Q1 2022 Eiger BioPharmaceuticals Inc Earnings Call
Good day, and good day, ladies and gentlemen, and welcome to the idea of bio Pharmaceuticals first quarter two.
Financial results and business update conference call at this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
If anyone should require operator assistance. Please press Star then zero on your telephone.
Minder this call will be recorded I would now like to introduce Sarah Matheson Senior Vice President of corporate that's where the Tiger you may begin.
Thank you good afternoon, everyone and thank you for joining US today welcome to our quarterly financial results and business update call. We issued a press release earlier. This afternoon that our Q1 financial results, which is also available on our website at <unk> com.
For today's call, we will have prepared remarks from the management team followed by Q&A, we will use slides for the webcast.
A replay will be available on the investor section of our website.
Joining me on the call with prepared remarks, David Cohen, President and CEO , Sri reality, Chief Financial Officer, Eldon Mayer, Chief Commercial Officer, and Doctor Ingrid Chung Senior Vice President clinical development. We also have subject matter experts from our team Dr. Colin Hislop and Dr. Colleen Craig available for Q&A.
Before we begin I would like to remind investors that this call will include forward looking statements, including expectations concerning financial performance commercial products and potential future products in different therapeutic areas.
Pages of development. The forward looking statements rely on certain assumptions and involve risks and uncertainties beyond <unk> control, which could cause our actual results could differ materially.
These risks and uncertainties is contained in <unk> filings with the SEC, including our latest 10-K and 10-Q report available on the IR website in investors section.
Forward looking statements are based on information currently available to either and we assume no obligation to update these statements.
I'll now turn the call over to Dave.
Thanks Sarah.
These are very exciting times for <unk>, we are making significant advances across our pipeline, while strengthening the foundation of our business and expanding our leadership to support future growth as we believe that 2022 will be a transformational year for the company.
I'll begin with our most recent news and progress on our Peg interferon Lambda program for COVID-19.
Since we announced positive topline results from the Phase III together study in March our team has been focused on preparing our emergency use authorization application.
This is a priority milestone for us to make lambda available to the healthcare community, which remains in need of more effective therapeutic options to help vulnerable COVID-19 patients.
We are pleased with our ongoing engagement with FDA and look forward to submitting the EUA application.
We are excited by the progress and advancement of Lambda for COVID-19.
Which essentially has been a program driven by investigators in both phase II and phase III as we focus our internal efforts on Lambda for hepatitis Delta virus infection.
Leveraging investigator sponsored studies has enabled us to generate potentially registration, enabling data from a large clinical study in a highly capital efficient way we.
We expect to file our EUA application this quarter.
Exact timing will of course be contingent on when we receive the full together dataset, but based on our current discussions and our state of preparedness. We believe it is appropriate to expect the filing by the end of this quarter.
As a reminder, this is the second largest clinical study of a COVID-19 therapeutic with data from over 1900 patients predominantly vaccinated and across a range of Sars koby to variance.
Final review of this extensive and robust dataset is nearing completion and we intend to communicate the full analysis at the time of our EUA submission.
In terms of commercial readiness, we have launch quantities to support the introduction of Lambda should the FDA Grant emergency use authorization and we are actively planning for expanded production capacity.
As we continue to see new variance across the globe. It is clear that COVID-19 is far from over especially for vulnerable patient populations together demonstrated that despite widespread vaccination. There continues to be significant risk for morbidity and mortality from COVID-19.
The recent surge of COVID-19 infections in China, Hong Kong, and Europe highlight the ongoing and global threat of this pandemic and the need for an effective convenient therapeutic we believe peg interferon Lambda represents an effective one and done therapeutic that is potentially agnostic to the arising.
<unk> landscape of COVID-19, and that if authorized will be an important addition to the evolving armamentarium of COVID-19 therapeutics.
In addition to the exciting news from our COVID-19 program, we continued to execute on our HDD platform Mana Barnet and Lambda both in phase III with HDD affecting over 12 million people worldwide, the health care and economic burden as enormous.
As first in class therapies to treat and potentially cure. This devastating disease. We believe both of our product candidates offer opportunities for significant long term value creation.
Hepatitis Delta commercial opportunity in the U S and Europe is estimated to be more than 1 billion Ingrid.
Ingrid will provide more details on our continued progress in both phase III programs shortly.
Turning now to <unk> as we announced last week, we are advancing of extra tied into a phase III Registrational program for congenital hyperinsulinism by the end of this year our team as obtained alignment with FDA on the phase III clinical program.
Recently published Phase II results from our partners at children's Hospital of Philadelphia provide important foundational data that support proof of concept in this patient population, which gives us great confidence moving forward.
<unk> has been granted FDA breakthrough therapy designation and rare pediatric disease designation, making it eligible for a priority review voucher. Upon approval. Most importantly, <unk> has the potential to transform the lives of children born with this life threatening condition.
A key part of <unk> growth strategy is to advance clinical programs for underserved patients and a capital and resource efficient manner I believe our track record of effectively collaborating with investigators and institutions to provide early research and development support has demonstrated our ability to advance our pipeline.
In a fiscally disciplined manner.
I am encouraged to see our strategy is proving successful through the following examples.
Our landmark phase III deliver study in HDD is based on phase II proof of concept clinical trial work performed at the National Institutes of Health FTE.
FDA approval of <unk> can be the first treatment for progeria is the result of our partnership with the Progeria Research Foundation.
Our phase III of <unk> congenital hyperinsulinism program builds on Phase II research conducted at children's hospital of Philadelphia and of course, our pending EUA submission of Lambda for COVID-19 reflects our strong collaboration with Dr. <unk> joined Bel in phase III and that together study team in phase III.
This approach has been instrumental in supporting our ability to deliver on our mission to develop molecules into medicines for patients who need them. The most.
I am proud of our continued progress here, which is testament to our team's focus and commitment to this mission.
In summary, we entered this year with a clear operational plan for growth advancing our pipeline expanding commercial reach for Zoe can be and strengthening the foundation of our business to prepare for the future.
We've made progress against all of these objectives with a first quarter of solid execution and are in a strong position to deliver wins for patients and create value for our shareholders I will now hand, the call over to Ingrid to review our development progress.
Thanks, David starting with our COVID-19 clinical development program, we reported in March that together study met its primary endpoint with a 50% reduction in risk of COVID-19 related hospitalizations or emergency room visits importantly, this primary endpoint was achieved in a patient population that included.
Multiple variance and was predominantly vaccinated.
In the ever changing COVID-19 landscape. We believe these data reflect a generalizable as effects of Lambda in a real world population.
Together also demonstrated that earlier intervention with Lambda improves outcomes.
As stated the risk reduction in hospitalizations or ER visits was 50% in patients treated within seven days of symptom onset.
This improved to 67% in patients treated within three days of symptoms.
Perhaps more importantly, and this high risk population lambda reduce the risk of hospitalization or death by 60% among those receiving treatment within three days of symptoms.
All of these outcomes are demonstrated with superiority over placebo, which given the predominantly vaccinated population is extremely encouraging.
Adverse events were primarily injection site reactions with incidents indistinguishable between Lambda and placebo groups.
Concurrent with our top line data announcement in March we submitted a pre EUA request to FDA, our first opportunity to socialize the study and top line data with the agency.
We have continued to engage positively and are preparing to submit our complete EUA application this quarter.
<unk> is a large study of almost 2000 patients which provides many opportunities for sub analysis of the patient population.
But together study team is completing a comprehensive analysis of the full dataset, which will include sub analyses for variance and vaccination status.
In addition final kinetics will be collected or Sars COVID-19 two levels will be quantified at zero $3 seven.
This will be important not only to assess the correlation of viral clearance and clinical outcomes, but also to determine the effects of lambda on viral clearance an important indicator of carbon community spread.
As David said, we plan to share the full data analysis and host an investor call at the time of our EUA submission.
Turning now to our hepatitis Delta platform.
We're on track to report topline data from our phase III deliver study of two loan appointment based regimens by end of this year.
With 407 patients enrolled across 116 clinical trial sites and over 22 countries deliver as a landmark study.
It will generate the single largest source of HCV patient data from a well controlled clinical trial to better understand and characterize this devastating disease and if positive. These data will support global regulatory filings.
During our March call, we provided an update on the impact of Russia, Ukraine conflict on deliver.
And our continued monitoring of the situation, we have not seen an operational impact to date in Russia. However.
However, we are prepared with contingency plans to ensure continuity of drug supply as well as collection storage and analysis of lab samples.
As we previously communicated deliver remains more than adequately powered to demonstrate superiority on the primary endpoint, even if patients from Ukraine discontinue from study.
We are advancing our second therapy for HDD peg interferon Lambda and the phase III limit to study currently enrolling and dosing patients.
The primary endpoint of limited to as a durable Virologic response, which was previously demonstrated in phase two.
This post treatment endpoint is most meaningful for regulatory agencies and physicians as it demonstrates the durability of response to a finite therapy and potential for an HDD cure.
We also believe that Lambda Tolerability profile will make it the interferon of choice for physicians and patients leading to better compliance and improved outcomes.
Our strategic approach is to first seek regulatory approvals of <unk> based regimens based on the results of the deliver study we.
We will quickly follow with data from limit to which if positive could lead to approval of Lambda for HDD.
We believe this approach provides the most expeditious route to approval for both <unk> and Lambda.
In parallel we're generating data through the lift two study, which we believe will support the future use of our proprietary combination of Luna part of Atlanta for hepatitis Delta infection.
I'll now turn the call over to Eldon.
And then Greg I'll give a brief overview of our commercial business in the U S and a summary of our preparations in Europe .
We reported $2 $7 million and so it can be net sales in the first quarter in the US Importantly, we're pleased to have converted 80% of the identified U S patients to commercially reimbursed supply with 100% payer reimbursement coverage.
Our patient support center, we establish known as either one care has facilitated an efficient U S launch of <unk>.
Terry Gohl Avago wound care is unencumbered patient access as can be and this program has delivered continuous access to our innovative therapy with zero out of pocket costs for all patients.
With a <unk> opinion expected this quarter, we are actively preparing for launch in Europe , where there are approximately 20 identified patients.
Over half of these patients are currently receiving that can be either through <unk> early access programs or clinical trials, which we believe will drive an efficient commercial launch.
In preparation for launch we have established the appropriate infrastructure for successful commercialization across the EU, including distribution and patient support services. Once we receive full EMA marketing authorization, we will negotiate reimbursement country by country.
We are engaged actively with health care providers, managing progeria patients as well as with reimbursement authorities and local payers.
We've been encouraged by the positive response to that can be from physicians in France as part of our reimbursed early access program and look forward to bringing that can be to market across Europe to further support patients to need this.
This is an important milestone both for either and the progeria community I'll now.
Ill hand, the call over to <unk> for financial update.
Okay. Thanks Holden the press release, we issued this afternoon and included a financial update and I'll call out a few highlights here.
As Albert noted first quarter, there can be net sales were $2 $7 million.
This compares to $3 6 million reported during the same period last year.
As a reminder, we launched though can be in the U S. January 2021, and first quarter 2021 sales included the initial inventory build after specialty pharmacy.
Turning to our first quarter 2022, GAAP operating expenses cost of sales was approximately <unk> 1 million R&D expenses were $17 6 million and reflect an accrual of a $5 million milestone expense to BMS related to our phase III limit to study of Lambda for HBV.
SG&A expenses were $6 8 million for the quarter.
We reported a first quarter net loss of $22 6 million or <unk> 64 on a per share basis.
David noted a key part of our growth strategy is to advance innovative clinical programs for underserved patients and capital and resource efficient manner to continue to practice disciplined expense management and maintain a strong balance sheet that provides operating flexibility.
Our pro forma cash cash equivalents and investments were approximately $153 $5 million.
Accordingly.
<unk> either with a very strong balance sheet ahead of deliver top line data expected by end of this year, we anticipate our strengthened cash position will fund our planned operations into the fourth quarter of 2024 and allow us to advance our core HDD programs to registration as well as the phase III of expertise congenital hyperinsulinism.
Graham.
I'll now hand, the call back to David factory.
This is proving to be a pivotal year for either as we execute on clinical milestones to propel our pipeline forward leverage our commercial capabilities to expand our reach for Zoe can be and strengthen our business for the future the.
The compelling data from the together study have put us on a path to submit an EUA for COVID-19 later this quarter and we are committed to making lambda as widely available as possible to physicians and patients.
We have strong momentum in our HDD platform with phase III deliver topline data plan by end of year, the phase III limit Tuesday of Lambda enrolling patients and the phase III lift two study of <unk> of Atlanta combination initiating soon.
And we continue to execute across the rest of our rare disease pipeline, we expect a see HMP opinion on our Zoe Kennedy marketing authorization application. This quarter and are excited to start our <unk> phase III congenital hyperinsulinism program by end of year.
As we prepare for significant milestones this year and position ourselves for sustained growth, we are expanding and strengthening our infrastructure and team, including at the leadership level, We recently announced two new executive hires.
<unk> Technical officer, and a senior Vice President of corporate affairs, both of whom bring a wealth of global biopharmaceutical experience to <unk>.
At this point I'd like to thank our dedicated <unk> team for their relentless efforts across our programs and thank all of you for joining us today on this call operator, please provide instructions for the Q&A portion.
Thank you ladies and gentlemen, if you have a question at this time, please press the star and <unk>.
One.
And then the one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press <unk>.
You asked me, what's your limit yourself to one question and one follow up.
One moment for our questions.
Our first question comes from Maury Raycroft from Jefferies. Your line is open.
Hi, This is Jane Amanda.
Good morning Flying My question. Thanks for taking my questions. My question is for the EIA has FDA, giving you any sense of the window is still open.
Exactly.
Looking for in the food.
D'etats and then is there any concern about the lack of patient representative from U S.
Thank you.
Thanks, James I. Appreciate your question and good to have you on the call today I will turn to your questions over to Ingrid Chung Ingrid.
Yes hygiene, yes, we are actively engaged with the agency on our EUA application and we've been very pleased with our interactions to date and are confident that we can support this quarter regarding our dialogue with the agency they have not indicated any issues.
Regarding the together study being in a single country.
As you know this is a very large data set where we can generate a very comprehensive set of data with a lot of sub analyses and we think the agency will be looking forward to be reviewing this data.
In addition to the Brazil sites. We also have included data from a site in Toronto, Canada, followed the same protocol as the pivotal study.
So.
Include North American patients as well.
Yes, just to summarize Jane we're very confident in the data set and were confident we could submit by end of quarter and look forward to communicating further.
Okay that sounds good so I have one just to clarify.
Clarify question.
Together data will need to be published or do you need to.
Just a completed the analysis to submit that to the agents.
Ingrid.
Thanks, Yes, so our plan is to complete the secondary analysis.
All of it in totality and the FDA concurrent with that we will submit a manuscript that will include all of that data as well.
Okay. Thank you so much thanks for taking my question again.
Thank you.
Thank you. Our next question comes from the line of a.
Not some of it's from Citi. Your line is open.
Hi, Tim This is Oscar Cabrera on for Yigal, Thanks for taking my questions and congrats on all the progress how are you thinking about the timeline for the review period for you and maybe a potential timeline for an approval decision.
In terms of the gating factors for the <unk> I know you are completing the analysis, but can you be a little more granular in terms of what.
What's in the analysis in terms of those viral kinetics and maybe other biomarker analysis.
Will that also include stratification for variance and so on.
Sure So and thanks for your question I'll begin with regard to what.
What we're thinking we can't speak to how long the FDA will take to review and application was submitted we know that the longest integral we're aware of between application and approval was roughly three months and Thats merck's mildly peer there.
Importantly, we believe that together dataset are robust and compelling and represent a real world patient population thats highly generalizable to the U S and so we're excited and working very quickly as a priority to submit this EUA and I'll turn the second part of the question to Ingrid Yes.
Regarding your second question regarding what types of additional analysis will be included as you know this is a very large data set of almost 2000 patients and so there's many opportunities for sub analyses. So as mentioned earlier, we plan to conduct.
Primary endpoint looking at it across variance as well as different vaccination status regarding viral kinetics, because we are running plants koby quantification at 387, we will be able to look at viral load decline in viral load clearance and be able to look at correlation.
Two clinical outcomes, but more importantly, just to look at viral clearance since that is an indicator of community spread and Thats something that we believe the agency will be interested in the team.
Okay, great. Thanks for all of that maybe just one more I'll switch gears to <unk>.
It seems like you have some clarity on the plan for development.
You published some some nice looking Dave up.
Recently.
I had two questions one with the recast you just raised I think you alluded to this in your prepared comments, but do you feel confident about the ability to complete.
Our phase III study and maybe any detail details to share on the size and scope of that study.
Sure I'll, let Sri comment beyond the cash question. We're very pleased to have a strong cash position that we reported and that runway that we've guided to including cash sufficient to fund planned operations into Q4, 2020 does contemplate <unk> phase III congenital hyperinsulinism program.
And then your second part was related to study design and I'll, let Colleen Craig comment as much as we're able at this point Colin Thanks, David Yes, So we have not yet disclosed regarding the study design and endpoints.
However, what I can say at this point is that 3% to eight breakthrough therapy pathway, we had the benefit of working closely and collaboratively with FDA.
On study design and endpoints and we're aligned on an efficient program and we look forward to initiating this year.
Okay, great. Thank you so much for.
Answering my questions.
Thank you.
Thank you. Our next question comes from the line of Bert Hazlett from <unk>. Your line is open.
Yes, Mike Congrats and excuse me. Thank you for taking the questions as well.
Just a couple of.
One is with regard to financials could you remind us you mentioned a $5 million Dms could you remind us of any other potential milestones that are available to BMS with regard to Lambda program.
And then.
As you think about SG&A.
Would you expect them would you expect to increase SG&A materially.
Based on maybe a sales force increase.
With regard to advancement either with the UA.
Or with the <unk>.
EU with regard it so it can be.
Thanks.
Sure I'll pass that to Shri <unk> nice to hear you. Thanks for your question with regard to the BMS milestone of $5 million that we accrued this quarter was related to the.
The phase III limit to study have landed for HDD, we do have additional milestones payable to BMS, we haven't communicated specifically what those are just the aggregate amounts.
With.
We get closer to that next milestone for Lambda, we will provide more specific details with respect to SG&A.
Do not see a need to buildup SG&A to support an EUA. What we have communicated is that an EUA would set the stage for either too.
Supply purchases to agencies like BARDA, which is how we initially see.
Progressing which is what other therapeutics that have received EUA is have done as well. So we don't we do not contemplate an increase in SG&A on that front.
Okay terrific I had a follow up actually with regard to manufacturing David you're right.
Comments at the outset.
You actually mentioned actively planning for more production I think could you just give us a little more color there with regard to Lambda.
Yes sure.
The value of developing Lambda for hepatitis Delta virus infection is separate and distinct however in that path. We've run registration batches for Lam that preparing for an HDD BLA filing.
And in parallel also had opportunities to consider the pandemic and how land that might be made available on a global basis clearly the together data are compelling and based on that.
We're making plans and considering different pathways certainly to ensure that the numbers of Lambda manufacturing.
Meet our global demand in the future, but that said it's important to note. Our priority right. Now is focused on getting the EUA application filed and getting that authorization and then look forward to obviously, providing additional updates thereafter on next steps.
Okay. Thanks, I'll get back in the queue. Thank you. Thank.
Thank you.
Yes.
Thank you. Your next question comes from the line of Bryan Garnier from Baird. Your line is open.
Hi, This is Luke Harman on for Brian Thanks for taking our questions just.
Just a couple on the HIV program. So first of all you haven't disclosed total granularity on the phase III design can you comment on whether it's the design is to support a subpart H or full approval and as well as be the length of the safety follow up do you think youll need.
Yes so.
Lou for for listening and for your question we have communicated.
<unk> communicated that we're very excited now to have concurrence with FDA on a phase III program for <unk> in congenital hyperinsulinism and obviously the fact that <unk> is the only therapeutic in this space that has been granted breakthrough therapy designation as well as rare pediatric disease.
Designation, it's given us an opportunity we believe to accelerate and finalized discussions on our phase III program that being said, we've not communicated any specifics on study design or plans. Yet. However, we will plan to do that in the future.
Great and then just one on the backs of <unk>.
Is there any reason to think that the <unk>, one agonist approach might be differentiated from competitive assets, which.
Claim to operate downstream of beta cells or is this just the situation where you can let the data speak for itself.
So so.
I'll begin and then pass it to Dr. Colleen Craig the reason that we advanced of Exenatide and congenital hyperinsulinism is because we clearly believe there is a mechanistic differentiation versus anything else in the field and I'll, let choline expand on that thanks, David Yes. So thanks for the question.
There are several aspects that make a exit heightened uniquely suited for treatment of HIV and I'll just touch on <unk> and you mentioned that relate firstly as a first in class <unk> receptor antagonist FX.
<unk> represents a uniquely targeted therapeutic approach and exit <unk> upstream of the dis regulated secretion of insulin and that point you mentioned Thats correct.
And this had been shown to significantly lower insulin secretion, which is unique to <unk>.
And to prevent tasking and induced hypoglycemia and so in this way of exit 10.
Equally represents a preventive treatment for HIV.
Thing that I'd, just like to take a moment to touch on is that in Mexico.
And delivery is a subcutaneous injection.
Patient population.
It's something worth highlighting this is sherry practical pain and delivering two in particular.
<unk> patients.
It does not require a wearable device such as a continuum.
And does not require oral intake, which in this patient population in particular new units.
But also in patients with feeding intolerance.
Challenges.
We believe this route of administration.
Demand for this patient population and the last thing that I'll just point out is that an expedited is to date the only program in development for.
For HIV has been granted breakthrough therapy designation.
And we believe this speaks to the strength of the safety and efficacy data on clinically important endpoints.
Thanks Colin.
Is that mix.
That answer your question, yes. Thank you.
You're very welcome.
Thank you. Your next question comes from the line of Michael Higgins from Ladenburg Thalmann. Your line is open.
Thanks, operator, thanks, guys for taking the questions just a follow up on <unk> earlier regarding manufacturing post numbers to use authorization.
Just to put a scenario out there assuming approval this fall at which at this point seems likely.
How much timing do you think would be required before you would have enough to supply ex U S pretty tough question to answer without having the.
Those approvals on those requests coming in from ex U S, but just trying to get a sense for.
How much you're able to put out of the market, possibly later this year and then into.
Next year. Thanks.
I'll turn that question to Sri Thank you, Michael Hey, Michael Thanks for the question.
We have communicated is that we will have 300000 doses of Lambda available for initial launch quantities available for health care practitioners and patients and while we haven't provided specific specific numbers on what we can do in subsequent years within our existing manufacturing capacity for HDD.
As David indicated we are looking at opportunities to expand production. We have also previously communicated that we think our partnership our collaboration can help us scale up manufacturing is expand the global reach of window for COVID-19 outside the U S and together data help catalyze those discussions and as we move towards an EUA.
We think that'll be a gating event to further those discussions.
Okay. That's helpful.
We'll wait and see as long as you've got a call coming up in a month or so here.
Switching to of Exenatide I'm not hearing much on PVH to give us an update as to where it stands with that with that indication.
Sure Michael and we have been very thoughtful and very strategic about of exit tide.
For both congenital hyperinsulinism and also post bariatric hypoglycemia, we believe both of these indications are high unmet medical needs and that <unk> will be a targeted therapeutic for both of these patient populations again, we seek to succeed first in <unk>.
Most and we believe that beginning with congenital hyperinsulinism is an appropriate way to begin we like to believe that we are fiscally disciplined and also operationally and execution really disciplined and we want to ensure success in congenital hyperinsulinism, but clearly our thinking about postpaid.
<unk> hypoglycemia as a commercial.
Opportunity and importantly, an unmet medical need for underserved population in this case PVH and look forward to providing additional updates in the future.
Just a brief follow up on that are you, suggesting there would be a start for the phase III pushed into the start of 2023.
No no not at all for PVH only that we Brian to begin we plan to begin phase III for congenital hyperinsulinism this year and while we clearly value of extra tide.
For both congenital hyperinsulinism and post very accurate hypoglycemia, we believe that.
A disciplined approach is to begin with congenital hyperinsulinism.
Again, just to remind you we believe.
We will likely be.
Potentially an opportunity for a another priority review voucher upon approval.
Post bariatric hypoglycemia is also a major unmet medical need we believe of <unk> may be able to fill that need and we'll look forward to providing guidance in the future on how we move forward.
Okay Super helpful and real quick sorry.
Restocking in Q1 since Q1.
If you can comment there if you've seen any.
Normalization inventory channels. Thanks.
Yes, maybe I'll ask elderly to address that on the commercial front.
Sure, Yes during Q1 channel inventory.
<unk>.
Within normal ranges of eight to 10 weeks.
Specifically it did decline by about 20 bottles.
Going from 99 at the end of Q4 to 79 bottles to be to be precise at the end of Q1. However.
That is within the normal range, which for a low volume disease. Like this does fluctuate and we expect that to be within the 80 to 100 bottle range So very normal.
Sounds like Youre, suggesting that it's normalizing.
The quarter.
Yes.
I appreciate that thanks, guys.
Thank you.
Thank you again, if you have a question. Please press star and then one key on your Touchtone telephone.
I'm not showing any further questions I would now like to turn the call back to David <unk> for any further remarks. Thank.
Thank you very much and thanks to everyone for joining us today on this earnings call as <unk> heard we have a very busy year ahead with many value, creating milestones and we have the team we have the resources and the focus to deliver against all of these I look forward to providing future updates on our progress across all of our.
Grams, including near term updates on our Lambda COVID-19, EUA submission and we thank you again for joining us today have a great day.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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