Q3 2022 Biomarin Pharmaceutical Inc Earnings Call
Welcome to the Biomarin third quarter 2022 financial results Conference call.
The conference call today from Biomarin is Traci Mccarty group Vice President of Investor Relations. Please go ahead Traci.
Thank you Ross and thank you all for joining us today to remind you. This non confidential presentation contains forward looking statements about the business prospects of Biomarin pharmaceutical, Inc, including expectations regarding <unk> financial performance commercial products and potential future products in different areas of therapeutic research and development.
Since may differ materially depending on the progress of the Biomarin <unk> product programs actions of regulatory authority availability of capital future actions in the pharmaceutical market and developments by competitors and those factors detailed in <unk> filings with the Securities and Exchange Commission, such as 10-Q, 10-K and 8-K report.
On the call from Biomarin management team today are J J P enemy, Chairman and Chief Executive Officer, Jeff HR Executive Vice President Chief Commercial Officer, Fuchs, President worldwide Research and development, Greg Guyer Executive Vice President Chief Technical Officer, and Brian You Alert Executive Vice President Chief Financial Officer, I will now.
Turn the call over to our chairman and CEO J J B enemy.
Thank you Tracy and good afternoon, everyone.
Thank you for joining us today.
Results in the first nine months of 2022 represent a record year to date total revenues of more than $1 $56 billion.
In the third quarter total revenues grew 24% year over year and increased 31%. Excluding two then.
Also the revenues of $48 million in the third quarter and $102 million year to date.
Led to today's increase in full year 2022 boxes in Guyana.
Driving these impressive results is continued strong demand.
From across Europe , and the United States for Brooks So go figure.
We have begun increasing overall patients treated and notable uptake in Japan since launching there in August .
With no lower age restriction on the docks are the treatment in Japan, we are thrilled to share that one of the first patient was treated in the third quarter was a three week old baby.
Turning on to do our second most recently approved a large product opportunity rock Canyon gene therapy for the treatment.
Hey.
Since receiving European approval in the third quarter.
Now in the final stages of negotiating outcome based agreements or <unk>.
With the key payers in Germany.
Then with road, Kevin pricing in Germany.
And labelled commercial product we have.
And ready to ship, we expect to treat the participations there in the fourth quarter.
And in additional EU countries, beginning in the first quarter of next year.
Jeff will provide an update on the European launch in a moment.
Briefly on what activity light states. The BLA is under review.
We're very pleased to have received acceptance of the BLA for the FDA two weeks ago and with a <unk> date of March 31 2023.
The FDA also recently informed us that they plan to hold an advisory Committee meeting.
We have said before we have been preparing for a potential outcome for some time.
As a good opportunity to discuss the demonstrated people benefit an established safety profile and I'll repeat again on the largest gene therapy clinical program ever conducted.
As we near the end of 2022, an awestruck by what has been accomplished in the last 12 months by Bob read I'm pleased at the top of it it.
He is our transition to profitability and the approval of our two largest product opportunities.
So the approvals late last year enabled the most successful quarter in Washington, the history of the company and underscored our capabilities across research development regulatory commercial and manufacturing.
Everything is the same capabilities, we intend to extract maximum value from Octavian beginning with our European launch this quarter.
I want to thank my colleagues for their contributions to achieving this significant milestone we have solidified our foundation for growth.
<unk>.
We will build on this momentum for the remainder of 2022 and beyond as we complete our transition to an earnings growth story.
A unique accomplishment in our industry.
For sure.
Thank you for your continued support and I will now turn the call over to Jeff. Please.
Please go ahead, Sir commercial business updates Jeff Thank.
Thank you J J.
I am very pleased with the performance in the third quarter, resulting in $505 million in total revenues, which represents 24% growth year over year, including to ban and 31% growth excluding too bad year.
Year to date and in the third quarter all brands marketed by Biomarin with the exception of Kuban in balance.
Demonstrated double digit revenue growth year over year.
Starting with box Sogo, we are pleased to share that as of September 30, an estimated 700, then 13 children were being treated across 29 active markets, including a number of children in Japan, Japan is unique in having high awareness and an established treatment network.
A Congress Asia based on the existing use of growth hormone <unk>.
And we expect it to be a material contributor to future growth.
As a result of robust box. So go uptake across all commercial markets, we are increasing full year guidance to between $140 million to $170 million for the full year.
We're thrilled with the reception and interest from families seeking box OCA treatment with 12 months of experience launching the world's only approved genetically targeted treatment option for achondroplasia.
We are on our way to recording the most successful launch commercial launch in Biomarin is history.
The successful global launch of box Gogo is an excellent primer for the next product launch in 2022 Octavian in Europe .
As part of the initial launch we are in the final stages of negotiating outcomes based agreements with payers in Germany. These.
Agreements allow us to capture full value for rock ABN and will allow patients to be treated while we go through the full price and reimbursement process.
We're targeting payers that we estimated cover 85% of hemophilia a patients in Germany.
These are multi year agreements that cover payer risk of patients potentially returning the prophylaxis redirect biomarin financial commitment and return for substantial and full upfront payment.
We expect to treat our first German patients in Q4 and look forward to sharing progress at our next update.
On the rocks heavy an EU approval call on August 24, we committed to update you on the European list price on September 15th the first European price was lifted in Germany in the amount of 60781 euros per vial, which for an average.
Patient consuming 32 vials.
Wait to 194 million euros.
It is important to note that our net revenues will include the mandatory rebate currently 7% to the German health care system. Some additional negotiated discounts and a reserve estimate our obligations against the outcomes based agreements, resulting in expected net revenue.
For patients less than one 5 million euro net of all discounts and reserves.
Relative to our experience with box sogo and previous brands. We believe that this level of net pricing in Germany will be closer to the final net price to be negotiated with GBA for federal reimbursement.
Cuz instead of using the free pricing period in Germany, we are going through robust negotiations as part of initial market access.
With our first commercial rocked avian update and four six quarters, we look forward to providing a number of metrics to help you understand the progress with launch. These include total quarterly revenue name and number of active markets milestones of numbers of patients treated and other color.
Her commentary relative to the launch considering that individual patients are substantial contributions to revenue.
Simplify our external tracking we plan to provide updates on patient uptake by numeric milestone, which will include the first patient treated the first 510 and 25 patients treated and then an incremental 25 to fall.
Turning now to the U S with the right Padian BLA under review, we are preparing for potential launch based on the March 31, the different date.
Cost of therapy for the treatment of severe hemophilia a in the United States is high and well understood by Payors based.
Based on this and the potential for rock Fabienne to provide significant savings to the healthcare system. We.
We were pleased with the draft evidence report issued on September 13th by the Institute for clinical and economic review or either.
At a presumed price of $2 $5 million. The report referred to rock Damian as a dominant treatment relative to <unk> on cost effectiveness brought Fabian was projected to have lower costs of $4 million slightly higher quality adjusted.
Eight years and slightly lower bleed this.
This report by a neutral third party underscores our belief that cost savings to payers will be a significant contributor to <unk> update and an overall opportunity in the United States.
Turning to clean out or enzyme replacement therapy brands, which collectively achieved record year to date results as noted last quarter and due to uneven ordering patterns. We do continue to expect a higher concentration of revenues in the first half of the year compared to the second half with Vimizim trending to the low.
And a full year guidance and <unk> trending towards the higher end full year guidance.
15% growth year over year and revenue of $38 million in the third quarter was driven by 20% growth in commercial patients versus one year ago.
Now to <unk> net product revenues grew 9% to $66 million in the third quarter as compared to the third quarter of 2021, 5% revenue growth year to date, while positive trails are overall growth expectations and what we continue to believe balance sheet you can achieve in the long.
Her term looking ahead, while Palin Zika is expected to continue to grow from year to year in the theater resuming substantial growth rates next year will likely be constrained until our new strategies gained momentum.
This year, while we have not updated full year revenue guidance, we do expect full year revenue to be at the lower end of the guidance range.
But anyway with the PKU franchise Kuban contributed $57 million in revenue in the third quarter of 2022 relatively flat compared to the second quarter of this year as we have stated previously Kuban nears the end of its lifecycle since losing market exclusivity in the U S. In October .
In 'twenty, we are gratified to be able to retain meaningful market share and resulting revenues.
Going forward, we anticipate generic competition to enter the European two van market in mid 2023 somewhat sooner than previously expected.
And with the assumption that this will further reduce our market share and revenues in.
In conclusion, we expect to end the year strong and anticipate increased demand for all of our commercial brands with the exception of Gilead.
We believe that Russ robust prescription demand for box sogo represent the foundation for continued growth, including in new markets for the remainder of the year.
The team in Europe is very excited to be launching the world's first gene therapy treatment for hemophilia, a with Brian <unk> and we look forward to updating you on the launch progress at our next quarterly update.
So thank you for your attention and I will now turn the call over to Hank provide the R&D update.
Thanks, Jeff and thank you all for joining us today.
With rotating approved in Europe , and the successful BLA Resubmission, we look forward with great anticipation to patients in Europe experiencing a life following a life altering treatments.
Followed with the world's first gene therapy product, let's see their hemophilia a.
The journey of <unk> TV in European approval has been both predict unpredictable and gratifying and I want to thank my team teammates and colleagues for their tenacious pursuit of Octavian advancement in the face of many headwinds throughout the process.
We now turn our focus to the U S review and are energized and inspired by what has been achieved in Europe .
As J J mentioned FCA recently informed us of their plans to hold an advisory committee meeting to discuss for Octavian.
Although no date has been set for this meeting this is something that we've been preparing for for over the last few months. We believe the AD com will provide a good forum to review the demonstrated bleeding control an established safety profile of Octavian.
We're also encouraged that FDA has so far approved 11 original BLA is for cell and gene therapies, five of which added comps and were approved.
Related to the in an effort to manage expectations throughout the review process. We plan to only update those milestones that are material to Directv and journey for.
For example, we do plan to share that the Advisory Committee meeting with available.
Thank you for your understanding as we focus our energy on quality Communications with the agency Advisory Committee preparation at all other elements of the BLA review process.
Turning now to the recently presenting findings of the more in depth hole genomic analysis of the Zucchini case discussed in September for the subjects in our phase III study as.
As presented at the European Society of cell and gene therapy Congress in Scotland.
In depth sequencing analysis from the patient sample did not detect any integration of our TV vector DNA in the subjects leukemia cells.
Furthermore, we identified a collection of mutations across the patient's genome that are often observed in this form of leukemia. This was substantially the outcome. We expected based on prior signings that had been already submitted to the FDA now that we've completed our genomic studies. This case, where file of Essilor correspondence with global health authorities again in the coming days.
<unk>.
Moving to box over during the third quarter, we met with both the FDA and the EMA to collaborate on the path forward to submission of the supplemental applications for box go to expand the age range for which <unk> is indicated.
Based on the feedback that we've received we're on track to submit both applications by year end.
Turning to new box, although indications beyond achondroplasia, and 2023, and we look forward to reviewing 52 week data set for doctor diverse.
Desiccator sponsored phase II study in other genetic central conditions. These data will be the combination of the exciting preliminary data presented at the Endo meeting this past may and what form the basis of potential new indication selection in phase III planning for about the other special conditions.
Finally, turning to the earlier stage pipeline, we look forward to activating our I N D with <unk> one for the treatment of Duchenne muscular dystrophy in the first quarter.
It would be up to <unk>.
<unk> is a subset of chronic renal disease, we have moved forward with a multiple ascending dose portion of our phase two study with <unk>.
331 for hereditary angioedema dose patients in the phase one two requirement a study to evaluate this best in class investigational <unk> needed gene mediated gene therapy for people with hereditary angioedema.
We have recently progressed through escalation of the <unk> vector per kilo dose group, where our non clinical studies progression.
Sierra therapeutically relevant, especially on a <unk> inhibitor.
Our preclinical studies of <unk> hundred 40, <unk> continue to build our enthusiasm for its potential to dramatically improve liver health and people living with Alpha one antitrypsin deficiency.
We expect to file an IND with <unk> hundred 49 in the second half of 'twenty three.
<unk> hundred 93, formerly referred to as Dinos Zero-zero. One is on track to the very next gene therapy clinical candidates in this case for the treatment of hypertrophic cardiomyopathy caused by mutations in the Miocene binding protein <unk> three.
Our preclinical studies continue to generate exciting evidence for the potential of <unk> hundred 93 to improve cardiac hypertrophy, and diastolic dysfunction and patients living with hypertrophic cardiomyopathy.
We also expect to file the IND for <unk> III and the <unk>.
Second half of 2023.
It's been quite a busy time in the Ww R&D organization, that's inspiring to reflect at all that's been accomplished and again I want to thank my team for their unwavering perseverance moving are important medicines through preclinical clinical and regulatory reviews on behalf of patients. We serve we look forward to keeping you apprised of our progress with Octavian in the U S and look forward to potential approval in 2023.
Thank you for your support and I'll now turn the call over to Brian to update financial results for the quarter.
Yes. Thank.
Thank you Henk. Please refer to today's press release summarizing our financial results for full details on the third quarter of 2022.
Since J J and Jeff spoke to our revenue performance for the quarter and future revenue outlook.
We'll primarily focus on the remainder of our P&L and other key financial update this quarter.
As usual all results will be available in our upcoming Form 10-Q, which we are on track to file over the next couple of days.
Our 2022 key financial objectives of delivering double digit annual revenue growth together, while achieving our operational goals, while controlling expenses is resulting in solid GAAP profitability through Q3 and significant growth in non-GAAP income consistent with our plan for the year.
One more comment on total Biomarin revenue did that while most of our commercial brands have been tracking within our expectations. This year the strength of the global box Overwatch driving our increased product sales revenue estimates over the course of 2022 has compensated for the impact of foreign currency exchange rates as well as the.
Good growth with talent.
These factors have balanced each other and were pleased to maintain our total 2022 revenue guidance of 2.06 to $2 6 billion balance.
On the impact of foreign currency exchange rates, while we have a robust hedging program that is offered material protection. During 2022, the strengthening U S. Dollar impacted our year to date revenue growth by approximately 3% on a constant currency basis Q3 year to date revenue growth was 15%.
Lastly on foreign currency, our disciplined hedging program have a small amount of hedge contracts at favorable exchange rates in place for 2023, However, our non U S. Dollar denominated revenue base remains largely exposed to the current environment.
While we expect solid patient growth in both base business and our newly launched product next year. We also expect that the current foreign currency exchange rates will continue to be a headwind against 2023 revenue growth.
With respect to operating expenses for the third quarter of 2022 R&D expense came in lower than we expected mostly due to the timing of certain expenses that moved to the fourth quarter and SG&A expense fell in line with our expectations.
R&D expenses for the third quarter were $158 million exactly flat with the third quarter of 2021, and SG&A expenses for the third quarter of 2022 were $217 million as compared to $183 million in the same period last year.
The largest components of the increase in SG&A expense are the global box Sogo and European rock TV launches <unk>.
Balance sheet foreign currency re measurement as.
As well as expenses related to our recently announced organizational changes.
While we expect those organizational changes to bring significant operational and financial benefits to the future. We estimate that one time charges associated with the change it to be approximately $20 million to $25 million of which $5 million was recorded in the third quarter.
Moving to bottom line results for the third quarter and nine months of 2022, while we are on track to reported GAAP net income for the full year 2022, the company recognized a small loss for the third quarter.
Q3, GAAP net loss is mostly due to the timing of revenue and expenses on a quarterly basis over 2022, plus the onetime cost associated with the corporate reorganization just noted.
Bright some unplanned expenses and the negative impact of foreign currency exchange on the full year. It is noteworthy that we're maintaining our 2020 to GAAP net income guidance of $105 million to $145 million.
With respect to non-GAAP income Q3, 2022, non-GAAP income of $83 million was more than double with $34 million of non-GAAP income in the third quarter of 2020 months. Likewise non-GAAP income guidance for the full year 2022 remains unchanged at $350 million to $390 million.
Turning to total cash and investments we ended the third quarter of 2022 with approximately $1 65 billion.
Which is an increase of over $100 million compared to both year end 2021, and the second quarter of 2022.
While the company continues to experience quarterly timing different several cash flow categories, mainly working capital Biomarin generated $169 million of operating cash during the first nine months of 2022, which is a positive indicator of the progression and maturity of the business and this transformative year.
In closing with just two with just over two months to go in 2022, we look forward to closing out a potentially record breaking revenue year and solid footing for a sustainable and growing GAAP profitability into the future.
We look forward to providing further insights into our 2023 expectations early next year, which we expect will include substantial revenue growth driven by <unk> <unk>. Despite the headwinds of foreign currency and continued to be an erosion from generic competition.
Together with the improvements to our operating model through the reorganization. We expect continued leverage in our business that can support both our growing R&D pipeline and strong top and bottom line financial performance.
Thank you for your attention and we'll now open up the call to your questions.
Operator.
If you would like to ask a question. Please press star one on your telephone telephone keypad now and will be placed into the queue in order to receive please.
Please be prepare to ask your question when prompted once again, if you would like to ask a question. Please press star one on your phone now and.
And our first question comes from Phil Nadeau from Cowen and company. Please go ahead Phil.
Good afternoon. Thanks for taking my question and congrats on the progress Henk. One for you you mentioned that you've been preparing for the FDA had come from Octavian for quite some time.
There is to know what issues you anticipate will be discussed at the meeting kind of what questions are you preparing to field and has the FDA in any way indicated what discussion topics that are likely to bring up.
Thanks for the question, Phil It's really too early to anticipate any of that stuff. They just got a huge file for review and they are just underway and in any case.
As the days go by.
And I get asked this question I'm going to have to defer answering it.
Because so much of the questions are about things to speculate about rather than to know about what we'll tell you. What there is to know about what we know about it.
As I've said in my prepared remarks.
Yes.
Thanks.
Give us any sense of what you're preparing for now what with the cash.
Yeah I mean.
From our side.
We have an enormous amount of efficacy data.
Safety data wellbeing data.
Information about optical concomitant steroids strategy information about optimized monitoring of patients relevant safety information or package insert post approval plan. So we have and the reason why I said.
That we have months of prep already underway, because we have so much stuff that.
It's important that in addition to preparing the documentation of the BLA.
We're also preparing for a presentation of the central story of the BLA.
And as Tom as you know is a great opportunity to go through the accumulated information in a very fulsome way I mean, it's amazing on the one hand, we can summarize findings of two page press release top line. Thanks for again like Ford charts, but the reality of a review and approval processes. They're looking at somebody told me that we printed the BLA.
With the equivalent of seven tests, so theyre looking at seven tests worth of data.
That's very helpful. Thanks for taking my question and congrats again on the progress.
Yeah.
Our next question comes from <unk> Richter from Goldman Sachs. Please go ahead.
Good afternoon. Thanks for taking my questions in queue for me here just one on rock KPN in the launch in Europe could you talk about how quickly you can get the two key payers that two key remaining payers in Germany onboard in any guidance. If we start to think about the cadence of launch starting in four Q and then secondly.
What are your outcomes here with regard to your discussions with the FDA on moving box they'll go into younger patients.
Okay.
Thanks, Avi and I'll take the first question. So as we've described probably as Wang.
Length over the last six months or so.
We have devised.
In consultation with German payers prior to the approval outcomes based agreement, which basically cover.
Payers risk of failure to respond or failure to be durable through a multi year period and we've previously advised that multi year period, we're targeting 5% to eight years, depending on the payer in Europe . So.
While we go through the federal process of reimbursement with the GBA.
During the three free pricing period in Germany, we determined that it would be.
Favorable to being able to treat patients early to negotiate outcomes based agreements with individual payer groups in Germany that we think will look largely like the eventual bedroll outcomes based agreements and in terms of the.
Outcomes base terms and also likely the discounts that we negotiate.
We think we're close with two of the three largest.
Payer groups in Germany, we don't have ink on those agreements yet, but we think that we're close and that will facilitate patients to me.
That said with our co diagnostic in Germany.
And to go through a liver function test.
To be treated.
It's worth noting that we've got some really important things done in Germany as J J noted that our price was lifted on September 15th that was an important step on.
Our tops organization has done an amazing job, we've got commercial label approved products sitting in a warehouse ready to ship, our commercial and medical teams have been doing.
Site readiness work with the key.
Treatment centers in Germany that we're targeting for <unk> patients to be treated.
We're well on our way for site readiness at least one site is 100% ready to go at this point. So we're poised and ready we've got that those outcomes based agreements that need to just get signed off and we will start moving patients.
And so that's what the cadence looks like.
<unk> seen some some data from maybe another analyst said.
Indications of patients that are kind of in Q with these key treatment centers, we think that that's true and we're looking forward to letting those patients get moving in Q4 get treated.
And so the second part of your question on box Sogo and regulatory interactions. Just a reminder of the three large pharmaceutical markets and devote sogo.
The ages.
Would be seeking for additional expansion are zero five states are under two in Europe , because we already have the full.
Range of range of ages approved in Japan, and I think the key feedback that we've gotten the key.
Yeah, but it is to pursue is based on the positive trends observed in growth.
The safety profile, that's been characterized as much larger populations at this point now.
And the recognition that treatment from birth and genetic conditions as of most immediate relevance, especially something like achondroplasia, where youre talking about severe skeletal dysplasia.
It's not a process that's done.
And so getting in early is really important too to families.
It was illustrated quite nicely by.
Just comments about our first patient in Japan.
So we think we have pretty good strong packaging, there's a pretty good basis for health authority acceptance of that package for review.
Which should further fuel the growth of our.
Oxoco.
Starting in the second half of next year.
Thank you.
Yes.
And our next question comes from Jessica Fye from Jpmorgan. Please go ahead Jessica.
Hey, guys. Good afternoon, Thanks for taking my question.
Is it possible that gives us oxoco patient number at the end of <unk> broken down by U S and rest of world.
And within that strong revenue number you reported how much of that box over revenue represents demand versus maybe some initial products into new markets as they come online.
Okay.
Hi, Jessica I'll field that question so.
We actually have not committed to breaking out geographically patient numbers.
We committed that launched providing global patient numbers last quarter, we did that as a way of <unk>.
Enhancing the color commentary on the U S launch, which at that point was six months other underway.
But the cadence of patient growth is strong across markets as we've noted.
Hum.
See that extreme weather.
Versus.
Initial stock yeah. So good good observation, we've made the same observation and we sell under some important markets, where there's there's distributors and where we think that there could be some forward.
Demand that is put into stocking. So examples of markets that we've had significant orders for that fall into that category includes.
Japan, Brazil, and Russia. For example, so we do think there is some forward buying.
It's a little difficult based on how dynamic the situation is to adequately characterize how much of those sales are forward buying.
And how much is responding to patient demand, but we've estimated in the revised guidance range. We've estimated of Q4.
Probably looks like continued strong growth in patient numbers and a little bit of the pipelining of initial inventory stocking and sorry, I can't be more precise than that.
But again, we had pretty strong growth in the number of patients in Q3 over Q2.
And that is going to continue in Q4.
And next year. Thank you.
Okay.
And our next question comes from Geoff Meacham from Bank of America. Please go ahead, Jeff.
Great Hey, guys. Thanks, so much for the question.
Just a follow up on Octavian you guys have given some perspective.
Payer conversation as Germany, but do you expect the rest of the larger countries to look that dramatically different in terms of outcomes based agreements I wasn't sure if at this point.
Different payers had different metrics on on risk benefit.
<unk> or cost benefit profile.
And.
The next question is just when you look at the.
The AAV antibody profile just talk.
Talk about a little bit about the how you characterize that and maybe how you expect ongoing monitored really so really happen.
As you rollout across Europe . Thank you.
Hi, Geoff I'll take the first part maybe turn over to Hank for the AAV five antibody profile question. So in terms of the outcomes based agreements that the details of those agreements, which are not really the main point my view the details can can vary.
A lot.
In terms of the terms.
This is simple so what we're covering in these agreements is a risk of failure to respond which by the way in our clinical studies, we have not actually experience a failure to respond to initial therapy, but anyway.
That's a risk that we can cover.
And a return to prophylaxis.
<unk> bees.
During an agreed upon time window in that time window is proving to be variable by by country.
So it's kind of simple we're guaranteeing that the product.
Patients are going to respond or Octavian and that they won't be bleeding in returning to prophylaxis through an agreed upon window of time, which is variable and the other piece that's variable.
We think is whether or not we get upfront payments or payments over time and this has been kind of a dynamic situation, we've been expecting in Germany and also in the U S.
Approval next year that we'll be looking at upfront payment.
Recognizing revenue upfront and some other markets and some of this has been a little bit surprising in new and dynamic some other markets.
Fed back to us that they'd like to get in on a pay over time model and maybe I'll just briefly ask Bryan to comment on his views on revenue recognition that occurs.
Got it.
If I heard it.
All of your peers in Germany.
Probably six to nine months from now.
It'll be a final.
Federal German price and all the parents, who would be a lie on that price.
This question up.
The deal has been doing we saw fears radar related to the initial pricing not the final pricing will be the same bar all fingers in Germany.
We see banks you see over next year.
Okay, sorry, if I misinterpreted.
Whether youre question sorry, yes.
No that was that was not just Germany, but across our.
Oh I see.
It's pretty pretty early in the launch but looking at other.
Maybe from constitute country asking are we stayed maybe in previous calls are.
For instance in France. They are now, although two or three years ago, they seem to be interested in.
On paper and then I'll come in basically three months a keen interest in our companies. If you remember I didn't want to pay over time instead of upfront so but at the end of the day financially, yes, as Brian is going to explain it doesn't make much of a difference yes, that's right so well.
Well hearing over the last couple of years that systems Werent setup for pay over time and they were interested in pay up front as we get deeper into these.
Actual obi a negotiations and exploration.
It ends up that some of the countries in Europe are just didn't pay over time, but importantly under the U S. GAAP revenue recognition rules, we would still recognize the entire rock TVN revenue upfront.
Instead of over time, if the payments over time, we'd be carrying that receivables, though there there could be a cash flow element for those pay overtime rock TV customers.
But importantly revenue would be recognized upfront.
Yep Okay.
There was a question about the AAV antibodies.
Yes.
And you had an element of your question that that pertained to ongoing monitoring maybe maybe Jeff you want to maybe you could help me reset.
We sat around the question you're asking.
Except for when you press Star one again please.
Yes.
Yes, yes definitely energy.
And if not okay. Jeff. This background you hear me. Please go ahead, yes, yes, perfect perfect Yeah, sorry, Hank I recognize obviously AAV testing is for the launch, but I'm just thinking about ongoing diagnostic obligations like factor rate for example.
This is all basically standardized clinical assay commercial lab kind of stuff.
As regards AAV diagnostic testing for the companion diagnostic and we do have a CE marked product that conforms to the trials that we've conducted and that's going to be available in a commercial lab with a short turnaround time and a very simple report to study and in addition, we have.
Ongoing work to study the population of patients who are <unk>.
<unk> positive by this test to see if they are also amenable to <unk> therapy and that could be a potential label expansion. Some time down the road, if we can get it to work.
But by and large things like ALC monitoring.
And in fact rate monitoring et cetera are really all just local lab cuts events.
Got you okay. Thanks, guys.
Yes.
Our next question comes from Chris Raymond from Piper Sandler. Please go ahead Chris.
Hey, Thanks cut.
Couple of questions I guess first on box sogo and the decision to submit.
For marketing in the sum.
This younger age group.
Just.
I know you've described a dynamic in the past, Jeff with the original labeling that favors faster uptake in Europe .
Should we be expecting and modeling a similar dynamic with this age group U S versus U S versus Europe or is there some other nuance.
Yes.
Thanks for the question Chris.
Think that.
Since we are talking about a label change.
That will be taken effect.
Year, and a half to two years after launch.
I would guide towards.
Kind of a.
Incremental material, but incremental increase in market opportunity in existing markets. So in European markets.
That's largely going to look like gaining access to the zero to two year old pay.
Patient population, which is probably like a 12%.
Additional market opportunity.
And by the way the initial experience in Japan, where we have a an age agnostic label has been.
Pretty positive so far with very young patients.
So if if.
If you might be considering.
Prescribers and parents going to be moving.
Moving really slow in that age segment will have to find out but the early returns from Jan Japan.
Would suggest that expect some uptake there and then in the U S that zero to five year old age segment. If we can get it expands the available opportunity there by like 30% so that could be a material increase.
Two to an existing by then an existing patient basis.
Pretty pretty large.
Okay, Great and then maybe a follow up for.
For Hank.
On the <unk> comment and this is maybe another question you can't answer, but we're being asked by folks. So please.
Please excuse me, but.
Do you have any indication if the agency from them. If they are they're going to want to hold this ad come with or without the three year data.
Don't have any indications.
Yeah.
Thank you.
And our next question comes from Matthew Harrison from Morgan Stanley . Please go ahead Matthew.
Great. Good evening, Thanks for taking the question I guess I guess two for me so.
The first one is just a follow on on how to think about dynamic in Europe .
For Barack kv and I get that.
The first part of this one is just.
You've talked about.
Patients in the fourth quarter, obviously can you just give us some sense and I know other people have asked us.
How much the system is actually set up in terms of being able to handle throughput in the fourth quarter versus how much of that capacity for demand.
Could could get taken up say in first half of 'twenty three of their patients that are waiting and then the second question is just.
Related to some of the pipeline candidates and I just wanted to Hank if you could just maybe broadly comment.
On some of the gene therapies that you have in the clinic now.
Where you are in terms of.
Dosing with those and how much safety data you have broadly.
So the safety data of broadly on gene therapies in the clinic, not including I guess.
Not including like maybe I think I got the basically the question obviously.
With PKU, we thought them.
Some questions and I think just people are just wondering some of your other sort of next programs, where you are in terms of building a safety pin yeah, well I mean, I'm zooming out macro big picture I'd say, a couple of things have been learned across the platform. Because we do have a handful of patients who've been treated with <unk> hundred seven we do have.
Sure a handful of patients treated with 331, so we do have two or three different indications through different.
Three different products essentially.
In preclinical and learning a lot about 293% as we get there, but I'd say across all of them you know infusion associated reactions of the most common adverse events.
The generally mild to moderate or manage.
Theres a frequency of transit M&A this post dosing.
For all of them, but nothing particularly severe of this has been observed with some of the other capsid generally well tolerated.
Get generally can get expression.
Maybe that was the very first dose level you go into the clinic with but pretty efficient in the scheme of health.
Health authorities patient advocacy groups don't really want a lot of dosing to occur at lower dose levels that are going to be effective.
So I would say overall pretty happy with the AAV five platform as a general matter.
Pretty happy through a range of doses that I think can deliver therapeutic effectiveness.
The only other thing to say is three to seven as it is.
Isn't stuck because of an outcome in humans, it's stuck because of a preclinical outcome that we don't actually think or know is translatable to the human situation, but do you know because we're careful we Wanna D bug.
What is going on in mice that received 307 and so we're doing research on that topic.
At some level, but.
But in general when we put it into the clinic in humans, it's proved itself to be safe in humans.
Okay and Matt.
Try to address your question about the.
Dynamic European situation then.
Kind of a cadence of patients in Q4 versus H. One 2023 first thing I'd say is really focus on Germany as the first place where we think we can get reimbursement through these outcomes based agreements that we've talked at length about we're on the cusp of having those that's one of the two big last pieces of <unk>.
Many that have already fallen in place that need to fall in place to treat patients commercially. So the second one being a site readiness, which we're also either they are on the cusp with our intended treatment sites. Once those two pieces are in are we.
Start pushing patients through the system.
And what I would say is with essentially two months left to go in this quarter and the holidays I'm more interested in proof of concept.
And.
Ensuring that the system is ready to go and primed in Q4 once we have that established I think.
Pushing additional patients through that system is a is a relatively small lift compared to what we've gotten to.
Already.
In Germany, I would not because it's a question we've had because I think.
Investors are not always or.
More familiar with the U S health care market than the European.
Once we have agreements in place and this should happen pretty soon now.
So there is zero impact even less regarding reimbursement brocade.
Patients I can join in.
In the U S. Even with according to prove it officially aversion to peers.
The times that pieces go through a lot of hoops.
In terms of your statement of medical necessity, they try to sort these out.
When you're a single payer system once the product is approved.
Approved for reimbursement there is no paperwork tiny amount anymore is already based on patient demand.
And in the health care provider.
And our ability to supply them, but we have that.
Okay.
And our next question comes from Joseph Schwartz from SBB Securities. Please go ahead Joseph.
Alright, thanks, very much I have a couple of questions about the steroids that may be used with rock came in it seems like the EMA recommended that physicians use them for a couple of months, which is much shorter than what was done in phase III.
It averaged over eight months and half of patients were still receiving immunosuppression at one year.
How should we interpret this difference is there any risk that this leads to subpar responses in the real world.
Then could you talk about the steroid regimen or regimens that are being studied in study 303, and what do you hope to learn here given its relatively small size short duration and single arm design are there any different scenarios coming out of study 303 that you foresee playing out.
So.
The.
Euro label reflects a sort of reasons conclusion to comparison of.
20, something patients who are directly enrolled into the pivotal clinical trial.
And.
They werent prospectively filed Thats, what separates <unk> from the other 112 patients that were subsequently enrolled after enrollment or whether the trial.
And when we conducted the interim analysis of the first.
917, 20, whatever patients.
And saw factory activities levels that were lower than in the prior trial investigators.
Investigators intensified their use of steroids with the belief that perhaps the transgene last act had losing activity could be recovered with additional series and what we learned was that more assurance isn't necessarily better by just comparing the outcome of those two populations both from annualized bleeding rate, but also factor eight levels at one and two years and so.
When the Europeans looked at the Navajo that data. They saw some is good more is not necessarily better and so they trimmed back to a regimen thats more like.
What you what was what's described labeling.
Calling for a shorter overall exposure to corticosteroids, principally by virtue of less sort of aggressive.
Maintenance as opposed to take rate and therefore, we expect the real world version of this to be actually similar to the trial world because.
Steroids steroids don't make a difference in outcome and lightning on steroids is going to be.
Better for patients.
And more facile.
Now the shifting gears, we said okay well.
There still is this difference between the phase one outcome in the phase three outcome as regards to maximum factory activity and we'd like to understand that a little bit better it wasn't the.
The answer isn't in the intensity of the steroid maintenance once an individual has transaminase because that's essentially a very showed 301.
<unk> is if we started corticosteroids as thoroughly as we started them in the prior trial before the concept would be before the trains out of that has just begun with those patients have higher factory activity levels and would they have a lower overall steroid use because you'd be ahead of it.
That trial is now fully enrolled with data is going to read out in the first quarter of next year.
And.
I'd say that the.
Evaluations that helps <unk> undertaken as exemplified by Europe as that.
This application with the information that's in our hand, we have to come to a conclusion on the balance of benefits and risks.
The available uncertainties and the European Commission came to a positive benefit.
In the absence of the 303 data the FDA has accepted our application in the absence of the 303 data that's a certain number for the quarter for Stuart.
So what do we hope to learn out of that but we hope to learn.
What we've got is good and maybe even a little bit better than where we would've ended if we'd only done heavy steroid version because I think we do we are able to substantially like my thought serious surgery. So we had this pretty good questions can we do better in the main read out of that in 20 patients is going to be like is there a factor.
Activity level more like it wasn't the 301 study the pivotal trial or is it more like in the phase one two study.
Okay.
Okay.
Hopefully that answered it and our next question comes from Gena Wang from Barclays. Please go ahead gena.
Thank you for taking my questions I have two.
You look at <unk>.
For the U S. Just wondering do you plan to submit to the FTE addition of genomic analysis data from the leukemia Keith.
And also for AD com.
Thanks.
As of March 31st 2023, do you expect.
That would be sometime.
Come January February timeframe.
For you monitoring tests, just wondering do you have any.
Feedback from the doctors Mccarty.
Monitoring test it seems like city.
Uh huh.
Lindsay.
Initially we'll be weekly.
First 26 weeks and then it would be every two to four weeks for the next 26 weeks.
Any feedback from the Doctor regarding this testing.
First in whole genome sequence, if we haven't submitted it already it's gonna be snowed at all.
Really create much of a surprise one way or the other at the health authority.
As regards Ed cut that Tom Tony I mean, there'd be entirely speculative to offer what I thought the outcome is going to be and what they might be looking for so that would be useless to do.
And then maybe I'll say something about the monitoring and Jeff can say something about the boundaries.
Thanks.
You know, obviously, everybody would love to swallow a pill or go away.
This is not quite that simple.
But at the same token because most of the labs are fairly routine types of labs, we should be able to put some systems in place to help patients access laboratory testing.
And then it gets tapered.
Patients get.
Further out.
So the docs perception of all of that I mean, especially in Germany. Since we got it. This is what we're supposed to do.
It sounded like part of the deal for that because you step back from that net of all of that screen people and counseling people and whatnot. They live an amazing life after they got their transfer.
Big picture Wise I think.
People are very much wanted to put up with the short term castle.
And then the chance of elaborate but we're going to make it as easy as possible for the <unk>.
Two of these monitoring data we already have some contracts.
At home care supplier suggested we expect yes. Thank you Jean good good observation on the monitoring tank said.
Everybody is interested in a monitoring schedule, but is as modest as possible, but well, while maintaining appropriate safety and monitoring of those patients. So we've extensively researched this is an issue as Hank said.
These tests are routinely available that's not much of an issue. We have we have programs in place to help make testing.
<unk> to patients exam.
Examples would be patients can't get routinely to a lab for blood draws we have programs in place and in Germany, We will in the United States also to help facilitate.
Testing that essentially comes a home or even to the workplace to facilitate convenience.
We think that theres not much more to us than that beyond influencing the buying decision and we think that the.
The benefits on that buying decision are very powerful with respect to costs associated with <unk>.
Monitoring so I think we're in good shape.
Definitely lighter than it once or twice a week when our intravenous Judah.
Factory.
Our next question comes from Paul Matteis from Stifel. Please go ahead Paul.
Hi, Thanks, so much for taking my questions I wanted to just clarify two quick thing on the <unk> TV price in Europe .
Can you just give a little bit more color about what exactly changed over the past say six weeks between when you talked about $1 5 million euros per treatment and now $1. Two five and how confident are you that if you go past, Germany, youre going to be able to hold price in other countries like you have with other products in your portfolio.
And then just on the <unk> review just a quick question for Hank I was wondering how you and the Biomarin management team are.
<unk> are not looking to be FDA decision on the CSO unicare he'd be gene therapy at the end of November .
And what regions, you see under Octavian and where there are limitations there. Thanks so much.
Hi, Paul.
Take a shot at the question on on pricing.
Which is confidential and we have not.
Yes. Finally concluded these agreements as you can tell but in general what what happened.
We determined that the payers that we are negotiating with we're requesting.
Additional discounts in addition to the 7% mandatory but all of our sales in Germany, you need to be rebated back to the German health care system and in addition to our obligations under the outcomes based agreement.
We had previously modeled than expected the GBA to be demanding those discounts.
And so as noted in the prepared remarks, where we think we're winding up is net net a little less than $1 5 million Euro and probably very close to where we will wind up with the GVA with final federal pricing now.
Now the pricing in Germany is usually a benchmark for the rest of Europe and.
Aside from certain named patient sales arrangements, usually Germany is the high watermark for.
Pricing in European market. So one of the reasons is it's important to get that German price.
Establish.
Out in the public domain, when we get that far.
The important point is the fact that.
Basically what we're negotiating now.
The final price of close to the final price, we anticipate do you have in Germany. After the <unk>.
The initial pricing.
The difference.
The.
I'm a failure of the application that spending for the agency with a <unk> date coming up shortly I would say.
Let's talk about two scenarios if they are approved.
Speaks favorably.
If they're not we have to see what the basis of their not being approved was in terms of what it could read in terms of Octavian oftentimes. These are very product specific types of considerations. So there may not be any read through or the reach who may be covered by the things that we've already done so.
Yes.
Our next question comes from Deb Chit chat open high from <unk>.
<unk> partners. Please go ahead.
Thank you this is Robert on for Doug Thanks for taking our question.
A octavian how confident is the company and expanding boxes of Oh, sorry, I'll have Octavian.
How confident is the company and expanding pumps they will go to younger patients.
Incrementally how many patients would this pads and achievable population. Thank you.
So it's a question that was confusing.
So the question of our updated the question.
Okay.
Operator, maybe we'll go to the next question was just trying to get the caller back. Thank you.
Our next question comes from Olivia Brayer from Cantor Fitzgerald. Please go ahead Olivia.
Hey, good afternoon, guys and thanks for the question I want to follow up on Rocky than you guys had been pretty transparent around the likelihood for three particular extension.
Can you give us a sense for what else do you plan to submit between now and March.
I assume it will include through your data, but anything else you guys can give us color on.
And as for the European launch any sense for a number of patients and some of those initial countries like Germany.
That are waiting and ready to go.
Those payer agreements are in place.
In terms of ongoing back and forth with the FDA. They they can't file an application unless they deem it to be complete and sufficient to address the review so we.
We don't anticipate anything specifically.
Because they have an atherectomy specifically because they wouldn't have filed the application that they still have pending request I hope that made sense and then during the course of the review they've been asking for what are called information requests all the time and we don't generally comment on installation requests or they've gone back and forth.
There's oftentimes a variety of different types of questions that come up during the review that it would be possible to share all of that.
So.
But I think the main encouraging thing is that as I said, we dropped 7% vessels worth of data on them and they made their filing decision pretty quickly.
We're encouraged by that.
And on the other question Olivia regarding numbers of patients that might be in Q between our market research and some of the other surveys that you may have seen from other analysts.
There's certainly a signal that there are early early adopters.
That are interested in treatment whether octavian.
We don't have the same ability in Europe , due to GDP or to get a patient specific data like we do in the United States. So our numbers are a little round it and relative.
Relative to our initial treatment centers.
We think that there is certainly double digits Ah patients that could be early adapters.
And the first few months following reimbursement approval that we could be pushing through the system and that doesn't count the.
Second wave of <unk>.
Intended treatment centers and as we've spoken about previously.
A hub and spoke model that we anticipate for Germany and other European markets.
Those centers, which would be characterized as spoke centers that have patients that would be pushing indoors.
Treatment centers so.
So the very tip of the spear, let's call. It a low ish double digits, probably more when we get beyond to the next layer of treatment centers.
And I can make one point of clarification I think.
There was someone who has a question.
Remember, who we say that we determine price net price.
It would be one to $1 million to $5 million at least that's not what we say.
So I'm seeing that.
The person that he came up with so we say it's likely.
Lastly, it should be the final price to be under one five but we can say with one point of that.
We don't know yet exactly where that's been Atlanta.
As we said because we basically are.
Trying to move towards the final the final price.
For Kevin which.
Which we anticipate to be a significant number.
Our next.
<unk> come from Tim Lugo from William Blair. Please go ahead Tim.
Hey, guys. This is lachlan on for Tim. Thanks for taking the question. Brian I was just wondering on the FX you quantified the impact on revenue year to date, but I may have missed this but was there any commentary on the impact of expenses year to date for FX.
Talbot.
It's may track going forward.
Yeah. Thanks for the question, it's a good one.
Obviously quantified revenue given the prominence and actually more of our more of our revenue base is denominated in foreign currencies, mostly the Euro then is our expense base, we do have a decent.
Operating expense level denominated in euro.
Our.
Primary <unk>.
Commercial operations in Dublin.
Technical operations.
Southern Ireland, London Research Center.
But so.
A decent level, but not the same as revenue so I quantified the 3% number for revenue it would be something probably about half of that.
And as a benefit.
Thanks.
Our next question comes from Robyn Karnataka from <unk> Securities. Please go ahead Robyn.
Colorado is your phone muted.
Yeah.
Hey, guys sorry. This is coupons were Robyn.
Thank you for taking my question.
I have a question on a label expansion both per box they'll do especially in the U S. Given that the data you have.
In under five years of age patients you know you saw positive trends.
What's your level of confidence that these data will support label expansion into younger patients in the U S, especially in the context of upcoming competitor data, where the trials are being run in two years and above.
What's your strategy to ensure that walks yoga gets to the younger patients as well and then on the other end of the range I was wondering what's the age of the oldest kids that are getting Rockville go.
Whether it's in U S or EU. Thank you.
Okay.
Yes, so I mean, I think our confidence about engaging in a successful application review with the agency is driven by a bunch of things like the fact that we actually have data and when I talked about when we're going to get data. The fact that it has a pretty safe profile in children.
The fact that that we have a huge and accumulating safety database both in clinical problem and now accumulating in the real world experience treating children with OXXO.
And.
I have said before.
Consideration here is also alluded to the genetic consideration, which is these children are born with this mutation so starting treatment from as early as you can identify the patient is something that's very much on geneticists mind all the time.
Whether you are a geneticist at the at a university or a geneticist with the SBA.
Recognize the contribution of genetics of the condition.
But that's a pretty significant motivator and.
And then maybe the last thing to say is that.
With the approval of the first approval with an initial group of Blackstone is in older children I think.
Agency.
Little bit more latitude around things like trends.
The biology of so consistent across the age range.
And if I may ask.
Decline in F&B.
Jeff answer the question on the oldest patient treated.
Can we just we just communicated that our youngest patient ever treated with three weeks all of a sudden we don't believe that or any of our competitors are collecting data on patients under two years of age. So we have significant data.
On a two years of age and now we're going to gather commercial data.
And the kids.
Yes.
She won't keep the Utica user base, so two to three months so with that.
Jeff you want to answer.
Yeah happy to so.
So we know that our we think we know that in some ways the value proposition for treating as early as possible trading for a long time.
Very powerful also noted that where we have the data I've been surprised that the diversity of ages of kids that have started therapy, including kids that are in the eight to 10 Euro range.
Adolescence, and even kind of laid out adolescence. So theres a lot of diversity we've got.
Diversity of kids that are starting treatment being treatment treated that said, where we have been able to measure <unk>.
And now that we've got an accumulation of material numbers of patients. It is true that there is a gradient.
We've got more kids treated in the younger age segments than we've got treated in the older age segments.
And so I wouldn't say there was a hard cut off anywhere but.
As they get into those older groups.
The numbers are less robust than the younger groups, which is probably not a surprise to anybody.
But to enable allowed us to treat until closure on the growth rate.
Chris generally occurs between Asia.
Third key 16, 18, 60 day itself will earlier on girls and boys.
The product is approved for Yum restaurants until 16 to 18 years of age now one of our one of our clinical trial patients.
That is a featured in our promotional materials.
<unk>.
It was 14.
The time that she was photographed for those promotional materials, she's probably 15 now.
And illustrating that kind of adolescent age group that can benefit from from treatment.
Okay.
Our next question comes from Joel Beatty from Baird. Please go ahead Joe.
Hi, Thanks for taking the questions for rock Canyon with the economy in person and also Florida Octavian.
Post operation going for the lines with regards to establishing centers to administer the drug commercially.
Okay.
Sure.
First of all your question was whether the outcome would be 8% yes.
Yes, everybody I've asked yes.
Sorry, the FDA has been continuing Ed comps by video teleconference.
Our expectation would be not because they've always always one you're going to have an outcome, but based on recent practice.
The expectation is that it'll be by video.
So sorry.
I'm not sure I got the second part of the question was what about launch prep and site readiness in the U S and the answer there is we have a <unk>.
Sales team.
Obviously, they can't promote rocket Ian but they can be doing things like site readiness supported by M. S sells in the United States.
So we've been targeting the largest treatment centers in the United States to educate about gene therapy.
Do site readiness types of activities and we think that we're going to be ready to go on that front like we are today in Germany should we be getting an approval on March 31 of next year.
Not on issuance.
And our last question comes from Luca <unk> from RBC capital. Please go ahead Luca.
Oh, great. Thanks, so much for squeezing me in and maybe apologies circling back on the question, but that wont be your best guess at this point your best guess for the timing of the odd comp I think three years data is coming in November to steroid data is coming in February is it fair to assume that the FDA will want to wait for both data set before.
At Com or do you think that you will have an AD com ahead of either of those datasets any color there would be helpful. And then maybe on Doug's Jojo can you just remind us the timing of conversion to full approval based on full adult height, and maybe bigger picture on simplification implications for your competitors. Thank you.
Ooh I'm going to leave you.
Little bit unhappy because on the on.
My Best guess is like who cares.
Even my family doesn't want my best guess.
It's just you have just too speculative at this point to talk about.
The types of <unk>.
Questions that there are a variety of recent solid advisory committee and exactly what reasonable is the agency is decided or even what they are.
Youre going to bring to the committee is you don't know until you know it.
But it's not useful to speculate about that.
A little bit the same answer on <unk> a little bit.
Uncertainty here that we can't really comment too much on it.
Can you just maybe on Doug's I'll go talk about implication should you get full approval for your competitors. Thank you.
Well.
I mean, that's.
Think there's sort of two conversations one is.
There is a time of events that have to happen to convert to full approval and we're playing that a little bit closer to our test for potentially competitive reasons in terms of what's required.
What is required is fairly well spelled out in our agreement with the agency.
Summarized.
Publicly communicated post marketing requirement for the application.
So and so that's one subject the other subject is as a general matter if there isn't indication for <unk>.
Product.
Is that a slowly improve and there isn't an accelerated approval option available so.
For example, about Sogo product X was indicated to improve final adult height.
Fully approved it wouldn't be possible to get an approval from on the basis of annualized growth velocity for example.
At this time there are no further questions I would like to turn the call back over to chairman and CEO J J P enemy for closing remarks well. Thank.
Thank you operator, and thank you all for joining us today, So our records.
Year to date results underscore the strength of our brands and execution across the organization at the end.
You've made is the addition of OXXO go to our commercial portfolio is an important component of our growth story.
And paves the way for our transition to sustainable GAAP profitability, but this year and beyond.
So we look forward to the European.
Also rooted in this quarter and to potential approval in 2023.
Combined we believe OXXO allocators will drive substantial value for our patients our employees and our shareholders. So thank you all for your continued support.
We look forward to seeing you said.
This concludes today's conference call. Thank you for attending.
The host has ended this call good.