May 9, 2024 - IOVA

Iovance's "Pending" Patients: The Hidden Key to Unlocking Q2 Revenue

Iovance Biotherapeutics' recent Q1 2024 earnings call was a symphony of positivity, brimming with bullish pronouncements about the successful launch of Amtagvi, their groundbreaking TIL cell therapy for advanced melanoma. Analysts, predictably, fixated on the headline figures: over 100 patients enrolled, a rapidly expanding network of authorized treatment centers, and a generally smooth reimbursement process. But hidden within the deluge of positive data lies a single word, almost glossed over, that could hold the key to understanding the true shape of Iovance's Q2 revenue: "pending."

During the call, Jim Ziegler, Executive Vice President of Commercial, explained that the company had at least 20 patients "in process," including 10 with scheduled or "pending" manufacturing slots. This seemingly innocuous distinction between "scheduled" and "pending" reveals a subtle but critical dynamic at play.

Centers, eager to offer this potentially life-changing therapy to their patients, are identifying and enrolling suitable candidates rapidly. However, the final commitment to schedule a manufacturing slot is contingent on securing reimbursement approval. This creates a pool of "pending" patients, essentially in a holding pattern, their tumor resections and subsequent revenue recognition hinging on the green light from payers.

This "pending" pool is the hidden reservoir feeding Iovance's Q2 revenue stream. The speed at which these patients transition from "pending" to "scheduled" will determine the initial velocity of revenue growth.

Hypothesis: Rapid Revenue Conversion

Hypothesis: Iovance's Q2 revenue will significantly exceed analyst expectations due to the rapid conversion of "pending" patients into recognized revenue.

Let's crunch some numbers. The company stated that "many" of the 100+ enrolled patients have already undergone tumor resection. If we conservatively estimate that 50% of these enrolled patients are "pending," that's a potential pool of 50 patients primed for conversion into revenue, assuming a high manufacturing success rate (which Iovance expects).

Revenue Breakdown

Each Amtagvi infusion is priced at $289,000. Each patient also requires Proleukin, potentially adding up to $99,960 per patient in additional revenue.

Even if only half of the "pending" patients receive infusions in Q2, that translates to:

Amtagvi Revenue: 25 patients x $289,000 = $7.225 million. Proleukin Revenue: 25 patients x $99,960 = $2.499 million. Total Q2 Revenue: $9.724 million

This back-of-the-envelope calculation doesn't even account for the 10 patients with already scheduled manufacturing slots, the additional 60 patients being screened, or the continued expansion of the ATC network. The potential for upside surprise is substantial.

Demand and Future Growth

This rapid conversion of "pending" patients to revenue speaks volumes about the robust demand for Amtagvi. It underscores the urgency felt by clinicians to access this new therapeutic option and suggests a high level of confidence in securing reimbursement.

Authorized Treatment Center Growth

Iovance is rapidly expanding its network of Authorized Treatment Centers (ATCs). The company had a goal of 50 ATCs by the end of May 2024 and has set a new goal of at least 70 ATCs by the end of the year.

While the initial focus is on advanced melanoma, Iovance has ambitious plans to expand Amtagvi's reach. Their pipeline is teeming with potential, including a registrational trial in frontline melanoma and investigations in lung and endometrial cancers. If this early launch momentum is any indication, Iovance is poised to become a dominant force in the rapidly evolving landscape of TIL cell therapy. The word "pending" may be small, but its implications for Iovance's future could be enormous.

"Fun Fact: The name "Iovance" is a blend of "innovation" and "advance," perfectly capturing the company's mission to pioneer life-changing TIL cell therapies."