Invivyd, a biotechnology company, recently held an earnings call to discuss their first-quarter financial results of 2024 and business developments, particularly focusing on their product PEMGARDA. The company announced the emergency use authorization (EUA) of PEMGARDA for the prevention of COVID-19 in certain immunocompromised individuals and plans to file an additional EUA for its use in treating mild to moderate symptomatic COVID-19 in similar patients.
Invivyd is committed to expanding its product offerings and is working on securing reimbursement and access for PEMGARDA. With a strong cash position of $189.4 million, the company is improving its projected year-end cash position and is enthusiastic about the future of its antibody prophylactics and therapeutics.
Key Takeaways
- Invivyd reported the EUA of PEMGARDA for COVID-19 prevention in specific immunocompromised individuals.
- Plans are underway to file for an EUA for PEMGARDA as a treatment for mild to moderate COVID-19 symptoms in a similar population.
- The company has contracted with three major distributors to ensure PEMGARDA availability.
- Reimbursement codes for PEMGARDA have been published by CMS, and the national account management team is actively promoting the product.
- Invivyd ended Q1 with a strong cash position and anticipates an improved year-end cash position by $20 million to $25 million.
- The company is focusing on innovation and the introduction of novel antibodies, including advancements in their proprietary discovery technology.
Company Outlook
- Invivyd is optimistic about the potential of PEMGARDA and its technology platform.
- The company plans to continue innovating and expanding its offerings to serve vulnerable populations.
Bearish Highlights
- The company did not provide specific guidance on the size of the commercial opportunity for PEMGARDA.
- It is still early in the launch phase, and detailed information on orders and potential sales was not disclosed.
Bullish Highlights
- Invivyd has received positive engagement from institutions and private payers for PEMGARDA.
- They are developing logistical support to assist patients in accessing the product and have created an online infusion site finder.
Misses
- Specific sales data and market trends for PEMGARDA will only be provided as the launch progresses.
Q&A Highlights
- The company is in ongoing discussions with the FDA about the development of their products and novel pathways.
- Invivyd is working to optimize their drug based on FDA guidelines for prevention and treatment, highlighting the potential of PAXLOVID as an alternative to remdesivir.
Invivyd's earnings call reflected a strategic focus on the commercialization and development of PEMGARDA, as well as their broader antibody portfolio. The company's efforts to secure reimbursement and access for their product, alongside their proprietary technology for anticipating viral evolution, underscore their commitment to innovation in the biotechnology sector.
As Invivyd moves forward with its EUA filings and commercial strategy, the market will be watching closely for updates on sales and the broader impact of their products on the treatment of COVID-19 in immunocompromised populations.
InvestingPro Insights
Invivyd's financial health and market performance provide a mixed picture for investors. With a market capitalization of $269.44 million, the company holds a significant presence in the biotech industry. Yet, its current P/E ratio stands at -1.30, reflecting market skepticism about future earnings. This is further underscored by an adjusted P/E ratio for the last twelve months as of Q4 2023 at -1.35, indicating consistent concerns over profitability.
An InvestingPro Tip reveals that Invivyd holds more cash than debt on its balance sheet, which is a positive sign for financial stability and may support their ongoing efforts to commercialize and develop PEMGARDA. On the other hand, the company is quickly burning through cash and suffers from weak gross profit margins, which are critical factors that investors should consider.
The stock performance has been volatile, with a significant price drop of 45.8% over the last three months, yet it also saw a large uptick of 61.43% in the prior six months. This volatility could be attributed to the company's recent developments and market reactions to its strategic moves. Analysts have noted that Invivyd is not expected to be profitable this year, and the company does not pay a dividend to shareholders, which may be a deterrent for income-focused investors.
For those looking to delve deeper into Invivyd's prospects, there are additional InvestingPro Tips available that could shed light on the company's future. With the use of coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights. There are 10 more InvestingPro Tips listed on InvestingPro for Invivyd, offering a comprehensive analysis for those interested in the company's financial and market performance.
Full transcript - Invivyd Inc (IVVD) Q1 2024:
Operator: Welcome to the Invivyd conference call. [Operator Instructions] Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Scott Young, Invivyd's Vice President of Investor Relations and Corporate Communications. Please go ahead.
Scott Young: Thank you, operator. A short while ago, we issued a press release announcing our Q1 2024 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's website under the press release and Events and Presentations sections, respectively. Today's discussion will be led by Marc Elia, Chairman of Invivyd Board of Directors and Chairman of the Executive Committee of the Board. He's joined by Jeremy Gowler, Interim CEO and Chief Operating and 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 regulatory plans, certain financial guidance, our future prospects and other statements that are not historical fact. 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, which is also available on our website. I will now turn the call over to Marc.
Marc Elia: Thanks, Scott, and thank you all for joining the call. A quick housekeeping note, this will be Scott's last quarterly call. He is moving on from Invivyd to spend this summer and join his vote prior to potentially starting his own business. We wish him the best and thank him for his help in getting us here. Thank you, Scott. To business. Turning to Slide 4. The last few months have been transformational for Invivyd, Invivyd has been built to address head on the unique scientific, medical and social challenges presented by SARS-CoV-2 and potentially other viruses in the future. In 2023, SARS-CoV-2 remained a leading cause of death for Americans and that is to say nothing of the broad medical misery imposed by this uniquely transmissible and dangerous multi-organ virus. When we talk about building a company to meet the challenges of SARS-CoV-2, what we mean is that we believe we are pioneering a still brand-new approach to antibody prophylactics and therapeutics. Engineered antibodies represent the promise of conferring to vulnerable populations, the immune response to viral threats that we all wish we could have following vaccination or infection, an immune response that may be necessary for staying safe and well rather than the immune response that keeps us alive but at continuous risk. Obviously, the risk of SARS-CoV-2 is highest for immunocompromised population who today benefit least from vaccination and represent a high disproportionate share of ongoing hospitalizations and deaths. We're starting our journey serving their needs but see the possibility of serving broader populations as we advance our technology and strategy. Broadly, our strategy is to combine the potential for high efficacy and attractive safety of modern monoclonal antibodies or mAbs directed against the SARS-CoV-2 spike protein with the opportunity for product evolution, one commonly sees in the vaccine industry. We set out on this mission because to us, it so far represents the only viable approach for bringing high-value medical options to populations in need. At this point, we see an attractive commercial opportunity for PEMGARDA in the near term, a rapid compact, capital-efficient pathway to generating novel options for 2 distinct use cases prep and potentially treatment and a scientific engine devoted to repeatable, reliable, best-in-class molecule generation. Of course, major questions have surrounded this strategy for now almost 2 years, in large part, regulatory and operational. We're thrilled that over the last year, we have started to answer those questions more definitively in partnership with a highly motivated and thoughtful regulator in the U.S. Food and Drug Administration. The recent emergency use authorization for PEMGARDA for PrEP of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise. And now the opportunity to file an application for EUA for treatment of mild to moderate symptomatic COVID-19 in a similar immunocompromised population, both represent the growing alignment between the core of our strategy and the posture of the major U.S. medical authority. Our aim is to build on and expand these early successes now by innovating to improve our products on all dimensions, the resistance to evasion that can be built into them, the potency of our antibodies and accompanying improvements in dose therapeutic index and form factor they might offer and the clinical data that we hope can substantiate broad use of antibody products in the future. Our agenda today is unique for a regular quarterly call. While we will review certain elements of our recent business progress, we will also provide context for the scientific and clinical thinking that underpins our corporate and commercial strategy and our enthusiasm for the future of Invivyd. Because this is not an R&D day, we will move relatively quickly through some concepts and hope that as you reflect on what you hear and read, you can engage with us on a follow-up basis if it is a further use following today's call. We have heard clearly from many of you that there are gaps in your understanding of our technologies, and we would like to take this opportunity to fill in those gaps so you can understand our company better moving forward through the launch. We believe that Invivyd's bespoke, proprietary and fully integrated discovery technologies, combined with potential rapid development pathways, represent an impressive competitive advantage designed to keep Invivyd serving vulnerable populations with high-value commercial products engineered to treat and protect from serious viral threats in perpetuity. We see the technological core of this engine as substantiating the economic vision for our firm, which is to advance high-value novel medicines with high speed, high capital efficiency and high confidence to ensure that shareholders also benefit from the substantial medical value we aim to create for vulnerable populations. A few final notes before we move on with our agenda. We are well engaged in a search for a permanent CEO, but we will not comment further at this time. Also, Jeremy Gowler will comment on multiple elements of the early PEMGARDA launch, but we will not be disclosing any more granular detail than that which he will walk through in his prepared remarks nor will we comment on any early sales trends other than to say that at this point, we are pleased with the organic demand we believe we're observing in the field. We have been moving quickly to establish the mechanical infrastructure, the institutional knowledge and the experience base that will allow appropriate vulnerable populations, their HCPs and broad health systems to access PEMGARDA routinely. I'll now turn the call over to Bill Duke, the CFO of Invivyd, to discuss our financial results and guidance.
Bill Duke: Thank you, Marc. Turning to Slide 5. We ended Q1 2024 with cash and cash equivalents of $189.4 million. We did not record any PEMGARDA revenue in the first quarter as orders and shipments began in April. In April 2024, we announced that following a comprehensive strategic review, the company is improving its projected 2024 year-end cash position by approximately $20 million to $25 million. Our updated cash guidance improvement was built to include the anticipated spend on 2024 incremental clinical commitments associated with our potential treatment EUA. The improvements were realized through comprehensive resource realignment, ensuring robust investment in the commercial launch of PEMGARDA in the discovery of novel monoclonal antibodies. We have recently undertaken a commitment to filing a second EUA application for PEMGARDA, focusing on the treatment of mild to moderate symptomatic COVID-19 for certain immunocompromised people. This is a potentially transformational opportunity for Invivyd near term as we move into the summer and fall, and we consider this route as a future cornerstone for rapid development of innovative molecules. We will not, however, alter our year-end cash and top line revenue guidance even if we achieve EUA treatment. At this point, we feel very comfortable with our near-term economic opportunity and look forward to updating our estimates in the fall at the earliest. Finally, as Marc mentioned, we look forward to continuing to innovate and introduce additional novel antibodies. We have studied the time and costs associated with generating the PEMGARDA clinical package that support PrEP and potential treatment. Going forward, we believe we can significantly reduce our clinical development time and costs, and we will look forward to sharing more detail soon. As you have seen from our prior descriptions of the target population and our recently disclosed commercial pricing, these use cases represent a total addressable market measured in billions of annual revenue when considering the roughly 500,000 people in the U.S. who are the most vulnerable and our initial focus. We are working to realize that potential and aim to expand the populations we can serve as our technology and strategy allow. With that, I'll turn the call over to Jeremy to update you on our launch.
Jeremy Gowler: Thanks, Bill. Moving to Slide 6. PEMGARDA is a high-value medicine for moderately to severely immunocompromised individuals who are in urgent need of protection from COVID-19. It fills a critical need not otherwise addressed in the marketplace today. Overall, we are very pleased with the strong interest we've seen thus far from patients and providers. Since authorization, we have so far received a surprising and gratifying level of unsolicited inquiries into our call center. Our field teams are having many positive interactions with our customers and are experiencing a high degree of interest in PEMGARDA. Now we are going through the logistics phase of the launch, where we are managing the processes around institution and payer access to ensure that PEMGARDA is broadly and conveniently available to those whom it is authorized. We are moving to ensure that PEMGARDA awareness and logistical support are in place prior to the broadest activation of HCP and patient interest in the coming months. Of note, PEMGARDA represents our first-generation technology. And as we will discuss later on in the call, we already have a follow-up map in VYD2311, which we believe holds the potential to have an improved product profile. The work we are doing today with PEMGARDA, we believe will pave the way for VYD2311 to seamlessly slot in behind it and build on PEMGARDA's anticipated success. Turning to Slide 7. We are a little more than 6 weeks post authorization and the commercial organization and functions supporting it have been hard at work to execute on the PEMGARDA launch. Our manufacturing colleagues worked very quickly to have product available within a week of authorization. In parallel, we contracted with 3 major distributors to ensure that our customers could procure PEMGARDA via their preferred procurement partner and subsequently shipped our first order. As of late, our focus has been on securing reimbursement and access. In mid-April, we announced that the U.S. Centers for Medicare and Medicaid Services, or CMS, published 2 healthcare common procedure coding system codes or HCPCS codes, a Q-code covering product reimbursement for PEMGARDA and a product-specific M-code covering the administration. This is critical because CMS provides coverage for nearly half of the moderately to severely immunocompromised people at higher risk for severe COVID-19, whom we are targeting. In parallel, our national account management team has been working to secure commercial reimbursement for PEMGARDA as well with private payers to ensure that the other half of the moderately to severely immunocompromised people who are eligible for PEMGARDA can access it. Our team of key account managers recently hit the ground running after completing extensive training, and they are now all fully deployed and calling on our roughly 1,150 targeted accounts to build awareness for the product and drive uptake. The early focus is on securing inclusion of PEMGARDA on institutional formularies as needed. We have had positive engagement and we see institutions taking it through the formulary committee processes already and some have already ordered product. With respect to the patient experience and access, we are putting an even greater focus on building out logistical support to assist moderate to severe immunocompromised people who are seeking PEMGARDA. This work includes the creation of an online infusion site finder to help those people trying to access PEMGARDA. This new tool, which will be accessible in the future on pemgarda.com, is under active development. And in parallel, we are engaging with infusion providers outside of traditional institutions to support patient access to the product. And finally, we are excited about the potential to submit and receive an additional EUA for PEMGARDA focused on the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised people should it be granted by the FDA. Since the commercial pathway and infrastructure already exists for the antivirals like Veklury, we are excited to have this additional use case for the product beyond PrEP as another potential way to capitalize on the work done to bring PEMGARDA to market. We will look forward to updating you more on our sales and relevant trends as the launch progresses. I will now turn the call over to Mark Wingertzahn, SVP of Clinical Development and Medical Affairs. Over to you, Mark.
Mark Wingertzahn: Thanks, Jeremy. It's been great to join in Invivyd at a fascinating time for the company and patients in need. Turning to Slide 8. As a reminder, our EUA for PrEP for COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise is based upon the ongoing Canopy Phase III clinical trial that includes 2 cohorts. First, we have a single-arm open-label cohort in immunocompromised subjects, the so-called Cohort A. Second, there is a randomized double-blind safety cohort in people at risk of SARS-CoV-2 infection from regular face-to-face meetings with exploratory clinical event endpoints, the so-called Cohort B. We have collected exploratory information on COVID events in both arms on an ongoing basis. Although obviously, the lack of a placebo arm renders the interpretation of events in the cohort A, a bit more opaque. Moving to Slide 9. As a reminder, in order to meet the immunobridging endpoint agreed to with FDA, we dosed to very high titers and then allowed the titers to decay with ordinary antibody PK subject to the half-life of VYD222, now PEMGARDA. You can well imagine that a redose will produce another major boost to titers, which we then expect will fall at a similar rate. As every dose involves a phase with very high titers, which then descent to lower levels, we look forward to seeing how we accrue any events we collect after our day 90 calculation in trough titers. Perhaps prior to a second dose, a time period that may give us information that could help us calibrate dose optimization going forward. Turning to Slide 10. As a reminder, we began the CANOPY clinical trial going into and then through the fall/winter 2023-20224 JN.1 wave. As a result, we saw a relatively robust attack rate in our study of about 3% to 5%. Although CANOPY was not prospectively designed or powered to demonstrate protection from symptomatic COVID-19, and that analysis of exploratory endpoints of symptomatic COVID-19 events in CANOPY were unrelated to FDA's review of our EUA application, we note the events have exploratory value as we consider the titers that may be associated with various levels of protection and think about dose and product profile going forward. We have previously disclosed that in Cohort B, our double-blind placebo-controlled cohort, we observed protection of 100% through day 67, a period that overlap with very high sVNA titers. Through day 90, we saw one breakthrough infection in the Pemivibart arm compared to 8 in the Placebo arm, yielding a relative risk reduction of approximately 94%. As highlighted on the previous slide, while we are aware that additional cases of COVID-19 have occurred in Cohort A and Cohort B post day 90, we are awaiting the upcoming analysis of the second dose blinded 90-day interval that will add additional resolution to our thinking. We look forward to sharing these data later this summer. Turning to Slide 11. Importantly, we recently announced our intention to submit an EUA request for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people. As described in our press release, we view this as a logical and welcome complement to our overall serial monotherapy bridging paradigm and a reassuring reminder of the intellectual alignment between Invivyd and the U.S. FDA. The anticipated treatment EUA submission will leverage already existing data sets from our STAMP and CANOPY clinical trials. In parallel to the anticipated submission of the EUA request, we plan to design and initiate a compact clinical trial focused on generating confirmatory safety, pharmacokinetic and clinical virology data. Importantly, treatment of mild-to-moderate symptomatic COVID-19 and certain immunocompromised people is a second use case for PEMGARDA and possibly follow-up molecules with shorter-term endpoints than PrEP, which may substantiate rapid innovation moving forward. Turning to Slide 12. This additional use case is important because even with vaccination, immunocompromised people are disproportionately impacted by severe COVID-19 outcomes and remain a major driver of ongoing hospitalization and death in the U.S. despite current small molecule treatment options. Moving to Slide 13. If authorized, PEMGARDA could be a welcome addition to the therapeutic armamentarium and a valuable potential option for certain people with moderate to severe immune compromise when alternative COVID-19 treatment options were not clinically appropriate or accessible. At present, there is no authorized antibody treatment of COVID-19 and among existing options, some are complicated by drug-drug interactions and others are mainly deployed in a hospital setting requiring burdensome repeat intravenous infusions on consecutive days. Turning to Slide 14. As we have seen since the beginning of COVID therapies, treatment option utilization ebbs and flows with overall viral presence. Nonetheless, in year 5 of the pandemic, COVID treatments remain heavily utilized. We are moving with considerable urgency as we believe that immunobridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing our efforts with PrEP. I am now pleased to turn the call to Robbie to discuss our analytics and Discovery (NASDAQ:WBD) Technologies.
Robert Allen: Thank you, Mark. Good afternoon. Many of you have expressed interest in hearing more about our work on virus evolution and the confidence we have in the quality and durability of PEMGARDA and our pipeline molecules. To start on Slide 15, I want to introduce VivydTools, which is our in-house proprietary software that tracks virus variation across our COV-2 from multiple sources, including clinical sample sequence data and the sequencing data collected from wastewater. As a general rule, variants that become clinically relevant are detected in wastewater well in advance of their broad emergence. Wastewater data also includes sequences of viruses that do not ultimately rise to high prevalence in the clinic. But these data provide a broad view of the mutational space that has been explored by the virus over time. We use this tool for 2 purposes: firstly, in furtherance of activity prediction and monitoring, but also, as you will see increasingly to power highly proprietary discovery approaches that we think give us a unique advantage in the field. On slide, as you can see on the left side of the panel on Slide 16, at Invivyd, we log and analyze variation observed across the spike protein down to very low frequency polymorphic explorations. In this small excerpt, you're seeing graphs which depict the various changes on the amino acid by amino acid basis across positions 403 to 432. While this view of the data allows you to appreciate multiple data sets simultaneously, the sharp eye among you may notice that some of these graphs do not have a lot of color and noise on them, whereas others do. That reflects the degree to which less or more polymorphic exploration has taken place at a given residue as the virus has evolved. By evaluating epitopic sites for our antibodies, including VYD222, we can assess how mutable or polymorphic our epitope is. We got finally in the areas we track as part of the assigned epitope of VYD222, we have observed polymorphic stability since the emergence of Omicron through to the present day. Turning to Slide 17. Of course, once we pick an antibody to develop it, we cannot change it. And so monitoring and analysis of variation gets much more valuable when we can incorporate it into the design of our screens and the selection of our antibody candidates. In a moment, I'm going to describe how this practice has been integrated into our pipeline. But for now, I will simply note the following. When we look at the variation across Spike and RBD, the area we want to contact with the mAb, we see evolution, sometimes saltation or large structural shares. And then we see reconvergence along previously documented exploratory pathways. In simplest terms, while we cannot expressly predict variation, we are beginning to better understand the nature of SARS-CoV-2 evolution. If we can create some level of data-driven intelligence in predicting future potential changes, we can identify future theoretical or synthetics by proteins that may not even exist yet as variance, but which represent probabilistic futures for which we want to prepare. And if we can do that, we can deploy our proprietary discovery technology that takes advantage of the high-throughput yeast-based mAb optimization platform from Adimab, directing it to perform operations that would be practically impossible with less advanced technology. Turning to Slide 18. What that means is that armed with information about viruses that have circulated are now circulating and then armed with synthetic depictions about what might circulate, we can execute boolean or logic-driven discovery screens in which we direct the platform to identify predefined antibodies, all based on the original framework of adintrevimab and now Pemivibart, which, for example, neutralize XBB and JN.1 and so on, but which do not interact with the residues we may worry about from our probabilistic work. We can then select those candidate antibodies and indeed confirm the activity we believe we wish them to have, both against current virus, but also, which embrace the anticipation of single or multiple future convergently evolved variants. Moving to Slide 19. We are looking for antibodies that are not limited by Mammalian immune suite such as we might see in convalescent serum or a mouse, we are seeking novel molecules that can go through rapid highly efficient development path and in each generation of molecule, we are looking to increase our design level confidence in resistance to variation and improve the overall pharmaceutical properties of our products. In practice, this approach started with adintrevimab, which was made early as the maturation of a SARS-CoV-1 antibody against Wuhan than its virus. The critical product attribute at that time was thought to have been achieved through conservation of H2 access, although the Omicron shift taught us and other sponsors that there were sufficient permissiveness in H2 access to make immune evasion a second critical dimension of the discovery process. Then we go to Pemivibart which is adintrevimab optimized against BA.2, but leaving as a criterion backwards-looking neutralization of ancestral pre-Omicron lineages, that constraint appears to be driving so far a highly encouraging conservation of the Pemivibart epitope across evolution, but impose at least a modest potency penalty on recent circulating viruses. Our next anticipated clinical candidate VYD2311, takes Pemivibart and optimizes it further for increased potency and assessed variation resistance. We will look forward to introducing you to 2311 more fully soon, but the early profile is very encouraging as it goes to improvement over Pemivibart in terms of possible dose, therapeutic index and route of administration. A bit earlier, still in Discovery, we are now integrating our forward-looking synthetic antigens to create antibodies that we believe have some in-built anticipatory intelligence, a process we expect to monitor and refine as we go. In these, we are now operating out past the frontier of what is, and we are actually discovering and qualifying molecules that are designed on multiple dimensions to address what we believe is likely in the future, a very unique approach in biopharmaceuticals as far as we are aware. Next, I'd like to turn it back over to Marc for some closing thoughts before we move to Q&A.
Marc Elia: Thanks, Robbie. In summary, as shown on Slide 20, we're constantly tracking, analyzing and considering variation. We do it both to monitor the probable activity of our current drug Pemivibart, to monitor the stability of epitopes for candidate drugs, including 2311 and others and now also to generate analytic findings that allow us to build antibodies, which anticipate probable changes and clearly retain activity. You will have and will, in the future, see various results of neutralization assays on our and other antibodies. We would encourage you to interpret those data with caution. Our colleagues at AstraZeneca (NASDAQ:AZN) on the EVUSHELD Fact Sheet characterized changes in neutralizing potency of less than 5 fold as "no change" which speaks to the variable nature of these assays and the tenuous uncertain relationship between those precise assay results and overall clinical activity. Worse, when and if an assay has changed or our laboratory is switched as a vendor, comparability becomes more fraud. As a consequence, while we at Invivyd will continue monitoring neutralization carefully, we will not update you all on an ad hoc basis. Rather, we will communicate our findings with the FDA and update our product fact sheet when applicable. The sum of all this work is that we believe we have excellent and growing evolutionary intelligence on SARS-CoV-2 and a unique ability to operationalize that intelligence. Our work can never be perfect as we are up against Mother Nature, and she always has tricks upper her sleeve. However, we are highly encouraged by our recent progress in our basic science, our clinical development, our growing regulatory alignment and our commercial efforts. Our goal with innovation over time will be to substantially expand the population to whom we can offer COVID-19 protection and treatment, to improve the profile of our products and thereby to substantially increase the medical value of our products for patients and providers and therefore, are value creation for shareholders. I'd like to ask the operator to open the line for questions.
Operator: [Operator Instructions] Our first question comes from the line of Maxwell Skor of Morgan Stanley.
Maxwell Skor: Congratulations on the progress. So to start with, can you elaborate a bit more on your marketing strategy, including whether you're exploring direct-to-consumer campaigns and which physician specialty is most likely to prescribe PEMGARDA? And then finally, you announced plans to initiate a compact clinical trial. I'm wondering how you'll leverage these data and whether you're running this trial in response to specific FDA feedback?
Marc Elia: Thanks, Max. Let me quickly touch on the second question you raised first, and I'll ask Mark to add anything I forgot, which is to say our reference to a compact trial is, I think, described a bit in our original press release, but the basis for EUA submission is largely analytics and a little bit of incremental work from our prior clinical development work, STAMP and CANOPY specifically, as it goes to the treatment EUA, which I think is what you're referring to. So the nature of that confirmatory study embraces elements of pharmacokinetic safety and clinical virology. That study is under active development. I'm sure as we refine those elements, we'll share some more details with you. But very quickly, Mark, did I leave anything off of that?
Mark Wingertzahn: No. It's, I mean just to dovetail on what you said, it's really going to be the evaluation, first and foremost of that treatment emergent resistance, if any, to Pemivibart and the collection of that safety and PK data. So largely incremental to the studies that we've already done.
Marc Elia: So I think Max, Jeremy can now give you a little more color on EUA, which is a pretty unique concept in pharmaceuticals, and I think has some boundaries and advantages that bear on your specific question about marketing.
Jeremy Gowler: Yes. Thanks, Max, and Marc for the introduction here. So I would say the early days were focused on raising HCP awareness for the product, and that's a really critical part because if patients go into access a product and the HCP knows nothing about it, then it kind of ends up at a dead end. So early days, we're focused on that as part of the launch. We have not ruled out not doing DTC in the future, and we're exploring that, and we do some targeted patient campaigns. What we also know a little bit about patients is these kind of sick, sick patients that we see the immunocompromised, they are very active in their management of their health. And so we've seen a lot of organic interest online and chat groups, et cetera, where there's a fair amount of interest in trying to access the product already. So we feel sometimes the patients are actually a little bit ahead of the HCPs in this regard, and we really do want to inform the HCPs early on. So that's the primary focus around the time of launch, and we'll explore expanding beyond that as time progresses.
Operator: Our next question comes from the line of Patrick Trucchio of H.C. Wainwright & Co.
Patrick Trucchio: Congrats on all the progress at the launch and pipeline. Just a couple of follow-up questions from me. The first is, I think it was noted that the reimbursement codes, Q code and M code cover reimbursement for half of moderate to severe immunocompromised people at highest risk for severe COVID-19 that you're targeting. So I'm wondering how we should think about reimbursement for the other half of the target patient population, timing of reimbursement and just how we should anticipate kind of the launch going with that other half? And then separately, can you discuss the potential approval pathway for PEMGARDA's treatment in immunocompromised individuals, and when you would envision being able to submit for an EUA and maybe clarify the timeline, including time to submission to potential authorization separately. Just how meaningful you anticipate this label expansion may be for peak sales potential PEMGARDA?
Marc Elia: Let me again, this is Marc. Let me again start with the second one, and then I'll pass it back to Jeremy on your coverage question. Look, I think in our press release, we explicitly said that our submission of EUA would be imminent in our language, that is generally a timeframe that would embrace weeks, let's say, rather than months or quarters, which would have caused us to pick those words instead. So as we tried to convey, this is an exercise rooted in intellectual alignment that draws from common material, common clinical experience as our PrEP EUA. At some level, all of these use cases are driven by sVNA titer. And if you think back to EVADE and STAMP, let's call them, parent clinical studies that leveraged adintrevimab, the same dose, the same route of administration, the same titers in effect, substantiated both a PrEP and a treatment use case. And so what we're simply doing is we're moving that fundamental posture into the broader PEMGARDA program, while simultaneously noting that it is a potentially very interesting addition to future antibodies, which, of course, have been traditionally highly effective in both use cases. So hope that helps and stay tuned. Obviously, we hope to be back to you with more color shortly. Jeremy, back to the CMS and cover...
Jeremy Gowler: Yes. On the commercial reimbursement side, we have our national account management team out there, earnestly working away and getting that for us. We understand the criticality of it given the other half of the population, as you mentioned. And so we're encouraged by the initial engagement we're getting, but of course, there's process and time that formularies need to go through, the payers go through other formularies. So we're working through that right now, but more to come as we go through this launch.
Operator: Our next question comes from the line of Evan Wang of Guggenheim Securities.
Evan Wang: Two from me. With some of the pipeline development, I know you guys spent some time on the discovery engine and next-gen products and how you will be approaching with, your approach going forward. So it seems like there's been plenty of discussion with FDA recently just with the support of the EUA for PrEP and then these new treatment discussions. So can you help provide some framework around development for VYD2311 and how you're thinking about development there? And then second, again, on the treatment opportunity. Just wondering how we should be thinking about this opportunity, understanding PAXLOVID or VEKLURY are pretty robust markets, but just given that the language is around alternative treatments or alternative options, when alternative options are not appropriate or accessible.
Marc Elia: Evan, this is Marc I think the fun part of defining and leading a brand new field of medicine is probably a little bit of the frustrating part for you, as you look for specificity and precision that is, as you know, the topic of ongoing dialogue and collaboration. So when we're in a position to tell you exactly how we think these things will look, we'll certainly tell you. As now, what we've experienced over, I would say, a 12- to 18-month period, starting with, it actually goes all the way back to the December FDA EMA joint discussion on the use of surrogates for rapid trialing of COVID-19 antibody therapeutics and prophylactics. What we are watching is a growing congruence and a growing concordance that we believe opens up certain novel pathways. And we are going to be designing those in real time. And indeed, that's what has been going on. And it is not meant to be evasive or not give you the color you're looking for, but rather to note, these things are evolving as Invivyd builds the real opportunities to evolve them. We have PEMGARDA. Hence, we have an opportunity to use it more broadly. What we have noticed with the FDA is they are very thoughtful, very engaged and very attuned to the magnitude of the unmet needs. And so as we continue and expand that collaboration, as noted in some of the prepared remarks, we're really looking forward to continuing to innovate these pathways and establish bespoke and proprietary pathways that may be to some extent really enabled by our unique molecules, okay, and our unique discovery engine. So that is what you're really watching in real time. And I think we're looking forward over the next weeks and months to seeing how this new avenue takes shape. And so on treatment, I'll ask Mark to comment a little more on what he sees as the opportunity. But we elected to not change our guidance. So we're probably not going to give you the quantitation you would hope on the size of the opportunity. However, it is something about which we are quite excited.
Mark Wingertzahn: Thanks, Marc. This is Marc's partner in crime over here. And I've been a drug developer for almost 30-years. And what I can say is we're going to certainly iterate and optimize based upon the skeletal framework outlined by the FDA to date, not only for prevention, but also for treatment. And where I do think that this potentially fits is, we certainly know remdesivir is very burdensome to not only healthcare practitioners, but also to patients. The multi-infusion that they need within a very, very short period of time, and again, are mostly relegated to those in-hospital use cases. And certainly, PAXLOVID will not go away, but PAXLOVID with their drug-drug interactions, and with a lot of the breakthrough symptomology due to the fact that they're really not being able to abolish the titers to a level that perhaps a mAb gets you to provides, I think, a very, very nice use case there, especially in those patients who are immunocompromised and have a lot of comorbid conditions as well as on a lot of other drugs that could interact unfavorably with the current drugs that are available.
Operator: One moment for our next question. Thank you. Our next question comes from the line of Michael Yee of Jefferies.
Jenna Jefferies: This is Jenna on for Mike. Our question is on what magnitude of orders or potential orders are you seeing right now, when are they coming? Have you shipped anything? And when would you start booking sales?
Marc Elia: Thanks for the question. We have made some very preliminary disclosures in prior press releases that I'll ask you to take a read through one last time. But at this point, we're not going to go into any incremental detail. This is the early phase of the launch. It is very quickly going to be the middle phase of the launch. And I think as we look forward to the summer and then the fall, we're obviously going to be in a position to give you some feedback and some information that is useful to you, right? At this point, I think it's a little bit early, although we over here are quite encouraged. I don't know that anything we could respond to you with today would be particularly informative as it goes to understanding how the balance of the year is likely to play out. So stay tuned, and we are looking forward just as you are, to getting into more of that detail as the launch progresses.
Operator: I am showing no further questions at this time. I would now like to turn it back to Marc Elia, Chairman of Invivyd's Board of Directors and Chairman of the Executive Committee of the Board for closing remarks.
Marc Elia: Thank you, and thanks to all of you for joining the call today and for your interest in Invivyd.
Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.