Precigen (PGEN) Q1 2026 Earnings Transcript

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Date

Wednesday, May 13, 2026 at 4:30 p.m. ET

Call participants

• President and Chief Executive Officer — Helen Sabzevari
• Chief Commercial Officer — Phil Tennant
• Chief Financial Officer — Harry Thomasian Jr.

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Takeaways

• Papzimias product revenue -- $21.6 million, up from $3.4 million in the previous quarter, reflecting initial commercial availability and growth in U.S. adoption.
• Total revenue -- $23.3 million, primarily driven by Papzimias, with the remainder from other sources not detailed; Papzimias sales contributed the core amount.
• Patient hub registrations -- Approximately 400 patients registered, with 25% from community practices, indicating broad penetration beyond academic centers.
• Payer coverage -- More than 90% of insured U.S. lives (an estimated 297 million) have coverage for Papzimias, spanning commercial, Medicare, and Medicaid.
• Operating loss -- $6 million, reflecting lower research and development expense and increased selling, general, and administrative expense related to commercial activity.
• Net loss -- $7.9 million, or $0.02 per share on a basic and diluted basis.
• Cash, cash equivalents, and investments -- $56.7 million at period close; management expects this, along with Papzimias receivables, to fund operations to cash flow breakeven by 2026.
• Cash used in operations -- $43.8 million, with $13 million attributed to nonrecurring items; first quarter collections do not yet include Papzimias sales receipts due to payment terms.
• Papzimias label and coverage -- FDA approval came with a broad label and no minimum prior surgery requirement; broad payer access enables rapid market integration.
• J-code implementation -- Permanent J-code assigned April 1 enables simplified claims processing and improved access through major and community centers.
• Clinical updates -- Initiation of a pediatric Papzimias trial is planned for fourth quarter; EMA review of Papzimias is ongoing for marketing authorization in Europe.
• Platform pipeline -- PRGN-2009 is in multiple Phase 2 trials with pembrolizumab in head and neck and cervical cancers, with data updates planned later in the year.

Summary

Precigen (NASDAQ:PGEN) reported that Papzimias revenue reached $21.6 million in its first full commercial quarter, indicating rapid adoption and momentum in both major centers and community practices. Management highlighted comprehensive U.S. payer coverage for Papzimias, now exceeding 90% of insured lives, supporting broad market access. A permanent J-code, implemented on April 1, was credited with streamlining reimbursement, and management affirmed that current cash resources and incoming receivables are expected to fund operations through breakeven in 2026. Plans include a pediatric Papzimias trial and a pending European regulatory decision, with efficacy and durability updates forthcoming at ASCO and for their PRGN-2009 oncology program.

• Harry Thomasian Jr. stated, "our cash used in operations for the quarter was $43.8 million and included $13 million of cash outflows that we do not expect to recur in future quarters this year."
• Phil Tennant indicated that, "with the advent of the J code, the permanent J code, that is something that over the next couple of quarters, we will do a deep dive on to understand exactly how quickly and how many of these patients are being converted and how we can help."
• Helen Sabzevari confirmed, "Papzimias net product revenue for Q1 2026 the first full quarter of availability was $21.6 million as compared to $3.4 million in Q4 2025."
• Sabzevari added that, "There are no restrictions on the number of surgeries a patient must undergo prior to treatment with Papzimias."
• Planned updates at ASCO in June will address new durability data and are expected to inform potential indication expansion efforts.
• EMA review of Papzimias for European marketing authorization is ongoing, with no timing detail provided on a decision.

Industry glossary

• J-code: A permanent reimbursement code assigned for a drug that facilitates medical billing and claims processing in outpatient and physician office settings.
• Papzimias: A first-in-class FDA-approved gene therapy indicated for adult patients with recurrent respiratory papillomatosis (RRP), based on a proprietary adenovector technology platform.
• AdenoVerse platform: Precigen's proprietary family of engineered adenovector serotypes designed for gene delivery in immunotherapy applications.
• Patient hub: A central service for managing patient access, enrollment, and support for specialty therapies, capturing a subset of commercial patient activity.
• PRGN-2009: An investigational immunotherapy candidate leveraging the AdenoVerse platform and being studied in combination with pembrolizumab for HPV-driven cancers.
• Pembrolizumab: An anti-PD-1 immunotherapy agent used as a standard of care in certain oncology settings; here, part of combination trials with PRGN-2009.
• RRP (recurrent respiratory papillomatosis): A rare, chronic disease caused by human papillomavirus (HPV) types 6 and 11, characterized by growth of benign tumors in the respiratory tract.

Full Conference Call Transcript

Helen Sabzevari: Thank you, Steven. And thank you to all those joining us for our Q1 update call. The approval of Papzimias in August 2025 has brought a novel first-line standard-of-care treatment for adults with RRT. In 9 short months, we have witnessed tremendous progress with the first commercial therapeutic launch in the disease's history. Since last reporting in March, the launch has continued to show accelerating momentum. The early success and trajectory continues to build on this landmark achievement for the patients families, healthcare providers, the RRP Foundation, and all of those impacted by this devastating disease.

I will begin by providing you with some general color around what we are seeing, and then turn the call over to Phil who will provide more specifics around commercialization. The accelerating trajectory we are seeing in revenue growth is robust. As reported in our quarterly report, Papzimias net product revenue for Q1 2026 the first full quarter of availability was $21.6 million as compared to $3.4 million in Q4 2025. Prescribers continue to add Papzimias to their practices at both major medical centers and community practices alike. Which has been a strong tailwind as we are seeing this increasing momentum continue into Q2.

This is a clear signal of the high level of enthusiasm among patients and physicians resulting in significant uptake of the therapy. Why we believe we are seeing such a significant launch trajectory? First, the full approval and broad label from the FDA. There are no restrictions on the number of surgeries a patient must undergo prior to treatment with Papzimias. We are seeing this as patients are being dosed across all severities and in the extensive payer coverage we have secured. Second, the transformative clinical data based on significant efficacy durable and ongoing responses with a median duration of follow-up of 3 years. Importantly, we look forward to updating the ongoing durability data at ASCO next month.

Third, the ease of administration of the drug has enabled broad and rapid uptake at not just the major medical institution, but increasingly at community practices. Specifically, the ease of dosing as well as the efficient distribution infrastructure we have in place, across the country allow rapid and effective integration into routine clinical practices. Finally, the power of this therapy is strongly supported by a landmark expert position paper released earlier this year. The paper is sponsored by the RRP Foundation and authored by 16 leading U. S. Physicians specializing in RRP was published in the Laryngoscope the premier peer-reviewed journal in otolaryngology. The paper recommends Papzimias as the new standard of care and the preferred first-line therapy.

Collectively, these factors mean that Papzimias has set a new benchmark for this space. Prioritizing medical therapy over repeated surgical interventions to improve patient outcomes. As a reminder, this therapy directly addresses the root cause of RRP by eliciting a targeted immune response against HPV 6/11. Papzimias also offers potential for redosing due to its mechanism of action and favorable safety profile. We are evaluating this in an ongoing clinical trial, which is enrolling patients as we speak. I will now turn the call over to Phil for details around our commercial launch. Phil?

Phil Tennant: Thank you, Helen, and a warm welcome to all those listening. I am delighted to share the most recent progress of our launch effort with details around the completion of Q1 and the sharp momentum we continue to see with Papzimias launch in Q2 of this year. As seen in our filings, we showed strong quarter-over-quarter product revenue growth in Q1 2026. Clearly demonstrating the expected acceleration of product uptake from $3.4 million to $21.6 million. As we report today, we continue to see comprehensive payer coverage and further activation of accounts across the country. I will now present some of the leading indicators we are observing as of today, translating to the launch acceleration.

Registrations in the Papzimias patient hub continue to grow. As of today, we have approximately 400 patients registered of which 25% are in the community setting. Underscoring the broad reach of Papzimias beyond academic and major centers and reinforcing that Papzimias can be effectively integrated into routine clinical beyond major centers. As previously mentioned, this does not account for non-hub patients directly enrolled by institutions. This continues to support the fact that there is expected pent up demand for the new standard of care for adults with RRP. Payer coverage has been exceptional and provides a solid platform for patient access to Papzimias. Total lives covered through commercial Medicare and Medicaid stands at an estimated 297 million.

All inclusive, this equates to more than 90% of insured lives covered in the US. As expected, we continue to see activation of accounts who are prescribing and ordering Papzimias across both major medical centers and community practices. We are seeing this trend continue into Q2 further fueled by the permanent J-code and dedicated field reimbursement resources we have implemented. As Helen mentioned earlier, the expert position paper continues to solidify Papzimias as the first choice for adult patients and treating physicians. We continue to have a significant presence at major scientific congresses in The US and beyond, both through publications and presentations and interactions with thought leaders and the broader treatment community.

This again reinforces the strong receptivity to Papzimias that we are seeing from the market. These congresses will continue to be a significant part of our commercial and scientific strategy moving forward. The assignment of the permanent J code on April 1st coupled with the durability of response that we are seeing in patients, is helping this impetus continue. The permanent J-code designation will further simplify claims processing and facilitate broader patient access through both medical centers and community practices. The significant quarter-over-quarter revenue growth is a clear sign that the healthcare community is embracing Papzimias. We are thrilled with launch performance in Q1, and expect these positive trends to continue into Q2 and beyond.

I look forward to sharing those Q2 results in August. I will now turn the call over to Harry for an overview of our Q1 financials. Harry?

Harry Thomasian Jr.: Thank you, Phil, and good afternoon to all of the participants on today's call. As you have already heard, we are extremely pleased with our top line financial results for the first quarter. I also want to add that not only do we surpass $21 million in Papzimias revenue, but our operating loss for the quarter was only $6 million Let me provide some further color on our overall financial results for the quarter. Total revenue was $23.3 million which included $21.6 million related to Papzimias sales. We saw demand for Papzimias continue to build as the first quarter progressed and we are continuing to see that demand increase as we enter the second quarter.

Research and development costs for the quarter were $5.6 million which compared to the prior year first quarter decreased by $4.8 million The majority of this change is explained by the fact that Papzimias' manufacturing costs were expensed prior to the FDA approval. As we look forward, we anticipate R&D expense will increase as the year progresses. Selling, general and administrative expenses for the quarter was $21 million, having increased by $8.7 million from the prior year's first quarter. The increase was significantly driven by increased commercial activities related to Papzimias.

Moving down the statement of operations, as I noted earlier, our operating loss for the quarter was $6 million Our net loss for the quarter was $7.9 million or $0.02 per basic and diluted share. Turning to the balance sheet. We ended the quarter with $56.7 million in cash, cash equivalents and investments. I do want to point out that our cash used in operations for the quarter was $43.8 million and included $13 million of cash outflows that we do not expect to recur in future quarters this year. The first quarter cash used also did not include any cash receipts from Papzimias sales based on customer payment terms.

With that said, we expect cash used in operations in the second quarter to be significantly lower than what we saw in Q1. We continue to reiterate based on our current financial forecast, our cash, cash equivalents and investments along with the collection of Papzimias receivables will fund operations through cash flow breakeven by 2026. And we currently do not see a need to access capital markets for additional funding. I would like to now turn it back to Helen for some closing remarks. Helen?

Helen Sabzevari: Thank you, Harry. I will now provide updates on the portfolio starting with Papzimias' clinical and regulatory update. We intend on initiating a pediatric trial in Papzimias in Q4 of this year as previously mentioned. In addition, our marketing authorization application continues under the review path by EMA for Papzimias. We are also pleased to announce our sponsorship of a third annual RRP Awareness Day in June. This event provides another excellent platform to raise global awareness of RRP and the new standard of care for its treatment in the U.S. Now turning to PRGN-2009. This is the same backbone as our approved therapy, Papzimias, expanding the proven AdenoVerse platform.

Our PRGN-2 thousand and 9 immunotherapy is designed to train the immune system to recognize and eliminate tumor cells infected with HPV and HPV 18. The root cause of major HPV driven cancers such as head and neck, and cervical cancers. These malignancies together represent nearly 5% of all cancer cases worldwide. PRGN-2009 is advancing in multiple Phase 2 clinical trials in combination with pembrolizumab in both head and neck and cervical cancers. I am very enthusiastic about the prospects of this program. We plan to provide updates on the program later in the year. With that, I will now turn the call over to the operator for Q&A. Operator?

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. You will hear a prompt that your hand has been raised. And should you wish to cancel your request, please press *2. If you are using a speakerphone, please lift the handset before pressing any keys. 1 moment, please, for your first question. Thank you. And your first question comes from the line of Jason Butler from JMP. Please go ahead.

Analyst (Jason Butler): Hi, thanks for taking the questions and congrats on the progress with Papzimias. A couple for me. First of all, can you speak to the number of patients that have now received at least the first dose? And if you are now also seeing patients complete the full course of therapy, Second question, on the redosing trial, can you just maybe hit a couple of the design highlights for the trial and when we may see initial cuts of data And then last 1 for me on PRGN-2009. The update that you will give later this year, can we expect to see any results from the ongoing Phase 2 trials, in that update? Thank you.

Helen Sabzevari: Thank you, Jason, for the question. So in regard to the first question, I am going to hand it over to Phil, and then I will take the last 2 questions.

Phil Tennant: Hey, Jason. Thanks for the question. Yeah. We are not commenting on the specific number of patients who have actually been initiated on treatment, but it is you can see from the revenue number, we are obviously making some very good progress there. And yes, given that we started our dosing in November and it is a 12-week regimen, then, yes, absolutely, we are starting to see patients who have completed treatment.

Helen Sabzevari: Yeah. And maybe I can also add that very clearly as patients are being dosed and finishing, all of the received their doses. So this is again going back to the regional data that we have presented the safety and efficacy and durability of Papzimias switch again points to that factor and ease of administration. In regard to the second question on redosing, we have currently started the redosing of the patient, the especially the patients that they had partial responses in our previous treatment. The in our previous trials, in pivotal trials, and we are have started with that.

And, clearly, our patients in the that are being dosed right now commercially obviously, we are very much excited, and from what we are hearing from the field, the physicians are extremely excited about some of the results that they are seeing currently. So for now, we are focusing on the partial responders that were in our original trials and we are gathering the information on that, and we will be reporting from that perspective. In regard to PRGN-2009, the answer is absolutely. We will be reporting data. And, actually, we are looking forward to that. This is as we have mentioned, there are Phase 2 trials, both, especially in head and neck, that is in combination with pembrolizumab.

And I think what is very important is our open label trial. So we obviously have had and have a continuous opportunity to follow the data. And we are looking forward to be sharing this in the second half of this year.

Analyst (Jason Butler): Great. Thanks again, and congrats again on the quarter.

Helen Sabzevari: Thank you. Thanks, Jason.

Operator: Thank you. And your next question comes from the line of Brian Cheng from JPMorgan. Please go ahead.

Analyst (Brian Cheng): Hey guys, thanks for taking our questions this afternoon. Congrats on a quarter. Maybe just first, out of the 400 patients that you are currently in the hub, can you talk about the pace of conversion that you are seeing to commercial products? And just curious if you can talk a little bit about just the pace of also recruitment into the hub Are you seeing any uptick since you launched? Just curious if you can talk about the pace there. And then we have a follow-up. Thank you.

Phil Tennant: Sure. Hey, Bryan. Thanks for the question. So Phil here. So I think the revenue is probably the first thing that speaks to the pace of conversion of the patients. it is a little early to go into definitive details on that. We are looking at that, of course. And I think with the advent of the J code, the permanent J code, that is something that over the next couple of quarters, we will do a deep dive on to understand exactly how quickly and how many of these patients are being converted and how we can help. We have implemented dedicated field resources to assist in that conversion.

And, you know, the momentum that we are seeing coming into Q2, suggests that we are making great progress. There. In terms of the pace of recruitment into the hub, I mean, you seen the numbers steadily increase as we started to report on hub numbers. And remember, this is only the Precigen hub. that we are commenting on, and there is a significant number of patients who are not using our hub who are being identified and treated. So that is another dynamic that is important. Yeah.

Helen Sabzevari: And perhaps Bryan, I can also add. This is Helen. I think what is very important, and Phil pointed this out is also the number of patients that are coming through the community center. Because this is extremely important, and as we reported now we have 25% of the patients are coming from community. So these really points out not only the large or expanded efforts on medical centers, but now the community docs and the centers are participating. And, again, a lot of those are not necessarily in the hub, and they are treating the patient as we speak. And also another important point is this is not basically, and it does not matter the severity of the patient.

Which is very, very important. Again, so we are very excited about this, the reach and the way that Papzimias has been basically embraced by physicians and patients.

Analyst (Brian Cheng): Thank you, Helen. Maybe just a follow-up here. As we think about as we think about how to model second quarter and obviously, moving into the rest of the year, what are some--are there any specific consideration that we should really think through as we run through our modeling exercise on Q2, Q3, and so on. And just like you did for the first quarter number, are you able to provide some guardrail in terms of what we could see numerically for the second quarter number? Thank you.

Helen Sabzevari: Okay. Yeah. Thank you, Bryan, for the question. So clearly, we have said we are not at this moment, providing the guidance However, you saw with from Q4 to Q1, And we have gone to over $21.5 million And also, we have acceleration as you have seen in really treatment and expansion of the treatment both at medical centers and community centers I think we are looking forward definitely to our Q2 and the results that we will be sharing, as far as revenue is concerned. I am not still set. I think the revenue will speak for itself as it gets presented.

Which really shows the bringing in the number of the patients continuously and the treatment as we are expanding. And 1 of the good indicators you can see that just from our hub, Again, which is limited because it is only our hub, and does not include patients from the others necessarily, you can see a continued expansion in the number of the patients or increase in the number of patients, which is again, it speaks to the fact of that this therapy is very much it is an accelerated fashion it is taken up by the field.

And 1 other thing that maybe I can speak to and Phil can add is from a perspective of what we are seeing at the conferences and the fact that how the physicians are speaking and basically putting the patients on this treatment. And it will it is really amazing, and it is quite encouraging. In regard to what we have. So Yeah.

Phil Tennant: I would just add, Bryan, that there are a few things that we are very confident about and that looking forward to reporting on more. Obviously, the strong payer position we cemented quite early and that gives us a firm foundation for what is to come. I would say, as Helen mentioned, we expect the continued activation of accounts who are ordering and using Papzimias and not only in the IDNs, in the community. We would expect that community trend to continue to strengthen. And, ultimately, the patient identification in line with our broad label to continue as we go through Q2 and beyond.

And, ultimately, all of that is laying the firm foundation for the long-term success of the product over multiple quarters and years. Not just over a single quarter.

Analyst (Brian Cheng): Great. Thank you, Phil. Thanks for the color. Congrats on the quarter again.

Operator: Thanks, Thank you. Once again, that is And your next question comes from the line of Swayampakula Ramakanth from H. C. Wainwright. Please go ahead.

Analyst (Swayampakula Ramakanth): Thank you. Good afternoon, Helen. Phil, Rutul, and team. Obviously, a fantastic quarter. With $21.6 million in revenues. Phil, if you can help us understand that number a little bit more, in terms of what portion of that was either part of pent up demand or flow from Q4 to Q1 in terms of getting the PIP policies processes set up versus patients who were treated. In the same vein, you disclosed 400 patients in the hub with 25% coming from the community. So how many of these 400 or so patients that you have in the hub have been infused at this point and also what is the average time somebody takes from enrollment to getting dosed?

And the last question from me is on the data itself. that is expected at the ASCO conference in terms of the durability data. How should we think about that data? Would that be helpful and supportive of any label expansions? And also, how should we think about that in terms of the current studies, whether it is pediatric or redosing? You know, will that give us some sort of a feel for how this should, you know, eventually read out. Thanks for taking my questions.

Helen Sabzevari: Thank you very much, RK, for the questions. This is Helen. And maybe I take the last question first, and then I will give the rest to Phil. In regards to the ASCO presentation, we are actually very excited about the durability response and the data that is going to be presented at ASCO. Clearly, we continue seeing the same kind of momentum and as far as both safety, durability of response and the efficacy that we have reported, and we are now building further on that at ASCO. So this is all going to be quite exciting for us.

And, yes, that data will be helping in further really adding for the durability of the respond and expansion of the indication. So we are looking forward to that. And also, that data further adds to the really, robustness of the platform. Which is, simply this is something that we are very excited about, the AdenoVerse platform to be used across a number of the indication and specifically on HPV related indications, both in rare diseases but also in oncology. And we think that data is another feather in the cap of AdenoVerse platform which we are moving towards the platform. So with that, I am gonna hand it to Phil to answer the others. Hey, RK.

Phil Tennant: Thanks for the question. So let me let me tackle your hub question first. I did refer to this a little earlier. I think we would like to see another couple of quarters before we communicate details of exactly the hub conversion and time to conversion and so on. I mean, what I would say is that it is it is pretty much as expected at the moment. But I think we do need another quarter or 2 to really understand it the meaningful trends there. Your first question was about carryover revenue. Yes. Absolutely.

Given that we have got a 3-month or 12 week regimen at the end of each quarter, you will see some revenue spillover into the next quarter. Would say from Q4 into Q1, that was pretty minimal. Given the level of revenue that we had in Q4, but you would expect that to be more as we go forward. And, you know, that the key thing there is that it is new patients. there is fueling. The business opportunity that we have seen in Q1.

Helen Sabzevari: Yeah. Maybe I can add to that. That what especially with what the achievement with the J-code that has been also extremely helpful in not only for institutes to be able to process the patient through much more rapidly. And I think we are seeing that trajectory going up, and we are seeing the same thing actually in Q2. So we are very excited about that.

Analyst (Swayampakula Ramakanth): Thank you. Thanks for taking all my questions. Sure. Thank you, man. Thanks, RK.

Operator: And there are no further questions at this time. I will now hand the call back to Dr. Helen Sabzevari for any closing remarks.

Helen Sabzevari: Thank you, operator, and thank you for all of the thoughtful questions. We appreciate the opportunity to provide you with this update on this historic product launch. I believe we are building the foundation of a meaningful portfolio for Precigen. And for the community of our patients. We look forward to updating you as the launch continues and specifically also further on our portfolio progress. With that, I wish everyone a wonderful evening. Thank you.

Operator: Thank you. And this concludes today's call. Thank you for participating. You may all disconnect.

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