Thank you, everyone. Thank you for joining us on this afternoon session here at the Jefferies Healthcare Conference. Very happy to have the members of the management from Invivyd up here on the panel with us. Importantly, you guys announced emergency authorization approval for your COVID antibody. And I would love to have Bill Duke, the CFO, and Mark Wingertzahn, Senior Vice President of Clinical Development, discuss that program and that product. And importantly, discuss the EUA. And importantly, discuss are we going to generate sales of this COVID antibody this year, given that the market seems skeptical. But importantly, you could obviously, obviously generate sales, and we should care about that. So talk to us about the EUA. And are you generating sales?
Sure. Thanks for having us. Short answer is yes. We launched PEMGARDA for PrEP in April and provided revenue guidance for 2024, net revenue guidance of $150 million-$200 million. Early stages of the launch, and we feel confident about what we're seeing today as far as uptake goes. What that really translates to is our sales force has been in the market now and in the field for just under two months to date. We were able to start booking sales in April, and we've seen nice organic demand generation to date.
Let me repeat that again. You've already been booking revenue since April, and there will probably be Q2 sales.
Yes, we will have Q2 sales.
And that's from stocking and for people who already are immunosuppressed. Just to be clear, this is for immunosuppressed. Let's say MS or a cancer patient, cancer patient. And they're like, okay, it's May, we're in the middle of summer. Doesn't matter. There's obviously low levels of COVID going on, but if I get COVID, that's bad. And there are already, there's some people actually getting it already.
Absolutely. The good thing about this was that we received our CMS codes quite early. And so in mid-April, we were able to announce those codes. The great thing about that is that means that 50%, roughly 50% of our targeted lives have full coverage. And so with that, that opened the doors for at least a good chunk of the target lives to start being able to receive product. Because we are a dropship model, it's really not necessarily a true stocking. It is there. The orders are being made with targeted patients in mind. So we feel strongly and good about that. We are also starting to make strides on the commercial front. The commercial front, as you can imagine, often takes a little bit more time because you need to go through various institutions' formulary processes. So we are in the midst of going through that.
We've seen good uptake there. We've also seen that these institutions, some of which have already been able to start ordering product.
Okay, let me dig a little into that. So, A, it's dropship, meaning if someone wrote a script, and this is for the prophylactic prevention of COVID. So you don't have to necessarily get it by FedEx tomorrow. But if you wanted to get access to the drug and you were able to get a script, it is shipped from the distributor over to them. You're booking revenue for that. So what is the price of the product? And then how do we think about how many scripts are being written? And where would these be? Would these be at hospital centers, primary care? Like what are the metrics to help me understand how many scripts you could actually be getting? And the price of the drug?
So the WAC price is $5,775 from a net price perspective. Think about it in the range of $4,100-$4,500. And so of course, that can vary from time to time, but we feel very good about what we've seen so far from a pricing perspective. With regards to what it means when from a dropship model, this is being dropshipped to the infusion institutions. So if that's in a hospital setting or if it's in an infusion clinic setting, that would be where the product is dropshipped to. And as you said, it's going from the third-party logistics provider to the wholesaler, and then it's promptly going directly to the infusion centers.
Are there any metrics to help me understand? I know it's early, but adoption, a lot of people here at this conference are also launching drugs. Talk about sites, sites that have written a script, how many people have placed an order. I guess I cannot track scripts on IMS, but talk to me about any metrics that would help me understand how things are going.
Sure. So internally, we're tracking all of those metrics that you speak to. I think that by the time that we get to Q2 earnings, we'll start talking much more publicly about our achievement of those. So right now, less, you know, we're keeping things a little bit tight with regards to the dissemination of that information. But we are positive about what we're seeing. We're seeing some institutions have already started repeat orders. We're seeing that, you know, it's starting with ones and twos in orders and are growing in orders. So I think overall, we feel positive about the traction to date.
You know, the reps that are in the field are really getting out there and talking to these infusion centers and talking to the prescribers, making sure that they understand the PEMGARDA product, what it means from an infusion time perspective and follow-up and really driving uptick in demand.
Very helpful. So I could obviously think about some major cancer center, which are treating patients who had a transplant or something pretty bad and they're very vulnerable. And therefore, that patient who is very concerned about COVID wants that, certainly could get access to it. There's some sick patients out there who would get that. And there's some onesies and twosies. To be fair, it's small numbers, but you're absolutely seeing some stuff being written.
Absolutely. And you know, we're doing everything that we can to make this more easily available to patients in need. So one of the things that we've done is the team has created an online infusion center tracker so that people can find out where they could actually be administered the product. So that's available on our website, pemgarda.com. At the same point in time, we're also working with infusion providers that are outside the traditional institutions to expand the availability to patients, especially as it requires outside of in more rural settings.
So yeah, so you could go to pemgarda.com. There's, if you typed in your zip code or whatever, you could find out where the locations are. You could get it either because there's a healthcare professional that could write the script or that your primary physician or your oncologist could write the script and that's where you could get it shipped to.
Send it to exactly.
Okay. Can you talk a little bit about the visibility? So you say $170 million. That's the guidance, $170 million?
$150 million-$200 million.
Okay, I took the midpoint. $150 million-$200 million. First of all, congratulations, because that would be one of the top commercial biotech launches.
By the way. So congratulations on that.
Where is the visibility on $150-$200 million? Where does that come from?
So early stage, what we're really pleased about is the fact that even as we just received the EUA, initial inquiries into Invivyd about product availability. There's a lot of patient advocacy groups who have been very active in letting us, you know, letting it be known that they have patients that are very much in need of this because it's quite detrimental to their overall lifestyle. So I think that that organic demand is something that we are feeling really positive about.
What kind of groups are those? Just, I'm not sure. So there's groups that reached out. You're in talks with kind of like what groups? And they would say, yeah, I've got 100 people who would definitely be because these are the 100 people who are in the transit line.
Yeah, I think there's a couple of things. So we can talk about the special groups. But for example, if you can imagine the major hospital facilities that have the immunocompromised, you had mentioned.
MD Anderson.
Exactly. So they have fed back to us that they have already their lists ready to go of the patients that they have identified. And as soon as it goes through the normal channels, P&T, Epic builds and things like that, that they're going to be pushing them out. So that would be something, you know, reality of what we're hearing on a daily basis that they've identified and handpicked those orphan-type categories.
Right. So major cancer centers, transplant centers, whatever, the major immunocompromised groups where those concentrated patients would be, which by the way, remind me, is about 7 million TAM people in the U.S.
That's absolutely correct.
TAM is about 7 million. So take your share of what those 7 million highly high-risk immunocompromised patients are. What % of those people would want to get a long-acting prophylactic COVID antibody? And those are primarily at these big centers, and you've been reaching out to them, and they've given you ideas of the numbers they think.
What we've said publicly is that for our addressable market that we're targeting right now is a smaller subset of that for PEMGARDA. We're targeting roughly 500,000 patients in the U.S.
How does that 500,000 come from versus the 7 million? Thank you for clarifying that.
Yeah, so they would be those moderate to severe patients, the solid organ transplants and things like that that you had alluded to. We've really wanted to really focus on that particular subset because we view it and what we've heard is they are truly the forgotten patients. They are the ones who have been excluded from trials and really have no other therapeutic options that are suitable for them.
Okay. I just did some quick math. If you did like 100,000 of the 500,000, so 20% of the type of market, by the way, that doesn't have to be by December 31st or so, but in a reasonable 6-12 month timeframe, 100,000 patients or 20% of those severely compromised people times $4,000 is $400 million. So your $170 million is another haircut to that, about half of that by December 31st. Okay, reasonable. Now talk a little. So that's the visibility. You've reached out to these major centers. We know the price of it. I ran you through some math on how to kind of get there. Now I understand though, before we get to 2025 and how this looks each year, that I understand that AstraZeneca had positive top line data for their COVID antibody. I don't have all the numbers in front of me.
Can you tell me, is AstraZeneca's antibody a competitor or what does AstraZeneca's drug do and how does that compete with you?
I would say it's a bit unclear.
Okay, talk to me.
We have not seen any specifics behind the announcement other than what they had put out. And again, one of the things that they did cite is that they met their primary endpoint, but they did call out that that was with variants that did not include F456L. And now F456L is a variant that is rising in significance and is prevalent right now. So what I would say is that we don't know. We don't know whether or not they're going to have a competitive target product profile. And we don't know what their plans are for further investment.
Let me clarify. So AstraZeneca technically has a long-acting antibody for the prevention of COVID. And they ran a phase III result. To be clear, by the way, this is actual infection data, right? Like a vaccine. And they reported positive data. However, you're telling me that it calls out the fact that the results do not include or it was not positive or does not include an analysis on that variant you just said. And that's actually a variant of concern that's been rising.
Go ahead, please.
It's certainly a variant that we are closely tracking. It's something that we've seen.
Did they call that one specifically out?
This is not like they did in the press release.
If you go back to the press release, it was something akin to that they generally met high-level primary endpoint. I've personally never seen that verbiage ever used in the press release.
High-level primary endpoint.
Yeah, it was a curious type of statement that certainly suggests that typically are consistent with other monoclonal antibodies. When the monoclonal antibodies work and are, you know, to a very specific variant, they work really, really well. But when the variant changes a little bit and the mAb becomes quiescent, effectively it's an all or none at that particular piece.
All right. I will reread that comment. I'm sure the lawyers were very keen on exactly the wording.
Absolutely.
That may or may not be a product. Again, I'm not even sure. Did they file it? We don't even know. It doesn't have EUA.
We don't. That's correct.
Okay. Now, how does that relate to your product then? Because if you just called out a variant of concern and that is rising and you, by the way, you don't have actual infection data, your approval is based on antibody titer data. So what is the antibody titer data on all the other variants and that variant?
Yeah, I mean, I could take it out and then Bill. So as part of any EUA commitment, the FDA, especially in the COVID space, you know, has asked for a lot of variant monitoring. So Invivyd is doing that and we're providing that data to the FDA and that goes directly into the fact sheet. We've seen nothing to date to suggest that, you know, there will be a concern. I mean, certainly we don't speak for the FDA, but there's certainly nothing that would suggest that we are quiescent against these variants.
But to ask more specifically, this is to do this, you basically take samples of the blood over periods of time and measure the antibody titers. The antibody titers are put on an assay of different COVID variants and you see how much neutralization it has. Therefore, if you did an assay that has the F456L, whichever number you mentioned, F456L, all you have to do is put the blood sample on there, measure the antibody titers of neutralization against F456L and the antibody titers very high against it?
To date, we have had robust neutralization data, so.
Against L456.
Across all the variants that we currently test.
No concerns there. Okay. I'm sure Astra could probably just do the same thing and may or may not have that.
Well, I think that's largely what happened where they were able to say that once the variants have shifted from one to the F456L, it became non-neutral. There were non-neutralization.
Interesting. Okay. All right. Now that also brings up the point of your potential competitive differentiation, but the power of your platform because you just put out a press release like a week or 2 ago talking about how going forward you may be able to get annual approvals or EUAs based on changes of the antibody each year. Now, can you describe what you announced and like what that means?
Yeah, I mean, I'll take a shot and Bill, anything else you have to say is, you know, we were very, very pleased when we talked to the FDA and asked for specific feedback about this, you know, this repeatable and expedient EUAs. That was the exact words that we put into the press release. Because as we just saw with AstraZeneca, for example, that all monoclonal antibodies we know historically have a finite shelf life.
So if we can stay ahead of those and actually then shift from, for example, PEMGARDA to VYD2311, that is the next antibody that's in the pipeline, which is, it appears to be more potent and has, you know, even greater pan protection, that we can again stay ahead of the curve and keep a product on the market or a follow-up mAb on the market so that the patients that, you know, are currently in the most need, these moderate to severe immunocompromised patients are not left without a treatment option, which has occurred with the removal of Evusheld.
Right. Okay. So each year you may change, modify and just show that. Now, couldn't someone else just follow along with that? Couldn't someone else do that?
In order to do so, you have to have, so part of the reason that we're able to take this approach is the fact that we have run past studies in a large segment of patients and we're able to do an immunobridging back to those results to show the titer levels. And so there's a few companies out there that have done these large-scale trials. AstraZeneca was one, which is why they were able to take an immunobridging approach as well. And then I think there's a couple others, smaller players that could also do this. That being said, you have to have made the investment in the larger patient studies in order to have this as a viable option. So this is something that we are able to take advantage of.
Okay. And also with the platform that we have, we are able to effectively know what the epitope is of concern and then very quickly manufacture and build the antibody against that particular epitope that might be different. And that is another distinguishing characteristic.
We've talked a lot about EUA and the ability to get each year different EUA approvals based on these immunobridging studies. As part of that, is there a regulatory discussion that says you need to get a full approval? Is there an aim to get a full approval? Does any of that matter?
I'm happy to take that. So certainly that would be the normal approach, right? EUA to BLA. But given the general alignment with the FDA on those repeatable and expedient EUAs with the immunobridging, you know, foundation or immunobridging concept and principles, the full approval is not something that we are currently planning to do given the serial nature of replacing the one antibody after another after another on that yearly type basis.
I would just add that we're not planning to do it in the immediate term. I think that that is something that we will constantly have as an option for ourselves. I think that one of the things that you have to look at is how long you think one of the mAbs is going to be on the market. One of the things that is obviously fantastic about PEMGARDA is the fact that it is authorized. It is the only mAb that is authorized currently. And so that being said, the product profile of a one-hour infusion with follow-up time is something that we look at and we say we think that we can improve upon.
That's one of the attributes that we really like about 2311, the fact that we may be able to have a more potent mAb and something that we will look at varying routes of administration, including IM SubQ . Those are significant attributes that would enhance the overall product profile. So with that in mind, that is why it's not an immediate focus for us, but it's certainly something full approval down the line could very much make sense.
Very good. Now, also in the recent or the last earnings update and corporate update, you made two announcements. One was that you gave some cash, year-end cash guidance. Then in a subsequent press release, you mentioned that you were making some changes to save an additional $20 million-$25 million. What is the year-end cash? Talk about if someone looks at that number and says, "Oh, wait a second, that's not a lot of cash," but it's actually technically higher because there's some deferrals of the cash that are just paid in January, even though the orders came in December. I was talking with my team about this. Normally, people do not talk about receivable cash just because, you know, maybe their cash balance is higher.
So any company that's like commercial and actually is shipping, they generally have a higher amount of cash or we're not worried about $20 million or $25 million. Your cash numbers are lower. So $20 million, $25 million matters. So what is the year-end cash? What would be the cash be more like in January? And is that enough cash to continue as a company or do you need to raise more money?
Yeah. So what we guided towards is that with the projected sales and the savings that we identified from a cash perspective of being able to save from cash outflows in the range of $20 million-$25 million, we are now saying that we expect to end the year with at least $75 million in cash. That $75 million in cash is cash and cash equivalents on hand. To your point, that does not include any receivables. What we've also publicly stated is that our collection terms are 75 days. And so at that point in time, the best way to think about this is you're only going to have a couple of weeks of Q4 revenues included in your ending cash balance. You'll have 75 days of potential receivables sitting at year-end.
So that cash will come into the business in Q1 and constantly think of it as that cycle. So that being said, you know, this is all about for us, the PEMGARDA launch. If we see the right uptake, we could be looking at ourselves and saying there's no need to raise cash. You know, that being said, we will look at things and if there's investments that we would want to make, we may be opportunistic, but the key point right now is we feel good about our projected cash balance at the end of the year and feel like that allows us to continue getting product to patients.
Okay. So let me repeat those numbers. So year-end guidance of cash is what?
At least 75 million.
At least $75 million. Is that based on the midpoint of the revenue?
It's on the low end.
The low end of 150-200. Okay. So if you're at the low end, you have $75 million, although it's actually technically higher because by January, February, you'd have incoming cash of how much? Well, whatever the receivables would be.
Exactly.
Okay. So it would be higher than that. Would $75 million plus the receivables, let's call it $100 and something million, $110 million, if you hit the low end of that, including the January cash, is that enough to not have to raise cash? If you hit the high end of that, that's easy.
Yeah.
200 million, you're good.
We have not talked about break-even yet. Obviously, we're in the early stages of commercial launch right now. We are less than two months into it. Obviously, we feel that there's a significant amount of demand. We'll be giving more guidance around that as we enter likely in the fall, but probably not before the fall as we see the real uptake as seasonality. You know, we expect that there'll be an influx of demand coming with the seasonality change. And so at that point in time, I think that we'll be able to give much more updated estimates at that point.
You'll refine things as we get to the fall.
Exactly.
As we see things. Okay. Guys, thank you very much. Appreciate you running through that.