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Precigen, Inc.
8/4/2026
Good afternoon, ladies and gentlemen, and welcome to the President's Second Quarter 2026 Financial Results and Business Updates Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, August 4, 2026. and I would now like to turn the conference over to Steve Harasym. Please go ahead.
Thank you, operator, and thank you to everyone joining us for Presagen's second quarter 2026 update call. We are pleased to be speaking with you today as we continue to see strong momentum across the commercial launch of Pepsimios. Joining me on today's call are Helen Sabzevari, our president and chief executive officer, Phil Tennant, our chief commercial officer, Harry Thomasian, our Chief Financial Officer, and Rutul Shah, our Chief Operating Officer. Helen will begin with an overview of the launch and key strategic updates. Phil will provide additional details on the commercial execution. Harry will review our financial results, and Rutul will be available for the Q&A section. Before we begin our prepared remarks, I remind everyone that we will be making various forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation and our SEC filings, which include risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that, I will now turn the call over to Dr. Sabzevari.
Thank you, Steve, and thank you to everyone joining us for our G2 2026 business update call. As we approach the one-year anniversary of Papremius' approval in August 2025, it is worth reflecting on what a meaningful milestone this has been for adults with RRP. Papremius brought the first and the only approved therapy and the new first line of standard of care to the RRP community. Nearly one year after approval, we continued to see a strong commercial momentum with broadening patient access, growing physician adoption, and increasing utilization across both major medical centers and community practices. I'll begin with a high-level overview of what you're seeing across the launch before turning the call over to Phil for additional commercial detail. Q2 represented exceptional growth from Q1. I'm proud to say that we generated $53.1 million in Paximius revenue compared to $21.6 million in Q1, representing more than 145% revenue growth and marks a significant financial milestone for President. Paximius revenue in Q2 propelled the company to a quarterly net profit even before we reached the first anniversary of FDA approval. These results reinforced the significant enthusiasm we continue to see among patients, physicians, and institutions. What is particularly encouraging as we move through Q2 and continuing to Q3 is that momentum is building across several dimensions of the launch at the same time. We believe we now have the commercial foundation for durable multi-year growth for Paximius. We are seeing a strong demand, broader access, expanding use across care settings, and continued physician adoption. These indicators give us increased confidence in the breadth and durability of pap smear's early commercial trajectory. We are seeing the benefit of launching with full approval and a broad FDA label translate into a real-world prescribing behavior. Importantly, the label does not impose a minimum number of prior surgeries before a patient can be treated with pap smear. As a result, physicians are able to consider Paximius based on the individual patient's clinical need. We are seeing use across a broad range of RRP patients, not just the severe cases. This supports our view that Paximius is being embedded earlier in the treatment paradigm. The clinical profile continues to resonate strongly with physicians and patients at the newest standard of care. Coptimus is not another intervention in a cycle of repeated surgical intervention. It is designed to address the underlying HPV 6 or 11 driver of the disease through a targeted immune response. Coptimus durability data continues to strengthen as the long-term follow-up matures. As we presented at ASCO, as of the April 30th cutoff, the ongoing durability of complete responses continues to increase with 83% of patients in ongoing complete response beyond three years, with the number of them I would like to emphasize that these durable, complete responders have not received any treatment for RRP after receiving Paximia. We believe this combination of transformative efficacy, durability, and ongoing responses and a favorable safety profile remains were all highly differentiated. Finally, the FDA granted Papimia's seven-year market exclusivity for adult RRP patients. This exclusivity into August 2032 adds an important layer of protection against prospective competition and supports the value of the commercial opportunity as we continue to expand access and adoption. Collectively, these factors have helped build a strong commercial foundation leading to a strong performance in Q2 and momentum for what we anticipate to be a continued growth. As we have said before, we believe the RRP indication has a blockbuster potential. With that, I will now turn the call over to Phil for more detail on our commercial launch. Phil?
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