Financial Data and Key Metrics - Q3 2024 total product revenue was $58.6M, exceeding the guidance range of $53M-$55M, driven by $41M from Amtagvi and $16.5M from Proleukin [9] - Year-to-date total product revenue through September 30, 2024, was $90.4M, including $54.9M from Amtagvi and $35.5M from Proleukin [10] - Net loss for Q3 2024 was $83.5M ($0.28 per share), compared to a net loss of $113.8M ($0.46 per share) in Q3 2023 [40] - Gross margin improved to $25.6M in Q3 2024, positioning the company more than halfway toward the target of over 70% gross margin in the coming years [49] Business Line Data and Key Metrics - Amtagvi revenue is recognized upon patient infusion, while Proleukin revenue is recognized upon delivery to distributors or hospitals [10] - 146 patients have been infused with Amtagvi since April, with 25 in Q2, 82 in Q3, and 39 in Q4 to date, reflecting increasing adoption rates [11][12] - The company has 56 authorized treatment centers (ATCs) and aims to onboard approximately 70 ATCs by year-end 2024 [12] Market Data and Key Metrics - Approximately 75% of Amtagvi patients are covered by private payers, with over 250M lives (95% of U S covered lives) having access to reimbursement [13][14] - The company is targeting global markets, with potential first ex-U S approval in H1 2025 and EU approval in H2 2025 [20][21] - Amtagvi represents a multibillion-dollar opportunity globally, addressing over 20,000 advanced melanoma patients annually in the U S and initial ex-U S markets [18] Company Strategy and Industry Competition - The company is focused on expanding its ATC network, improving manufacturing capacity, and optimizing operational efficiencies to meet growing demand [12][29][33] - Future growth drivers include global label expansions in frontline advanced melanoma, other tumor types, and next-generation TIL cell therapies [23] - The company’s intellectual property portfolio includes over 230 granted or allowed patents, providing exclusivity through at least 2042 [37] Management Commentary on Operating Environment and Future Outlook - Management reaffirmed full-year 2024 total product revenue guidance of $160M-$165M and 2025 guidance of $450M-$475M [17] - The company expects significant revenue growth in 2026 and beyond, with Amtagvi and Proleukin representing a $1B+ peak opportunity in the U S market alone [18] - Management highlighted strong demand, favorable payer coverage, and operational improvements as key drivers of future growth [12][17][33] Other Important Information - The company is advancing its clinical pipeline, including trials in non-small cell lung cancer, frontline melanoma, and endometrial cancer [56][64][68] - Next-generation programs, such as IOV-4001 (PD1-inactivated TIL) and IOV-5001 (IL-12 TIL), are under development to enhance efficacy and safety [69][73] - The company is expanding manufacturing capacity, with plans to increase annual capacity to over 10,000 patients through facility expansion and process optimization [35] Q&A Session Summary Question: Impact of holidays on Q4 infusions - Management expects a lull during holidays but remains confident in meeting annual guidance, with infusions projected to continue growing [79][80] Question: IL-2 stocking levels - Proleukin stocking levels are expected to stabilize after Q4 2024, with growth anticipated to follow a more traditional quarter-over-quarter pattern in 2025 [81][82][83] Question: Preconditioning practices - Larger ATCs with more experience are increasingly comfortable initiating preconditioning before Amtagvi arrival, reflecting confidence in manufacturing success rates [85][86][87] Question: Monthly infusion growth trajectory - Infusions grew month-over-month in Q3, driven by ATC expansion and improved manufacturing capacity, with continued growth expected in Q4 [90][91][92] Question: Gross margin improvement - Gross margin improvements are driven by increased capacity utilization, operational efficiencies, and cost optimization initiatives, with a target of over 70% in the coming years [95][96][97] Question: Dropout rate improvements - Dropout rates improved due to optimized launch processes, better patient selection, and surgical resection quality, with further improvements expected as the launch matures [100][101] Question: Reimbursement and lung cancer trial - Reimbursement clearance time has improved to three weeks, and the company expects data from the lung cancer trial in 2025, with potential approval in 2027 [104][105][107] Question: Out-of-spec rate trends - Out-of-spec rates are improving due to ATC experience and better patient selection, with new ATCs benefiting from early learning and peer-to-peer support [109][110][111]

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.46 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 9.68%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.37 per share when it actually produced a loss of $0.34, delivering a surprise of 8.11%.Over the last four quarters, the ...

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 September 30, 2024 ☐ 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) Delaware 75-3254381 (State or o ...

With a cutting-edge melanoma drug now on the market, the company is positioned for a breakout.Iovance Biotherapeutics (IOVA 7.54%) is going to finish the week strong on the stock market if its Thursday performance is any indication. Investors boosted the company's share price by almost 8%, following the initiation of coverage by an analyst who's bullish on its future. With that rise, Iovance easily eclipsed the S&P 500 index's 0.2% increase.Vast potential with melanoma drugThe analyst launching his Iovance ...

The biotech is making important breakthroughs, but is that enough? These are exciting times to be an Iovance Biotherapeutics (IOVA) shareholder. The biotech has made encouraging clinical and regulatory progress in the past year. Its most important product is helping it generate strong revenue growth, and although it has been a bit of a wild and volatile ride, its shares have performed much better than the broader market over the trailing 12-month period. It might be worth investing in the stock if the compa ...

Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial. In my previous Iovance Biotherapeutics, Inc. (NASDAQ: IOVA ) article, I discussed the company's preparations for the FDA's impending verdict on lifileucel, their tumor-infiltrating lymphocyte ("TIL") therapy for advanced melanoma. I was expecting the ti ...

There's plenty of upside with this stock, but it might take a while to realize. Iovance Biotherapeutics (IOVA 9.30%) is a hot biotech stock for a reason: It's almost certainly going to be growing its top line at a snappy pace over the next few years, and there's no other therapy that's quite like the one it recently started to commercialize. But, like most of the companies in its group, there are a lot of caveats and tidbits of industry knowledge that you'll need to appreciate before you can feel confident ...

Core Viewpoint - Iovance Biotherapeutics has received accelerated approval for its cell therapy treatment, Amtagvi, but investors should be cautious about potential dilution and the company's long path to profitability [1][2][9]. Financial Performance - Iovance generated $31.1 million in sales in its most recent quarter, but reported a net loss of $97.1 million, slightly better than the previous year's loss of $106.5 million [4]. - The company has used $220.7 million in cash for operating activities over the past six months, ending with $235.1 million in cash and $183.9 million in short-term investments [5]. Cash Flow and Dilution Risks - The company faces high dilution risk as it may need to raise funds through equity markets due to insufficient cash flow for operations and expansion [6][8]. - Iovance has a clean balance sheet with total liabilities of $195.8 million against total assets of $964.3 million, indicating a preference for share offerings to raise capital [7]. Market Expansion and Future Outlook - Iovance plans to launch Amtagvi in new markets, including the U.K., Canada, and Australia, which will require additional cash [6][9]. - While the company has growth prospects, the need for cash could lead to significant stock offerings, impacting current investors [9][10].

This company's new cancer therapy is producing remarkable results, but the company is losing money at a frightening pace. It's been a wild roller-coaster ride for Iovance Biotherapeutics (IOVA 0.25%). In February, the stock more than doubled in price, then it fell to a 52-week low in July. The stock has since recovered and at recent prices was up 47% for the year. Can Iovance keep soaring in the years to come, or is its big gain in 2024 more likely to fizzle out? Here's a look at what to expect in the near ...

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 ...