Transcript: Iovance Biotherapeutics Q2 2026 Earnings Conference Call

Iovance Biotherapeutics (NASDAQ: IOVA ) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below. This transcript is brought to you APIs. For real-time access to our entire catalog, please visit for a consultation.

Access the full call at Summary Full Transcript Daniel, Operator Welcome to the Iovance Biotherapeutics second quarter 2026 conference call. My name is Daniel and I will be your operator for today's call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session.

Please note that this conference call is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin. Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications Thank you, operator.

Good morning and welcome to the Iovance webcast to discuss our second quarter 2026 financial results, business achievements and corporate updates. 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 technology, 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. Frederick G. Vogt, Interim CEO and General Counsel 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. 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. S. sales from advanced melanoma alone. The opportunity in other indications is significantly larger.

Our third quarter performance of data 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.

S. as well as new markets and additional solid tumor indications. 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 Lung 202 trial in the pivotal cohorts in non-squamous non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly seven 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, or SAR-201, in two advanced soft tissue sarcomas. 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 a 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 2 data in the first five evaluable patients with metastatic serous endometrial cancer. In our N201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate.

We're submitting a protocol amendment and 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 G1201 is using IOV-5001, our next-generation IL-12—tethered TIL therapy. 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 TIL 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 Corleen Roche, our Chief Financial Officer, to detail our financial results. Corleen Roche, Chief Financial Officer 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 had included one-time nonrecurring impact 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 to $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 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 to $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 30, 2026, we had approximately $304 million in cash, 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.

Dan Kirby, Chief Commercial Officer Thank you, Corleen. As mentioned, Amtagvi generated record revenue with more patients treated than in any prior quarter. This commercial momentum is carrying into the third quarter. Adoption isn't just growing, it's broadening into new ATCs and earlier lines of treatment.

Today I will highlight three commercial priorities powering that trajectory for Amtagvi growth, which are rising physician awareness, continued expansion of our ATC network, and a deepening body of clinical evidence. The first priority is to continue to increase awareness of Amtagvi among both treating and referring physicians. Unaided awareness has increased nearly threefold over the past year, driven by two factors: 1) a new marketing campaign unveiled at ASCO and 2) improvement in sales force effectiveness measured by meaningful growth in both number of treaters and referrers. The second priority is increasing our footprint across both academic and community settings.

With more than 95 total ATCs today, we are on track to reach at least 110 by year's end. Community ATCs now represent a third of our network and are expected to increase significantly over the next several quarters. Each new ATC is widening our commercial reach to the patients who need it. The third priority is the continued expansion of our already deep, industry-leading clinical evidence.

The published five-year durability data and real-world response rates of greater than 50% in patients with two or three or fewer lines of therapy are convincing physicians to adopt Amtagvi earlier. In addition, at ASCO we released a new survival analysis from our clinical trial. 7%, or almost half. Independently, a growing number of our ATCs are publishing their own real-world experience.

Across these studies, response rates and patient outcomes consistently meet or exceed what we observed in our clinical trials, which support the emerging practice pattern of treating patients with Amtagvi as soon as possible after checkpoint inhibitor therapy. These aggregated real-world evidence data are being deployed across our sales force in conversations with ATCs and physicians. com for those interested. Underpinning all three priorities is ensuring coverage and access.

Amtagvi has strong payer coverage. More than 75% of Amtagvi patients are covered by private payers. Payers and plans that cover more than 250 million lives have added Amtagvi to their policies. S.

ATCs are strategically located in proximity to most addressable patients. More than 95% of patients live within 200 miles and 80% of patients live within 100 miles of an ATC. With our rapidly expanding ATC network and increased community presence, we expect even broader access to Amtagvi throughout 2026. Importantly, we are also proving we can deliver on our promise to patients with a turnaround time of 31 days or less using the only scaled centralized commercial manufacturing process approved by the FDA for TIL therapy.

Demand for Proleukin, our second product, remains strong. All three wholesalers have sold through their previous stocking inventory in the second quarter and are currently ordering in line with Amtagvi demand for the rest of the year. We expect quarter-on-quarter Proleukin growth tied to Amtagvi growth on a steady basis of approximately 16% of total revenue. , with two approvals of Amtagvi in Canada and Australia, we are continuing to expand in new markets for previously treated melanoma patients, a globally addressable population of more than 30,000 patients.

Our first ATC in Canada is ready to support international private-pay patients while we work toward public reimbursement. In Australia, I recently visited several of our onboarding ATCs as we collaborate to raise awareness and expand access to Amtagvi. Australia has the highest rate of melanoma in the world. We are opening our first ATCs for private-pay patients while we work with the government on pricing.

Looking ahead, regulatory approvals are pending in the United Kingdom and Switzerland. Elsewhere we continue to work closely with health authorities in the European Union towards resubmission. S. franchise for Amtagvi.

In summary, demand for Amtagvi is strong and continues to grow. Rising physician awareness is accelerating referrals, a growing network of ATCs is broadening access that is converting into more patients treated, and the deepening clinical evidence is expanding the addressable patient population. Iovance is committed to serving patients with a one-time cell therapy that delivers meaningful, validated, systemic clinical benefits. I will now hand the call back to the operator to begin the question-and-answer session.

Daniel, Operator To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q and A roster. Our first question comes from Andrew Tsai with Jefferies.

Your line is open. Andrew Tsai, Analyst at Jefferies Good morning. Thanks. Congrats on a great quarter.

So can you talk about this large upswing in Q2 that even came out well ahead of your guidance? Was it purely due to underlying demand or was there kind of any one-offs in the timing of shipments maybe being more favorable in Q2? Just wanted to check the box on that. And then secondly, on the lung update later in Q4.

Just wanted to clarify on the cadence of events we can expect here. Is it fair to assume you would first need to complete enrollment in this pivotal cohort first and then generate follow-up data on every enrolled patient before you top-line the data, or can the top-line data be on the majority of patients, not necessarily all patients, with follow-up? Thank you. Dan Kirby, Chief Commercial Officer So I'll take the first part on demand.

It's a great question. What we saw in demand was, as I said on the call script, essentially we saw that awareness is increasing among our physician base, both treaters and referrers. We are expanding our ATC network and then the clinical data is evidence of Amtagvi's efficacy. One thing that did happen in the first quarter that helped us in the second quarter was we had the manuscript published on our real-world evidence data that showed over 50% of the patients with two or fewer lines of therapy were responding.

That data helped propel our sales force and our commercial efforts to raise awareness further and encourage more patients to be treated. We expect this to continue and we are seeing this into the third quarter. Frederick G. Vogt, Interim CEO and General Counsel I'll just add to Dan.

Just to be very clear, Andrew, it's not a timing issue or anything. This is organic demand for the product. It's looking very good right now based on all the factors that Dan described and more, that we really do expect that demand is going to continue to increase significantly for Amtagvi throughout the coming quarters. On the lung, on your question about the lung 202 update: yes, I think it's fair to assume we're going to complete enrollment very soon and we would want to finish that process before we put any kind of material update out.