Q3 2019 Earnings Call

Ladies and gentlemen, please standby today's conference is scheduled to begin momentarily until that time your lines can be placed on hold thank you for your patience.

Again, ladies and gentlemen, please stand by today's conference is scheduled to begin momentarily until that time. Your line is one that can be placed on hold thank you for your patience.

Good day, ladies and gentlemen, and welcome to the immune cell Therapeutics third quarter earnings call. At this time all participants are in listen only mode. Later, we will conduct a question answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then.

On a touchtone telephone as a reminder, this conference call is being recorded thank you.

I would now like to turn the conference over to your host makes PTCL Vice President of Investor Relations. Please go ahead met him.

Thank you Katrina. Good afternoon. Thank you for joining us today to discuss Mr. third quarter 2019 financial result, and operational highlights.

Today's call is being webcast a replay will be available on our corporate website aim in dot com.

Joining me on the call today are Dr., Jason Dallas, President and Chief Executive Officer, Andrew Oxybate, Chief Commercial Officer, and Eric Bjerkholt, Chief Financial Officer. After prepared remarks, we'll open the call for Q and I.

Before we begin I would like to remind you that during today's call and too many session, we will be making forward looking statements.

These forward looking statements include Amiens expectations regarding potential benefits of pulp words here, including potential benefit for patients caregivers and Allergan [laughter] potential approval of California by the F D and E Bay, including approval timeline.

Central commercial launch of California, including launch timelines the potential rems from housewares, yeah, the potential receipt of comments to the M&A. The first potential markets in Europe , the timing for payers in the United States ads or is it formulary potential timing for completion of enrollment for Amy phase two.

Clinical trial for air to one the sufficiency of aim is cash resources Amy's ability to access an additional $130 million from its credit facility and amy's expectations regarding potential applications at the codell approach to treating life threatening food allergies.

Risks and uncertainties that contribute to the uncertain nature of the forward looking statements include the expectation that amiable need additional funds to finance operation a man's or any of its collaborative partners ability to initiate indoor complete clinical trials.

Unpredictability of the regulatory process the possibility the AG is or any of its collaborative partners clinical trials.

Well not be successful.

He means dependence on the success of California, the reliance on third parties for the manufacture of our product candidates.

Possible regulatory development in the United States in foreign countries in any his ability to attract and retain senior management personnel.

These forward looking statements are based on assumptions and are subject to risks and uncertainties that can cause actual results to differ significantly from the state. It on this call.

Given these risks and uncertainties you should not place undue reliance on these forward looking statements.

Please refer to the company's quarterly report on Form 10-Q for the quarter ended September 30, 2019 for some of the important risk factors that could cause actual results to differ materially from the forward looking statements made on this call.

Except as required by law immune disclaims any obligation to publicly update or revise any information to reflect the events or circumstances that occur. After this call.

Finally, I'd like to point out the Indian food allergy treatments are investigational and are not that FDA approved.

And now I'll turn the call over to Jason.

Thanks, CD and good afternoon, everyone. Thank you for joining us today to discuss all third quarter financial results come from operational highlights.

As a very exciting time for us as we're working closely with SPD to complete the review of the BLE propel fawzia.

If approved portfolio would be the first and only approved treatments for any form of food dollar tree, we look forward to offering a potential ft approved treatment option to the millions of children's and teens peanut allergy their families and the physicians who treat them.

Of course, we could not have done any of those without the patients caregivers investigators and the entire food allergy community, who participated in and supported all clinical trials.

Our immensely grateful to all of them.

I'll call today I'll review some of our achievements this quarter, Andrew will discuss how launch preparations and Eric will review the third quarter financial results.

As most of you know on September 13, the FDA Allergenic products Advisory Committee or apacs met to discuss and make recommendations on the safety and efficacy of California.

I'm delighted to reiterate that the apacs vote at seven to two that the efficacy data an eight to one safety data in conjunction with additional safeguard support the approval of California.

The FDA has requested the implementation of a risk evaluation and mitigation strategy for Rems program. If helpful. As there is approved.

The rents will help support the safe an appropriate use of portfolio.

As part of our original ballet submission, we proactively proposed a number of risk management matches that were consistent with the conduct of our phase three clinical trial protocol. These risk management measures form a cornerstone of the ramps.

Since the a pack meeting we had been working with the FDA to finalize the details of the Rob I do not expect its implementation to have a material impact on the timing of call forces approval.

Patient safety has been central to our since the beginning of portfolios development. It has undergone the same rigorous clinical development required by the FDA any drug candidates seeking regulatory approval.

As a result, we have generated at the largest most clinically robust database ever assembled for therapeutic approach to peanut allergy with over 1200 patients and I'll trials and well over a thousand patient years of experience.

Yeah approval would be significantly added just under a peanut allergy patients for I was just how foresee would provide a clinically validated pharmaceutical grade oral immunotherapy. Each dose has been precisely measured in sourced and manufactured to minimize lots a lot variability.

Oh patients from there can you give us portfolio would be a prescription therapy that is covered by insurance and administered by analysis to support it safe inappropriate use we will also support surfaces to patients and families to provide information promoted herons and ensure access. These services will include a variety of educational materials dedicated call Center.

A co pay card for eligible patients and price delivery options in consultation with their physicians, although we have not yet disclosed to price we intend to price thoughtful is yet to reflect its value as a biologic all immunotherapy that has undergone rigorous clinical development is manufactured under GMP standards and provides the infrastructure to support streamline patient acts.

Cissna systems.

We continue to educate the outages community as we as we generate present on publish portfolio data.

As outlined in our press release last week, we would be presenting data from more than half a dozen studies at the American College of asthma allergy and immunology annual scientific meeting taking place this week in Houston.

We will present additional safety and efficacy data on portfolio as well as real world insights regarding the implementation of Ireland in a therapy in clinical practice.

In closing I'd like to provide a brief updates on our regulatory process with powerful portfolio here in Europe , and our ongoing clinical trial program.

The European Medicines agency or EMEA is currently reviewing the marketing authorization application that we submitted in June we expect to receive the day 120 questions. This month and given the standard overall review time as 12 to 15 months marketing authorization in Europe could occur in the second half of 2020.

Upon approval, we expect our first European launch to be in Germany.

In September we submitted an application to Swissmedic the authority responsible for the authorization and supervision of therapeutic products in Switzerland. The standard review parents for Swissmedic is approximately 18 months.

Andrew will provide additional information our launch preparations in Europe .

Our phase three Poseidon trial evaluating the safety and clinical efficacy of pitfalls are in patients between one in four years of age continues to enroll and finally as we have previously announced in August we dose the first patients in our phase two clinical trial for patients with technology and we continue to enroll the study we expect to complete enrollment in the second half of 2020 .

I will now turn the call over 200.

Thank you Jason.

And they start with a with a brief apology.

I'll be bustling I had cooled and does fluctuate with a bit of a sore throat. So appreciate your indulgence in and listening to me.

I can assure you that's all I feel much better than I sound.

So as Jason mentioned this is an exciting time as we prepare to launch our first medicine. We're building a strong commercial organization, which has been specifically designed for Paul forces launch opponents potential FDA approval.

I mentioned on the loss cool the three critical areas, we have focused on.

Ensuring we have the best people in place to successfully introduced call force here to physicians and patients providing tools and resources to support the safe an appropriate use of California, and understanding the patient physician and payer communities.

We are finalizing the hiring for all of our Peachy field based approaches account manager roles. We've had over 5000 applications for these h. positions. We work that we were able to be very selective about who we hired the prices account managers or problems will work closely I will just and that seems to train them on the implementation protocol.

So the patients physicians and their office stuff, how positive safe experiences with powerful here. When we were recruiting we look for people with diverse skills, which were broader than those of traditional pharmaceutical sales representatives. Many of our highs of experience and specialty launches marketing market access patient services and commercial.

Operations.

Addition to experiencing fuel based sales rose.

As you know we were informed by FDIC just prior to our Advisory Committee that we should plants implements a formal rems program propel force here.

Even with the short degree and advance notice I am pleased by the incredible speed of execution and flexibility from both our internal team.

And departments to accommodate these requirements into our commercialization plans and as a result, we saw anticipate being able to launch Paul Fawzia. It approved January 2020 .

We just launched timeline in mind, we have set the employment start dates for our products. The company such as as January 2nd we have a rigorous training program develops on both.

As a reminder, with these 80 pounds, where appropriate resources to be able to cover the approximately 5400 Board certified I was just in the U.S.

Launch Archie more focused on supporting the 1300 oncologists, we have identified as a physician's most race, we initiate costs was the therapy soon after potential approval.

Our market access team has met with payers representing over 90% of covered lives. We continue to work with payers to help them understand how the product will be prescribed and administered biologists and stifel onto the appropriate patient propel fawzi will be.

While pays understand the unmet need we are addressing we expect the portfolio will be gradually audits formulary over the course of 2020 as pay a PNC committees meat.

Pricing inclusion on formulary, so powerful as it would be available volume medical exception.

We are establishing a patient support hub, which will provide products information and assistance navigating the California initiation process. This will consist of individual say with case management that provides a person on the phone to handle patient queries adherence programs and reimbursement support.

We also plan so for co pay assistance cost to reduce out of pocket cost for patients as well as a patient assistance program for qualified patients who are either uninsured or underinsured.

As part of our launch preparations we have can talk to significant amounts of market research with patients and that can give us as was the physicians who treat.

We recently completed a quantitative survey of 122, U.S. knowledge is with varying levels of experience with immunotherapy in order to better understand the unmet need for patients with peanut allergy and assess allergists potential use of California.

I'd like to share a few insights and learnings from the survey.

First 78% of all respond to said they are interested to know ITC to treat food allergies second amongst each physician respondents who do not currently administer oh I see.

There is strong agreement that there is a high unmet need in pediatric peanut allergy patients. The main reason. They currently don't provider like see is because there are no actually approved Archie therapies available.

Third nearly 60% to physician respondents are willing to prescribe for your rights away with only some of that patients, 31% said they would be willing to try after learning more about it.

The small minority indicates that they would wait and sold has grown the market for a few months and they have seen some preliminary usage data alderwood weights and switch is covered by insurance.

We also wanted to evaluate the readiness of the practices to administer California and there were two key takeaways.

First 99% said they currently have patients for 17 years of age, whom they treat with allergy shots.

This means that offices are physically sensitive to offer immunotherapy observed patients after dosing.

First off trend to administer punishment if necessary.

And second 90% of physician respondents report that that practice as a designated observation area for patients well being monitored.

We realize administering Oh oxy will require a modification to the existing work flow. However, we are encouraged by these data we feel the dates we are presenting on practice logistics at the college meeting in Houston. This week will support these findings as well.

Finally, we're making good progress in our initial European commercial pulled out.

As we previously announced we submitted our hey to the he May and June .

Application for Switzerland to Swissmedic in September .

Upon authorization.

First European launch market will be Germany, I noticed support is priority market, we have hired and Onboarded. Both the general manager the medical director for the Germany, Austria, Switzerland markets, there will be providing that's to be building that.

And preparing for potential launch in the coming months.

And with US I will turn the call over to Eric to review the financials.

Thank you Andrew.

We ended the third quarter in a strong financial position with 200 million of cash cash equivalents and investments compared to 304 million on December 31st 2018. The decrease primarily reflects net cash used in operating activities, partially offset by cash provided by financing.

Tivity, including net borrowings from our debt issuance in January 29 team of 36.1 million. We expect that this loan agreement plus cash on hand will fund the launch of California and progress our pipeline.

For the quarter ended September 30, 2019, net loss was 64 and a half million compared to a net loss of 51.7 million for the comparable period last year.

On a per share basis net loss for the quarter was one dollarsthree compared to 89 cents for the comparable period in 2018.

R&D expenses for the quarter ended September 30, 2019 were 30.6 million compared to 31.7 million for the comparable period in 2018. The decrease was primarily due to the completion of certain power for jet clinical trials, which was partially offset by higher costs really.

Got it to regulatory activities and increased contract manufacturing cost to support to potential commercialization of California, as well as costs related to the phase two clinical trial for air to a one.

General and administrative expenses for the quarter were at 34 million compared to 21.3 million for the comparable period in 2018. The increase was due primarily to additional employee related costs and external professional services as we continued to build our infrastructure to support.

The development and potential commercialization of California with that we will open the call for questions.

Ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone. If your question have we been answered all your with your move yourself from the Q. Please press the pound Keith.

For your first question, we have Charles Duncan from Cantor Fitzgerald. Your line is open.

Hi, guys first of all thanks for taking the question and Jason and team Congrats on the progress in the quarter.

Looking forward to next year, but to had one question on commercial and then one question on the pipeline I wanted to ask you regarding the commercial question. This is kind of the belva attempt at looking at pricing, but it really is a bomb pharmacoeconomic value and I'm I'm kind of wondering if if you have now.

New information that would impact your thoughts on that relative to say earlier at this fall.

Perhaps even the discussed rounds at the recent AD com or a device skin.

You know really refiling any thoughts on pharmacoeconomic value for Pell fours years going into a possible launch next year.

Yes, Thanks Chaz.

We have actually done quite a lot of work on the Pharmaco economics beyond just pure pricing and price setting.

This is an area that both commission some payers so very well use to there's a lot of reimbursement therapies, both to treat other kinds of allergies and to treat the complications and adults of allergic reaction.

But that being said I don't think we'd run anything fundamentally different over the last few months of I think every every piece of guidance. We've given in the past remains true, but let me hand over 200, Yeah. I mean for Jason. This is correct, we've been continuing to build on an economic model that we.

I would pay as we have discussions with them, but there's nothing fundamentally new that we've uncovered over the past few months in regards to them.

But it sounds like you have pretty firm understanding of Pharmacoeconomic failure and ready to launch should it be approved anytime soon.

Yes, we do and I guess, what I would say with regards to price chances that.

We've conducted research and we Brexit the research.

Between two sort of downs, the low down being.

The price point for the split therapy, which is out there today, which covers non life threatening conditions, which is somewhere between three and a half from $5000. The off trend of the research that we tested was the launch price point for us in the biologics, which is around 20000. So we've tested in between those two those two bounds and.

We feel that we've got pretty good understanding of what the appropriate price point will be based on that research.

It's very helpful. Appreciate that added color regarding the kind of pipeline question that I had this may be looking way way out ahead, but I'm kinda wondering as you as you think about application of that of the basic paradigm wondering as you as you look at mall.

Not allergy, how does that really differed from peanut allergy in terms of severity prevalence and maybe technical challenges that you could see and could we see an I'd for multi not in in 2020. Thanks, Yeah. So let me sort of take the middle piece of that first which is the prevalence of.

Multi enough so allergies to the composition of tree nuts, which is really walnut Hazel not.

And cashew with sort of.

Co existing relationship coexisting allergies to be cons into pistachios.

Is about as a group as as prevalent as peanut allergy is and so we see it as a sizable opportunity.

I think as much as we've been groundbreaking and innovative in terms of potentially now, bringing the first ever treatment for food allergy to to the market with Paphos here, we're trying to be even further.

Even more innovative if you like with with our multi not program by trying to actually bring one therapy that has all of those.

Not together in one place right and so this this both from a technical perspective and from a regulatory perspective is a gain yet another new paradigm, so where we're at now is actually trying to.

Physically makes a product that is stable and that is reliable enough for us to be able to think about it can go into the clinic and we think thats going to take us about the bulk of 2020, so I would not anticipating a 90 until the end of next year, there's a lot of technical complexity to this but.

If anything changed the way to think about this as we've decided to go a little slower upfront to go way quicker at the end because if we did each of these knutsen series it would be five or six different products over a course of many many years and the wed like to actually have a single solution that comes to market as a company that a little bit quicker than that whole process would take.

It makes sense to me and appreciate the added color. Good luck with the upcoming final review.

Thank you.

Next question is from Chris Raymond of Piper Jaffray. Your line is open.

Hey, Thanks, guys.

Just a couple of questions first I guess on access so we ran across a webinars put out by the American College, if allergy asthma immunology that I think you guys sponsored actually that walks through pretty detailed reimbursement coding throw a T.

Just curious can you.

Can you walk through the mechanics that you anticipate once approved for coding for reimbursement propel for his yet when we look at this at the materials. These codes look pretty comprehensive I guess you question is do you believe there's sufficient really for docs to be able to get.

Reimbursed pretty easily like on day, one up launch.

Or is there some sort of interim period, maybe where though there will still be barriers and you'll have maybe more of a have a tailored coding system or something like that in place.

You'll give us some perspective on that thanks.

Yes, Hi, Chris it's on returns thanks for the question so.

You're correct. So the college put out some guidance I think it was end of August only September around coating that they would recommend for the various stages of administering.

Oh I see immunotherapy.

Worth reminding that today with food a light see there are number of codes that are used out and so.

Our role is not to provide guidance to walk codes to use but to us at those educated outages as to which codes.

Our available either because they've been recommended by the college or currently being used today for food a wide C.

We're very confident the codes that exist.

We will be used can be used on there's also some discussions between the college in the Academy, which are the two professional bodies representing outages in the U.S. around aligning on codes that they would recommend together those are ongoing discussions and those those are not discussions of which were a paul but we are what those discussions are ongoing and so.

As though those codes on developed to not because some consensus is reached thus further alignment on its own even more specific codes that could be used Chris just sort of at a very high level. We don't anticipate that we need to have anything new out there for folks to be able to prescribe the gate.

As we look at it because the actual mechanistic. So this whole so similar to schedule subcutaneous immunotherapy codes that are traditionally in standardly used in the I was just office for those therapies will translate quite nicely and I think actually if you look at the college guidance, that's pretty much what it says.

Okay. Good and then just on the you guys talk a lot about helping allergists worth the work flow and the anticipated patient flow once approved I think I've heard you guys talked at length about having this initial 1300.

Physician target I would imagine you don't want to give a lot of details on this but can you just give maybe give some general.

You know sort of flavor for where where that 1300 dock population is in terms of having you know work flow.

Readiness, if you will.

Discussed, perhaps even some of these.

The next changing around there the walls and and specific.

Yeah ways that their offices are designed.

How extensive is that.

Yes, so I guess, the 1300, probably device once it into two broad categories. Chris. The first is you've got about 200 $250 just worried that processing some form of food artsy today or involved in our clinical trials and so that pretty much set up from ready to go into their comfort.

Bone familiar with the protocol and what would be needed the remaining group.

It really just depend on the on the individual practice in that particular physician in some cases, it's understanding what the space requirements all to allow the observation of patients and so making sure that either golf communal waseem area or if they prefer some some individual waiting rooms patients in other cases, it may be that they need to add some nursing.

And start to be able to help.

In other cases, it may be just office staff to help with some of the processing of the paperwork in the medical exceptions in prior or so.

It just depends on the practice and we see our jobs and make sure that will facilitate seen some best practice sharing between people that are doing it people that are getting comfortable with it and those that once alone how to do it.

And so that will evolve as we launch the drone.

This is maybe to add one thing to that Chris is that this is the too. So the two segments that makeup is 1300 already the two segments, who essentially are both willing and ready to initiate therapy. Now there are largely high throughput skit census, and so their ability to do high volume immunotherapy.

Procedures is already in place and so it's more of a fine tuning exercise in the practice and that's exactly why we pick them as our launch population I would just sort of interest point you to one of the posters that we'll be presenting at the college meeting in Houston over the weekend, which actually looks at the real world implementation of our immunotherapy versus get in this kind of.

Axis and just kind of an interesting read because it shows you at a high level that there's a lot of similarity.

Great Okay, and one more question if you don't if I might.

Just noticing a or to a one I think last time, you guys talked about it last quarter.

Enrollment was I think anticipated be mid 2020, and I think you guys are now describing it as second half can you maybe talk about is there any issue or challenges.

Specific to AG allergy versus peanut or is this just.

Just a normal.

Sort of wrinkle.

I think this is I wouldn't call. The wrinkles is kind of normal variation right. This was still early in the recruiting process here, we don't yet have all of the sites up and running and as we sort of loan from the sites what it takes to get patients and we will sort of revise our timelines. There is one added level of complexity with the AG program and that as they are actually to food challenge tests that has to happen with each of these patients. So.

Because there are two kinds of AG allergy.

An egg allergy to any kind of AG products versus an egg allergy only two eggs that are.

But are not baked. So there are population who are not allergic to baked AG, we actually have to do to food challengers and test them with both raw egg and baked AG preparations and slowed slightly more complex study.

And it's really important to do that because we have to tease out.

Powering of the study to ensure that we have sufficient representation of both components of the AG allergy and so I think it's just sort of normal tweaking tweaking of expectations as we as we learn about recruiting these patients, but there's no fundamental issue.

Great. Thanks, very much guys.

Next question from Kennen Mackay from RBC capital markets line is open.

Hi, This is Justin on for Ken and congrats on all the progress and forward momentum this quarter.

Quick question for us funds sort of the yeah.

Wait list that you guys have seen out there we did a recent physician check that.

Highlighted about 2000 patients.

Or sort of ready to go upon potential approval for California granted that's at a major health care center unlikely an outlier at the high end. We're just kind of wondering what the feedback is you're getting from the 1300 physicians that you've been in contact with and if you know they've also got weightless and if those are sort of in the dozens or.

Most of the hundreds.

Sort of what that pent up demand kind of looks like.

Yes, Hi, Justin it's Andrew.

Certainly what you've just shared is consistent with the conversations that we've also had with physicians when in 2000 and certainly be towards the high end.

They are all academic centers out there, which do have pretty large waiting list of there in the thousands you also have smaller allergy sensors, which.

It's more modest waiting lists and these are the dozens or the low hundreds that said the consistent theme is that if you look across.

The physicians that we talk to particularly those that.

Really ready and waiting too.

Prescribed the therapy upon approval.

There are all waiting list and there is a pent up demand for patients that would like to go on this product.

Anything else Justin.

No that's it thank you.

Okay. Thank you Doug.

The next question from Brian's question from Baird line is open.

Hey, good afternoon, guys. Thanks for taking my question on building a little bit off of Chris questions on reimbursement coding <unk> can you talk a little bit about how you envision covered working here with the Rems requirement first around specialty distribution or each of the escalation dose is going to be provided by the allergist their office.

Take home the the remainder of that those should the home and then when it switches and we'll meet more maintenance therapy.

Envision this.

Something that you can pick up the full dose.

At Cvs and how do you think insurers.

Kind of look at the true to the different payment models will the payment.

Burst.

Same level, whether it's <unk> ministered and given on the.

Vision, leaving the office or whether it's picked up in CVR.

Well so.

Great question, we have since the the development of the program really.

Then been planning on the specialty pharmacy model to distribute this product for a number of reasons, including the patient experience, but also keeping in mind.

The the safe experience for the patient and so.

The rems requirements, even though there are some additional things that we need to work through in terms of reporting.

The distribution portion of that is entirely consistent with the use of the specialty pharmacy model and so whether they're in the initial dose phase of the up dosing phase or the maintenance phase.

The plan is that we will continue to use specialty pharmacy to discrete products of patients.

The straight to the physician's office or to that the the patients home.

And I just would make the point, Brian that we talk about having built a number of the components of what is now the Rems program into our initial BLE submission and in fact this distribution model has been what we've planned all along one of the things that were very very conscious of as we think about particularly the up dosing phase is the risk that any into.

Vigil single patient has more than the dose that there on that exactly that time in their possession and we've created a model where that never happens on that there's some.

A number of checks and balances in the process to ensure that that doesn't happen.

Thanks, Chris the only other thing I would add as well just getting back to your point of your question around so the pricing differences.

At different points in the dosing procedure.

We have we've guided to this point, though we are looking at a flat pricing model, so that regardless of whether a patient is whether some of the up dosing phase or in the therapeutic maintenance dosing phase.

The price will be the same and so the distribution will be the same and this should be no difference from either the patient all the to pay perspective.

Great and then maybe just as a follow up on sort of how.

Then in initial launch goes when you think about the conversion of Allergist currently administer some form of all I'd versus those who haven't.

Adopted it as a treatment I mean, what level of work is involved in terms of training physicians.

On California, how different it is for those two different kind of treating physicians and you're going to see that as.

Somewhat of a rate limiting step.

The option in the beginning.

Well I certainly think the.

There will be some training upfront.

Positions that have not administered this before as we indicated earlier that a lot of the physicians. The reason that they haven't administered as because I've been waiting for an approved therapy to be able to stall.

Oh I see in so.

We will provide the training both through our process account managers as well as by facilitating some some peer to peer programs and best practice sharing from those in that sort of 200, a 250 number which offered practicing some form of allied see today. So the group, which are ready to go but need some of the initial training and so.

Next on how it's done the other thing I would say is that as we've consistently said, there's a there's a pretty good analog between the administration of shots for environmental allergies today and Hello, It's you will be administered I'll pull forward here is administered so.

Even though there's some training required around the specifics.

Certainly we don't think it's going to be acute paradigm shifts and many of these folks that have been processing environment lousy shots for a number of years now.

Great. Thank you that's very helpful.

Next question from Avon's second from credit Suisse, ladies Okay.

Oh, Thank you for taking my question Congrats on the progress I'm just one on how we should think about expense next year in terms of commercial ramp any color as to what type of expense guidance, you want to give or not guidance, which is how to think about the investor needs to make as you launch, California.

And then I've a follow up question.

Sure.

Hi, Kevin, Yes, sorry expenses next year, well clearly shift from R&D to commercial but with the expected revenues that we do anticipate that the operating burn next year will be lower than what we've seen this year.

Okay.

Okay.

And then my follow up question in terms of the potential launch in Europe . I know you had mentioned updates regarding your appetite. Your M&A application. You know is the physician demand in that are banned for an oil keep product for peanuts similar in Europe . What is your market research challenge, we can talk to frame that but.

Central opportunity.

Well I think I think it's it's it really depends on the on the particular country. Evan. So there are some countries in France is a good example, which we think is a really good opportunity for this drug where there are some use of food, though I'd see today by people a processing allergy. So that's a market where.

Much like the U.S. will be going in with a group of physicians are already understand not just.

Disease, but also how to to use.

Therapy to treat it on the other a on the other hand, there are other countries and Germany is one where denise more application around.

On the therapy as a way of treating this and so it really depends on the particular country. We're very bullish about Europe as an opportunity we think it is.

A longer term opportunities you just because of the fact that some other countries will go through some of this education that I mentioned, but.

It really depends on a country by country basis, and just to be quantitative. If you know there are 32 countries. When you talk about Europe and vast differences between them, but in the top five markets in Europe . We have about the same prevalence in terms of patients between four and 17, which would be the indicated population as we do in the us about a million in the hofh patients and so it is not a whole lot of difference between.

And that we do see big differences when we start looking at Asia.

It's just slightly less common but the need in Europe is just as high.

Sure and our phase three trials enrolled really well in Europe as well, so clearly the awareness and an unmet need.

Excellent. Thank you very much for taking the questions I appreciate it.

Thank you.

Next question from Paul Troy from Goldman Sachs Line is open.

Hi, this is conjecture.

Paul having the same thing could you talk a little bit about what kind of size you expect to need for sales force in Europe , and the cadence you could see with regard.

Commercial footprint there.

Yeah, and I suppose I would also direct you packs are they also we just gave around the.

Dependence on the actual country itself, so for a country like Germany, which is about 85 million people, obviously need a bigger sales organization, but it's still a fairly concentrated sub specially physicians that are prescribing. This and so you're talking about a pretty modest a magical number of people we'd have in the field.

Ports that group and then as you go into smaller and smaller countries you'd be talking about much smaller low single digit numbers of people in the field and so we think that Europe is something that's very manageable again because of the very focused number physicians that would that would treatments in preschool prescribed California and current.

Maybe one other consideration is just if you think about the timing on the staging of resource deployment right. Because really you get approved we do we got approved in the second half of next year. Your initial launches in Germany. It then takes at least 12 to 15 months to work through the reimbursement process in the in the other key markets and we will be extremely thoughtful about resource to plan.

Went in the stage fashion really kind of gated on certainty or higher degrees of certainty that you're going to get reimbursement as each of these markets. So that was sort of thoughtful about how we deploy resource rather than just casting a big footprints across Europe propagate.

Great. Thank you.

Second question is from Delek <unk> from Stifel line is open.

Hey, Thanks, guys.

And on the line and that's kind of touched on this but is there any more feedback that you guys can share from docs that you've heard from year reps right now thanks.

Well I would say ban is that.

The feedback continues to be this is a medicine that lot of physicians have been waiting for we indicated in some of our opening statements.

There is.

The main reason that a number of physicians have not been prescribing aloxi for patients to date is a lack of an approved therapy and so there'll be something approved that they can treat the patients with is something that they're very much looking forward to.

So our.

Focus is going to be very much on working with them and supporting them to understand how to administer the profit safely and effectively.

Yeah, So Derek just to be clear, we don't we don't actually have reps in the field out at the moment to have an MSL team up about 10 sales yeah.

For about a year right a how things on the floor, but that is really are complemented with some quite extensive physician research that we've done in physician segmentation work that we've done and I think the assumption that all outages behave the same is something that a while ago. We realized it's just not true and there really are discrete segments of Alan just in terms of both the way they treat patients.

And the way they think about oral immunotherapy, we've consciously decided to focus our launch effort on what we think of the two most ready segments, Oh, I see those who already doing it and those who tell us they are ready and excited about doing of not just waiting for an FDA approved option and to have high throughput clinics. There isn't started a third segment that we kind of see us phase two.

Well, we think our MSL sort of move into as we bring the commercial team on board to cover those first two segments and that's a population who are really willing to treat that maybe have a little more to learn about how to implemented into their practice and so we kind of see this in waves and on our whole approaches to sort of go to a place where are we going to sort of get early utilization for us and then go down into the.

The rest of the allergy population over time and there is no question that when you see a new therapy come into a therapeutic area that hasn't had a solution before that as that is exactly how it happens in any case right. There are folks to sort of wait to see what happens when you kind of want to address those folks once you've got really good experience in the practices, who are ready to adopt early.

So it's kind of way of saying there isn't there isn't really want to answers. Your question, it's really quite dependent on how you think about segmenting the population.

Got it thanks for the infill guys appreciate it.

Thanks there.

I'm showing no further questions at this time I would now like to turn the conference back to Dr. takes in Dallas.

Thank you so much.

Just to sort of summarize this is indeed, a really truly exciting time for us here at Aimmune as we potentially got close to bring in the first ever FDA approved treatment to children adolescents with peanut allergy Paphos here, if approved would be the first and only ft approved treatment for any kind of food allergy and they were really excited about that as we prepare for potential commercial launch of helpful.

As there were building out a commercial organization that other supporting functions in both the U.S. and Europe , and we've been able to attract extraordinarily talented individuals to help us in this important mission. We therefore have the resources both in terms of personnel and finances launch portfolios if approved as well as to advance our pipeline finally, I would like to thank the entire food.

Allergy community, especially the families who have participated in or a continuing to participate in our clinical trials without whom the progress. We've made to date would not be possible and I look forward to speaking with many of you in the coming weeks and months. Thank you very much.

Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.

And.