Q4 2019 Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the Aimmune fourth quarter 2019 earnings Conference call.
At this time, all participants' lines when I listen only mode. After the speakers presentation, there will be a question and answer session.
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I would now like to hand, the conference over to your speaker today, DD She'll Vice President Investor Relations. Thank you. Please go ahead ma'am.
Thank you operator, good afternoon, and thank you for joining us today to discuss Amy in fourth quarter and fiscal year 2019 financial results and operational highlights today's call is being webcast and replay will be available on our corporate web site at an immune dotcom.
Joining me on the call today, I got to Jason's, Dallas, President and Chief Executive Officer, Andrew Oxybate, Chief Commercial Officer, and Eric Bjerkholt, Chief Financial Officer. After our prepared remarks, we will open the call for Q and aim.
Before we begin I would like to remind you that during today's call and culinary session. We will be making forward looking statements. These forward looking statements include a means expectations regarding the potential benefits of California, the commercial launch a pill for ziad, including the timing for specialty pharmacies to be ready to dispense, California timing for payers in the United States to add.
Now for the to formulary and timing for proportionate to be available in the market the timing of potential approval upwards. There by the he may and Swissmedic potential timing for completion of a means phase two clinical trial for a our to a one potential timing for completion of enrollment of our phase III side and clinical trial for Paul for via the sufficiency of Amiens cash.
Cash resources.
Sounds to explore the use of biologics, including a mabs 7195, as adjuncts to our could it programs the potential benefits of using biologics as adjunct coded and amy's expectations regarding potential applications of the coated approach to treat 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 operations and means dependence on the success of California, Amiens ability to build a commercial field organization and distribution network. The degree of acceptance of how for the among physicians pace.
Healthcare payers patient advocacy groups and the general medical community Immunes ability to obtain favorable coverage and reimbursement from third party payers for pump or via a means of Billy ability to implement and comply with the rems for pull forward via a means or any of its collaborative partners ability to initiate and are complete clinical trials.
Unpredictability of the regulatory process, the possibility that means or any of its collaborative partners clinical trials will not be successful the reliance on third parties for the manufacturer of California, and our product candidates possible regulatory developments in the United States in foreign countries in a means 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 those stated on this call. Given these risks and uncertainties you should not place undue reliance on these forward looking statements. Please refer to our annual report report on form 10-K for the year ended December 31 2019.
I mean for some of the important risk factors that could cause actual results results to differ materially from 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.
And now I'll turn the call over to Jason.
Thank you Didi and good afternoon, everyone. Thank you for joining us today to discuss all 2019 financial results and recent operational highlights.
This is a very exciting time for us today munis, where in the process of launching our first FDA approved madsen portfolio, an oral immunotherapy for the mitigation of allergic reactions that may occur in peanut allergic patients following blackstones real exposure to pay those.
So still holds it was approved almost a month ago I'll process account managers will be actively meeting with our initial target group apologists.
We have also received strong inbound interest from other colleges. So looking forward to prescribing portfolio for their patients.
Andrew will provide additional details on the commercial launch progress shortly.
The FDA approval of portfolio was a significant achievements with a peanut and food allergy community and we have demonstrated with all immunotherapy using our coded platform can be a safe and effective therapeutic option.
Portfolio office peanut allergic patients their kakos analogist first of its kind treatment option.
Unlike all immunotherapy made from food that you can buy at the grocery store portfolio has been subject to the rigorous requirements of an FDA approved biologic pharmaceutical.
Every lots of every dose of portfolio has been prepared and analyzed for consistency of allogenic content on those.
In addition, since patients are ingesting be allergan, they get daily confirmation of the ability to tolerated on a switch on this test is not required in clinical practice.
In our registration studies, the medium amounts of peanut protein with patients could tolerate that screening was only 10 milligrams. After 12 months of treatment with portfolio. The medium tolerated amounts of peanut protein increased to 1000 milligrams. This was a 100 fold improvement.
This compares to a mid three fold improvement in the placebo arm.
With treatment beyond 12 months remedial tolerated amounts of peanut protein increased even further likewise the rate of adverse reactions, which were predominantly mild and moderate decreased over time.
Ill vision is to remain the before front of developing innovative therapies for food allergy.
As such we plan to explore the use of biologics was adjuncts to our code of programs.
As part of this vision, we're excited about the on licensing of Admob 7195, which we announced earlier this month.
My up seven one line five is an investigational anti GE monoclonal antibody that has three distinct mechanisms of action to reduce blood serum itchy and to suppress AG production.
Our goal is to see us a larger proportion of patients can achieve permission from the food allergy more quickly, but they may do a monotherapy alone.
As well as to make the journey to potential remission easier.
Before I think before turning the call over to Andrew I'd like to provide a brief update on our regulatory progress with portfolios in Europe, and our ongoing clinical trials.
On the regulatory front outside of the use our marketing authorization application for portfolio. There is being reviewed by the M- and we expect us to to be completed in the fourth quarter of this year.
In addition portfolio is also currently being reviewed by Swissmedic. The authority responsible for the authorization and supervision of therapeutic products in Switzerland, We expect to review to complete in mid 2021.
On the clinical development front, our phase three Poseidon trial, exploring the efficacy and safety of portfolio and peanut allergic children, aged one to less than full year olds is ongoing and that's expected to complete enrollment in the second half of this year.
Regenerons phase two trial of portfolio was dupilumab as an adjunctive therapy in patients with peanut allergy is also ongoing.
Beyond peanut allergy, we remain enthusiastic about the potential of our pipeline.
Our two a one is in phase two clinical trials for AG allergy and we expect to complete that study in the first half of 2021.
Finally, we continue to evaluate a multi tree not therapeutic program and are working with regulatory authorities to determine next steps right now I'll turn the call over 200.
Thank you Jason.
Mentioned, our promotional fuel team of AC parts of account managers has been meeting with you as physicians and that exceeds since February the for.
Given that the approval of portfolio occurred on January 31st this represents a graph of only one working day between the drugs approval on the deployment of the field organization I want to thank and recognize our entire organization and in particular, the fuel training see for their exceptional efforts enabling us.
As you might expect feedback from our fuel team indicate that there is a high level of excitement from both our outages on their patients in starting treatment with portfolio and our efforts since approval has been focused on working through the final steps to enable products be prescribed and dispensed to patients.
Let me for bond from additional detail in color around our efforts on the final steps.
The final specifics of the risk evaluation mitigation strategy or Rems program were received as part of the FDA approval portfolio of the end of January.
Since approval, we've been working to implement these final requirements and I'm pleased to shed on February 21st our website portfolio rooms Dot Com went line.
This website, along prescribing physicians on the healthcare facilities to complete the once on certification within the rents framework and provides the enrollment form physicians to download in order to enroll their patients in the program.
The overwhelming feedback we've received so far from outages in the stock is that the Ram certification processes quick and straightforward.
And we already have over 300 challenges certified in the first for working days since the website when line.
The other elements of the Rems program does the preparation of our contracted specialty pharmacies to dispense Paul Force you to patients.
This work is well underway that all the specialty pharmacies, we anticipate that it will be completed in the next two weeks or so.
The completion as we step will finalize the implementation of the Rems requirements and will mean it has only been six weeks between the approval of the product label on the final implementation of the entire Rems program I.
I would like to sincerely. Thank all of our employees, who have worked diligently to enable has accelerated timing as well as the support and partnership of our third party vendors involved in this effort.
The final step that will allow portfolio to be prescribed to patients is release of the finished product loss by FDA.
Please proceed is applicable applicable to all approved biologic medicines, and we start pause to be available at the very licensed by the end of March.
In the meantime patients can be enrolled in the rems by their positions prescriptions can be written on the benefits investigation process with patients can be performed followed by the initiation of the medical exception process.
While the requirements for the Rems program will be finalized as we highlighted earlier our team of branches account managers or pounds visiting positions on a softer education train them on par for the on his administration protocol.
In the first week following approval, we receive dozens and dozens of course in physicians to our support have a medical information service request in the visits over time to their office.
As we've highlighted on previous calls the focus of our Commons has been initially to engage with the 1300 or so outages or identified by our research seeing approximately 70% of afford to 17 year old patients with a confirmed diagnosis of penology.
In addition to the outreach of our Pam's, we've had a strong response to a series of one hour virtual broadcast on portfolio, which we're calling the power for the international event series.
This program consists of a series of six events presented that affords a clinical trial investigators who will discuss the profile and implementation of the drone and take questions from physicians or preparing to administer portfolio and their own clinics.
This series began this past Monday over the 24 and the response. These programs has been very positive with over 1700 registrations received from clinicians ameristar.
In addition to the efforts of our palms, our fuel payer team has been busy and of arrange post approval meetings with 31 payer accounts, which cover approximately 78% of the commercial and managed Medicaid lives in the U.S.
The first of these meetings occurred this week and the remainder scheduled over the next six to eight weeks through April.
The purpose of these meetings is to take the payer clinical committees through the details of the final product label to enable them to make a coverage recommendation to the payers PNC Committee, which will then make decisions on the final formulary positioning.
As we previously communicated we expect it will begin to see meaningful increases in formulary adoption later this year as the process plays out.
Until portfolio has formally covered by payer formularies portfolio like other newly approved medicines will be available via the medical exception process.
As a reminder, we have support hub fully staffed and trained with 40 professionals to complete the benefits investigation for patients as loss to provide guidance to outages sonesta off on how to complete the pipe work associated with this process.
With all of the excitement around the approval and launch of power for the in the US it's worth taking him as a highlight that our preparation activities are also progressing well in Europe.
As we previously noted we're planning for potential EMA approval in Q4. This year and have also fall in Switzerland, with a potential approval in mid Twentytwenty warm.
With these timelines in mind, we began the preparation of the doses that will eventually be submitted to European reimbursement authorities to facilitate the pricing and reimbursement discussions so California.
We're also continuing to some of our commercial organization across Europe and have now higher general manager for the UK in French markets, who joins the GM for Germany, Austria, and Switzerland, We hired in Q3 of last year.
In summary, we're extremely pleased with the progress that we're making around the commercialization of portfolio.
Since the announcement of our US approval the enthusiasm response and engagement that we receive from both the physician and patient communities has been energizing and we're thrilled that we're now just a matter a few weeks from the first patients being able to receive commercial products.
With this I'll now turn over to Eric to discuss the 2019 financial results.
Thank you Andrew we ended 2019 in a strong financial position with 158.2 million of cash cash equivalents and investments compared to 303.9 million on December 31, 2018. The decrease primarily reflects net cash used in operating activities.
Partially offset by cash provided by financing activities, including net borrowings from our debt issuance in January 2019 of 36.1 million.
In February of this year, we received a new 200 million equity investment from Nestle Health science, bringing the total investment in a immune to 473 million.
Following FDA approval. We also received the second tranche of our loan from KKR, which was 85 million.
Our year end cast together with a nestle investment and they can't get alone brings our year end pro forma attached to 443 million.
Based on our current business plan, we expect that these financial resources fully fund the company.
For the 12 month ended December 31, 2019, net loss was 248.5 million compared to a net loss of 210.8 million for the year ended December 31 2018.
On a per share basis net loss for the 12 month ended December 31, 2019 with $3, a 97 cents compared to a net loss per share of $3 67 stands for as our comparable periods a year before.
R&D expense for the 12 month ended December 31, 2019 was 124 million compared to 133.4 million in 2018.
The decrease was primarily due to lower clinical related expenses, partially offset by increases in regulatory quality and manufacturing expenses.
DNA expense for the 12 month ended December 31, 29 team was 125.8 million compared to 81.9 million for the comparable period in 2018.
The increase was primarily due to additional employee related cost and external professional services as we continue to build infrastructure to support the commercialization of California.
With that we'll open the call for questions.
Thank you.
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And our first question comes from the line of Chris Raymond with Piper Sandler. Your line is now open.
Hey, guys. Thanks for taking the question.
A couple of things.
Andrew I was kind of struck by your comments on the.
The number of physicians on that have been sort of side on the tough that are in the fourth year ramps web site, and we were kind of hunting around looking at it and.
Just kind of cross referencing that docs that are on that site that are listed.
Within another list of Docs, who are are listed as private practice, so I'd im sorry, t. practitioners it doesnt seem like there's much overlap.
So first of all I guess is that analysis, correct or maybe could you give us some sort of view of the population of these physicians.
In terms of how many are actually practicing whitey docs now versus.
Sort of ready and waiting.
Will that you've described.
Thanks.
Yes. Thanks for question person I think it's worth pointing out that it's only this is this is Dave for data. So we're only four days into this.
So I haven't done a comprehensive.
Check of what you just suggested would use of cross referencing across.
Looking at a list of people currently performing arts fees. Certainly there are also people on that list that are performing arts see today, but I haven't done an exhaustive comparison of the two worse and again, we're only four days into it. So what we are encouraged by is the fact that opted for days, we've had $300 that of certified.
We will we will look at that analysis and.
And trunkline, becoming days and weeks okay.
And then just on the you know the I guess the gating factors to launch you mentioned FDA approving the release of of actual product and lots can you just remind us.
Is that just a onetime or does every lot have to be you have to be approved and what's the sort of.
Frequency that if so thanks.
Yes, Thanks, Chris.
So every biologic product has to have every lot that manufacturers released by Sta that standard operating practices.
And it's perfectly normal so this to happen just after approval.
For the actually has up to 60 days to launch the relate to release the launch lots after approval. Once once you file up the data with them and actually normally what ft. Adults as they go through our release documents, we have obviously Q eight of the release. These lots. They go through those documents in there in a traditional sense. They also actually do their own testing on total those law.
Batches.
With all lots of FDA have actually told us they're not going to be doing any of the launch testing, they're just going to go through our quality release documents and in fact, they've actually started to release some of those lives. So we do expect us to two to not be a hold up in the process and happen relatively quickly over the course of next week.
Great. Thank you.
Thank you.
And our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Your line is now open.
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Hi, Jason and team. Thanks for taking my question and congrats on a great year progress had a couple of questions, perhaps for Andrew or you Jason.
Relative to all the activity metrics that you shared that that was really helpful try to get our arms around this new business model I guess going also to the Rems website that was mentioned on previous question. Im wondering if you think that it really reflects call it.
It physicians experience given the clinical trial experience that they hand, or if you think about the Doc locator function on that websites do you think that there is broader interest in.
Intel foresee then perhaps even you saw in that in the clinical trial protocols.
Well, so we only so it's a little while to speculate after only four days worth of data I think what we are seeing is.
Quite a mix of people that we are you would be.
Registering and service line pretty much immediately but also people that one on our radar screens certifying early so it's only four days in and we'll continue to track it but we're really heartened by the fact that it's over 300 after only four days and the.
The actual rates of certification has been pretty steady over that four day period as well, so easy and slowing down so far and we'll continue to guide to that on future calls as well as well as the actual number of health care centers that are so different because we can track that as well I think what I would say charges that are.
Goal at this point in our focus is on making certain that we continue to get folks signing up just to both prescribers and practices into the program rather than spending too much time to analytics on who has all who has been signed up yet I think we'll do that when we have quite a bit more data in there that's really about making sure. We're focused on getting list thats into the patients who need it right now.
It does seem to be a very helpful functionality for for patient care giver.
No.
Maybe I could ask and another question.
Related to.
I guess the upcoming client AI meeting can can you are there any key takeaways with the information that you plan to be presenting at that they don't you think perhaps are being overlooked by by the market.
Yes, Chaz actually there's quite a lot of interesting stuff that we're presenting a quota we did put a press release on on this already I think probably the places that are most important to go are and we mentioned this a little bit in the coal is increasing amounts of data on the fact that both the efficacy and tolerability of portfolio get better.
Over time, so we'll be presenting the 18 month data.
The efficacy will be presenting some more longer term safety data, that's a more quality of life data that we're going to be presenting at the meeting as well right and all of these things just continue to build on the story that saying on California drives up efficacy and makes the product more tolerable time. So there's some very interesting abstracts I think.
Yes, and last question is given.
Recent acceptance for review of potential competing product I guess I'm wondering as he is he thought through this strategy towards the ended the year emphasizing the salesforce and the messaging with tell for Seer has any of that changed and do you have perspectives on that potential competition.
No I, let Andrew and so the the question the second but I think at a macro level out thinking hasn't changed at all.
We have built what we think is the right infrastructure to launch portfolio successfully today, what we've always said is as as we learn how that goes we may tweak it a little bit if we find that the territory is to bagel that they're more interested targets in the territory that we may have initially anticipated we will expand our field team to be able to address that need, but we really don't.
So like we have to make too much any changes that will in fact from our field deployment right now magid, you want to talk a little bit about.
Yes, I don't have a radio throughout so that we as we've said we've got AC.
Account managers out there right now spread over 10 areas, we have the flexibility within that to add more we wish but certainly as we look towards the end of this year and into next year.
There is nothing currently that would lead us to thing we need to change our tool.
Okay very good thanks for taking the questions.
Thanks, John.
Thank you.
And our next question comes from the line of Liana Moussatos with Wedbush Securities. Your line is now.
Two questions one given that the FDA is releasing lot you can't get prescriptions until there are lot to really how should we think about Q1 revenues and my second question is.
I've been getting questions from investors about whom grew I T can you remind us.
Why aiming was founded based on who lighty problems.
Sure so.
Let me start with the second one first right. So I sort of rig recall that the company was founded in 2011, when a group of very frustrated patients parents physicians researchers the NIH the FDA and a bunch of other Vesta invested parties were extremely frustrated but there were.
Not sufficient attention being paid to the development of treatments for food allergies, despite huge advances being made and other fields of medicine.
And one of the reasons behind that one of the reasons that that was true will simply because there wasn't a well established regulatory pathway to get a treatment for food allergy.
Approved and obviously that has evolved tremendously up until now where we actually have not only are a pathway, but we have.
The clear Directionally, how the design clinical trials in the treatment of food allergy and actually unapproved product now along that journey the demand from patients and parents for something to treat their children has been extremely high and so.
Some physicians have been using normal food or variance of cleanup derives food products to do I see on the thing about ft approved product. There are sort of two major things that make an FDA approved product significantly better than foods that you combine the grocery store. The one is the certainty of the.
Allogenic expression. So there is there was published data out there that shows that if you went into a store important to different peanut flowers that were side by side on the shelf you can have up to a 400 fold delta in the expression of the Allergan in those two different kinds of pina flowers and in order to make certain that not only are we decent.
I think people, but that that the sounds Tyson is sustained immunomodulation continues and we have a shot of getting these people ultimately to remission you need to expose them to all three of the critical allergens consistently over time and that is really hard with food because of the change in the allogenic profile of each kind of food that you use the second we.
One is that at least very early on in the up dosing phase it's extremely hard to know exactly what those who are given what you use food and some of these doses are very low and with with that with our product each dose has to be measured and has to fit within a.
Very specific autolytic range to be able to actually make it through our Q a process.
To be released and so the amount of dose that you're getting in each in each product is consistent so those two things make us unique from being able to from trying to do this with food so that.
That was the.
The second part of your question other undertake the yet on the first question I'll I'll, let Eric address the Q1 revenue in a minute, but just to add to appoint a clarity around around the first question.
Prescriptions can be recent now and so from upfront process standpoint.
Once the challenges on the healthcare facility.
I have been certified in the Rems process and they can enroll the patients in the Rems program.
They can then write a prescription and not prescription can be sense either to the the hub that we have to perform the benefits and get investigation procedure or the specialty pharmacy that can equally powerful not as well and so prescriptions can be recent.
And yes, we are dependent on the lots being released the vehicles for them to receive products. Both prescriptions can be written now actually based on that average on speak to the Q1 revenue expectations Aliana as as you know we are not going to provide revenue guidance, but what I will say is that we record revenues.
When the specialty pharmacy irrevocably take control of product.
Assuming that though as we expect we get lots released in January and ship them to specialty pharmacies, we will be recording revenues in the first quarter in March.
Yes, So January yes in the first quarter. So we do expect to record revenue in the first so I think the reality is that we expect patients to start going on treatments in the couple of weeks.
But when I think the point, you're making liana is that as we think about the first quarter. It really will be a few weeks of revenue generation.
Thank you.
Thank you.
Our next question comes from the line of Kennen Mackay with RBC capital markets. Your line is now open.
Hey, guys. This is vikram on for Ken Thanks for taking over cushion.
One quick one for US could you elaborate how allergists are preparing for the increased patient flow in their practices with the launch and are there any capacity constraints that we should be thinking about.
Well, it's a good question and it really does vary by biology practice.
So your absent in some cases they are ready to go there been planning for this for a while now and so they know during the week what slawson assured you will there will be seeing patients in some cases. They may have opened up a couple of afternoons in other cases, there may be going to assess the morning clinic or something of that nature.
They need to hire additional nursing soft and they have done so.
We'll be able to accommodate that in other cases, there may be working through that and so what we expected to see a study build of capacity through this year, which is why we've said we do expect to see a relatively gradual build through the year of patients on the product as that capacity grows who clinics.
So.
It just it really does vary across the board what is I think.
Consistent with all the folks is a level of enthusiasm to do it. It's just a question of them working through logistics for their individual circumstances.
Got it that's Super helpful. Then have a follow up you said 300 practices have been enrolled over four days and the rate has been steady I guess, maybe you can comment on going forward, how shall we be thinking about that number.
Well that is something that we will be providing an update on.
Every earnings calls, we're providing an update on that as we've said our initial focus in terms of where the prices account managers are spending the time is discussing and working with the 1300 challenges that we had identified as seeing about 70% of patients will have confirmed diagnosis peanut allergy. So there will be working.
With that group and we'll be providing updates on that on the number of registered challenges.
Every quarter.
Got it Super helpful. Thank you so much.
Thank you.
Thank you and our next question comes from the line of Evan Seigerman with Credit Suisse. Your line is now open.
Well. Thank you so much for taking the questions gentlemen, congrats again on the approval on last month, just a few on kind of the commercial build out first of all have reps been visiting and physicians now that the products and approved has actually been happening and how should we be thinking about.
The potential assuming a expense over the course of the year and if theres any sort of ramp and waiting towards maybe the back half or is it now.
So I haven't I'll take the first part of our question and I'll, let Eric talked through the SGN a portion. So yes, we we received the approval almost 31st of January and.
Upon approval. We then became aware obviously of the final label specifics and also the final.
Specifically around the Rems program.
So the one thing we have to do about point would provide the final training to our practice account managers on those two things that we received approval and so that actually happened on the ensuing Monday, which was February referred.
As will serve as of February the fourth which is the choose the following the Friday, we got approval, we have our practice account managers out there across the United States talking to outages in the style.
Eric only as Jefferies.
Yes, I mean, not our field force started January 2nd so.
The bulk of the increase relative to last year on Randy occurred when that Salesforce.
Into the organization, so that they will be some growth throughout the year and ask DNA, but really not materially beyond the first quarter and we're not going to provide specific guidance, but I will say as as we start to ramp revenues. We do expect does our losses will decrease throughout the year quarter by quarter.
Third quarter.
And then just one quick follow up so you said that the reps have been.
Seen physicians and practices has there been any feedback from the physicians I know they don't have the product in their hands, but are they generally excited kind of whats the buzz among the physician practices when they interact with your field force.
Yes. It I mean, I think you're excited is a good word to use.
I'm proud to say, we've had a team of 20 medical liaison out engaging in medical exchange for over a year. So.
The level of excitement wasn't a surprise from that perspective, and the the feedback that we received.
Our promise incentives, but entirely consistent with them.
You know Evan I'd say, that's one on one place we get feedback promise from the field team. The other places from our hub and we had physicians, calling our hub within the first day asking for us to send people to go and meet with their practices and I've been involved and many launches in my there. This is the first time ever we've had doctors, calling us on day one asking.
Yes to send people to visit level, yes.
That's a great pornography, Jason I've I've worked in the industry for 16 years myself Ivan.
I cannot think cope with maybe one exception for specific oncology drug any time, where we were getting certainly this volume of coals from prescribing physicians and could you come towards me about the product. Please.
Excellent well I appreciate the color and congrats again speak soon.
Thank you.
Next question comes from the line of Zygmunt Chela with Roth Capital Partners. Your line is now.
Okay. Thanks for taking my question I think the fresh step up do you see.
Any additional details on the possible scenarios and that conversation outlet PR accounts are expected to happen in near term.
Yes, hi, guys the.
We are just starting the sort of next round of those discussions on the those discussions are very focused on conversations with the clinical committees of the payers because by processes. The payer what happens is the clinical Cmxsix makes a an evaluation based on the clinical benefit of the of the drug once we're able to review.
In detail now that we have the final.
Label because of the approval and so that's that's those are the discussions that are happening over the next sort of six to eight weeks.
Once those discussions will have a clinical committee will will make recommendations for PMC and then there will be the the discussion around the formulary status as the results of that so very early days in some of those discussions I think we've had four of those already this week.
We will progressing through through those over the next six eight weeks I would make one other comments that were not as you'll recall that we very consciously put our field payer team in place about a year ago. So that we could have our initial discussions with payers actually prior to approval just to make certain that they understood. What the product was or what it didnt to give them a heads up of what was coming and that it's been.
Extraordinarily helpful in terms of getting into these clinical discussions.
Quickly and ideally onto some of the very early PMT Committee agendas.
And Jason how are you guys presenting from the data that you're gonna have quad and meeting Tim.
Patient responses.
I believe.
After 12 months.
Because I think thats very helpful.
Yes, we have we actually have 18 months, which we've presented already and I think you've got to your data that's coming soon and cohort continues right. So absolutely I think this is a really important piece of data that we that we want to keep sharing this this by the way as the cohort that we'll get to the sort of three and four and five years of therapy. The first time, rather than so it's a very very import.
Good for us to continue to follow.
Right and then another question I know you have a while we get relationship then patient foundations, though and you just I want to get it seems that higher leveraging that relationship as part of the line strategy.
Well.
Certainly from from the I think from the founding of the company and certainly all the way through the developments of the drug and now obviously were commercialized.
We've been engage with the patient.
Support and advocacy groups across the US and also in Europe, and so we're continuing to have those discussions and there is the as excited I'm more excited about the availability of this now for the patients and we are offering. So they are very valuable allies, we as we work with the with the food allergy community.
Okay and then.
Okay, no sorry that advisors can make one more comments, which is that go back to my original did the question someone asked earlier about the funding of the company.
The company was founded by the advocates community community largely and so we're very much aligned with the needs to get these treatments to the patients as soon as we can.
Okay, and then last going about this item the steady wrapping up on in late this year. So just kind of when they get a sense that has enrollment then and then maybe kind of try to extrapolate and 10 point on that as you had that reception could potential.
Maybe first it in the.
Population that we explained that likely 17.
Yes, so if you recall the rationale for doing a study on the younger children is that it increasingly is clear that earlier you start therapy once food allergy as diagnosed the better the outcome and of course. The certainly you can get your child on treatment from the sooner you can get them on that passed onto Immunomodulation the better.
We did the initial study and four to 17 year olds, just because we wanted to make certain that we had a nice window and understood. How this product was going to work and it was actually as early as the previous they meeting when we had a discussion with the FDA around getting into this earlier population given the very robust profile that we saw the the molecule in the Palisades study.
So thats study as critical if that's a label expanding study for US we do expect to expand the label down to down to one year old for one year old so that the patients can initiate therapy very early the study has recruited is recruiting really well it's on track with where we want to be those very high demand for for treatments in the earlier age groups.
And so sort of the back end of your question is once we get that that yes, we will file that to expand the label, we will publish and obviously present those data once we see them.
Thanks, Jason.
Thank you.
Our last question comes from a lot of Port choice with Goldman Sachs. Your line is now open.
Hi, This is Dan Jenkins on but Paul.
Maybe taking a different here could you talk a little bit about the then core asset that you enlightened and license recently and what it was they agreed that asset or you found attractive in particular about that.
Sure occur impacts.
So we're very excited about the molecules the a map 7195 that we've licensed from from Xencor.
The thing that really excites us about this molecule is that we know that the suppression of AG and AG production of both being shown to be very helpful. In the management potentially of of over the magic diseases and this is a molecule that actually has three mechanisms of action. It binds it binds to AG it suppresses upstream IBG.
Production at helps IBG get cleared through the liver right.
And then the regatta, having all three of those mechanistic approach as it is unique there are molecule to do one or maybe one as a bit of Bose, but this is the only molecule that we know that does all three of those and we're really excited about using that in combination with immunotherapy because the one thing we know so far is that a.
A monoclonal IBG suppressing agent on its own while while it's certainly can enhance the ability to tolerate food does not cause the immunomodulation process that immunotherapy does and so it doesn't get you down that path of sustained remission over time that we think we can get to with immunotherapy.
However, if we can combine the two and have the Immunomodulation hackbright happened, maybe more robustly, maybe more quickly and maybe in more patients on monotherapy alone. That's a great win because the more patients that we can treat to essentially remission sooner in the therapeutic process, the better and that that's what it.
Sites are so much about using these these two treatments in combination.
Great. Thanks, and then you mentioned that you hired additional general managers in Europe can you talk about what your next priorities are to build out the commercial infrastructure in that region.
Yeah, absolutely so.
With the general managers, there will be looking apps.
The field organizations.
As we prepare for the for the approval towards the end of the year as you may be aware in certain countries in Europe, particularly in Germany. The notice periods for folks can often be three months or longer and so getting started on those recruiting efforts early.
Is what we need to do and so we're looking about right now and we'll be looking to bring those folks in the second half of the year.
Hey, thanks.
Everyone I'd make one other comment about this what's really important in Europe is not just building out a management structure, but centrally being able to work on very robust reimbursement dossiers submissions because other than Germany, which is a market that you can launch straight into when you got approval all of the other markets in Europe are.
Bound by the need to submit reimbursement dossiers and go through the local reimbursement process and so we've built that capacity in our European office in London, we will be ready to submit reimbursement dossiers in the core markets out approval in Europe.
Thanks much.
Thank you. Thank you.
This concludes today's question answer session I would now like to turn the call back to Jason Dallas for closing remarks.
Thank you everyone for your participation in the call today and for your ongoing support a baby and I'd also just like to thank the entire company for their contributions that have made aiming the global leader in food allergy treatments and particularly the commercial team, which has worked tirelessly to get portfolio to patients. We look forward to providing you with additional updates on our next quarterly call. Thanks, everybody.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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