Q4 2021 Eiger BioPharmaceuticals Inc Earnings Call
Yes.
Good day, ladies and gentlemen, and welcome to the I agree with bio pharmaceuticals fourth quarter and full year 2021 financial results and business update conference call.
At this time, all participants are in listen only mode.
Peter We will conduct a question and answer session and instructions will follow at that time.
If anyone should require operator assistance.
Press Star then zero on your telephone.
A reminder, this call will be recorded.
I would now like to introduce your host for today's conference Mr. Sui reality, Chief Financial Officer of Iger, you may begin.
Good afternoon, and thank you for joining us today welcome to our quarterly financial results and business update call we should.
A press release earlier this afternoon with our Q4 and full year 2021 financial results, which is available on our website and I grew bio dotcom.
For today's call, we will have prepared remarks from the management team followed by Q&A, we will be using slides for the webcast and we will have a replay available on the investors section of our website.
With me on the call with prepared remarks are David Cory President and CEO Eldon Mayer, our chief commercial officer and Dr. <unk> Chang Senior Vice President clinical development, Dr. Calling his mob senior Vice president of clinical and development operations will join us for the Q&A.
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.
Forward looking statements rely on certain assumptions and involve risks and uncertainties beyond <unk> control, which could cause our actual results to differ materially.
These risks and uncertainties is contained in <unk> filings with the SEC, including our latest 10-K and 10-Q reports available on your website in the investors section.
All forward looking statements are based on information currently available to <unk> and we assume no obligation to update these statements I will now turn the call over to David.
Thanks, Sri you were very excited about 2022, which we believe will be a transformational year for either.
Our strategy at Eiger has been to build a pipeline designed to bring much needed medicines to patients with urgent unmet medical needs and to create value for shareholders. Today, we have a diverse late stage portfolio that includes one approved product and five FDA breakthrough therapy designated program.
The promise of our pipeline is coming into sharper focus in 2022 with two phase III data Readouts planned. This year first in COVID-19, and then in hepatitis Delta virus at the core of our strategy is our HDD platform low enough on it and peg interferon Lambda.
Both in phase III in both first in class therapies to treat and potentially cure HDD.
H D D. As our primary focus and is expected to be the indication that drive near and long term value for iger.
HDD has a deadly global disease impacting more than 12 million people worldwide hepatitis Delta virus is always a co infection with HBV. However, HDD causes a much more rapid progression of liver disease in HBV alone.
50% of HDD patients are cirrhotic at the time of diagnosis.
I hear is pioneering the development of treatments in this space with our HDD platform that targets critical host processes involved in viral replication loan upon it and oral crenellation inhibitor and Lambda and immuno modulator offer different mechanisms of action are conveniently administered and should benefit HDD page.
<unk> alone and in combinations.
Loan upon is the only oral treatment in development for HDD is currently dosing and deliver our landmark phase III study deliver is expected to generate pivotal results that if positive will support registration of two loan upon it based regimens for HDD.
Deliver has enrolled 407 patients across 116 clinical sites in over 22 countries, including five sites in Ukraine.
We are deeply concerned for all those impacted by this conflict, including the deliver patients investigators and site staff and our CRO colleagues. We continue to closely monitor the evolving situation there with our CRO, we believe deliver remains more than adequately powered to demonstrate superiority of each.
The other final containing arm over placebo, even if patients from Ukraine discontinued from the study.
We have also implemented a number of mitigation measures for the 11 deliver sites in Russia, which should enable continued participation of these patients in this study Ingrid who will provide more details in a moment.
We look forward to reporting topline deliver data by the end of 2022.
Our second therapy in development for HDD as Lambda, a well tolerated interferon, which is now in a pivotal phase III study called limit too.
We're also pleased to be studying <unk> and Lambda in combination in the lift to study conducted at NIH. We expect the first patient to enroll in this phase II study during the first half of this year. We believe the combination of our two proprietary HDD product candidates, we will achieve our most robust antibody.
A real activity.
Has this been the case with other viruses, we expect combination therapies will be required to conquer HDD.
Our HDD strategy is clear first seek regulatory approvals of <unk> based regimens based on the results of the deliver study.
I'll deliver includes combination with peg interferon Alpha we will quickly follow with data and regulatory submissions for the approval of Lambda a well tolerated interferon based on the results of the limit to study.
This is an efficient pathway for potential approvals of both <unk> and Lambda for HDD in parallel we will generate data through the list. Two study that we believe will support future use of our proprietary combination for HDD.
The well over a decade I hear he's been leading the way in the clinical development of therapies for HDD. We have gained a deep understanding of the needs of patients and the physicians who care for them.
We believe that loan a finer than lambda will have the potential to become foundational HDD therapies hydro is well positioned to be a leader in HDD, a commercial opportunity projected to be in excess of $1 billion.
Now turning to COVID-19.
<unk> continues to evolve with over 450 million cases, and 6 million deaths around the world Thus far.
More treatments are urgently needed and we expect data from the phase III together study of Lambda for COVID-19. This month.
The study has completed enrollment of over 1800 patients when complete together will be among the largest clinical trials conducted of a therapeutic for COVID-19, if the data are positive we intend to submit an emergency use authorization application to FDA.
Resistance due to variance or new strains of Sars Covid. Two is an ongoing concern with approved vaccines monoclonal antibody treatments and recently approved oral <unk>.
Lambda is mechanism of action of stimulating the host immune response is agnostic to variance and as such we believe may be ideally suited to treat newly diagnosed COVID-19, outpatient as a convenient one and done subcutaneous injection alone or in potential combinations.
We're also making good progress across the rest of our rare disease pipeline of extra tied a novel first in class targeted therapy for two different orphan metabolic disorders will be phase III ready this year.
And with respect to Zoe Kenzie for Progeria, our first year of commercial launch in the U S has been a success.
In Europe , our MAA is under review and we expect to see HMP opinion in the first half of 2022 Eldon will have more details on Joe Kennedy as well as our initial plans for HDD commercialization in just a few moments.
Finally, we began 2022 with approximately $106 million in cash and total investments, which should fund planned operations through Q3, 2023, I'll now turn the call over to Ingrid to discuss our clinical development programs in more detail Ingrid.
Thanks, David we're making great progress across our clinical development programs and are preparing for two phase III data Readouts this year, and COVID-19, and H D D.
Our HDD platform strategy has been thoughtfully designed to generate regulatory approvals of multiple HDD treatment regimens. We believe a win for HDD patients is approval of therapies. That's the press HDD virus, which has been shown to lead to improved hepatic function improved liver histology and improve survival. This is also because of this.
With F D a industry guidance on the development of therapies for H D D.
We also believe that for chronic HCV therapy convenient administration as well as anti viral activity are important considerations for patients and their physicians when a foreigner and lambda potentially offer both.
In phase two the all oral regimen of Luna Barnett boosting with Ritonavir achieved a composite endpoint of a two log decline in HDD, RNA and normalization of liver enzyme or a L. P and 29% of patients at week 24 of treatment.
Luna find out with combined with peg interferon Alpha the response rate more than doubled to 63%.
Importantly, the combination of <unk> and peg interferon alpha with synergistic on the composite endpoint and proving both reduction in HDD viral load as well as a L. P. A normalization.
On a final visit with the Covid is the only therapy in development for HDD that has reported synergy on the composite endpoint when combined with peg interferon Alpha.
Our phase two data were the basis for that they let their study deliver it in a global phase III trial that we believe positions either it could be a leader in H D D.
But deliver primary endpoint is a composite of a two log decline in HDD R&D plus a L. P normalization as was demonstrated in phase two.
But deliver study design creates two opportunities for regulatory approval of a let up on our base therapy, an all oral combination with peg interferon alpha.
The liver is a landmark study generating the single largest source of HDD patient data from a well controlled clinical trial to better understand and characterize this devastating disease.
Well, we design deliver we apply conservative assumptions and the powering of the study modeling response rates well below what was demonstrated in phase two.
Regarding recent events five of the 116 deliver sites are in Ukraine.
Priority is patient care and patient monitoring to ensure continuity in this study.
We believe the study remains more than adequately powered to demonstrate statistical significance over placebo, even if the patients from Ukraine discontinued from the study.
And Russia, where there are 11 to lever sites. So far there has been no interruptions to patient visits safety monitoring or drug supply.
<unk> maintains a deliver drug depot in Russia, which will have sufficient drug supply for all patients through end of treatment.
We have developed contingency plans with our key arrow and central lab to ensure continuity of drug supply and that lab samples can be stored and analyzed without compromising the integrity of end of treatment results.
We implemented similar measures at the height of the Covid pandemic to successfully maintain patients and deliver.
As a result of these plans we are still tracking to deliver top line data by end of 2022, which if positive will support regulatory filings for them on a fine it seeking approval of to load up on that base regimens for H D D.
We're also excited to announce our second therapy for HDD Lambda into phase III limit to study.
And phase two Lambda was dosed once weekly in HDD infected patients for 48 weeks with 24 week follow up.
36% of patients who receive lambda achieved a durable virologic response or D. V are defined as HDD RNA below limit of quantitation or undetectable at 24 weeks post treatment.
This post treatment DVR endpoint is most meaningful for regulatory agencies and physicians as it demonstrates the durability of response to a finite therapy and a potential client HDD cure.
When it too is a randomized study two arm study arm. One is 48 weeks of Lambda Once weekly followed by 24 weeks of treatment.
To start with 12 weeks of no treatment, followed by 48 weeks of treatment.
The primary endpoint is the proportion of patients with a durable cure logic response at 24 weeks post treatment in arm, one compared to 12 weeks with no treatment and onto.
This is a very straightforward study of 150 patients where all patients will receive treatment.
We have started enrolling patients and are in process of activating 50 sites across 13 countries.
These sites have been primarily selected from the best performing sites and the deliver study, which should allow for efficient enrollment.
A successful outcome and limit to it could lead to approval of Lambda as a monotherapy for H D. D and also open the door for Lambda to become the interferon of choice and HDD combination therapy.
We believe that Lambda tolerability profile will be preferred by physicians and patients leading to better compliance and improve outcomes.
Well, that's hard to Lambda have distinct and complementary mechanism that can be used alone or in combination with each other and in combination with other HDD regimens to suppress virus.
Liver inflammation and improve outcomes.
Yeah.
[noise] ultimately our goal is complete suppression of HDD virus in HDD core to that and the combination of Lambda and bona Fide every ton of ear has achieved our most robust anti viral.
<unk> effects as demonstrated in the phase two lift one study.
In this study after 24 weeks of dosing, 77% of patients achieved the primary endpoint of a two log decline in HDD RNA and 50% of patients were either HDD Arden APL Q or undetectable.
After 24 weeks of follow up 23% of patients achieved a D D R and 55% of patients that underwent biopsies demonstrated an improvement in histology.
As David mentioned, we are excited to initiate a second phase two study of the combination of Lambda alone or find up economy are called lift to baidu.
By dosing for 48 weeks versus 24 weeks and this one we believe that a larger proportion of patients will demonstrate a durable response and remained below the limit of quantitation and HDD RNA post treatment.
<unk> two will generate critical data and publications to support the potential of this combination.
We expect enrollment to begin this year and look forward to providing more details on this study in the future.
Turning to COVID-19, and the phase III together study. We are excited that this study is now fully enrolled with over 800 patients and we expect data later this month.
As a reminder, the primary endpoint is the reduction of hospitalizations and emergency room visits and deaths. After a single dose of Lambda a potential for a one and done treatment for COVID-19.
Importantly, the study includes both under vaccinated and vaccinated patients and buyers will be sequenced and all patients to determine atlantis efficacy across variants, including delta and on the crime.
If the data are positive we plan to submit an emergency use authorization application to FDA.
I'll now turn the call over to Eldon for a commercial update.
Thanks, Ingrid I'm pleased to provide an update today on our initial plans for HCV commercialization and that can be launch with.
Deliver data by end of year, we're actively planning for HCV commercialization.
Estimated prevalence for HDD and the U S is 100000 patients and in Europe 200000.
Over the past year, we've engaged in market research speaking with physicians Kols and payers. Unlike HBV HCV hepatitis Delta as an orphan disease with significant unmet need.
Gilead is the lever ties, which has conditional approval in Europe for HDD recently launched at an initial price of approximately $150000 to 160000 for an annual course of therapy and approved countries.
Given this pricing, we would need to treat only 9000 patients or 3% of the prevalent market to achieve over $1 billion in total sales in the U S and Europe .
We anticipate that the lever Todd will be marketed in the U S ahead of launch and we believe that are second to market position confers important advantages that will allow us to leverage potential patient benefits of our products. For example by the time, we launched <unk>, we expect to increase awareness and diagnosis rates of HDD made possible by greater utilization.
<unk> of commercial HDD, PCR tests, and updates to Eagle and <unk> testing guidelines.
In addition, we believe the patient preference for a convenient oral HDD therapy will be high in the case of combination therapy, one of part of boosting with Ritonavir is the only therapy in development for HDD has reported synergy with peg interferon alpha on a composite endpoint improving both reduction in <unk>.
Viral load as well as ALC normalization.
We've also conducted research on HDD patients by geography as expected the HDD footprint overlap well with HBV, 70% of HPV scripts are written by just approximately 3500 prescribers.
Or around 10% of the total prescriber base. This will allow for a focused commercial launch in the U S. With a dedicated team solely focused on ensuring a successful launch in HDD.
These dynamics in mind, our plan is to prepare to launch one part of the U S with a targeted and efficient commercial team in Europe .
Parents future launch, but are preparing excuse me preserving optionality for strategic collaborations in China and rest of World. We believe that our partnership will be required to bring HCV therapies to market. We expect to deliver data by end of this year is an important gating event for future strategic collaborations.
We have also received exceptionally positive feedback from physicians kols and payers on Lambda for HDD.
Peg interferon alpha can be difficult for patients to tolerate leading to compliance issues and ultimately impacting treatment outcomes peg interferon Lambda by contrast is a well tolerated interferon with fewer and less severe aes. This was demonstrated in the 2016 head to head study in chronic HBV patients.
Specifically patients reported a marked difference and difficult to manage flu like symptoms and other adverse events that impact their daily lives.
Turning to <unk>. Our initial efforts have been focused on the approximately 20 identified patients in the U S where we launched in January 2021, as David noted the first year of U S. It can be launch was very successful we reported $3 4 million and it can be net sales in Q4, bringing our total net sales in 2010.
101 to $12 1 million importantly, we converted 80% of the identified U S patients to commercially reimbursed supply.
100% payer reimbursement coverage.
The patient support center, we establish known as either one carrier has facilitated an efficient U S launch the primary goal of idle one carrier's unencumbered patient access to as it can be in this program has delivered continuous access with zero out of pocket costs for all patients.
We are actively planning for launch in Europe in anticipation of regulatory approval with established required infrastructure across the EU, including distribution and patient support services as well as engagement with regulatory and reimbursement authorities.
Last year, we received approval for a reimbursed early access program or cohort HEU from French regulatory authorities and made our first shipment under this program in Q4 2021.
With that I'll turn the call over to three for a financial update.
Thanks to all of them. The press release, we issued this afternoon included a financial update and I'll call out a few highlights and as Albert noted Q4 as there can be net sales were $3 $4 million. This compares to $3 million reported in third quarter and reflects sales recorded from the shipment to France, partially offset by <unk>.
Shipments to our U S specialty pharmacy related to timing of patient refills.
For years, there can be net sales were $12 $1 million.
Turning to our fourth quarter and full year GAAP operating expenses cost of goods sold is approximately 0.1 million zero point $7 million for Q4 and full year 2021, respectively.
R&D expenses were $18 $2 million for the quarter and $64 4 million for full year 2021.
G&A expenses were $6 million for the quarter and $23 $9 million for full year 2021, you did reporting net loss of $21 8 million or <unk> 64 on a per share basis for the quarter.
Our full year 2021, net loss was $33 9 million or $1 on a per share basis. Our full year net loss reflects the onetime gain recorded in Q1 with sales as there can be priority review voucher IGN retained net proceeds of approximately $46 $5 million from that sale.
We began 2022 with a strong cash position with $106 million in cash cash equivalents and total investments.
Fund planned operations through Q3 2023.
Hand, the call back to David for closing comments. Thanks, Sri 2022 is a pivotal moment for iger.
We are poised to significantly advance our HDD platform this year.
<unk> III deliver data as planned by end of year Phase III limit two continues to enroll and the lift two combination study of <unk> and Lambda is planned to initiate in the first half of 2022.
We also look forward to data from the phase III together study of Peg interferon Lambda for COVID-19 within the next few weeks.
<unk> has the potential to be a one and done treatment for COVID-19 infection and if data from together are positive we plan to submit an EUA application to FDA.
Finally, our late stage robust pipeline of orphan therapies includes multiple breakthrough therapy designated programs and provides multiple opportunities to deliver much needed medicines to patients and value to shareholders. We look forward to providing additional updates throughout this year, including additional <unk>.
<unk> K O L events around diesel and <unk> and also in R&D day that we are planning for April of 2022.
At this point I'd like to acknowledge the <unk> team for their relentless efforts across our programs and thank all of you for joining us on our Q4 and full year 2021 call. Operator, please provide instructions for the Q&A portion of the call.
Understood. Thank you ladies and gentlemen, if you have a question at this time. Please press. The Star 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 the pound key.
We ask that you please limit yourself to one question and one follow up.
One moment for our question.
Our first question comes from the line of Maury Raycroft from Jefferies. Your line is open.
Hi, Congrats on the progress and thank you for taking my questions.
Was going to ask about deliver it sounds like you have contingency plans in place for deliver in respect to the five sites in the Ukraine, but can you say, how many Ukraine patients are actually in the phase III and how many of those patients are active or have completed the phase III.
Hi, Maury.
Thanks, very much for joining the call and for your question I'll pass that one over to Ingrid Chung.
Hey.
So we haven't provided guidance on patients by country. You are correct that we have five clinical trial sites in the Ukraine, and we continue to closely assess the evolving situation prioritizing patient care and patient monitoring to ensure continuity of study and we believe that delivers more than adequately powered to demonstrate superiority.
Simona final containing arms of <unk>.
Even if your cranium patients discontinued from the study yes. So as a result of our planning we're still tracking to deliver top line data by end of 2022, which if positive will support filings for loan our Barnett based regimens for actually two one appointment based regimen. So we're anxiously awaiting.
Those results.
Got it that's helpful and.
Can you talk more about next steps.
<unk> III together study is positive I guess have you had any preliminary contract ore stockpile and negotiations with the U S or ex U S countries and can you talk about plans to scale up manufacturing would that be done in house or with a partner.
Yeah, So I'll.
Give you an initial view and let the team opined if they're interested.
We've not yet seen data from that together study, but we definitely look forward to reporting soon and we'll provide additional details on our plans for manufacturing distribution and commercialization at that time. If the data are positive we plan to speak with regulators about submitting an emergency use authorization.
Patients I will add with regard to manufacturing we are lucky in some ways given the fact that HDD is our lead indication for Pegylated interferon Lambda, we've already manufactured multiple registration lots of Lambda and so we definitely <unk>.
Combined with the fact that Covid began now two years ago have been thinking a lot about manufacturing.
And the result of positive news coming out of our phase III registration, enabling study and so we haven't guided at this point beyond that but obviously with positive data look forward to providing much more guidance in terms of next steps.
Got it okay. Thanks for taking my questions I'll hop back in the queue.
Thank you.
Yeah.
Our next question comes from the line of Yigal <unk> from Citi. Your line is open.
Hi, David and integrated and team. Thanks for taking my questions. I know you don't want to give country by country as guidance on and enrolled patients, but I'm just wondering with respect to Russia. If those patients were to discontinue would you still have enough power to dominate demonstrates statistical significance.
Hey, Yigal, it's David Thanks, so much for joining the call today and for your question and clearly the Ukraine conflict is top of mind for everyone and we've definitely been tracking from day one.
And I'll turn the.
Question over to Ingrid to address issues daily speaking with our ops team and the CRO Ingrid.
Thanks for your question.
As you know deliver it's a landmark phase III study that has been enrolled 407 patients across 116 sites in 22 countries and so far in Russia, there hasn't been any interruption to patient visits safety monitoring our drug supply.
Maintains a deliver drug depot as I mentioned earlier in Russia, which we will have sufficient drug supply for all patients through week 48. The main impact in Russia is the timely export of patient samples for analysis, we've developed contingency plans with our CRM and central lab to ensure not only continuity of drug supply.
Also lap samples that can be stored and analyzed without compromising the integrity of these end of treatment resolved and as you know we've implemented many of these mitigation measures during the height of the COVID-19, pandemic and were able to successfully maintain patients and deliver.
I'll just add to further Ingrid point during the beginning of the Covid pandemic, we took charge and started managing many of these issues across the globe in 22 countries and we're able to learn a lot maintain all patients drug supply remote monitoring for labs to remote monitoring for our.
Monitors at each site and that information and experience has definitely been instrumental in managing through this first few weeks of the Ukraine conflict that as of now we feel very very confident that this study is more than adequately powered to succeed and look forward to providing future updates.
On this evolving situation.
Okay got you that's very helpful.
And then a question on HDD more of a conceptual question I mean, you have several phase III regimens, obviously, they want to find a monotherapy combo with peg Alpha and then of course <unk>.
Lambda monotherapy all in phase III, so that being said I'm very curious to get a better understanding of what the decision tree would look like down the road. Once these are commercially available in terms of our positioning will determine which regimen to prescribe.
Yeah, that's a great question Yigal and the HDD landscape. We believe we will definitely evolve as therapies are formally approved right. Now there is no approved therapy in the U S. But the three mechanisms that are currently in phase III between our own loan of foreign it's oral.
Interferon Lambda.
Once weekly well tolerated subcutaneous injection or Bulgaria, tied which isn't daily injection all have different mechanisms of action and investigators and key opinion leaders have already made it clear that they are interested in exploring combinations of these different mechanisms ultimately with the goal to suppress virus and hopefully.
Keep it suppressed when drug is removed or discontinued and so I think that the future is going to be exciting given the fact that we have what we believe will be a patient preference and an oral therapy and <unk> to be used as a monotherapy or in combination with any other agents in development all star.
They're encased Eldon, our England have any comments in addition to that especially vis vis the lift two study, where we're actually combining quantifying them and lambda at the NIH and grid, Yeah, I'll just add that the liver study and the <unk> study.
We see as the most efficient way of getting those two drugs approved and available to patients and physicians and we've already demonstrated combinations of peg interferon Lambda and Luna farnell into two study.
One study at 24 weeks treatment in 24 week follow up and this data was very promising as you know we're 77% of patients for the primary endpoint. In addition to 50% of patients with <unk> at the end of treatment and more importantly at 24 weeks post treatment can be 523% and you're able to earn lots of quick time.
So our next step is.
I am happy to lift the Tuesday, let's study, which will look at 48 weeks of treatment versus the 24 weeks, we believe that with longer treatment, we're going to be able to improve that durable.
Logic response that we saw.
And as David mentioned a.
Kols have already indicated that they are interested in combinations in there. They are very excited about lunar foreign at Atlanta as a combination treatment given their two complementary mechanisms of action Eldon, yes. The only thing I would add is as you know.
No.
That.
All of the studies for registration are being conducted with peg interferon Alpha.
And as you know with our Lambda in development, which has.
A nice tolerability profile, I think theres, a theres, a theres going to be a transition there towards replacing that drought, but the early data that we've seen with land as certainly as promising even as a single agent. So it would make sense for that drug to be a nice offering with its well tolerated profile alone or in combination.
As well with other agents that are out there.
Yeah.
And then just one one more quick one.
For the lift two for NIH and what does the NIH said about about their interest in that regimen in terms of potentially doing a phase III assuming that this smaller phase II was a success.
Hey, Hugo Yes.
I'll address that as well and let the team comment.
The NIH. We believe this is one of the best liver centers in the United States and so we're excited and honored that the liver section at NIH has such a strong interest in working with both loan of foreign had been peg interferon Lambda, we believe that the generation of <unk>.
Data from list, one and list 224 weeks combo treatment and 48 weeks combo treatment will lend themselves well to publications and also companion listings that will support reimbursement beyond that for the the <unk>.
Potential combination in registration in the future if we have strategic options, where that's an interest and easily funded will certainly be supportive.
We believe the Tolerability profile of Lambda is going to lend itself, well to physician and patient preference and at the NIH data will support that preference.
Great. Thank you.
Our next question comes from the line of Brian <unk> from Baird. Your line is open.
Hey, good afternoon, everyone. Thanks for taking my question.
Maybe I wanted to get some of your thoughts on just.
What we're seeing in terms of the European opportunity for <unk> I think the only I'd talked about $12 million in sales last quarter, which was flat over <unk> I guess, how do you think that translates in terms of.
Your view of the global commercial potential in HDD, and maybe you could just aside from sort of a sub Q versus <unk>.
Oral opportunity for Luna Foreign I mean, maybe talk about how we should think about once we see the deliver data.
What specific efficacy advantages disadvantages.
Compared to <unk> you Mike.
Youre welcome.
Hey, Brian its sure I can start on the first part of your question, we know that the conditional approval of <unk>.
<unk> has in Europe is in a limited number of countries. So we expect as that expands that we would see additional sales reported over time and maybe I'll, let Kelvin answer the question on the expectation that we have for high patient interest for an oral therapy sure I mean, we do expect that.
No.
There will be high demand for an all oral treatment regimen.
We believe also that convenience is always going to matter to patients and are very much.
Patient's peripheral oral therapies, especially when it comes to long term chronic dosing. So we think that will play an important role as.
As these therapies.
Come available on the market evolves I think it's very clear from the data that we've seen thus far.
All three of these mechanisms Brian have good activity at reducing HDD RNA, our HDD viral load and normalizing liver enzymes, specifically ALC, which that composite is the approvable endpoint and so we.
We don't believe that there is any question that the three products are likely on a pathway to be approved we believe that that's good news for patients it's going to provide optionality and importantly, again, because these drugs work by different mechanisms because a high likelihood that theyre going to be used in combination to determine ultimate.
Maximal patient benefit and so we view loan in Florida than Lambda as well positioned to benefit from what we believe is a growing future opportunity in HDD.
Great. Thanks, that's helpful.
Thank you Brian .
Okay.
Our next question comes from the line of Bert Hazlett from <unk>. Your line is open.
Yes. Thanks, just one more for me on the limit to just kind of thinking.
Along the same lines as the.
As you've articulated with regard to deliver just.
Okay.
How do you think about managing the enrollment of patients just given what's going on with Russia, and Ukraine, Obviously, Ukraine is having challenges more so than Russia, but do you expect to shift your enrollment criteria. So the enrollment so that other countries pick up the slack and are you concerned about timing of that.
That trial at all just thoughts there thanks, Yep Yep Hello good.
Good to hear you and thank you for joining the call today and for the question I'll pass that one to Ingrid paper and so as you know limit two is ongoing and we are right now in process of enrolling patients have activating approximately 50 sites across 13 countries.
While these sites have been primarily selected from the best performing sites and deliver.
We think should facilitate an efficient enrollment we're still early enough in enrollment where we're considering other sites to include given the situation in Ukraine, and Russia, and we will be able to provide more specific guidance on enrollment and data center I think the short answer is that we're lucky in that we are now just ramping up in activating sites and the limit to study for <unk>.
Lambda in HDD, and so we're going to have some optionality about which direction. We go for enrollment we don't anticipate any delays in our ability to enroll the lambda trial.
Okay, Great and then just.
Well briefed on so it can be.
When should we expect material revenue coming from the EU Paas.
Something along the lines of what was asked earlier, but maybe a different way just the EU revenue in terms of materiality.
Is that can that start in the second half of 'twenty two or is it further out based on reimbursement.
Hey production, Sri I can take that one so as we mentioned we're expecting a <unk> opinion in the first half of this year you launch will vary country by country will be able to provide more information on that once we have an approval out of EMEA.
We are actively planning for EU launch week.
Built infrastructure as Eldon mentioned that will support distribution and patient support services. We know that we will have to apply for reimbursement country by country and that would be the gating factor for booking revenues. We were pleased with the early access program revenues that we were able to book in Q4 in France, and we'll have more guidance in the future.
Okay great.
Thanks for taking my questions. Congratulations on the progress looking forward to a big 20 to us.
Thank you Barry.
Again, if you have a question. Please press star and then one key on your Touchtone telephone.
Our next question comes from the line of Farhan Sackcloth from Ladenburg. Your line is open.
Hi, this is <unk>.
On behalf of Mike Hagan, just wanted to ask two questions. There. So given the market dynamics in HBV what are your thoughts about the pricing of non op. On there then how would that be impacted by the approval of knockdown.
Okay, Hey, Farhan. This is David I'll direct that call to Eldon and we can go from there Eldon.
Yes, as we as I had mentioned in the script, we do have an important benchmark pricing in Europe for Hep codecs already.
And.
$150000 to $160000 and so we'll see how pricing unfolds in Europe for that product.
We would.
Fair assumption based on our analysis of it.
<unk> 9000 patients, which is 3% of the prevalent market would get us to $1 billion based on that pricing if.
If we assume that similarly, we think we'll have a strong value proposition as well as you've heard for a lot of foreign it so.
Thank you.
That's not an unreasonable assumption for now.
And Farhan I will just add to that a lot of foreign aid, we anticipate should be registered to the deliver steady results and in cereal immediately behind that Pegylated interferon Lambda due to limit to results and both of these studies are designed to most efficiently to get loan apartment and Lambda.
Proved as individual treatments for HDD and so the results of both of these studies should lead to.
The physicians ability to prescribe these two agents either as monotherapy or in combinations and so we haven't obviously received.
Final results and.
And guided on pricing I think the Bulgarian tied benchmark is a good one in Europe , and we have two separate therapies with two separate mechanisms that we believe will be approved alone, but likely may be used also in combination and so as obviously data become available we'll be able to.
More on thoughts on pricing, but we expect both loan of harnessing lambda to be prescribed on their own.
And to be priced on their own and certainly the idea of combinations will be.
Think top of mind for prescribers and patients as they try and.
Driving this virus to negative and keep it that way.
Alright.
Thanks for that I have one other question so congrats on the floor.
I'm just curious so out of the $3 4 million in Q4 sales how much of that is coming from from.
Yes, its approximately 800000 of that was reflected in the shipment to France.
I think we.
Mentioned in the past there are two to three patients in France.
The shipments in Q4.
Okay, great. Thank you so much for taking my question.
Thank you Farzana.
I'm not showing any further questions I would now like to turn the call back to <unk> for any further remarks.
Great. Thanks, everyone for joining us today. This concludes our call. If you have any additional questions feel free to contact us at <unk> at Eiger bio Dot com, we can reach out to a member of the management team.
Again.
Yeah.
Ladies and.
This concludes today's conference call. Thank you for your participation you may now disconnect.
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