The biopharma company is proving its recently approved cancer therapy is marketable. After watching its stock fall for weeks on worries of disappointing results, Iovance Biotherapeutics (IOVA 18.64%) has vindicated itself. Shares of the young biopharma company are up 24.2% as of 11:20 a.m. ET today in response to an impressive second-quarter report. This bullish jolt could also mark the beginning of a more prolonged move higher. Iovance's Amtagvi is off to a solid start In simplest terms, caregivers are emb ...

Iovance Biotherapeutics (NASDAQ:IOVA) stock is taking a beating on Friday after the biotechnology company announced its earnings for the second quarter of the year. Iovance Biotherapeutics starts that report with adjusted earnings per share of -34 cents. That's just barely above the -35 cents per share Wall Street was expecting. It's also better than the -47 cents per share from the same period of the year prior. Revenue reported by Iovance Biotherapeutics also came in at $31.11 million. That's another beat ...

Iovance Biotherapeutics Inc IOVA stock is trading higher on Friday after the company issued upbeat guidance for 2024 and 2025 and better-than-expected second-quarter earnings. On Thursday, the cancer cell therapy maker Iovance reported second-quarter sales of $31.12 million, surpassing the consensus of $24.6 million. The company reported EPS loss of $(0.34), down from $(0.47) a year ago, beating the consensus of $(0.35). Also Read: Iovance Biotherapeutics Price Forecast Slashed By 40% On Mutated Uptake For ...

Iovance Biotherapeutics, Inc. (IOVA) incurred a loss of 34 cents per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 37 cents. In the year-ago quarter, the company reported a loss of 47 cents. During the quarter, the company generated total revenues of $31.1 million — entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $22.6 million. In the year-ago quarter, Iovance recorded total revenues of $0.2 million. Q ...

TO VANCE 1 Corporate Overview August 2024 1 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Forward-Looking Statements Certain matters discussed in this press release 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," ...

Financial Data and Key Metrics - Q2 2024 product revenue was $31.1 million, including $12.8 million from Amtagvi infusions and $18.3 million from Proleukin sales [6][25] - Net loss for Q2 2024 was $97.1 million ($0.34 per share), compared to $106.5 million ($0.47 per share) in Q2 2023 [25] - Cost of sales for Q2 2024 was $31.4 million, primarily driven by Amtagvi and Proleukin sales, manufacturing costs, and royalties [27] - Cash position as of July 24, 2024, was $449.6 million, sufficient to fund operations into 2026 [24] Business Line Data and Key Metrics - Amtagvi revenue is recognized upon infusion, while Proleukin revenue is recognized upon delivery, serving as a leading indicator for future Amtagvi demand [6][26] - Over 55 patients have been infused with Amtagvi since its commercial launch in April 2024, with 25 patients treated in Q2 and over 30 in Q3 [10] - Proleukin Q2 revenue surpassed its total global revenue in 2023, reflecting strong demand tied to Amtagvi [26] Market Data and Key Metrics - The company has over 50 authorized treatment centers (ATCs) in the U.S., with plans to expand to 70 by year-end [7][14] - More than 90% of treated patients are within 200 miles of an ATC, and with 70 ATCs, nearly all melanoma patients will be within a two-hour drive [15] - Payers covering over 225 million lives (85% of U.S. covered lives) have implemented positive medical coverage policies for Amtagvi [16] Company Strategy and Industry Competition - Amtagvi and Proleukin represent a $1 billion peak opportunity in the U.S. market for advanced melanoma, with potential for label expansion to frontline melanoma, non-small cell lung cancer, and other indications [11] - The company is expanding its manufacturing capacity to support over 5,000 patients annually within a few years, with a long-term vision of serving over 10,000 patients annually [22] - Iovance holds over 210 granted or allowed patents, providing exclusivity for Amtagvi and related technologies through at least 2042 [23] Management Commentary on Operating Environment and Future Outlook - Management expects Q3 2024 product revenue of $53-55 million and full-year 2024 revenue of $160-165 million, with significant growth to $450-475 million in 2025 [9][10][31] - Gross margins are projected to exceed 70% over the next several years, driven by economies of scale and operational efficiencies [11][28] - The company is on track for regulatory submissions in the UK, Canada, Australia, and Switzerland, with commercial launches expected in 2025 [12] Other Important Information - The company is actively hiring at its Iovance Cell Therapy Center (ICTC) to meet growing U.S. demand and support clinical trials [20] - Manufacturing turnaround time for Amtagvi is approximately 34 days from tumor sample receipt to product shipment [21] - The company is exploring next-generation TIL therapies, including IOV-4001, IOV-3001, and IOV-5001, with IND-enabling studies underway [37][38] Q&A Session Summary Question: Does the guidance include Proleukin revenue? - Yes, the guidance includes both Amtagvi and Proleukin revenue [41] Question: What is the proportion of Proleukin used for Amtagvi? - The vast majority of Proleukin sales are driven by Amtagvi, though exact tracking is not possible [45] Question: What is driving confidence in the 2025 revenue guidance? - Confidence is based on strong launch dynamics, ATC expansion, and manufacturing capacity [49] Question: What is the average time from opt-in to infusion? - The entire process, including reimbursement approval and scheduling, takes about 3-4 weeks [58] Question: How is manufacturing success rate managed? - Manufacturing success rates are consistent with clinical trial experience, and out-of-spec products are accounted for in cost of sales [70] Question: How is the company managing ATC constraints? - ATCs are scaling well, with no significant constraints on bed allocation between CAR-T and TIL therapies [78]

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.34 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to loss of $0.47 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 8.11%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.45 per share when it actually produced a loss of $0.42, delivering a surprise of 6.67%. Over the last four quarters, th ...

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[160] - The company plans to launch Amtagvi™ in additional markets, including the European Union, United Kingdom, Canada, and Australia, targeting over 20,000 previously treated advanced melanoma patients annually[151] Manufacturing and Technology - The centralized manufacturing process for Amtagvi™ takes 22 days and produces billions of patient-specific T cells, which are then cryopreserved for therapy[158] - The Iovance Cell Therapy Center (iCTC) is the first FDA-approved facility for commercial TIL cell therapy, with a capacity to treat several thousand cancer patients annually, and expansion plans are underway[157] - The company has treated over 700 patients in clinical trials with TIL cell therapy products manufactured using proprietary processes[156] - The iCTC's flexible design allows for future expansion to meet growing capacity needs, aiming to address tens of thousands of patients[157] - The manufacturing process for Amtagvi™ is complex and subject to stringent FDA guidelines, impacting the ability to deliver the product to patients[178] Clinical Trials and Research - Ongoing registrational trials are supporting a supplementary BLA for TIL cell therapies in frontline advanced melanoma and advanced non-small cell lung cancer (NSCLC)[153] - The TILVANCE-301 clinical trial is expected to enroll approximately 670 patients to support registration in frontline advanced melanoma and confirm full approval in post-anti-PD-1 advanced melanoma[167] - The company is developing next-generation therapies, including genetically modified TIL cell therapy (IOV-4001), utilizing TALEN® technology to inactivate the PD-1 gene[169] - The company plans to submit an IND for IOV-3001 in the third quarter of 2024, aimed at improving TIL therapy treatment regimens[173] - A pre-IND meeting request for IOV-5001 is planned with the FDA in Q4 2024, with an IND submission expected in 2025[172] Financial Performance - Revenue for the three months ended June 30, 2024, increased by $30.9 million, or 12,970%, compared to the same period in 2023, attributed to the acquisition of worldwide rights to Proleukin® and the commercial launch of Amtagvi™[186] - Amtagvi™ generated $12,819 in revenue during the three months ended June 30, 2024, marking a 100% increase from the previous year[185] - Proleukin® sales reached $18,287 during the three months ended June 30, 2024, compared to $238 in the same period of 2023, reflecting a significant increase in market activity[185] - Total product revenue for the three months ended June 30, 2024, was $31,106, compared to $238 in the same period of 2023, indicating a substantial growth in sales[185] Expenses and Losses - Research and development expenses for the three months ended June 30, 2024, were $62,084, a decrease of 28% from $86,347 in the same period of 2023[187] - Selling, general and administrative expenses increased to $39,568 for the three months ended June 30, 2024, up 80% from $21,927 in the same period of 2023[187] - Cost of sales for the three months ended June 30, 2024 increased by $29.3 million, or 1,430%, driven by sales of Amtagvi™ and Proleukin®[188] - The company anticipates continued net losses as it invests in clinical and internal research and development programs[201] - Net loss for the three months ended June 30, 2024 was $(97,101) thousand, a decrease of $9.4 million, or 9%, compared to $(106,528) thousand in the same period of 2023[201] Cash Flow and Capital - As of June 30, 2024, the company had $419.0 million in cash, cash equivalents, investments, and restricted cash, including $228.7 million in cash and cash equivalents and $183.9 million in short-term investments[202] - Net cash used in operating activities for the six months ended June 30, 2024, was $220.7 million, an increase of $26.9 million compared to the same period in 2023[210] - Net cash used in investing activities for the six months ended June 30, 2024, was $71.7 million, compared to $3.4 million for the same period in 2023, driven by changes in the timing of maturities and purchases of investments[211] - Net cash provided by financing activities for the six months ended June 30, 2024, was $346.4 million, an increase of $87.2 million compared to the same period in 2023[212] - The company closed an underwritten public offering of 23,014,000 shares of common stock on February 22, 2024, generating total net proceeds of $197.4 million[207] - The company received approximately $152.4 million in net proceeds during the second quarter of 2024 through the sale of 17,017,492 shares of common stock[208] Patents and Intellectual Property - The company holds over 210 granted or allowed U.S. and international patents related to TIL technologies, ensuring exclusivity for Amtagvi™ through at least 2042[174] Revenue Recognition and Accounting - Revenue recognition for Amtagvi™ occurs upon infusion, while for Proleukin®, it occurs upon shipment or receipt, depending on legal title transfer[223] - Gross to net adjustments (GTN) reduce revenue at recognition, influenced by commercial arrangements and government programs, with significant judgment required for estimation[224] - Research and development costs are expensed as incurred, with clinical development costs being a significant component, and payments to third parties may result in uneven cash flow[225] Market and Currency Risks - The company acquired worldwide rights to Proleukin® in Q2 2023, establishing foreign subsidiaries that may expose financial results to foreign currency exchange risks[230] - Majority of product sales for the three and six months ended June 30, 2024, were in U.S. dollars, with immaterial foreign currency transaction gains and losses reported[231][232]

Exhibit 99.1 Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024 Strong Momentum Continues for Amtagvi™ (Lifileucel) U.S. Launch with $31.1 Million in Total 2Q24 Revenue Total Product Revenue Guidance of $53-$55 Million for 3Q24, $160-$165 Million for FY24, and $450-$475 Million for FY25 SAN CARLOS, Calif., August 8, 2024 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delive ...

Strong Momentum Continues for Amtagvi™ (Lifileucel) U.S. Launch with $31.1 Million in Total 2Q24 Revenue Total Product Revenue Guidance of $53-$55 Million for 3Q24, $160-$165 Million for FY24, and $450-$475 Million for FY25 SAN CARLOS, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported ...