Iovance Biotherapeutics(IOVA) - 2024 Q1 - Quarterly Results

Executive Summary and Company Overview First Quarter 2024 Overview Iovance Biotherapeutics reported strong momentum for its Amtagvi™ (Lifileucel) U.S. launch following FDA approval for advanced melanoma, with over 100 patients enrolled and expansion of Authorized Treatment Centers (ATCs) - Amtagvi™ (Lifileucel) received U.S. FDA approval on February 16, 2024, as the first T cell therapy for a solid tumor indication in advanced melanoma[1][3][4] - Over 100 patients have enrolled for Amtagvi therapy since approval, with successful manufacturing and delivery to many ATCs[1][3][4] - The company expects strong launch momentum to continue throughout 2024, with plans to expand ATCs to approximately 50 by end of May and over 70 by year-end[1][3][4] Recent Highlights and Corporate Updates Amtagvi U.S. Approval and Launch in Advanced Melanoma Following FDA approval in February 2024, Amtagvi has seen high demand, with over 100 patients enrolled and successful treatment initiation, rapidly expanding its network of Authorized Treatment Centers (ATCs) and securing strong reimbursement coverage - Amtagvi was approved on February 16, 2024, as the first treatment option for advanced melanoma after anti-PD-1 and targeted therapy, and the first and only FDA-approved T cell therapy for a solid tumor indication[4] Amtagvi Launch Metrics | Metric | Status/Target | | :----- | :------------ | | Patients Enrolled | >100 | | ATCs Onboarded (Current) | >40 | | ATCs Onboarded (End of May 2024) | ~50 | | ATCs Onboarded (End of 2024) | >70 | | Manufacturing Turnaround Time | ~34 days (on-target) | | Reimbursement Coverage | >75% by private payers, >200M lives authorized | - Amtagvi was added as a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network® guidelines for treatment of cutaneous melanoma[4] Lifileucel Launch Expansion and Pipeline Highlights Iovance is pursuing global regulatory submissions for Amtagvi in advanced melanoma and advancing lifileucel in other indications, including frontline advanced melanoma, NSCLC, and endometrial cancer, with several trials underway or planned Geographic Expansion The company plans to expand Amtagvi's reach into key international markets, with regulatory submissions scheduled for the EU, UK, Canada, Australia, and other countries, aiming to significantly increase the addressable patient population - Geographic expansion can more than double the total addressable patient population for Amtagvi in advanced melanoma[9] Amtagvi Regulatory Submission Timeline | Market | Regulatory Submission Timeline | | :----- | :----------------------------- | | EU | Q2 2024 | | UK & Canada | H2 2024 | | Australia & Additional Countries | 2025 | Lifileucel in Frontline Advanced Melanoma The registrational Phase 3 TILVANCE-301 trial for Amtagvi in combination with pembrolizumab is progressing well, supported by positive data from the IOV-COM-202 trial, which will be presented at ASCO 2024 - The registrational Phase 3 TILVANCE-301 trial is well underway to support accelerated and full U.S. approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma[9] - Global site activation and patient enrollment continue with strong momentum in the U.S., Europe, Australia, Canada, and additional countries[9] - An oral presentation of updated clinical data from Cohort 1A of the IOV-COM-202 trial, supporting the rationale for TILVANCE-301, will be presented at ASCO on May 31, 2024[9] Lifileucel in Non-Small Cell Lung Cancer (NSCLC) Enrollment has resumed for the registrational Phase 2 IOV-LUN-202 trial in post-anti-PD-1 NSCLC following the lifting of a partial clinical hold, with positive FDA feedback on trial design and potency matrix - Enrollment resumed for new patients in the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC soon after the U.S. FDA lifted a partial clinical hold in Q1 2024[9] - The FDA provided positive regulatory feedback on the proposed potency matrix for lifileucel in NSCLC and previously indicated that the single-arm trial design may be acceptable for approval[9] - Registrational cohorts are expected to be fully enrolled in 2025[9] Lifileucel in Endometrial Cancer A Phase 2 trial for lifileucel in advanced endometrial cancer is set to begin in Q2 2024, targeting patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy, addressing a significant unmet medical need - A Phase 2 trial of lifileucel in advanced endometrial cancer patients is on track to initiate in Q2 2024[9] - The trial will enroll patients with advanced endometrial cancer who progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy regardless of mismatch repair (MMR) status[9] - Endometrial cancer represents a significant opportunity, with an estimated 67,880 new cases and 13,250 deaths expected in the U.S. in 2024, and no currently approved therapies in the emerging second-line setting[9] Next Generation TIL Pipeline Iovance is advancing its next-generation TIL therapies, including IOV-4001 (PD-1 inactivated TIL) which is moving into Phase 2 efficacy, and preparing IND submissions for IOV-3001 (modified IL-2 fusion protein) and IOV-5001 (cytokine-tethered TIL therapy) - IOV-4001 (PD-1 Inactivated TIL Cell Therapy) has concluded its Phase 1 safety portion and is progressing successfully into the multi-center Phase 2 efficacy stage for previously treated advanced melanoma and NSCLC[14] - Iovance plans to submit an Investigational New Drug application (IND) for a Phase 1/2 clinical trial of IOV-3001, a modified interleukin-2 (IL-2) fusion protein, for use in the TIL therapy treatment regimen in Q3 2024[14] - IOV-5001, a genetically engineered, inducible, and tethered IL-12 TIL cell therapy, is in IND-enabling studies, with an INTERACT meeting planned with the FDA in Q3 2024, followed by an IND submission in early 2025[14] Manufacturing Capacity Expansion The Iovance Cell Therapy Center (iCTC) and a contract manufacturer currently have capacity for several thousand patients annually, with ongoing expansion at iCTC to support over 5,000 patients annually in the coming years - The Iovance Cell Therapy Center (iCTC), and a nearby FDA-approved contract manufacturer, are built today for capacity for several thousands of patients annually[11] - Capacity expansion is currently underway at iCTC to supply TIL cell therapies for more than 5,000 patients annually in the next few years[11] Upcoming ASCO 2024 Highlights Iovance will present updated clinical data for lifileucel in advanced melanoma, preclinical results for IOV-3001, and dynamics of circulating cytokines during lifileucel therapy at the ASCO 2024 Annual Meeting - An oral presentation will cover updated efficacy and safety data of lifileucel and pembrolizumab in immune checkpoint inhibitor-naive unresectable or metastatic melanoma from IOV-COM-202 Cohort 1A on May 31, 2024[15] - A poster will present data on IOV-3001, a modified interleukin-2 fusion protein, for potential use in tumor-infiltrating lymphocyte cell therapy regimens on June 1, 2024[15] - Another poster will detail the dynamics of circulating cytokines and chemokines during and after tumor-infiltrating lymphocyte cell therapy with lifileucel in advanced melanoma patients on June 1, 2024[15] Other Corporate Updates Iovance reported a strong cash position, sufficient to fund operations into H2 2025, and has begun recognizing significant Proleukin revenues, also highlighting its extensive patent portfolio, providing exclusivity for TIL technologies into 2038 and 2042 Cash Position (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :----- | :------------- | :---------------- | :----- | | Cash, cash equivalents, investments, and restricted cash | $362,600 | $346,300 | +$16,300 | - The current cash position and anticipated revenue from Amtagvi and Proleukin are expected to be sufficient to fund current and planned operations well into the second half of 2025[15] - Iovance is now recognizing all Proleukin revenues for commercial and clinical use and expects to recognize significant incremental revenues for Proleukin as part of the Amtagvi treatment regimen beginning in Q2 2024[15] - The company owns more than 120 granted or allowed U.S. and international patents for TIL-related technologies, with Gen 2 patent rights expected to provide exclusivity into 2038 and additional patent rights into 2042[16] First Quarter 2024 Financial Results Overview of Financial Performance Iovance reported a net loss of $113.0 million for Q1 2024, a slight increase from $107.4 million in Q1 2023, primarily due to amortization of intangible assets from the Proleukin acquisition, partially offset by initial Proleukin revenue Net Loss Summary (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss | $(112,976) | $(107,370) | $(5,606) | | Net Loss Per Share (Basic & Diluted) | $(0.42) | $(0.50) | $0.08 | - The net loss for Q1 2024 includes amortization of intangible assets acquired as part of the Proleukin transaction[17] Revenue and Cost of Sales For Q1 2024, Iovance recognized its first product revenue of $0.7 million from Proleukin sales in ex-U.S. licensed markets, incurring $7.3 million in cost of sales primarily related to inventoriable costs and non-cash amortization Revenue and Cost of Sales (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Product Revenue | $715 | $0 | +$715 | | Total Revenue | $715 | $0 | +$715 | | Cost of Sales | $7,261 | $0 | +$7,261 | - Cost of sales was primarily related to inventoriable costs associated with sales of Proleukin and non-cash amortization expense for the acquired intangible asset for developed technology[18] Operating Expenses Research and development (R&D) expenses decreased slightly to $79.8 million due to the transition to commercial Amtagvi manufacturing, while selling, general and administrative (SG&A) expenses increased to $31.4 million, driven by headcount and commercialization efforts Operating Expenses (in thousands) | Expense Category | Q1 2024 | Q1 2023 | Change (YoY) | | :--------------- | :------ | :------ | :----------- | | Research and Development | $79,783 | $82,734 | $(2,951) | | Selling, General and Administrative | $31,393 | $28,122 | +$3,271 | - The decrease in R&D was primarily attributable to the transition to commercial Amtagvi manufacturing, partially offset by increased costs associated with raw materials, clinical trials (Phase 3 TILVANCE-301), and planned EU regulatory submissions[19] - The increase in SG&A was primarily attributable to increases in headcount and related costs, including stock-based compensation, to support business growth and Amtagvi/Proleukin commercialization, partially offset by a decrease in legal costs[20] Selected Condensed Consolidated Balance Sheets As of March 31, 2024, Iovance reported an increase in cash, cash equivalents, and investments to $356.2 million, and total assets to $869.8 million, reflecting a stronger financial position compared to December 31, 2023 Selected Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :----- | :------------- | :---------------- | :----- | | Cash, cash equivalents, and investments | $356,195 | $279,867 | +$76,328 | | Restricted cash | $6,430 | $66,430 | $(60,000) | | Total assets | $869,830 | $780,351 | +$89,479 | | Stockholders' equity | $680,024 | $584,613 | +$95,411 | About Iovance Biotherapeutics, Inc. Company Mission and Focus Iovance Biotherapeutics, Inc. aims to be a global leader in TIL therapies, pioneering an approach to cure cancer by harnessing the human immune system, with Amtagvi as the first FDA-approved T cell therapy for a solid tumor - Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer[24] - Iovance's Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication[24] - The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer[24] Forward-Looking Statements Disclaimer and Risk Factors This section contains forward-looking statements subject to various risks and uncertainties, including those related to product commercialization, regulatory approvals, manufacturing capacity, market acceptance, reimbursement, and financial performance - 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[26] - Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of the company's control, that may cause actual results to be materially different[26] - Important factors that could cause actual results to differ materially include risks related to successful commercialization of products, regulatory approvals, market acceptance, pricing and reimbursement, manufacturing capacity, and the timing of clinical trials[26]