IVVD - NASDAQ

Good day, and welcome to the Second Quarter Invivyd Earnings Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to Katie Falzone, Vice President, Corporate Controller. Please go ahead.

Thank you, operator. A short while ago, we issued a press release announcing our Q2 2024 financial results and recent business highlights. That press release and the slides that are being used in today's webcast can be found in the Investors section of the Invivyd website under the Press Releases and Events and Presentations section, respectively. Today's discussion will be led by Marc Elia, Chairperson of Invivyd's Board of Directors and Chairperson of the Executive Committee of the Board. He is joined by Tim Lee, Chief Commercial Officer; Bill Duke, Chief Financial Officer; Dr. Robert Allen, Chief Scientific Officer; and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs. 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 pipeline and regulatory plans, certain financial guidance, 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-Q, which is also available on our website. I will now turn it over to Marc.

Good morning. Thank you all for joining us. Turning to Slide 4 in the deck you can find on our website. The second quarter of 2024 began with leadership transition at Invivyd. Our goal for transition was and remains to expand the scope of our corporate ambition and to improve our ability to deliver major medical value for vulnerable populations at substantial risk from respiratory viruses, especially COVID-19. We immediately began several initiatives, including some not yet visible to improve our operational posture and efficiency and to broaden the scope of our strategic aims. This morning, we're sharing our second quarter results in a broader business update. By way of executive summary, we are pleased with our rapidly expanding commercial footprint and our pipeline advancement. While we are not satisfied with our early net revenue results, we saw consistent growth across the second quarter, and we are seeing acceleration early in 3Q, and we are leaning forward and eager to deliver as we come into our major commercial moment for 2024, the fall/winter respiratory virus season. Over the next months, starting in September, millions of Americans are likely to consider together with HCPs, vaccine boost for COVID-19 disease. We aim to remind certain immunocompromised people and their care teams that more is available. For those immunocompromised persons who have been hopeful to access PEMGARDA, but have been frustrated by slow motion in the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19 and the option for protection presented by antibody prophylaxis and PEMGARDA specifically. Further, we are pleased to be advancing our pipeline molecule VYD2311, which we see as having a profile that could potentially expand this field of medicine. Improved molecules, combined with emerging data from contemporary antibody prophylaxis studies such as our CANOPY clinical trial and our competitor Astra

Thank you, Marc. Turning to Slide 10. I joined Invivyd in June of this year because I saw an extraordinary medical need for people who are immunocompromised, the technology platform with potential to serve those in need in a newly authorized pharmaceutical that could impact millions of lives. While much groundwork has been laid by the prior commercial leadership team, the executive experience brought to bear was that of a vaccine commercialization rather than biopharmaceutical and critically infused biologic therapies. My own career across Alexion, Biohaven and most recently, Amylyx where organizations where we found success working with and fighting for patient communities, which led me to perceive substantial opportunities in the coming years at Invivyd. I've moved quickly to onboard experienced people from my own network who are experts in commercializing therapies with a high unmet medical need, such as PEMGARDA. The situation for Invivyd today is markedly different than it was at the start of the second quarter. There were several key dynamics that I want to highlight. First, at the time of EUA, there was a near zero awareness of PEMGARDA in the clinical community, on which work began immediately and we have been accelerating. Second, among many healthcare providers, there has been a perception that COVID-19 is a seasonal threat to be addressed in the fall. This is ironic given the substantial summer wave that we currently find ourselves in, it is underway. Third, at the EUA late March into April, there was quite low ambient COVID-19 in the United States, which, of course, as usual, has changed quickly. Now what has not changed is the relatively robust interest in additional protection that we observe in the immunocompromised community. Since I joined, I've had the privilege of hearing directly from members of the immunocompromised community. They're very passionate about reclaiming an opportunity to live their lives without fear and risk of adverse outcomes just from normal lifestyles. Their need is real. Their motivation is real, and we aim to bring an intensity to our work that matches their own. We're preparing a major activation campaign to begin imminently to take advantage of the habits of healthcare providers who appear more focused on respiratory disease protection in the fall and the winter time frame. Turning to Slide 11. We've refined certain commercial launch metrics that we'll be reporting on a go-forward basis for clarity and usefulness. You will see in these numbers a marked acceleration across both the second quarter and coming into the third quarter. As we reported, and as you know, 50% of our target population is covered by Medicare and Medicaid, which provides full PEMGARDA reimbursement with the $0 copay. While we're not in a position yet to calculate total commercial lives covered, we're aware of successful reimbursement from the largest national and regional commercial payers. These payers collectively cover the majority of commercial lives. We expect our efforts to continue this acceleration. Turning to Slide 12. Survey work that we saw early in the second quarter attuned Invivyd well to some perception by healthcare providers who for immunocompromised people, specifically transplant surgeons and hematologists and oncologists. This group are keenly aware of the risks that pose to their populations by COVID-19. And yet in the large part, regard the mandate to consider protection as seasonal and related to the fall and winter. We will be engaging actively with these healthcare providers over the coming weeks and months to evolve the thinking on this pervasive, persistent disease that can substantially impact their patient population. Turning to Slide 13. In June, the CDC recommended universal COVID-19 boosting for every American over six years of age this fall. We expect updated vaccines in pharmacies within weeks. And if '24 resembles anything like 2023, millions of Americans per week will begin the vaccination process. As Marc alluded earlier in his remarks, boosting is a critical protective strategy, but the data on vaccine effectiveness strongly suggest considering additional protection for certain immunocompromised patients. We will look to take advantage of these dynamics. Turning to Slide 14. We have an opportunity to offer additional protection to people who are moderately to severely immunocompromised and at a high risk for severe COVID-19. The team is building the infrastructure to serve these communities. And our previously stated net revenue guidance represents a conversion of a small percentage of all of those who are in need. Turning to Slide 15. Over the next few weeks, with the commercial groundwork established over the second quarter, Invivyd will begin commercial messaging in the digital and traditional domains to drive healthcare provider awareness and immunocompromised population awareness. We are evaluating carefully every single opportunity to generate awareness in these critical markets and upcoming through the balance of 2024. We'll look forward to hearing your feedback on our work. We are not aiming to be subtle. With that, I'd like to turn the call over to my colleague, Mark Wingertzahn, to talk about our pipeline. Mark?

Thank you, Tim. Turning to Slide 17. As you know, we've identified VYD2311 via affinity maturation of pemivibart against the XBB lineage viruses in an effort to improve on the biophysical properties, including the in vitro measured potency of pemivibart. As you all may realize, if all other variables are equal, potency improvements in measured IC50s for an antibody can translate directly to lower doses that are required to achieve meaningful levels of sVNA titer, the pharmacodynamic variable that drives protection and efficacy for a COVID-19 antibody. These lower doses may in turn allow for the development of routes of administration that are more patient and system friendly than intravenous approaches. Turning to Slide 18. We are pleased to have Australian ethics approval for a first-in-human study with VYD2311 with dosing planned to begin at the end of August. This study plans to interrogate intravenous, intramuscular and depending upon titers achieved subcutaneous dosing. We felt strongly that interrogating multiple routes of administration could provide flexibility and optionality for achieving titers from one antibody that could be suitable for both COVID-19 prevention and treatment if authorized. Turning to Slide 19. The VYD2311 product profile will ultimately be determined by the observed safety across doses and administration routes, the in vitro potency measured by EC50 against relevant viruses, the in vivo pharmacokinetic and half-life profile demonstrated by VYD2311 and our early human testing and of course, dialogue with relevant regulatory agencies. However, we can envision evolution of the field from an infused therapy to any number of permutations, including a loading intravenous dose followed by a lower dose tighter maintenance to perhaps elimination of intravenous delivery altogether. We look forward to updating you on our progress as we move through the fall. With that, I'd like to turn the call over to our Chief Scientific Officer, Robbie Allen, to discuss the ongoing emerging virology in our field. Robbie?

Thank you, Mark. Turning to Slide 21. Given the investor interest in these topics, we thought we would quickly visit some of how we view the surrogate marker of SVNA titers that describes the possible clinical performance of our molecules and then provide an update with a view on next steps. First, recall that a key consideration in the FDA's thinking on COVID antibodies has been the concept of immunobridging, which is a form of bioequivalence analysis. These analytics use point estimates from antibody neutralization potency assays that have marked intrinsic variability, including several fold differences with pseudovirus assays and up to tenfold differences with authentic virus assays. This variability, while not contemplated directly in an immunobridging analysis in the form of a range is addressed directly by the FDA on the PEMGARDA fact sheet, where you can see the wide range of potential bridging values between PEMGARDA and adintrevimab depending on assay from 0.82 to 0.35. Turning to Slide 22. Single SVNA titer point estimates can, of course, become obsoleted quickly by virus evolution and associated evolution in estimated EC50 values from these assays. Even more complex before Omicron, there was a great propensity for single sweeping viral lineages as opposed to the rapidly shifting variant soup, we have seen since the Omicron saltation event. We, therefore, became interested in moving from a conception of antibody potency that indexes to one virus to a conception that reflects an ongoing weighted average EC50 calculation. This type of analysis might yield a more complete and useful portrait of overall activity, although, of course, these analytics are limited by the disparity in underlying assay systems that intrudes into all analyses of this sort. Turning to Slide 23. In furtherance of our serial monoclonal antibody approach to COVID-19, we have analyzed public pseudoviral data to evaluate weighted average EC50s and reflected that analysis against observed regulatory actions of authorization and relocation of authorization. In this example, you can see Evusheld depicted in its weighted average potency over time and associated de-authorization. Turning to Slide 24. To provide further insight to past regulatory actions of authorization and revocation of authorization, we extended this analysis across historic antibodies authorized for both treatment and prevention. Turning to Slide 25. When we extend the analysis to pemivibart and VYD2311, a compelling portrait emergence. Over the time since the selection of VYD222, dozens of virus lineages have emerged, becoming clinically meaningful and then have been outcompeted. This evolution continues to this day. Pemivibart weighted average values fluctuate without substantial appreciable change. This lack of meaningful change could be predicted by the structural biology of a conserved epitope, but challenged by the inherent variability of the assay systems that define these data. Turning our attention to our pipeline, although it is difficult to see on this chart due to its significant potency improvement and lack of meaningful change, VYD2311 has demonstrated early signs of potential improved potency with improved and stable IC50 values. Invivyd has built its platform to keep up with the inevitability of virus evolution. However, there are general principles around the conservation of epitopes we aim to take advantage of in order to increase the resistance of our antibodies to the effects of virus evolution. We will never be perfect. And by design, we hope to innovate at an attractive speed. The data such as these that accompany our structural biological insights and the power of our discovery platform will aid in this endeavor. Turning to Slide 26. Another challenge in applied virology with rapidly evolving viruses relates to the ability to secure reliable, high-quality academic or commercial partners that can handle authentic SARS-CoV-2 virus in an appropriate BSL-3 laboratory setting and perform timely and accurate neutralization analyses for us. Recently, one of our partners, a commercial provider of such services discovered a potential contamination event in their virus stocks, which in turn has rendered the JN.1 authentic virus value, it has generated a questionable reliability. Reassuringly, this authentic virus asset potency value against JN.1 is very similar to the independently generated pseudovirus potency value estimated for pemivibart viral against JN.1. The FDA and Invivyd have been in dialogue on this matter for about several weeks. And among other next steps, Invivyd will reassess pemivibart activity versus authentic JN.1 virus in a series of labs to determine a reliable number. Potentially also informative on the matter of JN.1 and the clinical meaning of SVNA titers generally is our preliminary analysis of the second half of the CANOPY study, which happened to occur during a time of JN.1 dominance in the United States in the winter of 2024. The FDA is also in receipt of these preliminary exploratory data. As Mark noted, we look forward to sharing these data soon when finalized and prepared for presentation. Overall, our goal as a company is to improve the usefulness, accuracy and informativeness of virology data to all key stakeholders. While these cellular bioassays are of clear interest and importance, they also have clear limitations that must be acknowledged by those of us in the business of making medicines to protect the vulnerable and treat diseases. We are and for now years have been in constant dialogue with the FDA and see many opportunities to improve our collective acumen on this topic, especially when we can all see contemporary clinical data from, for example, CANOPY and Supernova. I'd like to turn the call over to our CFO, Bill Duke, for final remarks prior to Q&A.

Thanks, Robbie. Moving to Slide 28. Right now Invivyd is at an exciting moment in our history. We are looking forward to rapid expansion of our commercial activities and are pleased to reaffirm the revenue and cash guidance provided previously. As we move through the fall, we will be in a position to refine that guidance. But for now, we remain comfortable with the boundaries within it. In addition, although Invivyd is a fully integrated biopharmaceutical company, we have been streamlining our operations over the last quarter and are starting to see the benefits of that work. Of note, our burn rate includes the majority of expenses associated with production of significant quantities of our next model molecule, VYD2311. At this point, we have contracted to produce approximately 130,000 doses of PEMGARDA. After exhausting that supply, we intend to transition rapidly to VYD2311, which may afford greater efficiency and lower COGS compared to PEMGARDA, depending upon the clinical product profile we see. Our favorite source of incremental capital to strengthen our balance sheet remains product sales and operating contribution. Nonetheless, we are in discussions with multiple potential sources of non-dilutive and dilutive equity capital should we assess a benefit associated with raising money. Mainly, however, we are looking forward to the upcoming commercial push in the fall/winter respiratory virus season. I'll now turn the call over to the operator to open for questions.

Operator? Operator, can you please open for questions?

Well, if you'll all give us a moment, we know there are questions in the queue. So we'll work on repairing whatever is going wrong. Okay. Well, we're going to try doing this ourselves and the results should be fascinating. Evan Wang, are you on the line at this point with us for a question? Apparently not.

Can you guys hear me? Hello?

Now, we can hear you. Okay.

Can you hear me? Okay, great. Yes. Thanks guys. Great to see all the progress. I guess just two or three for me. I guess just first off, Tim, would love to hear, I guess, now you're two months in, you shared some of, I guess, the work you've been putting in. But I guess, Tim, can you share a little bit more on your perspective on, I guess, what's needed still to optimize success in terms of, I guess, what did you like existing, what kind of changes did you can make and what's kind of remaining and what's the goal ahead of some of this fall immunization season? And then can you describe some of what you're seeing in terms of the summer wave and how -- I think there's some commentary on acceleration of commercial results in early 3Q, what we're seeing there? Thanks.

Yes. Thank you. Happy to. I think as I look back over the last two months, one of the comments that we made was around how we're rapidly starting to commercialize towards an infused biologic, which is just different than the vaccine world. One of those things we're doing is I really brought on a seasoned team and excited to let them a little bit loose on the market and helping to go deep here. We look at -- we're looking at things through an immediate lens, what we can do right away. As we looked at it, there was not much digital work that had happened. We've started beginning digital work already, continue to pull that through. We look to increase corporate campaign work and doing just simple things like updating our PEMGARDA infusion locator rapidly with the latest sites that are available. I think what we're seeing is that there are over -- I think we said this before, over 200 sites right now around the country and more who are rapidly coming on board. With that, there's a level of effort and work that has to be applied towards those. And that infrastructure build is what we've been focused on, and it's where we're going. I think your question around the summer wave is interesting because it's something that as you -- as we start to talk to people, it's probably something that people didn't want to talk about, but I don't know if it's the algorithms that have figured out my Internet history, but every single time I open the Internet now, I'm noticing more articles published about this increased summer wave, the effect that it's having on the general population. I think where we really lean into is that group of people who are immunocompromised, who really are looking for and needing protection. I think the other thing that we're starting to do that had not been done previously, was that we're starting to speak to and listen to and engage with the patient community. I think there's so many key learnings for us that we can glean from the immunocompromised population and how we can better -- be better partners. And I think as Marc said and I alluded to act with the urgency that this group needs in order to do the things that, quite honestly, many people take for granted. And I think these motivational stories are also allowing us to be a little bit more focused on what the true opportunity is here. So hopefully, I touched all your points. I kind of scribbled them down as you said, Evan, but I'm sure I probably missed someone, I'm happy to clarify.

We're thinking about this relative to some of the COVID vaccines. Is there -- I guess, how do you expect some of these sales in the second half to be weighted? Whether it would be kind of expected to be more 4Q weighted like some of the vaccines? And then to what degree do you expect any potential stocking here?

So let me first respond on the overall dynamic and then Tim and others can speak to inventory and whatnot. But look, I think we've taken advantage in multiple ways of the time period over the second quarter, right, which was notably quiet on all of the dimensions that Tim alluded to. The reality is that we are mainly geared up at this point to work on the stated habits and preference sets in the broad medical community, which, frankly, are not that different, I think, observably from some of our own habits. When it is somewhere in the Northern Hemisphere, people can feel disproportionately comfortable outdoors and exchanging air in seemingly non-threatening ways and then something magical happens. The back-to-school push begins. And in this case, this summer, we've had a fairly substantial summer COVID-19 wave. And look, we're at such a fascinating and sensitive part of the growth curve. I don't think we want to particularly comment on those revenue results we've achieved in early 3Q, but there was a reason we noted an acceleration. There are all these fundamental harmonics changing together, the progression of the season, the rise in ambient COVID and, of course, our own reinvigorated and re-led work. That's all gratifying, but it's not the big game. The big game is right in front of us, starting in a couple of weeks as people go back to school. As they go back indoors and the temperatures drop in the Northeast, it would seem as though a great, great many facets of the broad medical complex turn their attention toward prevention. And so for us, it's a little in this first year, probably a bit more like a Christmas retailer or somebody selling Easter candy. Your business probably doesn't happen meaningfully in September, but come spring, look out, right? So the whole purpose of the work over 2Q was to put us into position to hit that hard. So when you think about the distribution, we're not in a position to know because this is our first year, and we're launching. But when we look at the distribution of vaccine prophylaxis over this time period, you will appreciate quickly, I think, as we do, that September, October and November are very, very big months. And I think our expectation is that they will be that for us as well. Tim, inventory?

Yes, I think you'll see -- you won't see stocking. I think what we're continuing to do with our inventory is increased availability in the channel. We want to make sure that we have inventory for those in need and will continue to provide as needed basis and just-in-time shipping to ensure that they have them.

Thank you.

[Operator Instructions] Our next question will come from Maxwell Skor from Morgan Stanley. Your line is open.

Great. Thank you for taking my questions. Two for me, basically. Is it reasonable to assume you'll hear about the second EUA by year-end? And just directionally, the magnitude of this opportunity if you were to get a positive recommendation.? And then the second question, regarding availability, does the infusion site locator generally reflect availability? And what efforts are you making to get into, let's say, larger academic centers? Thank you.

Okay. Great. So on the treatment EUA, as you will have noted, it has been submitted and indeed on a variety of topics we are in discussion with FDA, but it's certainly not within our purview to opine on the timing of anything that they might choose to do or not do. I think we've always felt as though the sort of timing, your sort of hypothesizing would be reasonable. But let's all find out together. In terms of the magnitude of that opportunity, look, I think it is clear that in multiple domains of American medicine, people will commonly reach for treatment at a higher rate than they will reach for prevention. I think in the case of COVID, that's not always the best play, but -- so be it. So we'll have to see. But of course, we feel as though our hands are really quite very full with rolling out PrEP, and we view, therefore, treatment, both for pemivibart and potentially down in the future with the next molecule like 2311, potentially quite additive. But we're not in a position yet to I think, put numbers around that for you. So Mark, anything you would add on that?

No, I think that was well said, Marc. Thank you.

Okay. So then locator?

Thank you for the question around the infusion locator. I think what I'll tell you is being updated in real time right now. So if you were to look at it today, it's not an accurate representation of all of the sites around the country that are currently infusing and able to infuse PEMGARDA. What we are starting to do is act on multiple paths, right? So you mentioned the major academic medical centers. It is a priority for us. We have a dedicated field team out there doing that every single day going out to educate and create an opportunity for PEMGARDA for that immunocompromised patient population who needs it. In parallel with that, we've begun talks in the last two months on how we can better partner with some private infusion sites as well to ensure that there is access for this community. And so we're really running multiple trains on parallel tracks, but they happen to go at different speeds. But if the locator is something that you monitor, I think we'll see remarkably positive increase in numbers in the next seven days and continue as we online major national infusion centers as well as academic centers and local infusion centers as well.

Great. Thank you.

[Operator Instructions] And our next question will come from Michael Yee from Jefferies. Your line is open.

Hi guys. This is Kyle for Michael. A real quick question on the EU status. Could you please give us any updates on sort of filing in OUS?

Yes, sure. So very quickly, I think this is something that is under constant discussion here at Invivyd, but it would not surprise us. I don't think if over time, OUS migrated to a topic more germane to 2311 in light of the supply constraints we face on PEMGARDA. So we're always exploring those things, and it's something that I think global regulators are probably not entirely harmonized on their conception of the field. And therefore, there is sort of a limit to what we are willing to do de novo to support the opening of a new geography, particularly for a drug with the profile offered by pemivibart. So I think one statement that is, well, certainly on display publicly during the Olympics. COVID is a global problem, and there are global regulatory agencies that may wish to engage with us constructively and you would, of course, find us so constructively engaged. But right now, there's nothing on the horizon that I think bears highlighting.

Got you. And a quick follow-up for me. So could you please briefly talk about your visibility on ordering given we're already halfway through Q3?

Thank you. Sure. So you will note from our prepared remarks that we were willing to note some real acceleration in our commercial results into the quarter. But I think as we further endeavor to clarify, the big game commercially is still -- oh, I don't know, is it two weeks until Labor Day, somewhere in there, I think, is where we expect to see along with the availability of updated vaccines, a major, almost, I think, social and public health drive towards COVID prophylaxis. So we have observed something of a step change, but that step change isn't what we view as of the most meaning. The most meaning is going to be in results that lie ahead. And the good news is we don't have a whole lot longer to wait.

All right. Thank you so much.

Thank you.

[Operator Instructions] And speakers' I am showing no further questions from our phone lines.

Great. Well, thank you all very much for joining us this morning, and we look forward to fielding your questions later through the day. Thank you.