Company presenter. First off, my name is Jason Gerberry. I'm one of the Smid Cap Biotech analysts at BofA. I'm pleased to be introducing Vaxcyte and Andrew Guggenhime, Chief Financial Officer, and Jim Wassil, Chief Operating Officer. So, gentlemen, first off, thanks for joining us.
Thanks for having us.
Maybe a good place to start might just be kind of your overall perspective as a company that's working on next-generation pneumococcal vaccines, the broader macro backdrop, and how you think about that in terms of your efforts to advance your ultra-high valency vaccines from a development standpoint. Then we can jump into your adult program because that's the most advanced, and you've got the most, I think, rich data set to support that as you kind of move into phase III. Then we can pivot to the development work that you do to develop the vaccines in infants, which is ultimately the biggest chunk of the commercial market for developing pneumococcal vaccines. I don't know if maybe one of you guys wants to kick things off, and then we'll go into more specific questions.
Sure. Yeah, great. Thanks, Jason. And thanks for the opportunity to be here today. It's great to be here again at the DOA conference. Yeah, as you noted, we're a clinical-stage company focused on developing vaccines to prevent or treat bacterial infectious diseases. As you said, we are most known for our pneumococcal conjugate vaccine, or PCV, franchise. We'll get into the data, I know. To your question, Jason, as to the impact of the macro environment, it's certainly dynamic. It's certainly ever-changing. Fundamentally, it does not change our mission as a company and what we are pursuing, which is to continue to advance these vaccines. We're on the cusp of initiating a phase III program for the adult indication. We just unveiled positive data in the infant indication. We're certainly monitoring closely what is happening in Washington. There's certainly no lack of news and noise.
It is important, we think most important, to really distinguish the noise and the news flow from monitoring for any potential substance or policy change. We have not seen that yet. It really has not. Certainly, we are undertaking efforts to monitor and influence what is happening in Washington. In terms of the fundamentals of the company, our mission, the programs we are pursuing, it has not had an impact. We think those are unaffected by what is happening in Washington.
Okay. So maybe back to 31 and your adult program. It wasn't that long ago, you guys put up some pretty pristine data. The stock was riding at all-time highs. As you think about where you sit today, phase III development program that you're about to start middle of the year, maybe if you can--there weren't many holes in the data, right? It seems like there weren't many uncertainties. You were just going to power up your phase III study accordingly to how other studies have been done in the space. Maybe what are some of the uncertainties between now and kicking off that phase III study in the middle of 2025?
Yeah, just from a guidance standpoint, as I mentioned, we just reaffirmed last week our expectation to initiate the non-inferiority pivotal study, one of the NVP studies that comprises the phase III program on the heels of an end of phase II meeting with FDA. This is what I would characterize as the standard blocking and tackling to stand up a broad phase III program. Continue to expect to start that study by the middle of this year. The balance of the studies that comprise the phase III program, either of this year or next year, expect the non-inferiority study to be reading out next year with the balance of the studies no later than 2027.
Yep. And just, you said just blocking and tackling, that's sort of what we've got a program that is well precedented. We have other individuals or companies that have gone through and gotten approvals. Their trials are on clintrials.gov. Yeah, we're not going to get fancy here. We're going to do more of a lint wash repeat, do what's necessary to get licensure. With the 31 valent, I think we'll be in a very competitive space once we get out there on the market.
Just remind us, you have one non-inferiority immunogenicity study, one manufacturing sort of CMC type of study, and some additional-- the third study for the adult for safety purposes?
You need a certain minimum number of subjects exposed for safety. We're going to be doing the pivotal non-inferiority. That does not get us to that threshold. We will have to demonstrate manufacturing consistency in one study by doing multiple lots in the same study and showing consistency of the immunogenicity. From a competitive perspective, you want to be able to get this vaccine with other adult vaccines like flu. We want to demonstrate that. There are individuals who received, say, a PCV13, Pneumovax, PCV20. They could benefit from having expanded coverage. We want to demonstrate that we can be used after those vaccines as well. We are going to use those who were previously vaccinated with another pneumococcal vaccine and try and push for a catch-up vaccination. They moved the age of recommendation down to 50 years of age.
The reason for that was because there are a lot of at-risk adults. We want to focus on trying to get some data in at-risk adults as well. The additional studies get you to the safety threshold, but also give a lot of important information for a good ACIP recommendation.
Okay.
I would just say upon the commencement of the first phase III study, as we have customarily done, we'll announce some of the broad key parameters of the phase III program.
Yep. My next question, I know we've discussed this, but I feel like it's important to just ask it nonetheless. There's a lot of headlines around placebo-controlled trials in vaccines, broadly speaking. I don't think it's that well defined what settings that could pertain to. PCVs used to be developed using field studies a long time ago. I guess, where do you process this information? What's your informed speculation as to where these sort of changes, if they occur, where they could apply within the vaccine development kind of spectrum?
Sure. Yeah. Again, this is one of the many topics about which there's a lot of noise and news flow. We certainly all saw the Washington Post article a few weeks ago in which an HHS employee was quoted as referencing the need for placebo-controlled studies. Like with many issues, I think when you dig into it, it often tells a different story than can be initially perceived from a first headline. Sure enough, within a week of that article, Brett Giroir, who's a former acting FDA commissioner, worked in HHS. He had spent some time with McCarry and went on Fox for an interview. This particular topic came up.
If you look at his quotes indicating that for vaccines, where there's already been established safety and efficacy, the feasibility and need to do placebo-controlled trials to study efficacy is not something that would likely to be pursued. Senator Cassidy came out later with a tweet indicating the same. Based on what we have seen, based on where we are, we do not expect, particularly in the area of PCV, where you have done these initial field efficacy studies where the efficacy, immunogenicity, and safety profile of the vaccine is very well established, do not anticipate the need to do placebo-controlled efficacy studies.
What's been the level of FDA, I guess, interaction of late, and has that changed at all? I mean, there's just a lot of headlines around disruption at FDA and the feedback that you're able to get at the company.
Yeah, again, many headlines. We're fortunate to be operating under breakthrough therapy designation, which gives us the ability, and we're taking advantage of that opportunity to have more frequent discussions with FDA and discussions at more senior levels of FDA. Those discussions have continued. We have been having those. We'll continue to have those. Again, we're certainly reading about a lot of changes. Some of the day-to-day folks with whom we have been interacting haven't changed. We haven't seen a change in the timing of the responses they've offered to us as well. For some of the more senior folks who have been in the news, those are not, again, Jim mentioned this, this is a very well-established regulatory pathway.
Those are not folks that we would have expected to have engagement with, just given this is we're following the playbook that's been established by several trusted entities here.
Okay. With respect to the phase III specifically, I think there are two items that you plan on disclosing once you start the trial, which is dose and your active comparator, unless I'm missing something.
Among other components, yes.
Those are the big ones I think that a lot of investors focus on. What I wonder about is there's really two choices of active comparator: it's Capvaxive or PCV20. As you think about that choice, and when you run a phase II and you get results relative to PCV20, I imagine it's much more conducive to start your phase III because you know how much separation, how your serotypes compare against PCV20, whereas does using Capvaxive pose some technical challenges if you were to use that? What are some of the pros and cons of these? How are you thinking about that?
Yeah. So I think you've got that exactly right. We use PCV20 in the phase II. That gives us a lot of information on the number of subjects, how to power a study in phase III to ensure that we get success. If you go right into a phase III with Capvaxive, you don't have that type of information on the number of subjects to power to hit non-inferiority. That's number one. Number two is that the guidance from FDA and WHO is that you want to use the comparator that has the greatest number of serotypes in common with your vaccine. For us, that's PCV20. Even FDA and WHO guidance sort of points you to go to PCV20. If we do do Capvaxive, we've tried to do an analysis based on their data and our data, different assays, different studies.
We think we could do either of these and be highly successful. Either way, the data was so good with 31 that we're sitting in a good position going into phase III.
You think commercially either is an acceptable reference to do this kind of study?
Yeah. Once you get FDA approval, people go back. In fact, Capvaxive used PCV20 as their comparator in their study as well. We are using the exact same comparator from that perspective. I think that either comparator will not be differentiatable from a competitive perspective.
Okay. As you think about dose or any potential dose tweaks at the serotype level, there's a little bit of a, I guess, my knee-jerk reaction is if it ain't broke, don't fix it, right? You have good results, and you probably know what to carry forward. You're also learning, right? You've been trialing infants. Maybe there are serotypes that are more important that you maybe want to tweak. Am I thinking about it right, that there's still a little bit of fluidity from the data update, that maybe there's some refinements that you may consider making?
Yeah. I mean, I should first start by saying that this 24th day was a phase II dose-ranging study. We wanted to get a lot of information out of it. We designed the mixed dose specifically to try and give us a bit of foreshadowing as to what our 31 mid-dose would look like. We wanted to see certain serotypes when we pushed the dose, if we could see some sort of dose-dependent response. We did see a dose-dependent response. When we went into with 31, we actually had a high dose where instead of 2.2, we went to 3.3, except for three serotypes, 15 and 22F, which happened to be some of the lower performers in the 24th study as well.
We think when we see the 31 data with the information we got from the 24, with the knowledge that you can push dose, that we'll see some improvements in some of these serotypes that did not perform as well in the 24 study.
Okay. Maybe just shifting to the competitive landscape and thinking through your go-to-market scenarios. When you push 31-valent coverage, right, for, I guess, 32 epidemiologically relevant serotypes, you have got competitors talking about 30-plus. What does the world look like if there are multiple PCVs that are pushing 30+? Where do we get to a point of diminishing returns where it is like maybe the end market consumer payers are kind of viewing these things as interchangeable, PCV30 versus 31 versus 32? This looks like more of an oligopoly type of end market. Are there analog situations that you can point to? I am just kind of curious. Throughout VAX, I am sorry, VAX-XL, on a recent call, makes some wonder, what is the value proposition ultimately of that relative to what you have, which seems pretty full spectrum?
Maybe I'll start and Jim can chime in. I mean, we like the position of VAX-31. It's the broadest spectrum of vaccines for the adult population in the clinic. We're in the lead position as it relates to timing, as I said, getting ready to initiate that phase III program. Thirty one serotypes is the broadest. 95% disease coverage is the most. We think we're in a good competitive position. The announcement of VAX-XL, there really is an additional, I would say, the incremental bang for the buck, so to speak, with adding incremental serotypes at this moment in time is not substantial, right? The best you can do is collectively get an additional 5% of disease coverage.
As we've seen over time with the serotype replacement phenomenon, as we protect against more strains and a more probably protective broader serotype vaccine, it's likely, as we have seen, that these other strains, which aren't circulating to a material degree today, will rise and begin to circulate again. We want to be at the ready to rise to the occasion, so to speak, to the extent that does happen.
We haven't defined the specific composition of the VAX-XL program, but are looking at a number of serotypes not contained in VAX-31 that we, in our conversations with CDC and other bodies, think might be those that will rise up to be at the ready to do so, primarily from an offensive perspective to meet the need to treat more disease, but also to the extent the competitive landscape does change to stay ahead of the pack with respect to having the broadest and most broadly protective vaccine.
Yeah. It seems to me, and correct my paraphrase, but too, if you clearly have a first mover advantage from the ultra-high valency, the incremental gains in terms of coverage may be smaller, but you at least have first mover advantage. That position would be well, even if the market does get competitive because it's such a big market. Is that like a fair synopsis? I think getting preferential recommendation is really hard.
It is hard. We think VAX-31 has a profile that could warrant it. It's been granted before. I would also emphasize that it, frankly, is not that critical from a strategic or commercial opportunity standpoint. Case in point, if we look back in the more recent situation in the adult population, you have the approval of PCV15 and PCV20 before Capvaxive came in. Neither of those two vaccines had a preferential recommendation, but PCV20 garnered the overwhelming share, 95%+ share of the market because it covered more serotypes. That's really, look, again, we do believe that VAX-31 certainly warrants consideration for preferential recommendation given its profile. We're not hanging our hat on that. We don't think it's needed to deliver the commercial opportunity. We'll continue to monitor the landscape.
As I said, history has shown, you asked, Jason, if you have a world in which there are several vaccines on the market, history has shown in this space that the vaccine with the greatest number of serotypes and/or the greatest disease coverage will win the market.
Is there an incremental pricing premium with incremental serotype coverage still to be had, do you think, in this marketplace?
Historically, there has been, both U.S. and ex-U.S. Ex-U.S., they have a more formalized health economic assessment. You compare it to the standard of care. If you prevent more disease in that model, you can change that into a price premium. Same thing in the U.S. When you look, Pfizer went from PCV13 to 20. They had a substantial increase. Capvaxive, same thing, a premium price as well. We think that we can also increase the price commensurate with the incremental amount of coverage and disease prevention that we're delivering.
Right. The health economics in vaccines, particularly PCVs, are incredibly compelling. As Jim said, I mean, it's one of the greatest public health interventions in history. The health economics for these vaccines is pretty interesting.
I'm learning as an analyst, it's hard to get European pricing on drugs.
Last month or so.
It's probably even harder now.
Was Capvaxive, was it much of a premium relative to 13 in terms of the step-up? Do you feel like that was a good analog for a commensurate step-up?
I think if you're talking about Europe, I don't think the Capvaxive prices are out yet.
That's going to be the standard of care because PCV20 failed on the three doses, right, effectively too.
In infants.
In infants, yeah.
Yeah. Yeah. So Capvaxive is not designed for infants.
Oh, I'm confusing.
Yeah. So I think, and so you have the situation here where PCV15 is now pushing forward in some countries.
Yeah.
Eventually, we'll be able to see what the pricing is and whether or not there's a premium in some countries. There are some countries where you can get pricing fairly readily.
Okay. We're about halfway through, so I want to pivot to the infant program and your recent phase II definition work that was done. You've got, I guess, some booster data coming up by year end, if I understand right. Yeah, so I guess just trying to get a sense of what you saw, to the extent that you saw good translation relative to the adult data or just running into maybe some of the challenges of going to an underpowered study in a naive immune system with the infants and some of the variability with third-dose measurement. Just kind of how would you frame what you saw in the case of VAX-24?
I'll say adults, like you mentioned, are immunologically different than infants, mainly because we've carried pneumococci in our lifetime, and we've developed an immune response to the bug. We're no longer naive. The vaccine is actually a boost from our natural exposure where infants are naive and they have a developing immune system. That said, even though there are those differences, we did see a couple of commonalities, which was, one, we did see a dose-dependent response between the serotypes at a low, middle, and high dose. We were running a dose-ranging study to see what was necessary to design the best vaccine going forward in phase III. We saw that, and that gives us some information as to how to design a phase III program.
The other thing that we saw was that we did not see a significant amount of carrier suppression when you went from, for those that stayed at 2.2 micrograms, when you increased the dose to the mixed dose. That is similar to what we saw with the adult program where we went from 24 to 31, and we did not see a significant decrease in immunogenicity as well. The fact that we are not seeing the carrier suppression, the fact that we are seeing some dose-dependent responses means that we have, I think, some tools at our disposal to redesign this infant formulation and make sure that when we go into phase III, we have an optimal chance of success.
If you were to look at that VAX-24 data, and hypothetically, if VAX-24 was a go-forward vaccine, right, for phase III, are there certain serotypes you'd say, "Hey, there might be some endpoint risk versus others that you'd say clearly we feel like we have a good handle on solving for either through whatever assay we use or dose or just study powering"? I guess, how would you kind of frame that? I think there were like four or five serotypes depending on the measure that you looked at, IgG or the other immunogenicity measure.
Oh, both.
Yeah, both. Just how would you frame that?
Yeah. So I mean, for the 24, I think first I'll say is we did very, very good against the two most common circulating strains, which were 3 and 19F. Those account for 30% of circulating disease in infants right now in the U.S. That, seeing a 1.6 fold-2.8 fold higher improvement in immunogenicity, bodes well for having better clinical effectiveness or outcomes because the ones that we didn't do as well on were those that are currently not circulating and haven't circulated for some time. That said, we did see evidence of a dose-dependent response. Of course, we don't want to miss on any, if possible, going into a phase III. We believe that if we push dose, we'll see some improvements. It might not get all of them across the line, but I think it will help improve.
If we see the same improvements that we saw in the seven that we pushed our dose on, then I think we've got a good chance of hitting or at least meeting a few of those that were the misses in the phase II study.
Right. Jason, you alluded to this, right? Perfection is not a requirement in this field, nor has it been the standard or the precedent you mentioned, right, for Pfizer or PCV20 program in infants. They failed to hit the non-inferiority standard for 14 of the 20 serotypes after the primary series. They did hit it after the boost. The study was a dose-ranging study. We got the information to enable us to kind of design the optimal phase III program, whether that is VAX-24 or VAX-31 that we take in. We will get the results of that primary series next year. As Jim said, we are already exploring higher doses across the board in the high-dose arm for VAX-31 that were explored in the VAX-24 study.
Of the handful of serotypes for the VAX-24 data where we might have liked to see a stronger response, three of those are being dosed at an even higher level in this ongoing VAX-31 study.
That was going to be my next question, right? Because I mean, what really matters, I think, in a lot of investors' eyes is how next year, mid-year, when you get the VAX-31 infant data, what that may look like, how that may look similar to what we saw with VAX-24 or different. I think the focus is on the 20 established shared strains because I think it is very rare we ever see a miss on the novel incremental strains.
Yeah. With the novel incremental, you're absolutely right. For the four incremental strains above PCV20, we saw really, really good immunogenicity. Very, very highly immunogenic. If we can extend that to the 11 and the 31, then that bodes well for moving forward. For the others, and Andrew sort of alluded to this, we already increased our high dose from 2.2 to 3.3 micrograms. We increased the dose, and we've seen an improvement with dosing. There were three that we chose to increase to 4.4. Those three were three of the serotypes that did not perform as well in the 24th study. We're hoping to see a better response overall and hopefully improve these three that we pushed dose to 4.4 to a point where they can meet the non-inferiority.
Yep. Okay. We have to look forward to. I guess in the second half, we've got the booster data for VAX-24. I guess, what do you focus on with this data? Because I think your interim on booster was two-thirds, I think, of the exposure. You think that that's pretty robust, and probably the data do not look that dissimilar when we get the final booster, or is it just too hard to know?
I mean, I think that having two-thirds of the data gives us a good idea of where we're going to end up when we have the final dataset by the end of this year. I do think that you may see some slight changes. More importantly, what you'll get with the incremental data is a narrowing of the error bars. We missed on five of these serotypes, but we just barely missed on those five. I mean, with lower bounds, just crossed the non-inferiority threshold. If we can tighten those error bars, what we might see by the end of the year is actually seeing some of these that we consider misses with this interim dataset be pushed into a make or meet the non-inferiority criteria. Yep.
One of the serotypes, I think, was there was maybe an issue of assay cutoff with VAX-24. Where are you guys in terms of potentially looking to modify that assay and cutoff? I know in these infant trials, I think, was it Merck or Pfizer used a unique cutoff for certain strains?
Yeah. I mean, so that was 12F that Pfizer had a unique cutoff for. We are still doing our finalization of some of these assays as is expected. We may change the modification. We may. It depends. Ultimately, I think that for some of these, it is more dose-dependent response that can improve them more so than assay modification.
Okay. Any specific serotypes where you feel like it was just clearly a powering issue? When you go to a larger phase III, the compression of the error bars that you feel like, I don't know, a couple of the serotypes might just benefit merely from slight powering?
Yeah. I mean, that's the case. In those that were just barely misses, yes, I think tightening the error bars a little bit will give us a better chance. I think in particular, post-boost, and we already just talked about it, with two-thirds of the subjects in the phase II, the error bars are wider. So even when we tighten those, I think it'll give us a much better chance of a good look to what we'll see post-boost as well.
Yeah.
As we think about a prospective phase III program, as Jim said, right, one, it'll be larger than the phase II. That's additional serotypes that might have missed in a smaller phase II to hit in the phase III. We'll get the results of the higher doses for the VAX-31 study beginning next year, middle of next year. We also have the opportunity to further optimize again these phase II studies just to remind R&D dose-ranging studies to enable us to design an optimal phase III program. We'll have the opportunity to get warranted to further optimize specific serotypes if a need arises as we embark on a future phase III program.
As you accrue data next year for VAX-31 in infants, then you make a decision as a company, is it VAX-24 or 31?
That actually seems like a very straightforward decision unless 31 shows something bad, right? I mean, which we do not expect to happen based on the clinical experience that we have seen so far. I am just sort of curious, what factors might we be missing that maybe go into that priority rating decision?
Yeah. No, I do not think you are missing factors. I think it is relatively straightforward as it was in the adults' indication, right, where we saw the stellar data from the VAX-31 program that we unveiled, as you noted, in the fall of last year. It was very clear that that was the program to which to pivot for a phase III. That is the program we are about to embark upon. I think the calculus for the infant indication is very similar. We had positive data for VAX-24.
We'll get the first results of the VAX-31 study middle of next year. To the extent we see data that's frankly consistent with what we saw for VAX-24, we'll expect certainly the higher dose arm to be better. That's likely the program with which we move forward. I mean, it takes serotype coverage from 24 to 31. It takes disease coverage from 72%- 92% of circulating disease. To the extent we see kind of immune responses and a comparable safety and tolerability profile as we saw for the VAX-24 study, it's hard to imagine a scenario under which it wouldn't be VAX-31 that we would take forward.
Yep. In terms of the trials you're running, you've got two important VAX-31 trials, one that'll start soon and one that's already underway in infants.
What's the enrollment dynamics look like right now in terms of just the broader backdrop? Do you feel like any kind of anti-vax rhetoric at all is playing into slowing enrollment? Maybe you can walk through each of the two trials and how quickly you'd expect them to run. I think most of us expect the VAX-31 adult trial to be about a year, similar to the phase II. I don't know if you cut certain steps out, like the safety run-in that you do in the phase I, III versus the phase III for adults.
Yeah, that's correct. We don't have to do a safety run-in. We've already established the safety. We open the enrollment. Adults, we expect them to enroll fairly quickly. The main reason, there's so many more adults available just from that practicality perspective. With it being 50 years of age and above in terms of recommendation instead of 65, we are now open to doing enrollment in a broader age population. Yes, maybe a year or so for the adult study. For the infants, there was some impact on enrollment, I think, coming out of COVID already. We made adjustments. We've increased the number of sites that we're enrolling at. We haven't seen a decrease in the absolute number of enrolled infants in our studies. We had to do it by compensating for expanding our coverage of enough sites.
Overall, slightly decreased in terms of enrollment, but overall, easily compensated for by just adding a few extra sites.
Yeah. In an environment scenario for which we had planned on pace.
Yeah.
Maybe just in terms of an update, you're pretty well armed cash-wise, but you do have a high burn. Do you mind us kind of look ahead to the remainder of the year, your cash balance, and how long you think that will run you too as a company?
Yeah. Sure. Just as of a recent announcement, we have approximately $3 billion on the balance sheet as of March 31. What we historically have said is that that balance sheet is sufficient to take us through all of our anticipated milestones under an all-systems-go scenario for not only our PCV program, but also the pipeline that could fund all the key milestones in 2025, 2026, and 2027.
We have a bit of formal guidance that would include the anticipation of being able to submit a BLA. A balance sheet that does not necessarily get us through the potential launch of VAX-31 adults, but gets us through, as I said, several milestones over the next few years. We are already in an incredibly, I think, enviable financial position from a balance sheet perspective. I will say, and you might have noted this in the recent press release we issued in connection with our Q1 results, just in the context of the current dynamic, we are evaluating our investment priorities. We are evaluating our allocation of capital to, frankly, further strengthen the already strong financial position we are in. An evaluation that is underway and stay tuned. We believe the balance sheet is one of several competitive advantages we have.
We want to make sure we keep it that way.
Just like a quick word on where that gets you from a CMC readiness perspective in terms of manufacturing, the investment that you're making in Lonza and what you'd have at the end of that 2027 period from a manufacturing footprint perspective.
Yeah. As folks may know, we plan to launch out of the existing shared use facilities out of which we operate with Lonza for the initial launch of VAX-31 in adults. To support the global opportunity, not just for adults, for infants, we are building a new dedicated facility with Lonza that is expected to be completed by the early part of next year. We'll be done with that. We'll be beginning to manufacture product for that.
This cash runway we've outlined also includes the beginning of stockpiling of inventory levels to support the launch initially in the adult and ultimately the infant population. Over the next few years, we're in a very solid position from a manufacturing readiness standpoint.
All right. It looks like we're out of time, gentlemen. Thank you so much for joining us. Best of luck.
Great. Thanks, everyone.
Here we have President and CEO Mike Alkire and Chief Administrative and Financial Officer Glenn Coleman. Thank you both for joining us. I think the big focus for the past several weeks and months now has been the macro backdrop, what's going on there with tariffs, now the executive order on drug prices. There's a lot of focus on this presidential administration. Will they, won't they with tariffs?
But can you talk about what your healthcare provider members are currently experiencing as they think about all these uncertainties and really how Premier is positioned to help them?
Yeah, sure. First of all, thanks for having us. So a couple of things. You sort of mentioned the issues associated with tariffs. And that's coming and going. I feel like that's incredibly fluid. And so we'll see how that kind of plays out. But given that some of the negotiations that happened over the weekend with China, I think I'm a bit more bullish that we'll get some resolution around that. Things that are given that I'm not so sure that will change in any short period of time are the labor crisis that's affecting the healthcare system. So I think everybody's aware of this that follows healthcare.
We had a lot of folks resigning during COVID, people that we had expected to be in the labor force for a number of years. I just think that they got burned out and decided that was not for them. We have significant shortages. A lot of people talk about nursing shortages. When you go around talking with healthcare systems executives, we are talking about radiation technologists, pharm techs, just core people that you need to keep a hospital running. We still are struggling quite a bit with labor shortages. The impending Medicaid cut that was kind of championed, there were some conversations around yesterday. I think that is about, I do not know, potentially like an $80 billion impact on healthcare. That is going to be huge.
The healthcare systems are going to have to think about structurally how are they going to realign themselves so that they can absorb that kind of impact. I think shorter term, I think labor is longer term. These Medicaid cuts, these impending Medicaid cuts are going to be big drivers of how healthcare systems are going to operate. In terms of how are we sort of aligned to sort of support them. I know there are going to be some questions associated with, are these things going to have an impact on their ability to spend money on services and those types of things. I got to tell you, we've made the right levels.