SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- In a dramatic turn for Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), investors watched the company's shares plunge nearly 44% on May 9, 2025, after the San Carlos-based cell therapy pioneer reported a first-quarter revenue miss that sharply contradicted earlier upbeat assurances from management. Hagens Berman is now investigating whether Iovance violated U.S. securities laws and urges Iovance investors who suffered substantial losses to submit your losses now. ...

Core Insights - Iovance Biotherapeutics experienced a significant stock decline on May 9 following a disappointing first-quarter earnings report, with a loss of $0.36 per share compared to the consensus estimate of a $0.24 loss [1] - The company's revenue for Q1 was reported at $49.3 million, which fell short of the expected $81.53 million [1] Financial Performance - The earnings per share (EPS) loss of $0.36 indicates a larger loss than analysts had anticipated [1] - Revenue of $49.3 million represents a substantial shortfall from the forecasted revenue of $81.53 million, highlighting potential operational challenges [1]

Scientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not re ...

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]

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. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact name of issuer as specified in its charter) (State or other jurisdiction of (I. ...

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]