Iovance Biotherapeutics (IOVA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Good day and thank you for standing by. Welcome to the Iovance Biotherapeutics First Quarter twenty twenty five Financial Results Conference Call. At this time, participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will press 11 on your telephone. You will then hear an automated message advising your hand is raised. ...

PART I FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited condensed consolidated financial statements, including balance sheets, operations, comprehensive loss, equity, and cash flows, with notes on accounting policies and liquidity for Q1 2025 and Q4 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of March 31, 2025, and December 31, 2024 | ASSETS (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Cash and cash equivalents | $171,668 | $115,694 | | Trade accounts receivable | $70,938 | $69,340 | | Short-term investments | $188,045 | $208,087 | | Inventory | $65,545 | $51,520 | | Total Current Assets | $512,649 | $457,018 | | Total Assets | $966,740 | $910,426 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Total Current Liabilities | $122,693 | $122,341 | | Total Liabilities | $198,875 | $200,021 | | Total Stockholders' Equity | $767,865 | $710,405 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Details the company's revenues, costs, expenses, and net loss for the three months ended March 31, 2025, and March 31, 2024 | (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------- | :-------------------------------- | :-------------------------------- | | Product revenue | $49,324 | $715 | | Total revenue | $49,324 | $715 | | Cost of sales | $49,741 | $7,261 | | Research and development | $76,879 | $79,783 | | Selling, general, and administrative | $43,925 | $31,393 | | Total costs and expenses | $170,545 | $118,437 | | Loss from operations | $(121,221) | $(117,722) | | Net Loss | $(116,163) | $(112,976) | | Net Loss Per Share (Basic and Diluted) | $(0.36) | $(0.42) | | Weighted Average Shares Outstanding | 322,868 | 266,220 | [Condensed Consolidated Statements of Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Presents the company's net loss and other comprehensive income/loss components for the three months ended March 31, 2025, and March 31, 2024 | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net Loss | $(116,163) | $(112,976) | | Unrealized gain on investments | $(110) | $(69) | | Foreign currency translation adjustment | $7,450 | $(2,341) | | Comprehensive Loss | $(108,823) | $(115,386) | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Outlines changes in stockholders' equity, including stock-based compensation and net loss, from December 31, 2024, to March 31, 2025 | (in thousands, except share information) | Balance Dec 31, 2024 | Stock-based compensation | Common stock sold (net) | Preferred stock conversion | Unrealized gain on investments | Foreign currency adjustment | Net loss | Balance Mar 31, 2025 | | :--------------------------------------- | :------------------- | :----------------------- | :---------------------- | :------------------------- | :----------------------------- | :-------------------------- | :------- | :------------------- | | Total Stockholders' Equity | $710,405 | $22,970 | $148,942 | $0 | $(110) | $7,450 | $(116,163) | $767,865 | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash flows from operating, investing, and financing activities for the three months ended March 31, 2025, and March 31, 2024 | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(103,694) | $(122,279) | | Net cash provided by (used in) investing activities | $15,867 | $(111,506) | | Net cash provided by financing activities | $143,315 | $193,576 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $55,996 | $(40,700) | [NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY](index=13&type=section&id=NOTE%201.%20GENERAL%20ORGANIZATION%2C%20BUSINESS%20AND%20LIQUIDITY) Iovance Biotherapeutics, a commercial-stage biopharmaceutical company, focuses on TIL cell therapies, launching Amtagvi® for melanoma and expanding globally, while managing liquidity amidst ongoing net losses - Amtagvi® (lifileucel) is the first and only one-time, individualized T cell therapy to receive U.S. FDA accelerated approval for a solid tumor cancer, specifically for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor[30](index=30&type=chunk) - The company plans to launch Amtagvi® into additional markets with high prevalence of advanced melanoma, including the EU, UK, Canada, Switzerland, and Australia, with regulatory submissions already made or accepted in these regions, anticipating potential NDS approval in Canada by mid-2025[31](index=31&type=chunk) - Iovance manufactures Amtagvi® and investigational TIL cell therapies using centralized, scalable, and proprietary processes at its Iovance Cell Therapy Center (iCTC) and through a contract manufacturing organization (CMO)[33](index=33&type=chunk) Liquidity Position (in thousands) | Metric | March 31, 2025 | | :------------------------------------ | :------------- | | Cash, cash equivalents, and restricted cash | $178,049 | | Short-term investments | $188,045 | | Total available funds | $366,100 | | Net loss (three months ended) | $(116,163) | | Net cash used in operating activities (three months ended) | $(103,694) | [NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=15&type=section&id=NOTE%202.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the company's significant accounting policies for cash, investments, inventory, revenue recognition, stock-based compensation, R&D, SG&A, net loss per share, and use of estimates - Revenue for Amtagvi® is recognized upon patient infusion, while Proleukin® revenue is recognized upon transfer of control (shipment or receipt), reduced by gross to net adjustments for chargebacks, returns, rebates, and discounts[62](index=62&type=chunk)[63](index=63&type=chunk) - Upon FDA approval of Amtagvi® in February 2024, the company began capitalizing inventory and manufacturing costs for commercial Amtagvi®, expensing costs incurred prior to approval or for clinical/R&D use as R&D[49](index=49&type=chunk) Common Stock Equivalents Excluded from Diluted Net Loss Per Share Calculation (as of March 31) | Category | 2025 | 2024 | | :-------------------------- | :----------- | :----------- | | Stock options | 18,798,667 | 18,697,395 | | Restricted stock units | 12,160,195 | 12,080,735 | | Employee Stock Purchase Plan | 367,096 | 296,751 | | Series A Convertible Preferred Stock* | 97,000 | 97,000 | | Series B Convertible Preferred Stock* | 1,932,667 | 2,842,158 | | **Total** | **33,355,625** | **34,014,039** | [NOTE 3. CASH EQUIVALENTS AND INVESTMENTS](

Exhibit 99.1 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 to $250M-$300M 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 Biother ...

Financial Performance - Total product revenue for Q1 2025 was $49.3 million, with $43.6 million from Amtagvi and $5.7 million from Proleukin [3][14] - The company revised its full-year 2025 revenue guidance to a range of $250 million to $300 million, reflecting recent launch dynamics and growth trajectories [3][2] - The net loss for Q1 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 Q1 2024 [13][29] Product and Market Updates - Iovance has treated over 275 Amtagvi patients in the first 12 months of its U.S. launch, generating more than $210 million in revenue [2] - The company expects to infuse between 100 and 110 commercial patients in Q2 2025, following the resumption of full production at the Iovance Cell Therapy Center [3][2] - Regulatory approvals for Amtagvi are anticipated in the UK, EU, and Canada in 2025, with additional regulatory submissions planned for Australia and Switzerland [3][4] Operational Insights - As of March 31, 2025, Iovance had cash and cash equivalents of approximately $366 million, sufficient to fund operations into the second half of 2026 [4][13] - The company is focused on optimizing spending and reducing expenses, with cash burn for 2025 expected to remain below $300 million [4][3] - Manufacturing capacity is being expanded to support the anticipated growth in patient infusions, with a goal to serve over 5,000 patients annually in the coming years [12][9] Research and Development - Iovance is on track to report updated clinical data for its registrational trial in previously treated advanced non-small cell lung cancer (NSCLC) in the second half of 2025 [3][12] - The company is actively enrolling patients in trials for lifileucel in advanced endometrial cancer and is pursuing a frontline therapy strategy for NSCLC [12][12] - The next-generation TIL pipeline includes investigational therapies utilizing gene-editing technologies and modified interleukin-2 [12][12] Market Position and Strategy - Iovance's patent portfolio includes approximately 280 granted or allowed patents, providing exclusivity for its TIL therapies through at least 2042 [10] - The company is well-positioned in the current macroeconomic and geopolitical environment, with all manufacturing and intellectual property located in the U.S. [4][4] - Community referral activities are accelerating, creating significant opportunities for patient volume growth at treatment centers [8][8]

Company Overview - Iovance Biotherapeutics, Inc. is focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients [3] - The company aims to be a global leader in TIL therapies, utilizing the human immune system to target diverse cancer cells [3] - Iovance's product, Amtagvi®, is the first FDA-approved T cell therapy for a solid tumor indication, showcasing the company's commitment to continuous innovation in cell therapy [3] Upcoming Financial Results - Iovance will report its first quarter 2025 financial results and corporate updates on May 8, 2025 [1] - A conference call and live audio webcast will be held on the same day at 4:30 p.m. ET to discuss these results [2] Product Development and Market Position - The Iovance TIL platform has shown promising clinical data across multiple solid tumors, indicating potential for future growth [3] - The company is also involved in gene-edited cell therapy, which may enhance treatment options for cancer patients [3]

Group 1: Iovance Biotherapeutics - Iovance Biotherapeutics specializes in cancer treatment and received approval for Amtagvi, a therapy for advanced melanoma, which is the first of its kind for solid tumors [3][4] - The company generated $164.1 million in revenue last year, a significant increase from the previous year when it had minimal revenue [4] - Despite the approval and revenue growth, the stock has underperformed due to market dynamics and the complexity of administering TIL therapies, which take 34 days to manufacture [5] - The stock is currently priced under $4 per share, and the company is pursuing regulatory approvals and label expansions for Amtagvi, which could lead to significant upside potential [6] Group 2: CRISPR Therapeutics - CRISPR Therapeutics develops gene-editing therapies using the CRISPR/Cas9 technique and received approval for Casgevy, the first CRISPR medicine, which treats rare blood disorders [8] - The company has not generated substantial revenue since the approval, as manufacturing ex vivo gene-editing therapies is complex and time-consuming [9] - Casgevy is priced at $2.2 million in the U.S., targeting a market of approximately 58,000 patients with minimal competition, indicating potential for significant revenue once it gains traction [10] - The company has delivered returns comparable to the broader market since its IPO in 2016, and long-term investors may benefit from future breakthroughs in gene-editing products [11][13]

Core Insights - Iovance Biotherapeutics, Inc. is focused on developing novel tumor infiltrating lymphocyte (TIL) therapies for cancer patients, with pre-clinical data for IOV-5001 and five-year outcomes data for lifileucel to be presented at upcoming major oncology meetings [1][6] Group 1: Company Overview - Iovance aims to be a global leader in TIL therapies, utilizing the human immune system to target diverse cancer cells [3] - The company has achieved FDA approval for Amtagvi, the first T cell therapy for a solid tumor indication, and is committed to continuous innovation in cell therapy [3] Group 2: Upcoming Presentations - Pre-clinical data for IOV-5001 will be presented at the 2025 AACR Annual Meeting, highlighting its enhanced antitumor efficacy [1][6] - Five-year outcomes from the C-144-01 study of lifileucel in advanced melanoma will be shared at the 2025 ASCO Annual Meeting [1][6] - A trial-in-progress poster for lifileucel in frontline advanced non-small cell lung cancer will also be presented at the ASCO meeting [6] Group 3: Events and Engagement - Iovance will host a panel discussion featuring key opinion leaders in melanoma on May 31, 2025, with a live and archived webcast available on the company's website [6]

Core Viewpoint - Iovance Biotherapeutics has an approved drug, Amtagvi, for treating unresectable or metastatic melanoma, but its stock has significantly declined, raising concerns among investors about its future performance [1][2]. Group 1: Stock Performance and Market Sentiment - Iovance's stock has fallen approximately 57% since the beginning of the year as of April 22, indicating a significant sell-off [5]. - The percentage of short-sellers in relation to Iovance's float has been increasing, reflecting growing skepticism about the company's future success [3]. Group 2: Financial Health and Cash Flow - Iovance is experiencing poor cash flow, which may lead to further dilution for shareholders as the company has historically relied on issuing stock to fund operations [11]. - As of the end of 2024, Iovance had cash and short-term investments totaling $323.8 million, but ongoing high cash burn could deplete this cushion over time [10]. Group 3: Future Revenue Potential - Although Amtagvi has the potential to generate $1 billion in annual revenue, this is not expected until 2030, which raises concerns about the company's ability to achieve profitability in the near term [7][12]. - Iovance reported a net loss of $372.2 million last year, highlighting the financial challenges it faces [12].

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Core Insights - The biotech industry presents opportunities for significant returns in short timeframes due to clinical or regulatory advancements, with several companies projected to see substantial share price increases in the next year [1][2] Group 1: CRISPR Therapeutics - CRISPR Therapeutics is a leading gene-editing company that received approval for its therapy Casgevy, the first CRISPR-based medicine, but has struggled with sales post-approval due to complex administration [3][4] - Wall Street's average price target for CRISPR Therapeutics is $84.62, indicating a potential upside of 159%, making it a long-term investment consideration despite short-term volatility [4][5] - The company has a promising pipeline, including potential treatments for type 1 diabetes and cancer, appealing to risk-tolerant investors [5] Group 2: Iovance Biotherapeutics - Iovance Biotherapeutics specializes in cancer therapies using tumor-infiltrating lymphocytes and gained U.S. approval for Amtagvi to treat melanoma, achieving $164.1 million in revenue in 2024 [6][7] - The stock has a price target of $20.91, suggesting a potential upside of 543%, with upcoming regulatory approvals and a large patient base in the U.S. as catalysts for growth [7][8] - Iovance could be an attractive option for patient investors, given its innovative approach and potential for further clinical successes [9] Group 3: Regeneron - Regeneron is a well-established biotech firm facing challenges with its key product Eylea due to competition, but has a price target of $914.55, indicating a 50% upside [10] - A legal battle over Eylea's biosimilar could significantly impact share prices, while the success of Dupixent and a robust pipeline enhance its investment appeal [11][12] - The company has initiated a dividend program and continues share buybacks, reinforcing its position as a strong long-term investment [12] Group 4: Sarepta Therapeutics - Sarepta Therapeutics focuses on gene therapies for rare diseases and recently launched Elevidys, but faced a setback with a patient death linked to liver failure [13][14] - Despite the controversy, the average price target remains at $165.35, suggesting an upside of 182%, contingent on clarifying the cause of the patient's death [14][15] - Given the current uncertainty surrounding Elevidys, caution is advised for potential investors until more information is available [15]