Q4 2022 Amylyx Pharmaceuticals Inc Earnings Call
Okay.
Good afternoon, My name is Gary and I will be your conference operator today.
At this time I would like to welcome everyone to the analytics Forest Pharmaceuticals fourth quarter and full year 2022 earnings conference call.
All participants will be in listen only mode.
After today's presentation there'll be an opportunity to ask questions.
To ask a question. Please press star one on your telephone keypad.
Draw your question. Please press star two.
Please be advised that this call is being recorded at the company's request.
I would now like to turn the call over to Lindsay Allen head of Investor Relations and Communications. Please proceed.
Good afternoon, and thank you for joining us today to discuss our fourth quarter and full year 2022 earnings with me on the call are Josh Cohen, and just simply our co CEO Margaret Olinger, our Chief commercial Officer, and Jim Friday, Our Chief Financial Officer before we begin.
I would like to remind everyone that any statements. We make are information presented on this call that are not historical facts are forward looking statements that are based on our current beliefs.
And expectations and are made permanent the safe Harbor provision of the private Securities Litigation Reform Act of 1995 piece.
These statements include but are not limited to our expectations with respect to delivery out in Alberta that statements regarding regulatory development and the expected timing thereof, our business strategy and outlook and our expected financial performance and cash runway actual events and results could differ materially.
From those expressed or implied by any forward looking statement as a result of various risks uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC.
You're cautioned not to place any undue reliance on these forward looking statements and <unk> disclaims any obligation to update such statements unless required by law.
Now I will turn the call over to Dustin.
Thank you Lindsay and good afternoon, everyone.
Our mission is to one day and the suffering caused by AOS and other neurodegenerative diseases.
We just celebrated the 10th birthday and as we look back we're very proud of the progress we've made toward our mission over those 10 years.
2022 was in many ways. The most important year for us with the FTA approval of delivery for the treatment of adults with Alfa in the U S. Following its approval with conditions as Alberto there in Canada.
<unk> is a relentlessly progressive and universally fatal disease and relive Rio is the first approved treatment for AOS to demonstrate both a statistically significant.
Yes, I can benefit and function in the clinical trial as well as an observer benefits on survival in a longer term post hoc analysis.
We believe our therapy represents a meaningful advancement in treatment options for people living with a lot.
Since the approval we have seen strong interest in real live radio and we are encouraged by the early success of our commercial launch we.
We are very proud of our team for the way they have partnered with the analyst community and for the great progress they've made toward our goal of delivering the liberty owe to every eligible person in the U S and Canada.
But this is also just the start and all of US at <unk> remain steadfast and committed to the work ahead and our commercial launches and as we work to transform what it means to be diagnosed with AOS.
I will now pass to Jim to review, our fourth quarter financial results and then to Margaret to share insights on our launch.
Thanks, Justin we're pleased to share that at this point in our launch were meaningfully ahead of our expectations and encouraged by the interest and demand we've seen from the ALS community.
Margaret will share some of the important early metrics that we're tracking which should help you model, our near term opportunity and the total addressable market for the longer term.
But first I'll summarize Q4.
Net product revenues were $21.9 million for the quarter and $22 $2 million for the year with the vast majority of that revenue from the United States.
As you'll hear from Margaret in a few minutes, we're seeing robust demand demand from the ALS community.
Gross to net adjustments were approximately 18% in the quarter and in line with our expectations. We expect gross to net to remain in the 15% to 20% range for the year starting at the higher end of that range in Q1 due to the annual reset of Copays and deductibles and Medicare part D re enrollment as of January 1st.
Inventory levels at December 31st, where where we would've expected with roughly $7 million of inventory in the channel and specialty pharmacies.
This represented approximately two weeks of sales at our year end run rate, which we see as typical for a product launch at this point.
Cost of sales were $2.8 million for the quarter. This is slightly higher than we expect for 2023 as a whole as a percentage of revenues given the royalty accruals, we made during the quarter.
We expect our AOS royalty obligations to be fully expensed in the second quarter of this year and we have no future royalties for sales in the Nols going forward.
Research and development expenses were $22.8 million for the quarter compared to $13 $4 million for the same period in 2021 and $24 $9 million in Q3.
Going forward, we anticipate that R&D will grow as we continue to execute on Phoenix manage our phase four post marketing commitments and invest in our pipeline.
We expect our R&D expenses will be in the range of $25 million to $30 million per quarter as we move towards the end of this year.
Selling general and administrative expenses or SG&A were $40 8 million for the quarter compared to $14.9 million for the same period in 2021 and $29 $9 million in Q3.
The growth in SG&A during the fourth quarter was primarily driven by expenses to support our commercial launch activities and continued infrastructure built to support a publically traded commercial company.
We're investing in SG&A to support our strong commercial launch and expect our spend will be in the range of $40 million to $45 million per quarter as we progress through the year.
Net loss for the fourth quarter was $42 $7 million compared to a net loss of $28 $3 million for the same period in 2021.
Turning to our balance sheet, we're in a strong position at year end, we had cash and short term investments of $346 $9 million and zero debt.
Continue to expect our existing cash and short term investments will be sufficient to bring us to cash flow breakeven.
I'm excited about the progress we've made on the launch to date and look forward to sharing updates in the coming quarters.
All of us at <unk> remember that every day there are thousands of people living with ALS and our mission is to serve as many eligible people as possible.
I'll now pass the call to Margaret to share what we're seeing from the market in terms of interest and demand for <unk> and <unk>.
Great. Thanks, Jim.
Today, we are focused on three key priorities for our U S launch. The first is our effort to drive awareness in education about Reliv real for people living with AOS and clinicians.
This includes educating that really is the first approved drug for AOS to demonstrate a statistically significant benefit in function in a clinical trial as well as an observed benefit on survival in a longer term post hoc analysis.
As well as sharing publications on supporting clinical data such as the peer reviewed publication in the New England Journal of Medicine.
Our second priority is engaging with payers to work towards our goal.
During that every eligible person who can benefit from remember I O treatment has access as quickly and efficiently as possible.
The third is ensuring that people living with Iowa have positive interactions through their treatment journey with a delivery app and AOS clinics have positive interactions with amex.
This includes facilitating in Oregon is clear processor or people enrolled in the analytics care team support program, helping navigate the insurance process being able to field questions.
Optimizing people's experience as best we can.
Now.
Let's run through a few specific details to help illustrate the progress we're making on each of these focus areas.
Starting with our first priority of ensuring broad awareness of our delivery out.
We are seeing our efforts yield strong results and have observed rapid uptake following the fda's approval on September 29.
They were just over 1300 people living with ALS Unreal every out in the United States at the end of 2022.
And uptake has continued since then.
We remain optimistic about our ability to continue growing from here as we believe people with E. L F and their clinicians are eager to learn about and try a new treatment options.
By the end of this quarter. We believe we are on a pace to roughly double the amount of people on a rollover Yale on a net basis.
On the clinician side, we are encouraged by the prescriptions coming from the top AOS doctors and T. A L S centers.
But there is still significant opportunity for growth.
Prescribing was fairly concentrated with roughly 70 prescribers, mostly at major AOS centers, representing approximately half of all wherever your prescriptions during the quarter.
With regard to the total clinician market. We believe there are roughly 2700 potential a L. S prescribers in the United States.
Out of the roughly 500 prescribers approximately 55 of these clinicians prescribe or liberty out by the end of the fourth quarter.
From the health care office perspective about two thirds of the top E. L F centers and prescribe for Liberty out to at least one patient.
We see these numbers is encouraging.
As we expand our education efforts, we have an opportunity to see broader and deeper uptake among the key providers.
Another notable part of our launch is the interest that we are seeing across the spectrum of people living with E. L. F. When we look at the time since initial diagnosis.
We are encouraged that regardless of the time since diagnosis people with ILS are interested in and gaining access to this important new treatment.
In other words, we are seeing people onboard livery, all who have been newly diagnosed as well as others, who have been diagnosed for more than three years.
Shifting gears to our second priority insurance coverage.
More people have already gained access to redeliver out through their insurance, we had anticipated at this point in our launch.
U S insurers, representing approximately one third of the covered lives have already published formal coverage policies and the vast majority provide broad access to relive Rio.
In addition, many of the key players are included in this early group.
We remain engaged with insurers across the country.
<unk> commercial and Medicare plans, and we continue to anticipate that the majority of them will formalize their policies during the first half of this year.
Moving now to our third priority of ensuring people living with ALS, who have been prescribed where liberty O N E. L. F clinic have positive interactions. Our team is working expeditiously to get people living with a L. A who have been prescribed delivery all enrolled in the analytics care team support programs.
So none of that and on therapy.
Currently it is taking us a little more than 45 days between receiving an enrollment warm and delivery all being shipped.
We expect this process will speed up as more insurers implement formal coverage decisions.
In this interim period, while the majority of plans are determining their coverage policies access to really reality generally through the medical exceptions last prior authorization process. We have been pleased to see that approximately 80% of prior authorization request.
<unk> been approved on the first submission.
By most patients having unique coverage and related requirements.
Overall, our team has had great success, helping people with ALS, who have been prescribed weirdly rail gain access through their insurer.
In the limited cases, where access has been granted through and ensure we have used our interim access program and our patient assistance program for eligible patients in.
In the fourth quarter, roughly 10% of people taking delivery of all or part of these programs.
Yeah.
Now turning to our launch in Canada.
The interest in Albury Oeser remains widespread across the entire a L. S ecosystem in Canada, and most importantly, with the approximately 3000 Canadians living with a L S and their families.
We are encouraged by what we are seeing in treatment uptake.
Mirroring our efforts in the U S. We continue to educate Canadian payers on a L. S disease progression and <unk> efficacy and safety data to ensure broad an equitable access to as many eligible Canadians as possible.
On this front, we are pleased to have negotiated agreements with all of the largest private Canadian insurers to cover algorithms.
Representing approximately 80% of the privately insured population.
With respect to public government funding.
As expected we are in ongoing negotiations with the Pan Canadian pharmaceutical alliance or P. C. P I.
Which represents the provinces and territories in regards to the scope and breadth of coverage they will provide.
As a reminder, this process typically takes up to 12 months to complete.
<unk> as well as a E. L. F community at large will continue to advocate for people, who are covered by Canada public insurance options, Jeff equitable and broad access to Alberto's, they're similar.
Similar to what we have secured on the private side.
Yeah.
Time is something that's community just does not have a lot of and thus we have an elevated sense of urgency.
It's important to note that for now due to expected public reimbursement process timeline, we anticipate a more limited revenue opportunity in Canada.
At least the first half of 2023.
We are encouraged by the progress of our launches and our momentum to date and I am very proud of our team.
But there is much more work to be done.
As we look throughout the rest of the year our team remains vigilant in our efforts to educate a L. S centers and look forward to educating the general neurologists.
We believe we have a large untapped opportunity for additional growth as we conduct ongoing research.
Outreach, we remain committed to driving access with and support to every eligible person living with ALS, who can benefit from treatment.
With that I'll turn the call over to Josh and Justin for some final update and closing remarks.
Thanks Margaret.
I would also like to provide an update on where we see ourselves headed in the coming years in the United States and then provide updates on Europe , Phoenix and a new program more friends syndrome.
Starting with our current view of the addressable market. There are approximately 29000 people living with ALS in the United States given.
Given the relentless and fatal nature of AOS disease progression and recognizing that not everyone will be interested in treatment.
Hope is that eventually at least 10000 people who will be on <unk> at any point in time.
Shifting to Europe as expected, we completed the Sag meeting last month.
Certain major objections remain and the cgmp has adopted another round of questions for us to respond to.
Have those in hand, and due to this additional round of questions. We now expect an opinion from C. H M P midyear and a decision at the earliest in Q3.
Overall, we believe we have a strong scientific position.
Important broadly by the AOS community on a capable team leading our process.
While the review process is ongoing we continue to prepare to execute a successful launch in Europe if approved.
Now I would like to share some updates on Phoenix last month, we announced that the study was fully enrolled with 664 participants, which compares to 137 and centaur.
As you May recall, our goal was to include 600 participants in Phoenix, and we ended up enrolling more due to high demand.
<unk> is studying a similar group to Centaur was slightly broader inclusion and exclusion criteria we.
We have stratified Phoenix, there's some whether people would meet the centaur inclusion criteria or not and plan to analyze the subset of participants whose strictly meet the centaur criteria as well as the broader population.
Centaur met its Prespecified primary outcome with all clinical secondary outcomes trending in the same direction plus an observed difference on overall survival in a post hoc analysis of a well tolerated safety profile.
We are looking forward to Phoenix topline results anticipated mid 2024.
As a reminder, while we expect to get data for the primary outcome of AOS upper solid progression and several secondary outcomes in mid 2024, it's likely that overall survival data will take another year or more to mature due to the normal course of disease progression and people with Alex This is similar to centaur and which the final step.
Bible analysis was up to three five year time point.
So overall, we are confident in the design and execution of the study and looking forward to the outcome of Phoenix.
Turning to our R&D efforts, we are pursuing research a Gulf Amex 35, and other novel drug candidates in AOS and other neurodegenerative diseases.
We continue to work on new pipeline programs, new clinical indications and initiatives within the AOS community this year and in the coming years.
The first update today, we wanted to share more about our program to evaluate amex 35, and Wolfram syndrome.
Wolfram syndrome is an ultra rare disease affecting fewer than 5000 people in the United States.
Disease leads the multi system failure, resulting in blindness deafness diabetes ataxia, neuro degeneration, and typically death by early adulthood.
Several papers characterize the disease as a prototypical disease endoplasmic reticulum stress.
Our interest in more frame began when a family affected by the disease and a leading researcher Dr. Freeman Heiko Jurado at Washington University connected with us to inquire about collaborating on preclinical studies given the hypothesized mechanism of action of Amex 35.
What followed has been a roughly four year collaboration during which our R&D team conducted in vitro and in vivo studies together with walks you to evaluate the potential of Amex 35, and more firm syndrome.
These studies have very promising results some of which were recently published in the journal of clinical investigation insight.
At this time, we are close to kicking off a phase II study a wash in.
This study is a 12 participant open label study, which we believe will provide key insights to guide future studies directed at registration.
At this point are India's open and Doctor Your auto site was activated and will hopefully enrolled the first participant in the near term.
I'll now turn over the call over to Justin for a few closing remarks.
Thank you, Josh and parallel to all of the progress that we outlined on our call. Today, we are continuing to strengthen the breadth of our team's collective experience and perspectives were.
We are pleased to share that we recently appointed Caryn Firestone to our board of directors effective March 16.
Higher co founding aureus asset management, Karen spent 22 years with fidelity, where among other responsibilities. She managed the biotechnology sector fund.
She has a demonstrated track record of applying her strategic acumen and commercial mindset to drive progress in this space and we look forward to her counsel as we continue working toward our mission.
In closing, we take our responsibility to make a difference in the lives of people with AOS very seriously.
We are proud of the progress we have made to date and the fact that we are helping more than 1000 people and their families and their battles that AOS.
There remains much work to do and we're focused on ensuring quick and efficient access to delivery out for every eligible person who can benefit from it.
You all for your support and for your time today.
Now we'd be happy to take your questions. Operator, please open the call to Q&A.
We will now begin the question and answer session.
To ask a question you May press Star then one on your telephone keypad.
If you were using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
Please limit your questions to one with one follow up if you have additional questions you may rejoin the queue. At this time, we will pause momentarily to assemble our roster.
The first question is from Geoff Meacham with Bank of America. Please go ahead.
Afternoon, guys. Thanks, so much for the question.
Just had one on commercial and then a quick one on Europe and the U S. You mentioned the centers that are responsible for the bulk of scripts.
Wanted to get a sense as to the inquiries of the queue of patients across the broader ALS population I'm, just trying to get a sense of the breadth of awareness.
Whatever metric you guys can provide and then on the European market I know you probably can't get into specifics, but you can use from the questions that you've gotten be addressed with current data you think or a longer follow up or is it fair to say that you may have to wait to the Phoenix study I'm, just trying to get a sense, whether there's a maybe a middle scenario with a more narrow label that you can.
Still provide some limited you access in the next say 12 months or so thank you very much.
Thanks, Jeff I could take your question on the U S market first and then I can turn it over to Josh and Justin on the EU.
So as I mentioned Theres about 700, 2700 physicians that prescribed for E. L F, which is our broad target audience. During the first quarter. We are heavily focused on the top AOS centers and the top 500 prescribers of which 55% of them have written a prescription for <unk> in the fourth quarter so that.
Continues to be our focus there's a lot of opportunity that remains in those top prescribers.
But also a lot of patients are being seen by the general neurologist out in the communities and that's clearly you know our next a runway that we have to continue to penetrate this market much more broadly than we have today.
Yeah, and I'll add on.
Europe , So first I'd say.
As you've seen in the U S and Canada I think we have a really good case here. This drug has been approved twice and we have a team that's very used to making strong scientific arguments here.
So you know what I'd say is I think we have the right.
Typical arguments to make to support the approval of this product, but ultimately the decisions up to regulators. So you know.
I guess, we'll have to wait and see but I think we have all the right pieces in place.
To continue forward.
Okay, great. Thanks, so much.
The next question is from Omar <unk> with Evercore ISI. Please go ahead, hi, guys. Thanks for taking my question and congrats on the launch by my math I feel like you will either be at or fairly close to breakeven in <unk> could you. Please comment on that and could you give me a sense for whether the patient numbers at the.
End up December not as of now but at the end of December was approaching about 1500 at 2000, and if you could clarify that and then finally, how much inventory was in the four Q number that we just saw thank you very much.
Okay.
Yes, the humor, it's Jim I'll start with that maybe in reverse order so.
We did mention there was about a million dollars in inventory at the end of Q4 and that represented about two weeks at the run rate that we were at so and we think that's appropriate for where we were in the launch.
The first question I know was about when we're going to hit breakeven.
I think that right now it's still just really too early to tell right. We're only four months into launch I think a lot will depend obviously on what we spend in versus the revenue that we pull in but more specifically I think as we're seeing the demand increase right and again Margaret mentioned, there were 1300 patients on drug at the.
The end of 12 31 and at the end of Q4, and we're looking at roughly doubling that as we get to the end of March so 2600 patients plus or minus.
I think that one does have to be careful though right because all of those patients don't come on at once right as they come on through the quarter, we might get one month of revenue we might get three months of revenue depending on when the patient started.
And just as a reminder, as well we start for the first three weeks with a single dose of single Sachet product when we moved to Sashays a day for the remainder the remaining.
You know 11 months of the year. So just be careful as you extrapolate revenue there and.
I think I guess I would just say we're off to a really good launch I think we're probably going to be able to more than double our revenues in Q1, I'd say, we'd be closer to tripling our revenues than we are to doubling our revenues, but wouldnt want to give more guidance than that.
Thank you.
The next question is from Nida, but Trudeau garg of Citi. Please go ahead.
Hey, guys congrats on the quarter and thanks for taking my question I'm, just kind of following up a little bit on the last question just thinking about the pace of starts and it seems like there was a little bit of a warehousing effect as you expected in fourth quarter, but just trying to get a sense for how we think about the pace of starts.
After Q1 do you expect this kind of 1300 patients per quarter to be kind of a sustainable rate or should we expect their piece of new starts to kind of start to decline thereafter, and then just on the Phoenix commentary.
How should we I mean, how should we think about you know kind of next steps post the Phoenix top line I mean, it sounds like you're kind of guiding us to expect a decision on.
Kind of the long term kind of commercial status of real Israel based more off of overall survival data, but just wanted to clarify if I heard that correctly.
Oh, yeah. Thank you so much for the question and I'll start this is Margaret.
So we just want to reiterate we are very pleased with the growth we're seeing in the second.
In Q4 of 2022, and so far this year and we are you know when things are going really well, we're seeing an initial bolus in demand.
And to be honest with you. We just don't know how big this bolus will be or how long will it last but we expect continued growth in interest and demand as the initial prescribing you know has been relatively concentrated as I mentioned, we have a large untapped opportunity to build on our ongoing outreach and education efforts, we really see like we have a lot of runway ahead of us.
Yeah.
Yeah, Thanks, Margaret and just adding so I think survival is definitely a key endpoint in a L. S. I think it was just a biological reality, but it takes a while for survival events to accrue she wanted to be really upfront about that but I wanted to come back to we're really confident in the trial design and execution, we're really looking forward to this day.
Peter.
Personally I can't wait to unveil the Phoenix data when when we have that next year.
Yeah, and just one more point you know as Margaret emphasizes the demand I think that's on the plus side right. We're seeing early demand. It's very concentrated so far so we have a lot of breadth and depth to continue to look forward to I think as we expand this product on the other hand, no insurance coverage is still something that is not complete yet and I.
Don't believe it's going to be appropriate to make an estimate about what our future demand is going to look like until we get fully you know closer to 100% of the insurance decisions being made and again as Margaret mentioned at this point, we're about a third of the way through that so I think it's too early for us to really know what that demand curve is going to look like Nina again, how big and how.
Along that bolus might last until we really understand what the full breadth of coverages, it's going well so far but we're only a third of the way through.
Got it that's super helpful. Thank you.
You're welcome.
The next question is from Corinne Jenkins with Goldman Sachs. Please go ahead.
Yes, good afternoon, and congratulations on the quarter guys.
Maybe to start just in terms of the email questions I know you started.
We started that already but can you just provide a little more clarity or these questions that you could answer with data that you currently have on hand or is there any risk that you might have to generate additional data just sufficiently answer this.
Yeah I think the question is always with any regulator is what we have sufficient or is more data needed.
I'd say this drug has already been approved by two regulators I think we have a clear and strong scientific arguments.
To support the approval of this drug but of course, the regulator has to decide that too so.
So we're still going through the process, we're still going through the back and forth. So you know it's too early to know what the decision will be but I think we have the right team and the right arguments to continue moving forward through the process and I'll just add to that you know in the EMA.
While we don't know yet our anticipation is that this may be a conditional marketing authorization in the conditioning marketing authorization that condition would would.
Likely be completion of the Phoenix trial, So I think that's an important.
Part of your question too.
Yeah. That's really helpful. And then you mentioned a 10000 patients on drug target kind of steady state and in the past we've talked about with the launch curve might look like with an initial bolus and then steadying out until we get to a steady state. How are you thinking about it now that you're in the market and seeing kind of the demand that you've had thus far.
Far.
Yeah. So we're very excited about the opportunity in the long term to.
Hopefully be able to treat 10000 patients at any given time as you know there's 29000, a L. S patient suffering with this disease. Some patients we know will not be able to just unfortunately due to the natural progression of the disease.
<unk> be able to access treatment to the drug but we do know that really is all today is you know.
Roughly 9000, but the range is anywhere from eight to 11000. So we do have a goal an aspiration to become standard of care, where the first drug to really have function plus a survival from a long term post hoc analysis. So.
That's sort of our goal an aspiration and we feel confident that we can meet that goal how long it will take us to get to that point I think it's way too early in the launch to see that.
And then just in terms of that the slope of the ramp.
Your point it is very early months of the launch, but we are seeing very encourage level the levels of interest from both people living with ALS and clinicians and you know we said that Q4, we ended with 13 people on therapy, we expect to double that.
By the end of Q1, and again I just want to reiterate to everybody that is on a net basis.
It should give you a good sense of how the launch is progressing and while we do have that initial bolus of demand and we don't know how big and how long that will last we do really are very confident in the long runway. We have ahead of us so.
You know our focus remains on the 1300 patients on therapy today, and keeping them on therapy and then also.
Very encouraged by the insurance.
The favorability that we're seeing while it's only a third at this point, we have a very broad access to date and we're encouraged about the future.
Okay. Thanks.
The next question is from Marc Goodman with S V. B Securities. Please go ahead.
His high there's a lot of conversation about the Phoenix study I was just to make sure I understand just to be clear when you make a decision on whether the Phoenix study is successful or not would you be waiting for the survival data to actually make that determination.
Yeah.
I think what you know what we've said and I think what's the cases, we're going to do with subsidies.
Sure.
They are really really excited about the data that we're going to unveil and as the data comes in we'll we'll make the appropriate decisions in collaboration with the AOS community, but again, we have a lot of confidence in the trial design and the execution here and we're really excited to unveil those results next year, Yeah, and Mark just on further to your point too as Justin So.
The you know.
First we measure a function that at 48 weeks and then we will measure survival. These are really key endpoints for people living with ALS, they're really key endpoints or.
Doctors and the care team, who look after people with ALS. It's also what we saw in the Centaur study.
So you know the the study design and the data that we're collecting are based off of what we saw in the first study as well as what's important to the ALS community.
Alright, and then what you're saying is survival is very important to the Els community. So youre going to need to see that data to really understand what you have what you don't have.
It is certainly a critical endpoint.
Okay. Thanks.
And our last question today comes from Ananda Gauche with H C. Wainwright. Please go ahead.
Hey, guys. Thanks for the tanks down in Ah Congrats on the quarter are on behalf of Andrew.
Just had one question like anymore, and then boost up Google there were questions on phase two data and potential Oh positive phase three data now what has been the feedback as it had been negotiating with the peers, especially in terms of the data.
Yeah.
I think the question relates to how perish.
Asked about ongoing studies ongoing data I'd say, thus far we've seen broad and really good coverage from the payers of course, we're only a third of the way through its only a third of payers have released their policies, but thus far the engagement has been great. We've been you know the vast majority of it.
Broad coverage policies that were very happy with and I would just add to that that you know we have a really strong pair our medical affairs team that are having ongoing discussions.
With our clinical teams and I think these payers are really understanding just how devastating this disease is and you know more broadly our payer interactions today have been highly encouraging.
Great. Thanks.
Thank you there are no further questions at this time.
Turn the call back to Mr. <unk> for final comments.
Yes.
Thank you operator, we.
We are proud of the progress we've made to date and encouraged by the early success of our commercial launch.
We remain focused on the work ahead.
Our goal of delivering Reliv Rio to every eligible person living with AOS.
You all for joining us and thank you for joining the call have a good evening.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.
Yeah.
[music].