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Aimmune Therapeutics Inc (NASDAQ:AIMT)
Q4 2019 Earnings Call
Feb 27, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

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 are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

I would now like to hand the conference over to your speaker today, DeDe Sheel, Vice President of Investor Relations. Thank you, and please go ahead, Ma'am.

DeDe Sheel -- Vice President of Investor Relations

Thank you, operator. Good afternoon and thank you for joining us today to discuss Aimmune's fourth quarter and fiscal year 2019 financial results and operational highlights. Today's call is being webcast and a replay will be available on our corporate website at aimmune.com.

Joining me on the call today are Dr. Jayson Dallas, President and Chief Executive Officer; Andrew Oxtoby, Chief Commercial Officer; and Eric Bjerkholt, Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

Before we begin, I would like to remind you that during today's call and Q&A session, we will be making forward-looking statements. These forward-looking statements include Aimmune's expectations regarding the potential benefits of PALFORZIA, the commercial launch of PALFORZIA including the timing for speciality pharmacies to be ready to dispense PALFORZIA, timing for payors in the United States to add PALFORZIA to formularies and timing for PALFORZIA to be available in the market. The timing of potential approval of PALFORZIA by the EMA and Swissmedic, potential timing for completion of Aimmune's phase 2 clinical trial for AR201, potential timing for completion of enrollment of our phase 3 Phase 3 POSEIDON clinical trial for PALFORZIA, the sufficiency of Aimmune's cash resources, plans to explore the use of biologics including AIMab7195 as adjunct to our CODIT programs, the potential benefits of using biologics as adjunct to CODIT and Aimmune's expectations regarding potential applications of the CODIT 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 Aimmune will need additional funds to finance its operations; Aimmune's dependence on the success of PALFORZIA, Aimmune's ability to build the commercial field organization and distribution network, the degree of acceptance of PALFORZIA among physicians, patients, healthcare payors, patient advocacy groups and the general medical community, Aimmune's ability to obtain favorable coverage and reimbursement from third party payors for PALFORZIA, Aimmune's ability to implement and comply with the [Indecipherable] for PALFORZIA, Aimmune's or any of its collaborative partners' ability to initiate and/or complete clinical trials, the unpredictability of regulatory process, the possibility of Aimmune's or any of its collaborative partners, clinical trials will not be successful, the reliance on third-parties for the manufacture of PALFORZIA and our product candidates, possible regulatory developments in the United States and foreign countries, and Aimmune's 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 on Form 10-K for the year ended December 31st 2019 for some of the important risk factors that could cause actual results to differ materially from forward-looking statements made on this call. Except as required by law, Aimmune 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 Jayson.

Jayson Dallas -- President and Chief Executive Officer

Thank you DeDe, and good afternoon everyone. Thank you for joining us today to discuss our 2019 financial results and the recent operational highlights. This is a very exciting time for us at Aimmune as we're in the process of launching our first FDA approved medicine, PALFORZIA, an oral immunotherapy for the mitigation of allergic reactions that may occur in peanut allergic patients following accidental exposure to peanuts. Since PALFORZIA was approved almost a month ago, our practice account managers have been actively meeting with our initial target group of allergists. We have also received strong inbound interest from other allergists, who are looking forward to prescribing PALFORZIA for their patients. Andrew will provide additional details on the commercial launch progress shortly.

The FDA approval of PALFORZIA was a significant achievement for the peanut and food allergy community and we have demonstrated that oral immunotherapy using our CODIT platform can be a safe and effective therapeutic option. PALFORZIA offers peanut allergic patients, their caregivers and allergists a first of its kind treatment option. Unlike oral immunotherapy made from food that you can buy at the grocery store, PALFORZIA has been subject to the rigorous requirements of an FDA approved biologic pharmaceutical. Every lot of every dose of PALFORZIA has been prepared and analyzed for consistency of allergenic content and dose. In addition, since patients are ingesting the allergen, they get daily confirmation of their ability to tolerate it and a food challenge test is not required in clinical practice.

In our registration studies, the median amount of peanut protein that patients could tolerate screening was only 10 milligrams. After 12 months of treatment with PALFORZIA, the median tolerated amounts of peanut protein increased to 1000 milligrams, which is a 100-fold improvement. This compares to a mere three-fold improvement in the placebo arm. With treatment beyond 12 months, the median tolerated amounts of peanut protein increased even further. Likewise, the rate of adverse reactions, which were predominantly mild and moderate decreased over-time.

Our vision is to remain at the forefront of developing innovative therapies for food allergy. As such, we plan to explore the use of biologics as adjuncts to our CODIT programs. As part of this vision, we're excited about the unlicensing of AIMab7195 which we announced earlier this month. AIMab7195 is an investigational, anti-IgE monoclonal antibody that has three distinct mechanisms of action to reduce blood serum IgE and to suppress IgE production. Our goal is to see if a larger proportion of patients can achieve remission from their food allergy more quickly than they may do a monotherapy alone, as well as to make the journey to potential remission easier.

Before turning the call over to Andrew, I'd like to provide a brief update on our regulatory progress with PALFORZIA in Europe, and our ongoing clinical trials. On the regulatory front, outside of the US, our marketing authorization application for PALFORZIA is being reviewed by the EMA and we expect this to be completed in the fourth quarter of this year. In addition, PALFORZIA is also currently being reviewed by Swissmedic, the authority responsible for the authorization and supervision of therapeutic products in Switzerland. We expect the review to complete in mid-2021.

On the clinical development front, our Phase 3 POSEIDON trial exploring the efficacy and safety of PALFORZIA in peanut allergic children, aged one to less than four year olds is ongoing and it's expected to complete enrollment in the second half of this year. Regeneron's Phase 2 trial of PALFORZIA with 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. AR201 is in phase 2 clinical trials for egg allergy and we expect to complete that study in the first half of 2021. Finally, we continue to evaluate the multi-tree nut therapeutic program and are working with regulatory authorities to determine next steps.

Right now, I'll turn the call over to Andrew.

Andrew Oxtoby -- Chief Commercial Officer

Thank you, Jayson. As Jayson mentioned, our commercial field team of 80 practice account managers has been meeting with US physicians and their teams since February the 4th. Given that the approval of PALFORZIA appeared on January the 31st, this represents, a gap of only one working day between the drug's approval and the deployments of the field organization. I want to thank and recognize our entire organization and in particular, the field training team for their exceptional efforts in enabling this. As you might expect, feedback from our field team indicates that there is a high level of excitement from both our allergists and their patients in starting treatment with PALFORZIA and our efforts since approval have been focused on working through the final steps to enable products to be prescribed and dispensed to patients.

Let me provide some additional detail and color around our efforts on these final steps. The final specifics of the Risk Evaluation and Mitigation Strategy or REMS program were received as part of the FDA approval of PALFORZIA at the end of January. Since approval, we've been working to implement these final requirements, and I'm pleased to share that on February 21st our website palforziarems.com went live. This website allows prescribing physicians on the healthcare facilities to complete a one-time certification within the REMS framework and provides the enrollment form for physicians to download in order to enroll their patients in the program. The overwhelming feedback that we've received so far from allergists and their staff is that the REMS certification process is quick and straightforward and we already have over 300 allergists certified in the first four working days since the website went live. The other elements of the REMS program is the preparation of our contracted speciality pharmacies to dispense PALFORZIA to patients. This work is well under way at all the specialty pharmacies and we anticipate that it will be completed in the next two weeks or so. The completion of this step will finalize the implementation of the REMS requirements and will mean that it has only been six weeks between the approval of the product label and the final implementation of the entire REMS program.

I would like to sincerely thank all of our employees who have worked diligently to enable this accelerated timing as well as the support and partnership of our third-party vendors involved in this effort. The final step that will allow PALFORZIA to be prescribed to patients is the release of the finished product launch by FDA. This procedure is applicable to all approved biologic medicines and we expect products to be available at the very latest by the end of March. In the meantime, patients can be enrolled in the REMS by their physicians, prescriptions can be written and the benefits investigation process for patients can be performed followed by the initiation of a medical exception process. While the requirements for the REMS program were being finalized, as we highlighted earlier, our team of practice account managers or PAMs have been visiting physicians and their staff to educate and train them on PALFORZIA and it's administration protocol. In the first week following approval, we received dozens and dozens of calls from physicians to our support health and medical information service requesting the visit of PAMs to their office. As we've highlighted on previous calls, the focus of our PAMs has been initially to engage with the 1300 or so allergists who are identified by our research is seeing approximately 70% of the four year to 17 year-olds patients with a confirmed diagnosis of peanut allergy.

In addition to the outreach of our PAMs, we've had a strong response to a series of one hour virtual broadcasts on PALFORZIA, which we're calling the PALFORZIA national event series. This program consists of a series of six events presented by PALFORZIA clinical trial investigators, who will discuss the profile and implementation of the drug and take questions from physicians who are preparing to administer PALFORZIA in their own clinics. This series began this past Monday, February the 24th and the response of these programs has been very positive with over 1700 registrations received from clinicians and their staff. In addition to the efforts of our PAMs, our field payer team has been busy and have arranged post approval meetings with 31 payer accounts, which cover approximately 78% of the commercial and manage Medicaid lives in the US.

The first of these meetings occurred this week, and the remainder are scheduled over the next six to eight weeks through April. The purpose of these meetings is to take the paired [Phonetic] clinical committees through the details of the final product label to enable them to make a coverage recommendation to the payers P&C committee, which will then make decisions on the final formulary positioning. As we previously communicated, we expect that we'll begin to see meaningful increases in formulary adoption later this year as the process plays out. Until PALFORZIA is formally covered by payer formularies, PALFORZIA like other newly approved medicines will be available by the medical exception process.

As a reminder, we have a support of fully staffed and trained with 40 professionals to complete the benefits investigation for patients, as we also provide guidance to allergists and their staff on how to complete the paperwork associated with this process. With all of the excitements around the approval and launch of PALFORZIA in the US, it's worth taking a minute to highlight that our preparation activities are also progressing well in Europe. As we previously noted, we are planning for potential EMA approval in Q4 of this year and I've also filed in Switzerland with a potential approval in mid-2021. With these timelines in mind, we've begun the preparation of the dossiers that will eventually be submitted to European reimbursement authorities to facilitate the pricing and reimbursement discussions for PALFORZIA. We're also continuing to staff up our commercial organization across Europe and I've now hired a General Manager for the UK and French markets, who joins the GM for Germany, Austria and Switzerland that we hired in Q3 of last year.

In summary, we're extremely pleased with the progress that we're making around the commercialization of PALFORZIA. Since the announcements of our US approval, the enthusiastic response and engagement that we've received from both the physician and patient communities has been energizing and we're thrilled that we are now just a matter of a few weeks from the first patients being able to receive commercial products.

With this, I will now turn it over to Eric to discuss the 2019 financial results.

Eric Bjerkholt -- Chief Financial Officer

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 Aimmune to $473 million. Following FDA approval, we've also received the second tranche of our loan from KKR, which was $85 million. Our year-end cash together with Nestle investment and the KKR loan brings our year-end pro forma cash to $443 million. Based on our current business plan, we expect that these financial resources fully fund the company. For the 12 months 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 months ended December 31, 2019 was $3.97 compared to a net loss per share of $3.67 for the comparable period the year before.

R&D expense for the 12 months 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. G&A expense for the 12 months ended December 31, 2019 was $125.8 million compared to $81.9 million for the comparable period in 2018. The increase was primarily due to additional employee related costs and external professional services as we continued to build our infrastructure to support the commercialization of PALFORZIA.

With that, we'll open the call for questions.

Operator

Thank you. [Operator Instructions] And our first question comes from the line of Chris Raymond with Piper Sandler. Your line is open.

Christopher Raymond -- Analyst

Hey guys, thanks for taking the question. Just a couple of things. Andrew, I was kind of struck by your comments on the number of physicians that have been certified that are on the PALFORZIA REMS website. And we were kind of hunting around and looking at it and just kind of cross referencing the docks that are on that site, that are listed with another list of docks who are listed as private practice OIT practitioners. It doesn't 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 OIT docs now versus, the sort of ready and waiting pool that you've described? Thanks.

Jayson Dallas -- President and Chief Executive Officer

Yeah. Thanks for the question, Chris. I think, it's worth pointing out that it's only, this is day four data, so we're only four days into this. So I haven't done a comprehensive check of what you've just suggested, which is you know cross referencing across looking at a list of people currently performing OIT. Certainly, there are some people on that list that aren't performing OIT today, but I haven't done an exhaustive comparison of the two versus and again, we're only four days into it. So what we are encouraged by is the fact that after four days, we've had 300 allergists that have certified and we will look at that analysis and track that in the coming days and weeks.

Christopher Raymond -- Analyst

Okay. And then, just on the I guess the gating factors to launch. You had mentioned, you know FDA approving the release of the actual product and lots. Can you just remind us, is that just the one-time or does every lot have to be approved and what's the sort of frequency of that, if so? Thanks.

Jayson Dallas -- President and Chief Executive Officer

Yeah. Thanks Chris. So every biologic product has to have every lot that the manufacturers release by FDA, that's standard operating practice. And it's perfectly normal for this to happen just after approval. FDA actually has up to 60 days to release the launch lots after approval once you file a data with them. And actually, normally what FDA does is they go through our release documents, we have obviously QA-ed [Phonetic] and released these lots. They go through those documents. In a traditional sense, they also actually do their own testing on some of those launch batches. With our lots, FDA have actually told us they're not going to be doing any of their launch testing. They're just going to go through our quality of released documents and in fact, they've actually started to release some of those lots. So we do expect this to not be a hold-up in the process and happen relatively quickly over the course of the next week.

Christopher Raymond -- Analyst

Great. Thank you.

Operator

Thank you. And our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Your line is now open.

Charles Duncan -- Analyst

Hi Jayson and team, thanks for taking the question, and congrats on a great year of progress. Had a couple of questions, perhaps for Andrew or you Jayson. Relative to all the activity metrics that you shared, 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 in the previous question. I'm wondering, if you think that it reflects, call it physician's experience, given the clinical trial experience that they had or if you think about the doc locator function on that website, do you think that there's broader interest in [Indecipherable] perhaps even you saw in that in the clinical trial protocols?

Jayson Dallas -- President and Chief Executive Officer

Well, to be honest Charles, it's a little hard to speculate after only four days about the data. I think what we are seeing is quite a mix of people that we knew would be registering and certifying pretty much immediately, but also people that weren't on our radar screen as certifying early. So it's only four days in and we'll continue to track it. But we we're really heartened by the fact that it's over 300 after only four days and the actual rates of certification has been pretty steady over that four day period as well. So looking at the end, it's slowing down so far. And we'll continue to guide to that on future calls as well as the actual number of healthcare settings that we are certifying because we can track that as well.

Andrew Oxtoby -- Chief Commercial Officer

I think what I would say Charles is that, our goal at this point and our focus is on making certain that we continue to get folks signing up just to prescribers and practices into the program rather than spending too much time doing analytics on who has or who hasn't signed up yet. I think, we'll do that when we've got a bit more data in there. It's really about making certain that we're focused on getting this into the patients who need it right now.

Charles Duncan -- Analyst

It does seem to be a very helpful functionality for a patient or caregiver. So maybe I could ask another question related to I guess the upcoming client AEI meeting. Are there any key takeaways with the information that you plan to be presenting that you think perhaps are being overlooked by the market?

Jayson Dallas -- President and Chief Executive Officer

Yeah. Charles, actually there's quite a lot of interesting stuff that we're presenting at quarter-end. We did put a press release item on it already. I think probably the places that are most important to go are and we mentioned this a little bit in the call is increasing amounts of data on the fact that both the efficacy and the tolerability of PALFORZIA get better over-time. So we'll be presenting the 18-month data on the efficacy, we'll be presenting some more longer term safety data. That's the 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 staying on PALFORZIA drives up efficacy and makes the product more tolerable long time. So there's some very interesting abstracts I think.

Charles Duncan -- Analyst

Yes. And last question is, given the recent acceptance for review of a potential competing product. I guess I'm wondering as you talk through this strategy toward the end of the year and the sizing of the sales force and the messaging with PALFORZIA, has any of that changed and do you have perspective on that potential competition?

Jayson Dallas -- President and Chief Executive Officer

I'll let Andrew answer the question in a second. But I think on a macro level, our thinking hasn't changed at all. We have built what we think is the right infrastructure to launch PALFORZIA successfully today. What we've always said is as we learn how that goes, we may tweak it a little bit. If we find that the territory is too big or that there are more interested targets in the territory than we may have initially anticipated, we will expand our field team to be able to address that need. But we really don't feel like we have to make any changes at all in fact from our field deployment right now.

And then Andrew, do you want to talk a little bit about?

Andrew Oxtoby -- Chief Commercial Officer

Yeah. I don't have a great deal to add to that. As we've said, we've got 80 account managers out there right now spread over 10 areas. We have the flexibility within that to add more if we wish. But certainly, as we look toward the end of this year and into next year, there's nothing currently that would lead us to think we need to change that at all.

Charles Duncan -- Analyst

Okay. Very good. Thanks for taking the questions.

Andrew Oxtoby -- Chief Commercial Officer

Thanks Charles.

Operator

Thank you. And our next question comes from the line of Liana Moussatos with Wedbush Securities. Your line is now open.

Liana Moussatos -- Analyst

I have two questions. One, given that the FDA is releasing lots and you can't get prescriptions until there are lots to release, how should we think about Q1 revenues?

And my second question is, I've been getting questions from investors about home-brew OIT. Can you remind us why Aimmune was founded based on home-brew OIT problems?

Jayson Dallas -- President and Chief Executive Officer

Sure. So let me start with the second one first, right. So, sort of 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 invested parties were extremely frustrated that there was not sufficient attention being paid to the development of treatments for food allergies despite huge advances being made in other fields of medicine. And one of the reasons that that was true was simply because there wasn't a well-established regulatory pathway to get a treatment for food allergy approves. And obviously, that has evolved tremendously up until now where we actually have not only a pathway, but we have a clear direction on how to design clinical trials in the treatment of food allergy and actually an approved 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 variants of peanut derived food products to do OIT. And the thing about FDA approved product, there are sort of two major things that make an FDA approved product significantly better than food that you can buy in the grocery store, but one is the certainty of the allergenic expression.

So there is published data out there that shows that if you went into a store and bought two 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 allergen in those two different kinds of peanut flowers. And in order to make certain that not only are we desensitizing people, but that desensitization is sustained and that immuno-modulation continues and we have a shot at 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 allergenic profile of each kind of food that you use.

The second one is that at least very early on in the up-dosing phase, it's extremely hard to know exactly what dose you're giving when you use food. And some of these doses are very low. And with our product, each dose has to be measured and has to fit within a very specific analytic range to be able to actually make it through our QA process and to be released. And so, the amount of dose that you're getting 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 was the second part of your question.

I will let Andrew take the first.

Andrew Oxtoby -- Chief Commercial Officer

Yeah. On the first question, I'll let Eric address the Q1 revenue in a minute. But just to add a point of clarity around the first question. Prescriptions can be written now. And so from a from process standpoint, once the allergist and the healthcare facility have been certified in the REMS process and they can enroll the patients in the REMS program, they can then write a prescription and that prescription can be sent either to the hub that we have to perform the benefits and get the investigation procedure or the specialty pharmacy that can equally perform that as well. And so prescriptions can be written. And yes, we are dependent on the lots being released to be able for them to receive product, but prescriptions can be written now actually based on that.

Eric, do you want to speak to the Q1 revenue expectations?

Eric Bjerkholt -- Chief Financial Officer

Yeah. Liana, as you know, we're not going to provide revenue guidance. But what I will say is that, we record revenues when the specialty pharmacy irrevocably takes control of product. So assuming that 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.

Andrew Oxtoby -- Chief Commercial Officer

You said January -- in the first quarter.

Eric Bjerkholt -- Chief Financial Officer

Yeah. So we do expect to record revenue in the first. And I think the reality is that we expect patients to start going on treatments in the couple of weeks. But 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.

Liana Moussatos -- Analyst

Thank you.

Operator

Thank you. And our next question comes from the line of Kennen MacKay with RBC Capital Markets. Your line is now open.

Bikram Singh -- Analyst

Hey guys, this is Bikram on for Kennen. Thanks for taking our question. One quick one from 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?

Jayson Dallas -- President and Chief Executive Officer

Well, it's a good question and it really does vary by biology practice. So, you have -- in some cases, they are ready to go, they've been planning for this for a while now. And so they know during the week what slot in their schedule they will be seeing patients. In some cases, they may have opened up a couple of afternoons. In other cases, they maybe go into a Saturday morning clinic or something of that nature. And if they need to hire additional nursing staff, they may have done so and to be able to accommodate that. In other cases, they may be working through that. And so, what we expect is to see a steady 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 grow through clinic. So 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 the logistics of their individual circumstance.

Bikram Singh -- Analyst

Got it. That's super helpful. Then I 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?

Jayson Dallas -- President and Chief Executive Officer

Well, that is something that we will be providing an update on every earnings call. We'll be providing an update on that. As we've said, our initial focus in terms of where the practice account managers are spending their time is discussing and working with the 1300 allergists that we had identified as seeing about 70% of patients with a confirmed diagnosis of peanut allergy. So they'll be working with that group. We'll be providing updates on the number of registered allergists every quarter.

Bikram Singh -- Analyst

Got it. Super helpful. Thank you so much.

Jayson Dallas -- President and Chief Executive Officer

Thank you.

Operator

Thank you. And our next question comes from the line of Evan Seigerman with Credit Suisse. Your line is now open.

Evan Seigerman -- Analyst

Hi, all. Thank you so much for taking the questions. and 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 physicians now that the products been approved? Has that actually been happening? And how should we be thinking about the potential SG&A expense over the course of the year if there's any sort of ramp and weighting toward maybe the back half or is it now?

Jayson Dallas -- President and Chief Executive Officer

So Evan, I'll take the first part of the question and I'll let Eric to talk through the SG&A portion. So yeah, we received the approval on the 31st of January and upon approval we then became aware obviously of the final label specifics and also the final specifics around the REMS program. And so, the one thing we had to do at that point was provide the final training to our practice account managers on those two things that we received an approval. And so that actually happened on the ensuing Monday, which was February the 3rd and as of February the 4th which was the Tuesday following the Friday we got approval, we've had practice account managers out there across the United States talking to allergists in that slot [Phonetic].

Eric, on the SG&A please?

Eric Bjerkholt -- Chief Financial Officer

Yeah. I mean, our field force started January 2nd. So the bulk of the increase relative to last year already occurred when that field force came into the organization. So there will be some growth throughout the year in SG&A, but really not materially beyond the first quarter. And we're not going to provide specific guidance, but I will say, as we start to ramp revenues, we do expect that our losses will decrease throughout the year quarter by quarter.

Evan Seigerman -- Analyst

And then just one quick follow up. So you said that the reps have been seeing physicians and practices. Has there been any feedback from the physicians? I know they don't have the products in their hands, but are they generally excited? Kind of what's the buzz among the physicians and the practices when they interact with your field force?

Andrew Oxtoby -- Chief Commercial Officer

Yeah. I mean, I think excited is a good word to use. I mean, I have to say we've had a team of 20 medical liaisons out engaging in medical exchange for over a year. So the level of excitement wasn't a surprise from that perspective and the feedback that we've received through our PAMs since then has been entirely consistent with them.

Jayson Dallas -- President and Chief Executive Officer

Evan, I'd say that's one place we get feedback from is from the field team. The other place is from 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 in many launches in my day and this is the first time ever we've had doctors calling us on day one asking us to send people to visit them.

Eric Bjerkholt -- Chief Financial Officer

Yeah. That's a great point actually, Jayson. I've worked in the industry for 16 years myself. I cannot think of with maybe one exception for specific oncology drug any time where we were getting certainly this volume of calls from prescribing physicians saying, could you come and talk to me about the product please.

Jayson Dallas -- President and Chief Executive Officer

Excellent. Well, I appreciate the color and congrats again. Speak soon.

Eric Bjerkholt -- Chief Financial Officer

Thank you.

Operator

Thank you. And our next question comes from the line of Zegbeh Jallah with ROTH Capital Partners. Your line is now open.

Zegbeh Jallah -- Analyst

Hi, guys. Thanks for taking my question. I think the first of a few would be any additional details on the possible scenarios from the conversations with peer accounts that are expected to happen in the near term?

Eric Bjerkholt -- Chief Financial Officer

Yeah. Hi, Zegbeh. We are just starting the sort of next round of those discussions. And those discussions are very focused on conversations with the clinical committees of the payers, because by process of the payer what happens is the clinical committee makes an evaluation based on the clinical benefit of the drug, once we're able to review it in detail now that we have the final label because of the approval. And those are discussions that are happening over the next sort of six to eight weeks. Once those discussions that have, the clinical committee will make recommendations with P&C and then there'll be the discussion around the formulary status as a result of that. So very early days in some of those discussions. I think we've had four of those already this week and we're progressing through those over the next six to eight weeks.

Jayson Dallas -- President and Chief Executive Officer

I would make one other comment Zegbeh and that is, 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 better that, they understood what the product was or what it did give them a heads up of what was coming. And that has been extraordinarily helpful in terms of getting into these clinical discussions really quickly and ideally onto some of the very early P&C committee agendas.

Zegbeh Jallah -- Analyst

Okay. And Jayson, are you guys presenting some of the data that you're going to have at the quad AI meeting in terms of patient responses, I believe up to 12 months?I think that's really helpful.

Jayson Dallas -- President and Chief Executive Officer

Yes. We we actually have 18 months which we've presented already. And I think we have got two year data that's coming soon and cohort continues, right. So absolutely. I think this is a really important piece of data that we want to keep sharing. This by the way is the cohort that will get to the sort of three and four and five years of therapy for first time around and so it's a very, very important group for us to continue to follow.

Zegbeh Jallah -- Analyst

Great. And then another follow-up question. I know you have a really good relationship with education foundations. So Andrew, just kind of want to get a sense of how you are leveraging that relationship as part of the launch strategy?

Andrew Oxtoby -- Chief Commercial Officer

Well, certainly, I think from the founding of the company and certainly all the way through the developments of the drug and now obviously we've commercialized, we've been engaged with the patient support and advocacy groups across the US and also in Europe. And so we continue to have those discussions and they're as excited or more excited about the availability of this now for the patients than we are. And so they're very valuable allies as we as we work with the food allergy community.

Zegbeh Jallah -- Analyst

Okay. And then final one here. Just -- go ahead.

Andrew Oxtoby -- Chief Commercial Officer

Sorry, but I just got to make one more comment which is that. Go back to my original to the question someone asked us earlier about the finding of the company. The company was founded by the advocacy community largely. And so we're very much aligned with the need to get these treatments to the patients as soon as we can.

Zegbeh Jallah -- Analyst

Okay. And then just the last one about POSEIDON with the steady wrapping up in late this year. So just kind of want to get a sense of how has enrollment then and then maybe kind of try to extrapolate some points from that as to how the reception could potentially be versus in the current population that we're exploring in four to 17?

Eric Bjerkholt -- Chief Financial Officer

Yeah. So if you recall the rationale for doing a study on the younger children is that it increasingly is clear that the earlier you start therapy once food allergy is diagnosed, the better the outcome. And of course, the sooner you can get your child on treatment and the sooner you can get them on that path down to immuno-modulation the better. We did the initial study in 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 pre-BLA meeting when we had a discussion with the FDA around getting into this earlier population given the very robust profile that we saw the molecule in the PALISADE study. So that study is critical. That's a label expanding study for us. We do expect to expand the label down to one year old, so that the patients can initiate therapy very early. The study is recruiting really well. It's on track, with where we want to be, there's very high demand for full treatment in the earlier age groups. And so sort of the back-end of your question is, once we get that data, yes, we will file that to expand the label, and we will publish and obviously present those data once we see them.

Zegbeh Jallah -- Analyst

Thanks, Jayson.

Operator

Thank you. And our last question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

Corinne Jenkins -- Analyst

Hi. This is Corinne Jenkins on for Paul. Maybe taking a different track here. Could you talk a little bit about the Xencor asset that you in-licensed recently, and what it was that drew you to that asset, that you find attractive and particular about that?

Jayson Dallas -- President and Chief Executive Officer

Sure, Corinne. Thanks. So we're very excited about the molecule, the AIMab7195 that we've licensed from Xencor. The thing that really excites us about this molecule is that we know that the suppression of IgE and IgE production have both been shown to be very helpful in the management potentially of allergic diseases. And this is a molecule that actually has three mechanisms of action. It binds to IgE, it suppresses upstream IgE production and it helps IgE get cleared through the liver, right. And in the regard to having all three of those mechanistic approaches, it is unique. There are molecules that do one or maybe one and a bit of those. But this is the only molecule that we know that does all three of those. And we really excited about using that in combination with immunotherapy, because the one thing we know so far is that a monoclonal IgE suppressing agents on its own, while it certainly can enhance the ability to tolerate food does not cause the immuno-modulation 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 immuno-modulation happen maybe more robustly, maybe more quickly, and maybe in more patients than 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's what excites us so much about using these two treatments in combination.

Corinne Jenkins -- Analyst

Thank you. And then you mentioned that you hired two additional general managers in Europe. Can you talk about what your next priorities are to build out the commercial infrastructure in that region?

Jayson Dallas -- President and Chief Executive Officer

Yeah, absolutely. So with the general managers, they will be looking at the field organizations as we prepare for the approval toward 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 at that right now. And we'll be looking to bringing those folks in the second half of the year.

Corinne Jenkins -- Analyst

Great. Thank you very much.

Jayson Dallas -- President and Chief Executive Officer

Corinne, 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 dossier submissions, because other than Germany, which is a market that you can launch straight into when you get 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 and we will be ready to submit reimbursement dossiers in the core markets at approval in Europe.

Corinne Jenkins -- Analyst

Thank you so much.

Operator

Thank you. And this concludes today's question-and-answer session. I would now like to turn the call back to Jayson Dallas for closing remarks.

Jayson Dallas -- President and Chief Executive Officer

Thank you everyone for your participation in the call today and for your ongoing support of Aimmune. And I'd also just like to thank the entire company for their contributions that have made Aimmune the global leader in food allergy treatments, and particularly the commercial team which has worked tirelessly to get PALFORZIA to patients. We look forward to providing you with additional updates on our next quarterly call. Thanks everybody.

Operator

[Operator Closing Remarks]

Questions and Answers:

Duration: 45 minutes

Call participants:

DeDe Sheel -- Vice President of Investor Relations

Jayson Dallas -- President and Chief Executive Officer

Andrew Oxtoby -- Chief Commercial Officer

Eric Bjerkholt -- Chief Financial Officer

Christopher Raymond -- Piper Sandler -- Analyst

Charles Duncan -- Cantor Fitzgerald & Co. -- Analyst

Liana Moussatos -- Wedbush Securities -- Analyst

Bikram Singh -- RBC Capital Markets -- Analyst

Evan Seigerman -- Credit Suisse AG -- Analyst

Zegbeh Jallah -- ROTH Capital Partners -- Analyst

Corinne Jenkins -- Goldman Sachs -- Analyst

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