Invivyd Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 15, 2025

There are 9 speakers on the call.

Operator

Thank you for standing by, and welcome to Nvivit's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again.

Operator

I would now like to hand the call over to Katie Bozzoni, SVP Finance. Please go ahead.

Speaker 1

Thank you, operator. A short while ago, we issued a press release announcing our Q1 twenty twenty five financial results and 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 Enviva website under the Press Release and Events and Presentations sections, respectively. Today's discussion will be led by Mark Alia, Chairman of Enviva's Board of Directors. He is joined by Tim Lee, Chief Commercial Officer Bill Duke, chief financial officer Doctor.

Speaker 1

Robert Allen, chief scientific officer and Doctor. Mark Wingertsaad, senior vice president of clinical development. 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 Invictus assumes no duty to update such statements.

Speaker 1

Additional information on the risk factors that could affect Invictus' 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 Mark.

Speaker 2

Good morning, and thank you all for joining us. Turning to slide four. The first quarter and our early second quarter has been a very busy and productive time marked by transition. Our commercial organization is now wholly internalized, new in the field, and reflects an intentional bet by this management team that our new internal team will drive broader adoption of PEMGARDA with associated commercial results. While it is early, our leading indicators are promising and we remain targeting near term breakeven with continued revenue growth and operating expense management.

Speaker 2

Scientifically, we're very pleased with what we see in the evolutionary journey of SARS CoV-two relative to the epitope we are exploiting with pemibibart. And as now, we see no obstacle to long term growth in our commercial PEMGARDA business. We have secured access to additional non dilutive capital to grow if certain conditions and milestones are met, and we are expanding our pipeline to multiple disease areas in which we believe our scientific approach can add value to patients in need. Specifically, we have added discovery programs against new viral targets with the potential for identifying best in class medicines for diseases outside of COVID nineteen. Our previous work in influenza continues at a low intensity, but bird flu with pandemic potential has not meaningfully emerged.

Speaker 2

And in the very recent short time, we have actually seen more US deaths from measles outbreaks than we have seen from avian influenza over the past year or so. At this point, it is reasonable to expect that trend to continue, and our focus has shifted accordingly toward early measles discovery. Last year, we initiated a new discovery program for an RSV monoclonal antibody that Robbie Allen, our CSO, will describe in a bit more detail. RSV presents a very clear, high value competitive landscape and some molecular properties we believe we can target to generate a potential best in class monoclonal antibody with blockbuster commercial potential. As we grow and expand our COVID franchise, we will accordingly want to make targeted financially responsible investments in discovery that can yield drugs we can capitalize for development, either in concert with the equity markets or with potential strategic partners.

Speaker 2

There has been no shortage of interest in our work from potential partners, particularly those with a vaccine footprint. It's important to note that our corporate goals, including targeting near term near term breakeven, are audacious by design and reflective of our integrated strategic and operational choices. In the big picture, we want to create as much medical value for patients and society as fast as possible, and then we want to translate that value into per share shareholder value as efficiently as possible. In an easy biotech financing environment characterized by low interest rates and long return horizons with blue skies for investors, it is much easier for companies to raise large quantities of dilutive equity that may enable a mediocre or farfetched biological premise to survive to the next catalyst. But such a business strategy rarely translates into long term per share compounding of shareholder value.

Speaker 2

We are taking the opposite approach and trying to be highly disciplined with our expenditures and capital base to the maximum extent, and not just because these days, the biotech investing backdrop and equity cost of capital has been tougher. We've been taking our approach because we see full operational proof of concept in our ability to make medicines rapidly and efficiently, and we wish to exploit that advantage, which we see as unique in the industry, as we grow our business so that our shareholders can benefit accordingly. Turning to slide five, in the bigger social picture, it is important to note that our fundamental corporate strategy reflects a great many macro level realities that have also undergone transition, transition, specifically a US election result and new public health leadership focused on chronic disease who are moving in directions on multiple fronts that comport well with our business strategy. As a quick reminder, invivid was started based on a simple reality that SARS CoV two was a unique virus designed to prey on a distinctly vulnerable human population. It was clear early that vaccines for COVID nineteen disease would work over the short term, but that waning responses would be problematic for every person, especially for immunocompromised persons.

Speaker 2

And on top of that, immuninvasive omicron viruses have added another headwind, as has the growing underlying burden of long COVID. More, given the handling of COVID nineteen vaccine policies, there is a regrettable secular shift underway with respect to American attitudes toward vaccination as a whole. Reviewing the last year's events with respect to COVID nineteen vaccines, such a shift is indeed regrettable, but perhaps not surprising. Monoclonal antibodies can be designed to overcome challenges with vaccination. After all, we are all born immunocompromised and preloaded with a suite of non self monoclonal antibodies from our mothers.

Speaker 2

And yet, in the pursuit of freedom from the burden of SARS CoV two, our regulatory and public health complex for four years was single mindedly focused on exposing humans serially and broadly to spike protein, largely in mRNA form, in an effort to get us our protective antibodies the hard way, rather than, as mom and mother nature might suggest, providing mechanisms for humans to access additional antibody support so that humans don't need to choose between dangerous infections and increasingly debatably effective vaccination. Unique in the industry, Invivid has now fully developed through multiple placebo controlled RCTs, two monoclonal antibodies against SARS CoV two, adentrevimab against ancestral viruses like Delta, and now pomivibart against contemporary immune evasive omicron viruses. More in our recent CANOPY Phase III clinical study assessing safety, immunobridging, and exploratory clinical efficacy analyses, we are reporting clinical results from a modern American population, specifically a population that has preexisting immune experience or seropositivity in both study and placebo arms. To some observers of the vaccine industry, conducting such studies is undoable or unthinkable. And yet to us and others in the monoclonal antibody business, those studies are business as usual.

Speaker 2

You will see elements of our recent citizen petition to the US FDA that focuses in on these issues because to us, there is clearly within reach a mechanism to scale access to monoclonal antibodies if and when regulators so choose. As you will see later in this morning's call, we have multiple parallel conversations with public health authorities designed to expand the consequences of our discovery and development work. With that, I'll turn the call over to Tim Lee to discuss our commercial progress in the quarter.

Speaker 3

Thank you, Mark, and good morning all. Turning to slide six. The first quarter cemented our transition from a contracted, largely outsourced model designed to hit a short seasonal window to a best in class commercial footprint to drive consistent growth via an in house team. We did not have a fourth quarter call, so it's been six months since I've had the opportunity to speak with the broad investor community. And it's worth sharing a few general observations from the fall and winter before we walk through key indicators.

Speaker 3

Mark and the team asked me to create a best in class commercial effort to put behind Camgarda and our future molecules. I'm pleased with what we've done so far. But in many ways, we are just getting started. First, we spent an enormous amount of time with health care providers and health systems simply reeducating on the existence of monoclonal antibodies as an alternative therapy available today. What began as a commercial interest largely driven by those who knew and anticipated PEMGARDA, we're now beginning to see institutional orders that are just beginning to reflect the underlying medical need.

Speaker 3

Protocols, pathways, real world experience, and word-of-mouth in the clinical community are still in the early innings, and we expect real growth to follow as this familiarity rises. Second, healthcare providers begin with real skepticism on the ability of PEMGARDA to navigate virus evolution, particularly following the FDA's misguided and harmful insertion of inaccurate third party virology data into the PEMGARDA fact sheet last fall. The combination of our communication of the underlying science, along with the empirical reality of the attractive continuing activity, is now gaining notice and belief. Third, the understanding of COVID-nineteen of the community has undergone a notable evolution. Most healthcare providers are now moving beyond the pandemic era concept of an acute respiratory syndrome, the SARS part of SARS CoV-two, and now see acute infection and corresponding respiratory disease as part of a much broader, more insidious long term health challenge.

Speaker 3

We are and we believe now on the forefront of educating these clinicians on why patients who are battling cancer, navigating transplant, or who lack sufficient immune cells to mount a response to vaccination need a protective option. The untapped market potential ahead of us remains numerically best. As we execute in our new posture, we expect to see a meaningful acceleration in product growth. Now I can get into the specifics of execution on slide seven. You see here the top level metrics accompanied by three of the structural elements we have installed at MVivid.

Speaker 3

We have moved to a focused, trained, in house team, ending our relationship with contract representatives. We have established and built a culture of accountability and measurement. We have substantially refined our messaging and believe that we are recognized as leaders in the COVID nineteen field by health care providers and institutions broadly. All of these elements are the keys to each successful launch in pharmaceutical growth initiative nation over my career. We're also beginning to make some progress around numerous fronts, including contracting.

Speaker 3

While not contemplated in the very early launch, we are receiving scaled interest from organizations who wish to derive value from commitments to our large ordering and are pleased to be working with them. We're seeing ourselves placed in pathways, protocols, and guidelines nationally, leading to a deeper understanding of Comgarta. Turning to slide eight. Slide eight shows the continued steady growth in our commercial reach. While Q1 revenues dipped from Q4, we believe much of that is attributable to the lack of feet on the street.

Speaker 3

In January and February, as we trained up and deployed, hired our new sales team, Encouragingly, we've seen strong revenues thus far in q two, including, for example, our biggest ever commercial day and biggest ever commercial week. Day by day, the highs are getting higher and the lows are getting higher as well. This is the hallmark of ongoing growth. Turning to slide nine. We would note that professional societies and guideline writers are taking notice of our work.

Speaker 3

In addition to the IDSA guidelines, we now have PIMGARDA in the NCCN guidelines for B cell lymphomas, which is a substantial US population, which deserves high quality protection. We routinely see from KOLs at medical conferences an awareness of non relapse death, for example, among patients who undergo CAR T therapy or deep immune ablation to manage lymphomas. And infectious disease deaths is a major contributor to that. Within infectious disease, COVID-nineteen is again a dominating contributor to that. Moving to slide 10.

Speaker 3

Of course, in contrast to other infectious diseases, COVID is ever present and characterized by periodic waves. While the sales of COVID nineteen treatments are highly influenced by surges in disease, and we saw that clearly among certain bigger pharmaceutical companies in their Q1 earnings calls, prevention via monoclonal antibody may be a bit more predictable and steady. COVID is always a threat for these populations. As we go into the warmer months, we tend in The US to see waves of COVID-nineteen among the Southern states that will be launching a targeted digital campaign regarding the likely summer surge accordingly. Finally, on slide 11.

Speaker 3

On pricing. We took in March a modest price increase, and still, PEMGARDA remains one of the lowest priced antibodies ever launched. Obviously, the original pricing analysis contemplated larger volumes and potentially lower risk and lower acuity patients, and especially consider the potential for COVID nineteen treatment. With treatment off the table for the moment, we took a small price increase to better reflect the value this medicine brings to populations in need. Note, the price increase only took effect in March and will be updated by CMS beginning in July.

Speaker 3

Next slide, please. We're pleased that PEMGARDA continues to be available through EUA and maintained focused commitment on serving the immunocompromised community. I'll now turn the call over to Robbie to discuss some of our progress in research and development. Robbie?

Speaker 4

Thanks, Tim. It's an exciting time to be in infectious disease prevention and treatment as the central authorities in The United States reconsider the state of the world for COVID-nineteen and beyond. I'll begin on slide 14 by commenting on our now multi year work with antibodies directed against the receptor binding domain or RBD of the SARS CoV-two spike protein. This is obviously a validated target and has been targeted repeatedly by our colleagues and competitors at other companies who would like to produce highly effective treatments and preventatives for COVID-nineteen. The challenge they and we faced and that we believe we are overcoming is evolutionary.

Speaker 4

Invivid's proprietary technologies are designed to yield antibody medicines that target special real estate on a biological target in motion such as SARS CoV two. So far, pemimavart has been a total success on that front. When we back of the envelope calculate the sheer number of a million SARS CoV two infections and consider the quantitative dynamics of infections, the fidelity of the SARS CoV-two polymerase, etcetera, we begin to estimate that the virus has explored quadrillions of molecular variants over the past years, and throughout, the epitope that defines the formibobar binding site has remained structurally intact. Accordingly, the product potency as assessed in best in class industrial systems has remained accordingly stable. Reinsuringly, of course, for our pipeline molecule two thousand three and eleven, VYD 2,311, the same is true only EC50 values are holding more stable at much more potent levels.

Speaker 4

In fact, neither the measured potency nor any change for VYD two thousand three hundred eleven would be visible if we placed our neutralization data onto the chart at the bottom of slide 14. Why? Slide 15 shows a graphical depiction of the SARS CoV-two spike protein with a blue area shaded indicating the pemivibar depatope. Genetic and structural change observed over time at each amino acid residue in the spike is represented by intensity yellow for minor, orange for moderate, and reddish for substantial change. You will note some yellow in a few spots of our epitope, but that change was all in the Omicron transition ever since then, three years, which can be in some ways considered a new phase of the pandemic or a very different endemic phase, our finding site has remained quiescent.

Speaker 4

More, as vaccination rates have dropped, pressure applied to the RVD at the population level has also dropped. Even more intriguing data out of the Bloom Lab at Fred Hutchinson demonstrates that children who have not been vaccinated but who have been primarily infected by XVB virus variants appear to generate antibody sweeps directed more toward the internal domain and away from RVD. While these NTD mutations are in keeping with the known immune evasive properties of omicron variants, there appears to be less evidence of selective pressure at those classically and historically antigenic sites on RVD near the primitive barbinding site, and viruses isolated from these more recent childhood infections. In short, we feel very good about continued Pembarka activity over the long term based on the observed stability of the pimavabart epitope. Slide 16 provides a little more color on a discovery program we are moving through now related to RSV.

Speaker 4

Respiratory syncytial virus is a major medical burden, and there is a well developed commercial category devoted to the use of monoclonal antibodies to prevent infection in neonates and children under two years at risk from seasonal RSV. At present, nirsevimab or Vifordis is the class leading antibody, although pabalizumab is still used and Merck's clasrovimab has a near term PDUFA date. The two more contemporary antibodies have certain strengths and liabilities, and the variation of the target F protein makes the RSV landscape an excellent opportunity to see if our platform can generate an attractive medicine to compete with the class leaders. In our screening and engineering, we can establish certain parameters designed to yield best in class properties, and we will look forward to updating on our progress later this year. Slide 17 provides further detail on our recently announced measles discovery program.

Speaker 4

By degree, measles share some of the same features as COVID and RSV in terms of multiple circulating variants that require an engineered broadly neutralizing monoclonal antibody, but which also presents a highly validated antibody target considering the generally understood efficacy of, for example, both MMR vaccine and IVIG in the post exposure prophylaxis setting. We have begun our work and our goal would be a tool useful for the treatment of acute infection and also useful in post exposure or even pre exposure prophylaxis use cases. We will look forward to reporting on our progress before the end of this year. I'll now turn the call over to Mark Wingerzon and Mark Alia to discuss clinical and regulatory.

Speaker 5

Thanks Robbie. Good morning everyone. In early February we reported our initial progress with VYD2311, our next generation antibody designed to improve upon pembrobar. As a reminder on slide 19, all Invivid COVID nineteen antibodies share identical scaffolding, and generally our discovery product process works such that each successive monoclonal antibody is a minor but essential tweak from the last. This process results in molecules that are near identical in terms of amino acid sequence.

Speaker 5

In fact, generally changed about to a similar or even lesser extent than let's say mRNA COVID vaccines from one generation to the next. With VYD2311, we are not trying to solve a problem related to variation or some threat to familiopar activity. Rather, we are trying to engineer more medically and commercially attractive features into our medicines. Slide 20 quickly outlines our first in human dose and route of administration ranging clinical trial designed to provide maximum forward flexibility for our go to market and regulatory conversations. You can see the cohorts on the slide and the concepts behind assessing them initially.

Speaker 5

We will be wrapping up the study soon and will be pleased to provide an update in the next weeks on our progress. Turning to slide 21, it reminds us very quickly the properties of VYD two three one one relative to vivipibart and what we think those properties allow for. It is our belief that two three one one can be a major step forward for people sick with COVID nineteen and people highly vulnerable to COVID nineteen, whether immunocompromised or not. VYD two three one one represents a potential step change in accessibility and scalability for protection compared to PEMGARDA and may present the opportunity to also create a highly efficient and effective treatment. With that, I'd like to turn the call back to Mark Alia who will discuss our regulatory experience with our COVID-nineteen treatment EUA request and some next steps.

Speaker 2

Mark? Thank you, Mark. As previously mentioned, we've been watching evolution at HHS and FDA with great interest. One of the key messages new HHS and FDA leadership sent has been a desire for greater transparency, especially as it relates to communication between FDA and industrial sponsors. At this time, we have not seen any convention emerge on this front among our colleagues in industry, nor do we have any guidance on this topic from the agency.

Speaker 2

However, we are aligned with the notion that transparency is a generally good thing for regulators, patients, sponsors, and citizens. With that in mind, and given the sheer volume of correspondence, between companies like ours have with FDA, we are today beginning by providing direct excerpts and data from one recent correspondence back in February, specifically the declination by the legacy Biden FDA of our application for expansion of our EUA to include treatment of active mild to moderate COVID in immunocompromised persons with no treatment options. This action generated many questions to our company from HCPs and patients, and we hope that today's presentation provides some answers. Importantly, we believe our presentation today reflects both the core of the scientific review by the agency and the bulk of their communication to us on the topic and would resemble in some ways the major points the agency might render to, for example, an advisory committee if that were an operative forum. We are including our rebuttals to those points, which ultimately will build to our intended next steps.

Speaker 2

Importantly, at invivid, we are Americans and taxpayers, and some of us are patients too, in addition to industrial sponsors. And so we view our partnership with FDA as fundamentally collaborative on behalf of patients in need. Slide 22 describes the operative background. Immunobridging of antibodies for COVID nineteen has its roots in a December 2022 joint EMA FDA webinar attended by regulators and academic and industrial experts, including in vivid, and was devoted to accelerate COVID nineteen monoclonal antibody development. In our case, our immuno bridging prototype molecule adentrevimab went through full phase three registrational RCTs for both PrEP and treatment of COVID-nineteen.

Speaker 2

And as such, adentrevimab represents a biophysical profile well associated with demonstrated placebo controlled clinical efficacy. Industry, academic and regulatory confidence in svna titer or clinical antibody antiviral activity is sufficiently high to use that surrogate as a way to bridge from one clinical data set to a new molecule without the need for full pre authorization clinical studies, just as we did for our prep authorization. From a regulatory perspective, it was clear in 2022 and has been clear for the last three years that EUA was the pathway FDA preferred or believed was the best fit with what was understood to be a short useful life of all COVID nineteen monoclonals. This is of course a contrast of vaccines, which enjoy full approval and SBLA updates on the basis of similar comparative titers. Either way, in the spring of twenty twenty four, a bridging EUA for treatment seemed to be a structure that might suit both our and FDA's interest sets depending on the nature of the titer bridge, just as was the case for our PrEP authorization.

Speaker 2

The clear desire from the agency throughout has been for what they would consider, quote, conservatism, unquote, or the highest possible antiviral titers and therefore antibody dose to satisfy some of the epistemological limitations of immunobridging. This is an understandable desire if you remember that the first job of the agency is assurance or confidence in likely clinical benefit rather than stewardship of a medicine's overall profile. There are of course consequences to the degree of insurance required by the agency that takes some careful thought in unpacking, which is where we'll spend some time today. It is an important exercise in part for reasons embedded into our citizen petition. There is a wide gap between the assumptions and habits of CBER and CEDAR respectively as between assurances traditionally required of COVID vaccine versus assurances traditionally required for COVID monoclonal antibodies.

Speaker 2

And we believe regulatory evolution is required for the benefit of patients in need. A few more background points. First, pemivibart and adintrevimab, despite being near identical molecularly, have very different potencies and hence different routes of administration and doses, which means their PK and PD profiles cannot overlap, but can be easily compared to one another visually and quantitatively. Second, the proposal for EUA expansion was for immunocompromised persons for whom alternative therapies are inaccessible or not clinically appropriate. So the choice here is between pemivibart or nothing.

Speaker 2

Third, we will not touch much on the pemivibart safety profile in this overview, both because pemivibart was and remains authorized for use by people who are well, which would seem to create a safety pathway for use by people who are sick, and because the bulk of FDA feedback relates to the science of assurance of efficacy benefit in immunobridging. Slide 23. The major FDA finding on the application for treatment presented in terms that are drawn straight from the EUA statute is that they are unable to reasonably conclude that the known and potential benefits of pemibibart in treatment outweigh the known and potential risk. They offered four specific scientific conclusions related to assurance of clinical benefit in the immuno bridging exercise, which we have paraphrased here and will present in more detail on the next slide. Slide 24 depicts curves and comparison between adentrevimab and pemivibart PK and PD expressed as SBNA titer or clinical antiviral activity, the primary basis for immunobridging.

Speaker 2

On the upper left chart, you can see that adentrevimab being administered intramuscularly starts with very low circulating titers and rises slowly over five to seven days toward its peak. By contrast, pemibibart is dosed intravenously and so begins instantly very high and then settles over time. You can read below the FDA interpretation of the comparative curves, which they describe as, quote, similar to or higher than, unquote, adentrevimab for only three days, after which it is less than. And you can see a table in the upper right expressing the ratio of those two curves over various increasingly longer time periods. The agency here is justifiably focused on whether pamivabart delivers comparative titers to adentrevimab for the longest possible time.

Speaker 2

Next slide, 25, conveys our perspective on this primary immunobridging. In contrast to FDA description, we see pemibibart titers as much higher than or comparable to adentrevimab for four days, then modestly below for day five, after which the pemibibart titers settle below adentrevimab, but are of course still quite high compared to nothing for many days and then weeks given the half life of the molecule. Why are we at Invibid so interested in five days? Three reasons. First, over five days, adintrevimab conferred the majority of its measured virologic benefit compared to placebo, even starting at very low titers.

Speaker 2

Second, treatment alternatives, Paxlovid and Ligebrio, are five day regimens themselves, after which, of course, they stop and confer zero antiviral activity. And third, as a general statement, treating early in the course of an infection of COVID-nineteen is associated with improved outcomes. So to us, that five day duration comparison is rather interesting, and the seven day comparison is attractive. Although we agree that conferring long term antiviral activity to help with persistent shedding or viral rebound is a wonderful potential benefit of using long acting antibodies in treatment setting. Finally, to us, while an immuno bridging analysis like this one compares a predicate antibody to a new antibody, of course, for patients in need today, the actual choice, in front of FDA is between the new antibody and nothing at all, to which we will return in a moment.

Speaker 2

Slide 26, next slide, depicts one of two conceptually and substantively similar meta analyses presented to the agency. In this case, you can see that pemivibart is not among the most potent antibodies ever developed for COVID nineteen, which we understand and agree with. It is however, well within the range of effective mAb titers and would provide antiviral activity a good bit above sotrovimab used to treat COVID nineteen to great effect in the pandemic phase of COVID nineteen. Also on this chart on the right side, so excuse me, the left side of the curve, you will see convalescent plasma titers. Convalescent plasma, interestingly enough, retains a treatment DUA.

Speaker 2

And you can see that the range of antiviral activity conferred by convalescent plasma is far below both sotrovimab and pemivibart. Nonetheless, the FDA notes here that they would wish pemivibart to be nudged more to the right to sit among other mAbs, irrespective of the fact that moving rightward appears to have a de minimis predictive effect on expected clinical outcomes. Slide 27 presents our view on this point. Moving rightward may confer some benefit to patients, and we may be able to do it with newer molecules. But alas, we are once again not picking between all of these molecules as if any of the comparators currently exist.

Speaker 2

The only active molecules depicted on this chart are pemibibart and the components of convalescent plasma well to the left. Further, agency leadership was well aware and communicated to us in the past that antibodies have been consistently overdosed, which seems like a minor, maybe even academic problem until now, when a decision has to be made about an antibody like pemivibart. We look at the activity conferred by pemivibart and see it as well in an antiviral range validated by RCT is having an attractive treatment effect. Slide 28 is the FDA language describing the residual clinical uncertainty of what pemivabart dose may be optimal for those severely immune compromised patients who are fighting an active infection without adequate immunologic response. On slide 29, we simply note on this point, there is a peculiar and deeply unfortunate consequence to the FDA's perspective for patients in such clear need.

Speaker 2

Slide 30 relates to the fact that indeed comparator antibodies are different and may have subtle differences in mechanism of action, and those differences may be difficult to measure but weigh on regulatory consideration. Slide 31, next, notes our view that indeed, other than neutralization activity, we assessed and found effector function essentially identical between pemivibart and adentrevimab, which should not be a surprise given the identical backbones. As for antibody non neutralization, non effector activities that are undescribed and unmeasured by both industry and FDA, those are a little hard for us to assess and respond to. We would humbly submit that these ambiguities are ever present in medicines new and old, And indeed, we would welcome guidance on what unknown and undescribed thing we might measure going forward. So slide 32, where are we?

Speaker 2

Well, we have a new leadership team at the FDA, a changing agency, and as described, changing priorities at FDA and HHS. We intend to continue engagement with FDA both on pemivibart, which is here today, and on our new molecule, VYD2311, which we have accelerated rapidly through early clinical development. As a final point on the matter, slide 33 depicts the result of a similar analysis for bridging to treatment for VYD2311 using arithmetic from currently circulating variants. You can see on the y axis that both proposed doses of VYD2311 provide SVNA titer well in excess of aditrevimab, and indeed can either approach from below or well exceed the titers delivered by REGEN COVE, which sat toward the top of the old antibody leaderboard if you're keeping score at home. With data like these for VYD2311, we see the majority of the agency's pemibibart concerns well addressed.

Speaker 2

We hope that this comparison and recitation of the pemibibart treatment declination logic answers outstanding questions in the field. We will be working up a manuscript to describe the situation for a scientific journal in the next weeks. In the biggest picture, we're thrilled with the medical potential we see in our medicines. We appreciate the FDA's alignment with our desire for greater public transparency, and we look forward to reengaging with a new FDA to discuss pamivabart, VYD two thousand three hundred and eleven, and this field of medicine generally. Needless to say, it is our overarching goal as a company to bring important, high value medicines to patients in need as rapidly as possible.

Speaker 2

I'll now turn the call over to Bill Duke to talk about the financials before we move to Q and A. Bill?

Speaker 6

Thank you, Mark. Turning to slide 35. Prior to today's call, we released our Q1 twenty twenty five results, including PEMGARDEN net product revenue of $11,300,000 in March ending cash and cash equivalents of approximately $48,000,000 As previously mentioned, to drive long term top line growth, we made a strategic decision to internalize our sales force at the beginning of twenty twenty five. Although the shifts created a short term headwind reflected in pemgarden net product revenue during Q1, We are now seeing positive momentum with the return to growth and early signs of acceleration in Q2. We are pleased with the continued execution of financial discipline, reporting a continued reduction of operating expenses.

Speaker 6

We reported $27,400,000 in operating expenses in Q1 twenty twenty five compared to $32,300,000 in Q4 twenty twenty four, a 15% reduction of quarter over quarter. This was after a decrease from Q3 to Q4 of over 50%. We anticipate operating expenses will continue to decrease in the second quarter as we have manufactured sufficient supply of PEMGARDA and VYD2311 and do not plan for a significant further manufacturing expense in the near term. Backed by a strong cash position and potential to access up to $30,000,000 in non dilutive funding through our term loan facility with SVB secured in April, we remain focused on growing PEMGARDA top line revenue, continued financial discipline, and continue to target profitability by the end of the first half of twenty twenty five. I'll now turn the call over to the operator to open the call for questions.

Operator

Thank you. As a reminder, to ask a question, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again. Our first question comes from the line of Michael Yee of Jefferies. Please go ahead, Michael.

Speaker 7

Hey, good morning, guys. Thanks for taking our questions. This is Kyle Yang for Michael Yee. Just a few from us. The first one is, could you please characterize your recent interaction and or experience with a new agency, particularly on EUA, including maintaining your EUA for COVID prevention and use of EUA for future applications, including for treatment, and also use of surrogate endpoints such as virus titers for approval?

Speaker 7

The second one real quick is on Q1 sales. Could you please characterize the headwinds that you encountered in q one? I understand your team briefly discussed it. Could you please expand on that and tell us how you addressed, you know, these areas, you know, of improvements in the second quarter. And just help us think about your sales in q two and how do you and your confidence, what gives you confidence that you're going to see the momentum continue in the second quarter?

Speaker 7

Thank you.

Speaker 2

Great. Thanks so much. Let me start and then I'll ask Tim to answer the second part. So regarding EUA, you asked a couple different things. But with respect to maintenance of EUA, it is actually our preference to move with the FDA beyond that construct.

Speaker 2

Indeed, it's generally understood that EUAs are designed to effectively convert at some pace and subject to some mechanism. We've not actually had that conversation with the new FDA, which as you may or may not know is effectively recently seeded, we're looking forward to it very much. Critically, our current EUA for the prevention of COVID-nineteen in certain immunocompromised persons, yes, was generated on the basis of immuno bridging, but of course, carries with it the results of a randomized clinical study interrogating both safety and exploratory clinical efficacy. So in our minds, those data are unique in the field. This is the point we've raised, in a few different domains, particularly our recent citizen petition.

Speaker 2

So unlike any other company we're aware of that has an authorized preventative or approved preventative, we actually have contemporary efficacy data. And so would seek to leverage that in one form or another subject to discussion with the FDA of moving toward BLA. That would be our preference. And it would certainly be our preference going forward. So I don't think any of that is either of know, nerve wracking nor surprising.

Speaker 2

It's in fact embedded into the very nature of a granted EUA. We're really looking forward to talking with them about that. On a go forward basis, I think what we see is a pretty clear scientific and I mean, of academic and clinical understanding that SVNA titers are a highly useful validated surrogate endpoint. And you can see that embedded into of course, the work that we've done with FDA to date. And in fact, the evolution of our of our product fact sheet, which alludes to some of the meta analytics describing these relationships.

Speaker 2

So, you know, we we see the endemic virus situation as an opportunity to normalize all of this away from EUA into a a landscape akin to an accelerated approval with a post market conversion study, which I think not coincidentally perhaps appears to be the direction of travel for COVID nineteen vaccines. All of that is to us highly welcome and embedded into all of our plans for both pamivabart and our molecules going forward. You have to remember that an EUA does not carry an express obligation to generate randomized clinical data on the other side of it. But of course, accelerated approvals do. So we would look forward to that paradigm.

Speaker 2

And it's going to be a major feature of what we believe will be our upcoming discussions with the agency. So I hope that's clear. If it's not, please, please get back into the queue. But meanwhile, I'll ask Tim to expand on our Q1 changes and our confidence going forward.

Speaker 3

Yeah, of course. Thank you, Mark. I think we I brushed over pretty quickly, but when I look back at what we were able to do in Q1, it was pretty remarkable. We decoupled from the contract sales organization and built our own best in class sales team, trained them and deployed them by partnering with our human resource team to make all of this happen in weeks. And so we did see a disruption in field activity.

Speaker 3

But with that, we were really thoughtful in how we made that approach and amplified some of the air cover that we can do with digital marketing and others to fill a little bit of that void. I think what we're pleased with seeing right now, and I shared it on the key launch metrics slide, is that when you look from January 1 through the April thirtieth, we're seeing a really nice increase in breadth, depth, as well as unique accounts that the team is calling on. So we've really refocused around what we're calling a core four of specialists, including rheumatology, where we've seen a high degree of acceptance and adoption. And it's been a really good area of focus for us. I also look at where PEMGARDA is available.

Speaker 3

When I had my first call about a year ago with you, we had about 120 sites. Right now, if you go to our Infusion Finder, we have over eight eighty sites. So we continue to drive access to PEMGARDA really broadly through multiple channels and are starting to see that. And as alluded we're seeing some of our we're seeing some really strong numbers into Q1 right now and are excited about that.

Speaker 8

Thanks so much.

Operator

Thank you. Our next question comes from the line of Patrick Trucchio of H. C. Wainwright. Go ahead, Patrick, your line is open.

Operator

Please make sure your line isn't muted. And if you're on a speakerphone, lift your handset.

Speaker 8

Hi. Good morning. I'm sorry I was on mute. This is Luis in for Patrick. Thank you for taking our questions.

Speaker 8

And, again, we understand that there are these are challenging times, which we appreciate all of the team's work and progress so far. So on a on a on a follow-up question a little bit to what was discussed earlier, can you discuss a little bit more in detail the measles program, if you plan to pivot measles, if you what every details you can share on the expected clinical trial development path and potential market size, and how and in the context of your current cash position and the non dilutive loan facility, how you're planning to prioritize?

Speaker 3

Thank you.

Speaker 2

Yeah. Let me let me start. And this is Mark, and I'll see maybe Robbie can add some color. But when we're discussing our discovery programs, that is spending that is essentially in all of our standing budgets and it doesn't represent a particularly incremental draw from our forecasted cash balances. It is a matter of priority.

Speaker 2

So yes, we're adding a program, for example, in measles, but I want to say you might have used the word pivot, which is not something that I would agree with. We're not pivoting any more than when we leave English class and go to math class, we're pivoting and deciding to just focus on math. We're adding something that we think could be potentially important and that could create a lot of value for patients in need and shareholders over time. So doing these early discovery programs provides us with a basis for considering clinical development under the right circumstances. And again, as stewards of capital, we are always going to try to be disciplined about spending shareholder money only on those projects that we see having a very, very attractive near term return profile.

Speaker 2

Now, in the case of measles, there may well be some interest in even the national level and we will look forward to exploring that potential. But I don't think you can consider any of it as a change or a particular, draw on our capabilities or interests elsewhere. It is all about adding optionality and setting into place the, ability to grow over the long term, both in terms of our, you know, the scale of our business, but more importantly, growing the scale of our anticipated medical impact. Is that clear?

Speaker 8

Yes, that's helpful. Thank you so much.

Operator

Thank you. I would now like to turn the conference back over to the company for any closing remarks.

Speaker 2

Okay. Well, thank you very much all for joining us this morning, and we will look forward to any further questions in a follow-up later today. Thanks all. Bye bye.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Powered by Quartr

Key Takeaways

  • Enviva has internalized its commercial team to drive broader adoption of Pemgarda, with early Q2 indicators promising as it targets near-term breakeven through revenue growth and operating expense management.
  • Data show the Pemibart binding epitope has remained structurally intact despite SARS-CoV-2 evolution, supporting long-term potency of Pemgarda and validating advancement of next-generation antibody VYD-2311 with enhanced antiviral titers.
  • The company is expanding its pipeline beyond COVID-19 with low-intensity influenza work, a newly launched measles discovery program and an RSV monoclonal antibody project, aiming for best-in-class potential in multiple infectious diseases.
  • Enviva continues dialogue with the FDA after EUA treatment expansion was declined over immunobridging concerns, and plans to pursue a BLA or accelerated approval path for Pemgarda and VYD-2311 using serological surrogate endpoints.
  • Financially, Q1 net product revenue was $11.3 million, operating expenses decreased 15% sequentially to $27.4 million, and the company ended March with $48 million in cash plus a $30 million term-loan facility, targeting profitability by mid-2025.
AI Generated. May Contain Errors.
Earnings Conference Call
Invivyd Q1 2025
00:00 / 00:00