Executive readout · one minute
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Earnings call · FY2026 Q2
Executive readout · one minute
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Management tone
Confident
Net tone +88 · low hedging
Forward guidance
1 guided metrics
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From the 8-K filed Aug 6, 2026.
| Metric | Period | Guided | Basis |
|---|---|---|---|
|
Total revenue
FY26
|
$350M – $370M | — |
How the reported period landed and where the business moved.
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We really do expect that demand is going to continue to increase significantly for AMPAG throughout the coming quarters. On your question about the Lung 202 update, yes, I think it's fair to assume we're going to complete enrollment very soon, and I don't think it's fair to assume that we would wait for every single patient to be coming. Patients may still be coming for their first evaluation, and that kind of really urge everybody to watch carefully.
Thanks so much. Congratulations. Thank you. Our next question comes from Yanin Zhu with Wells Fargo. Your line is open.
Great, great. I'll add my congrats on a very strong quarter. Maybe from Fred's comment, it sounds like for the next two quarters, you expect the sales or the demand to further build upon the current demand level or the second quarter demand level. I just want to see if that's the correct interpretation. And in terms of, you know, given your visibility into the third quarter and perhaps also into the fourth quarter, can you talk about your expectation and also the guidance sounds like it's going to come during the third quarter. Or is that the case rather than at the next quarter's earnings call? Perhaps also a question on Tilvance 301, can you give an update on where you are? And it sounds like you have a presentation at Esmo, yeah, can you talk about what can we expect the data there?
Sure, yeah. Let me cover the first two and then Dan can comment and then I'll come back to Tilvance at the end. Yes, I think you heard correctly. Demand trends are very positive right now for the Ampag-D product and we expect increasing demand Q3 and Q4. We're obviously seeing quite a bit of Q3 right now. We want to just evaluate the whole situation because we really focus on long-term guidance here. We want to make sure we can give good guidance for the full year before we announce it. But you are correct. We are intending to make a separate announcement of guidance so you know one morning you'll wake up to some hopefully very positive news I think from my advance on the guidance as we get that visibility and they exactly when but obviously some top but yes that's very strong and tag me strong and as we pointed out for looking demand is very strong and you want to comment and add some detail to that sure for Q3 right now as you mentioned Jan and we do have a pretty good side into Q3 the demand continues to grow and so we're very confident that Q3 will build upon the success in Q2.
We expanded our sales force. We continue to evaluate putting promotional activities in place, such as new TB that growth driving, not only through 2026.
And then I'll come back and answer your question about Tobin S01. That study continues to run well. We're very happy with the performance of the study. At ESMO, we're going to, again, in an oral session there, highlight some of the compelling clinical characteristics of ampagomy plus pembrolizumab in the frontline setting, including the fact that almost a third of patients go into a complete response we have a very rapid velocity of response meaning we can drive patients in the response much faster than other alternative therapies we think and we'll show much more insight I think from the predecessor phase two study obviously Tilvance is a randomized trial that we can't look at right now it's blinded we'll read that the interim point hopefully hopefully relatively soon although these trials take a long time to run as you know but we're going to show the compelling clinical characteristics and I think it's going to be a very important output for people in the field especially since the some of the excitement around leg three is faded especially post-ASCO with Regeneron's results and you know off the leg is still in some cases being questioned is whether it's the right combination in the frontline setting and there really is a extremely large need for something some alternative to ipi-devo in the frontline setting for these patients we think like the Lucille's characteristics are perfect for this would be one-time therapy combined with what may end up being fairly limited PEMPRO dosing, and the fact that we can drive a large percentage of patients into what's effectively a cure.
Great. Thanks for the update. Thank you. Our next question comes from Edzer DeRoot with Barclays. Your line is open.
Great. Thanks for taking the question, and congrats on the strong second quarter. One question on margins, and then one on lung. And you had a meaningful step up, obviously, in gross margins in the second quarter. Maybe if you could talk about the remaining opportunities to improve margins further relative to current levels and where you think mature commercial margins could ultimately trend to over time, that would be great. And then on Lung, obviously, the durability exceeds historical benchmarks from what you've previously shown. Is the internal goal there to replicate earlier data from an efficacy and durability standpoint? And also, with enrollment nearly complete, have you continued to enroll patients with similar baseline characteristics from the prior update? Thank you.
Hi, Esther. It's Coraline. So, I'll answer your margin question. The driver is a number of things. and as you know we've been focusing on this internally and we've been talking about it obviously higher volume which you can see but we have all of our manufacturing in-house and those efficiencies are also helping margin as well as these projects that we have where we're continuing to focus on margin improvement and operational efficiencies within the plant I would think about that in terms of you know one other point I'll just add to what Corleen said is as we Dan and others pointed out here realizing and then perlucan sales expected to increase this year and then stabilize at the right percentage
going forwards. Perlucan is a very high margin product, so you can expect a little bit of tailwind there On Lung 202, I just want to ask two questions to answer. One was, is our internal goal to replicate the durability, to actually exceed the durability because when we reported the durability earlier, we had a short follow-up and I think what we're seeing right now, although we're not going to pre-release the results here, obviously right now, we're seeing very strong durability, I think very similar in overall when we get a response, it's usually pretty durable. Whether it ends up being two years, three years, whatever it's going to be, we'll find that out when we do the ultimate stats analysis at the end, but it looks pretty good. I think any of those options are in the marketplace in terms of a product that will attract a lot of prescribers and patients to a one-time therapy like that. And then you mentioned with enrollment nearly complete, since I think we are seeing similar baselines or we don't have a lot of heterogeneity in our population, we're very comfortable with how we enroll these studies. And, yes, I think we're seeing similar patients come through right now than we were throughout the study. Obviously, we changed our lymphed deflation to make it so on patients, and we're seeing really good results with that right now in terms of the study.
Great. Thanks for the color, and congrats again.
Thank you. Our next question comes from Rennie Benjamin with Citizens. Your line is open.
Hey, good morning, guys. Thanks for taking the questions, and congratulations on an amazing quarter. Just two questions from us. I guess one regarding the outlook and the fact that you're reviewing guidance. Can you talk a little bit about what factors go into providing this reviewed outlook and kind of what prevents you from providing that guidance now? And related to that, you know, does Replimune's recent positive, you know, FDA advisory committee feedback and maybe even the Obsidian, you know, going public, does that kind of impact guidance? And if not, kind of what are your thoughts regarding at least Replimune's agent coming into the marketplace? And just as a final question, the endometrial study, Fred, you had mentioned, you know, systology-based patient selection and that there are protocol amendments going on right now. Can you talk a little bit or provide some color regarding the protocol amendments and, you know, how that study will ultimately reach conclusion? Thanks.
Let me take the last one first, Freddie, because it's fast. It's a protocol amendment to focus on the serious subtype, and it really links up with the disclosure we had last quarter about the response rate that we're seeing and that precise approach to how we deliver tele-therapy to certain histological sub-populations in our studies well we have a lot more to say about that across all the indications soon on the guidance what we're doing with the guidance internally is we're going to make sure we understand Q3 but really we want to understand full year we're not looking to give guidance that is just sort of short term we're really focused on long-term guidance to show the strength of the product. Overall, we really, obviously, we cater to long investors, long holders of the stock, and we want to make sure they have the information they need to understand the overall trajectory. So what we're going to do is make sure we have our demand understood fully. Obviously, it's very good, and then we will come back out at some point, which I can't tell you exactly when it's going to be during the third quarter, and we will announce something that I think everybody will find. On the competitor front, obviously, there's a lot of noise out there. I just want to stress that people have their drama that's going along with the FDA. Obviously, the product could get approved, or it is primarily competitive. The virus is very similar to that product, as well as the top of the lag that are being recycled in the community right now. It has a lot of barriers, like TVEC did, and when a company goes to launch a product, we expect AmtagV is a much more compelling option, I think, for patients with its long-time profile and really fantastic efficacy and tons of real-world experience now. And so we think that'll be good. And with the other company, Obsidian, it's a tilt competitor. I think people have in this area before they sort of just randomly assume that some other tilt company is going to come out of nowhere and somehow conquer the world here. So just bear that. There's reality with all these things. Many investors have visited us and see the scale of what we do and can see the power of what we do and how much we're taking the questions.
Thank you. Our next question comes from David Dye with UBS. Your line is open.
Great. Thanks for taking my questions, and also add my congratulations on a great quarter. I have two questions. So on time with demand, can you just talk more about the demand in various across different ATCs? Do you see more demand concentrating in large ATCs, or do you see increased demand in smaller and newly activated ATCs that have a follow-up?
Thanks for the question. What we saw and what we are seeing right now is the ATCs that we originally opened in 2024 are starting to grow based on patient type and basically information that we have that's been published recently the ATCs that we onboarded last year in 2025 those are continuing to accelerate some of them are hitting their strides so to speak and then in the first half of this year we've been opening ATC now so we do see there's a few months between an ATC activation to them starting to treat patients and then comfort level goes up so we are seeing growth across the different segments uh in regard to larger ATCs and whether they're contributing
to more i think our larger ATCs are still growing we still haven't had an ATC um that we can say has reached complete peak because they keep looking for new patients and patient types then um so we are seeing across our stuff great thanks for the color and then on community ATCs which now represent roughly one-third of the network uh how does patient volume reform behavior and and reimbursement experience differ between community and academic centers?
Great question. So, for patient volume, they have the patients there, and it's really not the number of patients. It's what time we're getting these patients. So, as we said in the real-world data that got published earlier this year, is that patients that are on two or fewer lines of therapy have an over 50 percent response rate. Those patients reside primarily in the community, so we see referral there. The volume of patients are there, and they're there earlier. We do see the community ATCs are having learning curves. Most of the community ATCs, we started to onboard in the second half of last year. I joined in the first half, and that would be that it's organic referral patterns within the network, which are much easier to maximize than referring to the academic.
Thank you so much.
Thank you. Our next question comes from Colleen Cousy with Baird. Your line is open.
Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals that treated patients has changed over the last few quarters. And then also just on just growth bottlenecks like patient identification referrals, et cetera, what do you expect to be the biggest constraint on growth going forward? And just wondering if you could talk about how you plan on addressing that. Sure.
So as we look at the conversion to referrals, what we do see is earlier patients. and earlier patients coming in. We're using that data in both non-personal media as well as in face-to-face with our field courses to get that word out. So again, we are seeing the referrals come in earlier, which means we have time to treat the patients. So that is the change in the referral pattern as well. We have gone after, I've mentioned in previous calls, the VRAP mutated patients because that is a very important patient type, 40% of our market that we were having trouble accessing before we're getting tumor tissue earlier, that is helping us ID these patients earlier to get tissue so we can manufacture for infusion at the right time. And then as far as constraints with it, the constraints that we're working on is really more penetration into the larger community networks, and we see that as an opportunity we've made within their own networks. We've got some up right now in those areas.
This concludes the question and answer session. I would now like to turn it back to Fred Vogt for closing remarks.
Thank you for joining us. This was a record quarter for revenue and fusions and margin. Our pipeline is advancing rapidly with new registrational trials, next-generation clinical programs, and new approvals outside the United States. We are energized by the growing number of patient stories that show the power. We remain deeply grateful to the patients. I want to thank our exceptional high advance team, our dedicated shareholders, our covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next generation total.
This concludes today's conference call. Thank you for participating. You may now disconnect.
SEC filing · Item 2.02
Filed Aug 6, 2026 · complete as-filed document
SEC periodic report
Filed Aug 6, 2026 · complete as-filed document