If you have any questions, please reach out to your Morgan Stanley sales representative. So great, I would like to welcome William Duke, CFO of Invivyd, to the stage. Thank you very much for joining me today. It's been an exciting year for Invivyd. For those in the audience who are not familiar with the story, can you provide some background leading up to the company's first Emergency Use Authorization granted in March 2024 for Pemgarda?
Sure. So first off, thanks for having me today. So Invivyd is focused on delivering protection for important and viral infectious diseases. And so the first disease that we're focusing on is SARS-CoV-2. So with regards to our authorization, we submitted the application for EUA in December of last year. We received our EUA for our first mAb, which we expect to be a part of a serial effort to deliver antibodies for these patients as the disease takes different directions. And so Pemgarda was issued its EUA in March. We were able to launch with a commercial team in Q2, and we are now working our way through even more rapid launch efforts as we enter the important fall viral season for respiratory diseases.
Great. So before we dive into the launch, can we just touch on new management? There's a new management team in place and their relevant experience.
Sure. So we've had some departures at the management level team. The most critical new hire that we've made is a Chief Commercial Officer, Tim Lee. So Tim Lee joined the company in June and was really focused on the bolstering our commercial launch activities. Tim's experience with Amylyx and Biohaven with very successful launches under his belt really made him a very attractive candidate. He knows the rare disease space as well as general medicine space very well. And given the fact that COVID is not a rare disease in and of itself, but we are focused on the immunocompromised, and those people often have rare disease underlying afflictions. And so our sales efforts are towards those prescribing physicians and those key centers that kind of treat these patients. So as a result, that really made him a very ideal candidate for us.
Great. So now getting into the launch, we're talking about Pemgarda here. It's a monoclonal antibody in the preventive setting for immunocompromised individuals. So previously in the second quarter, you reported Pemgarda net product revenue of $2.3 million and reiterated year-end cash and cash equivalents of, let's say, $25 million. This is based on anticipated 2024 net product revenue of $150 million-$200 million. So could you just lay out basically your strategy, the team's strategy for meeting these goals at the end of the year?
Sure. So we're really focused on this key season coming up right now with regards to the launch. Again, we look at, for the immunocompromised, COVID is a concern throughout the entire year, but their care teams are oftentimes very much focused once activities start moving indoors. The fact that we have kind of laid the groundwork to be receiving and helping patients receive doses has really kind of exponentially increased as we moved through Q2 and into early Q3. So we've been reaching out to these care facilities, making sure that we get through formularies, and also working with commercial payers to make sure that reimbursement is available. With regards to our overall efforts, you know, we feel like we are well positioned as we enter this season.
From the revenue guidance perspective, that contemplates roughly 30,000-40,000 doses being sold throughout the year, for the remainder of this year. And so we still feel very confident with regards to that, given that where we're positioned now, the underlying mechanics that we put in place so that we can get product to those in need and this important viral respiratory disease season.
So let's touch first on coverage, payer coverage. Could you just talk about the mix there, covered lives, any sort of color around that?
Sure. So we were fortunate, and we received our Medicare, Medicaid reimbursement right out of the gates with HCPCS codes being issued early in Q2, following our EUA. So that covered approximately 50% of the targeted population. You know, so the rest of the other 50% is made up of a variety of commercial payers. We have seen really good uptake with regards to national coverages as well as large regional coverages, and so we're feeling quite confident at this point that we have people in need are able to get our product reimbursed.
Great. And then diving in a bit deeper on the patient profile, when you say immunocompromised, what does this include? Are these just transplant patients, patients receiving chemotherapy?
Sure.
What is the broader identity?
So immunocompromised patients. In U.S. standards, we approximate that there's nine million patients in the U.S. We're focused on a subset of those, and we said that our target is approximately just under five hundred thousand of those immunocompromised, and that is stem cell and solid organ transplant patients, as well as those suffering from hematological cancers. And so that comprises approximately just under five hundred thousand patients in the U.S. So that is the subset that we are currently targeting.
And is there a path to maybe including other groups under this umbrella? Let's say, patients who are multiple sclerosis patients who are receiving medication or other sort of patient identities.
We're definitely looking to expand that. You know, we have talked about what we have in terms of doses available. As we kind of think through that, we are definitely expanding to other patients who could potentially benefit and kind of fall in under the, that domain of the immunocompromised, that vaccines really don't take effect for or don't benefit from. So, you know, as that, as we get further into launch, we will definitely be looking at that. We also have that in mind as we ultimately transition to our next gen product as well.
Great, and then in regards to the treating physicians, these are mostly hematologists, surgeons. How, what is your sales force really targeting?
We're targeting those centers where these patients visit most, and where their care teams reside. There's approximately 1,200 U.S. centers that we're predominantly focused on. Because of that footprint, we're able to do so with a relatively modest sales force. As we expand that population and as we expand to other immunocompromised sets, that's where you can see sales force may start to diversify.
Okay, and then in regards to marketing, educating both physicians and potential patients, I know there's limitations when you have a EUA, but could you just walk us through what efforts you're undertaking now and you hope to do in the future?
Sure. So education is a big part of the commercial effort as well. So just making sure that people have disease awareness, but also what the benefits Pemgarda can offer to these immunocompromised. So with regards to... You know, we have educators that we've hired that can work with prescribers, but also infusion clinics, so that they can get more and more comfortable with Pemgarda and understand how this can impact the patients that are under their care.
Okay. And then in regards to ordering, you have a great infusion center finder website, but how does the ordering dynamic work, and are you building up supply? What do the numbers look like right now?
Sure. So we have a sell -through model, so we are actually we sell into major distributors, the Cardinals, McKesson. And so we sell through those distributors to ultimately to the prescriber slash infusion centers, where the product will then be dispensed. So when we recognize revenue, we're recognizing revenue as it's sold to ultimately to get in the hands of the end patient, not through those distributors, so to speak. Because of our inventory volumes that we're gonna have on hand, we are not stocking the channel. We're not having our distributors sit on product. We have a relatively very fast turnaround, where we can get product to the end facility in a matter of twenty-four to thirty-six hours, in most cases.
Okay. And could you give us any color or insights into the third quarter? How are orders looking? I imagine they're tracking with overall infection rates in the country, if you can speak to either of those.
Sure. So one thing that we highlighted on our Q2 call was the progression that we've had with accounts that have ordered. So we exited Q2 with approximately 113 accounts that had ordered. We disclosed that as of the end of July, that number was up to 208. So we've seen nice traction. That's to the extent that we've actually said publicly, but we continue to see that good traction in which heading into this key respiratory disease season, you know, we always looked at the post-Labor Day season through Christmas as a real critical point for all of these key patients in need.
Great. And so basically, could you just provide some takeaways in regards to gating factors or potential risks to your year-end guidance?
Sure. I think that any time that you're looking at a commercial launch, it's always about commercial uptake and how you can actually deliver on that need. For us, it had to do with laying that initial groundwork so that we could kind of facilitate the process for getting the patient the end product. One of the things that we've kind of really put a lot of effort into is making sure that there are more infusion centers available, where the product could be delivered. So we're continuing that effort, but we're seeing nice trajectory there. As far as risks to overall, again, if a new variant came up and we were not showing efficacy against it, it might derail.
The good thing is that since Pemgarda has been on the market, we've been able to show that we've been able to deliver sustained results against the variants that have been most dominantly in circulation.
Great. So I think that's a good segue into talking about what variants are currently circulating and what trends you're seeing in the COVID landscape, in the endemic setting. Could you just speak to the parental strain, the sub lineages that are currently emerging and Pemgarda's activity?
Sure. So dominant strains today, the most dominant one right now is KP.3.1.1. We just earlier this week released the fact that we showed strong activity against that variant strain in pseudovirus assays. So it's a positive for us because right now, that estimates are saying that that's approximately 42% of variants in circulation right now. There are other variants as well, LB.1. And so we're feeling very good about Pemgarda's continued activity against these strains. We are constantly monitoring for what is the next variant that could potentially take on a sizable percentage of that share.
So we have a very strong system in place where we monitor and surveil these variants and watch for our continued activity, and then we directly relay that information to the FDA as well.
Okay, that's helpful. Yeah, I'd like to get into a bit of the interactions between Invivyd and the FDA regarding the fact sheet, monitoring these variants. How often are you interacting with the FDA, and what is the requirement in regards to whether Pemgarda is still active against potentially an emergent variant?
Sure. So our FDA fact sheet right now says that we would retain authorization, provided that we can deliver results against at least 10% of the variants in circulation. And so, you know, if you're showing that you are not delivering against more than 90%, that is where you could be at risk of losing authorization. For right now, given where we are, we are showing that against all dominant variants in circulation that we've already tested, that we continue to show activity, which has been a very good thing for us.
As far as what's next, we are constantly monitoring wastewater results in testing our Pemgarda as well as our 2311 , which is our next generation against these variants, and then we are reporting that information to the FDA. So part of our authorization does require that we kind of provide results on a regular basis to the FDA, but against variants in circulation, so there is a regular form of communication.
Is it quarterly, is it monthly, or is it dependent on what's circulating?
It's dependent upon what's circulating.
Okay, that's helpful. You also noted on your 2Q call potential vendor contamination event, if I remember correctly. If you can elaborate on the potential implications of this and what it means more broadly.
Yeah. So what we had alluded to was that we had a vendor, a lab that was doing authentic assay work for us that had a potential contamination event. That meant that the data that had been reported may not be reliable. So what that data was was related to the JN.1 variant. And so the positive side of this for us was that we actually had exploratory clinical data with our CANOPY study during the same time that that variant was dominant in circulation. So we did release that information publicly and showed that we had strong protection against JN.1 during that period of time and that information is now in our fact sheet.
For the first time, we were able to get that exploratory endpoint data into the fact sheet, and that is now something that our sales team is actually able to speak to, prescribers in infusion centers very much about.
Yeah, that was, that was impressive. If you maybe you can give us the highlights in regards to, basically this is falls under the treatment paradigm of what Pemgarda could potentially do in regards to, lessening severity of disease, et cetera. But if you can give us the highlights and summary there, that'd be great.
Yeah, so we were able to show that for protection, that we were able to protect patients to the order of 84% reliability against variants that were in circulation during the 180-day follow-up period. So we look at that as very strong results, especially when you compare against what vaccines are able to offer and other forms of therapy are able to offer. So that is something that obviously we were quite pleased to be able to kind of educate people about. And then again, we are constantly monitoring future variants and currently circulating variants, and we do so in pseudovirus assays.
Pseudovirus assays. So, are you contracting this work out? How does that work in regards to the-
Yeah, so the pseudovirus assay work is being done by a large scale lab, very well-known laboratory, and so we actually have been able to develop our assays with them. We're able to actually review their work on a regular basis, and we're able to produce strong results as a result.
Okay, that's very helpful. And I guess circling back, just briefly, there are two preprints that are out there, in regards to describing Pemgarda's activity against some of the variants we've discussed, KP.3.1.1, LB.1. Could you speak to them? There seems to be a disconnect between what some of these groups are actually seeing and what you guys are reporting.
Yeah. So these are third-party laboratories that are not associated with Invivyd at all. They made their own pemivibart and tested it in their own assay. And so as a result, we can't really comment on the quality of product that they tested or the quality of their assay. So when those results came in, we actually advised that we will have our own pseudovirus assay work within a matter of weeks, and we were able to release that information earlier this week. And we've been able to show that we've had continued activity against these very variants in question.
We'll get more specifics, hopefully, in the coming days, weeks, with regards to an updated fact sheet, because we've already relayed that information directly to the FDA, and are now working towards a fact sheet revision.
So the fact sheet would then include a quantitative analysis of neutralizing antibody titer?
That would be the expectation, 'cause that's what we have for our other assay, for other variants, so that would be my continued expectation.
Okay, great. Last thing on the preprints. They do note this S31 deletion as potentially being related to decreasing efficacy of Pemgarda. Any thoughts around that deletion and the implications around that?
Based on what we've seen in our assay work, we don't see that it's causing a problem for us.
Okay. That's very helpful. So now moving on to you. There's a lot of things going on at Invivyd. You also have a treatment EUA that you submitted. Could you provide a bit of background on what led to this submission?
Sure.
and, any insights into the timeline?
Sure. So we had dialogue with the FDA once we had already been issued, the prevention EUA. And so at the suggestion, after conversations with, the FDA, we submitted for treatment as well, thinking that we could actually show, via, bridging of results in the clinical studies that had been done, that we could, show a benefit for treatment for in the immunocompromised once they are afflicted with COVID as well. So that EUA has been submitted. As far as timelines go, there's no set timeline when we will hear, but we are in regular conversations with the FDA about it. Now that we have information on more currently circulating variants, I would expect that those conversations to enhance.
Mm-hmm, and the dynamic here, I understand an immunocompromised patient who is going to pursue Pemgarda in the preventive setting, they can go to infusion center. But if they're sick already, how does that change that dynamic?
Yeah. I mean, it would be very similar. They would still be looking for an infusion, 'cause that is what Pemgarda is set up for right now, is an infusion. As we migrate to our next pipeline program, we are looking for... right now, we think that we, we're seeing strong results in the potential to reduce dose and maybe change form of administration. So whether that means a shortened IV cycle or if it means intramuscular/subq, that'll be determined, and that's why we're conducting the trials right now.
How long is the infusion right now?
The infusion for Pemgarda is a sixty-minute infusion, one-hour infusion, followed with a two-hour follow-up. Now, these patients that we are targeting right now are immunocompromised, receiving IV therapies for other indications, for other disease states, so this is would be something that they are accustomed to already.
Okay, that's helpful. In regards to follow-up from the phase 3 CANOPY trial, should we be on the lookout for a publication or additional data in the near term?
I believe that is underway, yes.
Okay. And then the last question regarding Pemgarda launch. Manufacturing capacity, I know we touched on it, but I think you quoted on the second quarter call over a hundred thousand doses. What are the implications of the treatment EUA? Will you expand manufacturing? And is your guidance for year-end's net sales include the treatments?
So we did not break out where the you know, we have not altered our guidance, and we have not refined it publicly to state what percentage is treatment versus prevention. What we're authorized for right now is prevention, so and we issued that guidance with prevention in mind. So we look at you know, treatment as a potential opportunity to further enhance our overall penetration rate with regards to the Pemgarda. As far as the guidance goes, the guidance assumes, as I think I said before, between thirty thousand and forty thousand doses this calendar year. We have publicly stated that we have a hundred thousand doses available between now and year-end, and then we will have an additional doses come Q1.
And that'll add approximately another 25-30 thousand doses in totality. With regards to our manufacturing plans, we have already manufactured clinical supply for two three one one, our next product candidate, and we'll begin shortly thereafter, you know, the commercial manufacturing as well.
Okay, that's helpful. Before moving on to the next generation, let's just touch on the competitive landscape. I know AstraZeneca, they have a program out there. It didn't seem to be as efficacious against currently circulating variants, but any comment around AstraZeneca's effort to develop a monoclonal antibody?
Not at anything other than what they've publicly stated. So, you know, again, we know that they submitted their EUA shortly before we submitted ours. They haven't been issued the EUA to date. And to be quite honest, we're focused on our launch activities and our future product development as well. But right now, we're the only monoclonal antibody on the market for prevention.
And they did receive approval or authorization in Europe.
Mm-hmm
... if I'm correct. Any thoughts on Invivyd expanding into Europe?
You know, right now we are focused in the U.S. That being said, we will look at other opportunities, as we progress further, whether it be for Pemgarda versus a future pipeline program, still remains to be seen.
Would that be a big lift for the company in regards to supply or sales force? How would that look?
You know, right now we have an external sales force, so we would definitely be looking at the sales force size structure at the appropriate times. But again, our immediate plans are remain in the U.S.
Okay, that's helpful. Okay, now let's move on to the next generation, monoclonal antibody. That's VYD-2311. I believe you reported this week that the first patient's been dosed in this-
Yes
- study. Before we get into that, basically, how is this second generation antibody changed versus Pemgarda? And what is it targeting? Is it targeting a similar binding domain? Any insights there would be helpful.
Yeah, it's targeting a similar binding domain. It is an evolution from Pemgarda, Pemivibart, with slight modifications to it. What we're seeing is that we believe this has enhanced potential for dosing, lowering the dose, and remaining efficacious against variants in circulation. So every time that we're testing Pemgarda, we're also testing 2311 in these pseudovirus assays. We've been pleased with the results that we've been seeing. We're excited to have received, you know, get the first patient dosed. Again, we're following a very similar pathway with what we've done with Pemgarda. So first-in-human trial, we will obviously analyze those results.
We'll speak to the FDA about it, and then we'll look at, you know, how to advance that product to what would lead to a study that could be used for an EUA submission.
The initial patient that was dosed, this is a healthy volunteer study, correct?
Yes. Yes.
Would you imagine another study being required, a larger study, similar to what was required for Pemgarda?
Right now, we envision a similar regulatory pathway than we did for Pemgarda. As far as the number of patients, that will really be driven off of discussions with the FDA. We think that, you know, as a baseline, we're looking at the pathway and the study sizes that we used for Pemgarda, but thinking there might be some efficiencies that can be gained.
Okay, and you're running this study in Australia?
Correct.
The reason behind that?
Just speed to be able to get it done. We actually had very good interactions with the Australian sites, and the fact that we are able to utilize the same clinics, et cetera, that we had done with Pemgarda, with positive results.
Will the FDA require you to run this in the U.S. before an EUA?
The secondary study will be done in the U.S.
Okay. And, I mean, you've made efforts, I think, to try and streamline the regulatory process to maybe reflect closer to what vaccines and vaccine-
Sure
- boosters are going through. What could you explain that process? What would be the goal, the long-term goal in regards to the regulatory?
Yeah, I mean, we continue dialogue with the FDA. We continue to work on the most expeditious way that we can get future programs to patients in need, and trying to collaborate with the FDA on exactly what that looks like. Right now, we're utilizing the EUA pathway to do so, and that is gonna be a continued effort. There may be a world in which, down the line, that we're able to go to full approval in a more expedited manner that would be currently available, and those are the discussions that we're gonna continue to have with the FDA and see if we can kind of bridge that gap.
In the best case scenario, two-three-one-one, could you see being approved next year, the year after? What does it look like?
Yeah. So the best proxy that we have is the pathway that we did for Pemgarda. So Pemgarda, first in-patient study was done in March of 2023. We actually moved to EUA submission in December of 2023, and were authorized in March of 2024. So we think that there's some efficiencies that can be gained from that cycle. That being said, we have Pemgarda on the market now, and we have product available, so we're very much focused on that, but actually also wanting to continue that development of that next generation product, because we think that it can be very beneficial for our patients as well as you know, a benefit for our investors as well.
So, best case scenario, you would fall into something similar to the COVID booster dynamic-
Mm-hmm
- where you identify potentially an emergent variant, change the formulation or identify a different monoclonal antibody, and then, potentially get it on the market in time to actually treat it?
Absolutely.
And what the timeline you think, again, in the best case scenario?
Sure
... I don't want to push you, but, eight to 12 months would-
I think that is a reasonable estimate, yes.
Okay, that's helpful. Great, so in regards to just the key catalysts over the next six to twelve months, can you highlight what Invivyd... we can expect from Invivyd?
Sure, I mean, you know, we're gonna be continuing to deliver on the commercial side with regards to our Pemgarda sales. We have the treatment EUA that's under consideration now with the FDA, so hopefully, we're gonna be able to speak more about that in the near future. As well as launching our, you know, once we have our first in-human trial results, we'll be into discussions with the FDA on two-three-one-one, and be able to give an update as to what EUA pathway looks like on that.
In the VYD-2311 patients who are being dosed to healthy volunteers, you're starting with IV, and then-
Correct
- Other administration routes?
Right, so we start with IV. We'll be looking at intramuscular as well, and once we have that, those results, we'll then ascertain whether or not it makes sense to also look at something, potentially like subQ.
SubQ. And how many patients are going to be enrolled in the healthy volunteer part?
I believe it's 30, but I'd have to check for you.
Okay, that's helpful. I guess just kind of summing up in the last few minutes, what do you think investors should focus on or really, if they were to dive into the Invivyd story and gain conviction, what do you think either investors are missing or you'd like to highlight as something they could do some work on?
I think the thing that we're most focused on is the fact that there's a percentage of the population that really needs another element of protection from COVID. You know, we are sitting here today in a public forum, having conversations. You know, these immunocompromised folks are not comfortable in that environment. Look at it as, you know, they're putting themselves severely at risk of hospitalization or something worse, and so we're looking to provide them that benefit so that they can go about normal activities themselves, and I think that understanding that, you know, despite the fact that we're continuing our activities on a normalized basis during COVID, they are not able to do so, so they're feeling a bit left behind, and we're trying to provide them with the opportunity to go about normal activities, you know, more normalized activities.
So I think that there's a real need out there. We're very pleased to have Pemgarda on the market and being able to help these patients. We work a lot with patient advocacy groups and are hearing really positive responses from them, and we wanna make sure that they can get this product.
Should we expect any, marketing efforts? Should the-
Yeah.
I know the U.S. Open or the NFL is starting now, but anything in that regard?
We are gonna be doing things on a... We're working on that, and we're starting to roll it out. Definitely some social media campaigns, definitely more getting out in front of not only for these immunocompromised patients, but their care teams, and making sure they understand the benefits and that this product is available. So yes, I'd say stay tuned.
Great. Well, thank you very much, Bill.
Great.