Iovance Biotherapeutics, Inc. Common Stock 2026 Q2 Earnings Call

Sarah, you may begin. Thank you, operator.

Good morning and welcome to the Iovance webcast to discuss our second quarter 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com. This conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, payer interactions, licenses and collaborations, cash position, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Thank you, Sarah. Iovance is the global leader in innovating, developing, and delivering TIL therapy for solid tumors, today and for the next generation. The second quarter of 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the second quarter while our foundation for growth expanded. More Authorized Treatment Centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record Amtagvi demand. We also greatly exceeded both our Amtagvi and total revenue guidance ranges for the second quarter. Second quarter margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency at scale.

Looking ahead, we maintain our peak assumptions for Amtagvi and Proleukin of more than $1 billion in U.S. sales from advanced melanoma alone. The opportunity in other indications is significantly larger. Our third quarter performance to date is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our full-year guidance during the third quarter. We are now providing commercial Amtagvi to more than 50 patients a month on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become. We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced and our pipeline grew.

We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest unmet need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring TIL therapy forward for more patients in the U.S., as well as new markets and additional solid tumor indications. Nearly 2,000 patients have received Iovance TIL therapies in commercial and clinical settings across hundreds of centers in the U.S. and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients. In our registrational trials, enrollment is nearly complete in our IOV-LUN-202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly 7 times that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work toward a supplemental Biologics License Application in 2027.

We're moving quickly with our registrational SARATOGA trial for IOV-SAR-201 in two advanced soft tissue sarcomas. As we announced today, the U.S. FDA granted Fast Track designation in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, validating the promise of the initial clinical data for lifileucel, as well as the substantial unmet medical need in both indications. In a pilot study with one-time lifileucel therapy, the objective response rate was an unprecedented 50% in the first six evaluable patients, compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications that comprise more than 90% of all cancers.

For example, a histology-based biomarker strategy produced striking early Phase II data in the first five evaluable patients with metastatic serous and endometrial cancer. In our N-201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate. We are submitting a protocol amendment engaging with the FDA on an expedited approval pathway based on this patient population. Our leadership in TIL therapy includes continuous investment in next generation programs. A new trial known as G1TIL1 is using IOV-5001, our next generation IL-12 tethered TIL therapy. This Phase I/II basket trial will run across prevalent solid tumors representing more than 100,000 U.S. deaths annually, including metastatic colorectal, triple-negative breast, and estrogen receptor-low breast cancers. We expect to provide more updates this year. Today, profitability is in sight, and with it, lasting value for patients and shareholders alike.

Iovance is the first and only company in the world to take cell therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline. With healthy commercial momentum, a broadening pipeline, and solid execution, Iovance has never been better positioned for long-term success. I'll now ask Corlene Roche, our Chief Financial Officer, to detail our financial results.

Thanks, Fred, and good morning, everyone. Our highest ever quarterly revenue and margin clearly demonstrate our commitment to top-line growth, operational excellence, and financial discipline as we build a sustainable self-funded business. Second quarter total revenue was more than $99 million. That is up 66% year-over-year and 39% sequentially from the first quarter, which have included one-time non-recurring impacts from our internal manufacturing upgrades. Amtagvi was the key growth driver, reaching a new high of approximately $91 million in the quarter. We exceeded our second quarter Amtagvi guidance range of $79 million-$81 million. Second quarter Amtagvi revenue increased roughly 51% over the first quarter of 2026 and 68% year-over-year, reflecting a robust increase in patient demand and adoption. Proleukin contributed about $9 million in the second quarter, slightly down from $11 million in the prior quarter due to timing of wholesaler inventory stocking.

For the full year of 2026, we anticipate that Proleukin as a percentage of total revenue will be in line with 2025. Consistent with the prior quarters, overall gross-to-net impact remains minimal at less than 2%. Margin increased to approximately 56%, up from 41% in the first quarter and above our previous all-time high of 50% in the fourth quarter of 2025. With the year-to-date 2026 margin of 50%, the second quarter benefited from higher Amtagvi volume, continued cost optimization, and maturing internal efficiencies during our first full quarter of manufacturing exclusively in-house. We are also deploying and advancing artificial intelligence tools to drive significant future cost efficiencies and new product pipeline insights. As we expand our business as well as our development pipeline, we are very closely managing operating expenses.

Research and development expenses were about $59 million, down from $62 million in the prior quarter, reflecting ongoing efficiency gains as we progress all of our programs. This marks the fourth consecutive quarter of cost savings through R&D optimization. Selling general and administrative expenses held essentially flat at about $39 million, even as revenue grew roughly 39%. With clear operating leverage from our commercial infrastructure, we expect to gain further efficiency with targeted investment across the business. I will now cover our outlook for the rest of the year. Based on strong second quarter sales, we are reviewing our previously issued full year 2026 total revenue guidance of $350 million-$370 million and plan to share more detail in the third quarter. We are well capitalized to fund both the launch and our pipeline.

As of June 30th, 2026, we had approximately $304 million in cash equivalents, and short-term investments. This cash position is now expected to fund operations into the second half of 2028. When I joined Iovance, the priorities were clear: grow revenue, expand margins, and manage spend to reach profitability as quickly as possible. On my one-year anniversary, I am pleased to highlight that all three of these priorities are translating into positive results and lasting value for patients and our shareholders. I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our commercial progress.