EIGR (2022 - Q1)

Good day, ladies and gentlemen, and welcome to the Eiger BioPharmaceuticals First Quarter 2022 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. [Operator Instructions] As a reminder, this call will be recorded. I would now like to introduce Sarah Mathieson, Senior Vice President of Corporate Affairs at Eiger. You may begin. Sarah Ma

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 with our Q1 financial results, which is also available on our website at eigerbio.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 and a replay will be available on the Investors section of our website. Joining me on the call with prepared remarks are David Cory, President and CEO; Sri Ryali, Chief Financial Officer; Eldon Mayer, Chief Commercial Officer; and Dr. Ingrid Choong Senior Vice President of Clinical Development. We also have subject matter experts on 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 and stages of development. The forward-looking statements rely on certain assumptions and involve risks and uncertainties beyond Eiger's control, which could cause our actual results to differ materially. A description of these risks and uncertainties is contained in Eiger’s filings with the SEC including our latest 10-K and 10-Q reports available on the Eiger website in the Investors Section. All forward-looking statements are based on information currently available to Eiger and we assume no obligation to update these statements. I will now turn the call over to David.

Thanks, Sarah. These are very exciting times for Eiger. We're 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 Peginterferon Lambda program for COVID-19. Since we announced positive top-line results from the Phase 3 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 2 and Phase 3 as we focused 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 expect to file our EUA application this quarter. Exact timing will, of course, be contingent on when we receive the full TOGETHER data set. 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 1,900 patients predominantly vaccinated and across a range of SARS-CoV-2 variants. The final review of this extensive and robust data set 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 large 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 variants 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 surges 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 Peginterferon Lambda represents an effective one and done therapeutic that is potentially agnostic to the arising variant 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 continue to execute on our HDV platform, lonafarnib and lambda both in Phase 3. With HDV affecting over 12 million people worldwide, the healthcare and economic burden is enormous. As first-in-class therapies to treat and potentially cure this devastating disease, we believe both our product candidates offer opportunities for significant long-term value creation. The hepatitis delta commercial opportunity in the US and Europe is estimated to be more than $1 billion. Ingrid will provide more details on our continued progress in both Phase 3 programs shortly. Turning now to Avexitide. As we announced last week, we are advancing Avexitide into a Phase 3 registrational program for congenital hyperinsulinism by the end of this year. Our team has obtained alignment with FDA on the Phase 3 clinical program. Recently published Phase 2 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. Avexitide has been granted FDA Breakthrough Therapy designation and Rare Pediatric Disease designation making it eligible for a priority review voucher upon approval. Most importantly, Avexitide has the potential to transform the lives of children, born with this life-threatening condition. A key part of Eiger's growth strategy is to advance clinical programs for underserved patients in 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 proving successful to the following examples; our landmark Phase 3 D-LIVR study in HDV is based on Phase 2 proof-of-concept clinical trial work performed at the National Institutes of Health. FDA approval of Zokinvy, the first treatment for Progeria is the result of our partnership with the Progeria Research Foundation. Our Phase 3 Avexitide congenital hyperinsulinism program builds on Phase 2 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. Jordan Feld in Phase 2 and the TOGETHER study team in Phase 3. 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'm proud of our continued progress here, which is a 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 Zokinvy 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'll 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 the TOGETHER study met its primary endpoint with a 50% reduction in risk of the COVID-19-related hospitalization or emergency room visits. Importantly, this primary endpoint was achieved in a patient population that included multiple variants and was predominantly vaccinated. With the ever-changing COVID-19 landscape, we believe these data reflect generalizable 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 in this high-risk population, Lambda reduced 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. TOGETHER is a large study of almost 2,000 patients, which provides many opportunities for sub-analysis of the patient population. The TOGETHER study team is completing a comprehensive analysis of the full data set, which will include sub-analyses for variants and vaccination status. In addition, viral kinetics will be collected where SARS-CoV-2 levels will be quantified at days zero, three and seven. This will be important not only to assess the correlation of viral clearance and clinical outcomes, but also to determine effects of Lambda on viral clearance an important indicator of curbing 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 are on track to report top line data from our Phase 3 D-LIVR study of two lonafarnib-based regimens by end of this year. With 407 patients enrolled across 116 clinical trial sites in over 22 countries D-LIVR is a landmark study. It will generate the single largest source of HDV 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 D-LIVR. In our continued monitoring of the situation, we have not seen an operational impact to date in Russia. 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, D-LIVR remains more than adequately powered to demonstrate superiority on the primary end point, even if patients from Ukraine discontinue from study. We are advancing our second therapy for HDV Peginterferon Lambda in the Phase 3 LIMT-2 study currently enrolling and dosing patients. The primary endpoint of LIMT-2 is a durable virologic response, which was previously demonstrated in Phase 2. This post-treatment endpoint is most meaningful for regulatory agencies and physicians, as it demonstrates durability of response to a finite therapy and potential for an HDV cure. We also believe that Lambda's 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 two Lonafarnib based regimens based on the results of the D-LIVR study. We will quickly follow with data from LIMT-2, which if positive could lead to approval of Lambda for HDV. We believe this approach provides the most expeditious route to approval for both Lonafarnib and Lambda. In parallel, we're generating data through the LIFT-2 study which we believe will support the future use of our proprietary combinations of Lonafarnib and Lambda for hepatitis delta infection. I'll now turn the call over to Eldon.

Thanks, Ingrid. I'll give a brief overview of our commercial business in the US and a summary of our preparations in Europe. We reported $2.7 million Zokinvy net sales in the first quarter in the US. Importantly, we're pleased to have converted 80% of the identified US patients to commercially reimburse supply with 100% payer reimbursement coverage. The patient support center we established known as Eiger OneCare has facilitated an efficient US launch. The primary goal of Eiger OneCare is unencumbered patient access to Zokinvy and this program has delivered continuous access to our innovative therapy with zero out-of-pocket costs for all patients. With the CHMP 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 Zokinvy either through Eiger's early access programs or clinical trials which we believe will drive an efficient commercial launch. In preparation for launch, we've 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 have 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 Zokinvy from physicians in France as part of our reimbursed early access program and look forward to bringing Zokinvy to market across Europe to further support patients in need. This is an important milestone both for Eiger and the Progeria community. I'll now hand the call over to Sri for a financial update.

Thanks, Eldon. The press release we issued this afternoon included a financial update and I'll call out a few highlights here. As Eldon noted, first quarter Zokinvy net sales were $2.7 million. This compares to $3.6 million reported during the same period last year. As a reminder, we launched Zokinvy in the US in January 2021 and first quarter 2021 sales included the initial inventory build at the specialty pharmacy. Turning to our first quarter 2022 GAAP operating expenses. Cost of sales was approximately $0.1 million. R&D expenses were $17.6 million and reflect an accrual of a $5 million milestone expense to BMS, related to our Phase 3 LIMT-2 study of Lambda for HDV. SG&A expenses were $6.8 million for the quarter. We reported a first quarter net loss of $22.6 million or $0.64 on a per share basis. As David noted, a key part of our growth strategy is to advance innovative clinical programs for underserved patients in a 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. Importantly, this provides Eiger with a very strong balance sheet ahead of delivered 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 HDV programs to registration as well as the Phase 3 of Avexitide congenital hyperinsulinism program. I'll now hand the call back to David.

Thanks, Sri. This is proving to be a pivotal year for Eiger, as we execute on clinical milestones to propel our pipeline forward leverage our commercial capabilities, to expand our reach for Zokinvy and strengthen our business for the future. 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 HDV platform with Phase 3 D-LIVR top line data planned by end of the year, the Phase 3 LIMT-2 study of Lambda enrolling patients and the Phase 2 LIFT-2 study of Lonafarnib and Lambda combination initiating soon. And we continue to execute across the rest of our rare disease pipeline. We expect a CHMP opinion on our Zokinvy marketing authorization application this quarter and are excited to start our Avexitide Phase 3 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, a Chief Technical Officer and a Senior Vice President of Corporate Affairs both of whom bring a wealth of global biopharmaceutical experience to Eiger. At this point, I'd like to thank our dedicated Eiger 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. [Operator Instructions] Our first question comes from Maury Raycroft from Jeffries. Your line is open.

Hi. This is Jane [ph]. I'm on Maurice's line. Thanks for taking my question. My question is for the EUA has FDA giving you any sense of the window is still open. What exactly are they looking for in the full TOGETHER data? And then is there any concern about the lack of patient representative from US? Thank you.

Thanks Jane. I appreciate your question and good to have you on the call today. I'll turn your questions over to Ingrid Choong. Ingrid?

Yes. Hi, Jane. 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 submit this quarter. Regarding -- in 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 subanalyses 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 that follow the same protocol as the TOGETHER study. So we'll include North American patients as well.

Yeah. Well just to summarize, Jane. We're very confident in the data set and we're confident we could submit by end of quarter and look forward to communicating further.

Okay. That sounds good. So also I have one -- just a clarify question to do the -- this TOGETHER data will need to be published, or do you need to just complete the analysis to submit to the agency? That’s it.

Ingrid?

Thanks. Yes. So our plan is to complete the secondary analysis and submit all of it in totality to the FDA. Concurrent with that we will submit a manuscript that will include all of the data as well.

Okay. Thank you so much. Thanks for taking the question again.

Thank you.

Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Your line is open.

Hi, team. This is Ashik Mubarack on for Yigal. Thanks for taking my question, and congrats on all the progress. How are you thinking about the time line for the review period for in the EUA, maybe a potential time line for an approval decision? And in terms of the gating factors for the EUA, I know you're completing the analysis but can you be a little more granular in terms of what's in the analysis in terms of those viral kinetics and maybe other biomarker analyses and will that also include stratification for variants and so on? Thanks.

Sure. So -- and thanks for your question. I'll begin with regard to what we're thinking. We can't speak to how long the FDA will take to review an application once submitted. We know that the longest interval we're aware of between application and approval was roughly three months and that's Merck's Millipore. Importantly, we believe that the TOGETHER data sets are robust and compelling and represent a real-world patient population that's highly generalizable to the US. 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.

Yeah. So 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 2,000 patients. And so there's many opportunities for some analysis. So as mentioned earlier, we plan to conduct primary endpoint looking at it across variants, as well as different vaccination status. Regarding viral kinetics, because we are running SARS COVID quantification at days zero, three and seven, we will be able to look at viral load decline and viral load clearance and be able to look at correlations to clinical outcomes. But more importantly just to look at viral clearance since that is an indicator of community spread. And that's something that we believe the agency will be interested in seeing.

Okay, great. Thanks for all of that. Maybe just one more. I'll switch gears to Avexitide. It seems like you have some clarity on the plan for development and you published some nice looking data recently. I had two questions. One with the cash you just raised, I think you alluded to this in your prepared comments, but do you feel confident about your ability to complete a Phase 3 study? And maybe any detail -- what details can you share on the size and scope of that study? Thanks.

Sure. I'll let Sri, comment.

Yes, on the cash question, we're very pleased to have a strong cash position that we reported and that runway that we guided to including cash sufficient to fund planned operations into Q4 2024, does contemplate the Avexitide Phase 3 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, Colleen.

Thanks, David. Yes. So we have not yet disclosed regarding study design and endpoints. However, what I can say at this point is that through the breakthrough therapy pathway, we've had the benefit of working closely and collaboratively with FDA, on study designs and endpoints and we're aligned on an efficient program that we look forward to initiating this year.

Okay, good. Thank you so for answering my questions.

Thank you.

Thank you. Our next question comes from the line of Bert Hazlett from BTIG. Your line is open.

Yes. My congrats. Excuse me – thanks for taking the questions. Just a couple of ones with regard to financials. Could you remind us -- you mentioned the $5 million of BMS, 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 EUA or with the EU with regard to Zokinvy. Thanks.

Sure. I'll pass that to Sri.

Hi, Bert nice to hear you. Thanks for your question. With regard to the BMS milestone the $5 million that we included this quarter, was related to the Phase 3 LIMT-2 study of Lambda for HDV. We do have additional milestones payable to BMS. We haven't communicated specifically what those are just the aggregate amounts. With -- as we get closer to that next milestone for Lambda, we will provide more specific details. With respect to SG&A, we do not see a need to build up SG&A to support an EUA. What we have communicated is that, an EUA would set the stage for either to supply purchases to agencies like BARDA, which is how we initially see the EUA progressing, which is what other therapeutics that have received EUAs have done as well. So 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 to begin your 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, Bert. The value of developing Lambda for hepatitis delta virus infection, is separate and distinct. However, in that path, we've run registration batches for Lambda preparing for an HDV BLA filing. And in parallel, also had opportunities to consider the pandemic and how Lambda might be made available on a global basis. Clearly, the TOGETHER data are compelling. And based on that, we are making plans and considering different pathways certainly to ensure that the numbers of Lambda manufacturing meet a 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 you .

Thank you. Next question comes from the line of Brian Skorney from Baird. Your line is open.

Hi. This is Luke Herrmann on for Brian. Thanks for our questions. Just a couple on the HI program. So first of all, you haven't disclosed total granularity on the Phase 3 design. Can you comment on whether the design is to support a Subpart H for a full approval and as well as the length of the safety follow-up, you think you'll need here?

Yes. So, no thanks Luke, for listening and for your question. We have communicated that we're very excited now to have concurrence with FDA, on a Phase 3 program for Avexitide in congenital hyperinsulinism. And obviously, the fact that Avexitide 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 finalize discussions, on our Phase 3 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.

And then just one on Avexitide's mechanism. Is there any reason to think that the GLP-1 agonist approach might be differentiated from competitive assets, which claim to operate downstream of beta cells, or is this just a situation where you're going to let the data speak for itself? Thanks.

So the -- I'll begin and then pass it to Dr. Colleen Craig. The reason that we advanced Avexitide in congenital hyperinsulinism is, because we clearly believe there is a mechanistic differentiation versus anything else in the field. And I'll let Colleen expand on that.

Thanks, David. Yes. So thanks for the question. There are several aspects that make Avexitide uniquely suited for treatment of HI. And I'll just touch on a few. And you mentioned the first, really, first -- as a first-in-class GLP-1 receptor antagonist, Avexitide represents a uniquely targeted therapeutic approach. Avexitide works upstream of the dysregulated secretion of insulin and that's what you mentioned. That's correct. And this is -- Avexitide has been shown to significantly lower insulin secretion, which is unique to Avexitide and to prevent fasting and meal-induced hypoglycemia. And so, in this way, Avexitide uniquely represents a preventive treatment for HI. The other thing that I'd just like to take a moment to touch on is that, Avexitide -- the route of delivery as a subcutaneous injection in this patient population is something worth highlighting. This is a very practical way of delivering to particular -- in pediatric patients that does not require a wearable device, such as a continuous pump and does not require oral intake, which in this patient population, in particular, neonates and infants, but also in patients receiving intolerant may raise challenges. So we believe this route of administration makes the most sense for this patient population. And the last thing that I'll just point out is that, Avexitide is to-date the only program in development for HI that 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, Colleen. Does that answer your question?

Yes, it does. 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 Bert's earlier, regarding manufacturing post emergency use authorization. Just to put a scenario out there, assuming your approval this fall, which at this point seems likely, how much timing do you think would be required before you have enough to supply ex-US? Pretty tough question to answer without having the -- those approvals and those requests coming in from ex-US, but just trying to get a sense for how much you're able to put out in 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. What we have communicated is that, we will have 300,000 doses of Lambda available for initial launch quantities, to make it available for health care practitioners and patients. And while we haven't provided specific numbers on what we could do in subsequent years, within our existing manufacturing capacity for HDV, as David indicated, we are looking at opportunities to expand production. We've also previously communicated that we think a partnership or collaboration could help us scale up manufacturing and expand the global reach of Lambda for COVID-19 outside the US. And the TOGETHER data helped catalyze those discussions. And as we move towards an EUA, we think that will be a dating event to further those discussions.

Okay. That’s helpful. We’ll bet, you’re seeing essentially a better call coming up in a month or so hear. Switching to Avexitide. I'm not hearing much on PBH. Can you give us an update as to where it stands with that indication? Thanks.

Sure, Michael. And we have been very thoughtful and very strategic about Avexitide for both congenital hyperinsulinism and also post-bariatric hypoglycemia. We believe both of these indications are high unmet medical needs and that Avexitide will be a targeted therapeutic for both of these patient populations. Again, we seek to succeed first and foremost. 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 executionally disciplined and we want to ensure success in congenital hyperinsulinism. But clearly, our thinking about post-bariatric hypoglycemia as a commercial opportunity and importantly an unmet medical need for underserved population in this case PBH 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 three push through the start of 2023?

No, no. Not for PBH, only that we plan to begin Phase three for congenital hyperinsulinism this year. And that while we clearly value Avexitide for both congenital hyperinsulinism and post bariatric hypoglycemia, we believe that a disciplined approach is to begin with congenital hyperinsulinism, which again, just to remind you, we believe we'll likely be potentially an opportunity for another priority review voucher upon approval. However, post bariatric hypoglycemia is also a major unmet medical need. We believe Avexitide may be able to fill that need and we look forward to providing guidance in the future on how we move forward.

Okay. Super helpful. And real quick Sri, restocking in Q1 or since Q1, if you can comment there, if you've seen any normalization in the trade channels. Thanks.

Yes. Maybe I'll let Eldon to address that on the commercial front.

Sure. Yes. During Q1, channel inventory actually 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 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 model range, so very normal.

It sounds like you're suggesting that it's normalizing since the quarter?

Yes.

Appreciate that. Thanks guys.

Thank you.

[Operator Instructions] I'm not showing any further questions. I would now like to turn the call back to David Corey for any further remarks.

Thank you, very much and thanks to everyone for joining us today on this earnings call. As you've 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 programs 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.