Q3 2024 Invivyd Inc Earnings Call
Yeah.
Good day and thank you for standing by welcome to the Q3 2024 and visit earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation, there will be action and answer session to ask a question. During the session you will need to press star one on your telephone.
I didn't hear an automated message of IV, new your hand, just raced to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, Katie <unk> Senior Vice President of Finance. Please go ahead.
Katie: Thank you operator, a short while ago, we issued a press release announcing our Q3 2024 financial results and recent business.
<unk>.
Katie: That press release and the slides that are being used on today's webcast can be found in the investors section at the end of its web site under the press release and Investor presentations section's effectively.
Speaker Change: Today's discussion will be led by Mark Alia, Chairman of embedded board of director and Chairman of the Executive Committee of the Board. He is joined by Kim Lee Chief Commercial Officer, Bill to Chief Financial Officer, Dr. Robert Allen just outside.
Speaker Change: The golf with her doctor market, whether it's on senior Vice President of clinical development and medical Affairs.
Speaker Change: During today's discussion, we'll be making forward looking statements concerning among other things, our corporate and commercial strategy, our research and development activity, our regulatory plans certain financial guidance, our future prospects and other statements that are not historical facts.
Speaker Change: 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.
Speaker Change: These forward looking statements speak only as of the date of this call and in debit assumes no duty to update such statements additional information on the risk factors that could affect and visits that can be found in our filings made with the securities and exchange Commission, including our most recent Form 10-K 10-Q, which are also available on our website I will now turn the.
Mark Alia: Call over to Mark.
Mark Alia: Good morning, and thank you for joining us.
Mark Alia: The third quarter was marked by a promising start and then an unusual commercial headwinds the dividends been beverages through six this headwind is rooted in the academic virology complex U S. FDA and unfortunately as a result reached hcp's and vulnerable populations that can benefit from more protection from symptomatic COVID-19.
Mark Alia: Yeah.
Mark Alia: As a reminder, inhibitors discovered developed and is now commercializing a monoclonal antibody against Sars Cov two.
Mark Alia: This virus is now in its endemic phase following a pandemic that range through the immunologically naive human population, but now it's endemic phase still carton shocking quantity of death illness, and long term damage, even among the young and healthy while the backbone of population health for COVID-19 remains vaccine boosters contemporary data from <unk>.
Mark Alia: Very consistently reveals the limitations of vaccine boost in terms of the level of protective efficacy at least can achieve and as human already experienced immunologically from prior vaccination or infection. These.
Mark Alia: These limits are universal Mark humans, although the immuno compromised population, who may receive less benefit due to an inadequate immune response to vaccines are more variable are more vulnerable and bearing even greater burden requiring additional protection.
Mark Alia: Fortunately and debit has conducted randomized clinical studies on monoclonal antibodies in both the pandemic phase and now the modern endemic phase of Sars Cov, two and the results are unambiguous.
Mark Alia: Clonal antibody can render a major step change in protective efficacy against symptomatic COVID-19 compared to placebo.
Mark Alia: Unlike modern vaccine boost epidemiologic studies, which reveal about a 40% to 50% reduction in the likelihood of a COVID-19 related hospital stay or urgent care visits for about 60 days after which benefits fades rapidly exploratory efficacy data on <unk> from our cannot be phase III clinical trial demonstrated in an immuno.
Mark Alia: Competence population, 80% to 90% reduction in the risk of getting symptomatic COVID-19, the first place.
Mark Alia: Over twice dosing during a six months period.
Mark Alia: And visited recently shared long term follow up data from canopy, showing that indeed robust protection remains even at low residual drug levels.
Mark Alia: After a six after six months following cessation of dosing consistent with prior publications and indeed, consistent with our overall corporate thesis for scaled monoclonal antibody protection of potential low doses and attractive routes of administration.
Mark Alia: Against this backdrop remains Sars cov, two virus genetic variation a source of fascination and constellation for the academic and regulatory communities and a major focus of our work internally at exhibit.
Mark Alia: <unk> two is displayed remarkable genetic mutability and there exists a substantial cottage industry devoted to describing and considering those mutations from.
Mark Alia: From an <unk> point of view as a pharmaceutical company variation is why we have made a major investment in technology designed to understand and address that variation and why do we select the molecules, we select with barriers to resistance in mind.
We're all incredibly proud that so far in vivid stands alone in both attempting in accomplishing this goal and the contemporary context of a post OMA chronic era utilizing rapid approval pathways in concert with FDA.
Mark Alia: <unk> long standing and continue to anti viral activity to date is a remarkable scientific accomplishment and one we are eager to repeat with an improved drug profile.
Mark Alia: Well Wes applied virology is an inexact science all the more in exact outside of an industrial highly controlled context and there are many labs globally that seek to understand our molecules using processes and systems of unknown quality and reagents of unknown characteristics.
Mark Alia: One of those systems and labs has presented an unusual headwinds cashed out on the activity of our molecule against contemporary lineages, notably <unk> Dot one dot one observations made at Columbia University over the summer and into the fall.
Mark Alia: <unk> Dot one dot one susceptibility to out made its way into the U S. FDA and disappointingly the agency broadcast that out into the HCP and vulnerable populations by not just factsheet updates, but also email blast and tweet or whatever tweaks are called now while the pet and garden Factsheet was corrected in late September with robust neutralization.
Mark Alia: Data generated through exhibits industrial virology effort.
Mark Alia: With this opportunity to drive utilization in the late third quarter and into the fourth quarter infectious disease season was badly damaged.
Mark Alia: And because it has been seeking to repair this dip in the end market up to and including news today in which the New England Journal of Medicine has published not just a letter to the editor from exhibit.
Mark Alia: But also a second piece from this laboratory describing their neutralization results against our lab made antibody, which has to be corrected at the 11th hour by new inventory at all as you can see online.
Mark Alia: The piece now describes quote research grade unquote under the park, which is a critical and sadly late emerged distinction.
Mark Alia: To the New England Journal Medicine correction. It was implied that authentic <unk> manufactured by debit was used in these systems.
It is a science based company and therefore has a deep respect for the scientific process, but we are also in the business of trying to save lives and believe that the researchers and regulators considering scientific claims are to exert real caution in making claims about authorized medicines for human use on the basis of rapidly emerging science that may lack appropriate rigor and.
Right control.
Mark Alia: Meanwhile, in visit remains working to drive awareness of our medicine. Among hcp's that we believe disrupts disease pathogenesis and has been shown to protect vulnerable Americans who are in need of protection against symptomatic COVID-19 timber.
Mark Alia: Tim Lee our Chief commercial officer will describe our ongoing efforts and are thinking about building. This important category of medicines and our SVP of clinical development and medical Affairs, Mark Wintertime, we'll touch on recent cannot be data points the way to scaling our work far beyond what we can do with <unk> as an intravenous medication.
Mark Alia: More generally our great hope it and visit these recent events, our strong and consistent data.
Mark Alia: The upcoming government transition can all present, an opportunity for regulators to consider an impressive and growing totality of data that shows quite clearly one.
Mark Alia: Test boost treat paradigm championed by the current administration is having ended the pandemic unfolds is left behind extraordinary ongoing human misery.
Mark Alia: Two monoclonal antibody protection, especially when deployed in the contemporary human population on top of immune experience for vaccination of infection can be a substantial unlock in terms of high levels of protection from symptomatic disease itself.
Mark Alia: Three <unk>.
Mark Alia: Protection is low serum virus neutralizing antibody titers has now been demonstrated by monoclonal antibodies in both the pandemic and modern endemic phase of Sars Cov, two and such data can be leveraged to make products that would look and feel rather like a vaccine for example, intramuscular or similarly convenient administration.
But which could be distinguished by high efficacy and durable equitable protection, all without forcing human subjects to encounter the Sars cov two despite approach in vaccine form and experience associated reacted unisys and for companies like <unk>.
Have been and remain prepared to action these initiatives as soon as key governmental stakeholders array.
Mark Alia: Despite the extraordinary recent circumstances surrounding this company and our ongoing <unk> launch we've been gratified to see our recent return to product growth. We are pleased with the durability of <unk> and our next generation of antibodies <unk> 'twenty $3 11 in the face of virus variation.
Mark Alia: And we stand prepared to radically scale the impact of our work near term.
Mark Alia: With that I will turn the call over to Mark <unk> Senior Vice President of clinical development and medical Affairs.
Speaker Change: Thank you Mark if we could turn our attention to slide six.
Mark: Efficacy results from the immuno competent or from the ongoing 12 month canopy study as well as the major COVID-19, various waves during that time are depicted on the current slide.
Mark: As you may recall that cannot be study is an ongoing 12 month clinical study designed to evaluate safety tolerability and efficacy of <unk> for pre exposure prophylaxis of COVID-19 in adults, aged 18 years and older.
Mark: Persist participants received two doses of <unk> infused 90 days apart and then were followed through month 12. The study was conducted from fall 2023 through winter of 2020 for making this study one of the few if only COVID-19 studies conducted in the contemporary population.
Mark: Over the entire one year period, an impressive rate of relative risk reduction from symptomatic COVID-19 was observed with <unk> versus placebo strong protection was observed with <unk> Garda over multiple variant waves and limited lineages of Sars Covid two not only during the active dosing period, but also during the.
Mark: Six month follow up washout period.
During the active treatment period, and 84% relative risk reduction from confirmed symptomatic COVID-19 versus placebo was observed in the immuno competent arm of canopy also known as cohort b.
A substantial degree of protection remained over months seven to 12 after cessation of drug during a <unk> three and <unk> dot <unk> dot one dot one wave with an overall, 76% relative risk reduction versus placebo observed in this cohort over the full 12 months reassure.
Mark: Reassuringly the safety profile for <unk> remained consistent with the <unk> factory.
Mark: The strong protection observed during the washout period is particularly impressive given the low residual tighter levels and while there are no head to head trials. We believe that protection can follow from fewer doses of antibody then the doses of vaccine boost that would be required to get protection for immuno compromised persons who are.
Mark: Unlikely to Mount an adequate immune response to the COVID-19 vaccine.
Mark: If we turn our attention to slide eight.
Mark: And take a look at our pipeline as you know we've identified <unk> via affinity maturation of barred against SPV lineage viruses in an effort to improve on the biophysical properties, including in vitro measured potency.
Mark: Potency improvements in measured IC <unk> for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SG&A tighter.
Mark: Pharmacodynamic variable that drives protection and efficacy for a COVID-19 antibody. These lower doses may in turn allow for the development of routes of administration that are more patient and system friendly than intravenous approaches.
Mark: The first in human study with BYD 2311 began at the end of August and as interrogating intravenous intramuscular subcutaneous dosing to provide flexibility and optionality optionality for achieving titers from one antibody could.
Mark: Could be suitable for both COVID-19 prevention as well as treatment.
Mark: We are currently assessing authorization pathways and plan to discuss.
Speaker Change: In light of the canopy 12 month clinical efficacy and safety data with regulators and look forward to reviewing our progress with BYD 2311 at our next earnings call I will now turn the call over to Tim Lee, Our Chief Commercial Officer Tim.
Tim Lee: Thank you Mark and good morning.
Tim Lee: Turning to slide 10.
Tim Lee: The third quarter began commercial transformation.
My first full quarter, and David and I am excited to share some of the foundational work that we've built.
The immuno compromised community.
Tim Lee: I came to inhibit because of our mission to serve people who are immunocompromised.
Tim Lee: This committee is made up of fighters people, who are battling cancer people have received an organ transplant for bone marrow transplant.
Tim Lee: Primary immunodeficiency advanced HIV and are actively being treated with high dose course corticosteroids.
Tim Lee: Corticosteroids.
Tim Lee: These are all conditions that can lead people to be vulnerable to an opportunistic virus that causes systemic damage and.
Tim Lee: And it's why in 2024, approximately every 90 minutes a person in the U S died of COVID-19.
Tim Lee: COVID-19 continues to be the leading cause of hospitalization and death from respiratory infection in the United States.
Tim Lee: Protecting this community is a noble mission.
Tim Lee: Proud to be a part of it.
Speaker Change: Turning to slide 11.
Speaker Change: Data from the CDC.
Speaker Change: That ICU admissions for all Americans are greater this season.
Speaker Change: Then left.
Speaker Change: Clearly demonstrating that <unk> continues to have a lasting impact.
Speaker Change: Turning to slide 12.
Speaker Change: You can see the COVID-19 can cause systemic damage.
Speaker Change: With no organ system spared from its impact.
Speaker Change: Turning to slide 13.
Speaker Change: It is what the immuno compromised community in mind.
Speaker Change: We're building our commercialization plans.
We fought through real headwinds through the month of September as the Perms artifact sheet was updated to include reference to third party data.
Speaker Change: Was not reflective of some gardens continued neutralization activity for the immunocompromised community as Mark noted.
Speaker Change: Clinicians and patients more importantly were confused by these statements.
Speaker Change: Putting this behind US we are focused on our mission to serve the immunocompromised community at scale.
Speaker Change: We're partnering with community independent in infusion centers.
Speaker Change: Along with academic centers and integrated delivery networks.
Speaker Change: Increased sites of care for this community.
Speaker Change: We're developing a digital presence and recently conducted our first speaker program during the week in Los Angeles.
Speaker Change: We're bringing the sales team from a contract field force to direct hire.
Speaker Change: And believe it's the right decision to serve this community.
We believe now is the right time to restructure this team and it will better serve our future growth.
Speaker Change: We're excited to be investing in patient support programs to ensure there's a smooth access for patients who are prescribed <unk>.
Speaker Change: We're investing in field reimbursement management team and building a federal accounts team.
Speaker Change: With a focus on immuno compromised veterans and their families.
Speaker Change: We also added an inside sales team with a focus on rheumatology.
Speaker Change: And are impressed by the early results.
Speaker Change: Turning to slide 14.
Speaker Change: Those actions.
Speaker Change: Along with as you can see growth across all launch metrics are positioning us to serve the appropriate immuno compromised community at a larger scale.
Speaker Change: With that I'd like to turn the call over to our Chief Financial Officer.
Speaker Change: For final remarks prior to the Q&A.
Speaker Change: Thank you Tim turning to slide 16.
Speaker Change: As you may have seen at the end of October we pre released our Q3 results, including garden net product revenue of $9 3 million in Q3 2024.
Speaker Change: In September ending cash of approximately $107 million.
Speaker Change: Which is consistent with the results reported this morning.
Further we noted that we expect to finish 2024 with $65 million or more in cash and cash equivalents.
Speaker Change: At the same time, we withdrew the guidance of $150 million to $200 million of net product revenue and we guided to earlier this year, citing recent headwinds from U S. FDA late Q3, 2020 for warranty on potential for substantially reduced activity.
Speaker Change: Sure.
Speaker Change: Through the Pilbara factsheet and other media based on a contested third party preprint, reflecting biologic activity data from a non <unk> antibody.
Speaker Change: As has been noted.
Speaker Change: As Tim mentioned, we are excited about <unk> potential to reach appropriate immune compromised patients.
Speaker Change: As such we are targeting near term profitability with existing cash and cash equivalents anticipated growth of net product revenue.
Speaker Change: Various operational efficiency improvements underway.
Speaker Change: The good news is that we.
Speaker Change: <unk>.
Speaker Change: Previously recorded as research and development expense, a significant amount of inventory in preparation for the emergency use authorization submission.
Speaker Change: As we have managed the significant supply of Tim Garda and do not plan for significant further manufacturing expense in the near term.
Speaker Change: With continued modest net.
Speaker Change: On X revenue growth, we expect that we would turn profitable by the end of June 2025.
Speaker Change: I will now turn the call over to the operator to open the call for questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone in with your name to be announced until the <unk>. Your question. Please press star one again, please standby, while we compile the Q&A roster.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Our first question is going to come from the line of Maxim <unk> with Morgan Stanley. Your line is open. Please go ahead.
Speaker Change: Great. Thank you everyone.
Could you provide any additional color on the treatment EUA for Perm Garda, if you've received any feedback from the FDA and also.
Speaker Change: Reason I understand for pulling guidance, but what would give you confidence in providing guidance again should we expected.
Speaker Change: At the end of the year early next year, if you can walk us through the thought process there that'd be great. Thank you.
Speaker Change: Hey, Max Good morning, why don't I start this is Marc and then I'll see if anyone from inhibitor.
Speaker Change: Once to China, Firstly on the treatment EUA application.
Speaker Change: We have been in the process of updating it timely. This is a bridging analysis as defined by the FDA and so we have taken our opportunities as our virology has.
Speaker Change: Fault to update analytics and make sure that those analytics are in front of them.
Speaker Change: We've not heard anything.
Speaker Change: About it other than I think a general statement that.
Speaker Change: The FDA is aware of our perspective on all of these various issues and we'll be rendering some feedback and thoughts to us on that and a multiple of topics. Soon so we shall see and stay tuned.
Speaker Change: On the topic of confidence in guidance I think look.
Speaker Change: We are forced to project into the future when we project into the future we draw heavily on the recent past and I think if perm Garda revenue were to grow in a fashion consistent with the recent past inclusive.
Speaker Change: A very very difficult period in the late summer early fall, we feel very good about.
Speaker Change: About our prospects for meeting that and indeed.
Speaker Change: Of course, it involved two dimensions right the rate of revenue growth and our ability to manage our expenses, which is part of what bill was alluding to so I think in this case.
What we are indexed toward is that the guidance conception doesn't require some.
Speaker Change: <unk>.
Speaker Change: Bolus as it were of seasonally driven revenue it would now embrace the simple continuation of trend.
Speaker Change: <unk>.
Speaker Change: We obviously feel as though we have exited the majority of the period Embraer.
Speaker Change: Embracing confusion certainly on.
Speaker Change: The activity of <unk> against <unk> Dot one dot one and feel good about our ability to to drive from here forward and I guess just to add to that I would ask Tim to comment a little bit on what he has seen over recent weeks.
Tim Lee: Yes, Thank you Mark.
Tim Lee: I think we're very pleased with with the trend and the growth that we're seeing.
And I think that's all in light of the kind of the checklist that I presented.
Tim Lee: All of the things that we're doing right now up to and including bringing in.
Tim Lee: Our sales team increasing a digital presence.
Tim Lee: And.
Tim Lee: Working to increase access at independent infusion centers.
As well as academic infusion centers and integrated delivery networks.
So I think as I look at where we are.
Tim Lee: And the activities that we're putting into place right now.
Tim Lee: Yes, very very excited about what that will mean.
Speaker Change: Great. Thank you.
Speaker Change: Thank you and one moment as we move on to our next question.
Speaker Change: Our next question is going to come from the line of Michael Yee with Jefferies. Your line is open. Please go ahead.
Michael Yee: Hi, good morning, Thanks for the updates.
Michael Yee: Two questions on revenue can you help us understand while you expect steady growth for growth based on the metrics Youre disclosing.
Michael Yee: Talking about significant step wise increases month over month, when we're talking about modest growth.
Michael Yee: And to that extent.
Speaker Change: Does that change in the first quarter in the second quarter I think there's a perception of seasonality, but may be you think differently because of the population and whatnot. So help us understand the fourth quarter, and then what that looks like versus the second quarter.
Speaker Change: Then on the Opex.
Speaker Change: Of course, the natural question is.
Speaker Change: That has to change as well in order to hit profitability. So is that expected to be significant declines in R&D over the next few quarters, because I think what you said that you don't expect a significant manufacturing campaign. Thank you.
Speaker Change: Hi, Mike Good morning, and let me I'll ask.
Tim.
Tim Lee: Comment a little bit more on revenue and bill on Opex, but let me just start by saying what you might have read already in our in our <unk>.
Speaker Change: Press release is that we have begun the process already of modifying our base burn.
Tim Lee: And clearly.
Tim Lee: Areas on which we will not ever compromising indeed might allocate incremental spend would be our commercial presence.
R&D is a topic that has to by definition flex with what is occurring with the company clinically.
Tim Lee: We're coming off of canopy spend we are not yet arriving at a registrational spend for 2000, and 311 and as bill alluded to in the past we have expense manufacturing largely through R&D. So you would have seen organically or rather well.
Tim Lee: Would see organically anyway, some change in our overall burn we're simply looking to tightened that up and accelerate that reduction in burn, but but why don't I ask bill to comment a little bit further on that and then turn it over to Tim.
Speaker Change: Sure I think Marc highlighted the key points here with regards to manufacturing spend of course, we manufactured at risk a significant amount of temp Garda and prior to <unk> and then continued to produce <unk> Garda throughout this year at this point in time, we've substantially completed the manufacture.
Speaker Change: <unk> runs in the expenses associated with that which will not necessarily be repeated as we go forward in 2025, I think that's one of the most significant elements that you can look at from a reduction of spend.
With regards to 'twenty 311, and we have also.
Speaker Change: Continued veeva also done manufacturing for $23 11 in 2020 for those expenses have flowed through R&D expense for this year as that has not yet been some.
Speaker Change: Industry.
Speaker Change: So as a result as that winds down we will also seek relief to the P&L R&D as we go forward in 2025.
Speaker Change: Just other streamlined expenses of course, we are investing heavily in commercial we will continue to invest on the <unk>.
But that being said I think the largest thing that you can see is the drop on the R&D expense side.
Yes.
Speaker Change: Great Great question, I think as we look.
Speaker Change: At our recent activity.
Speaker Change: In Los Angeles.
Speaker Change: The conversations that we've had with the infectious disease.
Speaker Change: <unk> and their community as well as individual meetings.
Speaker Change: The seasonality is not.
Speaker Change: It's not a contract I think is something that.
Speaker Change: We're hearing even from some of the largest independent infusion networks across the country.
Speaker Change: People who serve.
Speaker Change: Those fighting.
Speaker Change: Answers and other.
Speaker Change: Other conditions I mentioned earlier and so as we look at the opportunity to serve this group it's seasonality it doesn't affect those people who are on different therapeutic regimens that will.
Speaker Change: Impact their immune system I think as we look at who our core.
Speaker Change: Is.
It is people who.
Speaker Change: Are fighting for their life because of cancer therapies because of organ transplant because of the <unk> stem cell transplants.
Speaker Change: And others.
Speaker Change: Those conditions and therapeutic regimens.
Speaker Change: Don't know seasonality I think protecting them is what we're we're gearing up towards and excited to say from a breadth and account utilization work. We're pleased with that our opportunity is to drive depth through increased access and thats. What the team has been one of the one of the many things on the checklist.
Speaker Change: I went through earlier that the team has been solely focused on it.
Speaker Change: Fighting for this community to have access to something that will protect them as I said from a.
Speaker Change: A virus that is.
Speaker Change: That is looking to cause systemic damage.
Speaker Change: It's probably worth my adding Mike just for clarification of all of our vocabulary right. We use terms like seasonal because there is a perception in the HCP community that infectious disease, and certainly respiratory infectious diseases have a quote season unquote and certainly back in the summer we were looking to take advantage of that.
Speaker Change: <unk> as we went to large scale COVID-19 disease Sars Cov, two is not seasonal at all.
Speaker Change: <unk> ever present, pervasive and presents with periodic waves right. The periodicity of the way or it might be biannual or tri annual or frankly, we may have yet to see what a true equilibrium looks like I think.
Speaker Change: A part of what Tim is getting at is that at the scale, we are reaching right now which in our view is very small.
Speaker Change: No that we would see any particular effect of seasonality because we are so early in our growth.
Speaker Change: But I think it's also fair to say that as we scale our business it would be natural and rational to have some relationship to at least periodicity and.
Speaker Change: While it may be confusing we may from time to time, and certainly hcp's and the vulnerable may referred to seasonality, but I think it's too early to worry or wonder about Q4 into Q1 I think the point that Tim is trying to convey is that from a growth standpoint, we feel so young and so early in our penetration into the highly vulnerable.
Speaker Change: Population I don't think we believe we've yet achieved the scale, where those kinds of dynamics will come to the fore, but we'll all have to find out together.
Speaker Change: Thank you.
Speaker Change: Thank you one moment our next question.
Speaker Change: Our next question is going to come from the line of Jason Kolbert with <unk> capital. Your line is open. Please go ahead.
Speaker Change: Good morning, Thank you very much.
Speaker Change: I saw the R&D number came in very high but it corresponds I'm sure almost one to one with the inventory build which showed up on the balance sheet.
Speaker Change: <unk> is what is the what is the commercial value of that inventory on the balance sheet. It's obviously substantially higher than what you are carrying out.
Speaker Change: I guess bill can comment a little bit in general I don't think we want to get into the level of specifics that would reveal sort of temporary net pricing by implication, but let's just say it. This way in vivid has produced or is ramping up production of well in excess of one hundreds of millions of dollars.
Speaker Change: Of product inventory in revenue terms and.
Speaker Change: The accounting of that.
Speaker Change: I think will flow through in the coming quarters as diminish spending.
Speaker Change: Bill would you add anything to that no I think thats very well stated.
Speaker Change: The reason for that.
Speaker Change: Discrepancy between markets that are good for the market value and what we're carrying it is don't forget that we expense.
Speaker Change: Most of <unk> direct costs prior to EUA.
Speaker Change: The granting of the EUA so costs that were incurred as we lead up to the EUA.
Speaker Change: To the point that those inventory amounts have not yet been sold group remained on our balance sheet. So.
Speaker Change: That's a piece of why the discrepancy between our inventory balance on the balance sheet and what the market external value would be.
Speaker Change: Those inventory amongst our sell through.
Speaker Change: Thank you very much.
Speaker Change: Wanted to ask you kind of a probing question. When you look at how to engineer a moat more potent next generation Formula Perm Garda.
Speaker Change: And even potentially moving from IV to I am more sub Q.
Speaker Change: What are your scientifically has to do how do you make those changes can you give us some insights into your process.
Speaker Change: Yes.
Speaker Change: Look this is mark Youre Bad luck is that Oh wait actually Ravi is logging. So he will be able to rapidly clean up whatever I tell you that he feels is off base, but but the reality is we've already done that work and it's well manifested in our next generation molecule BYD 23, 11, right, which is in its first in human study.
Speaker Change: Right now.
Speaker Change: What we effectively do is avail ourselves of a vast combinatorial library that can interrogate spike.
Speaker Change: Spike protein and <unk>.
Speaker Change: Offer up hits almost in the manner of if youre familiar with small molecule chemistry screening right and so we can select antibodies with enhanced biophysical properties by screening combinatorial libraries against Spike protein that is let's say more and more contemporary and in doing that what we.
Speaker Change: Discover is that we are able to.
Speaker Change: Substantially enhance our potency.
Speaker Change: With very modest changes to the overall.
Speaker Change: Structural identity of <unk>, and which is indeed itself not so so different structurally than that in terms of about so you might even think of it as a process of directly the molecular honing in which we are continuing to interrogate what appears to be a pretty enriched.
Speaker Change: Site on on the Spike.
Speaker Change: Sure.
Speaker Change: Which should not be surprising given the foundational hypothesis of the company right that there are these territories on spike that are essential for <unk> to access and therefore are central for viral fitness and we wish to exploit that via monoclonal antibody now that is easier said than done and involves a lot of technological.
Speaker Change: Tricks and sort of.
Speaker Change: Trade secret as it were in our approach other companies do not have access to those sorts of technology stacks and approaches so we feel.
Speaker Change: We are proud of having done this work now on our third cut but.
To the extent that glossed over in simplistic terms.
Speaker Change: Feel free to follow up with Ravi or Raleigh by all means correct.
Speaker Change: Yes.
Speaker Change: I think that the description that you provide.
Speaker Change: Embraces.
The answer to the question that was asked definitely in terms of how we go about doing this the one thing I will add is that we are equipped in the laboratory to.
Speaker Change: To do this.
Speaker Change: At any time and we do it all the time.
Speaker Change: So we are constantly updating our working knowledge of how antibodies are acting against current variance and looking into future space using the technologies that we have to assure ourselves of antibodies will maintain activity to meet the target product profile that we've described and enabled.
Speaker Change: <unk>.
And we will enable through two or three one morning on so hopefully that helps with your with your question.
Speaker Change: You actually answered my follow on question, which is it sounds like the platform is going to ultimately show utility beyond time Gordon Covid.
Speaker Change: Yes, I think that particularly in situations, where we have dynamic targets.
Speaker Change: They have conventionally required.
Speaker Change: Great deal of.
Speaker Change: Our periodic vaccine effort or even though monoclonal antibody effort.
Speaker Change: We have an ability to address those types of targets that as that was borne out through the work we've done in COVID-19. So that's very true.
Great update thanks, so much everybody.
Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one one moment our next question.
Speaker Change: Our next question comes from the line of Patrick <unk> with H C. Wainwright. Your line is open. Please go ahead.
Speaker Change: Good morning team this is luis spending for Patrick.
Speaker Change: I would like to ask a follow up question also on <unk> 311 regarding the regulatory authorization paths and lessons learned so.
Speaker Change: Would there be.
Speaker Change: Will there be a need for separate trials for treatment and prevention.
Speaker Change: Based on with regard to fast track would would it would there be a possibility that <unk> could be approved for both treatment and prevention I'm, just thinking about and if so if there is an accelerated path forward for <unk> and then I have follow up questions.
Speaker Change: Thanks.
Speaker Change: So the short answer is.
Speaker Change: Stay tuned and these are topics are active consideration certainly at our end and we believe at FDA as well it's important to remember.
Speaker Change: That.
Speaker Change: The treatment EUA application discussed and submitted.
Speaker Change: In collaboration with the FDA Indeed drew upon the same clinical data generated for our prep authorization right at some level.
Speaker Change: And SG&A tighter is an SPN a tighter conferred by a given antibody and.
Speaker Change: And vivek benefits from prior work with that Intrepid Mab, which generated strong data from randomized controlled studies demonstrating.
Speaker Change: Hi, clinical efficacy in the context of both.
Speaker Change: Treatment and prep and indeed, those those clinical benefit signals, where conferred by the identical antibody at the identical dose in the identical route of administration. So we feel very confident scientifically that our work with <unk> and certainly our work with <unk> hundred 11 represents the dips.
Speaker Change: Climate clinically.
Speaker Change: Very attractive.
Speaker Change: Anti viral titers, and you sort of step back and ask yourself, how controversial a concept could this even being pharmaceuticals right. I don't think there are many people left on Earth, who wonder whether or not having some measure of antiviral activity either when you are worried about encountering via.
Speaker Change: Roland ocular out in the community or when you are experienced an active infection.
Speaker Change: I think we universally regarded that as a good thing.
Speaker Change: So I think.
Speaker Change: We're in the business of passive prophylaxis with novel monoclonal antibodies generally and we would eagerly await to be in the business.
Speaker Change: Treatment of active Sars cov, two infection, particularly among immuno compromised persons in an outpatient context.
Speaker Change: We believe we can do those things now because we make novel antibodies I think it is also safe to say that we and the FDA would jointly wished to assess the safety of these molecules in a reasonable and some of that data. We have previously press released as a function of our discussions with FDA.
Speaker Change: And having done those things.
Speaker Change: We would look at the operative science and think to ourselves well my goodness. If we are bridging to predicate antibodies or if we are availing ourselves of more general concepts like a correlated protection some of which you can read hot off the presses. This morning in the New England Journal of Medicine.
Speaker Change: There are.
Speaker Change: Surrogates, which is of course, the classical strategy for advancing rapid drug development and authorizations <unk> approvals and so I think what pens on $23 11.
Speaker Change: As we are currently gathering our in vivo first in human experience, we wish to assess safety and in vivo pharmacokinetics in operative.
Speaker Change: Human subjects through a variety of routes of administration and then we will very much look forward to discussing.
Those data with the FDA and.
Mark Alia: Dialogue on how much residual uncertainty really remains in the category I guess I'll pause there and ask market. If you can add anything to that no. No. I mean, it was it was well said I mean, I think that we enjoyed as you've mentioned we enjoy the fact that.
Mark Alia: The immuno bridging concept that was employed for for prevention is also directly.
Speaker Change: Able to be extrapolated to the treatment paradigm as well. So it really is one effectively as you can imagine exposure study getting PK levels as well as tighter levels and employing that versus the relevant variance at the time to make sure that our monoclonal antibody has protection across.
Speaker Change: The current as well as what they.
Speaker Change: Our embedded tools within invigorate, our future the future variant landscape.
Speaker Change: That makes a lot of sense and regarding the follow.
Speaker Change: Follow up question was will.
Speaker Change: This decision for potential treatment and prevention.
Speaker Change: Rapid approval will that depend on discussions on the tightest threshold in other words.
If the.
Speaker Change: The path to approval in say prevention.
Speaker Change: Each has a very high convincing compelling tighter threshold then maybe you can.
Speaker Change: We're confident about.
Speaker Change: Men approval rapid approval in treatment as well.
Speaker Change: And when can we have.
Speaker Change: When do you expect to have that finished readout for titers.
Speaker Change: Great.
Speaker Change: Mark can add some detail, but I think.
We are in the process of course of doing the clinical work required to generate that profile in human subjects right now with 23 11 as it goes to tighter levels and confidence.
Speaker Change: I think our confidence is more or less unwavering for now about two and a half years right. So.
Speaker Change: Employees previously published.
Speaker Change: <unk> relationship in science translational medicine, showing antibody efficacy in a prep context down to very low titers and you would've seen us very recently reminding.
Speaker Change: Ourselves and indeed, the world and I think the FDA, but that concept is generalizable.
Speaker Change: And I think we believe evergreen across all Sars cov, two variance because we see that relationship.
Speaker Change: Pete itself and our long term canopy follow up.
Speaker Change: So.
There is an aspect to the residual uncertainty here in which any reasonable person can say with some anti viral titer is good more is always better. The challenge of course is that that's not necessarily the pathway to an equitable scalable.
Speaker Change: Sure.
Speaker Change: Category of Medicine, right. So if we have a.
Speaker Change: Yeah.
Speaker Change: Our hunger problems. This Thanksgiving I can solve it by getting you a good meal or I can try to solve it by asking you to sit in <unk> III turkeys, you will be full and potentially satisfied either way the latter strategy, which is the strategy of seeking a very high dose and a very high titer.
Speaker Change: May be.
Speaker Change: Leave a little bit to be desired in terms of the scalability and advisability of that strategy. So I think our view would be.
Speaker Change: Knowing the $23 11 is at least as we see it a turn maybe a good turn more potent than <unk>.
Would be to assess the pharmacokinetic profile and see how long of a half life, we have calculate those titers and.
Speaker Change: Really reflect those titers against the totality of evidence that we've seen so far right. So the <unk> immuno bridging pathway to a data point drawn from the <unk> study that is one data point and I think a total of 12 clinical observations from the year 2021.
Speaker Change: We now have a wealth of data, including data from our contemporary context, and frankly, we're looking forward to someday seeing a publication of the Astrazeneca Supernovas study because that may have a little more context. In addition to our canopy data that says hey in a modern context. This relationship continues to hold we can we believe because.
We're using such high affinity highly potent engineered recombinant antibodies, we can generate attractive clinical protection we believe.
Speaker Change: At relatively low titers, our goal as a company is not too.
Serve at an extraordinary tighter a small number of people or a relatively smaller number of people. Our goal as a company is to democratize protection by conferring an appropriate amount of tighter to the largest possible number of people because if you go back to the beginning right.
Our intention is and vivid was never to create a niche or sort of orphan drug.
Speaker Change: Drug for a virus that is so pervasive and damaging so.
Speaker Change: I guess each observers mileage may vary when it comes to understanding and reflecting on the totality of clinical data generated to date, but I think from an <unk> perspective, we feel very good about the potential benefit we can bring and are eager to scale protection to the map.
Speaker Change: Some number of people.
Speaker Change: So that makes sense. Thank you that makes them want them.
Speaker Change: Absolutely. Thank you.
Speaker Change: Thank you and I would now like to hand, the conference back over to Mark and Leah for closing remarks.
Mark: Alright, thanks, everybody for joining us today and indeed it is.
Speaker Change: An opportunity to reflect on what we hope is been a very unusual period in our corporate history. We are available all day for questions and answers and again, we will just get ourselves back to the business of trying to.
Speaker Change: Grow our core business and.
Speaker Change: Scale protection as fast as we can to as many people as we can thanks again bye bye.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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Speaker Change: Good day and thank you for standing by welcome to the Q3 2024 and visit earnings Conference call at this time all participants.
Speaker Change: Are in a listen only mode. After the speaker's presentation, there will be a question and answer session to ask a question. During this session you will need to press star one on your telephone.
Katie <unk>: Inherent nanometer message advising you your hand, just raced to withdraw your question. Please press star. One again. Please be advised today's conference is being recorded I would now like to hand, the conference over to your speaker today, Katie <unk> Senior Vice President of Finance. Please go ahead.
Katie <unk>: Thank you operator, a short while ago, we issued a press release announcing our Q3 2024 financial results and recent business highlights.
Katie <unk>: That press release and the slides that are being used on today's webcast can be found in the investors section at the end of its website under the press release and Investor presentation sections, respectively.
Speaker Change: Today's discussion will be led by Marc <unk> Chairman of embedded board of director and Chairman of the Executive Committee of Court is joined by Kim Lee Chief Commercial Officer, Belgium, Chief Financial Officer, Dr. Robert Allen Chief Scientific Officer.
Speaker Change: And Dr Mark <unk>.
Speaker Change: Senior Vice President of clinical development and medical Affairs.
Speaker Change: During today's discussion, we will be making forward looking statements concerning among other things our corporate and commercial strategy.
Speaker Change: Research and development activities.
Speaker Change: Regulatory plan certain financial guidance, our future prospects and other statements that are not historical facts.
Speaker Change: 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.
Speaker Change: These forward looking statements speak only as of the date of this call and as evidenced Theres no duty to update such statements additional information on the risk factors that could affect <unk> business can be found in our filings made.
Mark: 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.
Good morning, and thank you for joining us.
Mark Alia: Third quarter was marked by a promising start and then an unusual commercial headwind that Nvidia has been managing through.
This headwind is rooted in the academic virology complex the U S FDA and unfortunately as a result reached hcp's and vulnerable populations that can benefit from more protection from symptomatic COVID-19.
Speaker Change: As a reminder, inhibitors discovered developed and is now commercializing a monoclonal antibody against Sars koby to.
This virus is now in its endemic phase following a pandemic that range through the immunologically naive human population, but now innocent msas still causes shocking quantity of death illness, and long term damage, even among the young and healthy while the backbone of population health for COVID-19 remains vaccine boosters contemporary data from <unk>.
Speaker Change: CDC very consistently reveals the limitations of vaccine boost in terms of the level of protective efficacy. It boosts can achieve in a human already experienced immunologically from prior vaccination or infection.
Speaker Change: These limits are universal among humans, although the immuno compromised population, who may receive less benefit due to an inadequate immune response to vaccines are more variable are more vulnerable and bearing even greater burden requiring additional protection.
Speaker Change: Fortunately and vivid has conducted randomized clinical studies on monoclonal antibodies in both the pandemic phase and now the modern endemic phase of Sars Cov, two and the results are unambiguous a monoclonal antibody can render a major step change in protective efficacy against symptomatic COVID-19 compared to placebo.
Speaker Change: Unlike modern vaccine boost epidemiologic studies, which reveal about a 40% to 50% reduction in the likelihood of a COVID-19 related hospital stay or urgent care visits for about 60 days after which benefit fades rapidly exploratory efficacy data on <unk> from our canopy phase III clinical trial demonstrated in an.
Speaker Change: Immuno competent population and 80% to 90% reduction in the risk of getting symptomatic COVID-19 in the first place.
Speaker Change: Over twice dosing during the six months period.
Speaker Change: And visited recently shared long term follow up data from canopy, showing that indeed robust protection remains even at low residual drug levels.
Speaker Change: After a six after six months following cessation of dosing consistent with prior publications and indeed, consistent with our overall corporate thesis for scaled monoclonal antibody protection as potential low doses and attractive routes of administration.
Speaker Change: Against this backdrop remained Sars cov, two virus genetic variation a source of fascination and consternation for the academic and regulatory communities and a major focus of our work internally at exhibit.
Speaker Change: <unk> two is displayed remarkable genetic mutability and there exists a substantial cottage industry devoted to describing and considering those mutations from.
From an <unk> point of view as a pharmaceutical company variation is why we have made a major investment in technology designed to understand and address that variation and why do we select the molecules, we select with barriers to resistance in mind.
Speaker Change: We're all incredibly proud that so far in debit stands alone in both attempting in accomplishing this goal and the contemporary context of a post <unk> era utilizing rapid approval pathways in concert with FDA.
<unk> long standing and continue to antiviral activity to date is a remarkable scientific accomplishment and one we are eager to repeat with an improved drug profile.
Speaker Change: Alas applied virology is an inexact science all the more exact outside of an industrial highly controlled context and there are many labs globally that seeks to understand our molecules using processes and systems of unknown quality and reagents of unknown characteristics.
Speaker Change: One of those systems and labs has presented an unusual headwind the cast doubt on the activity of our molecule against contemporary lineages, notably <unk> Dot one dot one observations made at Columbia University over the summer and into the fall.
Speaker Change: <unk> Dot one dot one susceptibility to out made its way into the U S. FDA and disappointingly the agency broadcast decked out into the HCP and vulnerable populations by not just factsheet updates, but also E mail blast in tweet or whatever tweaks are called now while the Perm Garden Factsheet was corrected in late September with robust neutralization.
Speaker Change: Data generated through exhibits industrial virology effort <unk> opportunity to drive utilization in the late third quarter and into the fourth quarter infectious disease season was badly damaged.
Speaker Change: And if it has been seeking to repair this digitally end market up to and including news today in which the New England Journal of Medicine has published not just a letter to the editor from envision.
But also a second piece from this laboratory describing their neutralization results against our lab made antibody, which had to be corrected at the 11th hour by Newland Journal as you can see online.
Speaker Change: Please now describes research grade unquote under the bark, which is a critical and sadly late emerged distinction.
Speaker Change: Turning to the Newland Journal medicines correction it was implied that authentic <unk> manufactured by debit was used in these systems.
Speaker Change: <unk> is a science based company and therefore has a deep respect for the scientific process, but we are also in the business of trying to save lives and believed that the researchers and regulators considering scientific claims are to exert real caution in making claims about authorized medicines for human use on the basis of a rapidly emerging science that may lack appropriate rigor and.
Speaker Change: Great control.
Tim Lee: Meanwhile, in visit remains working to drive awareness of our medicine. Among hcp's that we believed disrupts disease pathogenesis and has been shown to protect vulnerable Americans who are in need of protection against symptomatic COVID-19, Tim.
Tim Lee: Tim Lee our Chief commercial officer will describe our ongoing efforts and are thinking about building. This important category of medicines and our SVP of clinical development and medical Affairs, Mark Wintertime, we'll touch on recent cannot be data points the way to scaling our work far beyond what we can do with <unk> as an intravenous medications.
More generally our great hope it inhibitors that these recent events, our strong and consistent data.
Tim Lee: Upcoming government transition can all presents an opportunity for regulators to consider an impressive and growing totality of data that shows quite clearly one.
Tim Lee: The test boost treat paradigm championed by the current administration is having ended the pandemic unquote has left behind the extraordinary ongoing human misery.
Tim Lee: Two monoclonal antibody protection, especially when deployed in the contemporary human population on top of immune experience for vaccination of infection can be a substantial unlock in terms of high levels of protection from symptomatic disease itself.
Tim Lee: Great.
Tim Lee: <unk>, that's low serum virus neutralizing antibody titers has now been demonstrated by monoclonal antibodies in both the pandemic and modern endemic phase of Sars Cov, two and such data can be leveraged to make products that would look and feel rather like a vaccine for example, intramuscular or similarly convenient administration.
Tim Lee: But which could be distinguished by high efficacy and durable equitable protection, all without forcing human subjects to encounter the Sars cov two despite approach in vaccine form and experience associated reacted Unisys <unk>.
Tim Lee: And for companies like <unk> have been and remain prepared to action. These initiatives as soon as key governmental stakeholders array.
Speaker Change: Despite the extraordinary recent circumstances surrounding this company and our ongoing Perm Garda launch we've been gratified to see our recent return to product growth. We are pleased with the durability of <unk> in our next generation antibody <unk> 'twenty $3 11 in the face of virus variation.
Speaker Change: And we stand prepared to radically scaled the impact of our work near term.
Mark Alia: With that I will turn the call over to Mark <unk> Senior Vice President of clinical development and medical Affairs.
Mark Alia: Thank you Mark we can turn our attention to slide six.
Mark Alia: Efficacy results from the immuno competent or from the ongoing 12 month canopy study as well as the major COVID-19, various waves during that time are depicted on the current slide as.
Mark Alia: As you may recall that cannot be study is an ongoing 12 month clinical study designed to evaluate safety tolerability and efficacy of <unk> for pre exposure prophylaxis of COVID-19 in adults, aged 18 years and older.
Mark Alia: Persist participants receive two doses of <unk> infused 90 days apart and then were followed through month 12. The study was conducted from fall 2023 through winter of 2020 for making this study one of the few if only COVID-19 studies conducted in the contemporary population.
Mark Alia: Over the entire one year period, an impressive rate of relative risk reduction from symptomatic COVID-19 was observed with <unk> versus placebo strong protection was observed with <unk> Garda over multiple variant waves and limited lineages of Sars Covid two not only during the active dosing period, but also during the <unk>.
Mark Alia: Six month follow up washout period.
Mark Alia: During the active treatment period, and 84% relative risk reduction from confirmed symptomatic COVID-19 versus placebo was observed in the immuno competent arm of canopy also known as cohort B a.
Mark Alia: A substantial degree of protection remained over months seven to 12 after cessation of drug during a K P. Dot three in K P. Dot <unk> dot one dot one way with an overall, 76% relative risk reduction versus placebo observed in this cohort over the full 12 months reassure.
Mark Alia: Reassuringly the safety profile for <unk> remained consistent with the Perm Guard a factory.
Mark Alia: The strong protection observed during the washout period is particularly impressive given the low residual tighter levels and while there are no head to head trials. We believe that protection can follow from fewer doses of antibody then the doses of vaccine boost that would be required to get protection for immuno compromised persons who are.
Mark Alia: Unlikely to Mount an adequate immune response to the COVID-19 vaccine.
Mark Alia: If we turn our attention to slide eight.
Mark Alia: And take a look at our pipeline as you know we've identified <unk> 2311 via affinity maturation of a bit of a barred against SPV lineage viruses in an effort to improve on the biophysical properties, including in vitro measured potency.
Mark Alia: Potency improvements in measured IC <unk> for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SG&A tighter.
Mark Alia: Pharmacodynamic variable that drives protection and efficacy for a COVID-19 antibody. These lower doses may in turn allow for the development of routes of administration that are more patient and system friendly than intravenous approaches.
Mark Alia: The first in human study with BYD 2311 began at the end of August and as interrogating intravenous intramuscular subcutaneous dosing to provide flexibility and optionality optionality for achieving titers from one antibody could.
Mark Alia: Could be suitable for both COVID-19 prevention as well as treatment.
Mark Alia: We are currently assessing authorization pathways and plan to discuss.
In light of the canopy 12 month clinical efficacy and safety data with regulators and look forward to reviewing our progress with BYD 2311 at our next earnings call I will now turn the call over to Tim Lee, Our Chief Commercial Officer Tim.
Tim Lee: Thank you Mark and good morning.
Tim Lee: Turning to slide 10.
Tim Lee: The third quarter began commercial transformation.
Speaker Change: My first full quarter, and David and I am excited to share some of the foundational work that we've built.
Speaker Change: The immuno compromised community.
Speaker Change: I came to inhibit because of our mission to serve people who are immunocompromised.
Speaker Change: This committee is made up of fighters people, who are battling cancer people have received an organ transplant for bone marrow transplant.
Speaker Change: Primary immunodeficiency advanced HIV and are actively being treated with high dose course corticosteroids.
Speaker Change: These are all conditions that can lead people to being vulnerable to an opportunistic virus that causes systemic damage.
Speaker Change: And it's why in 2024, approximately every nine minutes a person in the U S dice with COVID-19.
Speaker Change: COVID-19 continues to be the leading cause of hospitalization and death from respiratory infection in the United States.
Speaker Change: Protecting this community is a noble mission.
Speaker Change: And I am proud to be a part of it.
Speaker Change: Turning to slide 11.
Speaker Change: Data from the CDC shows that ICU admissions for all Americans are greater this season.
Speaker Change: Then last one.
Clearly demonstrating that <unk> continues to have a lasting impact.
Speaker Change: Turning to slide 12.
Speaker Change: You can see that COVID-19 can cause systemic damage with no organ system spared from its impact.
Speaker Change: Turning to slide 13.
Speaker Change: It is what the immuno compromised community in mind.
Speaker Change: And we are building our commercialization plans.
Speaker Change: We fought through real headwinds through the month of September as the Perm Garden back sheet was updated to include reference to third party data.
Speaker Change: Was not reflective of some gardens continued neutralization activity for the immunocompromised community as Mark noted.
Clinicians and patients more importantly were confused by these data.
Speaker Change: Putting this behind US we are focused on our mission to serve the immuno compromised community at scale.
Speaker Change: We're partnering with community independent in infusion centers.
Speaker Change: Along with academic centers and integrated delivery networks.
Speaker Change: Increased sites of care for this community.
Speaker Change: We're developing a digital presence and recently conducted our first speaker program during the week in Los Angeles.
Speaker Change: We're bringing the sales team from a contract field force to direct hire.
Speaker Change: And believe it's the right decision to serve this community.
Speaker Change: We believe now is the right time to restructure this team and it will better serve our future growth.
We're excited to be investing in patient support programs to ensure there's a smooth access for patients who are prescribed <unk>.
Speaker Change: We're investing in field reimbursement management team and building a federal accounts team.
With a focus on immuno compromised veterans and their families.
Speaker Change: We also added an inside sales team with a focus on rheumatology.
Speaker Change: And are impressed by the early results.
Speaker Change: Turning to slide 14.
Speaker Change: Those actions.
Speaker Change: Along with as you can see growth across all launch metrics are positioning us to serve the appropriate immuno compromised community at a larger scale.
Speaker Change: With that I'd like to turn the call over to our Chief Financial Officer.
Speaker Change: For final remarks prior to the Q&A.
Speaker Change: Thank you Tim.
Turning to slide 16.
Speaker Change: As you may have seen at the end of October we pre released our Q3 results, including garden net product revenue of $9 3 million in Q3 2024.
Speaker Change: In September ending cash of approximately $107 million.
Speaker Change: Which is consistent with the results reported this morning.
Speaker Change: Further we noted that we expect to finish 2024 with $65 million or more in cash and cash equivalents.
At the same time, we withdrew the guidance of $150 million to $200 million of net product revenue and we guided to earlier this year, citing recent.
Speaker Change: Headwinds from U S. FDA late Q3, 2020 for warranty on potential for substantially reduced activity.
Speaker Change: Through the Pilbara factsheet and other media based on a contested third party preprint, reflecting biologic activity data from a non commit right antibody.
Speaker Change: As has been noted.
Speaker Change: As Tim mentioned, we are excited about <unk> potential to reach appropriate immune compromised patients.
As such we are targeting near term profitability with existing cash and cash equivalents anticipated growth of net product revenue and various operational efficiency improvements underway.
Speaker Change: The good news is that we.
Speaker Change: <unk>.
Speaker Change: Previously recorded as research and development expense, a significant amount of inventory in preparation for the emergency use authorization submission.
Speaker Change: As we have managed the significant supply of Tim Garda and do not plan for significant further manufacturing expense in the near term.
With continued modest net.
Speaker Change: On X revenue growth, we expect that we would turn profitable by the end of June 2025.
Speaker Change: I will now turn the call over to the operator to open the call for questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced <unk>. Your question. Please press star one again, please standby, while we compile the Q&A roster.
Speaker Change: Okay.
Sure.
Our first question is going to come from the line of Maxwell will work with Morgan Stanley. Your line is open. Please go ahead.
Speaker Change: Great. Thank you everyone.
Speaker Change: Could you provide any additional color on the treatment EUA for Perm Garda, if you've received any feedback from the FDA and also.
Speaker Change: Reason I understand for pulling guidance, but what would give you confidence in providing guidance again should we expected.
Speaker Change: At the end of the year early next year, if you can walk us through the thought process there that'd be great. Thank you.
Speaker Change: Hey, Max Good morning, why don't I start this is Marc and then I'll see if anyone from inhibitor.
Speaker Change: Wants to chime in firstly on the treatment EUA application.
Speaker Change: We have been in the process of updating it timely. This is a bridging analysis as defined by the FDA and so we have taken our opportunities as our virology has.
Speaker Change: Fault to update analytics and make sure that those analytics are in front of them.
Speaker Change: We've not heard anything.
Speaker Change: About it other than I think a general statement that.
Speaker Change: The FDA is aware of our perspective on all of these various issues and we'll be rendering some feedback and thoughts to us on that and a multiple of topics. Soon so we shall see and stay tuned.
Speaker Change: On the topic of confidence in guidance I think look.
Speaker Change: We are forced to project into the future when we project into the future we draw heavily on the recent past and I think if perm Garda revenue were to grow in a fashion consistent with the recent past inclusive.
A very very difficult period in the late summer early fall, we feel very good about.
Speaker Change: About our prospects for meeting that and indeed.
Speaker Change: Of course, it involves two dimensions right the rate of revenue growth and our ability to manage our expenses, which is part of what bill was alluding to so I think in this case.
What we are indexed toward is that the guidance conception doesn't require some.
<unk>.
Bolus as it were of seasonally driven revenue it would now embrace the simple continuation of trend.
Speaker Change: <unk>.
Speaker Change: We obviously feel as though we have exited the majority of the period Embraer.
Embracing confusion certainly on.
Speaker Change: The activity of <unk> against <unk> Dot one dot one and feel good about our ability to to drive from here forward and I guess just.
To add to that I would ask Tim to comment a little bit on what he has seen over recent weeks.
Tim Lee: Yes, Thank you Mark.
I think we're very pleased with with the trend and the growth that we're seeing.
Tim Lee: And I think that's all in light of the kind of the checklist that I presented.
Tim Lee: All of the things that we're doing right now.
Tim Lee: Including bringing in.
Tim Lee: Our sales team increasing a digital presence.
Tim Lee: And.
Working to increase access at independent infusion centers.
Tim Lee: As well as academic infusion centers integrated delivery networks.
Tim Lee: So I think as I look at where we are.
Tim Lee: And the activities that we're putting into place right now.
Tim Lee: Yes, very very excited about what that will mean.
Speaker Change: Great. Thank you.
Thank you and one moment as we move on to our next question.
Speaker Change: Our next question is going to come from the line of Michael Yee with Jefferies. Your line is open. Please go ahead.
Michael Yee: Hi, good morning, Thanks for the updates.
Michael Yee: Two questions on revenue can you help us understand while you expect steady growth for growth based on the metrics Youre disclosing.
Speaker Change: Talking about significant step wise increases month over month, or we're talking about modest growth.
Speaker Change: And to that extent, how does that change in the first quarter in the second quarter I think there's a perception of seasonality, but may be you think differently because of the population and whatnot. So help us understand the fourth quarter and then what that looks like versus the second quarter and then on the Opex.
Speaker Change: Of course, the natural question is.
Speaker Change: That has to change as well in order to hit profitability. So is that expected to be significant declines in R&D over the next few quarters, because I think what you said was that you don't expect a significant manufacturing campaign. Thank you.
Speaker Change: Hi, Mike Good morning, and let me I'll ask.
Tim.
Speaker Change: Comment a little bit more on revenue and bill on Opex, but let me just start by saying.
Speaker Change: What you might have read already and are in our.
Speaker Change: Press release is that we have begun the process already of <unk>.
Speaker Change: Modifying our base burn.
Speaker Change: And clearly those areas on which we will not ever compromise and indeed might allocate incremental spend would be our commercial presence.
Speaker Change: R&D is a topic that has to by definition.
Speaker Change: Next with what is occurring with the company clinically.
Speaker Change: We're coming off of canopy spend we are not yet arriving at a registrational spend for 2000, and 311 and as bill alluded to in the past we have expensed manufacturing largely through R&D. So you would have seen organically or rather well.
Speaker Change: Well, we'll see organically anyway, some change in our overall burn we're simply looking to tighten that up and accelerate that reduction in burn, but why don't I ask bill to comment a little bit further on that and then turn it over to attempt.
Bill: Sure I think Marc highlighted the key points here with regards to manufacturing spend of course, we manufactured at risk a significant amount of time Garda and prior to <unk> and then continued to produce 10 Garda throughout this year at this point in time, we've substantially completed the manufacturing run.
Bill: <unk> and the expenses associated with that which will not necessarily be repeated as we go forward in 2025, I think thats one of the most significant elements that you can look at from a reduction of spend.
Bill: With regards to 'twenty 311, and we have also.
Bill: Continued veeva also done manufacturing for $23 11 in 2020 for those expenses have flowed through R&D expense for this year as that has not yet been submitted for you. So as a result as that winds down we will also seek relief to the P&L R&D as we go forward.
In 2025.
Other streamlined expenses of course, we are investing heavily in commercial we will continue to invest on the commercial but that being said I think the largest thing that you can see is the drop on the R&D expense side.
Bill: Yes.
Bill: Great Great question, I think as we look.
Bill: At our recent activity IP week in Los Angeles.
Bill: And the conversations that we've had with the infectious disease clinicians.
Bill: Clinicians in their community.
Bill: As well as individual meetings.
Bill: Sure.
Bill: The seasonality is not.
Bill: It's not a contract I think is something that we.
Bill: We're hearing even from some of the largest independent infusion networks across the country.
Bill: People, who serve those fighting.
Bill: Cancers.
In other.
Bill: Other conditions.
Bill: Mentioned earlier and so as we look at the opportunity to serve this great seasonality it doesn't affect those people who are on <unk>.
Bill: Bridge therapeutic regimens that will.
Bill: Impact their immune system I think as we look at who our core is.
Bill: Is.
Bill: It is people who.
We are fighting for their life because of cancer therapies because of organ transplant because of the <unk> stem cell transplants.
And others.
Bill: Those conditions and therapeutic regimens still don't know seasonality I think protecting them as what work, we're gearing up towards and excited to say from a breadth and account utilization work. We're pleased with that our opportunity is to drive depth through increased access and that's what the team has been.
Bill: One of the one of the many things on the checklist.
Bill: I went through earlier that the team has been solely focused on yes.
Bill: Yes. He is fighting for this community to have access to something that will protect them as I said from a.
Bill: A virus that is that.
Bill: That is looking to cause systemic damage.
Speaker Change: It's probably worth my adding Mike just for clarification of all of our vocabulary right. We use terms like seasonal because there is a perception in the HCP community that infectious disease, and certainly respiratory infectious diseases have.
Speaker Change: Season, Unquote, and certainly back in the summer we were looking to take advantage of that dynamic as we went to large scale COVID-19 disease Sars Cov two is not seasonal at all.
Speaker Change: Ever present, pervasive and presents with periodic waves right. The periodicity of the way or it might be biannual or triangle or frankly, we may have yet to see what a true equilibrium looks like I think.
Speaker Change: A part of what Tim is getting at is that at the scale, we are reaching right now which in our view is very small.
Speaker Change: No that we would see any particular effect of seasonality because we are so early in our growth.
Speaker Change: But I think it's also fair to say that as we scale the business it would be natural and rational to have some relationship to at least periodicity and.
Speaker Change: While it may be confusing we may from time to time, and certainly hcp's and the vulnerable may referred to seasonality, but I think it's too early to worry or wonder about Q4 into Q1 I think the point that Tim is trying to convey is that from a growth standpoint, we feel so young and so early in our penetration into the highly vulnerable.
Speaker Change: Population I don't think we believe we've yet achieved the scale, where those kinds of dynamics will come to the fore, but we'll all have to find out together.
Speaker Change: Thank you.
Thank you one moment our next question.
Speaker Change: Our next question is going to come from the line of Jason Kolbert with <unk> capital. Your line is open. Please go ahead.
Speaker Change: Good morning, Thank you very much.
I saw the R&D number came in very high but it corresponds I'm sure almost one to one with the inventory build which showed up on the balance sheet.
Speaker Change: What is the real what is the commercial value of that inventory on the balance sheet. It's obviously substantially higher than what you are carrying out.
I guess bill can comment a little bit in general I don't think we want to get into the level of specifics that would reveal sort of temporary net pricing by implication, but let's just say it. This way in vivid has produced or is wrapping up production of well in excess of one hundreds of millions of dollars.
Speaker Change: Product.
Speaker Change: Inventory in revenue terms and.
Speaker Change: The accounting of that.
Speaker Change: It will flow through in the coming quarters as diminished spending.
Speaker Change: Bill would you.
Speaker Change: Add anything to that no I think thats very well stated part of the reason for that.
Speaker Change: Discrepancy between markets that are good for the market value and what we're carrying it is don't forget that we expense.
Speaker Change: A large amount of pen garlic costs prior to EUA granting.
Speaker Change: Granting of the EUA, so costs that were incurred as we lead up to the EUA.
Speaker Change: To the point that those inventory amounts have not yet been sold group remained on our balance sheet. So.
Speaker Change: That's a piece of why the discrepancy between our inventory balance on the balance sheet and what the market external value would be.
Speaker Change: Those inventory amongst our sell through.
Speaker Change #100: Thank you very much and I just wanted to ask you kind of are probing question. When you look at how to engineer a moat more potent or next generation formula Perm Garda.
And even potentially moving from IV to I am more sub Q.
Speaker Change #100: What are your scientifically have to do how do you make those changes can you give us some insights into your process.
Speaker Change #100: Yes.
Mark Alia: Look this is mark Youre Bad luck is that a way of actually Ravi is logging. So he will be able to rapidly clean up whatever I tell you that he feels is off base, but but the reality is we've already done that work and it's well manifested in our next generation molecule BYD 23, 11, right, which is in its first in here.
Mark Alia: <unk> study right now.
Mark Alia: What we effectively do is avail ourselves of a vast combinatorial library that can interrogate.
Mark Alia: Spike protein and <unk>.
Mark Alia: <unk> hits almost in the manner of if youre familiar with small molecule chemistry screening right and so we can select antibodies with enhanced biophysical properties by screening combinatorial libraries against Spike protein that is let's say more and more contemporary and in doing that what we do.
Discover is that we are able to.
Substantially enhance our potency.
Mark Alia: With very modest changes to the overall.
Structural identity of <unk>, and which is indeed itself not socio different structurally than that in <unk>. So you might even think of it as a process of directed the molecular honing in which we are continuing to interrogate what appears to be a pretty enriched.
Mark Alia: Site on on the Spike.
Mark Alia: Which should not be surprising given the foundational hypothesis of the company right that there are these territories on spike that are essential for <unk> to access and therefore are central for viral fitness and we wish to exploit that via monoclonal antibody now that is easier said than done and involves a lot of tech.
Mark Alia: The logical tricks and sort of.
Trade secret as it were in our approach other companies do not have access to those sorts of technology stacks and approaches so we feel.
Mark Alia: Particularly proud of having done this work now on our third cut but.
Mark Alia: To the extent that I have glossed over in simplistic terms feel.
<unk> free to follow up with Ravi or Ravi by all means correct.
Mark Alia: Yes.
Mark Alia: I think that the description that you provide.
Mark Alia: Embraces.
The answer to the question that was asked definitely in terms of how we go about doing this the one thing I will add is that we are equipped in the laboratory to.
Mark Alia: To do this.
Mark Alia: At any time and we do it all the time.
And so we are constantly updating our working knowledge of how antibodies are acting against current variance and looking into future space using the technologies that we have to assure ourselves of antibodies will maintain activity to meet the target product profile that we've described and enabled.
Fruit from Garda.
Mark Alia: And will enable through two or three one morning on so hopefully that helps with your with your question.
Speaker Change #101: You actually answered my follow on question, which is it sounds like the platform is going to ultimately show utility beyond time Garden Covid.
Speaker Change #102: Yes, I think that particularly in situations, where we have dynamic targets.
Speaker Change #102: That have conventionally required.
Speaker Change #102: Great deal of a.
Speaker Change #102: A periodic vaccine effort or even though monoclonal antibody effort.
Speaker Change #102: We have an ability to address those types of targets that is.
Speaker Change #102: <unk> out through the work we've done in Covid.
Speaker Change #102: That's very true.
Speaker Change #103: Great update thanks, so much everybody.
Speaker Change #103: Thank you as a reminder, if you would like to ask a question. Please press star 111 moment for our next question.
Speaker Change #104: Our next question comes from the line of Patrick <unk> with H C. Wainwright. Your line is open. Please go ahead.
Speaker Change #105: Good morning team this is luis spending for Patrick.
Speaker Change #105: I would like to ask a follow up question also on <unk> need 2311 regarding the regulatory authorization paths and lessons learned so.
Would there be.
Speaker Change #105: Will there be a need for separate trials for treatment health prevention or based on with regard to fast track what it would there be a possibility that <unk> could be approved for both treatment and prevention I'm, just thinking about and if so if theres an accelerated path forward for <unk> and then I haven't.
Speaker Change #105: Question.
Speaker Change #105: Thanks.
Speaker Change #105: The short answer is.
Stay tuned and these are topics are active consideration certainly at our end and we believe at FDA as well it's important to remember.
Speaker Change #105: The treatment EUA application discussed and submitted.
Speaker Change #105: In collaboration with the FDA Indeed drew upon the same clinical data generated for our prep authorization right.
Speaker Change #106: Some level.
Speaker Change #106: And SPN, a tighter is an SPN a tighter conferred by a given antibody and <unk>.
Speaker Change #106: <unk> benefits from prior work with that Intrepid, Mab, which generated strong data from randomized controlled studies demonstrating.
Speaker Change #106: Hi, clinical efficacy in the context of both.
Speaker Change #106: Treatment and prep and indeed, those those clinical benefit signals, where conferred by the identical antibody.
Speaker Change #106: Identical dose in the identical route of administration. So we feel very confident scientifically that our work with <unk> and certainly our work with $23 11 represents the deployment.
Speaker Change #106: Clinically <unk>.
Speaker Change #106: Very attractive anti viral titers.
And you sort of step back and ask yourself.
Speaker Change #106: How controversial concept could this even be pharmaceuticals, right I don't think there are many people left on Earth, who wonder whether or not having some measure of antiviral activity either when you are worried about encountering viral inoculum out in the community or when you are experienced an active infection.
Speaker Change #106: <unk>.
Speaker Change #106: I think we universally regarded that as a good day.
So I think.
Speaker Change #106: We're in the business of passive prophylaxis with novel monoclonal antibodies generally and we would.
Speaker Change #106: Equally away to be in the business of treatment of active Sars cov, two infection, particularly among immunocompromised persons in an outpatient context.
Speaker Change #106: We believe we can do those things now because we make novel antibodies I think it is also safe to say that we and the FDA would jointly wish to assess the safety of these molecules in a reasonable and some of that data. We have previously press released as a function of our discussions with FDA.
And having done those things we would look at the operative science and think to ourselves well my goodness. If we are bridging to predicate antibodies or if we are availing ourselves of more general concepts like a correlated protection some of which you can read hot off the presses. This morning in the New England Journal of Medicine.
Speaker Change #106: There are.
Surrogates, which is of course, the classical strategy for advancing rapid drug development and authorizations <unk> approvals and so I think what pens.
Speaker Change #106: On 23 11.
Speaker Change #106: As we are currently gathering our in vivo first in human experience, we wish to assess safety and in vivo pharmacokinetics in operative.
Human subjects through a variety of routes of administration and then we will very much look forward to discussing.
Speaker Change #106: Those data with the FDA and in effect dialogue ing on how much residual uncertainty really remains.
Mark Alia: In the category I guess I'll pause there and ask market. If you can add anything to that no no.
Speaker Change #107: Well said I mean, I think that we enjoy that as you've mentioned, we enjoy the fact that.
The immuno bridging concept that was employed for prevention is also directly.
Speaker Change #107: To be extrapolated to the treatment paradigm as well so it really is one effectively as you can imagine exposure study getting PK levels as well as tighter levels and employing that versus the relevant variance at the time to make sure that our.
Speaker Change #107: Monoclonal antibody has protection across.
Speaker Change #107: The current as well as with our embedded tools within invigorate, our future the future variant landscape.
Speaker Change #108: That makes a lot of sense and regarding the.
Speaker Change #108: Follow up question. It was will this decision for potential treatment and prevention.
Rapid approval will that depend on discussions on the tightest threshold in other words if.
Speaker Change #108: The path to approval in say prevention beaches, very high convincing compelling tighter threshold then maybe you can.
Speaker Change #108: Are you more confident about.
Men approval rapid approval in treatment as well.
Speaker Change #109: When can we have when do you expect to have that finished readout for titers.
Speaker Change #110: Great. So again, Mark Mark can add some detail, but I think.
Speaker Change #110: We are in the process of course of doing the clinical work required to generate that profile in human subjects right now 23 11.
Speaker Change #110: It goes to tighter levels and confidence.
Speaker Change #110: I think our confidence is more or less unwavering for now about two and a half years right. So.
Speaker Change #110: Dividend play as previously published.
Speaker Change #110: Lovely relationship in science translational medicine, showing antibody efficacy in a prep context down to very low titers and you would've seen us very recently reminding.
Speaker Change #110: Ourselves and indeed, the world and I think the FDA, but that concept is generalizable.
Speaker Change #110: I think we believe evergreen across all Sars cov, two variance because we see that relationship.
Speaker Change #110: <unk> itself and our long term cannot be follow up.
Speaker Change #110: So.
Speaker Change #110: There is an aspect to the residual uncertainty here in which any reasonable person can say with some anti viral titer is good more is always better. The challenge of course is that that's not necessarily the pathway to an equitable scalable.
Speaker Change #110: Yes.
Speaker Change #110: Category of Medicine, right. So if we have a.
Speaker Change #110: Yeah.
Speaker Change #110: Our hunger problems. This Thanksgiving I can solve it by getting you a good meal or I can try to solve it by asking you to sit in <unk> III turkeys you will.
Speaker Change #110: I'll be full and potentially satisfied either way the ladder strategy, which is the strategy of seeking a very high dose and a very high titer.
Speaker Change #110: May.
Speaker Change #110: Leave a little bit to be desired in terms of the scalability and advisability of that strategy. So I think I'll review would be.
Speaker Change #110: Knowing the 'twenty 311 is at least as we see a turn maybe a good turn more potent than <unk>.
Speaker Change #110: Would be to assess the pharmacokinetic profile see how long of a half life, we have calculate those titers and.
Speaker Change #110: Really reflect those titers against the totality of evidence that we've seen so far right. So the <unk> immuno bridging pathway to a data point drawn from the <unk> study that is one data point and I think a total of 12 clinical observations from the year 2021.
Speaker Change #110: We now have a wealth of data, including data from our contemporary context, and frankly, we're looking forward to someday seeing publication of the Astrazeneca Supernovas study because that may have a little more context. In addition to our canopy data that says hey in a modern context. This relationship continues to hold we can we believe because.
Speaker Change #110: We are using such high affinity highly potent engineered recombinant antibodies, we can generate attractive clinical protection we believe.
Speaker Change #110: At relatively low titers, our goal as a company is not too.
Speaker Change #110: Serve at an extraordinary tighter a small number of people or a relatively smaller number of people. Our goal as a company is to democratize protection by conferring an appropriate amount of tighter to the largest possible number of people because if you go back to the beginning right.
Our intention is and vivid was never to create a niche or sort of orphan.
Speaker Change #110: Drug for a virus that is so pervasive and damaging so.
Speaker Change #110: I guess each observers mileage may vary when it comes to understanding and reflecting on the totality of clinical data generated to date, but I think from an <unk> perspective, we feel very good about the potential benefit we can bring and are eager to scale protection to the map.
Speaker Change #110: Some number of people.
That makes sense. Thank you that makes them want them.
Speaker Change #111: Absolutely. Thank you.
Speaker Change #112: Thank you and I would now like to hand, the conference back over to Mark <unk> for closing remarks.
Alright, thanks, Thanks, everybody for joining us today and indeed it is.
Speaker Change #112: An opportunity to reflect on what we hope is been a very unusual period in our corporate history. We are available all day for questions and answers and again, we'll just get ourselves back to the business.
Speaker Change #112: Trying to.
Grow our core business and.
Speaker Change #112: Scale protection as fast as we can to as many people as we can thanks again bye bye.
Speaker Change #113: This concludes today's conference call. Thank you for participating you may now disconnect.