IVVD - NASDAQ

Good morning, everyone, and welcome to the Q3 2025 Invivyd Earnings Conference Call. [Operator Instructions] Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Katie Falzone, Senior Vice President of Finance. Please go ahead.

Thank you, operator. A short while ago, we issued a press release announcing our Q3 2025 financial results and recent business highlights. That press release and the slides that are being used on today's webcast can be found in the Investors section of the Invivyd website under the Press Release and Events and Presentations section. Today's discussion will be led by Marc Elia, Chairman of Invivyd's Board of Directors. He is joined by Tim Lee, Chief Commercial Officer; and Bill Duke, Chief Financial Officer. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K and 10-Q, which are also available on our website. I will now turn the call over to Marc.

Thank you, Katie, and good morning, everyone. The third quarter for Invivyd marked a turning point in our company's history, and we hope also mark the beginning of substantial change in how we may prevent COVID for vulnerable Americans in the near future. In the third quarter, in addition to growing our PEMGARDA commercial franchise, we received feedback from the U.S. FDA to develop our vaccine alternative antibody, VYD2311, for broad populations that continue to suffer from COVID and who are not adequately served by current COVID vaccines. This feedback and our next steps with Invivyd are the results of years of Invivyd innovation and dialogue on that innovation with the FDA. By focusing on molecular evolution and by demonstrating the clinical benefits of our medicines in prospective randomized placebo-controlled clinical trials, we believe we and the FDA are working within the same highly robust intellectual framework for evaluating new medicines, all for the benefit of vulnerable populations and the American public. Following receipt of FDA feedback, we immediately moved in late summer to raise capital to power our intended studies, and in total, raised approximately $87 million in capital in the quarter and shortly thereafter. This infusion of capital leaves Invivyd well funded to execute our pivotal clinical program as well as to expand our current commercial organization in anticipation of VYD2311 launch, all while staying highly disciplined on our operating expenditures. As a reminder, we have anticipated launch quantities of VYD2311 and a route to scaling manufacturing and supply further as we approach launch. The next 12 to 18 months promises to be an extraordinary time for Invivyd. On today's call, I'll briefly review some aspects of our upcoming pivotal program for VYD2311, which is on track to initiate around year-end and deliver top-line data in mid-2026. And then Tim Lee will walk through recent progress with PEMGARDA and comment on the future commercial landscape for VYD2311. Finally, Bill Duke will review our financials, and then we will be happy to take your questions. We recently conducted a webinar that contains substantial detail on our work with monoclonal antibodies and our plans for moving forward with our pivotal declaration and LIBERTY clinical studies. I will briefly touch on some design elements and background logic for those studies today, but recommended for more detail, listeners revisit our investor event webcast from last week. To start, it's important to remember that the category of COVID prevention was born with mRNA vaccines during the first year of the COVID pandemic. At that time, speed to market was priced over the collection of long-term placebo-controlled clinical data. As a result, the placebo-controlled efficacy data we have from COVID vaccination is principally from the 2 original major studies of mRNA vaccines, each with a relatively short efficacy follow-up of 7 to 8 weeks, at which point the efficacy data was unblinded and the vaccines were authorized. These studies were, of course, conducted then in immunologically naive humans rather than in today's seropositive human population and were conducted at a time of immunologically responsive original SARS-CoV-2 virus rather than against the immunologically evasive viruses we face today. So other than measuring modern antibody titers that may not relate particularly to past observed protection in RCTs, there is very little controlled data on the efficacy of COVID vaccines beyond this original 2-month look to inform current clinical protection and overall risk-benefit. The FDA has used those original data and various real-world data sets and immunologic data to construct labeling language for the vaccines in our current environment. Both mRNA vaccines are indicated for use at least 2 months after the last dose of COVID-19 vaccine. But that statement does not provide any information on likely protection in a modern context if used maximally, for example, every 2 months, or used as most people use it once a year. Finally, CDC and ACIP recommendations have generally been consistent with FDA language recommending vaccine utilization once or twice per year or no more than every 2 months for certain vulnerable populations. The point is that while COVID vaccines remain a blockbuster medical category despite widespread skepticism, as a society, we do not have any modern randomized data describing current or long-term vaccine efficacy. We do not have any placebo-controlled prospective clinical trials demonstrating the safety and efficacy profile of repeat vaccine dosing. And we do not have any prospectively designed placebo-controlled information on the relationship between vaccine-induced antibody titers and clinical protection over either the short or long term. We designed the declaration study to address several of these issues in a compact fashion in order to advance our knowledge around COVID protection while rapidly moving VYD2311 to BLA submission if the study is successful. By using a single dose of VYD2311 with a 3-month measurement and by evaluating in parallel the safety and efficacy of monthly repeat dosing, we believe Invivyd can, in one single study, provide more information on the extent, durability, and quantitative predictability of protection from COVID than we have had from COVID vaccines over the past 5 years. We are also evaluating currently our options for evaluating longer-term protection with VYD2311 as our modeling suggests that meaningful protection following a single dose would last for a year. More in the LIBERTY study, we plan to assess in a head-to-head study the safety and tolerability profile of VYD2311 versus active comparator mRNA vaccines. Why? The single most important reason Americans avoid COVID vaccination for is safety, and we see a critical opportunity to avoid the weaknesses of cross-trial comparison and by contrast, simply demonstrate what we expect to be the major safety advantage of antibody-based prophylaxis. Based on our prior studies of low-dose intramuscular antibodies, we expect a highly favorable side effect profile that reflects the absence of inflammation and immune engagement that can be uniquely offered by antibodies. Antibodies and VYD draw directly from normal human immune biology and do not require inflammation like a vaccine boost, and so a clear demonstration of safety and tolerability advantage may be a critical piece for educating HCPs, vulnerable populations, and policymakers on the merits of our approach. Net, we believe that declaration of LIBERTY provides an incredible opportunity to demonstrate the power of our antibodies in protecting people from COVID. And we anticipate that our data expected mid-2026 will add to our growing body of information that can provide major confidence in a potentially superior medical approach to protection compared to COVID vaccines. Our clinical and regulatory groups have been moving quickly to stand up these studies, and we will look forward to updating you on our progress in the coming weeks and months. I will now turn the call over to Tim Lee, our Chief Commercial Officer, to talk about our progress with PEMGARDA and our expectations for the VYD2311 commercial journey. Tim?

Thank you, Marc. Last week in our investor webcast, I said that we believe there is an enormous near-term opportunity for Invivyd. Now I'll get into the future that we see. We said that Thomas Jefferson quoted, I'm a great believer in luck. The harder I work, the more I have of it. We are able to help certain immunocompromised people avoid COVID today, while planning a broad swath of Americans avoid COVID in the future with our next-generation antibody. There's a lot to digest here from this slide because we are taking the actions that I told you that we take during our Q1 earnings call, and they are working. I told you we're beginning to make progress on contracting. Today, we have more than 15,000 contracted GPO sites. I told you that we are refining messaging. And today, we have more than 1,200 sites offering infusion, and 76% of those accounts are reordering. I told you that we're beginning to be seen as a leader in COVID, and we're acting as leaders, and that means that we've been to more than 125 conferences. And all of this is enabling us to move from helping a smaller patient population today via infusion to a potential vaccine replacement with our next-generation antibody, if approved. At our Q1 call, I shared that the IDSA guidelines and the NCCN guidelines for B-cell lymphomas included HMGRDA. As you can see here on this slide, today, numerous medical societies and guidelines make that recommendation. And it's important that the medical community is recognizing the importance of antibodies in preventing COVID because the long-term impact of the disease continues to be dire. The impact on children exposed to COVID-19 in uterine to our brains, to our cardiovascular systems, we should all want to avoid getting sick with COVID. We see a future that needs a widely available and accessible option to prevent COVID for most Americans. Current options simply are not enough, and we need to provide patient choice. Now for HCPs and immunocompromised people can scale to a much bigger market share should VYD2311 be approved. We have found that people do not want to miss out on life because of COVID. They are on social media, and they are receptive to learning more. I talked about the number of conferences we've been at, and I wanted to share where we are from a commercial perspective. We're meeting HCPs who are most interested in keeping their immunocompromised patients protected against COVID and understand the damage that COVID continues to cause for immunocompromised people who are in their care. As we consider the size of the potential commercial opportunity at this point in 2025, COVID vaccine uptake is substantially below that of influenza vaccine uptake, despite people being more concerned about getting COVID than they are about getting the flip. As we've seen in the CDC data, the reason why people do not get the COVID mRNA vaccine is a concern about side effects. We see extraordinary medical value to create a business to scale. So our goal is simple, not easy, but simple. We want to provide people with a choice as they seek protection against COVID. And we believe that this has blockbuster potential because there are so many people that we can help. We see an enormous near-term commercial opportunity for Invivyd. Last year in the U.S., COVID vaccine sales totaled $3.8 billion. And yet, as we reviewed, the vaccine appears to be less than an ideal solution. We believe we make substantial safety, efficacy, and durability of efficacy of protection from COVID, and we're looking forward to getting started should VYD2311 be approved. With that, I'll turn it over to Bill.

Thanks, Tim. I will quickly review our financials, and then we will be opening the line for questions. Our revenues continue to grow in the third quarter, up 11% quarter-on-quarter and 41% year-over-year, reflecting our continued efforts on driving awareness in the market. We also substantially improved our cash position, not just from our underwritten public offering in August, but also by a reverse increase through our initial ATM facility, now effectively exhausted and at much better prices than our August 2025 financing. Invivyd is now well capitalized through anticipated pivotal data of VYD2311 in mid-2026, on continued growth and continued operational discipline, potentially well beyond. With that, we will take your questions.

[Operator Instructions] Our first question today comes from Josh Schimmer from Cantor Fitzgerald.

This is Alex on for Josh Schimmer, and congrats on a great and exciting quarter. So my first question is, do you plan on winding down PEMGARDA once the next-gen product is approved? And if so, over how much time? And then I have another question.

Alex, thanks for the question. I think the easiest answer right now is simply no. PEMGARDA is, as you know, perhaps a medicine that has some slightly less attractive properties in terms of scalability and accessibility, but it does remain a differentiated medicine at the molecular level. And while the market may someday pass it by, we would have no plans to actively sunset.

And then my second question is, can you please clarify the coordination between CBER and CDER that is required for the LIBERTY study?

Well, I can certainly tell you what we know, but I think that sort of insight is best left as a question to the FDA. I think what you are simply observing in our work is that by virtue of a law that I think dates back all the way to 2002, there are different responsibilities between CBER and CDER, and therapeutic monoclonal antibodies have traditionally been handled by law by CDER. And so when we, in effect, comingle these sorts of prophylactic medicines in a study, I would imagine that there would be some level of dialogue between those 2 centers on the nature and boundary sets of our study. So of course, I can't tell you what they're going to talk about with one another. But I think from our perspective, it's all about essentially getting confidence and alignment on what to us looks like a relatively straightforward in, right? So there are mechanistic and fundamental questions that so far have only been answered in animal systems. For example, what does happen if you concomitantly administer both a vaccine and a monoclonal antibody? It wouldn't be crazy to imagine they might interact. Now the meaning of such an interaction, I don't know that we see a particular issue one way or the other, right? Animal work suggests that applying a monoclonal is almost like putting a little piece of masking on an antigen. And so you redirect some of the immune response to vaccine. But it's not clear to us that it will change in one way or the other. I think our suspicion would be that in seeking to advance a broadly labeled, broadly indicated monoclonal, we would want to do this sort of experiment, and the FDA would wish to reflect on such an experiment to support labeling language and a description that is useful to HCPs and vulnerable populations about what is the nature of such a combination. So again, I think it's really just from our standpoint, a logistical step that will involve a slightly unusual coordination at their end because, to my knowledge, nobody of late has actually sought to combine such assets in one single clinical study. But that's a very different statement than us thinking it involves any particular risk one way or the other in any particular extraordinary process. I think we just wanted to flag it because I think it's an unusual study in a really, really good and interesting way, and we're very much looking forward to conducting it.

And our next question comes from Patrick Turchio from H.C. Wainwright.

This is Abella on for Patrick Turchio. Congrats on all the progress. Could you please discuss the commercial team's current reach and any plans to expand beyond infusion centers as you transition towards intramuscular delivery for VYD2311? And then I have one more.

Yes, great question. I think as you know, right, it is certainly a foundation that we've been building out around an infused specialty medication. What we're starting to do is build upon that broad foundation to meet the specialists who currently care for immunocompromised patients, as well as those who will be the right target audience for 2311 should it be approved. And so the foundation we've built is scalable. I think you'll see more from us around some air cover around digital assets and reach into the community, and then an increase in field presence as we go forward through the next year.

And then also, you mentioned early-stage discovery efforts in RSV and LIBERTY. How do you intend to differentiate those programs? And what's the realistic timeline for development candidate nomination?

Great. Well, these are programs that are in the discovery space right now. And in fact, they have very different contours. Differentiation for nasals antibody is, at this point, relatively easy to claim because there aren't any. And so we are approaching that virus with the same philosophical construct we would use for most of our discovery work in COVID and beyond. So -- by that, I mean, we want to look at virus variation. We want to look at druggable targets that are on that virus, and we want to use the platform we have to try to create the highest potency, broadest coverage, most attractive biophysical medicine we can. Now the same is true in the RSV space with one distinction, of course, which is there are already relatively, if not very high-quality, antibodies that are blockbuster commercial medicines. And so in all of these opportunities, I think we look at potential differentiation through a couple of different lenses. The first one we would think of is a differential resistance profile because when we get out of the discovery space and into the commercial market, viral resistance, just like an antibiotics, is a principal concern. And so it is advantageous if we can bring something to the world that can be a backstop or an important addition to an existing armamentarium, just different in terms of the risk profile of the medicine presents to vulnerable populations in HCP. So resistance can be thought of as one of the first key things. Now after that, there are any number of biophysical properties from overall potency to cost of goods and expression yields, advantages in dose and delivery that get to sort of more fine-tuning at the molecular level. And so I think we are interested in providing an update on both of those programs before the end of the year. And after we have sort of polished up something and found something we're happy with, our suspicion would be that they would both be candidates for relatively rapid advancement into the clinical space. After which, for example, RSV and measles will diverge. RSV is relatively well-understood clinical development territory. Measles, as you might imagine, is not. And so they could end up being pretty different-looking development campaigns with pretty different-looking use cases in effect. But we are just excited about the progress we're making in the discovery space, and we'll look forward to giving you all an update as soon as we can.

And ladies and gentlemen, with that, we'll conclude today's question-and-answer session. I'd like to turn the floor back over to Marc Elia for any closing remarks.

All right. Thank you all for joining us this morning and for helping us keep it nice and tight. We and the team will be around for the rest of the day to follow up with any questions you might have. Thanks very much.