Looking After The Future

Alder BioPharmaceuticals, Inc. (ALDR) Q2 2019 Earnings Call Transcript — The Motley Fool

Questions and Answers:
Operator
Thank you. Ladies and gentlemen, if you have a question at this time, please press * then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the # key. To prevent any background noise, we ask that you mute your line once your question has been stated. As a reminder, ladies and gentlemen, that is *1 for questions.
And our first question comes from Brian Abrahams from RBC Capital Markets. Your line is now open.
Brian Abrahams — RBC Capital Markets — Analyst
Hey, guys. Thanks very much for taking my questions. I really appreciate the additional color on the commercial strategy. I guess, first off, I was wondering if you had any updated views on the current market dynamics among the CGRPs, the types of patients being put on, overall access and discounting in the space? Beyond just gaining share, how much room for overall market expansion do you see from here and what are the types of steps that you need to take to help build that out? And then I have one follow-up. Thanks.
Robert Azelby — Chief Executive Officer
Sure. So, to relate to the market dynamics, basically what we’re seeing is, first of all, we just had market research come back and that 85% of doctors see all the subqs as being the same, so commoditized. But what we’re seeing in the marketplace is from new to brand share perspective, Lilly and Aimovig have about 40% share and AJOVY about 20%, but it’s hard to assess AJOVY because of its Q3 administration. As it relates to access, we are not hearing a lot of noise on access, the PBMs are making them choose between two of the three, but as it relates to the ability of patients to get access to the product, we haven’t been hearing a lot of noise on that. In fact on the pricing situation, Brian, that has really seemed to have quieted down, so I don’t have a lot more insight on what the net discounts are occurring now, except for the ones that we discussed on the last earnings call, which was around 40%.
And then finally on expansion, this market is totally untapped, right. It is about 14 million patients eligible before the launch of the anti-CGRP, about 27% of them are being treated. What we hear from clinicians is that people are coming back into the healthcare arena to actually get the product. In fact, you hear academics saying the wait times have gone from four months to six months, where private offices are adapting more quickly by adding more nurse practitioners to meet the additional demand. So overall, this marketplace is shaping up very well.
Brian Abrahams — RBC Capital Markets — Analyst
That’s really helpful. And then maybe just shifting from the US dynamics to Europe. Just curious, your latest go-forward plan for Europe, how the dynamics, commercial requirements, and pricing may be a difference there versus the US? And is there any timetable for filing your application there or would that be something that would await a potential partnership? Thanks.
Robert Azelby — Chief Executive Officer
Sure. So, number one, as we’ve said in the past, Brian, is we’re open to an ex-US partner to help take epti around the globe. And obviously, when we look at the epidemiology, the disease afflicts as many people over in Europe as it does in the US, so it’s non-discriminatory as it relates to the impact on patients. And we were pleased with the uptake the Board has released the other day, about $24 million worth of sales in the second quarter and it hasn’t been on the market that long. And so, the uptake there is has been quite good. And then finally, to your question about us filing at the EMA. We were very, very active in terms of making sure, we’re repackaging our BLA in terms of the needs required by the European agencies. So, we’re active on that, but we haven’t given the timetable on that, but we continue to progress it. And the reason we don’t give a timetable on it is the BLA in the US is still our priority. So, we’re actively engaged with the FDA. But we’re very, very active on that end of the spectrum.
Brian Abrahams — RBC Capital Markets — Analyst
Thanks so much, Bob.
Operator
Thank you. And our next question comes from Jessica Fye from JP Morgan. Your line is now open.
Yuko Oku — JP Morgan — Analyst
Hi, this is Yuko on the call for Jessica. Thank you for taking our questions. Regarding epti in the acute setting, how big would you anticipate that study starting in the second half will be? And would you walk us through how we should think about the commercial opportunity in that setting?
Robert Azelby — Chief Executive Officer
Sure. So, we haven’t provided any guidance on the size of the study as of yet. And the reason why is we’re going with the FDA. We’re going to speak to the FDA to make sure we’re aligned on the outcomes because this is slightly different. We’re taking an opportunity to treat acutely in the prevention marketplace. So, we want to make sure that we’re aligned with the FDA on what that structure of the study would look like. So, stay tuned for that. But we do still anticipate initiating that study at the back end of 2019. As relates to the commercial opportunity, just to be clear, the biggest opportunity we see is to treat and prevent opportunity in the prevention marketplace. So, the same marketplace we hope to launch in February of next year.
But what we hear from clinicians is that if you had both a treat and prevent in your label, we get a substantial uptick in market share. Because that’s clearly differentiated and here’s why. If you are a chronic migraine patient, you’re suffering greater than 15 headache or migraine days a month. That means that on every other day you go to see your clinician, you’re suffering from symptoms of the migraine. And if you assume each migraine is between 4 hours and 72 hours, you will be suffering at a much greater percentage of the symptom of the migraine.
And so, when these chronic migraine patients come in, they’re looking for relief. And when the doctor says you have a prevention therapy that could not only prevent migraines over the next three months but also treat that patient in the chair within a couple of hours, that gives you a much greater opportunity in terms of brand choice. That is the largest commercial opportunity of the elements. We do think there’s an opportunity in the ER, which we have more work to do and then there is an opportunity with patient suffering between one and three migraines a month. But the vast majority of the commercial opportunity is in the prevention marketplace in terms of clinical differentiation and branch here.
Yuko Oku — JP Morgan — Analyst
Okay. Thank you.
Operator
Thank you. And our next question comes from Paul Matteis from Stifel. Your line is now open.
Alex Puthumana — Stifel — Analyst
Hi. This is Alex on for Paul. Just a couple of quick questions here. First one on epti, given the trend in the other CGRP launches, do you expect sampling to be a major part of your launch and how would that work with an IV?
Robert Azelby — Chief Executive Officer
So, obviously, when we step back, we get that question as a fair bit. Nadia, you can feel free to jump in here as well. First of all, we’re very grateful for the work that the Amgen team did, the Lilly team did and AJOVY team did in terms of giving out all those free products over the first year. That allowed for over 700,000 new RXs 386,000 new to brand patients, and over 30,000 docs or approximately 30,000 docs writing the product. And that has kind of really set the tone in the marketplace in terms of setting up payer coverage. So, for us when we come to the marketplace, we don’t anticipate doing a product program as large as that and we think that the payers are now accustomed to the anti-CGRPs. The fact that we’re a medical benefit product will fit into the standard processes as we move forward. So obviously, we’ll have some samples, but it wouldn’t be a program like you see with all that free product over a year, but we’re still working through what is used and how we’ll do that as we get closer to the launch. Nadia, anything there?
Nadia Dac — Chief Commercial Officer
The only thing I’ll add is also the other piece that we look at is to make sure that patients aren’t overburdened with out of pocket costs and of course, we’re looking at programs to make sure that we help them with those out of pocket costs. That’s separate from samples altogether and something that you’re seeing in the market as well.
Alex Puthumana — Stifel — Analyst
All right, that’s helpful. And then quickly on 1910, can you talk a little bit about — sorry, on the, what was that other trial? On the pay cap study. How do you expect that to be going?
Robert Azelby — Chief Executive Officer
Yes, sure. So, it is ALD1910, so you’re correct. We’ve executed the preclinical work here. We’re just dotting the i’s and crossing some t’s, and we expect to be first in human here in the second half of 2019. We’re very, very optimistic. The preclinical data and the animal data looks really, really exciting. However, we now have to put it in humans and see the outcome. But keep in mind, we view this as a big commercial opportunity and we’re really excited by the eptinezumab and we get about 60% of patients to a 50% response, but that means 40% of patients still need new therapies. And so, the marketplace for ALD1910, if we’re successful, is quite large.
Alex Puthumana — Stifel — Analyst
Great. Thanks.
Operator
Thank you. And our next question comes from Charles Duncan from Cantor Fitzgerald. Your line is now open.
Charles C Duncan — Cantor Fitzgerald — Managing Director
Hi, Bob and team. Congrats on the progress in the quarter and thanks for the granularity on the account characterization. That’s helpful. I was wondering if you could just provide a little bit more color? I think you mentioned in your prepared remarks that you kind of projected possibility of epti garnering call it 20% to 30% of the CGRP prevention market. And 20% in a market of call it four products is not as impressive as 30%, although both would be nice to have. And I guess I’m wondering what are the key swing factors that you see in getting 20% to 30%? Do you feel like you need that treat and prevent label to get to the 30% or would that be upside to that estimate?
Robert Azelby — Chief Executive Officer
So, first of all, Charles, let me just clarify. When we say 20% to 30% that’s the market research that we’re getting back. We haven’t expounded on what share we think we’re going to get. We’re working through that as we speak. So, that’s from the market research. To your second question on would the acute study be an uplift to that 20% to 30% share? It would be, right. So, it’s not included in that 20% to 30% share. And then lastly, I’m just going to go to the point that Nadia made today that 2,000 accounts represent 80% of the anti-CGRP prescription. If we just go down because we’ve done account profiling on the top 500, right, 80% of them have infusion capabilities in-house, 2/3 are private offices, they are big Botox users. 80% of them write Botox.
What we also see is that the Botox sales are not declining and when we ask those physicians why they say, hey, we like the quarterly treatment. We like to have the procedure in our hands. We like the fact that it’s procedure-oriented and it adds economic value to our practice. So, it’s been very sticky on the chronic side. Eptinezumab, when it launches, we believe it’s going to be very attractive to those particular sites for all the same reasons, especially in the episodic migraine space where they’re actually writing prescriptions going out through CVS versus having it in their hand in the practice. So, we’re very, very optimistic about the uptake of epti, not only in those 500 accounts but going out of the 2,000 accounts that represent 80% of the business. And so more to come as we start getting into what we believe the share uptake will get from an organization versus what we tell you what the market research says.
Charles C Duncan — Cantor Fitzgerald — Managing Director
Okay. That’s helpful. I appreciate the added color. With regard to the sales experience that you’re getting in terms of the resumes you’re evaluating, it would seem to me that there is a major player that has recently had an acquisition bid. They sell this drug called Botox and I’m just kind of wondering if you see there being a real experience in neurology and specifically with headache specialists that are coming across your desk in terms of the resumes?
Robert Azelby — Chief Executive Officer
So, Charles, I’ll defer that to Nadia. We won’t comment on the particular company that you are speaking to, but Nadia, if you can share some thoughts on the type of resumes. But more importantly, the description of the candidate that we think best suits our needs?
Nadia Dac — Chief Commercial Officer
Yes, happy to. Thanks for the question. We’re being very selective with the type of sales leaders and representatives we’re bringing on. Buy and bill experience is critical for this group along with neurology and/or experience in specialty focus diseases, in addition to track records of success that really has to be in place. Our national account directors also have deep experience and relationships with key payers. So overall, I’m extremely encouraged and proud of the level of talent we’ve been able to attract and continue to attract to Alder. So, I wouldn’t say it’s from one competitor only, it really needs to be a talent that meets that kind of formula.
Charles C Duncan — Cantor Fitzgerald — Managing Director
Okay. That makes sense. The last question is, I know the US strategy is your focus, but just going back to an earlier question. If you consider the kind of information and how you’ve characterized the strategy here in the States, how does it compare to the ex-US markets? Are the account dynamics similar, infusion suites, etcetera?
Robert Azelby — Chief Executive Officer
So, Charles, you know what Erin is our Chief Operating Officer and leading all things operationally including our discussions ex-US. So, Erin why don’t you take that?
Erin Lavelle — Chief Operating Officer
Sure. I think we definitely see significant disease prevalence across the globe. In terms of account dynamics, each country really has a different dynamic. A lot of single-payer systems, a lot of different budget impacts across those countries. So, there is no simple answer when it comes to account dynamics. What I would say is that the epti profile is still very compelling to doctors across the globe. So, when we see the depth of response you see the 75% and 100% responder rates as well as the fast onset of prevention, all of those really carry a lot of weight in every market really.
Charles C Duncan — Cantor Fitzgerald — Managing Director
Does that suggest that when a partnership is signed, it could involve multiple players or multiple different partnerships depending on the geography?
Robert Azelby — Chief Executive Officer
Yes. Charles, well, we’ve said in the past, we’re looking for those that are a good strategic partner from a reputation perspective, with good relationships, and they have the ability to take epti globally. That would be great. So, if you could find one partner and all the other pieces of the deal played out that would be preferred to having two partners. But we’re not opposed to having two. It all depends on how all those pieces lineup.
Charles C Duncan — Cantor Fitzgerald — Managing Director
Thanks for taking my questions. I look forward to some news following in the near-term.
Robert Azelby — Chief Executive Officer
Thank you, Charles.
Operator
Thank you. And our next question comes from Jim Birchenough from Wells Fargo. Your line is now open.
Jim Birchenough — Wells Fargo — Managing Director
Hi, guys. Congrats on all the progress. A few questions. Just first on the payer side, could you maybe describe the formulary decision or the positioning within the formularies you’ll be seeking? Do you think you’ll have to displace an existing CGRP, displace Botox, or do you think there’ll be a distinct position for an IV CGRP under the medical benefit?
Robert Azelby — Chief Executive Officer
So, Jim in the conversation we’ve had today with payers, as Nadia said, we have an account team that’s just about to go out and hit the payers on an account-specific level. We will give more details on it. But we don’t see us being the second line to the currency GRPs at all. What we’ve been told by the payers is they like the depth of response, the speed of response. They like the compliance element. They love the fact that they only pay for the product when it’s actually infused into the patient. And based on the fact that it’s an IV and different mode of administration makes it very, very attractive. And they like to make different modes of administration available to the patient. So, we don’t anticipate us having to displace or being up in front. We think we’re going to fit right in with the current landscape with more to go.
Jim Birchenough — Wells Fargo — Managing Director
And would you expect on day one, if an account wants to purchase eptinezumab, they’ll be able to purchase it with the comfort that it will be reimbursed? I’m just trying to get a sense of whether there is some precedent on how quickly reimbursement will be in place and what you do to limit the account’s exposure to buying it and not having that certainty?
Robert Azelby — Chief Executive Officer
Sure, Jim. Yes, basically we will launch with a miscellaneous J-code and we’ll put all the programs similar that you would see in a medical benefit programs such as dating for the clinicians, product replacement for the clinicians if they’re told that it’s going to get reimbursement, it doesn’t. We’re going to have a help services hotline, help them walk through it. Miscellaneous codes used to be a real challenge back in the early part of 2000. So, the payers have gotten much better. It’s not like having a standard J-code which flows through the system, because it has to be pulled out. But overall, we don’t anticipate a huge delay and we expect to do nice wraparound services that you would see in any medical benefit launch products.
Jim Birchenough — Wells Fargo — Managing Director
And then just one final question, maybe just on capacity. If you think about the 500 centers or accounts that are trading 50% of the CGRP patients right now, do you have a sense of how many beds that is or what patient capacity there is? And I’m just wondering, this could be a big new product in their hands. Are you seeing any efforts right now to start expanding capacity?
Robert Azelby — Chief Executive Officer
So, what we don’t have yet, we’re still working through the account profiling to go account by account to understand how many IV chairs they actually have. So, more to come on that. But anecdotally there is not a meeting we go to, whether there is a private office, saying, hey we are going to add chairs and we’re going to build new IV capabilities and then in the academic centers, they talk about bringing in nurse practitioners and extenders to help manage the increased demand. So far, it’s all been very, very encouraging. Nadia?
Nadia Dac — Chief Commercial Officer
I just wanted to add a couple of things. So, the thing I think about is it’s a 30-minute quarterly IV. So, it’s simple. It’s not a bed or in the infusion center like you would think about for chemotherapy. So, when we do engage with physicians in these centers, they’re not looking at this as something that would be difficult, particularly those that already have infusion capabilities. We’re actually impressed with the numbers of physicians that are also inquiring whether they should be increasing their capacity and starting to infuse in their centers.
Jim Birchenough — Wells Fargo — Managing Director
Great. Thanks for taking the questions.
Operator
Thank you. And our next question comes from Evan Seigerman from Credit Suisse. Your line is now open.
Evan Seigerman — Credit Suisse — Analyst
Hi, all. Thanks for taking my questions and congrats on the progress. One quick question on the ongoing lawsuit between Amgen and Novartis regarding the manufacturing of epti. Do you foresee this as a potential risk to commercial supply? Then I have a follow-up question.
Robert Azelby — Chief Executive Officer
Sure. So, we don’t see that as a risk. As you know, we signed this agreement in December of 2018 and went live in January of ’19. That was after Amgen notified Novartis of the potential breach in their contractual terms. Sandoz does not have a clause for termination of convenience and more importantly, we’ve had a long-standing relationship with Sandoz. Our relationship, every day we work with them. They’re making a commercial product for us right now. We’re partnering in our engagement with the FDA and so I don’t lose an ounce of sleep on that particular item because our engagement has been so good with them and we understand the issues that are going on.
Evan Seigerman — Credit Suisse — Analyst
And then when you’re thinking about the commercialization of epti, do you envision that as a buy and bill situation for physicians or will the product be procured from say a specialty pharmacy and shipped to the physician’s office where they infuse it? I’m trying to understand some of the commercial dynamics and some of those nuances?
Robert Azelby — Chief Executive Officer
Sure. I think the way I would use an analog would be the way Botox is used today, right. There is a large percentage that buy and bills for the products. So, you go, acquire that product through specialty distribution, but then some clinicians who don’t want to take the risk for buy and bill, but they do like the procedure. So that would be dropped off through specialty pharmacy and so we anticipate that we’ll be using both specialty distribution and specialty pharmacy at the time of launch.
Evan Seigerman — Credit Suisse — Analyst
Okay. Great. Thanks for taking the questions. I appreciate it.
Operator
Thank you. And our next question comes from Marc Goodman from SVB Leerink. Your line is now open.
Rudy Li — SVB Leerink — Analyst
Hi. Thanks for taking the question. This is Rudy on the call for Marc. So, two quick questions for the acute study. I know you’re still discussing the trial with the FDA. Just wondering what will be the enrollment criteria to make sure that you’re enrolling the right patients who are the candidates for prevention therapy? And what kind of efficacy data should we expect for the acute treatment, especially for the onset of treatment effects as every infusion is here? Thanks.
Robert Azelby — Chief Executive Officer
So basically, for an acute study, the way we would recommend people doing, Paul jump in whenever you deem appropriate. A good analog would be the way Allergan and Biohaven have done their acute studies in terms of the patient populations. Now again, we still have to go and confirm this with the FDA. But if you were asking us today that would be more in the episodic round, maybe bleeding a little bit into the chronic round of people suffering between 4 and 12, let’s say, migraines per month. And so that’s what we’d be looking at. And then from an efficacy data perspective, the way the current oral CGRPs have gone after it is the standard FDA endpoint is relief of two-hour pain and two-hour most bothersome symptom. So, we’re engaging with the FDA on would that be the hurdles that we would have to jump over as well, knowing that we not only want to treat, but we want to prevent for the next 90 days? Paul, anything to add?
Dr. Paul Streck — Chief Medical Officer
No, Bob. I think you highlighted it very well. The only thing I would say is we want to ensure that we put forth a trial that is appropriate from a regulatory perspective to ensure that as we move forward with potential label update, with the new indication that it would check all the boxes that the regulators require related to a slightly expanded population from what they’ve seen in the acute space.
Rudy Li — SVB Leerink — Analyst
Great. Thanks. That’s very helpful.
Operator
Thank you. And our next question comes from Difei Yang from Mizuho. Your line is now open.
Alexander Lim — Mizuho — Managing Director
Hi. Good afternoon, guys. This is Alex on for Difei. I have a question on potential competition from oral CGRPs and specifically in the prevention setting. Do you think oral CGRPs will eventually compete directly with subq and potentially eptinezumab?
Robert Azelby — Chief Executive Officer
Yes. So, we get asked that question a lot, all the time. I think the verdict is still out, right. So when we sit here and say we’d like to see the 50%, 75% and 100% responder rates, what’s the rapidity or the speed of which that onset actually occurs in terms of prevention? Obviously, these folks are going to have to take a pill every day or maybe two times a day and so we’d like to see the persistence and compliance. And then a little bit on the safety side over a longer-term period rather than doing acutely, but doing it chronically. What does the adverse event profile look like? It is receptor-based. There is some noise that receptors and constipation. So overall, I think the verdict is still out and so we’re very encouraged by epti’s clinical profile in terms of the speed and the depth of response and we think we’ve set a very, very high bar.
Alexander Lim — Mizuho — Managing Director
Great. Thank you.
Operator
Thank you. And our next question comes from Matthew Luchini from BMO. Your line is now open.
Na Sun — BMO Capital Markets — Analyst
Hi, this is Na Sun on for Matthew. I have a question based on what we’re hearing most payers make patients choose between Botox or an anti-CGRP. And with physicians being more familiar and comfortable with the safety profile of Botox, do you anticipate anti-CGRPs to continue to mostly treat patients who are refractory to Botox? And if so, what are some strategies to overcome that hurdle? Thanks.
Robert Azelby — Chief Executive Officer
Yes. So, two comments there. I think the first comment, you got to realize is, Botox is only indicated in chronic migraine, right. So, they are on the far end of the spectrum, where the anti-CGRPs including eptinezumab, we expect to go from an episodic migraine all the way through chronic migraine. So, Botox is a smaller element. We estimate Botox having about 250,000 patients on the product. We already know that the anti-CGRPs and that’s after eight years or nine years now, the anti-CGRPs are approaching 400,000. So, we don’t think we’re going to be a niche there. As it relates to eptinezumab competing against Botox, we’re very encouraged by our profile in terms of the depth of response and the speed of response, especially against Botox in the chronic migraine space. So, we think we’re going to be quite well there.
And then the last point I would say to you and I think it was the first point you were making was they’re making them choose. The reason they’re making them choose is doctors because there is free subq CGRPs available. With Botox, many doctors were adding the anti-CGRPs on top of the Botox because it was free. But now payers when they’re saying the free product went away, the payers were saying, hey is no data in combination, you need to choose. So, I think there are slightly different topics that is going on now as it relates to why payers are doing that. It’s more of a cost perspective. Nadia?
Nadia Dac — Chief Commercial Officer
And just to add a little bit about that. Of course, the physician choice is critical in this. They are key decision-maker, but the patient’s choice is equally important, and the patient will be a part of that decision as well. What we hear very often from our patient market research is less frequent administration is something that’s very appealing to them. So, if they are on subq plus Botox, and they’re taking that monthly or if the orals are added in simple treatment regimens are something that could be very appealing to the patients.
Na Sun — BMO Capital Markets — Analyst
Thank you.
Operator
Thank you. And our next question comes from Jeff Hung from Morgan Stanley. Your line is now open.
Jeff Hung — Morgan Stanley — Analyst
Thanks for taking the questions. Can you remind us of any direct to patient initiatives you’re considering and how they might better educate patients on eptinezumab versus the other CGRPs?
Robert Azelby — Chief Executive Officer
Nadia, do you want to take that, what we’re thinking about from a direct patient perspective?
Nadia Dac — Chief Commercial Officer
Yeah, we haven’t necessarily talked about this previously, but of course, we’re in the process of analyzing and not only the HCP market, but as well as the patient market to understand what levers to press and what’s going to be most influential, let’s say, in terms of empowering the patient. But what we do know is that a seamless onboarding is critical for the patients when they start on epti. So, we are evaluating what’s the best service models to provide to those patients to make it simple, both on the provider as well as the patients. And we just finished extensive patient journey work to really understand the time of treatment decision, their experience on current treatments, and where are the places that we can communicate with those patients. So we’re not ready to say whether we’re going to do mass-market promotion, but you could assume that at launch we would have a focused effort similar to our healthcare provider efforts to make sure that we’re targeting the right patients, those that would prefer less frequent treatment options, that want to treatment in their physician’s hands, may not want to self-inject or actually are quite tired of having to do that at home, and want to be involved in their care with the physician as well.
Robert Azelby — Chief Executive Officer
And just to add, in the market research that’s been very, very consistent is the biggest driver and the biggest differentiator of eptinezumab is the speed and depth of response. And when we share that clinical profile with patients, they get excited by the fact that they may get prevention much earlier and get really, really deep response rates. And so, I don’t want to leave that piece off. The messaging will still be based around the speed and depth of response.
Nadia Dac — Chief Commercial Officer
Absolutely.
Jeff Hung — Morgan Stanley — Analyst
Okay. Great. And then can you remind us what’s needed to build out health services and any update on the progress toward that effort?
Nadia Dac — Chief Commercial Officer
So, we have our team as of this week in fact. The leadership team is on board and working on all of those aspects as well. So, we’ll have a partnership in place and to make certain that we have an approach to make the onboarding simple, but ongoing infusions as well. So, any kind of barriers that may be there that we can be addressing appropriately along the treatment journey.
Robert Azelby — Chief Executive Officer
And Jeff, the team we have is we’re tracking, we’re executing very well. We’ll be ready to go with all those services come the first quarter of 2020.
Jeff Hung — Morgan Stanley — Analyst
Okay. Great. And maybe one last one. Any advantages or challenges you faced in building out the sales force given prospective candidates familiarity with CGRPs? Like for those who have had experience with one of the other CGRPs any feedback you’ve heard from them that was surprising? Thanks.
Robert Azelby — Chief Executive Officer
Nothing that surprising, but I would say, we’re getting a lot of resumes and lot of knocks on the door, and we’re very pleased with the sales leadership people we put in place, not only from a sales perspective but also from a payer perspective. And so, we think the same dynamic is going to take place when we start to hire out the salesforce.
Jeff Hung — Morgan Stanley — Analyst
Thank you.
Operator
Thank you. And our next question comes from Carter Gold from UBS. Your line is now open.
Andrew McQuilling — UBS — Analyst
Hi, guys. This is Andrew in for Carter. Thanks for taking our questions. I have a couple. If I can just quickly ask another on your market research, it’s 20% to 30% CGRP share. Do you see this as more new patients, therefore expanding the broader class or stemming more from patient switch? And secondly, on your acute study — Yeah. Go with that first.
Robert Azelby — Chief Executive Officer
If we take the first one, right, 20% to 30% would be a combination. We do believe when we launch the product in the first quarter, there’s going to be a bolus of patients that had not done well on the other anti-CGRPs and they’re looking for the next opportunity. But that’s not going to be our focus. Our focus is going to be on new to CGRP therapies, just because of the clinical profile that we provide, not only for the patients, we think will be differentiated. But the feedback we’ve garnered from the clinicians, especially the 2,000 that we’re targeting, that they really like the epti clinical profile. So, we think we’re going to get more than our fair share of new patient starts as well.
Andrew McQuilling — UBS — Analyst
Got it. Understood. And secondly, on your acute study. I guess I wanted to understand the expected pace of enrollment for the study. Specifically, do you see challenges in keeping patients from treating their migraine at the onset with triptans, NSAIDs or the like instead of holding out so they could be treated at the center? I guess I just wanted to understand the dynamics there, particularly given the acute nature of the migraine.
Robert Azelby — Chief Executive Officer
So, I’ll let Paul go in the detail, but I will let you know, that’s a great question because we have to get someone with the migraine from their home into the account to get the infusion. Obviously, we did all that work through the feasibility work we did before we decided to move forward with the trial. But Paul, any other things to add?
Dr. Paul Streck — Chief Medical Officer
Yes, certainly. Bob, as you mentioned with the feasibility trial, we looked at the logistics of when does the patient begin to understand that they’re developing a migraine? How to appropriately move them into the clinic so we can infuse the CGRP and follow them over the course of the appropriate period to ensure that they’ve been relieved of migraine pain as well as most bothersome symptoms. So the short answer is, yes, we’ve evaluated the appropriate way to identify the migraine at its onset, move them, identify the centers that can get them there, appropriately evaluate them, and ensure that they are able to be returned to the home. So, all the logistics of that working through. So, we feel very good about that as we plan to get it off the ground by the end of the year.
Andrew McQuilling — UBS — Analyst
Got it. And one more if I could. I wanted to just get your thoughts on how you’re viewing BD at this juncture, specifically is their appetite to expand further into migraine or diversify into other neurological areas?
Robert Azelby — Chief Executive Officer
Can you repeat the question, I missed the first part of it? You broke up on me.
Andrew McQuilling — UBS — Analyst
I guess I was just trying to understand how you’re viewing BD at this moment, at this juncture? Is there any appetite to expand further into migraine or diversify into other neuro areas?
Robert Azelby — Chief Executive Officer
First of all, from a CGRP perspective, we think there may be many more indications to pursue and so we’re working through them. The acute was the one that came to the top when we did our lifecycle management discussions last fall. When we put that on the top of the list, right? So, we’re going to execute that, but they’re still other opportunities to expand epti into other particular indications that may be associated with CGRP, not only in headache types of diseases but other diseases as well. We’re also excited about pay cap and the different pathway that proposes and if there are other indications to pursue there. And then obviously, Erin, who leads our BD efforts, we’re always open to potentially find a good partnership. We will have our commercial footprint established. So, if we could ever find another product to put in the bag, we will be open to that as well, if all those particular elements fit together.
Andrew McQuilling — UBS — Analyst
Okay. Great. Thanks, guys. I appreciate the color.
Operator
Thank you. And our last question comes from Danielle Brill from Piper Jaffray. Your line is now open.
Nirav Shelat — Piper Jaffray — Analyst
Hey, everyone. Thanks for taking my questions. I just have a couple. This is Nirav on for Danielle, by the way. You mentioned you will have miscellaneous J-codes. I was wondering if you could elaborate on the process of actually getting one and how long it will take?
Robert Azelby — Chief Executive Officer
Sure. It’s in flux right now, but we’re going to stay with the old process because if the new process kicks in, we may get a permanent J-code quicker. But if we assume the old process, we’ll file for J-code in the fourth quarter of 2019. And as long as we get approved by March 30 of 2020, so in the first quarter of 2020, we would get a permanent J-code, January 1, 2021. That’s the process.
Nirav Shelat — Piper Jaffray — Analyst
Got it. Okay. Thanks. And the other question I had was the pay cap study. I was wondering and I’m not sure if someone’s already asked this. I had to hop on a little late, but have you decided between sub1 or IV for the pay cap study?
Robert Azelby — Chief Executive Officer
We have not. Both of those options are on the table for us. We want to see how this product operates in patients and so we still have time to make that decision. So, we haven’t decided on that yet.
Nirav Shelat — Piper Jaffray — Analyst
Got it. Thank you so much for the color.
Operator
Thank you. And this does conclude today’s question and answer session. Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude today’s program. You may all disconnect. Everyone, have a great day.
Duration: 58 minutes
Michael Horowicz — Stern, Investor Relations
Robert Azelby — Chief Executive Officer
Dr. Paul Streck — Chief Medical Officer
Nadia Dac — Chief Commercial Officer
Carlos Campoy — Chief Financial Officer
Erin Lavelle — Chief Operating Officer
Brian Abrahams — RBC Capital Markets — Analyst
Yuko Oku — JP Morgan — Analyst
Alex Puthumana — Stifel — Analyst
Charles C Duncan — Cantor Fitzgerald — Managing Director
Jim Birchenough — Wells Fargo — Managing Director
Evan Seigerman — Credit Suisse — Analyst
Rudy Li — SVB Leerink — Analyst
Alexander Lim — Mizuho — Managing Director
Na Sun — BMO Capital Markets — Analyst
Jeff Hung — Morgan Stanley — Analyst
Andrew McQuilling — UBS — Analyst

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