer treatment, with a focus on continuous innovation [5] Financial Results and Corporate Updates - The financial results for Q4 and full year 2024 will be disclosed on February 27, 2025 [1] - The live audio webcast for discussing these results will be available for registration [2][4] Upcoming Events - Iovance will participate in TD Cowen's 45th Annual Health Care Conference on March 3, 2025, and Barclays 27th Annual Global Healthcare Conference on March 13, 2025 [8]

Core Viewpoint - Iovance Biotherapeutics has seen a significant decline in its stock price despite initial excitement over the FDA approval of its treatment, Amtagvi, for melanoma, raising questions about its financial health and future prospects [1][2]. Financial Performance - Iovance's stock peaked at over $18 in February but has since dropped by 32%, currently trading at just over $6 [2]. - The company reported $58.6 million in sales for the most recent quarter, falling short of its $147.6 million in expenses for the same period [3]. - Projected revenue for 2025 is estimated to be between $450 million and $475 million, which may still not cover the company's expenses [4]. Cash Flow and Expenses - Over the past three quarters, Iovance has burned through $279.7 million in cash from operations, with $397.5 million in cash and equivalents reported at the end of September [5]. - The company is facing increasing costs as it commercializes Amtagvi, which may lead to further cash burn [4]. Share Dilution Concerns - Iovance has been increasing its share count significantly, raising concerns about potential stock offerings to secure cash for operations [6]. - An increase in share supply could lead to a declining stock price unless investor sentiment improves [7]. Long-term Potential - Despite current losses and cash burn, Iovance is in the early growth stages, with potential revenue from Amtagvi projected to reach $846 million by 2029 [8]. - With a market capitalization of less than $2 billion, Iovance may represent an undervalued investment opportunity, albeit with associated risks [9]. - Investors willing to take on risk may find Iovance appealing due to its modest valuation and growth potential [10].

Core Viewpoint - Iovance Biotherapeutics has an innovative cancer treatment approach but has struggled with investor confidence, resulting in a 71% decline in share price over the past five years [1] Company Overview - Iovance focuses on enhancing patients' cancer-fighting cells, specifically tumor-infiltrating lymphocytes (TILs), by collecting and reinserting them after manufacturing treatments [2] - The company received regulatory approval for its advanced melanoma treatment, Amtagvi, in February 2024 [2] Manufacturing and Administration Challenges - The manufacturing process for Amtagvi takes 34 days and can only be conducted in specialized centers, which may hinder the company's growth over the next five years [3] - Iovance is seeking approval for Amtagvi in multiple countries, including Canada, the EU, the U.K., Australia, and Switzerland [3] Revenue and Market Potential - In Q3, Iovance reported revenue of $58.6 million, having treated only 146 patients by the end of that period [4] - The company estimates the potential to treat 20,000 patients annually in the U.S. and anticipates total revenue could reach around $1 billion by the end of the decade, driven by Amtagvi's progress [5] Pipeline and Future Indications - Iovance is conducting clinical trials for Amtagvi in new indications, including non-small cell lung cancer (NSCLC), with a target for U.S. approval by 2027 [6] - The company is also exploring treatments for cervical and endometrial cancers, and aims to establish a network of qualified treatment centers by 2030 [7] Financial Outlook and Risks - Revenue growth is expected, but challenges in therapy administration and manufacturing timelines may impact profitability [8] - The company faces risks related to regulatory approvals and potential setbacks in its pipeline, which could significantly affect its market value [9]

Industry Overview - The biopharmaceutical industry is known for producing dramatic market movements due to clinical trial results or regulatory decisions [1] Company Focus: Iovance Biotherapeutics - Iovance Biotherapeutics is pioneering a new approach to treating cancer, with its first therapy, Amtagvi, showing strong sales despite the stock being down 88% from its 2021 peak [2] - The stock is currently underappreciated, with analysts predicting a potential 280% gain from recent prices, targeting $23.77 per share [3] Product Success: Amtagvi - Amtagvi, approved by the FDA for advanced-stage melanoma, has shown promising results, shrinking tumors in 31.5% of patients in clinical trials [5][7] - The therapy involves a complex process of harvesting tumor-infiltrating lymphocytes (TILs) from each patient and requires a weeklong lymphodepletion process before infusion [6] - Third-quarter sales of Amtagvi reached $42 million, with Proleukin sales adding $16.5 million [7] Future Prospects - Iovance expects total 2025 revenue to be between $450 million and $475 million, with potential European approval of Amtagvi expected in the second half of the year [8] - The company is expanding its reach with the phase 3 Tilvance-301 trial for frontline melanoma and a phase 2 lung cancer study, with updated data expected later this year [9] - Iovance is also developing a next-generation TIL therapy, IOV-4001, which aims to improve the effectiveness of TILs by targeting programmed cell death protein 1 [10] Financial Performance - Despite strong product sales, Iovance's gross margin is narrow due to the high manufacturing costs of Amtagvi, with gross profit at 32% of top-line revenue in the third quarter [11] - The company reported $397 million in cash at the end of September 2024, after burning through $294 million in the first nine months of the year [12]