Precigen, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, operator, and thank you to everyone joining us for Precigen'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 PAPZIMEOS. 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 Q2 2026 business update call. As we approach the one-year anniversary of PAPZIMEOS approval in August 2025, it is worth reflecting on what a meaningful milestone this has been for adults with RRP. PAPZIMEOS brought the first and only approved therapy and a new first-line standard of care to the RRP community. Nearly one year after approval, we continue 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 we are seeing across the launch before turning the call over to Phil for additional commercial detail. Q2 represented exceptional growth from Q1.

I am proud to state that we generated $53.1 million in PAPZIMEOS revenue compared to $21.6 million in Q1, representing more than 145% revenue growth and marks a significant financial milestone for Precigen. PAPZIMEOS revenue in Q2 propelled the company to a quarterly net profit even before we reach the first anniversary of FDA approval. These results reinforce the significant enthusiasm we continue to see among patients, physicians, and institutions. What is particularly encouraging as we move through Q2 and continue into 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 PAPZIMEOS. 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 PAPZIMEOS' 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 PAPZIMEOS. As a result, physicians are able to consider PAPZIMEOS 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 PAPZIMEOS is being embedded earlier in the treatment paradigm. The clinical profile continues to resonate strongly with physicians and patients as the new standard of care. PAPZIMEOS is not another intervention in a cycle of repeated surgical interventions. It is designed to address the underlying HPV 6 or 11 driver of the disease through a targeted immune response. PAPZIMEOS durability data continues to strengthen as the long-term follow-up matures.

As we presented at ASCO, as of the April 30th cut-off, the ongoing durability of complete responses continues to increase, with 83% of patients in ongoing complete response beyond three years, with a number of them beyond four years of being surgery-free. I would like to emphasize that these durable, complete responders have not received any treatment for RRP after receiving PAPZIMEOS. We believe this combination of transformative efficacy, durability, and ongoing responses, and a favorable safety profile remains highly differentiated. Finally, the FDA granted PAPZIMEOS 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? Thank you, Helen, and welcome to everyone joining us today.

I'm pleased to provide an update on the continued progress of our commercial launch. Q2 represented a meaningful acceleration across the business, with strong demand, expanding patient access, and increasing engagement from physicians and institutions as PAPZIMEOS continues to establish itself as the new standard of care for adults with RRP. Importantly, the commercial indicators we are seeing that this is the beginning of a durable growth story. As Helen mentioned, in Q2, PAPZIMEOS generated $53.1 million in revenue compared with $21.6 million in Q1, reflecting continued strong launch performance since the first full quarter of sales in Q1. Launch to date, PAPZIMEOS revenue exceeded $78 million at the end of Q2, underscoring the continued strong momentum we are seeing across all aspects of our launch effort.

As per my commentary in previous quarters, there are a number of factors and leading indicators continuing to support the impressive launch performance. Patient engagement through the PAPZIMEOS SUPPORT continues to grow. As of today, the total HUB number is well over 500 patients. This reflects steady patient identification and continued interest from both major academic centers and community settings. Importantly, PAPZIMEOS SUPPORT data do not capture all patients, as a meaningful proportion of treated patients are coming through non-HUB-using institutions. Sites are becoming increasingly confident in their own processes for securing patient access, which could mean more patients in the future receiving PAPZIMEOS without necessarily requiring PAPZIMEOS SUPPORT intervention. We believe the current picture reinforces the breadth of demand for the brand irrespective of our HUB utilization. Payer coverage remains exceptional and continues to provide a strong foundation for access.

With the addition of approximately 18 million covered lives in Q2, total commercial and government coverage is now approximately 315 million lives, representing nearly all potential covered lives in the U.S. market. In my experience, this compares extremely favorably to the typical speed and breadth of coverage for newly approved treatments in the U.S. As expected, we also continue to see activation across both major medical centers and community practices. We feel the permanent J-code, which became effective April 1st, has been particularly important as accounts move from initial engagement to routine use. It provides a standard pathway for reimbursement, it helps institutions process claims more efficiently, and it reduces uncertainty for sites that are still building PAPZIMEOS into their workflows. Together with our field reimbursement support and favorable payer coverage, this has helped bring forward additional accounts and supported continued adoption across both academic centers and community practices.

Taken together, the Q2 numbers show clear and continued acceleration across leading indicators, including HUB registrations, new patient starts, payer coverage, and account activation on top of the FDA-granted market exclusivity and robust quarter-over-quarter revenue growth. We are extremely pleased with the launch performance to date and believe these trends provide a strong foundation for continued growth. The key point is that PAPZIMEOS remains early in its launch curve with a substantial continued opportunity in RRP. I'll now turn the call over to Harry for an overview of our Q2 financials.