Iovance Biotherapeutics, Inc. (IOVA) incurred a first-quarter 2025 loss of 36 cents per share, wider than the Zacks Consensus Estimate of a loss of 25 cents. In the year-ago quarter, the company reported a loss of 42 cents per share.Quarterly revenues totaled $49.3 million, entirely from the sales of its two marketed drugs. This figure missed the Zacks Consensus Estimate of $80.5 million. In the year-ago quarter, Iovance recorded total revenues of $0.7 million. (Find the latest EPS estimates and surprises o ...

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.42 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -44%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.27 per share when it actually produced a loss of $0.26, delivering a surprise of 3.70%.Over the last four quarters, the c ...

Financial Data and Key Metrics Changes - Total product revenue for Q1 2025 was $49.3 million, including $43.6 million from EMTAGV and $5.7 million from Proleukin, compared to $0.7 million for Proleukin in Q1 2024 [37][38] - Net loss for Q1 2025 was $116.2 million or $0.36 per share, compared to a net loss of $113 million or $0.42 per share for Q1 2024 [37][39] - The average standard gross margin for the first four launch quarters was 32%, with a standard gross margin of 10% for Q1 2025, negatively impacted by lower revenue and higher cost of sales [39][40] Business Line Data and Key Metrics Changes - The U.S. commercial launch of EMTAGV generated over $210 million in revenue in its first year, with nearly 300 patients infused [8][9] - First quarter product revenue was lower due to reduced manufacturing capacity from scheduled maintenance, higher patient drop-off rates, and lower manufacturing success rates [9][10] - The company anticipates between 100 and 110 commercial patient infusions in Q2 2025, indicating a rebound in demand [15][16] Market Data and Key Metrics Changes - The company is preparing for potential approvals for EMTAGV in the UK, Canada, and the EU, with additional regulatory submissions underway in Australia and Switzerland [12][13] - The company expects a peak sales opportunity of over $1 billion in the U.S. and over $2 billion globally for EMTAGV in its current approved indication [14] Company Strategy and Development Direction - The company is focused on expanding its ATC network and improving engagement with medical oncologists to drive earlier patient referrals for EMTAGV [18][24] - The company is also working on international expansion and pipeline developments in lung cancer and other solid tumors [12][13] - The management emphasizes the importance of operational efficiencies and economies of scale to optimize cost of goods and improve gross margin over time [33][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in growth prospects under the new Chief Commercial Officer, who is enhancing commercial operations to drive ATC adoption [12][15] - The company revised its full-year revenue guidance to between $250 million and $300 million for 2025, considering growth trajectories and demand trends [13][42] - Management noted that the macroeconomic environment is favorable, with minimal impact from tariffs on their products [33] Other Important Information - The company has a robust patent portfolio with approximately 280 granted or allowed patents, providing exclusivity through at least 2042 [34] - The company is committed to optimizing spending and reducing expenses throughout the organization, maintaining a cash runway into the second half of 2026 [42] Q&A Session Summary Question: Can you confirm whether you're seeing a spike in patient uptake to support your guidance for Q2? - Management confirmed strong demand and confidence in the projected number of infusions for Q2 [54] Question: What barriers exist for ATCs that have infused fewer than ten patients? - Management indicated that many ATCs are ramping up and that infrastructure improvements are underway to enhance patient treatment capabilities [56][59] Question: How does the revised guidance reflect on the expected number of infusions for 2025? - Management clarified that the guidance implies over 500 patients infused throughout the year, indicating significant growth compared to the previous year [63][65] Question: What drove the higher patient drop-off and lower manufacturing success in Q1? - Management attributed these issues to patient selection and tumor procurement techniques, with confidence in a rebound in Q2 [70][74] Question: Will annual maintenance impact manufacturing capacity in the future? - Management confirmed that while annual maintenance is necessary, future impacts will be minimized as the facility expands [85][90]

Financial Data and Key Metrics Changes - Total product revenue for Q1 2025 was $49.3 million, including $43.6 million from EMTAGV and $5.7 million from Proleukin, compared to $700,000 for Proleukin in Q1 2024 [40][41] - Net loss for Q1 2025 was $116.2 million or $0.36 per share, compared to a net loss of $113 million or $0.42 per share for Q1 2024 [40] - Average standard gross margin for the first four launch quarters was 32%, with a standard gross margin of 10% for Q1 2025, negatively impacted by lower revenue and higher cost of sales [42] Business Line Data and Key Metrics Changes - The U.S. commercial launch of EMTAGV generated over $210 million in revenue in its first year, with nearly 300 patients infused [7] - First quarter product revenue was lower due to reduced manufacturing capacity from scheduled maintenance, higher patient drop-off rates, and lower manufacturing success rates [8][9] - The company anticipates between 100 and 110 commercial patient infusions in Q2 2025, with a strong demand trend [15] Market Data and Key Metrics Changes - The company expects to report updated data from its registrational trial of lefalusol in previously treated advanced non-small cell lung cancer and first clinical data in endometrial cancer [13] - The company is on track for potential approvals for EMTAGV in the UK, Canada, and the EU, with additional regulatory submissions underway in Australia and Switzerland [13] Company Strategy and Development Direction - The company revised its full-year revenue guidance to between $250 million and $300 million for 2025, focusing on ATC engagement and training to drive revenue growth [45] - The company is expanding its ATC network and enhancing community referrals to improve patient access to EMTAGV [19][27] - The company aims to establish EMTAGV as the preferred treatment option for appropriate patients, emphasizing education for medical oncologists [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in growth prospects under the new Chief Commercial Officer, who is enhancing commercial operations to drive ATC adoption [12] - The company is well-prepared to supply ongoing demand and deliver commercial products globally, with minimal impact from tariffs [36] - Management highlighted the importance of operational efficiencies and economies of scale to optimize costs and improve gross margins over time [36] Other Important Information - The company has a robust patent portfolio with approximately 280 granted or allowed patents, providing exclusivity through at least February 2042 [37] - The company is focused on driving operational efficiencies and reducing expenses while maintaining a cash runway into the second half of 2026 [45] Q&A Session Summary Question: Insights on revised guidance and patient uptake - Management confirmed strong demand and confidence in the guidance of 110 patients for Q2 2025 [56] Question: Barriers for ATCs with lower patient infusions - Management noted that only a few ATCs that infused more than 10 patients were involved in clinical trials, and they are working to improve the performance of other ATCs [58][59] Question: Clarification on revenue guidance and infusion assumptions - Management indicated that the guidance is conservative and expects continued growth throughout the year, driven by increased adoption and new ATCs [64][67] Question: Manufacturing success rates and patient drop-offs - Management explained that the increase in patient drop-offs was related to patient selection and tumor procurement techniques, with confidence in a rebound in Q2 [71][84] Question: Strategies for improving ATC performance - Management is implementing a "white glove service" to assist new surgeons and centers in optimizing their processes for better outcomes [102]

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]