Precigen, Inc. ($PGEN)

Good afternoon, ladies and gentlemen, and welcome to the Precigen Full Year 2025 Financial Results and Business Updates Conference Call. [Operator Instructions] This call is recorded on Wednesday, March 25, 2026. I would now like to turn the conference over to Steve Harasym. Please go ahead.

Thank you, operator, and thank you to all those joining us for our Fourth Quarter and Year-end 2025 Update Call. Joining me today are Helen Sabzevari, our President and CEO; Phil Tennant, our Chief Commercial Officer; and Harry Thomasian, our CFO. Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in the presentation and in our SEC filings, which include risks and uncertainties that could cause actual results to differ from today's forward-looking statements. With that, I will now turn the call over to Helen.

Thank you, Steve. I would like to extend a warm welcome to all those joining us for our update call today. In the short time since the early and full approval of PAPZIMEOS in August, the standard of care first-line treatment for adult RRP, we are seeing a tremendous progress with the first-ever therapeutic commercial launch in RRP. These substantial advancements constitute a pivotal milestone for all the stakeholders impacted by RRP, including patients, their families, health care providers and the RRP Foundation. As we commenced commercial sales in Q4, Precigen has completed the transformation from an R&D company to a product revenue-generating commercial biotech company. Phil will detail the specifics of the launch progress later in the call, but I wanted to highlight the accelerating trajectory we are seeing in the revenue growth. We do not plan to provide revenue guidance on a regular basis. But instead, focus on indicators, we believe are important for gating progress of the launch trajectory from a long-term perspective. That said, as we are only a few days away from completion of Q1, which is the first full quarter of PAPZIMEOS' commercial sales. We think it is helpful to provide investors with color on the PAPZIMEOS sales ramp-up. As reported in our 10-K, net product revenue for Q4 2025 was $3.4 million, with shipments commencing in November. As prescribers at major medical centers and community practices continue to add PAPZIMEOS to their practice, we are seeing a strong momentum in Q1. As a result, based on the commercial activity to date, we expect revenues in Q1 to exceed $18 million. This is a clear sign of the enthusiasm we are seeing from patients and physicians alike, leading to a robust uptake in the therapy. I will now provide a brief recap on the reasons we believe we are seeing such a strong interest in PAPZIMEOS. PAPZIMEOS received full FDA approval with a broad label for adult RRP with no restriction based on the number of prior surgeries. This reflects the truly transformative clinical data, including unmatched efficacy, a strong and durable ongoing responses and a pivotal study powered by prospectively defined primary endpoint of complete response rate. Thanks to its mechanism of action, PAPZIMEOS also offers the potential for redosing, if needed, which is being evaluated in the clinic now. With the full approval powered by unmatched efficacy, we have significantly raised the bar for any future competitor entering the adult RRP space. Let's examine the key facts which led to FDA's approval. PAPZIMEOS directly addresses the root cause of RRP by eliciting a targeted immune response against HPV 6 and/or 11. To be clear, we enrolled and treated more severe RRP patients and achieved an unmatched complete response rate with an impressive durability of responses with more than 3 years of follow-up, which is echoed and appreciated by physicians in the field. It not only surpassed the highest statistical bar using the most rigorous efficacy endpoint ever evaluated in RRP, but produced the strongest data demonstrated in the field to date. Given the underlying cause of RRP, these results readily extrapolate to less severe patients as reflected in the FDA's broad label approval for PAPZIMEOS. In contrast, extrapolating results from a less severe population to a more severe cases is far more challenging and less reliable. What I just detailed has been supported by landmark expert consensus paper sponsored by the RRP Foundation and authored by 16 leading U.S. physicians specializing in RRP published in laryngoscope, a top peer-reviewed journal in the field. The paper recommends PAPZIMEOS as the first immunotherapy, which is the newest standard of care and preferred first-line treatment for adults with recurrent respiratory papillomatosis, or RRP. These developments represents a pivotal advancement for the RRP community, prioritizing medical therapy over repeated surgical interventions to improve patients' outcome. I will now turn the call over to Phil for details around our commercial launch. Phil?

Thank you, Helen, and hello, everyone. I'm delighted to share the most recent highlights of our launch efforts with comments on Q4 results, but also bringing everyone up to speed on the exciting progress we are making with the PAPZIMEOS launch in Q1 of this year. As mentioned earlier, we made great progress in Q4 in setting the platform for accelerated brand uptake. This included continued progress in expanding payer coverage, further activation of accounts across the country and the initial prescriptions for PAPZIMEOS. As we speak today, I can give you more granularity on some of the leading indicators of strong launch performance. Hub patient numbers continue to grow. As of JPMorgan in mid-January, we had over 200 patients in the Precigen patient support hub. As of today, that number is well over 300 indicative of the pent-up demand for the new standard of care for adults with RRP. Payer coverage continues to expand. In early January, we had approximately 170 million lives covered, which has now increased to approximately 215 million, including nearly all major payers across commercial, Medicare and Medicaid. Including regular Medicare and Medicaid fee-for-service lives means that we now have approximately 90% of insured lives covered in the U.S., which is phenomenal progress for a rare disease drug like PAPZIMEOS. Brand utilization is accelerating across the country in both the large institutions and academic centers as well as in the community setting. Pleasingly, we are seeing utilization across a range of patient severities, which speaks to the broad label of the brand. And finally, as Helen mentioned, the publication in January of the expert consensus paper clearly positioning PAPZIMEOS as the first choice for adult patients with RRP is a significant statement of intent from the KOL community and a testament to the strong efficacy and safety profile of the drug. The significant increase in revenues anticipated in Q1 that Helen mentioned clearly shows how the health care system is embracing the first and only approved medicine to treat adult RRP. We are very pleased with the momentum we are seeing, and we'll, of course, provide final revenue numbers during our Q1 earnings call later next quarter. In terms of outlook, we expect these trends to continue, assisted by the assignment of the permanent J-code from April 1 and supported by the continued durability of response that we are seeing in patients. We expect continued institutional activation as well as significant utilization within community practices. We look forward to sharing further progress with you at the Q1 call as we continue to drive this fundamental transition of a debilitating condition that has been surgically managed for over 100 years into one that is now therapeutically managed. I'll now turn the call over to Harry for an overview of our financials. Harry?

Thanks, Phil. We sure are exciting times for both Precigen and the RRP community as a whole. I want to spend a couple of minutes discussing our results for the year ended December 31, 2025, and our financial position as of that date. Revenue for the year totaled $9.7 million versus [ $3.9 ] million in 2024, resulting in an increase of $5.8 million or 149%. This increase was primarily driven by the commencement of PAPZIMEOS product revenue, which totaled $3.4 million in 2025. It should be noted that the first sale of PAPZIMEOS was recorded in November of 2025. Thus, revenue for the year only reflects a partial first quarter of the PAPZIMEOS launch. While speaking of revenue, I do want to reiterate that the first quarter of 2026 is showing a tremendous ramp of PAPZIMEOS revenue from the fourth quarter of 2025. As Helen mentioned, based on our commercial activity to date, we expect revenue for Q1 of 2026 will exceed $18 million. We're thrilled with the early launch results and encouraged by the launch trajectory. I also want to repeat that we do not plan on providing forward-looking revenue projections in the future. Due to the timing of our year-end earnings call being close to the first quarter end, which provides us an understanding of where we believe first quarter revenue is trending, we feel we can provide this guidance as a help to our investors' understanding of the PAPZIMEOS launch trajectory. Continuing with expenses on our statement of operations, research and development expenses decreased by $11.7 million, or 22.1% and compared to the year ended December 31, 2024. The decrease was primarily driven by a $9.4 million reduction in costs as a result of the strategic prioritization of the company's pipeline announced in 2024. In addition, the company, upon FDA approval of PAPZIMEOS, began classifying manufacturing-related costs to inventory which ultimately will be recorded as cost of products and services when the related inventory is sold. Manufacturing costs related to PAPZIMEOS were recorded as research and development expenses prior to the FDA approval of PAPZIMEOS. Selling, general and administrative expenses increased by $28.8 million, or 69.8% compared to the year ended December 31, 2024. This increase was primarily due to a $27.3 million increase in costs incurred related to PAPZIMEOS' commercial activities. Our net loss attributable to common shareholders was $429.6 million, or $1.37 per share for the year ended December 31, 2025. These results include two large noncash items related to our preferred stock and related warrants in 2025. In 2025, the preferred stock was converted to common shares and the warrants were reclassified to equity, thus such items will not recur in the future. These noncash items totaled $318.5 million or $1.02 per share of the $1.37 loss per share reported. Turning to the balance sheet. We ended the year with $100.4 million of cash, cash equivalents and investments. Based on our current projected business plans, we believe that these funds plus anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow breakeven, which we currently expect to occur by the end of 2026. For more information on our financial statements, I refer you to today's press release and our 10-K, which were filed with the SEC after market close this afternoon. With that, I'd like to turn it back to Dr. Sabzevari.

Thank you, Harry. I wanted to briefly provide other portfolio updates. We are actively advancing plans to commence a PAPZIMEOS clinical trial in pediatric RRP population. We hope to have this initiated in the fourth quarter of this year. Additionally, we have begun efforts for geographic expansion. This is seen with the validation of the marketing authorization application to the EMA for PAPZIMEOS. Of note, we are seeing positive feedback from top leaders in Europe on the prospect of a new medical standard of care. To that end, we are also pleased to announce that we will be sponsoring activities around the third annual RRP Awareness Day in June. This will present another opportunity to help spread global awareness of this disease and the new standard of care for its treatment. Other than PAPZIMEOS, we continue to advance the platform with PRGN-2009. This program utilizes the same AdenoVerse technology as PAPZIMEOS. PRGN-2009 is designed to activate the immune system to recognize and target HPV16 and 18, the root cause of HPV-associated cancers, such as head and neck and cervical cancers that represent almost 5% of all global cancer patients. PRGN-2009 is currently being investigated in combination with pembro in multiple Phase II clinical trials in head and neck and cervical cancer. I'm very excited about the prospect of this program and look forward to updating you in our upcoming Qs. With that, I will now turn the call over to the operator for Q&A. Operator?

[Operator Instructions] Your first question comes from Jason Butler of Citizens Bank.

Congrats on the progress. And specifically, really, thanks for giving the 1Q guidance. That's really helpful. Two questions for me. First, can you help us think about how you guys are planning the flow of patients from the hub to receiving reimbursed drug? Do you expect the majority of the 300 patients to ultimately get reimbursed treatment? And in what kind of time frame, understanding it's still early in the launch? And then second question, are you now at the point where patients are starting to get their second dose in the treatment regimen? Then can you give us any color about like the proportion of patients that are eligible or are getting the second treatment?

Jason, thank you for the questions. And definitely, I think for the first question, I'm going to defer it to Phil. Phil, maybe you can go through that.

Yes. Well, obviously. Jason, we're obviously very pleased about the continued recruitment of patients into our hub. And just a reminder that, that isn't a complete picture because we are seeing significant conversion of patients from our hub, but we're also seeing utilization from patients that are not in our hub, as we've talked about previously, that's not the complete picture, the Precigen support hub. So we're pleased that we're seeing patients being treated from both sources. In terms of that conversion speed, we -- clearly, the patients that are in our hub, that is a clear intent from the market that those patients are in need of treatment, and we want to make sure that the vast majority, if not all of those patients are converted on to treatment. That is obviously our goal. In terms of the speed at which that is being, that will happen and the patients will be converted. It really will vary by patient by patient and institution by institution. What we've done in the fourth quarter and continue to do in the first quarter is get all the pieces of the puzzle in place, in particular, the payer coverage and obviously, the identification of patients. Now it's really up to the IDNs to continue to be activated. And once you have all of those things in place, the actual prior authorization with the payer should only take a matter of weeks. But really, it's about the activation of the IDNs and that is, for some patients, the rate-limiting step, but we've made great progress throughout Q4 and into Q1 in terms of converting those patients.

And Jason, maybe I can add further to what Phil mentioned. Our hub, clearly, the patients keep coming in, and you're absolutely correct that they are converted, but this is a continuous process for the hub. It is not a onetime thing that the patient comes as patients get basically prepped and treated then new patients are entering to our hub, but it's very important to stress what Phil mentioned that our hub is not the only source for the patients, there are a number of other hubs that, for instance, large centers, they have their own hubs. And they can be entering, and we have seen that for the enrollment. In regard to the second question that you had as far as have the patient moved from the first treatment to second, absolutely. The patients are moving through all their treatments and some of them that have started last year, for instance, they have moved through their last treatment. So this is, as I mentioned, is a very fluid momentum in the hub that patients enter. They get prepped and Phil can speak further to that. And as they go through their treatment, other patients walk-in.

I was just going to make another point about the hub because obviously, we mentioned that we will have the permanent J-code as of April 1. And that will streamline and smooth the whole process by which patients pass through from our hub benefit verification institutional readiness, and then prior authorization with the payers. So that's going to be a help as we go into Q2.

Your next question comes from Swayampakula Ramakanth of H.C. Wainwright.

It's great to notice that not only the launch is going well, but certainly this year -- this year or this quarter, it has ramped up quite a bit. Having said that, I'm just trying to understand a little bit more of the nuances, especially with the flow of patients through the hub into the conversion. And also, how is the J-code, how is that helping out in terms of adding more patients not only in this quarter, but also getting them up for the next quarter. I would think that it takes a certain amount of time between the patient coming into the clinic, and then getting the therapy.

RK, thanks for the question. So it's Phil here. The J-code really does simplify the workflow and billing process from both a provider perspective and a payer perspective. We are aware, looking at some analogs of rare disease launches that some payers have been hesitant to take on the financial risk and that, of course, with our experience. But now with the permanent J-code, that sort of disappears and it's a streamlining of the administrative process and it increases certainty and, of course, speed at which these patients should be processed.

Yes. And maybe I can add that, RK, this is not specific to PAPZIMEOS. This is for any drug that is out there, including all the checkpoint inhibitors. There is always that transition and it would be the streamlining and making it easier on some of the centers to do that. And I think this is the trajectory that we see, which we are extremely excited to go from Q4 to Q1, exceeding, as we have said, $18 million, it's very important in the preparation that the team did at the early onset of approval after approval and really appreciating the number of the payers that the team got in the first -- in the beginning of the fourth quarter, because as we all know, for patients entering to the hub and even in the other hubs, the reality of the situation stands with the payers and making sure that all of the elements for getting treated, is there and big part of that was the payer's approval. And now with more than 200 million lives covered, which is an amazing amount. This is why you are seeing the trajectory of very fast acceleration from the Q4 to Q1 going from where we were in Q4 to excess of $18 million in Q1. And I think this is quite exciting, and we're having now all of the components of the commercialization in place the payers, the hubs, the institute coming in. And finally, the J code, this just makes it for the next trajectory as we move to the Q1, Q2 and Q3 and Q4.

Perfect. No, I certainly sense the excitement and what you're experiencing. Thinking about the MAA and also the European -- potentially European launch. In terms of your discussions with the regulatory body there, where are things now? And do you expect the approval in the first half of '27? Or should we assume it is going to be later? And also in terms of the launch. So should we send a fill back to Europe and get that launch going over there?

Yes. So as you know, we had submitted our EMA application as we shared with the market last year. And it has been -- the application is under review. So we are excited about that. And I think from -- for instance, what we are receiving from physicians across Europe. And we just had a presentation at UroGen, which is one of the major conferences in the field of HPV and especially on RRP, there has been a tremendous enthusiasm from the physicians really looking forward to having this first line and a standard of care therapy, which is now a U.S. also to be applied in Europe. So we are looking forward, obviously, as the BLA undergoing review in Europe, and we obviously will not -- it will be, I think, your assumption around the time. It perhaps is a good guess, but we will leave it to the European authorities when they have a decision and they communicate, we will definitely share with market. So we look forward to that as well.

Your next question comes from Brian Cheng of JPMorgan.

Just a couple from us. Can you clarify on the $18 million revenue guidance here? Is the $18 million guidance inclusive of collaboration and service revenues, in addition of PAPZIMEOS product revenue? Or is the $18 million only referring to PAPZIMEOS' product revenue?

Brian, this is Harry. Good to talk to you. Yes, that $18 million, which you said, we expect revenue to exceed includes all the PAPZIMEOS. No other revenue.

Okay. And can you talk about the $18 million projection? Is there a stocking effect that accounts into the projection compared to patients that have received PAPZIMEOS. And then maybe just on top of that, can you talk about the number of doctors that are now actively prescribing PAPZIMEOS? And how effective is the conversion rate from your patient hub compared to the academic hub?

Yes. Thanks, Brian. In terms of the stocking, so there's very little stocking that we see. We do see a range of orders in terms of the vials that order. Remember, each institution can order 1 vial at a time or they can do all 4 vials at a time. We do see some 4s and 2s, but predominantly, it is 1s, but we do see a mix. So -- but very little stocking as such from the institutions. In terms of the number of doctors, I mean, obviously, the number of prescribers is increasing, and we've -- for all the reasons that we've talked about, and we see that increasing momentum as we hit in Q1, we've obviously still got more work to do and more prescribers to bring on board, but we're very excited by the response that we're getting from the institutions and the prescribers, and that number is increasing consistently.

Yes. And maybe what I can add, Brian, to this is, clearly, the consensus paper, it really has now make it very clear that PAPZIMEOS is the first and only a standard of care for RRP and for all adult RRP, which is actually very interesting because we see the enrollment of the patients or treatment of the patients across the severity of the disease. And this is another important point that we have said according to the label that was given to PAPZIMEOS, which is for broad RRP patients regardless of severity, and that's exactly what we are seeing as far as the treatment is concerned and how the physicians are taking up this treatment.

Brian, just to your question on hub versus nonhub. I mean what I would say there is that we're seeing conversion from both sides and patients that are in our hub, but patients who are not in our hub, and we're seeing a significant contribution from both.

Your next question comes from Michael DiFiore of Evercore.

And congrats on the obvious product progress you've had in the launch. Two questions for me. You called out community uptake as a pleasant surprise. Like I know it's early, but as the community channel develops, what have you learned about what differentiates the community sites that become repeat prescribers versus those that adopt more of a wait-and-see approach? And I have a follow-up.

Yes. Thanks, Michael. It's Phil here. Look, we always had community in our sites. That was an obvious part of our strategy. I think what we saw when we were soon out of the blocks after the approval was the extreme interest from the community in utilizing PAPZIMEOS. And we've got various mechanisms in place so that we can, for a low cost, provide them all the logistics they need to use and uptake the drug. So we actually think the community is going to be a significant contributor to our overall business as we go forward for those reasons. And the initial experience is very positive.

And I can add -- this is Rutul, Mike, I can add to it, as Phil pointed out, we have done is, in addition to our end-to-end cold chain validated logistics in place, as Phil pointed out, we have multiple solutions now available for community practices who may not have cold-chain storage to acquire them at a very low cost as well as just in time shipments to essentially completely avoid need for the cold storage. So that is also aiding in our efforts to get them on board and continue to prescribe PAPZIMEOS.

I see. Very helpful. And my last questions are, if there's any color you could add on the current channel mix of U.S. payers and how we should think about gross to net cadence for the balance of the year?

Yes, I'll let Harry talk to gross to net. In terms of the payer mix, it's pretty much as we expected, and we communicated prior to launch, which was about 60% to 65% commercial, and that is indeed what we're saying, and then the rest, Medicare, Medicaid and on the government channel. So yes, 65% or so is commercial.

Mike, this is Harry. On the gross to net, we've historically guided, and we continue to guide. We anticipate the gross to net will be in the high teens, low 20s. And we've seen those play out as we've seen revenue to date.

There are no further questions at this time. I will now turn the call back over to Dr. Sabzevari. Please continue.

Thank you again for joining us for our year-end 2025 update call. As you can see, we are making tremendous progress on the PAPZIMEOS commercial launch. We are looking forward to providing the full Q1 results and detailed commercial progress in May. Have a good evening.

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.